/ills ALVAREZ & MARSAL HEALTHCARE INDUSTRY GROUP Report of the Independent Consultative Expert (ICE) on Parkland Health & Hospital System Dallas, Texas February 2, 2012 Submitted To: Centers for Medicare and Medicaid Services and Parkland Health & Hospital System Submitted By: Alvarez & Marsal Healthcare Industry Group, LLC Columbia Square 555 Thirteenth Street, NW, 5th Floor West Washington, DC 20004 +1 202 729 2100 www.alvarezandmarsalxom At Table of Contents Introduction Conditions of Participation Cross Reference 1. Background on Systems Improvement Agreement (SIA) and Gap Analysis 1.1. 2011 CMS Surveys and System Improvement Agreement (SIA) Terms 1.2. Gap Analysis Project and Methodology for Conducting Study 2. Findings 2.1. Parkland Health & Hospital System - General History and Statistics 2.2. Organization, Governance and Leadership 2.3. Culture 2.4. Access and Throughput 2.5. Nursing/Provision of Care 2.6. Human Resources 2.7. "House Wide" Issues 2.7.1. Patient Safety/Patient Rights 2.7.2. Compliance with Law/Regulations 2.7.3. Medical Staff 2.7.4. Resident Supervision 2.7.5. Medication Management 2.7.6. Infection Control 2.7.7. 2.7.8. 2.7.9. Environment of Care Discharge Planning and Case Management Utilization Review 76 98 101 108 116 123 128 133 138 141 30 33 45 48 57 65 24 26 3 18 2.8. Quality Assessment / Performance Improvement (QAPI) 3. Departments / Unit Specific Findings 3.1. Emergency Department 3.2. Psychiatric Services / Psychiatric Emergency Department, Inpatient Unit and Ambulatory Services 3.3. Women Infants and Specialty Services (WISH) 3.5. Procedural Units 3.5.1. 3.5.3. Surgery and Perioperative Catherization Lab 143 174 188 3.4. Inpatient Units (including Medical/Surgical, Specialty and Intensive Care Units) 200 206 220 221 3.5.2. Endoscopy Confidential Section for investigation and review by quality assurance/improvement committees or designated agent(s). and Pursuant privileged. 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential A 3.6. Clinics 3.6.1. 3.6.2. Outpatient Specially Community Clinics including Schools, Juvenile and Jail 224 227 232 236 240 247 255 259 261 263 265 3.7. Physical Medicine and Rehabilitation 3.X. Shared Services 3.8.1. 3.8.2. 3.8.3. 3.8.4. 3.8.5. 3.8.6. 3.8.7. 3.9. HIM Pathology/Laboratory Services Pharmacy Radiology/Imaging Respiratory Services Pood and Nutrition Services Contracted/Outsourced Services Organ and Tissue & M Conclusion, Next Steps and Action Plan Submission Appendix Independent Consultative Expert (ICE) Members and Backgrounds Exhibits A. S y s t e m s Improvement Agreement (SI A ) B. Glossary o f Terms and Abbreviations C. Parkland Health & Hospital System Organizational Chart D. Parkland Health & Hospital System Location and Services 269 274 Confidential Section for investigation and review by quality assurance/improvement committees or designated agent(s). and Pursuant privileged. 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential "When is it that enables an institution to take in stride such a series of history jolting events'? Spirit? Dedication? Preparedness? Certainly alt are important, but the underlying factor is people. People whose education and training is sound. People whose judgment is calm and perceptive. People whose, actions are deliberate and definitive. Our pride, is not thai we were swtp/ up by the whirlwind of tragic history, but that when we were, we were not found wanting. " Memo to All Employees from C. Jack Price - Administrator. November 27, 1963 Introduction Parkland Health & Hospital System (Parkland or Hospital) is one of the nation's oldest and busiest "safety net" public hospitals, the nation's 20 th largest. Last year over 175,000 patients were seen in Parkland's emergency department. Parkland had over 40,000 inpatient admissions and performed 25,516 surgeries and procedures in the Hospital's 2011 fiscal year. Parkland operates the nation's second largest labor and delivery units. Last fiscal year, 12,391 babies came into the world at Parkland, an average of 34 per day. As a safety-net hospital, Parkland's doors are open to all comers. A majority of Parkland's patients qualify as indigent having no form of insurance and not being covered by Medicare or Medicaid. Many of Parkland's patients are not only indigent but homeless as well, many of them with multiple medical, behavioral, social and substance abuse issues. There are a large number of Parkland's patients who are undocumented immigrants. And as a county hospital, Parkland is a receiving facility for individuals taken into custody by the Dallas Police Department, the Dallas S h e r i f f s Department and other law enforcement agencies. Approximately 70% of patients brought to Parkland's psychiatric emergency department are brought by a law enforcement officer under an Apprehension by a Peace Officer Without Warrant (APPOW) or some other form of custody. Parkland is also challenged by federal, state and local health care funding for the uninsured and indigent, which limits the options for discharge care, with significantly few local resources available for nursing home care, skilled nursing care, home health care, hospice or substance abuse care for patients without insurance, who are indigent or who by law may not qualify for Medicare, Medicaid or other public assistance, such as undocumented immigrants Parkland has a storied past and fills a critical role in health care that goes beyond the borders of Dallas County and the State of Texas. Parkland's stated vision is an ambitious one: "By our actions, we will define the standards of excellence for public academic health systems. " But there is a wide chasm between that vision and the reality of care being delivered at Parkland today. Parkland Hospital Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. /lis Since 2008, Parkland has been under near constant surveillance and investigation by surveyors for the Texas Department of State Health Services (DSHS or the State) and the Centers for Medicare and Medicaid Services (CMS) for scores of patient complaints, injuries and deaths, many of which were extensively reported in the media. Following the reports of a psychiatric patient who died in February 2011 while in seclusion and two other psychiatric patient deaths, CMS and the State conducted a survey in May 2011 that resulted in a "Condition Level Deficiency" finding on patient rights. A full survey by CMS in July 2011 led CMS to make an "Immediate Jeopardy" finding by which CMS determined that the Hospital's emergency medical treatment procedures and infection control procedures constituted "immediate jeopardy" to patients. On a follow-up survey in August 2011, CMS found additional issues around nursing services and emergency services that led CMS to issue a termination notice, notifying Parkland that CMS would terminate the Hospital's Medicare participation by September 30, 2011. In order to forestall Medicare termination, Parkland entered into a Systems Improvement Agreement (SI A) with CMS on September 28, 2011. As part of the SIA, Parkland agreed to engage an "Independent Consultative Expert" (ICE) who would serve several functions. First, the ICE would survey all Hospital operations against the Medicare Conditions of Participation (CoP) regulations and issue a report on where the Hospital had "gaps" or failed to comply with a CoP. Second, the ICE would examine Parkland's Quality Assessment and Performance Improvement (QAPI) function and similarly determine whether Parkland's QAPI functions met Medicare standards. Third, the ICE would submit an "Action Plan" outlining the steps that Parkland would have to take in order to get back into compliance with all Medicare CoP. And finally, the ICE would be required to function as a "compliance officer" to notify Parkland's Board of Managers (BOM) and CMS when Parkland failed to meet the requirements of the Action Plan or failed to meet any Medicare CoP. On October 25, 2011 the Parkland Board of Managers voted to engage Alvarez & Marsal Healthcare Industry Group (A&M, ICE Team, we or our) to serve as the ICE and "compliance officer" under the SIA. Our selection was approved by CMS on November 1, 2011. A&M commenced its engagement and on-site work at Parkland on November 8, 2011. From that time until the completion of this r e p o r t - w h i c h constitutes the "Gap Analysis" period required under the SIA - A&M has had up to 17 professionals including hospital/healthcare operators, clinical personnel including nurses, a physician and a former Joint Commission surveyor on-site at Parkland surveying all areas of Hospital operations against the Medicare CoP. Our professionals had access to Hospital employees, physicians, and patients. We participated in dozens of Hospital committee meetings including meetings of the Board of Managers, senior leadership, medical staff, medical staff committees, infection control and quality committees, and the daily Hospital operations committee or "daily huddle," which we recommended that the Hospital institute in November. We also interviewed scores of administrators, physicians, employees and patients to assess Parkland's operations, patient care and service. The level of Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 4 access we have been given is significant and Parkland's Board of Managers and leadership have been committed to ensuring that we have access to everything we need to complete our work. Rarely has such a large health care organization been the subject of such intense regulatory scrutiny, along with management change, as Parkland has been over the past year. During this time of regulatory scrutiny, Parkland's governance and management has undergone significant changes. Five of the members of Parkland's seven-person Board of Managers are new to their positions as of February 2011. Several senior hospital administrators have resigned or retired in the past few months including: the chief operating officer, the head of human resources, the chief nursing officer and the chief executive officer. Other individuals in Hospital departments such as the Hospital's psychiatric emergency services department are new to their positions. In December, Parkland's Board of Managers appointed an interim Chief Executive Officer, Dr. Thomas Royer, who recently retired from a large not-for-profit health care system. A new chief nursing officer has also been recently hired. It is also rare for a Hospital to operate under a SIA. A SIA is typically the last measure - if CMS agrees to one - before CMS terminates a hospital from the Medicare participation. While Parkland's Board of Managers and much of the Hospital's management appear to recognize the gravity of the challenges facing the institution and the very real possibility of terminal regulatory action by CMS or DSHS, during our survey period we were struck by the number of Hospital employees, managers and physicians who did not seem to share that sense of urgency around Parkland's current state of intense regulatory oversight as we observed them in meetings and their daily work. Despite changes in senior leadership and a re-commitment of purpose by the Board of Managers, there remain major gaps throughout the Hospital in complying with Medicare conditions and standards. Our report details deficiencies in complying with Medicare's Conditions of Participation, including serious problems with: o o o o o o o o Timeliness and quality of patient care Patient rights and patient safety Safe patient "hand-offs" and continuity of patient care Role and organizational structure of nursing and nursing practice Case management and discharge planning Infection prevention and control Medication management Supervision of medical residents Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 5 o o o Emergency medical treatment, particularly psychiatric emergency treatment Quality Assessment and Performance Improvement (QAPI) functions Progressive discipline and accountability. These gaps were made evident daily by several significant or adverse patient events that occurred during our survey period, which are all further mentioned or detailed in our report: o Between September 1, 2011 and November 30, 2011 over 200 Parkland patients eloped or left against medical advice. One of those eloping patients was under "one-to-one" surveillance for suicidal ideation, yet managed to run into a busy street before being recovered. Several other patients were able to elope or leave without being properly clinically discharged (e.g., having ports and lines properly removed) or given proper discharge planning and instructions. o A patient presenting to the Emergency Department (ED) intake nurse and reporting suicidal thoughts, was sent unescorted to an open waiting area and was not escorted immediately for care or covered by a one-to-one sitter until care was available. The patient eloped after approximately 30 minutes of waiting. Following an intensive search and dispatch by the Parkland Police Department, the patient was ultimately recovered at home. o We identified several patients who were discharged with minimal and ineffective discharge instructions and assistance, including psychiatric emergency room patients who were discharged with bus-vouchers and instructions to "call 911" in the event of recurring reports of suicidal ideation. o A nursing home patient presenting to the ED, suffering from a traumatic brain injury (TBI), was left unattended in "soft restraints" (devices made of material that are designed to safely fit around the wrists, ankles, or chest of a patient to prevent excessive movement), in the ED, fell off of his chair and sustained possible head injuries. o We noted multiple instances of patients not receiving timely or proper intake, triage or a medical screening examination (MSE) in the ED. In one instance on a day shift, we observed a patient in the ED general waiting area seated in a waiting chair with an intravenous line in her arm and the IV bag being held by the companion who accompanied the patient to the hospital. The patient appeared to have a decreased level of consciousness, was moaning in pain and was incontinent of urine while the patient's companion attempted to contain the urine. The patient had arrived by ambulance but was sent to the general waiting area. The patient was unnoticed by the Intake Nurse until our surveyor arrived o An inpatient with cerebral palsy sustained facial injuries after being assaulted by a hospital visitor while the patient was seated in a wheelchair on a Hospital entrance deck near the ED. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 6 o At a Dallas County juvenile facility where Parkland runs a medical clinic, failure to follow procedures to secure medications led to a pharmacy breach where medication was stolen by juvenile inmates, ingested, and ultimately led to adverse reactions that required several of the juveniles to be transferred to the Parkland ED. o Safety errors in inpatient, procedural and specialty units may have led to or contributed to: significant burns to a patient due to mis-firing of the electrosurgical cautery device during surgery; the death of a patient from respiratory arrest based on a drug being administered to the patient by a nurse without a written or verbal order for the medication; cases of wrong site thorancentesis; and a transfusion error in the administration of a blood product for one patient intended for another patient. o "Crash carts" - carts stocked with emergency medical equipment, supplies, and drugs for use by medical personnel especially during efforts to resuscitate a patient experiencing cardiac arrest - were not properly monitored or stocked. o o Patient restraints were applied without proper documentation. Pain management medication was inappropriately administered in order to obtain patient sedation without necessary documentation. Any one of these events could have been deemed to be a "trigger event" so as to constitute a possible finding of "immediate jeopardy" by CMS, which would put the Hospital on a short track to immediate Medicare termination. Medicare defines "immediate jeopardy" to mean "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 CFR ?489.30. The grid below outlines the number of events at Parkland since November 8 th that potentially could have constituted a "trigger event." Although the existence of a trigger event does not in itself cause the hospital to be found to be putting patients in "immediate jeopardy," the number of events that could qualify as a trigger event is in itself extremely troubling. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 7 Triggers to findings of "Immediate Jeopardy" Under Medicare CoP Text in Red Indicates a Reported Event at P a r k l a n d Serving as a Potential Trigger Issue A. Failure to protect from abuse Trigger Events 1. Serious injuries such as head trauma or fractures; 2. Non-consensual sexual interactions; e.g., sexual harassment, sexual coercion or sexual assault; 3. 4. Unexplained serious injuries that have not been investigated; Staff striking or roughly handling an individual; 5. Staff yelling, swearing, gesturing or calling an individual derogatory names; or 6. Bruises around the breast or genital area; or suspicious injuries; e.g., black eyes, rope marks, cigarette burns, unexplained bruising. Actual Parkland Events Patient with traumatic brain injury (TBI) in Emergency Department, left unattended while in "soft restraints" and falls off chair. Allegation of patient in Psychiatric Emergency Room being placed in "choke hold." Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 8 Ais Issue B. Failure to Prevent Neglcct 1. Trigger Events Lack of timely assessment of individuals after injury; Lack of supervision for individual with known special needs: 3. 4. Failure to carry out doctor's orders; Repeated occurrences such as falls which place the individual al risk of harm without intervention: 5. Access to chemical and physical hazards by individuals who are at risk; 6. Access to hot water of sufficient temperature to cause tissue injury; 7. Non-functioning call system without compensatory measures; 8. Unsupervised smoking by an individual with a known safety risk; 9. Lack of supervision of cognitive ly impaired individuals with known elopement risk: 10 Failure to adequately monitor individuals with known severe self-injurious behavior; 11. 1. Actual Parkland Events TBI patient in soft restraints left unattended. 2. ED patient reporting "suicidal thoughts" left unattended and elopes. 3. Psychiatric ED patient under 1:1 observation ingests hand sanitizer. 4. Psychiatric ED patient treated for "suicidal ideation" discharged with instructions to "Call 911." 5. Inpatient with suicidal ideations under 1:1 observation elopes. 6. Persons presenting to ED not identified by ED intake nurses. 7. Inappropriately documented medical restraints. 8. Pain medications utilized for "moderate sedation." 9. Medication provided by nurse without physician order. 10. Inappropriate placement and use of feeding tube. 11 Inpatient in wheelchair on ED entrance deck assaulted by visitor. i Failure to adequately monitor and intervene for serious medic-al/surgicaI conditions? 12. Use of chemical/physical restraints without adequate monitoring; 13. Lack of security to prevent abduction of infants; 14. Improper feeding/positioning of individual with known aspiration risk; or 15. Inadequate supervision to prevent physical altercations. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 9 A i ? I M Trigger Events C. Failure to protcct from psychological harm A pp 1 ication o f chern ica l/ph vs ica I restraints without clinical indications: Presence of behaviors by staff such as threatening or demeaning, resulting in displays of fear, unwillingness to communicate, and recent or sudden changes in behavior by individuals; or Lack of intervention to prevent individuals from creating an environment of fear. D. Failure to Actual Parkland Events 1. Inappropriately documented medical restraints. 2. Pain medications utilized for "moderate sedation." 1. Administration of medication to an individual with a known history of allergic reaction to that medication; 2. Lack of monitoring and identification of potential serious drug interaction, side effects, and adverse reactions: 3. Administration of contra indicated medications; 4. Pattern of repeated medication errors without iintervention: 5. Lack of diabetic monitoring resulting or likely to result in serious hypoglycemic or hyperglycemic reaction; or 6. Lack of timely and appropriate monitoring required for drug titration. Pain medications utilized for "moderate sedation." Medication provided by nurse without physician order. protect from undue adverse medication consequences and/or failure to provide medications as prescribed E. Failure to provide adequate nutrition and hydration to support and maintain health Food supply inadequate to meet the nutritional needs of the individual; Failure to provide adequate nutrition and hydration resulting in malnutrition; e.g., severe weight loss, abnormal laboratory values; Withholding nutrition and hydration without advance directive; or Lack of potable water supply. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. Issue F. Failure to protect from widespread nosocomial infections; e.g., failure lo practice standard precautions, failure to maintain sterile techniques during invasive procedures and/or failure to identify and treat nosocomial infections G. Failure to correctly identify individuals Trigger Events 1. Pervasive improper handling of body fluids or substances from an individual with an infectious disease; 2. High number of infections or contagious diseases without appropriate reporting, intervention and care; 3. Pattern of ineffective infection control precautions; or 4. High number of nosocomial infections caused by cross contamination from staff and/or equipment/supplies. Actual Parkland Events 1. Failure to follow hand hygiene protocols; dirty patient rooms; inappropriate "terminal cleaning" procedures. 1. Blood products given to wrong individual; 2. Surgical procedure/treatment performed on wrong individual or wrong body part; 3. Administration of medication or treatments to wrong individual; or 4. Discharge of an infant to the wrong individual. 1. Administration of blood product on a patient intended for another patient. 2. Wrong site surgery. 3. Administration of imaging procedure to wrong patient. H. Failure to safely administer blood products and safely monitor organ transplantatio n 1. Improper storage of blood products; 2. High number of serious blood reactions; 3. Incorrect cross match and utilization of blood products or transplantation organs; or 4. Lack of monitoring for reactions during transfusions. 1. Administration of blood product on a patient intended for another patient. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. Issue of " J J T Failure to provide safety from fire, smoke and environment hazards and/or failure to educate staff in handling emergency situations Trigger Events 1. Nonfunctioning or lack of emergency equipment and/or power source; 2. Smoking in high risk areas; 3. Incidents such as electrical shock, fires; 4. Ungrounded/unsafe electrical equipment; 5. Widespread lack of knowledge of emergency procedures by staff; 6. Widespread infestation by insects/rodents; 7. Lack of functioning ventilation, heating or cooling system placing individuals at risk; 8. Use of non-approved space heaters, such as kerosene, electrical, in resident or patient areas; 9. Improper handling/disposal of hazardous materials, chemicals and waste; 10. 1 i. 12. 13. Locking exit doors in a manner that Obstructed hallways and exits Lack of maintenance of fire or life Unsafe dietary practices resulting in does not comply with NFPA 101 ; preventing egress: safety systems; or high potential for food borne illnesses. Actual Parkland Events Hallways obstructed with equipment and cleaning carts. A A & M Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 12 J. Failure to provide initial medical screening, stabilization of emergency medical conditions and safe transfer for individuals and women in active labor seeking emergency treatment (Emergency Medical Treatment and Active Labor Act) 1. Individuals turned away from ER without medical screening exam; 2. Women with contractions not medically screened for status of labor; 3. Absence of ER and OB medical screening records; 4. Failure to stabilize emergency medical condition; or 5. Failure to appropriately transfer an individual with an unstabilized emergency medical condition. Considering that Parkland knows it has been under intense scrutiny by the State, CMS and the ICE for the past few months, the number of negative patient events that have occurred just since November 8, 201 1 is surprising. The frequency and number of these potential trigger events suggest that self-corrective actions taken by the Hospital in response to the CMS surveys this summer have not been effective in creating a safer care environment. As these events have occurred, we have asked ourselves and have asked Parkland's Board of Managers and senior leaders: "Why do these events, which potentially jeopardize patients, continue to occur?" Some contend these events are due to the continuing crush of high and largely unscheduled patient volumes. Others suggest it is due to the fact that a large part of the Hospital's patient population suffers from a myriad of other social-economic conditions: homelessness, substance abuse, long-term mental health issues, lack of family, financial and other social support. Others suggest that the problem is funding: not having enough financial resources to provide enough staff and adequate space to care for a challenging patient population. Some suggest it is a result of the academic medical mission, which may put training and teaching of new doctors above a safe patient experience or where supervision of residents is lacking. Others suggest Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 13 patient eare is compromised because proper nursing staff cannot be recruited or because the role of nursing practice has been marginalized and nurse management itself is weak or non-existent. Others suggest that the patient care failures are the result of broken processes, poor or nonexistent underlying operational structures Still others suggest that problems persist because of a "culture" at the Hospital that does not hold anyone accountable for failure, or worse is "desensitized" or "numb" to the challenging patient population and the series of adverse care events. And others - particularly members of the news media - simply blame management at all levels, starting at the Board of Managers, to the CEO and senior leaders to department leaders, for failing to lead, manage and hold people accountable. Our assessment is that all of these factors may contribute in some way to the continuing failures in patient care. Organizational culture plays a part. Leadership plays a part. Accountability plays a part. A challenging patient population, with critical gaps in funding and lack of a continuum of care for all patients also plays a part. But perhaps fundamentally, all problems begin - and all solutions start - with people. When people think of a hospital they often think of buildings, bricks, mortar and expensive equipment. Indeed, Parkland's future is largely being pinned to the public hopes arising from a new billion dollar hospital that is making its way up from the ground across the street from the hospital building opened nearly 60 years ago. But hospitals are not simply buildings, bricks and mortar. Fundamentally, hospitals are people: nurses, doctors, doctors-in-training, technicians, care assistants, social workers, cleaning staff, billing and office clerks, administrators and board members. In the end, health care is only as good as the people who deliver the care. Health care delivery becomes more complicated year after year. N e w technologies offer the promise of cure or life extension but all create complexity. A single break in a complex care delivery chain can result in devastating, if not catastrophic, results for a patient. Parkland has many good and caring people. We encountered them every day as we made our rounds through the hospital, attended meetings and interviewed patients. We saw them perform complicated surgeries, care for patients and offer words of tender encouragement. But Parkland also has employees and staff who do not at all times exhibit those traits that are desired when a loved one is in their care: ED intake nurses oblivious to a patient with an IV in distress in the waiting room or a young child and mother prone under a water fountain in the ED waiting area; a labor and delivery employee inattentive to a patient on the unit while she curled her hair at her desk; a resident physician inattentive to a patient in distress while he finished his lunch; a housekeeper who leaves for a lunch break, mid-way between sanitizing a room, leaving a patient in a bed in a hallway for several hours; two resident physicians indifferent to patient privacy and Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. a sterile environment taking cell phone photos of a patient in surgery; and a nurse dispensing strong narcotics to a patient without any written or verbal orders from a physician to do so. Our report focuses upon the "gap" between the Medicare standard or "Condition of Participation" (CoP) and the Hospital's current or actual practice against that standard. Although some view the Medicare CoP as "technical" instructions and believe that quality patient care can be delivered without following the letter of the CoP, Medicare CoP must be viewed as the minimum standard for safe, effective and quality patient care. If the Medicare CoP are met, by definition, the hospital is providing safe, effective and quality patient care. Hospitals are governed by nearly 100 separate requirements in the Medicare CoP. Our survey found that Parkland failed or had deficiencies in more than half of those requirements or standards. While some of these deficiencies might be considered lesser or technical deficiencies, several deficiencies were significant, many of them directly relating to a safe environment for patients. Significant deficiencies were found in the following Conditions of Participation sections: o 42 CFR ? 482.13 - Patient Rights o o o o o o o o o o o o 42 CFR ? 482.13(c) - Privacy and Safety 42 CFR ? 482.13(e) - Restraint or Seclusion 42 CFR ? 482.21 - Quality Assessment and Performance Improvement Programs 42 CFR ? 482.13.22 - Medical Staff o (Conduct of Ongoing Professional Practice Evaluation (OPPE)) 42 CFR ? 482.23 - Nursing Services 42 CFR ? 482.25 - Pharmaceutical Services 42 CFR ? 482.30 - Utilization Review 42 CFR ? 482.41 - Physical Environment 42 CFR ? 482.42 - Infection Control 42 CFR ? 482.43 - Discharge Planning 42 CFR ? 482.55 - Emergency Services 42 CFR ? 489.20 - Emergency Medical Treatment and Active Labor Act (EMTALA) Deficiencies were also noted in the following Conditions of Participation sections: o o o o o o 42 CFR ? 482.12 - Governing Body 42 CFR ? 482.26 - Radiologic Services 42 CFR ? 482.27 - Laboratory Services 42 CFR ? 482.51 - Surgical Services 42 CFR ? 482.54 - Outpatient Services 42 CFR ? 482.56 - Rehabilitation Services Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. o 42 CFR ? 482.57 - Respiratory Care Services The number of deficiencies found during our survey leads to an overall concern about the safety of the care environment at Parkland. If the deficiencies catalogued in this report are not addressed and remedied, Parkland could not pass a CMS hospital survey and would not continue as a Medicare participating hospital. More importantly, if deficiencies in care and safety are not addressed in a timely and effective manner, trigger events that could harm patients will inevitably occur. Over the course of our survey we kept Parkland management apprised of our survey findings. We initiated 18 debrief meetings during which we provided preliminary survey findings along with the Medicare CoP in question or violation for individual departments. Our report notes some of those actions actually taken by or being taken by the Hospital to address CoP deficiencies that we identified. While we are hopeful that other proposed, but not yet implemented actions, will actually be taken, succced and be sustainable, unless specifically noted in our report we have not validated that actions proposed have actually addressed or repaired a deficiency with sustainable results. The proof of the effectiveness of any corrective action should be a corresponding decline in the number of adverse events with actual - or only barely averted - patient harm. While we were surprised by the number of deficiencies we identified, we were encouraged by the manner in which several department/unit managers and Hospital leaders worked to address our findings and to begin to resolve those deficiencies. The Chief of Hospital Operations has been particularly and positively engaged in personally working to effect change and improvement in the very challenging psychiatric services departments. Our Gap Analysis will be followed up by a separate "Action Plan" in which we specifically outline those concrete steps that we believe the Hospital should take to address all of the Medicare CoP deficiencies, and more importantly, to create sustainable change and an environment for safe, effective and quality patient care. Parkland Hospital is a unique medical institution that can, as its own "vision" suggests, be a standard-bearer for quality and service among public, safety-net hospitals. Parkland's 100 yearplus history is filled with many notable accomplishments that came long before and continued long after those dark, November days in 1963 when Parkland's name was broadcast around the world. While knowledge among physicians of the famous "Parkland Formula" for burn treatment is probably now universal, few people also recall that Parkland was the second hospital that the federal government enrolled as a Medicare provider hospital soon after the program commenced in 1965. But at this point in its history, Parkland faces regulatory, safety and patient care deficiencies in nearly every aspect of its organization and delivery system. These deficiencies did not arise Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 16 overnight and will not be remedied in a day. Addressing all of the deficiencies noted in this report will require fundamental restructuring of Hospital organization, leadership, policy and procedure, process and work flow, and metrics for monitoring performance and compliance. Doing all of this successfully and doing all of this quickly will be a heroic challenge. But if there is an unyielding sense of urgency and determination by every member of the Parkland team, these challenges can be met and Parkland can again become a place for safe and effective care for all of its patients. Ultimately, the fate of Parkland and its success under the Systems Improvement Agreement will not be decided by regulators or consultants. The people of Parkland - the nurses, doctors, administrators, board members and every staff member - will determine the fate and future of Parkland, be that success or failure. "Parkland is a hospital where the struggle between life and death, disease and health is our bread and meat. Rarely a 24-hour period passes that doesn 7 bring to our door someone with a story of tragedy, suffering, injustice or violence. To each of these we offer an outstretched hand - sometimes to cure, often to relieve and always to comfort" Rev. Kenneth Pepper, Parkland Hospital Chaplain, November 25, 1963 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 USC 11101 et. seq., this information is confidential and privileged. \1 /?h M Im Medicare Conditions of Participation Cross Reference Reference Sections Conditions of Participation V&?'i^?ferl'i?.ia&yfco-.o ' > ?. ' o j * o ?itfofeVl? ti fi ?482.11 Condition of Participation: Compliance with Federal, State and Local Laws ?482.12 Condition of Participation: Governing Body ?482.12(a) Standard: Medical Staff. ?482.12(b) Standard: Chief Executive Officer ?482.12(c) Standard: Care of Patients ?482.12(d) Standard: Institutional Plan and Budget ?482.12(e) Standard: Contracted Services ?482.12(f) Standard: Emergency Services ?482.13 Condition of Participation: Patient's Rights ?482.13(a) Standard: Notice of Rights ?482.13(b) Standard: Exercise of Rights ?482.13(c) Standard: Privacy and Safety ?482.13(d) Standard: Confidentiality of Patient Records ?482.13(e) Standard: Restraint or seclusion. ?482.13(f) Standard: Restraint or seclusion: Staff training requirements. ?482.13(g) Standard: Death Reporting Requirements ?482.13(h) Standard: Patient visitation rights ?482.21 Condition of Participation: Quality Assessment and Performance Improvement Program ?482.21(a) Standard: Program Scope ?482.21(b) Standard: Program Data 2.5, 2.7.5, 2.7.6, 2.7.8, 3.2, 3.3, 3.4, 3.6.1, 3.6.2, 3.8.1, 3.8.2 2.6 2.2, 3.8.6, 3.8.7 2.2 2.7.1, 3.1, 3.2, 3.3 2.5, 2.7.1, 3.4 2.7.1, 3.1, 3.6.1, 3.8.1 2.7.1, 3.1, 3.5.1 3.5.1 2.5, 2.7.1, 3.1, 3.2, 3.4 2.2, 3.1 2.2, 2.7.3, 2.7.4, 3.2, 3.3, 3.8.3 2.2 2.2, 2.7.4 2.6, 3.3, 3.7 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. Conditions of Participation ?482.21(c) Standard: Program Activities ?482.21(d) Standard: Performance Improvement Projects ?482.21(e) Standard: Executive Responsibilities ?482.22 Condition of Participation: Medical staff ?482.22(a) Standard: Composition of the Medical Staff ?482.22(b) Standard: Medical Staff Organization and Accountability ?482.22(c) Standard: Medical Staff Bylaws ?482.22(d) Standard: Autopsies ?482.23 Condition of Participation: Nursing Services ?482.23(a) Standard: Organization ?482.23(b) Standard: Staffing and Delivery of Care Reference Sections 3.1, 3.2, 3.7, 3.8.3 3.8.1 2.7.3, 3.1 2.7.3 2.7.3, 3.8.1 2.7.1, 3.2, 3.3, 3.6.1 2.5, 3.2, 3.3, 3.6.1 2.5, 2.6, 2.75, 3.1, 3.2, 3.3, 3.4, 3.5.2, 3.6.1, 3.6.2, 3.7, 3.8.1 ?482.23(c) Standard: Preparation and Administration of Drugs ?482.24 Condition of Participation: Medical Record Services ?482.24(a) Standard: Organization and Staffing ?482.24(b) Standard: Form and Retention of Record ?482.24(c) Standard: Content of Record ?482.25 Condition of Participation: Pharmaceutical Services ?482.25(a) Standard: Pharmacy Management and Administration ?482.25(b) Standard: Delivery of Services 2.5, 2.7.2, 2.7.5, 3.3, 3.6.1, 3.8.3 3.1, 3.9 2.7.4, 3.1, 3.6.1 2.7.5, 3.5.1, 3.7, 3.8.3, 3.9 2.7.5 2.7.5, 3.3, 3.5.1, 3.8.2 2.7.5, 3.2, 3.5.1, 3.5.2, 3.6.2,3.8.2 Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 19 ?i Conditions of Participation ?482.26 Condition of Participation: Radiologic Services ?482.26(a) Standard: Radiologic Services ?482.26(b) Standard: Safety for Patients and Personnel ?482.26(c) Standard: Personnel ?482.26(d) Standard: Records ?482.27 Condition of Participation: Laboratory Services ?482.27(a) Standard: Adequacy of Laboratory Services ?482.27(b) Standard: Potentially Infectious Blood and Blood Components ?482.27(c) Standard: General blood safety issues ?482.28 Condition of Participation: Food and Dietetic Services ?482.28(a) Standard: Organization ?482.28(b) Standard: Diets ?482.30 Condition of Participation: Utilization Review ?482.30(a) Standard: Applicability ?482.30(b) Standard: Composition of Utilization Review Committee ?482.30(c) Standard: Scope and Frequency of Review ?482.30(d) Standard: Determination Regarding Admissions or Continued Stays ?482.30(e) Standard: Extended Stay Review ?482.30(f) Standard: Review of Professional Services 2.7.9 2.7.9 2.7.9 2.7.9, 3.7 2.7.9 3.8.3 3.8.3 Reference Sections Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 20 A* Conditions of Participation ? Aft ? f*-'?L ti ..."ssW--' c **iS ' ii->- i.i-R ?482.41 Condition of Participation: Physical Environment ?482.41(a) Standard: Buildings 1 : Reference Sections .' a o . e; -- ' 2.7.6, 3.1, 3.2, 3.3, 3.4, 3.5.1, 3.6.1, 3.6.2, 3.8.1, 3.8.3 2.7.1, 2.7.7, 3.1, 3.3, 3.4, 3.5.1, 3.5.3, 3.8.1, 3.8.3 X II M ?482.41(b) Standard: Life Safety from Fire ?482.41(c) Standard: Facilities ?482.42 Condition of Participation: Infection Control 2.7.7, 3.8.4 2.7.7, 3.1, 3.2, 3.8.1, 3.8.3 2.7.6, 2.7.7, 3.1, 3.2, 3.3, 3.4, 3.5.1, 3.5.3, 3.6.1, 3.6.2, 3.7, 3.8.1, 3.8.3, 3.8.5 ?482.42(a) Standard: Organization and Policies ?482.42(b) Standard: Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services ?482.43 Condition of Participation: Discharge Planning ?482.43(a) Standard: Identification of Patients in Need of Discharge Planning ?482.43(b) Standard: Discharge Planning Evaluation ?482.43(c) Standard: Discharge Plan ?482.43(d) Standard: Transfer or Referral ?482.43(e) Standard: Reassessment ?482.45 Condition of Participation: Organ, Tissue and Eye Procurement ?482.45(a) Standard: Organ Procurement Responsibilities ?482.45(b) Standard: Organ Transplantation Responsibilities 3.8.7 2.7.8, 3.7 2.7.8, 3.2, 3.7 3.2 Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 21 Conditions of Participation ?482.51 Condition of Participation: Surgical Services ?482.51(a) Standard: Organization and Staffing ?482.51(b) Standard: Delivery of Service ?482.52 Condition of Participation: Anesthesia Services ?482.52(a) Standard: Organization and Staffing ?482.52(c) Standard: State Exemption ?482.52(b) Standard: Delivery of Services ?482.53 Condition of Participation: Nuclear Medicine Services ?482.53(a) Standard: Organization and Staffing ?482.53(b) Standard: Delivery of Service ?482.53(c) Standard: Facilities ?482.53(d) Standard: Records ?482.54 Condition of Participation: Outpatient Services ?482.54(a) Standard: Organization ?482.54(b) Standard: Personnel ?482.55 Condition of Participation: Emergency Services ?482.55(a) Standard: Organization and Direction ?482.55(b) Standard: Personnel ?482.56 Condition of Participation: Rehabilitation Services ?482.56(a) Standard: Organization and Staffing Reference Sections 2.7.5 3.7 3.1 3.1 3.7 Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 22 Conditions of Participation ?482.56(b) Standard: Delivery of Services Reference Sections 3.7 ?482.57 Condition of Participation: Respiratory Care Services ?482.57(a) Standard: Organization and Staffing ?482.57(b) Standard: Delivery of Services ?489.20 E M I ALA Basic Section 1866 Commitments Relevant to Section 1867 Responsibilities ?489.20(1) ?489.20(m) ?489.20(q) ?489.20(r) ?489.24 Special Responsibilities of Medicare Hospitals in Emergency Cases ?489.24(a) Applicability of Provisions of this Section ?489.24(c) Use of Dedicated Emergency Department for Nonemergency Services ?489.24(d) Necessary Stabilizing treatment for Emergency Medical Conditions ?489.24(e) Restricting Transfer Until the Individual is Stabilized ?489.24(f) Recipient Hospital Responsibilities ?489.240) Availability of On-call Physicians 3.8.4 3.8.4 3.1 3.1 2.7.1, 3.1 Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 23 Section 1: Background on Systems Improvement Agreement (SIA) and Gap Analysis 1.1 CMS Surveys and Systems Improvement Agreement (SIA) Terms On September 28, 2011, a 19 month Systems Improvement Agreement (SIA) was put into place between The Centers for Medicare and Medicaid Services (CMS) and Dallas County Hospital District d/b/a Parkland Health and Hospital System (Parkland or Hospital) in order to promote consistent compliance with the Medicare Conditions of Participation (CoP) for Hospitals at 42 CFR ? ? 482.1 1 - 482.57 and all the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) at 42 CFR ? ? 489.20 and 489.24. CMS surveys on May 12, 2011, July 21,201 I, and August 31, 201 1 found non-compliance with various Medicare Conditions of Participation for Hospitals, which included five deficiencies that represented "immediate jeopardy" to patient health and safety. Due to the impact Parkland termination would have on the community, CMS afforded Parkland an additional opportunity to achieve and maintain compliance with the Medicare Conditions of Participation for Hospitals and EMTALA. Terms of the agreement are as follows: 1. Obtain Independent Consultative Expert (ICE) Review; 2. Acquire Expertise in the development and implementation of an effective Quality Assessment and Performance Improvement (QAPI) Program; and 3. Engage an Independent On-Site "compliance officer". The SIA requires that the Independent Consultative Expert Review be a comprehensive hospitalwide analysis of its current operations to industry accepted standards of practice to ensure compliance with all Medicare Conditions of Participation for Hospitals and EMTALA requirements related to timely provision of care. The review must contain recommendations for hospital-wide changes and improvements to ensure compliance with all Medicare Conditions of Participation for Hospitals and EMTALA. The review must provide assistance in implementing and evaluating such changes and improvement. The experts retained for the QAPI Program review must conduct an analysis of the current QAPI Program in terms of its ability to meet the requirement of 42 CFR ?482.21 for an effective, ongoing, hospital-wide, data driven program that is utlilized to develop performance improvement actvities and projects that improve timeliness and quality of care and safety of patients. The analysis will include evaluations of adequacy of the program's resources, the qualifications of staff, and levels of engagement of the governing body, administrative officials, and medical staff. In both the Independent Consultative Expert Review and analysis of the QAPI Program, a detailed written plan will be developed with recommendations and details of implementation Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. including milestones to lead to compliance of Medicare Conditions of Participation for Hospitals and EMTALA and to close gaps identified in the QAPI Program. For the duration of the S1A, the "compliance officer" will provide oversight and coordination of Parkland's compliance efforts in accordance with the reports and plans as required and provide feedback about Parkland's improvement and compliance of Medicare Conditions of Participation for Hospitals and EMTALA. The "compliance officer" will be working with the Chief Executive Officer, the Chief Medical Officer and Corporate Compliance Officer to coordinate the QAPI Program with accountability for specific goals and objectives. 11/8/2011 A & M On-Sitc 4/1/2012 First Monthly Update Report 2/1/2012 4/1/2013 Final M o n t h l y U p d a t e R e p o r t 9/30/2011 SIA Begins 4/1/2012-4/1/2013 M o n t h l y S t a t u s of I m p l e m e n t a t i o n Plan & Q A P I P r o g r a m to C M S A \ G A P S u b m i t t e d in F i n a l \ 9/28/2011 SIA Signed ))))!) V 2/10/2012 A c t i o n P l a n D u e to C M S 11/8/2011 -4/30/2013 Compliance Function A copy of the SIA is included in the Appendix as Exhibit A. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 25 M 1.2 GAP Analysis Projcct and Methodology for Conducting Study The Alvarez and Marsal Healthcare Industry Group, LLC (A&M) Independent Consultative Experts (ICE) Team has utilized diverse methods to systematically survey and analyze Parkland Health & Hospital System (Parkland or Hospital) during the comprehensive hospital-wide analysis as specified in the Systems Improvement Agreement (SIA) entered into with the Centers for Medicare and Medicaid Services on September 28, 2011. The independent assessment was conducted during the period November 8, 2011 through January 19, 2012. The A&M ICE Team was comprised of a leadership team and a core team of consultants (surveyors) augmented by subject matter expert consultants. While all campus and off-campus services and programs were included in the independent assessment/survey, there was specific emphasis on Emergency Services and Psychiatric Services as both were areas with significant and "immediate jeopardy" findings in the last CMS surveys. Multiple methods were utilized to indentify deficiencies and gaps in compliance, gain an understanding of the root causes of these deficiencies and gain knowledge of the organization in order to have an appropriate level of context on the environment, organization structure, culture, leadership, and governance as well as the breadth of services provided, the challenges faced by the organization and the communities served by Parkland. Interviews A&M personnel conducted interviews throughout the survey process that included physicians, nurses, mid-level providers, social workers, management, administration and technicians from most services and departments of Parkland. Interviews were also conducted with key leadership and faculty of the University of Texas Southwestern Medical Center (UTSW). With permission of the individual patient, A&M interviewed patients to solicit their perspective and experience on quality, safety and satisfaction with the care that was rendered. Onsitc Surveys and Observations Surveys were conducted of campus-based and ambulatory services for compliance with CMS Conditions of Participation. Areas were inspected and deficiencies were identified based upon specific Medicare Conditions of Participation for Hospitals at 42 CFR ? ? 482.11 - 482.57 and all the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) at 42 CFR ? ? 489.20 and 489.24. During the surveys, onsite observations were conducted to witness check-in, intake/triage, and registration processes; communication between care providers, care providers with patients, administrative and support personnel with patients, discharge instructions and discharge/check-out processes; and patient transfer and hand-off. Areas were surveyed for infection control, environment of care and patient safety conditions. A & Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 26 As Rounds In addition to onsite surveys and observations, rounds were made from the lens of both a surveyor and administrator on rounds including joining a pre-existing set of rounds (e.g., Facilities), or randomly selected units to observe existing conditions (environment of care, infection control) and patient care and safety. The Charge Nurse was made aware of our presence on the unit and participated in a brief, informal interview. Often information was requested for additional follow-up and analysis - e.g. recent admissions, procedures or discharges for Resident oversight review and appropriate level of documentation. Within certain procedural areas, consultants shadowed a staff member to observe a procedure (from start to finish) to evaluate the process, delivery of care, team interaction and compliance with safety and infection control. Attendance of Meetings and Committees As part of the structure of the work plan for the engagement, A&M attended regularly scheduled meetings to provide updates to Parkland leadership and other management and clinical leadership forums, the Parkland Board of Managers (BOM), and the Dallas County Commissioners. We also attended standing departmental, leadership and management, and committee meetings to observe meeting practices. Meetings were attended with key stakeholder groups including Medical Staff meetings and committees. The table below depicts recurring meetings and the frequency of each meeting. ' ; . -j Meeting Frequency Monthly - As scheduled and Ad Hoc Weekly Weekly Monthly Monthly Daily Monthly As scheduled Weekly Board of Managers Meeting Briefing call for Texas DSHS/ CMS Briefing for CMS Regional Office Chief Resident Meeting Chiefs of Clinical Services Meeting Daily Huddle Medical Staff Executive Committee Patient Care Review Committee (Peer Review) Patient Safety Meeting Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 27 Meeting Sfc Z&'HlHflHSm Quality & Compliance Committee of the Board of Managers Quality of Care Committee Root Cause Analysis Meeting Senior Clinical Meeting Senior Leadership Meeting Bi-monthly As scheduled Bi-weekly Weekly Frequency Monthly - As scheduled Chart Review Chart reviews were conducted on three different conditions: (a) random sampling for appropriate documentation, Resident oversight, and appropriate discharge plan; (b) to validate care provided when there was a suspected violation of a CoP; and (c) as part of a "root cause analysis" of an incident or event. Documents and Data A&M reviewed Parkland generated financial and operational data to supplement the survey and provide context. Documents reviewed include: policies and procedures, organizational charts, staffing models/grids, corrective action plans, performance improvement plans and documents, floor plans of physical plant and quality plans. Committee bylaws and minutes were also reviewed. Regularly produced reports such as patient safety reports, Daily Huddle follow up, census reports and others were reviewed as required. Reports and documents were reviewed for trends, omissions, compliance and context. Disclaimer on Parkland's Documents. Financial Statements, Business Records and Medical Records In preparing this report, A & M has relied upon the integrity of Parkland's financial statements, audited and unaudited, and other Parkland-generated records, reports and business records. A&M has relied upon the authenticity of documents and materials provided by Parkland to A&M and has not confirmed by independent audit or other procedure the accuracy of financial or operating data presented to us, including data in reports, committee minutes any such statements or materials. With respect to patient medical records reviewed, we have relied upon the authenticity of the medical records kept in the Hospital's Electronic Medical Record system. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. Initial Findings Meetings Meetings were held with key senior leadership, departmental management and physicians to discuss the initial findings of the survey, including deficiencies tagged to Conditions of Participation, and preliminary actions that might be achieved by local department management were presented. Follow-up surveys and observations were conducted to re-inspect conditions. The table below depicts all the initial findings meetings held with senior leadership, departmental managers and physicians. Debrief o House-Wide Issues Inpatient Units: Medical/Surgical Critical Care Emergency Services (ED, ESD) Psychiatric Services Women and Infant Specialty Services (WISH) Perioperative Services and Anesthesia Cardiac Catheterization Lab Community-Oriented Primary Care Clinics (COPC) Campus-Based Specialty Clinics Community-Oriented Primary Care Clinics (COPC) Medical Staff Quality, PI, Safety (QAPI) Utilization Review/Case Management Infection Prevention/Control Radiology Respiratory Therapy Physical Medicine and Rehabilitation Nutrition Services Pharmacy Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 29 Section 2: Findings 2.1 P a r k l a n d H e a l t h & H o s p i t a l S y s t e m - G e n e r a l H i s t o r y and S t a t i s t i c s Parkland Health & Hospital System (Parkland or Hospital) operates 968 licensed beds located at 5201 Harry Mines Boulevard in Dallas, Texas. As the hospital for the Dallas County Hospital District (d/b/a Parkland Health & Hospital System), Parkland serves as Dallas County's public hospital. It is funded in part by a specially designated property tax. Parkland is the 20 th largest hospital in the nation (by number of licensed beds 2010 '). Parkland also operates numerous outpatient clinics on campus and in the community, and also manages the health system for the Dallas County Jail, which is the 7th largest jail system in the nation . Parkland is the primary teaching hospital for the University of Texas Southwestern Medical Center (UTSW). Parkland has the nation's 4th largest residency training program, including the nation's largest Obstetrics & Gynecology residency training program'. Parkland's Labor & Delivery unit is the second largest in the U.S. (number of births annually). Parkland is designated as a Comprehensive Regional Level I Trauma Center and verified Regional Burn Center. The Parkland Formula (IV fluid resuscitation protocol) for burn patients, developed by Dr. Charles Baxter at Parkland Hospital at Southwestern University Medical Center in the 1960s, dramatically changed survival rates for severely burned patients, and is still the IV fluid treatment of choice in nearly every burn center in the United States today. Parkland operates ten Centers of Excellence 4 in the following specialties: o Trauma o Burns o Spinal Cord Injuries o Cancer o Endocrinology o Women & Infants o Epilepsy o Gastroenterology o Cardiology o Orthopedics From 2008 to 2010, Parkland's total operating revenues have increased $116M excluding premium revenue or 19.49%, primarily due to increases in Net Patient Service Revenue and Subsidies. During the same time period, operating expenses have increased $126M excluding claims or 13.03% due to increases in Salaries, Wages and Benefits, Pharmaceuticals and Supplies and Other. Overall inpatient volume for the same time period has remained flat, but emergency and outpatient visits have increased significantly during the same time period, with a 36.36% increase in emergency visits and a 8.58% increase in outpatient visits. This is primarily due to the addition of the Urgent Care Center in 2009. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 30 Below is the Parkland operating statement from 2008 to 2010 from its audited financial statements as of and for years ended September 30, 2010 and 2009. Fiscal Year End September 30 (Amounts in Thousands) Operating Revenue: N e t Patient S e r v i c e R e v e n u e D S H , U P L , and T r a u m a Tobacco Settlement Premiums O t h e r , net 385,442 180,672 17,518 386,002 13,233 Audited 2008 Audited 2009 % Change 2008 Audited 2010 % Change 2009 7.81% -0.18% 180,347 15,039 -14.15% 2.64% 396,211 7 2 , 4 7 8 447.71% 415,562 475,384 184,124 8,254 437,862 45,426 14.40% 2.09% -45.12% 10.51% -37.32% 6.61% Total Operating Revenue Operating Expenses: Salaries, W a g e s a n d B e n e f i t s Purchased Medical Supplies S u p p l i e s and O t h e r Pharmaceuticals Claims 982,867 1,079,637 9.85% " 1,151,050 558,068 110,333 211,006 85,664 301,832 622,490 109,080 221,020 87,844 346,057 11.54% -1.14% 4.75% 2.54% 14.65% 655,339 112,922 230,434 92,166 400,872 5.28% 3.52% 4.26% 4.92% 15.84% 7.59% 11.02% 24.70% 12.71% Total Operating Expenses EBIDA Depreciation and Amortization 1,266,903 (7.84,036) 3 6 7fi7 --1^386,491 (30^X54) 43,107 (349,961) 454.571 9.44%- 1,491,733 8.03%. 17.24% _ 9.09% 2.28% _ (340,683) SI 7 5 6 Total Operating lncome/(Loss) Non Operating Revenues* (320,803) 444,452 (394,439) 500.703 10.15% Capital C o n t r i b u t i o n s 3,976 3,437 Change in Net Assets Net Assets - Beginning of Year 127,625 726,422 108,047 854,047 -15.34% 106,264 962,094 -1.65% Net Assets - End of Year Patient Discharges ER Visits (includes UCC) OP Visits FTEs 854,047 41,474 130,020 973,391 8,263.35 962,094 41,364 147,197 983,820 8,509.66 12.65% -0.27% 13.21% 1.07% 2.98% 1,068,358 41,294 177,428 1,056,949 8,556.96 11.05% -0.17% 20.54% 7.43% 0.56% * Non Operating Revenues is compromised of Ad valorem tax support, Grants and Contributions, investment Income and Interest Expense. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 31 Parkland employs more than 8,500 people. Full Time Equivalents (FTEs) increased 4.4% from 2008 to 2011. Depicted below are the changes in FTEs by division from 2008 to 2011. JL ! Division 2008 Clinical Support Services CO PC EPO Facilities Jail Health Medical Affairs Medicine Services Nursing Administration Pathology PC HP Mgmt Services Pharmacy Radiology Surgical & Trauma Svcs Women & Infant Specialty Administrative Functions Grand Total *TES. 279.23 507.45 24.65 619.98 254.06 644.06 956.93 337.25 349.10 16.92 338.93 203.65 1,325.79 1,185.44 1,219.91 8,263.35 jv , .j 2011 295.15 490.30 25.05 593.85 302.26 690.12 1,017.04 383.41 348.14 14.71 371.67 211.44 1,377.03 1,177.40 1,329.71 8,627.27 2008 to 2011 % Change Variance 5.70% 15.92 (17.14) -3.38% 0.40 (26.13) 1.60% -4.21% 48.19 46.07 60.11 46.16 (0.96) (2.2!) 18.97% 7.15% 6.28% 13.69% -0.28% -13.05% 32.74 7.79 51.24 (8.04) 109.80 363.93 9.66% 3.82% 3.87% -0.68% 9.00% 4.40% 1 2 3 4 Beckers Hospital R e v i e w http://www.daIIasshcriffsorfice.com/ 2 0 1 0 - 2011 A C G M E Data R e s o u r c e Book Parklandhospital.com Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 32 2.2 Organization, Govcrnancc. and Leadership Medicare Conditions of Participation and Standards for Governing Bodies The Medicare Conditions of Participation require all hospitals to have an effective governing body legally responsible for the conduct of the hospital as an institution. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body. C >>iuiki.r 'if P:fffi.-ipat<<-.n: mh'.g Ikhly - ! 15 O.vOl.fli ?s p l..":.V.!0j Several standards are imposed by Medicare on governing boards and bodies such as ultimate oversight and regulation of the medical staff: o o o o o o Determining who can be a member of the medical staff, in accordance with state law; Appointing members of the medical staff who are recommended by existing medical staff members; Assuring that the hospital has medical staff bylaws, rules and regulations and approving those bylaws, rules and regulations; Ensuring that the medical staff is accountable to the governing body for the quality of care provided to patients; Ensuring the criteria for selection are individual character, competence, training, experience, and judgment; and Ensuring that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship or membership in a specialty body or society. ?<<$?.. I ?fax I) (?) Governing Board; Standard; Mcdrcai Maff \ iS.(>>&.t> I A- ffcP 2 M The hospital governing body is also responsible for appointing a chief executive officer (CEO) who is responsible for managing the hospital. i48!L"!(b; Gowniing lk>>ar) And, the governing body is also responsible for ensuring that the hospital complies with its obligations under the Emergency Medical Treatment and Labor Act (EMTALA), not only in a dedicated emergency department, but also in any off-campus departments of the hospital. For off-campus departments, the governing body must assure that the medical staff has written policies and procedures in effect with respect to the off-campus department(s) for appraisal of e m e r g e n c i e s a n d r e f e r r a l w h e n a p p r o p r i a t e . $48':.? ;.!(0( I ? services. LD.04.0?XM (BP 2) i ') G o \ e m ? % iUxly; SfetfRimtl Lmefgeney Parkland Board of Managers - Organization and Background Parkland Health & Hospital System (Parkland or Hospital) is the operating name of the Dallas County Hospital District. The Dallas County Hospital District is a political subdivision of the State ofTexas, that being Dallas County, Texas. In addition to operating a hospital, Parkland operates multiple Community Oriented Primary Care clinics throughout Dallas County, including clinics within the Dallas Independent School District. Parkland also manages the Jail Health Unit of the Dallas County Jail System, which includes five facilities and management of health services at four juvenile facilities. The Dallas County Hospital District is governed by a seven member Board of Managers, all of whom are appointed by the Dallas County Commissioners Court. The Commissioners Court approves Parkland's annual budget and the Commissioners Court is responsible for authorizing and approving any taxes levied in Dallas County to support Parkland. The Parkland Board of Managers (BOM) functions as the Hospital's Governing Body. Members of the BOM are appointed for two-year terms, or until a successor is nominated and approved by the Commissioners Court. Board members meet the fourth Tuesday of each month and do not receive compensation for their service. The BOM is responsible for governing policies and also has budgetary oversight for the Dallas County Hospital District. The BOM elects its own Chairman, Vice-Chairman and Secretary. The BOM Bylaws create several board committees including: Budget & Finance; Audit & Compliance; Strategic Planning; Human Resources; Joint Conference; Facilities; Information Systems; Legal Affairs; Quality of Care and Patient Safety; Behavioral Health; Contracts; and Legislative and Advocacy. In addition to hiring and evaluating the Chief Executive Officer (CEO), the BOM is also responsible for approving the hiring and evaluation of the Chief Compliance Officer, the Chief Audit Officer and the General Counsel. All three of those positions are currently filled by fulltime employees. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 34 Five of the seven current BOM members are relatively new to the BOM, having been appointed and taken office in February 201 I. These new members were thrust into roles that required critical and time-consuming involvement in hospital affairs during the period of intensive CMS and State oversight, surveys and investigations that occurred throughout 2011. From our interviews with BOM members it appears that during some of the initial CMS and State survey work they were not as informed as they should have been by senior management on CMS surveys and findings and that management did not initially share with the BOM critical information and documents regarding the CMS surveys. The BOM should be informed completely and immediately regarding all investigations and inquiries by state or federal regulatory bodies that involve allegations of patient harm that could adversely affect hospital licensure or participation in federal programs. The level of BOM briefing and involvement with CMS and State survey work and the SIA has increased dramatically since the summer of 201 I. During our survey period, the BOM has met on numerous occasions, both at regular and several specially called meetings, with the Hospital's senior leadership to be briefed on, understand and ask questions about CMS and State survey work, regulatory oversight and the Hospital's progress under the SIA. BOM members were intimately involved in the screening and selection of candidate firms to serve as the Independent Consultative Expert (ICE) under the SIA. During the period of our survey work, the BOM has met with the A&M Team on multiple occasions both with and without senior management present in order to hear candid reports from us regarding our work and preliminary findings. BOM members have been very engaged at all meetings that we participated in. Given the relatively compact size of the board at seven members, the BOM has an advantage over other hospital governing bodies in terms of scheduling meetings and having all members have the opportunity to contribute personally and effectively at meetings. We have found the BOM to be very engaged and appropriately concerned about Parkland's challenges with regard to patient care and corresponding regulatory oversight by CMS and Department of State Health Services (DSHS). The BOM has adopted several positive corporate governance reforms to demonstrate their independence including meeting in executive session, as necessary, without management to candidly discuss and appraise management's performance. The BOM has also retained independent legal counsel to advise them regularly on their fiduciary responsibilities under State law and Medicare CoP and the BOM Bylaws. During the period of our survey work, the BOM has also replaced the Hospital CEO, appointing Dr. Thomas Royer to serve as the Interim CEO. The BOM awarded Dr. Royer an initial contract through June 30, 2012. During our survey work we have spent significant time with Dr. Royer and other members of the senior leadership team both to apprise them of some of our preliminary findings and to understand the steps that management has taken or intends to take to address the CMS and State concerns, as well as our concerns as the ICE surveyor. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. Other senior positions have also changed since the SIA was signed including the ChiefNursing Officer and the Chief Human Resources Officer. findings on Governing Body We have attended meetings of the BOM during our survey period and reviewed the BOM's duties as a governing body required by the Conditions of Participation including their role in: reviewing and appointing members of the medical staff; monitoring and overseeing the quality of care and patient safety at the Hospital; and monitoring the provision of emergency services as required by EMTALA. With respect to its current review of Medical Staff appointments, reappointments and disciplinary actions, we note here and in the section of our report on Medical Staff that the BOM appears to be exercising its proper role. The BOM devotes a separate part of its meeting to review and discuss all recommendations on Medical Staff appointments, re-appointments and discipline. The BOM hears directly from the President of the Medical Executive Committee who discusses the Medical S t a f f s recommendations and answers questions regarding all recommendations. The BOM is an active participant in Medical Staff membership decisions and does not act by way of a "consent agenda" on such matters. ?4S-M2{aXH i "h Governin>> Board; Standard: Medical StolT/.sWw ihtponJ W*a/fc< I /-' h Ui 0.! 01 d-.P h 1,0 >>} Of ai 0 1' ij The BOM, in its oversight capacity of the Medical Staff, must insist upon the implementation of a more vigorous Ongoing Professional Practice Evaluation (OPPE) program for all Medical Staff members. The BOM should take the lead itself, and direct senior management, to engage continuously and collaboratively with key Physician leaders not only in structured hospital committee meetings, but in daily collaboration and outreach with all Physicians. We would also encourage the BOM to continue to devote significant amounts of its agenda to overseeing the Hospital's compliance with the SIA and implementation of the Action Plan as well as to enhanced trending and metrics reports in its quality oversight function. With respect to the management organization, we would encourage the BOM and CEO to evaluate the current organizational structure to ensure that departments are not "silo-ed" and that span of control does not become too great for any one individual in a significant leadership position. We believe that the BOM is energetically engaged in overseeing the efforts to improve patient care at Parkland and return Parkland to compliance with all Conditions of Participation. They clearly recognize the gravity of the situation facing the Hospital. It is up to the BOM to continue to impart that message of urgency to all of Parkland's employees and staff and hold accountable those employees and staff members who are not meaningfully addressing and fixing the deficiencies noted by CMS, the State and in this report. Although the BOM is actively working to improve all aspects of care at Parkland, as the governing body the BOM is ultimately accountable for the Hospital's compliance with all of the Medicare Conditions of Participation. Until the Hospital makes meaningful and sustainable progress in coming into compliance with all CoP, by definition the BOM cannot be said to be in compliance at this time with all CoP standards related to Governing Bodies. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 44 2.3 Culture An organization's culture is typically defined by the collective behavior of a group of people who share a common understanding of the organization's mission, vision, values, beliefs and habits that are perceived to be an "acceptable norm" for behavior in the organization. An organization's culture becomes the internal language or code by which members of the group communicate and interact with one another and the way in which day-to-day life is carried out by the organization. Members of the organization - and those who are its customers, suppliers or advisors to the organization - are evaluated through this lens and are assessed by their ability or willingness to adopt or adapt to this "norm". Leadership generally sets the cultural tone and agenda at most organizations. Parkland is no exception. In our interviews we have heard statements, that historically, there has been the institution-wide belief that "Parkland is different" or "Parkland is too big to fail". We have also heard the statement that "Parkland specializes in resurrection medicine" the adage owing to Parkland's long-standing and well-known trauma services and capabilities. The themes of these three cultural statements, conflated together, typified some of the initial responses by senior leadership to the CMS and State survey findings from the summer of 2011: that being the belief that Parkland's historical reputation and unique status as an important safety net hospital would somehow cause CMS to pull back from the brink and not act to terminate Parkland's Medicare contract. In addition to the cultural view that "Parkland is different" or "Parkland is too big to fail," our interviews often detected a culture that might be described as "self-immunized" or "desensitized" to adverse patient events or to the socio-economic, physical and behavioral health disparities and/or other needs of the community of patients who seek care within the Parkland system. None of this is to suggest that Parkland is an organization without heart, compassion or understanding and embracement of mission. We observed many dedicated employees and doctors who consistently provided quality and compassionate care to the patients they served. Over time, however, as volumes have increased and as resources and services at Parkland have been taxed, there appears to be a widely shared belief that quality or compliance sometimes has to take second place in order to maintain access and expedited patient throughput. Otherwise, it is believed that high volume and high acuity demands cannot be met, and patients could not be treated. It was expressed to us on more than one occasion that if all of the Medicare Conditions of Participation, the Emergency Medical Treatment and Labor Act (EMTALA) and State rules and regulations were met to the letter, that the system would experience even longer care delays and that many patients would be unable to get into the Parkland system. One interviewee noted that the system would be "gridlocked" if regulations and rules were required to be followed to the letter. Examples of such a view - "quality and compliance vs. access" - come in the form of Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. taking short cuts in some of the basics of providing care; lapses in infection control practices; unsafe or incomplete clinical hand-offs in chaotic environments; brusque interactions with patients; and delays in carc. Many other large and busy hospital systems, including many safety-net providers have demonstrated that quality care in a safe environment can be achieved while still complying with governing body regulations, Conditions of Participation, State laws and best practices. These organizations have demonstrated the ability to maintain access and provide timely care in a challenging, complex, high acuity and high demand environment. The Parkland health system is very large and very complex, which requires Hospital leadership to ensure consistency in policy, procedure and practice the highest priority. Navigating this complex system is often extremely difficult from the vantage point of the patient, as we heard in many of our patient interviews. The current organizational structure contributes to the lack of consistency through silos of management in which each area operates independently. This has caused a loss of ability to benefit from a system wide focus and to develop best practices. There is wide variability in compliance with rules, regulations and hospital policies across these multiple silos. Many of the units and departments have developed "sub-cultures" of their own dependent upon the strength and effectiveness of the unit's leadership. These unit-specific cultures and norms come across in simple ways like variations in the way nurse staffing is done, or tolerance for the environment of care, i.e., cleanliness, on the unit. Within this large and sometimes fragmented organization, one can easily and readily transfer ownership and accountability for problems to another tower of the organization. For example, with respect to the quality of care at the Hospital, "quality" is often viewed just as a department in the hospital - the Quality Department - that has the sole responsibility for the quality of patient carc, as opposed to the actual unit or department where care is delivered. While interdepartment forums, committees, and task forces exist to resolve issues, we found that most initiatives lacked a clcar line of accountability and responsibility for action and implementation. During the many meetings we attended, issues - some fairly important and urgent - are reported and progress tracked in multiple and large forums, but the outcome is not always a consistent application and hardwired change. Initiatives often lack clearly assigned accountability for action, implementation and results by an individual with skills, experience and organizational appointment/empowerment to actually effectuate change. There has also been a lack of a robust set of metrics by which the organization holds itself accountable to performance and progress. Without such a set of metrics, it is difficult to hardwire change and initiatives throughout the organization. A very basic example is hand washing hygiene. While there have been multiple campaigns, educational efforts and raised awareness, lack of compliance with this basic infection prevention technique is prevalent throughout the Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 46 organization. The organization does not properly monitor, measure, reward or discipline for compliance infractions and report those infractions against any rigorous metric. Despite the existence of the Systems Improvement Agreement (SIA) and the many months of intense regulatory scrutiny, large parts of organization still operate in a "business as usual" mode and lack a sense of urgency to address issues, investigate and take corrective actions around patient safely and sub-optimal care that have been the focus of regulatory action. We saw this typified in what should have been an easy exercise of making sure that all of the crash carts in the Hospital were consistently and safely stocked and monitored. These issues cannot be addressed through standard operating tactics such as standing quality and safety committees, re-creating new policies or conducting a training program. The delayed approach of root cause analysis (RCA) or the acceptance of poor outcomes cannot be the approach to patient safety incidents. The organization must take seriously each and every patient safety or adverse event incident and respond QUICKLY by creating a plan to address the deficiencies, gathering resources to act urgently, and hardwiring change so that the risk of reoccurrence is mitigated. Hospital policy requires that initial RCAs be conducted swiftly after an adverse event, optimally within 24 hours of the event. During our survey period, however, no RCAs were conducted within this expedited time period. Most RCAs were conducted several days - or even several weeks - after the adverse event is detected and reported. Parkland needs to embrace this imperative for change in its culture by capitalizing on the individuals within the ranks who work hard and are committed to the mission. The Interim CEO has challenged the organization to focus on Parkland's mission by creating an environment of excellence and create an ideal patient experience. The entire senior leadership team must disseminate this message through their direct reports to the front line until every associate in the organization begins to live and breathe this new culture. In short, a new norm or culture for Parkland must be fostered to ensure that: o o o o o o o Patients are viewed as individuals with individual needs and the requirement to provide individualized solutions beyond the delivery of the acute episode of care. Every patient is every employee's responsibility. Every employee and medical staff member is responsible for quality and safety. Quality and safety are the top organization-wide goals and will be measured by stringent metrics. Personal accountability is paramount. Employees and staff who "drop the ball" or do not follow the rules must be sanctioned. Everyone must lead by example. Every associate understands that "It all depends on me." Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. 2.4 Access and Throughput Access and throughput are challenging issues nationally particularly for the underserved patients with no access to primary care and/or means to pay for healthcare. Public hospitals consistently have a higher percentage of uninsured or underinsured populations seeking access than at other not-for-profit, for-profit and community hospitals. Access and throughput become more of a challenge for a hospital like Parkland given the multiple points of entry into the system and interdependencies of various functions and departments to provide a continuum of care. There are multiple points of entry into the Parkland Health and Hospital System with a high volume of unscheduled patients presenting for one of the following reasons: Point of Entry UnscheduledWalk In Type of Services Emergency Services - Self or Referred by Community Oriented Primary Care (COPC) or specialty clinic Urgent Care Services Labor and Delivery Services Referred Ambulatory Services Primary Care Prescription Refills Unscheduled EMS/Transport Emergency Services Trauma Services Transfer from other facilities Unscheduled Police Scheduled Appointment Apprehended by Peace Officer Without Warrant (APOWW) Other Law Enforcement Escort Same Day Surgeries Scheduled Admissions (Same Day Admits) Ambulatory Services Specialty Clinics (on campus and in community) Transfers Pediatric Patients presenting to Main Emergency Department Pediatric Burn Patients High and Variable Volume The Hospital is challenged with a high volume of patient visits, which for the most part, are unscheduled and therefore create a highly variable workload. This variability constantly challenges the organization in managing capacity (rooms/beds/chairs/bays, operating rooms, and Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 48 diagnostics) to staff to projected volume and creates a need to continually make adjustments to access and throughput. The average daily census (ADC) for the entire hospital in 2011 was 510 inpatients per day, according to Parkland's Decision Support (DS) and Admissions, Discharges and Transfers (ADT) group. The occupancy rate for Medical/Surgical units as reported by Finance - including Observation Status patients - was 85% in 2011. The average length of stay for adults-only was 5.1 days in FY 2011 according to DS and ADT sources. Including the Neonatal Intensive Care Unit (NNICU) population the average length of stay was 5.6 days for FY 2011, Of the approximately 125,000 patients that present annually to the Main Emergency Department (ED) each year, approximately 25% are admitted to the Hospital. These "unplanned" admissions from the ED represent 85% of all hospital admissions. The Psychiatric Emergency Department (PED) sees an average of 27 patients per day, based on calendar year 201 I. Forty-six percent of the patients arrive by Apprehension by Peace Officer without Warrant (APOW W), by ambulance or the Dallas Police Department. Lack of sufficient ambulatory capacity/access to accommodate primary care needs of the community and/or productivity issues of existing primary care structure (Community Oriented Primary Care), contributes to the high volume of unscheduled (and perhaps non-emergent/nonurgent) patients that seek care on the Hospital campus day to day. The Urgent Care Center (UCC), which was originally intended to relieve volume to the Main ED by providing a Fast Track for patients presenting with an Emergency Severity Index (ESI) Level of 3, 4 and 5 (indicating stable patients), has become an alternative access vehicle for non-urgent primary care. The UCC which is open from 08:00 to 17:00 had over 52,000 visits in 2011, 100% of which were unscheduled encounters. Thirty percent of the UCC patients were re-routed from the Main ED. Nearly 100 patients present directly to UCC (unscheduled) by 09:00 most mornings. Patients present unscheduled in the Main ED at all times of the day and night needing dialysis. Most of these dialysis patients are indigent care patients who are often undocumented immigrants or transient patients not enrolled in a public benefit program and use the ED either episodically or as a means of last resort in order to obtain dialysis treatment. These dialysis patients occupied nine ED beds, on average, at 06:00 on 46 days of a recent 50-day period. Patients under Apprehension by Peace Officer without Warrant (APOWW) present an enormous challenge for the ED. Parkland treated over 4,500 A P O W W patients in the Emergency Services Department in fiscal year 2011. A P O W W procedures are labor intensive and can create additional complications. These patients can only be located in restricted areas of the ED and Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. require 1:1 observation. Up until recently, psychiatric A P O W W patients were admitted directly to the FED. However, in its efforts to stabilize patient care in the FED, Parkland has limited the admissions of psychiatric A P O W W patients directly to the Psychiatric ED when possible. This limitation of admissions has created greater backlogs of APOWW patients in the Main ED. More than 12,000 babies were born at Parkland in fiscal year 2011 of which more than 900 were admitted to the Neonatal Intensive Care Unit (NNICU). The (Women's) Intermediate Care Center (ICC), which provides urgent care for women, treats approximately 19,000 patients per year. The ICC is part of Parkland's Emergency Services and 100% of the volume of patients encountered in ICC are unscheduled. Of the surgeries performed on the Main campus (not within the ambulatory surgery center), 40% are unscheduled. A high percentage of unscheduled cases is typical in hospitals with a busy trauma service. Impediments to throughput and expedient disposition from the Main ED result in bed shortages, boarding and overcrowding of the ED resulting in sometimes unsafe conditions and long dwell times for patients. The ED then goes onto a "divert status" which impacts access issues for the community. Parkland Main ED was on diversion status for an average of 221 hours per month from the period January through November 201 1. Impacts to Throughput Because of the multiple portals to care for unscheduled (emergent and urgent) episodes of care, patients may present to any number of portals (e.g. psychiatric patients presenting to Main ED; urgent needs presenting to the Main ED). These multiple points of entry result in multiple handoffs of care to appropriately transition the patient from one care venue to another, thereby increasing the patient's dwell time or worse, delaying care, or worse, risking the patient to become lost or injured in a hand-off. The unscheduled nature of a most of Parkland's ED volume creates long dwell times and level of frustration to patients who perhaps elope and/or leave without being seen (LWOB) as a result of long wait times. There are several issues that impact and create overcrowded and sometimes unsafe conditions in the Main ED. As the UCC begins to close the intake valve of patients in preparation for ending the day in that unit, the patients are directed to the Main ED increasing its workload. When the PED is at capacity, psychiatric patients are seen in the Main ED where the appropriate resources are not always available. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 50 The 201 1 average dwell times in Emergency Services are as follows: 7 * Fiscal Year 2011 Average Door to Doctor (min) Door to Admit (hr) Door to Discharge (hr) Main Emergency Department 74 8:25 5:35 Psychiatric Emergency Department n/a 17:38 10:22 Urgent Care Center 94 2:14 2:53 Immediate j Care Center n/a 5:57 6:52 The national average of patients who Leave Without Being Seen (LWOBS) remains approximately 2.5%. For 2011, the average LWOB percent at Parkland was 5.2%, though the LWOBS time from September to December 2011 was 8.9%. Expediting patient flow throughout the ED is dependent upon other clinical services within the department to expedite care - diagnostic imaging, laboratory and pathology, respiratory services and consultations by admitting and/or specialty physicians as well as services such as capacity within the dialysis unit. Impediments to disposition from the ED or the Operating Room (OR)/Post Anesthesia Care Unit (PACU) come from the unavailability of appropriate level of care staffed inpatient beds at the time of need. A lack of available beds results in longer than acceptable boarding of patients in the ED and potentially in the PACU. Bed availability is generally impacted by multiple drivers - availability of the physician on the service to facilitate the admission, a room turnover (cleaning) by Environmental Services (EVS), a bed assignment from ADT, and finally the availability of nursing staff to conduct a safe and appropriate hand-off of the patient. Labor and Delivery (L&D) patients are taken directly to triage for observation of labor and evaluation for indications of admission. Active labor patients are admitted to the Labor and Delivery unit. In this situation, the limitations to access and throughput are related to actual physical plant capacity (i.e., not enough L&D unit beds, even if staff was available to staff all beds.) Postpartum patients are admitted from Labor and Delivery. Volume in the postpartum unit is frequently over 100% of capacity. A classroom on the unit is used for holding patients until a bed is available. During peak census, which was observed frequently during the A & M survey, patients were seen recovering in the hallways because the labor room was needed for an incoming patient. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 51 Bed Management A number of drivers facilitate effective management of the Hospital's bed capacity. While the ADT function at Parkland is the gate keeper, there arc many other key stakeholders who hold the keys to expediting throughput in the Hospital. Beds arc assigned by the Admissions-Discharges-Transfers (ADT) function, which acts as a "matching agent" to identify the right bed according to the physicians order - medical/surgical, isolation requirements, gender, sitter requirements, telemetry, etc. Provided there is an "available" bed, the unit-based Charge RN is in control of accepting or forestalling the transfer of care to the unit based upon the current census, acuity, and availability of nursing staff on the unit to conduct an appropriate hand-off and admission to the unit. If the bed is available, but not "clean," the bed is "unavailable" for placement of a patient. EVS has responsibility for room turnovers and has a target of 40 minutes from the time of notification for cleaning until the bed is ready. From November 1st through January 12th, average turnaround time averaged 58 minutes. EVS can create another delay in admission to a bed. In order to facilitate the appropriate bed turn, patients in beds need to be discharged timely. The discharge is largely dependent upon an early and comprehensive plan of care that includes advance discharge planning. To manage the valuable resource of inpatient capacity, physicians need to round early enough to discharge patients timely. At Parkland, the surgeons round early in the morning which facilitates early discharges. The Medicine Service rounds very late in the morning or sometime in the afternoon. Rounding at this later time, sometimes delays discharges to late afternoon and/or early evening. Frequently, the Main ED is approaching maximum capacity by 09:00. This coupled with the holding of patients exacerbates the problem of bed availability for patients being admitted from the ED. The Medicine Service also has limitations on the number of patients assigned to a Hospitalist. The Residents who care for patients on the Medicine units are capped under Accreditation Council for Graduate Medical Education (ACGME) regulations. The total patients presenting from the ED to Medicine units is capped at 60. When the "cap" limits are reached, admitted patients are held in the ED until at least 07:00, the following day. A study was performed for the month of November 2011 which revealed Hospitalists reached their "cap" of admitted patients on seven of the 30 days in November. Residents reached their "cap" every day in the month of November. As a result of the patient "cap" and the "compassionate dialysis" patient population, it is not uncommon for the ED to begin the morning with approximately 80 - 85% occupancy of beds at a time when patient arrivals begin to peak in a few hours. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. At Impact oF Inadequate Primary Care Capacity The Community Oriented Primary Care (COPCs) Facilities are designed to provide primary care in the community near the patient populations served. COPC includes a network of 11 primary care health centers, 11 school-based clinics and homeless medical services. They provide pediatric, adolescent and adult primary care, women's health and senior care services. These medical services include health and preventive maintenance check-ups, sick visits, and urgent Patients acccss the clinic primarily by contacting a centralized scheduling center. Patients are provided with appointments based on their physical location or need. There is no Formal triage process in the COPCs, but if the patient expresses a need for immediate assistance, e.g., symptoms of pneumonia, their care is usually advanced ahead of others. If the person seeking a COPC appointment is an established patient with a primary care physician, there is effort to schedule the patient with that doctor. If an appointment cannot be given in a timely manner with the primary care physician, the patient is referred to a "today" clinic or the Parkland Emergency Department. The "today" clinic is 100% walk in and no appointments are given. In the scenario of patients presenting late in the day just prior to closing, patients may not have a Full work up prior to the clinic closing, but the provider and nurse will briefly see and speak with the patient to determine if the patient should be referred to the UCC or to the Main ED. There are a total of six today clinics. There are no locations that have evening hours. The average volume seen in these clinics is approximately 20 patients per day. The average dwell time (time from registration until discharged) is two hours. There has not been consistent coordination of care between the hospital campus and the COPCs. Case Management in the hospital is limited; therefore eFFective, on-going coordination between Case Management/Discharge Planning oFten does not occur. Some oFthe chronic care disease management services are being managed in the hospital Quality Department. There is better coordination oFcare between pneumonia and diabetic patients and the COPCs. There are significant wait times in the clinics to get an appointment, particularly For the adult and geriatric populations. From the COPC access report for all clinical services, the time period wait time (reported October 1, 2010 through September 1, 2011) for new patients ranged from a few days for pediatrics to months for adults and geriatric patients. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 53 Ai Clinic/Patient Population. Average Wait Time for New Patients for 3n1 Available Appointment 176 days 106 days 5 days 9 days 7 days 71 days Adult Patients Adult/Geriatric Patients Pediatrics Geriatric Average Mental Health Average Overall Average Without adequate access and/or capacity at the COPCs, patients will continue to utilize the Parkland Emergency Services Department (including the UCC) for primary care needs that are really not of an emergent nature and thereby occupying valuable capacity in the Main ED contributing to the "unscheduled" volume on the Hospital campus. Case Management and Discharge Planning The Hospital lacks a proactive and progressive case management and discharge planning system which causes a delay in discharges (Discharge Management and Case Management, Section 2.7.8). Delayed discharges, as well as capacity lost to length of stay outliers, render the inpatient medical, surgical, and intensive care units without the bed control they need to meet incoming demand. Discharge planning is frequently done on the day of discharge resulting in increased length of stay and outliers. A large percentage of the patients have difficult placement issues. Discharge planning is complex given the patient population and available resources to the population. Parkland provides health care to those patients lacking social and financial support, undocumented residents, non-English speaking persons, disabled persons, homeless people, victims of abuse, substance abuse dependent patients, and patients under hold of the criminal justice system. Inter-disciplinary care rounds do not occur as a routine practice for any units except for the critical care units. Some patients remain in the Hospital long after acute care is no longer needed because the patients cannot be discharged into another setting because no other care facility will take the patients. Looking at an example of a patient with a two month stay that should have been Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 54 A* i limited to four days clearly demonstrates the inappropriate use of limited inpatient resources. The patient unnecessarily occupied a bed for 56 days in this scenario. This is not an unusual situation at Parkland, and it is easy to see that a number of these patients could potentially create a strain on capacity. While most admissions to the Hospital come through the Main ED, case managers are not proactively engaged in seeking out cases for care management but currently act only upon a requested consultation. The model which exists in other busy EDs across the country is to actively participate in the admission of the patient to ensure appropriate admission criteria is met and a discharge plan begins on date of admission. Lack of a Well-Coordinated Continuum of Care An effective healthcare system should be able to provide access to "cradle to grave" healthcare services. Services do not necessarily need to be provided by the same provider, but the access to a network of services should exist. Parkland does not have an extensive network of resources within the community to facilitate discharge of patients who do not have resources or a place to receive post-acute care. These resources either do not exist within the community or cannot be accessed by the patients and/or Parkland has not entered into contractual arrangements with outside agencies such as Home Health Agencies, Hospices, residence substance abuse centers or Nursing Homes to facilitate placements. A prime example is the behavioral health population that often returns for multiple episodes of emergency care because there is not a well developed system or continuum of care for long-term psychiatric or substance abuse care. A more consistent coordinated discharge planning process with the clinics is needed, considering the backlog in the main ED and the capacity challenges for the acute care Hospital. Additionally, as a component of this process, identifying those patients who have chronic diseases and/or who are not compliant with their treatment regimen would allow the Hospital to contact these patients in a more proactive manner and potentially avoid clinic and/or ED visits. There are several initiatives underway to enhance referral processes between the Hospital and the clinics. A plan is being considered for patients presenting to the Parkland ED, to be screened by a physician in the triage area. If clinically appropriate, the ED would refer the patient to either a primary care physician (if the patient has one assigned) or to a "today" clinic. Telephonic virtual appointments are also being explored using mid-level providers, such as nurse practitioners. The plan is to utilize mid-level practitioners to call patients with issues or concerns that have contacted the scheduling center or to proactively call patients with chronic diseases and assist them in managing their health. Specialty clinics at the Hospital report excessive wait times for appointments. Currently the Rheumatology clinic has nearly a five-month wait to obtain an appointment. The Hospital is II. M Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 55 limited by space within the clinic tower. Additionally, clinics are a significant area of teaching activity, and Residents are limited to the number of patients they can see in a four-hour period. In an effort to provide continuity of care, patients are scheduled exclusively with a specific Resident. However, as Residents rotate to various facilities, there may be a delay in care causing long wait times between appointments before the Resident rotates back to this service/location. Conclusion High volume and largely unscheduled episodes of care drive and constrain access and throughput in all of Parkland's ambulatory and inpatient settings. Many of these issues will need to be addressed in the Action Plan in order to correct deficiencies in the Conditions of Participation. Many of the corrective actions will require systemic change in the efficiency, communication and inter-dependencies of operations and current silo structures and all actions will require commitment from leadership at all levels and across the organization. throughput. No one singular correction will resolve the issues that are currently barriers and bottlenecks to access and A series of inter-dependent and linked systems of care needs to come together in this operational turnaround effort. The continuum of care is a strategic topic that needs to be addressed by the Parkland senior leadership team and the BOM in order for long-term solutions to the quality of care problems caused by access and throughput to be addressed. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 56 2.5 Nursing/Provision of Care Nursing care goes to the heart of the service that hospitals provide and defines much of a patient's care experience. While a physician may round, or examine or provide procedural interventions to a patient during an inpatient stay or outpatient visit, it is the nurse who provides the constancy of observation and continuity of care to patients. It is the nurse who regularly checks the vital signs and monitors the telemetry and oxygen in the intensive care units and on the medical/surgical floors. It is the nurse who administers intravenous fluids and medications, who assists the patient in nutrition, ambulating, washing and toileting. In the procedural units it is often the nurse who preps the patient for the procedure, assists the physician in the surgery or procedure and monitors the patient post-surgery or procedure for recovery. In the emergency department, urgent care clinics and outpatient clinics, it is the nurse who triages the patient's condition, takes initial vital signs and history and transmits information to the physician for the physician's examination, evaluation and disposition. Nurses are the constant eyes and ears of hospital care, intervening or seeking intervention from physicians or other caregivers when assistance is needed. Given its size, Parkland has a large staff of nursing professionals. Parkland employs over 2,800 nursing FTEs. Due to the large number of nursing staff caring for such a large patient population on an inpatient and outpatient basis, Parkland requires a nursing leadership structure that ensures proper oversight for safe and effective nursing care for all of Parkland's patients. The nurse executive or Chief Nursing O fficer (CNO) in charge of the nursing service must promote nursing quality by being incorporated into all patient care areas within the organization. Directly, or indirectly through nurse house supervisors or unit supervisors, the CNO must oversee the nursing care for all patients. The CNO must develop and implement policies and procedures that govern the provision of nursing care, treatment, and services throughout the organization. The CNO must hold nurses and their nursing supervisors accountable for all of their nursing care, and the CNO must be involved in all decisions to hire, promote, educate, discipline or terminate a nurse. Additionally, because Parkland operates a large graduate medical education (GME) program with new physicians in training, it is particularly important to have a well-organized, welltrained, seasoned and vigilant nursing service to assist in monitoring the clinical practice of the Resident staff. The CNO must also be linked to the Hospital's GME efforts to ensure that Residents are properly supported in their training. Nursing service at Parkland is currently organized in a matrix reporting structure with responsibility and accountability of nursing reporting to a service line vice president with operational responsibilities, rather than to an individual with nursing credentials and qualifications. In this model, while nurses may ostensibly "report" to a CNO who is responsible for establishing and overseeing nurse practice standards, in actuality, there, is no direct reporting Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC II10! el. seq., Ill is information is confidential and privileged. relationship to the C N O for a nurse's day-to-day performance. At Parkland, there are no patient care areas reporting directly the CNO. This nursing structure has led to numerous patient care issues because of inconsistency in nursing practice across the house. While service line structures and matrix nursing organizations exist in other large health systems, such a nursing organization requires a strong commitment and respect for compliance with nurse practice standards and a highly collaborative management model between operations and nursing. With the hiring of a new nurse executive, Parkland has the opportunity to develop a new organization structure for nursing to revitalize the standards and develop models for accountability to the CNO. In the Hospital's procedure based areas (e.g., surgery, interventional cardiology, interventional radiology), many of the units do not report directly to nursing but have nurse oversight to ensure the nurses are connected to relevant policy, procedures and quality reporting. From our interviews and survey rounding, however, it was evident that these units were not synchronous with some house-wide nursing practiccs and standards or had been allowed to develop practices for their own unit. For example, the catheterization lab and interventional radiology did not practice standardized procedures in maintaining a sterile environment for invasive procedures. Surgical scrub attire and traffic flow were not following required standards of care for restricted a r e a s p e r f o r m i n g i n v a s i v e p r o c e d u r e s . ?482.23(a) TAG V 0 3 8 6 Standard: Nursing Services; V f M L O L v i O'-.P /. 6i - MIO.":. O!. 01 ?El' 2. 4. 5>> - i J>J>4J} I J? il-T 3, ?oo The C N O ' s role and influence should extend beyond the acute care hospital setting into all patient care areas in the Parkland system, including all o f t h e outpatient and off-site clinics. In interviews with nurses in the outpatient clinics, particularly the Community Oriented Primary Care (COPC) clinics, the nurses stated they felt disconnected to the campus nurses and the standards of nursing practice that Parkland has enacted that govern off-campus nurses as well. Nurses in the clinics said they often find out about Hospital nursing practices, standards and initiatives through informal communications. For example, nurses in the clinics that we interviewed were not aware of the Hospital's quality assessment and performance improvement p r o g r a m s . ; ;i'2 ?! ? u > : A - 0 2 6 3 C??K????;1 o? ['?iriictyaiim: Qt;??lfi> Assessment ami Performance Program. ,v&/>/.<. s'lun o:J? ii'Pif i'co.i oi.oi ;w J. 22, 2Jj It was also evident that Parkland's current nursing structure is fragmented, as demonstrated by inconsistent " h a n d - o f f communications among nursing staff. For example, hand off communication is episodic between the inpatient units and the Preoperative Holding Unit. We observed little communication between the nurses transferring the care of the patient to the Preoperative Holding R~N. This lack of communication was also evident in other procedure based areas with transfers and hand-offs of patients between inpatient units. There was also variability in documentation in Epic, the electronic medical record (EMR), that the nurse hand-off was conducted. We observed that many RNs in procedure-based units (such as the gastroenterology laboratory) did not know there was a field in the Epic EMR to document the hand-off. throughout the Hospital and all ambulatory settings. Doliwn of Caw: /'(' .02 I?2.0! fill' I.Ji; Patient Care Staffing Nurse staffing at Parkland is currently based solely upon census or visits. We found no consistent method to staff the clinical areas with nurses based on acuity of the patients in the unit. A consistent method used at Parkland to staff the patient care units with nursing is to use of a grid for patient-to-staff ratios, or the number of patients to assigned staff. Patient assignments are based on location, by grouping together, and not based on the patients' individual needs or acuity. In some settings, the staffing pattern was fixed, regardless of the number of patients on the Medical Surgical Units. During interviews on 7 South (Medicine) and 7 South South (Diabetes Unit) the nurse stated that both units have a similar patient mix although 7South is staffed with ,"< M4 (J2.f>! fi-j'h, The CNO should take the lead in establishing and monitoring safe patient " h a n d - o f f ' practices AG: \-0$95 Srandani: Utaiimg and Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 59 fewer Registered Nurses. This was explained to A&M as the result of a budget reduction in a previous fiscal year. CMS Conditions of Participation clearly state that the Registered Nurse responsible for nursing services must determine the types and numbers of nursing personnel and staff necessary to provide care for all areas of the Hospital. $ <-"Y-Mfhjc") FAG: VOW? < omliiifu of NgL'ijMion: Ktifstm.'. Services. Staffing rWiway^Ft W: PC'U 0 (flP ii Clinical Competency Patient care assignments in the provision of nursing care must be commensurate with the qualifications of personnel available. The competencies of each nursing staff member, the identified patient care needs, and the prescribed medical regimen must be commensurate in the patient care assignments. Competencies of staff members should be immediately accessible. Core competencies for the clinical staff are primarily the responsibility of the Clinical Education Department, which employees 56.5 PTEs including administration support, managers, and Critical Care and Trauma Nurse Internship faculty. The Department provides direct educational support for all RNs, LVN's, unlicensed personnel, and health unit clerks in the direct patient care areas, including jail health. It provides Neonatal Resuscitation Program (NRP), Advanced Cardiac Life Support (ACLS) and Basic Life Support (BLS) training for the entire system. The Department also provides limited support to the clinical non-nursing areas and Residents and/or attending Physicians. The Clinical Education Department is also responsible for all clinical student placements, which currently is about 2,100 students per year from nearly 100 different programs, exclusive of medical students and Residents As referenced in the Human Capital/Human Resources section of our report (Section 2.6) we were unable to identify required individualized core competencies for each nursing department. A central repository of the compiled information on competency events is not maintained in the Parkland Human Resources Department or anywhere else within the Hospital. A list was provided, but it was not complete as the Operating Room and Psychiatric Emergency Department was omitted from the list. The Hospital could not verify to us that staff had achieved expected competency as personnel files were incomplete and the report was incomplete and d i f f i c u l t t o d e c i p h e r . f48,i.23(b;.i5) 1AO: A-0397 Sttmdtfd: Staffing and Deliver? of ("are: HR.Ol.PZfll o SilVii 06.0i ?id-' !)- f.D.05.06.0! s! .P : iW !j 4). Additionally nursing personnel must assign care of each patient to other personnel in accordance with the patient's needs and qualifications and competency of the nursing staff. This requires that competence of staff be measured and ongoing testing and education be provided to the staff based on the patients' needs and the population of patients regularly being served. While there are departments that do identify key competencies for their staff, a documented organizationwide plan is not present. And while a competency plan is an important component of providing nursing care, competencies of all clinical staff must be measured with ongoing strategies to maintain and ensure the staff level of competency meets the needs of the patients. ?4fci23{l>)(Jl Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 60 1 AO: A-O.w? Standard: Staffing mid Deliver* o l V a t v : I Hi 01 o?.0f lj SIR MM 05 (LP 3) ??HM) .06.01 'LP !}- l.ikOi 06.01 ?Ef' b Annual core competencies we reviewed were not adequate to ensure clinical staff is receiving proper training unique to their patient population. For instance, annual core competencies for nurses on (he newborn nursery unit consisted of: 1) infection prevention, 2) phototherapy and 3) syringe pump. Additional competencies as described below would provide more specific knowledge to nurses providing care to newborns: o o o o o o o Care of the newborn in the first days of life Care of the newborn requiring medical intervention Recognition of trouble flags in the neonate Understanding the thermoregulation process in the newborn Caring for the newborn in a culturally diverse environment Assisting the family with integration o f t h e newborn Understanding the physiological responses in the newborn HRHJ tr Oi d.P h LD.O; ityOJ iFJ' V; ?IftGi.ftf S-iK^-l-MbHi) I AO A-0397 Snmdard: jJMsvrn $5 (&P JJ H,fl)U>6 0/ 'W 11 - HR.Of.0&tU (BP I J Verbal Orders Verbal orders from physicians to nurses can contribute to mistakes in treatment and errors in medication administration. In best practice, verbal orders should be accepted only in urgent or emergent situations or in procedural cases where a physician may be in sterile garb unable to write or enter an order. In all cases, verbal orders should be read back to the doctor by the nurse and the read back should be documented appropriately in the medical record. Parkland's total verbal order rate in the inpatient setting is approximately 10% of all physician orders. Based on data provided to A&M for second quarter of calendar year 2011, verbal orders constituted 9% of all medication orders of approximately 51,000 medication orders in that time period. The goal of EMR with Computerized Physician Order Entry (CPOE) is to reduce the incidence of verbal orders as they can contribute to errors through transcription and read backs. At Parkland, there are Hospitalists and Residents who cover inpatient units 24 hours a day. The need for verbal orders should be minimal as all physicians can log on to any computer in the house to write an order for any patient. There have been incidents during the ICE survey period where medication was dispensed and orders obtained after the fact. In reviewing patient safety record events for September through November 2011, medication errors constituted 10% of the reported safety related events and the third highest category of Patient Safety Incidents. Of the medication error sub-categories, wrong patient and wrong drug constituted 43% of the errors. Considering that medication errors are already an opportunity for improvement, reductions in Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 11101 et. set/., this information is confidential and privileged. 61 verbal orders are needed a I Parkland lo remove yet another variable that could result in errors a n d i n j u r y t o p a t i e n t s . J4R2.2 HcjflffiJ l'A Ul -V'-v tt-.P 3. o/. Parkland's nursing staff must also comply with Hospital policies and state laws regarding the control of and access to medications. All medications must be kept in a secure and locked area. An incident of drug diversion occurred in the clinic at the Medlock Adolescent Center because drugs had not been secured and stored as required by Hospital policy and regulatory requirements. In that case, 12 bottles of Schedule II drugs were stolen by one of the juvenile residents because the drugs were not locked in the controlled substance cabinet. Additionally, staff did not consistently perform a count of the Schedule II drugs by shift and as additional staff came on duty, so this particular diversion was not discovered until the next day. Following this event and an investigation of the drug diversion and theft, administration leaders responsible for the Medlock Clinic changed their policy to institute and require multiple counts of Schedule II drugs, in addition to monitoring security to ensure the drugs are locked in the secure cabinet after administration. i-IS..J3{c)(2}(ii I Aj Admifthtfaumi <<>f Drus>><< iH"!)~:.i-< 0~ I ?' Use of Restraints The intent of a restraint is to protect the patient and staff from harm and to avoid removal of medical devices. The decision to utilize restraints should not be driven by diagnosis but a comprehensive individual patient evaluation. The evaluation should include a physical assessment to identify medical problems that may be causing behavior changes in patient. Addressing these medical issues may eliminate or minimize the need for the use of restraints. Through departmental rounds, observations of patient care areas and chart review of medical records A&M found that nurses in the Medical/Surgical areas were only using "Non-Violent Restraint'" orders even after there is documentation of a patient's violent act toward himself or others. Using a non-violent restraint order requires less documentation and monitoring than a violent restraint order, but it is incorrect to use a non-violent restraint order when the restraint is being administered because of the patient's compromising actions towards himself and others. Parkland's nursing leadership, together with the appropriate physician leadership, should review the appropriate order sets for all areas that use restraints and modify all order sets to ensure that the appropriate order sets exist. There should be efforts to utilize less restrictive methods to protect the patient and/or staff before restraints are initiated or used. On a single day of chart reviews, six out often charts reviewed for Medical/Surgical Unit patients, showed that restraints were mentioned in the treatment plans but the charts did not contain a specific care plan to the patient's individual issue, age or other factors required in c o m p l e t e d o c u m e n t a t i o n . ?482.13(e)(2) I AO: A-0164 Standard: Pattest Rights. jS4S2.U>)TAG: A0166: Pi '.OlOXOi (EP >. 41 !>< H3.05.OJ OJ> h Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 62 There is a general lack of knowledge surrounding proper ordering and documentation of restraints. Interviews with staff indicate confusion regarding the use of violent restraints. Some staff stated the violent restraint order set was for psychiatric patients only. Although the patient may be confused, if the main reason for use of restraints is behavior that exhibits hitting, biting, or scratching, the violent restraint order set must be used. ?-481 LH:r}i!} I'M'>>: A-Oi i'"! Standard: \oticc We observed that non-violent restraints were being automatically applied when a patient is intubated, without an assessment and appropriate documentation as to need. H83. 13i;oU) -US: A0117 Slaiidaul: Nolkv iA Rights; Hi tU.iH Si (}.}> 2h When appropriate, and after the RN's assessment, families should be involved in the effort to support the patient's care and to possibly avoid restraints. This intervention is not used or found on chart review. In addition, the required one-to-one intervention is only documented by a check list and not described to help fully understand the individual's care needs. There is lack of documentation as to the attempt to reduce the use of restraints in the majority of the charts reviewed. According to information derived from chart reviews, alternatives for restraints are rarely documented or observed. There was an instance where a patient's mother was at the bedside and she removed her son's restraints. She was advised that she could not remove them and was told to leave them on. This does not constitute is an acceptable practice as the nurse did not evaluate an alternative to use of restraints, such as the constant presence of the mother, to d e t e r m i n e if they can be d i s c o n t i n u e d . > IflA t3(c> 1 .\OrA-QI54 Standard: Restraints and Seclusion; oAAA oi m ;hi> ;:<. In order to evaluate compliance with Joint Commission documentation standards relevant to restraints, we conducted an audit of several medical records and found that even though the mandated actions appear as if they are in compliance, the standardized process in Epic fails to meet the content needs of the standard. The electronic record choices make all of the treatment plans look the same and not individualized to each patient. Restraints may be mentioned in the treatment plans but they are not specific to the patients' individual issues, age or other factors. As referenced in the Medical/Surgical Report Section 3.4, we found a 14 year old burn patient's plan o f c a r e for restraint use identical to that of a 60 year old man. ?48:. 13(c) TAG:A-0! 54 Standard: Rc-.,i;Arai :nki 5t.>>Jv<<8>>: P(' (ij (&* >\ i) Additionally, we note that the Hospital's restraints policy is fragmented into three or four policies and does not reflect the recent changes to restraints rules issued by CMS. Medical record reviews indicated a lack of documentation of a face-to-face assessment within one hour of the hold or seclusion. Further chart review found two records with restraint orders, yet the charts did not have documentation that would indicate the need for restraints. The documentation of restraint episodes is difficult to find and fails to document the patients' individualized care needs. ?482.Uiej<4>7 stand>>'!*! Restraints awi Seclusion: PCMM01 (F.P Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 63 Review of the daily restraint log for a six-week period of time ( 2 - 3 days per week) indicated an average of 60-70 patients are in restraints each day. Utilizing 65 patients as an average, this equates to 10% o f t h e entire Hospital census and 17% if WISH census is removed. An article in The Journal of Nursing Scholarship. 2007, 39(1)30-7, identified a use rate 50 episodes per 1,000 patient days or 5%, in a review of 40 acute care facilities. Utilizing this study, Parkland's rate is twice the expected rate. Quality Assessment and Performance Improvement (QAPI) As further discussed in the section on QAPI (Section 2.8) there is a lack of departmental and patient population-specific quality monitoring and improvement activities. Nursing and patient care areas lack the required unit and population based Quality Assessment and Performance Improvement programs. Due to the currently divided structure in the nurse executive's role, there is an inability to implement an effective, ongoing program to measure, analyze, and improve the quality of nursing care, treatment, and services of each patient care area. ?482.21 I AG: A-02&5 Conditions of Participation: Quality Assessment and Performance Improvement Program. $482~!3{a) TAG: A-03.8i> Standard: Organization; SRM2.01 iU fEP /. 6> - ?.DM.'M.Ol (EP !] Conclusion The matrix reporting relationship for nursing within the Parkland organization structure adversely impacts the ability of nursing leadership to effectively and directly manage nursing and influence and monitor nursing practice standards and directly impact patient safety and quality of care. The current structure and executive role definitions do not meet the intent of Conditions of Participation in requiring a single registered nurse to be responsible for nursing services. The current fragmented structure has led to challenges in enforcing house-wide nursing standards and has contributed to issues regarding: o o o o o Inappropriate staffing ratios and mixes Undocumented nursing competencies Inconsistent documentation of plans of care Incorrect use and documentation of restraints, and Over-utilization of verbal orders. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 64 2.6 Human Resources The Human Resources Department (HR) is comprised of five areas: HR Administration, Benefits/Compensation, Leadership and Organizational Development, and Employee Experience, Workforce Planning and Recruitment, responsible for sourcing, recruitment and selection, training, orientation (onboarding), employee relations and administration of compensation and employee benefit programs. A key role of fIR is to support the organization's need for human capital by interpreting the requirements of the hiring department into a job description, develop key criteria including education, experience, skills and competencies required to perform the job and, finally, assist in the identification and management of the organization's talent. HR is also responsible for overseeing pay practices, HR policies and procedures with regard to merit, performance, promotion opportunity and progressive discipline. In as much, the HR function provides a crucial role in the heath care organization by assisting in the recruitment and retention of employees who will directly or indirectly provide and support patient care. The quality of the talent and human capital, in large part, determines the quality of the care, treatment, and services it provides. Our review of the HR function at Parkland indicates that the Department has not historically assumed a key role in helping to monitor and police the quality of the Hospital's employee caregiver staff. Until a change under Dr. Royer's leadership, the Chief HR Officer has not been an active participant at the tabic with executive leadership. As part of our review of the HR function, the Independent Consultant Expert (ICE) survey team reviewed documents, personnel files, and interviewed key personnel of the Human Resources Department to gain an understanding of the structure and effectiveness of the Department. Review of HR policies and procedures indicated some policies are inadequate to assure that there are competent staff consistently throughout the organization. Inconsistencies exist among different departments when it comes to managing employees particularly with regard to progressive discipline and management competencies. HR Administration HR Administration is comprised of support staff for all operational divisions of the Department. Executive assistants and support staff for all areas of HR report to the Director of this Department. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 65 Benefits/Compensation The Benefits/Compensation Department is responsible for benefits administration, payroll, Human Resources Information System (HRIS), data management, maintenance of personnel records and oversees the personnel and activities of Occupational Health. Leadership and Organization Development Department The Leadership and Organization Development Department (LOD) was initially designed to work with hospital division/department leadership to support their business strategy and objectives. Over the past three years, the primary function of the Department has been to provide tools and education to develop leadership skills for management personnel of Parkland. Within the past four months, HR has discontinued the leadership enhancement activities. It has been refocused on the re-design of the Department with priorities of a performance management system, employee training programs, efforts to enhance employee engagement and patient/customer satisfaction. The decision to revise the focus of the LOD Department was a result of the Hospital's latest unfavorable CMS survey as well as two other factors - the employee engagement survey and patient satisfaction survey scores. The first was an organization-wide employee engagement survey that was conducted by Parkland in April 201 I, results of which placed the hospital in the 50 lh percentile in a national healthcare database. The employee engagement survey indicated that there was a high rate of employees who considered leaving the organization or felt that senior management was not concerned about them. Many employees felt that they were not involved in decisions that impacted their environment as well as infrequent recognition of a job well done and infrequent feedback on their performance. The second was a patient satisfaction survey scores that placed the Hospital below the 20 lh percentile compared to organizational peer groups. A draft outline of the objects of the LOD indicates a primary focus will be on redesigning the performance management system and increasing patient/customer satisfaction through an education process for Parkland employees. Employee Experience Department The Employee Experience Department is comprised of eight Business Partners who act as liaisons between hospital management and employees. Each Business Partner is assigned to a specific Parkland operational division. Business Partners assist divisional management with employee relations issues related to corrective actions, coaching/conferences, performance appraisals, and resolving employee grievances, etc. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 66 The business partner model which has been in effect for three years is still perceived as a "relatively new" concept to the Hospital. An ideal business partner model requires HR to be closely involved with their divisions to include strategic planning, talent management and succession planning, as well as understanding customer issues and operational challenges. "employee relations" function. The Employee Experience Department is also responsible for the maintenance of the HR Policies and Procedures. It was reported that the policies and procedures were reviewed for accuracy by the Director in June 2011. The Director stated that the policies and procedures are reviewed every three years to ensure relevance. There is no formal cross-functional committee responsible for policy review which would be a fairly common practice in other organizations. Workforce Planning and Recruitment Workforce Planning and Recruitment is responsible for recruiting and hiring all employees except physicians, Certified Registered Nurse Anesthetists (CRNAs) and Psychologists. The Department is responsible for hiring Nurse Practitioners (NP) and Physician Assistants (PA), however, the Medical Staff Office is responsible for credentialing those individuals. The recruitment team is comprised of nine Recruiters, two Senior Recruitment Specialists, and one Executive Recruitment Specialist. Nurse recruiting is performed by all of the nine recruiters. The two Senior Recruitment Specialists coordinate the Recruiters and provide specialized assistance when necessary. These Senior Recruiters are the only Registered Nurses on the team. The Hospital outsources the pre-employment screening function through a third party vendor. The vendor performs the CMS required background checks, work history, criminal checks, education verification, professional licensure/certification verification and primary source validations The ICE survey included a review of personnel files of currently employed and recently terminated employees. Background checks were present and appropriate in all personnel files reviewed. Findings: Talent Management Parkland provides a career path promotion model which allows employees to advance job codes. This career path is initiated by a supervisor. The system enables supervisors to promote employees on the career path to higher job grades without posting an open position. There is no formal career plan model for management levels. Historically, the HR Department has not been an active participant in the executive leadership decision making process such a deciding who is qualified for promotion to management The business partner model at Parkland, perhaps due to cultural challenges, operates as more of an Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. At positions. The ICE team was unable to determine the current management selection process. While management competencies exist, they are broad and not individualized for the requirements of the position at a specific time. As management vacancies occur, there should be a more comprehensive evaluation taken to ensure that the appropriate individual with the required competencies is identified to fill the role and the organization is not acting precipitously to just fill a vacancy. In order to sustain change in the organization, the most qualified individuals must be in leadership and management roles to lead the change. The organization has been resistant to succession planning in the past. No formal plan is in place at this time. HR recognizes the organization's need a succession strategy, however until the CMS survey is complete, they do not feel it is a priority at this time. Corrective Action Plan Policy (Progressive Disciplinary Process) Parkland's Corrective Action policy provides guidelines for progressive disciplinary processes based on prohibited behavior and performance issues. Depending upon the level of unsatisfactory behavior, employees are counseled through a process which entails a combination of 1) coaching conference, 2) written warning, 3) written counsels, 4) final warning, and 5) termination. Investigative suspensions may be used before termination as well. Parkland views the corrective action policy as a method to notify employees of work deficiencies to help them improve and contribute to the goals of the department. The policy does not require intervention by the HR function until the written counsel stage of the process. This practice has resulted in inconsistent verbal counseling for similar offense in the different departments Parkland policy provides two tracks of corrective action: one for attendance which includes absences and tardiness and one track for all other prohibited behavior (including poor performance). Employee attendance occurrences are reviewed utilizing a point-based system combining all time and attendance based issues. This includes not clocking in/out, tardiness, unscheduled absences, unapproved absences and incomplete shifts. Corrective action for attendance is based on "number of occurrences" in a twelve month period. Occurrences are monitored by the HRIS (PeopleSoft system) and when a threshold is reached, an automated message is sent to the employee and supervisor. HR is not advised of the infraction and does not monitor occurrences of attendance violations. Points are accumulated on a rolling 12-month cycle. Six occurrences result in a written warning from the department supervisor, eight occurrences result in a written counsel, nine occurrences result in a final warning and ten occurrences result in termination. Employees can reduce the number of points on their record by attending an Attendance Self Improvement Class or remaining occurrence-free for three months. The corrective action for attendance issues is ineffective. The structure of the progressive disciplinary plan enables employees to manipulate the system by their ability to monitor the number of occurrences they accumulate and how they fall into the 12-month rolling average. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 68 Furthermore, the automated system stops at the supervisor level and does not include a review by HR. Unexpected, unplanned and excessive absences cause disruption to a staffing plan and sometime result in care capacity issues and/or delay in patient care. The disciplinary process for unsatisfactory behavior for all issues other than attendance including poor performance is based on a corrective action policy grid which indicates 1) first level of corrective action is a written warning, 2) followed by a written counsel, 3) followed by a final warning, and 4) finally termination. The grid is subject to interpretation and is left to the judgment of the supervisor who has no obligation to involve the HR Department in the event of a written warning. Until most recently - December 2011 - HR did not even have access to patient safety reports which might include patient safety incidents related to specific employee actions and therefore could not follow up on any of the incidents that might require start of progressive discipline process and/or immediate termination of an employee. The progressive disciplinary process is not consistently applied throughout the organization and is reliant on the sole judgment of the department supervisor. Initial "Coaching Conferences" and "Written Warnings'" are the responsibility of the department supervisor and are not monitored by HR. Interviews indicated that there is a great deal of subjectivity in the corrective action program, and supervisors and managers can use a wide breadth of judgment to determine what disciplinary action will be taken. The reliance on individual supervisors to "interpret and enforce" policy guarantees variation in compliance and outcomes given each supervisor's own individualized approach, experience, management style and education/knowledge of HR policies. The intention of employment-related policies and procedures is to ensure a consistent approach across the organization. Personnel files were reviewed of employees who had been recently terminated "with cause" to understand the progressive disciplinary process and "test" its effectiveness. During staff and management interviews it was stated the disciplinary action varied depending on the manager. Some individuals are given a longer disciplinary process than others. Examples of this behavior were noted in the personnel files reviewed. Final warnings were followed by three months with no attendance violations, and when points dropped off the employee record, an attendance violation occurred again. In one reviewed file, the cycle continued for five years. This degree of subjectivity was mirrored in annual performance appraisal ratings. In most files we reviewed, employees with recurring attendance or job performance issues were given satisfactory performance appraisal ratings. It is also noted that the rating system in the performance appraisal does not lend itself to indicate a problem employee. Categories on the performance appraisal are not weighted by importance and are aggregated with the identical weights. Therefore, a low score in professional behavior carries the same weight as a low score in attendance. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. The following is an example of a personnel file that reflects the inconsistency in documenting unsatisfactory employee behavior and then providing a satisfactory annual performance evaluation. In this example, the progressive discipline policy was not followed as multiple "final warnings" were provided before termination actually occurred. When questioned, a senior HR leader relayed that final warnings were in effect for one year. We were unable to locate that specific element of the policy within the policy statement. Additionally, the timeline indicates a lack of adherence to hospital policy in regard to "final warning". Sample Personnel File Reviewed Date Corrective Action / Evaluation , Written Counsel Written Counsel Annual Evaluation Written Counsel Final Warning Annual Evaluation Annual Evaluation Prohibited Behavior / Evaluation Score ' o ' . y: t - , 8/24/06 8/28/06 8/1/07 8/21/07 4/22/08 8/1/08 8/1/09 Employee was rude to patients Poor performance Employee rated as "fully successful" Employee did not assess infant in her care Poor patient care Employee rated as "fully successful" Employee rated as "fully successful" received a low score on patient satisfaction 10/10/09 12/10/10 6/3/11 Final Warning Annual Evaluation Final Warning Lack of compassion with patient Employee rated as "meets expectations" Gave patient a larger dose of morphine than ordered, failed to complete documentation, inaccurate documentation 12/2/11 Termination Discharged a patient without being seen by physician Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 70 Ai Corrective Actions 1,200 1,000 800 600 400 200 0 428 269 142 Attendance SFY09 FY10 M FY11 1,038 922 419 262 164 Behavior ^s Work Performance Corrective Actions -- Generally when an organization experiences high volume of absenteeism. there is an underlying reason for this abuse. reasons within the scope of llie ICE survey. We were unable to identify these underlying Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 71 Reasons for Termination 201 Other 246 Co-Workers 1 IFY09 o FY10 i FY11 9 8 10 10 10 14 20 12 Rewards Leave of Absence Management : 6 7 18 Job End 24 42 34 Health Work Performance Retirement Inappropriate Behavior Family Advancement 50 84 100 150 200 250 Reasons for Terminations - The following graph represents terminated employment in FY 2009 - FY in FY 2011, were /hose seeking advancement in more stable environments. outside of Parkland. independent qualified and high performing We did not do additional 2011. 43% of the terminations During challenges limes or limes of uncertainly in organizations, personnel seek to find employment research into the specifics of the spike in leaving voluntary terminations Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 72 Quality Asscssmcnt/Pcrformance Improvement The HR department measures indicators such as turnover, number and type of corrective actions, time to fill open positions, but is not involved in a performance improvement program that is integrated with the hospital. ?48?.?! o>oo:o:,< 1 ! D.iU.04.oi (HP h A Turnover and "Time to Fill" are generally well accepted metrics for evaluating the organization's ability to recruit and retain personnel as well as the HR Department's cycle time for placement of personnel within the organization. Comparison Metrics \r . J; ?F%2QIQI FY2011 74.2 62.6 11.6% 12.5% 8.3% 10.6% 69.6 60.6 12.8% 13.2% 10.0% 11.8% FY2012 72.1 64.7 13.7% 17.5% 10.7% 14.8% Days to Start - All External New Hires Days to Start - Nurse External New Hires Turnover Nurse Turnover Voluntary Turnover Nurse Voluntary Turnover Nursing which is generally the largest employee group of any hospital/health system has had an increasing turnover rate of those leaving Parkland voluntarily. Again, increases in voluntary terminations during limes of crisis should be evaluated by the organization to ensure there are retention measures in place to stabilize and prevent erosion of qualified and high performers. Conclusion HR function has not participated as a member of the executive leadership team which generally signifies the importance of the role of HR (in recruiting, retaining and rewarding employees). This lack of oversight has allowed many HR policies to be inconsistently enforced in the organization. Some employees with performance concerns lacked corrective action plans and were allowed to remain working in patient care areas. l,D.02.0.>.> DPI In addition, we found the annual core competencies in the patient care areas were not adequate to ensure that clinical staff are receiving proper training unique to their patient population as evidenced in Competency Validation list supplied by Clinical Education. ?482.2?t?5(5): JAG: 0397 ! IR.Oi PC.01 TP I License Verification Workforce Planning and Recruitment is responsible for licensure verification during the hiring process. Licensure verification from the Board of Nursing is required before the nurse can begin work. Nursing Administration reports that documentation of license verification is not consistently provided at time of hire by Workforce Planning and Recruitment. The failure to consistently complete this process before an employee begins work could cause a nurse to be on duty without licensure verification. The fail safe practice for Nursing Administration is to ensure that license has been verified BEFORE the new employee is entered into the Automated Nurse Scheduling Office System (ANSOS). The units that do not utilize ANSOS as a scheduling tool do not have that fail safe measure in place. Verification of licensure which is "owned" by Workforce Planning and Recruitment must ensure they provide this service timely for every single n e w hire. * f i(c) ? \ G : - W << ^ ' . * 5S2.23(b1{2) t AG: .v-?C^-? . H j. 6) Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 75 2.7 House Wide Issues 2.7.1 Patient Safely/Patient Rights Patient Rights ?482.13 CUm4itioa of I'saruVipaiion: Portent's iRighlft A Imspilai nsmk-eS ltrowoli; cacii }>ai4curt$ rigftts. The Medicare Conditions of Participation protecting patient rights are fundamental obligations of every hospital provider. These conditions govern every aspect of a patient's care and interaction with a hospital, its employees and medical staff. These rights - detailed in the sections below include the right to: be informed and consent to treatment decisions; be assured privacy and dignity in care settings; be free from abuse and harassment; be assured a safe environment for care; be protected when the use of restraints or seclusion are medically warranted; and have medical information protected and kept confidential. The patient complaints and adverse patient care events that triggered the CMS and State surveys starting in 2008 and continuing through the summer of 2011 focused on allegations that patient rights were not respected, or worse, that Parkland patients suffered abuse. CMS initiated its first survey in the fall of 2008, following the death of a patient in the emergency room following a prolonged wait. The CMS findings resulted in a line of $50,000 and findings of two EMTALA violations. CMS and State surveys also resulted in 2010 and 201 1 from the complications related to the treatment of a patient who underwent a partial knee replacement, which ultimately resulted in the amputation of the patient's leg above the knee. As a result of the CMS and State review of this case, Parkland was cited by DSHS and CMS for deficiencies around: Governing Body - awareness; Medical S t a f f - accountability to governing body for quality of care; Documentation - date & timing of entries; Patient Safety; and Performance Improvement. The most notable episode involving allegations of patient rights concerned a psychiatric patient who died in February 2 0 I I , while in seclusion. This episode, along with an investigation into two other psychiatric patient deaths, led to a survey in May 2011 with a "Condition Level Deficiency" findings by CMS and the State. A full hospital survey and a follow-up survey in July 2011 and August 2011 led to CMS "immediate jeopardy" findings on EMTALA and infection control violations. During our survey period beginning November 8, 2011, through the time of this report, we continued to observe or were made aware of patient events where patient rights and safety may have been compromised. During our survey period several patients eloped from the hospital, many while under direct one-to-one observation. One of those patients who eloped was being watched for suicidal ideation and managed to run into a busy street before being recovered. Another psychiatric patient in the Main Emergency Department (ED) was able to evade a one-to- Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. one sitter and eloped off-campus before being recovered by the Parkland Police Department. Yet another patient in the medicine unit under Apprehension by a Peace Officer Without a Warrant (APOWW) and under one-to-one observation went to the bathroom and left the floor; the patient returned on his own after a two hour absence. Several other patients were able to elope or leave without being properly clinically discharged (e.g., having ports and lines not properly removed) and not given proper discharge instructions. One patient, who had been discharged, was found wandering in front of the Hospital without a shirt on with EKG stickers still affixed and had an unsteady gait. The patient had no ride home and was waiting for a train that docs not run on Sundays. The patient was recovered for reassessment and given transportation home. Between September 1, 201 I and November 30, 201 1, the hospital had nearly 200 reports of patients who eloped or left against medical advice. During our survey period, we identified several patients who were discharged with minimal and ineffective discharge instructions and assistance, including psychiatric emergency room patients who were discharged with bus vouchers and instructions to "call 911" in the event of recurring suicidal thoughts. Another patient presenting to the ED intake nurse reporting suicidal thoughts was sent to a waiting area un-escorted and was not assigned a patient by a one-to-one sitter or immediately escorted to a physician or nurse for triage. The patient eloped after approximately 30 minutes of waiting. Following an intensive search by the Parkland Police Department, the patient was ultimately recovered at his apartment and returned to the Hospital for treatment. A nursing home patient presenting to the ED, suffering from a traumatic brain injury (TBI), was left unattended in soft restraints in the Emergency Department, fell off of his chair and sustained possible head injuries. During our survey we also noted multiple instances of ED patients not receiving attention, triage or a medical screening examination (MSE) in a timely manner. In one instance on a weekend evening shift, our surveyor observed a mother with her young child lying under the water fountain in the Emergency Department waiting area. The intake nurse was unaware of the women and child's status, and in fact, was reading homework materials when interviewed by our surveyor. During another day shift, we observed a patient in the ED waiting area, seated in a waiting chair with an IV bag being held by the patient's friend. The patient appeared to be in visible pain and was urinating on the floor while the friend attempted to contain the urine in a bag. The patient had arrived by ambulance but was sent to the general waiting area. We inquired with the intake nurse why the patient had not been escorted back for treatment. Our surveyor remained on the scene until the patient was escorted to a room for assessment and treatment. In another incident, an Emergency Department patient who had been triaged and given an MSE, but was kept waiting for an additional 14 hours before it was noticed by a staff member that the patient's care had not been completed. ?489.2*1; Special Responsibilities of Medicare i ioi^iioif in i-.nUTgfev'\ Casi's Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 78 An inpatient with cerebral palsy, in a wheelchair, on the outside rear entrance deck to the ED, sustained facial injuries after being assaulted by a hospital visitor while the patient was seated on the ED entrance deck. In a Dallas County juvenile facility where Parkland runs a medical clinic, failure to follow security procedures led to a pharmacy breach where medication was stolen by juvenile inmates and ingested, ultimately leading to adverse reactions which required several of the juveniles to be transferred to the Parkland emergency department. During our survey period, the following safety errors in inpatient, procedural, and specialty units were investigated: burn to a patient due to mis-firing of the electrosurgical cautery device during surgery; medication errors that may have contributed to the death of a patient due to respiratory arrest based on a drug being administered to the patient by a nurse without a written or even a verbal order for the medication; wrong site thorancentesis; and a transfusion error in the administration of a blood product for one patient intended for another patient. During our survey period we also noted that "crash carts" (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel especially during efforts to resuscitate a patient experiencing cardiac arrest) were not properly monitored or stocked. $482.4 U * ) T A G : 0 7 0 ! Slandard: Building. EC.02.04.03 (EP3) PC.G2.0l.ll ( E P 2 . 3 ) . And, as noted below and elsewhere in this report, medical restraints are being applied without proper documentation and medications administered for intent to manage pain for sedation with minimal documentation of the clinical effect and assessment and re-assessment of the patient's response to the medication. In total, between October 2010 and the end of November 2011 the hospital experienced almost 50 "sentinel events" as defined by Joint Commission sentinel event criteria. Finally, as noted elsewhere in this report, we found numerous instances where the environment of care was compromised by physical plant problems, hallway obstructions or lapses in infection control procedures. While improvements and changes are underway to further protect patients, such as heightened training of one-to-one sitters, in order to address elopements, improvements in security and better discharge planning and assistance - Parkland continues to experience events that violate patient rights. This environment continues to present risks to patients and presents challenges to the assurance of a safe care environment for patients and respect for patient rights as mandated by the Medicare Conditions of Participation. All of the episodes noted above that have occurred during our survey period, individually and taken together, suggest that the Hospital is not currently meeting the conditions in ?482.13 related to the Protection of Patient Rights. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 78 A & M Obligation to Inform Patients of their Rights t; t82.iJ<;i)( I) A hosfiit;d atusl iiil'mm ciu'h patient. 01 uIk-u appropriate, the patient's representative (as H?lon< ti under State law). of flic patient's rights, in advance of furnishiug di discontinuing partem care \U>>ene\er possible. Hospitals must inform every patient, or when appropriate, the patient's representative as allowed by State law, of the patient's rights. Whenever possible, this notice must be provided before providing or stopping care. All patients, inpatient or outpatient, must be informed of their rights as hospital patients in a language or manner that the patient (or the patient's representative) can understand. Additionally, every Medicare beneficiary, who is an inpatient (or their legal representative), must be provided the standardized notice, "An Important Message from Medicare" (IM), from the hospital within two days of admission. The IM is a standardized Medicare form and cannot be altered from its original format. The IM is to be signed and dated by the patient to acknowledge receipt. Medicare regulations require hospitals to present a copy of the signed IM in advance of the patient's discharge, but not more than two calendar days before the patient's discharge. In the case of short inpatient stays, however, where initial delivery of the IM is within two calendar days of the discharge, the second delivery of the IM is not required. Parkland has written policies and procedures governing patient admissions practice. We reviewed these policies, which appear to require provision of the required notices to all patients and the required "Important Message from Medicare." During our survey visits to outpatient clinics we observed instances of clinic staff discussing the patient rights information with patients. During our survey of the Health Information Management (HIM) Department (the service in charge of medical records maintenance) we discussed the Parkland procedures for providing patients with information on patient rights and for Medicare patients to receive the IM. However, during our chart reviews we saw evidence to suggest that patients were not always provided with information on their rights and that Medicare patients were not receiving their IM. Of charts reviewed, 20% did not have evidence that patients received documentation regarding their rights. Of the Medicare charts we reviewed, over 50% of the charts did not include a signed "Important Message from Medicare" form. We did not see evidence that any IM form was signed prior to discharge. As such, wc do not believe that all of the elements of this standard are met. j;q i '.<<<<< I > i M'i: A-ON ? SPIKJSH: Nvrficeof Rights- Rid 1.01.01 ;SP-3* Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 79 /Is Patient Complaints and Grievances ?482.13(a)(2) The hospital musl establish a process for prom pi resold (ion of patient grievances and must inform each patient w Itoin to contact to file a grievance, The hospital's govern iug bo must approve and be responsible for the effective operation of i lu* griwanee process, and must review ami resolve grievances, unless it delegates the responsibility in w riting f > :i grievmce committee. 'I lv grievance process must include a < mechanism for timely referral of patient concerns regarding (ptnlitj of care or premature discharge to the appropriate Ltilization and Quality Control Quality Improvement Qrgntiiztition. At a minimum: ?482.l3(a)(2)(i) The hospital must establish a clearb explained procedure for the submission of a patient's written or verbal grievance to the hospital. ?48.\13{a)(?)(ii) I he grievance process must specify time frames for review of t he oM'ie anoc ?ntj the pro*, ision of a re,spunse. S ' taX-H''" !a iiN resolution of i>>e grievance, the hospital must provide (he patient with written notice of its decision that conrain - the name of the hospital contact person, the steps taken oa behall"of ihe patient to investigate the grievance, the results of the grie\a nee process, and the dale of completion. Medicare CoP require that every participating hospital have a formal process for promptly resolving patient complaints and grievances. Patients should have reasonable expectations of care and services and the facility should address those expectations in a timely, reasonable, and consistent manner. Although the Medicare CoP, on grievances, sets forth specific time frames and documentation for a response to a grievance, Medicare also expects that a hospital will have a process to comply with a relatively minor request in a timelier manner than a written response. For example, a change in bedding, housekeeping of a room, and serving preferred food and beverage may be made relatively quickly and would not usually be considered a "grievance" and therefore would not require a written response. Hospitals must inform patients or their representatives of the internal grievance process, including who to contact to file a grievance (complaint). As part of its notification of patient rights, the hospital must provide the patient or the patient's representative a phone number and address for lodging a grievance with the State agency. The hospital must inform the patient that he may lodge a grievance with the State agency directly, regardless of whether he/she has first used the hospital's grievance process. Parkland has an established department to receive and review patient complaints and grievances. The Hospital has a written procedure that addresses two types of patient complaints, and Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 80 provides definitions accordingly. A "complaint" is defined as dissatisfaction expressed verbally regarding care or other concerns. This does not include allegations of abuse, neglect, or harm. A "grievance" is a formal or informal written or verbal complaint by a patient regarding abuse, neglect, or issues related to the Hospital's compliance with CMS Conditions of Participation, or any written complaint, or any complaints that the involved staff are not able to resolve within their shift. The Patient Relations Department (PRD) tracks and manages both patient complaints and grievances. There are monthly Grievance Committee meetings. The minutes reflect the Committee's review of the grievances and generally its action plan to resolve the concern. While there is general compliance with documenting the action plan, there are some months that the action plan/conclusions are blank. The A&M team was told that the timeline to respond to patients within 48 hours is tracked and that the timeline is being met, but the reporting of this result is manual and that no data was available to review during our survey period. The most recent report to the Parkland BOM regarding grievances was for the time period, July 2010 - March 2011. A breakdown of complaints and grievances was presented by hospital division, e.g., WISH, Medicine, etc. The breakdown only shows a pie chart of top five complaints and grievances (e.g., "rudeness/attitude of staff') and does not show resolution and actions taken in order to improve the results. The only action plan defined was that the division leader would present data at the Performance Improvement Committee (PIC) meeting. Actions need to be measurable and monitoring should reflect trends of issues and concerns in which leaders can respond, such as a breakdown by department, etc. While the Grievance Committee is working to meet the intent of the CMS standards, there is not full compliance at this time. Plans of Care P'l8?.!.>(t>>)(!) T h e paiiesif h a s t i t e r i g h t t o p a r t i c i p a t e in ft<< d e v e l o p m e n t i m p l e m e n t a t i o n of h i s o r h e r p ? a >> o f cu r e . This CoP requires the hospital to actively include the patient in the development, implementation and revision of his/her plan of care. It requires the hospital to plan the patient's care, with patient participation, to meet the patient's psychological and medical needs. The patient's (or their representatives) right to participate in the development and implementation of his or her plan of care includes, at a minimum, the right to: participate in the development and implementation of his/her inpatient treatment/care plan or outpatient treatment/care plan; participate in the development and implementation of his/her discharge plan; and participate in the development and implementation of his/her pain management plan. During our survey, we observed several instances of incomplete or lack of individualized plans of care. During our survey we also observed several instances of incomplete pain assessments and reassessments post medication. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 81 Based on our survey and interviews, we do not believe this standard is met. Informed Consent to Treatment ? 4 8 ? . I 3 { < ) j ( :.) '?'he patient or o r V >> - r ^ i r c . M s j f H i h v (o>.',t,Um ' t:. ?.-mi d i w g b i s w b e i n g i n l m inert o f h b o r h e r h e a f i i i s t a t u s , b e i n g s u v y h e d in c a r e p l a n n i n g a a d treaimeusV bein.n able to rcqu&TD o r refaM' trcjstinesH. i'lvis right JKWSJ unnecessary or i n a p p r o p r i a t e . CR KT b<>, isioa of t r e a t m e n t o r services d e e m e d medically The right to make informed decisions means that the patient or patient's representative is given the information needed in order to make, "informed" decisions regarding their care. A patient may wish to delegate his right to make informed decisions to another person (as allowed under State law). During our survey, we were advised of a patient whose surgery had to be terminated prior to the beginning of the surgery but after anesthesia had been administered because no signed informed consent for treatment existed for the procedure or anesthesia. On another occasion, the anesthesia consent had an incorrect anatomical site written on the form. The anesthetist crossed out the wrong site and wrote in the correct site. Parkland policy does not have language to guide staff on the steps to correct consents and if cross outs are allowed and specifically should cross outs be used to correct anatomical sites. The consent policy also does not have any language when patient signs in the wrong place. A patient signed, in error, in the section of the anesthesia consent that states the patient had taken a narcotic within the last six hours. In reviewing patient safety events over the last two months, we noted an event where, though the nurse attempted to w o r k with multiple physicians to potentially obtain patient consent, the patient did not give consent for moderate sedation but was still sedated at the end of the procedure being performed. Finally, through our review of the safety reports, we saw a report of a surgical resident placing a femoral arterial line both without consulting the primary team or documenting patient consent. Based on our survey and interviews we do not believe all elements of this standard are met. A d v a n c e Directives ?-t82. 1.3(b)(3) The patient has the right to formulaic advance directives and to have hospital staff !i ; practitioners \\ ho pro- ide arc ii the hospital comply \\ ith these directives, iti Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. :n Coiilaiu't: pntviilci s'}. ' ! ?O.Iflf) u (his pit. i (Dclinition). ?489.102 of this |Wrt (Ri>qiiircnen(s fer i; ifi4). 10-1 im' tiiis pari. Medicare defines an "advance directive" as "a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated." Every patient, whether inpatient or outpatient, has the right to formulate advance directives, and to have hospital staff implement and comply with his advance directive. Medicare regulations specify the rights of a patient (as permitted by State law) to make medical care decisions, including the right to accept or refuse medical or surgical treatment and the right to formulate, at the individual's option, advance directives. Parkland has a policy and procedure on Advance Directives. Additionally, as part of both the inpatient and outpatient admission processes, patients are to be provided with information about their right to have an advance directive. Admin o-0S Patieni Sa*fDowmi?nation \ct Our survey documented that the existence of Advanced Directives are initially queried at the time of admission. The existence of an Advance Directive is also asked during the initial nursing assessment. Our chart review found documentation that nursing and admission staff had asked about the existence of an Advance Directive. Wc did not observe any charts or observe in interviews, however, instances where the patient asked for further information on Advance Directives if they answered "no" to having an Advance Directive. The pamphlet given to patients on Advance Directives is not included as a part of the medical chart. To document receipt of the information on Advance Directives, the patient signs a statement during the admissions process regarding advance directives and their right to ask for additional information on Advance Directives. Patient signatures on this issue were validated on chart review. Based on our survey and interviews we believe this standard is met. Family Member and Physician Contact ooIN." . . - . ; : ) . ' h " | >? ; !t;l|i h i t * 0.<<: U> hs>>Vt ? f >> ! ' >> ! h ?HVm ) M rCfi?'i'SCfVlTiiiVP \?S" h i s Of 5k-;- d i o k e and his pi' Nsr << << n piiy sfciaK notified ptoi8?{??i\ <> to the hospital. For every inpatient admission, the hospital must ask the patient whether the hospital should notify a family member or representative about the admission. If the patient requests such notice and identifies the family member or representative to be notified, the hospital must provide such notice promptly to the designated individual. The explicit designation of a family member or representative by the patient takes precedence over any non-designated relationship. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 83 The hospital must also ask the patient whether the hospital should notify his/her own physician. In the case of scheduled admissions, the patient's own physician likely is already aware of the admission. However, if the patient requests notice to and identifies the physician, the hospital must provide such notice promptly to the designated physician, regardless of whether the admission was scheduled in advance or emergent. When a patient is incapacitated or otherwise unable to communicate and to identify a family member or representative to be notified, the hospital must make reasonable efforts to identify and promptly notify a family member or patient's representative. If an individual who has accompanied the patient to the hospital, or who comes to or contacts the hospital after the patient has been admitted, asserts that he or she is the patient's spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide this individual information about the patient's admission, unless: A. More than one individual claims to be the patient's family member or representative; B. Treating the individual as the patient's family member or representative without requesting supporting documentation would result in the hospital violating State law; or C. The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient's spouse, domestic partner, parent or other family member. Based on our survey and interviews we believe this standard is met. Personal Privacy All patients have the basic right to respect, dignity, and comfort. "The right to personal privacy" includes at a minimum, that patients have privacy during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate. The right to personal privacy also includes limiting the release or disclosure of patient information such as the patient's presence in the facility or location in the hospital, or personal information such as name, age, address, income, health information without prior consent from the patient, as required by the federal Privacy Rule. However, patients that are admitted due to emergency circumstances may not wish that family members or significant others be uninformed Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 84 as to their presence or status. The hospital should have procedures in place, in accordance with State law, to provide appropriate information to patient families or significant others in those situations where the patient is unable to make their wishes known. People, not involved in the care of the patient, should not be present without the patient's consent while the patient is being examined or treated. Video or other electronic monitoring/recording methods should not be used while patients are being examined or treated without the patient's consent. If an individual requires assistance during toileting, bathing, and other personal hygiene activities, staff should assist, giving utmost attention to the individual's need for privacy. Privacy should be afforded when the physician or other staff visits the patient to discuss clinical care issues or conduct any examination. During our survey, we were made aware of a complaint that Resident Physicians used a cell phone camera to lake photographs of a patient's surgery. We did not see evidence that the patient consented to the photography in accordance with the Hospital policies on photographing or filming surgical or care procedures. We were advised that the Residents were counseled for this breach of patient privacy and their failure to follow Hospital policy and procedure. In the community-based clinics there were observations of patient privacy rules and policies not being followed. We observed patients standing in a clinic laboratory doorway waiting for their blood to be drawn while another patient was in the laboratory. The patient in the doorway watched and heard all conversations between the lab technician and the patient in the laboratory. During our survey, we learned of an incident in the Emergency Department where a patient with a medical condition that the patient did not wished to have shared with family members was nonetheless shared with family members when Emergency Department staff conferred with the patient's family members. At the check in desk of the Main Emergency Department, patients and visitors are requested to stand behind a red line in order to protect patient privacy. It was observed frequently, that patients and visitors do not stand behind the red line and often are standing immediately next to the patient being interviewed by the intake nurse. Based on our survey and interviews we do not believe this standard is met. Safe Environment ?4H-2 J.3{c.i{2) - T h e fFflir<<>>>>t has rtgiti h> receiva* tare i s >i snfe <>hnsf o r h a r a s s m e n t The intent of this CoP is to prohibit all forms of abuse, neglect (as a form of abuse) and harassment whether from staff, other patients or visitors. The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment. The hospital must have Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 88 mechanisms/mcthods in place that ensure patients are free of all forms of abuse, neglect, or harassment. Medicare defines "abuse" as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. Medicare defines abuse to include: staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. The following components are suggested as necessary for effective abuse protection: A. Prevent. A critical part of this system is that there are adequate staff on duty, especially during the evening, nighttime, weekends and holiday shifts, to take care of the individual needs of all patients. Adequate staff would include that the hospital ensures that there are the number and types of qualified, trained, and experienced staff at the hospital and available to meet the care needs of every patient. B. Screen. Persons with a record of abuse or neglect should not be hired or retained as employees. C. identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect. D. T r a i n . The hospital, during its orientation program, and through an ongoing training program, provides all employees with information regarding abuse and neglect, and related reporting requirements, including prevention, intervention, and detection. E. Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment. F. Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment. G. Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law. Based on our survey findings at the beginning of this sub-section, entitled "Patient Rights", section 2.71, we do not believe all elements of this standard are met. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 89 Confidcn tialit y o F Patient Records and Medical 1 nlbrmation t?482.1J40) S l u m ! . ilr r ' r . i i l i ' . l c i i l i . t l ? i o? P a t h s >> ! Rccoiil.s ?CI* c l i n i c a l r e c o r d s . ? 4 8 2 . t 3(fi o f h i s Hospitals are required to have sufficient safeguards to ensure that access to all information regarding patients is limited to those individuals designated by law, regulation, and policy; or duly authorized as having a need to know. No unauthorized access or dissemination of clinical records is permitted. Clinical records are kept secure and are only viewed when necessary by those persons having a part in the patient's care. Parkland has extensive policies and procedures to ensure the confidentiality of patient medical information as required by federal law. Parkland also requires all employees to undergo initial and follow up education on patient medical information privacy. The Compliance Department is tasked with enforcing the Hospital's medical information privacy policies and conducting investigations regarding potential breaches. The Hospital has a Privacy Officer directing these activities in the Compliance Department. Parkland's policies and procedures on confidentiality of clinical records appear to meet the Medicare Condition of Participation standard and federal privacy law, however, during our survey, we were informed of a breach of patient medical record confidentiality when a patient's family members were advised about a patient's very sensitive and personal medical condition despite the patient's desire that no family member be told of that medical condition. This situation was referred to the Compliance Department for further investigation and action. Our review of the Health Information Management (HIM) Department, which is responsible for the integrity of the medical record, indicated that security is adequate for the department. The hospital utilizes an electronic medical record (EMR) on the Epic system. Epic leaves an electronic "footprint" whenever a record is accessed. Every employee or medical staff member with Epic access has a unique identifier and password, so HIM can maintain a record of everyone who has accessed a medical record through Epic. HIM is also capable of running special reports to document each individual who accessed a medical record on Epic. Additionally, if a Parkland employee or medical staff member makes a change to a medical record in Epic, the original entry is always retained and can be accessed, although not all staff members are aware of this feature within Epic. Based on our survey and interviews, we believe that most elements of this standard are met, however the confidentiality breach described above suggest training may need to be enhanced to prevent against similar disclosures in the future. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 90 Access lo Medicai Records hv Patients ? 'iS?.l -tdt(2) I he patient has die right to access nfnrmation contained in Ids or her -linical records within a reasonable nine frame. The hospital must not frustrate the legitimate effort<< of indb idnals to gain access to their own medical records and must actively seek to meet these requests' as quickly as its record keeping system permits. Federal law requires that patients should be allowed to inspect and obtain a copy of health information about them that is held by providers; and that providers may not withhold information except under limited circumstances. Parkland's HIM Department handles all internal requests for clinical records. Additionally, there is a service window outside of the HIM Department, which is open during regular business hours where patients can request copies of their medical records. Patients sign a release form and a copy of the record is printed from the electronic medical record (EMR). If the record is an older record, which does not reside on the Hospital's EMR system Epic, that record must be retrieved from a warehouse. Patients can have those records mailed to them or come in for a copy within two to three business days. Legal requests for medical records take somewhat longer, usually one week. But patients who personally request their medical record, and that record is in EMR form, get a copy of their record almost immediately. Patients, relatives, and lawyers or legal representatives are required to show proper identification in order to request any medical records. Individuals must "prove" their relationship, guardianship, power of attorney, etc., in order to obtain medical records for a patient. Additionally, when records are requested as part of a legal proceeding, through subpoena or otherwise, FIIM staff reviews the completeness and accuracy of the subpoena or other document in accordance with State law and federal privacy rules. Based on our survey and interviews we believe this standard is met. Protections Against Restraints and Seclusions ?482.13(e) S t a n d a r d : Restraint t>r secSasioa. All patient* have the d g b l to be free from physical or mental abuse, and corporal punishment. All paricnts have Che right to be free trim), restraint! or seclusion, of any form, imposed as a means of coercion* discipline, eoRveniiBiee>> o r vehuiaifem by staff. Restrain* or sccUision may >>fitly be imposed to ens<>fdr.tte physical o-afetj o f U m patient, a staff member, o r others and must be discisadiitR-ii :il itu: earuY..; possible dmc. The Medicare rules on restraints and seclusions are intended to identify patients' basic rights, ensure patient safety, and eliminate the inappropriate use of restraint or seclusion. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. AIs Every patient has the right to receive care in a safe setting. The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. Each patient has the right to be free from all forms of abuse and corporal punishment. Each patient has the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may not be used unless the use of restraint or seclusion is necessary to ensure the immediate physical safety of the patient, a staff member, or others. The use of restraint or seclusion must be discontinued as soon as possible based on an individualized patient assessment and re-evaluation. A violation of any of these patients' rights constitutes an inappropriate use of restraint or seclusion and would be subject to a condition level deficiency. The decision to use a restraint or seclusion is not driven by diagnosis, but by a comprehensive individual patient assessment. For a given patient at a particular point in time, this comprehensive individualized patient assessment is used to determine whether the use of less restrictive measures poses a greater risk than the risk of using a restraint or seclusion. The comprehensive assessment should include a physical assessment to identify medical problems that may be causing behavior changes in the patient. For example, temperature elevations, hypoxia, hypoglycemia, electrolyte imbalances, drug interactions, and drug side effects may cause confusion, agitation, and combative behaviors. Addressing these medical issues may eliminate or minimize the need for the use of restraints or seclusion. Staff must assess and monitor a patient's condition on an ongoing basis to ensure that the patient is released from restraint or seclusion at the earliest possible time. Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion should be discontinued. However, the decision to discontinue the intervention should be based on the determination that the need for restraint or seclusion is no longer present, or that the patient's needs can be addressed using less restrictive methods. Hospital leadership is responsible for creating a culture that supports a patient's right to be free from restraint or seclusion. Leadership must ensure that systems and processes are developed, implemented, and evaluated that support the patients' rights addressed in this standard, and that eliminate the inappropriate use of restraint or seclusion. Through their QAPI program, hospital leadership should: o o o Assess and monitor the use of restraint or seclusion in their facility; Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by State law and hospital policy when the use of restraint or seclusion is necessary. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 92 Patients have a right to receive safe care in a safe environment. However, the use of restraint is inherently risky. When the use of restraint is necessary, the least restrictive method must be used to ensure a patient's safety. The use of restraint for the management of patient behavior should not be considered a routine part of care. The use of restraints for the prevention of falls should not be considered a routine part of a falls prevention program. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence that the use of physical restraint, (including, but not limited to, raised side rails) will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries. In fact in some instances reducing the use of physical restraints may actually decrease the risk of falling. Parkland's recent history on the use of seclusion and restraints, particularly in its psychiatric treatment areas, is troubling. The initial CMS survey in May 2011 focused on the death of a patient while in seclusion. During our survey, we continued to find use of restraints not in compliance with the Condition of Participation standard. We noted written orders that were inconsistent with documentation of patient behavior. We noted patients who exhibited symptoms of violent behavior being placed in non-violent restraints for ease of staff as opposed to patient safety. We also observed that a patient's plan of care referenced use of restraints before the patient demonstrated behavior to require use of restraints. The Hospital is tracking the use and trends of violent and non-violent use of restraints. For violent restraints, their usage and the required assessment elements are reviewed daily. This process has been in place since October. The data and findings are forwarded to the Psychiatric Nursing Director and the EVP of Operations. One-to-one or 1:1 continuous monitoring during the first hour of seclusion or restraint is the area of greatest opportunity for the three month analysis. Lessons learned and action plans are documented, for each month. The lessons learned are the same for all three months of review. If the intervention hasn't worked after two months, new strategies are needed. It would be useful to provide a monthly total of findings but also provide a month to date total, to compare previous months to the current. It is necessary though to change interventions if there is no change in behavior. It is important to note, that for the Psychiatric Emergency Department, there is an overall decline in the use of seclusion for the department over the three months of monitoring. Non-violent restraints are also tracked, but have been less of a focus for the last three months. The non-violent restraint usage is entered into a national database and usage can be compared to other hospitals. The last two quarters of data are not available to review at this date to Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1/101el. seq., this information is confidential and privileged. At benchmark against other organizations. The number one reason for the use of non-violent restraints is the pulling/dislodging of essential medical devices. Results from the restraint analyses are reviewed in the Restraint Committee, and then forwarded to the Safety Committee of the House-Wide Quality Committee. As the restraint review process is relatively new for the organization, interventions should be analyzed for their effectiveness and either continued or changed. The use of restraints is a critical issue in the Medical/Surgical Units. The intent of a restraint is to protect the patient and staff from harm and avoid removal of medical devices. The decision to utilize restraints should not be driven by diagnosis but a comprehensive individual patient evaluation. The evaluation should include a physical assessment to identify medical problems that may be causing behavior changes in patient. Addressing these medical issues may eliminate or minimize the need for the use of restraints. When a restraint is ordered for a patient exhibiting violent behavior, the Epic system only allows the medical-surgical nurse to choose a non-violent restraint order. In addition, an order for nonviolent restraints requires less staff intervention and assessment which might be required for a patient exhibiting violent behavior. Review of a medical record revealed a patient described as requiring restraints for patient safety. The patient had a physician's order for wrist restraints for several days, then a second order for ankle and wrist restraints several days after that. There was no documentation of the patient's continued behavior or the required intervention for a less restrictive method to manage the patient. The order was repeated for 4 days. ?482.23. ?482. ?3(e) TACf:A-Di 54. PC.ti3.05.01 {Ft 1 3. 4} There is a general lack of knowledge surrounding proper ordering and documentation of restraints. Interviews with staff indicate confusion regarding the use of violent restraints. Some staff stated the violent restraint order set was for psychiatric patients only. Although the patient may be confused, if the main reason for use of restraints is behavior that exhibits hitting, biting, or scratching the violent restraint order set must be used. ^SJ'.iif^ TACr.A f)154; i'( '.<">?.,o5.01 (HPi. 4j. \ < i ; A 0 | 6 6 (-1) P('.(?3.(15.03 fgf> 57; 13. TAG: AO I Ri.Oi.Oi.Ol (1 p \ .ft It was observed that non-violent restraints are being automatically applied when a patient is intubated, without an assessment and appropriate documentation as to need. ?482.1L ?482 I U..A-0154 ssandanl Motiro o i ' l & m s . Hi. IAU'1 (MP 2' When appropriate, and after the RN's assessment, families should be involved in the effort to support the patient's care and to possibly avoid restraints. This intervention is not used or found on chart review. In addition, the required one-to-one intervention is only documented by a check list and not described to help fully understand the individual's care needs. There is lack of documentation as to the attempt to reduce the use of restraints in the majority of the charts reviewed. According to information derived from chart reviews, alternatives for restraints are Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 94 rarely documented or observed. There was an instance where a patient's mother was at the bedside and she removed her son's restraints. She was advised that she could not remove them and was told to leave them on. This is an accepted practice as an alternative to use of restraints (HP ? ; : 1 X 2 TAC?: AO i 15 RL?l ?! Of lEP ; and as an evaluation tool to determine if they can be discontinued. $43113(41 i AG.A-0154 /'; '>K2 I.He?;4)? A i \<,:A?IM> Pi' 5 Through the audit of medical records in order to evaluate compliance with Joint Commission documentation standards relevant to restraint, we found that even though the mandated actions appear as if they are in compliance, the standardized process in Epic fails to meet the content needs of the standard. The electronic record choices make all of the treatment plans look the same and not individualized to each patient. Restraints may be mentioned in the treatment plans but they are not specific to the patient's individual issues, age or other factors. For example, we found a 14 year old burn patient's plan of care for restraint use identical to that of a 60 year old man. P(' iU 0? lU (!.p i) (AiVA-OnA! Standard: Patient Rights: ?482.13fe)i4K<<> ? A ? j : \ 0 I 6 ( >> K tU.03.Hf iJ.P3.4j: In addition, we note that the current Parkland restraints policy is fragmented into three or four policies and does not reflect the recent changes from CMS. Our medical record reviews indicated a lack of documentation of a face to face assessment within one hour of the hold or seclusion. Further chart review found two records with restraint orders, yet the charts did not have documentation that would indicate the need for restraints. The documentation of restraint episodes is difficult to find and fails to document the patient's individualized patient care needs. 54R \ !3(-j}( TAX i:A ;u"A> ih'jOJK? IL ft-.P Ik J4K2.1.VM4 Kii)(a) TA<,:AOIVK P< O?Ji3 II O P A'. Review of the daily restraint log for a six-week period of time ( 2 - 3 days per week) indicated an average of 60-70 patients are in restraints each day. Utilizing 65 patients as an average, this equates to 10% of the entire hospital census and 17% if WISH census is removed. An article in The Journal of Nursiim Scholarship, 2007, 39(1)30-7, identified a use rate 50 episodes per 1000 patient days or 5%, in a review of 40 acute care facilities. Utilizing this study, Parkland's rate is twice the expected rate. S.>?;i ?%:: fA<=: i: TAC.-Atlifx>> (4): $48.1 IX TAG: A (?I I? Based on our survey and interviews we do not believe this standard is met. Visitation Rights ?4?>2.i3?Ji) Standard: Patient visitation rijilits. A iio.spital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any elininiHv ii>* t i n s s e c t i o n . ofhis or her tflsftaiSon r i g ! ? i s . i n c l u d i n g a.n\ c l i n i c a l r i . v 4 r k i i o u o r Hij&Itatio<< o n s a c ! ) r i g h t s , w h e u lie o r s h e is (2) Inform each pa dent (or support person, where a p p r o p r i a t e ) of the right, subject to his or her consent, to r c c e h e tfcf visitors whom he or she designates, including. but no! limited to, << spouse, a domestic p a r t n e r ^in-eluding >> s mje-3e> domestic p a r t n e r ) , auoiher family osertbi" . o>. a frcenil. .:<> vvsfhdrav. <>f deny such rouso^t af u*l\ time. (A- St.t 1 est 1 ict, limit, o r otherwise de<<> visitation privilege>> or t h e basis of race, color, national origin, religion, sex. gender identity, sexual orientation, or disability. (4) Knsare that all tisitors e>>jo\ fall and eqmd visitation j?r>>v$kges consistent with patient preferences. Hospitals are required to develop and implement written policies and procedures that address the patient's right to have visitors. If the hospital's policy establishes restrictions 01* limitations on visitation, such restrictions/limitations must be clinically necessary or reasonable. Furthermore, the hospital's policy must include the reasons for any restrictions/limitations. Parkland's policy on visiting hours is broad and addresses general hours of visitation, but lists those departments that are exceptions, with no limitations, e.g., Labor & Delivery, Emergency Services. The Hospital policy states that visitors in the main hospital will be given a visitor's pass by the unit charge nurse if they are going to be present after 20:00. This practice was not witnessed as a common practice on off shift surveys. If the Hospital's policy is to require the visitor's pass, then it should be enforced organizationally or the policy should be changed. No violations of the CMS Conditions of Participation and this standard were noted, but the Hospital is not following its procedure consistently. I oi.fll ?Li' 2 J O V Conclusion The patient rights and safety provisions in the Medicare Conditions of Participation are the cornerstone rights that must be assured for every patient in every Medicare hospital. These rights are guaranteed to all hospital patients, not only Medicare patients. From the number of adverse patient events cited throughout this section and throughout the report we do not believe that Parkland is currently guaranteeing these rights in a consistent manner to all of its patients. As we have discussed above, patients with special needs have not been properly monitored and have been permitted to injure themselves or elope and therefore were not provided with a sale environment. Patients who were ignored and not given timely triage and treatment in the Emergency Department did not having their EMTALA rights respected. Patients were neglected by being discharged from the Hospital without proper planning and assistance. And, patients whose medical information was shared with others against their will had their privacy rights violated. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 96 During our survey period w e have witnessed or been made aware o f patient care events and activities that violate most o f the provisions in the Condition o f Participation on Patient Rights including the standards governing: o o o o o o o o The right to receive required communications from Medicare The right to an e f f e c t i v e complaint and grievance process. The right to participate in and be k n o w l e d g e a b l e about their plan o f carc. The right to make informed d e c i s i o n s about their health care. The right to personal privacy and privacy o f their medical information. The right to receive carc in a safe selling. The right to be Ircc from abuse and neglect, and The right to be free from unnecessary restraints or seclusion. For these reasons w e d o not believe that most o f the standards regarding the Conditions o f Participation on Patient Rights are being consistently met at this time by the 1 lospital. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 97 2.7.2 Compliance of Laws and Uemilalions Hospital's participating in Mcdicarc must ensure that all applicable Federal, State and local law requirements are met. r r u u ^ . : I awih ! : A I'eik?"al SihW mid U>>ea! t m iaiii<><<: t eropi-i Elsewhere in this report we evaluate the Hospital's compliance with certain laws including laws on emergency medical treatment and patient privacy. Our analysis of the Hospital's compliance with federal laws on patient privacy, including its requirements under the Health Insurance Portability and Accountability Act (H1PAA) and the associated federal privacy and security regulations and state laws regarding confidentiality of medical records is further set forth in Section 2.7.1 regarding Patient Rights, and Section 3.9 regarding Health Information Management. Our analysis of the Hospital's compliance with federal laws on emergency medical treatment, specifically the Emergency Medical Treatment and Labor Act (EMTALA), are addressed in Section 3.1, Emergency Department, 3.2 Psychiatric Services and 3.3 Women Infants and Specialty Service (WISH). With respect to the consent decrees and other potential violations of federal or state laws f42 (TR jf.1H2.1 i ivlaud to the health and safe!v of ; the United States Department of Justice (DO.)) recently moved to terminate court-ordered oversight over the Dallas County Jail including the health units at the jail operated by Parkland. On November I 1, 201 I United Slates District Court Judge David C. God bey granted the request of the DOJ and Dallas County to end court supervision of a lawsuit concerning conditions at the Dallas County Jail, including conditions at the jail health units operated by Parkland. The DOJ and Dallas County had entered into a comprehensive settlement agreement in 2007 that required specific remedial measures be taken at the Dallas County Jail regarding medical care, mental health care, sanitation and environmental health to alleviate conditions that violated the constitutional rights of individuals confined to the jail. With respect to the Flospital's obligation to ensure that all staff that are required by the State to be licensed must possess a current license, and the Hospital's requirement to assure that these personnel are in compliance with the State's licensure law, (-12 O R ?4S2.I ii.es - The hospital must assure ?J-.as personnel arc Ik-ensed or meet other applicable standards that are required b> State or local laws), w e outline in Section 2.6 Human Capital, the Hospital's policies and procedures for ensuring that all employed staff possess required licenses. The Hospital's Human Resources Department is responsible for recruiting and hiring all employees except physicians, Certified Registered Nurse Anesthetists (CRNAs) and psychologists. The Department is responsible for hiring Nurse Practitioners (NP) and Physician Assistants (PA), however, the Medical Staff Office is responsible for credentialing those individuals. With respect to ensuring that all medical doctors on the medical staff including Residents, and NPs and PAs possess appropriate licenses, we Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 98 outline in Section 2.7.3, Medical Staff, the Hospital's policies and procedures for ensuring that all medical staff possess required licenses and certifications. With respect to compliance with State laws and regulations, we highlight below, three instances where the Hospital may not have been in compliance with State laws, in order of magnitude. The first non-compliance with laws concerns compliance with the Texas Nursing Practice Act. We reviewed a patient death from respiratory arrest that occurred during our survey period, where the death appeared to follow from the administration of a narcotic drug. The drug appeared to be administered to a patient by one of the Hospital's licensed nurses where the nurse did not appear to possess either a written or verbal order from a physician for administration of the medication. Texas Nursing Practice Act, Texas Occupations Code Section 301.002(2). The nurse was subsequently terminated by the Hospital and we were informed that the Hospital notified the Texas State Board of Nursing about the incident. ?4>; .'.23;,'!,; < : u>: >>.<< it; > 11 \t ;i6.:!f.t>i ti!' it During our survey we also observed that durable medical equipment (DME) is often provided without charge to outpatients in the Hospital's Physical Medicine and Rehabilitation (PM&R) Department. Parkland's PM&R Department does not hold a state DME license, however they dispense DME such as canes, crutches and walkers. The Hospital informed us that it was under the belief that a state DME license was not required because the DME is distributed without charge to patients. The institution also had an orthotic lab that manufactures custom back braces and post operative braces as prescribed by surgeons. The Texas Administrative Code, 25Medical Device Manufacturers and Distribution License, appears to require an application be submitted to the Texas Regulatory Licensing Unit to obtain a license to dispense DME. Additionally, our survey found that the Hospital does not issue an Advance Beneficiary Notice (ABN) form to patients who receive DME supplies. The Hospital does not have a policy regarding the dispensing of DME supplies, therefore patients are not treated consistently insured and otherwise covered patients (such as Medicare and Medicaid beneficiaries) do not receive free DME supplies from the I lospital and are provided with a list of DME suppliers in the area, but uninsured or indigent patients may receive DME supplies free of charge from Parkland. Custom compression garments are supplied to Parkland HEALTHplus (PHP) covered patients only, even though PL1P does not cover compression garments. During our survey we notified Hospital administration about our concern that the Hospital needed to obtain a DME license to dispense DME even if the DME was being dispensed to patients without charge. The Hospital advised us that the PM&R Department, working with Parkland's legal counsel office, would obtain a binding legal opinion on the need to obtain a DME license and if required by the opinion would immediately proceed to obtain the required DME licenses or refrain from dispensing free DME without a license. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 99 A & M As noted elsewhere in this report, during our survey we observed some refrigerators containing patient medicine or food supplies without consistent temperature logs being maintained. We also noted that refrigerators maintained for the convenience of hospital employees and staff to store personal food items did not consistently log temperatures. Oral guidance initially received from the Texas Department of State Health Services (DSHS) suggested that not only must patient refrigerators be regulated with respect to temperature, but that staff refrigerators should be similarly regulated. The Hospital agreed to obtain a binding legal opinion on the need to maintain temperature logs for staff refrigerators. The Hospital also agreed that in no event, would patient refrigerators be used to store staff items and that staff refrigerators would not be used to store patient medicine and food supplies. The Hospital agreed that appropriate signage would be posted on all patient and staff refrigerators to remind staff of these rules. Conclusion Because of the incident regarding drug administration without an order and the current lack of DME licensure, we cannot conclude that all elements of this condition are met. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. 2.7.3 Medical Staff As part of the Gap Analysis, the A&M Survey Team evaluated the Medical Staff Services function at Parkland. Our review consisted of interviews with the Medical Staff Services Director and staff, a review of the Medical Staff Bylaws, Rules and Regulations, and review of samples of initial applications and reapplications for medical staff privileges for both Physicians and Allied Health Professionals. While most elements of the Medical Staff Conditions of Participation (CoP) are met, the Hospital does not at this time have an effective Ongoing Professional Practice Evaluation (OPPE) program as part of its Medical Staff credentialing and peer review process. Applications/Credential ing The general function of the Medical Staff Office meets the CMS Conditions of Participation requirements. The files are adequately secured; they are well organized and easy to access when retrieving specific information. The initial application process is appropriate. There is no preapplication process. The Hospital seldom grants temporary privileges in the initial application process. When temporary privileges are granted, all the required elements (e.g., State licensure, DEA number, National Practitioner Databank) are validated by primary sources and their use for credentialing is time-limited. Only in cases of immediate patient need are temporary privileges granted. The Hospital performs its own primary source verification for all new applicants. There are few delays for Medical Staff applicants and most applications are normally processed within the time period specified in the Medical Staff Bylaws. There are delays, however, when processing some of the Allied Health Professional applications. This delay stems from a disconnect between the Human Resources Department and the Medical Staff Office during the hiring process. The Human Resource Department and Medical Staff Office do not coordinate effectively regarding new hires and the need for credentialing, therefore the application process is delayed. Focused Professional Practice Evaluation (FPPE) is applied appropriately during initial applications and follow-up is timely for new applicants. Requests for new privileges are processed through a formal channel. There is no utilization of practice information from other organizations or "grandfathering" involved in this process. Temporary privileges may be issued but only in cases of immediate patient need. Again, Focused Professional Practice Evaluation is applied appropriately and follow-up is timely for those Medical Staff applicants seeking new privileges. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. The re-application process is appropriate from a processing point of view. There is, however, room for significant improvement in the quality assessment of Medical Staff members, including improvements in OPPE for all categories of staff. OPPE is the ongoing assessment of an existing medical staff member's performance. Since January 2008 hospital medical staffs have been required to collect physician-specific data regarding six core competencies as defined by The Joint Commission, the American Board of Medical Specialties (ABMS) and the Accreditation Council for Graduate Medical Education (ACGME). These are the same six core competencies currently used to rate Medical Residents. The six core competencies can be summarized as follows: 1. Patient Care: Practitioners are expected to provide patient care that is compassionate, appropriate, and effective for the promotion of health, prevention of illness, treatment of disease, and care at the end of life. 2. Medical/Clinical Knowledge: Practitioners are expected to demonstrate knowledge of established and evolving biomedical, clinical, and social sciences, and the application of their knowledge to patient care and Lhe education of others. 3. Practice-Based Learning & Improvement: Practitioners are expected to be able to use scientific evidence and methods to investigate, evaluate, and improve patient care practices. 4. Interpersonal & Communication Skills: Practitioners are expected to demonstrate interpersonal and communication skills that enable them to establish and maintain professional relationships with patients, families, and other members of health care teams. 5. Professionalism: Practitioners are expected to demonstrate behaviors that reflect a commitment to continuous professional development, ethical practice, an understanding and sensitivity to diversity and a responsible attitude toward their patients, their profession, and society. (The Joint Commission considers diversity to include race, culture, gender, religion, ethnic background, sexual preference, mental capacity, and physical disability.) 6. System-Based Practice: Practitioners are expected to demonstrate both an understanding of the contexts and systems in which health care is provided, and the ability to apply this knowledge to improve and optimize health care. We did not observe that Parkland's re-credentialing process is currently collecting and utilizing data to assess these six core competencies when conducting OPPE review as a part of the recredentialing process. ?48.i.22i!)iTAG. \-Oj40 Ssiiiiuasx?: Compost!w >>fthe Medicai Sisifi ViS.0fe0I.03 ?.FF 12, m .VIS 06.01,03 i'F.F 3 ,8. V. 10; Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Information for OPPE can be acquired in a number of ways such as: L Monitoring clinical practice patterns through process and outcome monitoring 2. Periodic chart review 3. Direct observation of procedures and patient care 4. 5. Simulation exercises Proctoring assistants at surgery, nursing, and administrative personnel Some types of data that can be collected and used to perform OPPE can include: 1. Morbidity and mortality data 2. Operative and other clinical procedures and their outcomes 3. Requests for tests and procedures 4. Practitioner's use of consultants 5. Length of stay (LOS) 6. Transfusion practices 7. Infection rates 6. Discussion with others involved in the patient's care including consulting physicians, At present we did not find that this type of data was being collected on an organized basis for each Medical Staff member in order to effectively conduct OPPE. Until OPPE is improved and expanded, the organization will remain out of compliance with the CoP. '?8 i.22ia)i n t , \ u : 03 W /oUuAid. C o (:;;'o o ition -jf A,- \U Aieai Si,'.- <;/ ?i j; It appears from records and interviews that the Board of Managers (BOM), functioning as the "governing body", is more involved in the awarding of privileges now than in the past. The BOM has been asking more questions about applicants and it has eliminated using a consent agenda process for new and re-appointment applications. The Medical Staff Office also supports the Impaired Physician Program. Knowledge of this program, however, is not widespread in the organization. The Medical Staff should increase efforts to make this program known to all of its members. Delineation of Privileges Applicants requesting membership on the Medical Staff with or without privileges are sent a secure link via e-mail. Applicants complete the application and the appropriate privilege listing using a credentialing database. The applicant selects the correct privilege group and follows the prompts to select requested privileges. Depending on the specialty, the initial core set of privileges may have subsets that may need to be filled out by the applicant if they are requesting Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. privileges beyond the central Core. For example - Family Practice contains a "core" set of privileges. If the applicant wants to perform Obstetrics, they would have to complete an "add on" request set of privileges for consideration - the Core Level II Set. After the applicant has filled in the appropriate requests for privileges along with the rest of the application, the Medical Staff Office processes the application, performs primary source verification, DEA inquiry, letters of recommendation, transcripts and National Practitioner Data Bank inquiries, etc. After all elements are complete, the file is reviewed by the relevant department chair and a recommendation is made to proceed or the department chair asks for further information. After the file has cleared the relevant department it is taken to the Credentials Committee for consideration. The Credentials Committee may recommend approval to the Mcdical Executive Committee (MEC) or the Credentials Committee may ask for further information. After clearing the Credentials Committee the application is taken to the Medical Executive Committee for consideration. If there are no further inquiries, the application is taken to the BOM for consideration. Only after all questions have been answered and the BOM approves the application does the candidate have authority to practice at Parkland. Although the policies and procedures to obtain Medical Staff privileges appear to be in compliance with Medicare Conditions of Participation, there are gaps in validating privileges necessary to perform certain procedures at Parkland. Our survey found that there is currently no seamless interface for an operating room scheduler to determine the proper credentials of a given physician. While the OR room scheduling utilizes the Epic EMR system, a scheduler needs to access the "Core Privilege Plus Viewer" within the Parkland Intranet to verify privileges. Furthermore, Epic and the credentialing system will allow the scheduling of a procedure to be performed by an uncredentialed provider. In interviews with the OR scheduler, it was stated that the individual in charge of scheduling is very well acquainted with staff privileges and stays well informed of new physicians and new procedures that may require credentialing. This process, however, is people-dependent and not process-dependent, and presents an opportunity for error. During our survey, we observed several surgeons who use the mini-fluoroscopy who did not have recorded privileges to operate the fluoroscopy unit. 6ift? 'A:;;;-! i \G: \-o>>?3 i o f f.v. of PartkrpjrtiiMi. (ArtfcjffcaiStart: \i'> 03.01 .0<< ii.!' ?.s. The Parkland Medical Staff Bylaws, Rules and Regulations are well written and contain the required elements for the CMS Medical Staff CoP and Joint Commission. They are not however consistently enforced. Non-compliance with Bylaws, The Rules and Regulations are required to be handled through the Peer Review system under the category of "Behavioral" indicators. However, the published indicators do not include areas of compliance that are problematic at Parkland, e.g., medication reconciliation, adherence to infection control policies and procedures, and Resident oversight. When items are referred for action, Parkland's current peer review program does not appear to determine if the non-compliance events/behavior is a trend that Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 104 requires more aggressive action such as FPPE. ?4?.\? *fai I'AO: AMSA) Cowtiiion of Participation: Mcuicai Ma.iT: MS 09 01 0! -EE 2) Peer Review As noted above, the Hospital's continuing peer review process, "Ongoing Professional Practice Evaluation'" (OPPE) is in its infancy. The MEC has delegated to its Patient Care Review Committee (PCRC) the authority to conduct initial peer review at Parkland. Cases are referred to the PCRC by the Patient Safety Officer. The PCRC "scores" the cases and recommends actions to the MEC. If the Medical Staff member disagrees with a finding or recommendation of the PCRC and MEC, he/she may exercise his formal review rights, which includes a fair hearing before a panel of Medical Staff members. Very few cases at Parkland appear to be referred to a formal peer review. Currently, two people process peer review background work for more than 1,000 physicians. The team does not have support to trend prior eases or assess if a case is an exception or a trend. Peer Review investigations, actions and reports are frequently viewed as "one-time" or " o n e - o f f ' events. We did not see evidence of analysis of previous behaviors or trends when cases are brought to peer review, and were therefore unable to determine if the recommended actions were appropriate. Trending and assessment of prior cases and behavior patterns is critical to the success of the peer review process and should be implemented at Parkland. ? Us2.!I>: A-03 (< Patient Safety Net reported events (PSNs) are currently the primary source for identifying and funnel ing issues for peer review. PSN reports account for 85% of the referrals to peer review. The remaining 15% are direct referrals (e.g. daily rounding, observation). From the database reviewed by our surveyors, the two sources are not providing the number of charts for review that should normally be seen in an organization of this size and complexity. Peer review should be drawing many more cases for PCRC and MEC review from a wider funnel of all sources including PSNs, rounding, patient complaints, daily huddles, Epic/informatics, databases, department meetings and Residents/GME. ? 482 22thi TAG: A-03 i? Standard: Medical Stafi Oi';j) ! V . P ^ n d a r o MedicA Staii Organ i/miofi and A Parkland's peer review process is missing key indicators that should trigger peer review including: medication reconciliation, which is a an issue of significant concern to CMS and a requirement of the Parkland Bylaws; delays in care; and, adherence to infection control. The Patient Safety Department uses inadequate indicators to draw conclusions from PSN reports. The indicators are not objectively written, e.g. "baby with Apgar less than 5 at 5 minutes due to inappropriate care." The indicator would be better written "Apgar less than 5 at 5 minutes." Similar to our observation above that Parkland's Mcdical Staff recredentialing process does not effectively do OPPE, we found that the peer review process also does not effectively incorporate OPPE standards. For example, we did not observe Parkland's peer review process utilizing the six core competencies in OPPE review as we noted above. ?48L?,2(i>> I ,\> Standard: Cotmxisiiioti oftfk: Viedvai Si ail; \!s.O;i.0I lYM I P L P . - MS 06.01.05 P A is. 9. ?01 The current peer review system at Parkland does not employ OPPE surveillance reports and techniques to identify practice trends for individual Medical Staff members. For example, the Medical Staff should be collecting trending data on all Medical Staff members to ascertain the quality and efficiency of their care. Measures such as: length of stay, re-admissions, surgical complications, surgical site infections and core measures should be utilized as a means to: 1) identify physicians who are outliers, in comparison to the rest of the Medical Staff or a department, and 2) help to better inform the peer review process to determine whether a particular case with a bad outcome is a "one o f f ' outcome or whether it is emblematic of a trend with that physician. Both the peer review process and the re-credentialing process should also consult external data bases such as those maintained by professional societies, governmental agencies or proprietary resources like the Vermont Oxford or Delta Group databases. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 106 Autopsies With respect to Autopsies, Parkland Policy and Procedure Admin 4-01 meets the CMS CoP standard. However, on chart review, the following was found: o o o None of the charts contained an order for an autopsy Only one chart contained a note in the progress notes indicating that an autopsy was offered and the family agreed In two of the charts, a note indicated that an autopsy was offered and the family refused; subsequently, an autopsy was performed but the note was not amended (in one instance the family changed their mind, in the other the Coroner required an autopsy) o o The autopsy reports indicated that the Attending was notified but does not name the Attending There were no notations in the nursing notes to indicate that Pathology had been notified that an autopsy had been requested In addition, Texas Health and Safety Code Title 8. Chapter 671.001 Standard Used in Determining Death recently issued additional requirements for autopsies. These items must be corrected and the new requirements added to the process, i 2 2 ( t h T A G : A - 0 K>! \u;ikI K^jdarti: Vie?iwii start; W OS nl ill ?kP V During our survey period we learned of cases where Residents may have been doing procedures late at night or in early morning hours (i.e., thoracentesis, "DobhofP' nasogastric feeding tube placement and verification of proper placement), where the procedure was incorrectly performed (wrong-site thoracentesis) or incorrectly validated on x-ray ( " D o b h o f f ' feeding tube placement). These procedures and associated negative outcomes suggested that procedures may be performed by Residents that could wait for Attending Physician or even Senior Resident participation and oversight or it may indicate that not all Residents know when to escalate issues to their Chief Resident or Attending Physician. Our interviews with several Teaching Physicians suggested that certain procedures by Residents may be occurring late in the day or night because all of the necessary ancillary support or pre-procedure work-up (e.g., imaging and laboratory tests) may not have been performed in a timely manner. ?482.i2?ajp) I AG A 0049 Standard: Medical Staff: MS Ojjtit Hi ii.P A' Close supervision of Residents is also required in decisions to discharge patients. During our survey period we were made aware of an incident reported as a patient safety event by an Attending Physician. The Attending Physician noted that a patient from the Jail was sent to the Parkland ED for symptoms of cholcycystitis and was then admitted to the Hospital for two days. The patient was returned to Jail with chart note that liver function tests (LFTs) and bilirubin were "down trending." Bilirubin was actually going up and patient was returned to the Parkland ED for bilirubin of 7.0. The Physician making the report stated, "Residents need closer supervision. Patients should not get discharged until cleared by attending (physicians)." ?-(SA.t.A'aj(5j TAG A0040 Standard: Medical Staff: MS.ilS O?.0i tEP 3) Resident Oversight in the Operating Room and Procedural-Based Areas In the procedure based areas observed by the A&M Team (OR, Anesthesia, GI lab, Cardiac Catheterization Lab, Interventional Radiology) Attending Physicians were observed as present at the beginning and during the substantive part of the procedures. Attending Physicians were witnessed to have reviewed Resident orders as well. The survey team observed CRNAs and Residents being supervised by Attending Physician in pre-anesthesia evaluation clinic for anesthesia assessment and during intubation, anesthesia maintenance during procedures and emergence. The survey team did note that History and Physicals (H&P) for surgery were not Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. uniformly detailed and did contain errors - in one case, the H&P information was erroneous and vague. The H&P stated the patient had a tracheostomy. Upon questioning and examining the patient, the patient did not ever have a tracheostomy. The H&P stated the patient had chest surgery but did not have any detail regarding the chest surgery. Form ami Retention offc<rd: W(U fQ til (t'P !} TAG: A-043H. Standard: Attribution "Attribution" is the term used to signify association of a patient with the correct Resident on call, and thus indirectly, with the Attending Teaching Physician supervising a particular patient's care. Each UTSW Department maintains a monthly schedule delineating the Resident personnel staffing on the on call teams along with the name of the Supervising Physician. The staffing schedule is provided to the Hospital Call Center. The Resident schedule is also provided to the ADT (Admission, Discharge, and Transfer) Department which inputs a limited number (two) of Resident names attributed to the care of each individual patient. The Hospital page operator maintains a manual call system, that is, the Resident physicians must manually call and notify the page operator of any changes they make to the published resident call schedule. The Attending Physicians in charge of a given patient also change with the turn-over of covering Residents. There are often as many as four hand-offs in a 36 hour period. The nurses in various inpatient service units (typically the General Medicine floors) do not have a reliable way of knowing when the last Resident known to have cared for a patient under his charge has "signed o f f ' (or "handed-off') the patient's care to the next Resident physician on duty. Nurses questioned about this procedure by A&M reported that they have had to make two or three calls to the Resident they believed was still on duty before realizing that they need to page the next resident on call. Since the Attending Physician in charge of a given patient also changes with the turn-over of the covering Residents, further difficulties are created for nurses when they attempt to call the Attending Physician they believe is caring for their patient at any given time. Our analysis identified two main sources for this attribution problem: a) Residency directors have an A C G M E mandate to ensure that there is no violation of the new ACGME policies governing extended hours and the amount of time Residents spend in clinical activities each day. The current view of the Program Directors is that the ACGME may determine Residents who answer their pagers after they have met the daily number of hours proscribed by the residency requirements may be in violation of the new rules. In response to this perceived risk, some Teaching Physicians, Program Directors and Residents reported their impression that Residents should not to answer their pagers as soon as they have met their hourly limit for the day, and that they should instead immediately sign out (hand-off) to the next shift of Residents on call. As a result, Resident's are signing off at numerous and various unscheduled times of the day in a Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. volume that may be exceeding the capability of the current call system to monitor and keep up with the changes. b) The methodology used by Parkland to track the changes in Resident patient attribution is not automated. Consultant Physicians' answering services and unit nurses have difficulty identifying who is the primary team or person caring for a patient. The Epic EMR system has a feature that identifies the Resident on call, but locating it requires navigation through several screens, and the feature does not provide the ability to record all the different teams nor all the Residents that provide care for patients over the course of a hospitalization. The methodology used to track the changes in Resident patient attribution is not automated. Each medical service is relied upon to maintain its "treatment team" list, i.e., identifying the PGY1 and upper level Residents caring for the patient, so that other services and nurses will know who to contact for supervising physician coverage. The ADT (Admission, Discharge, and Transfer) department tracks the name of the patient's Attending Physician as well as the name of the physician's service, but after serial hand-offs have occurred that information may not have been accurately tracked for the nurses to identify the Residents or Attending they should call for important communication in relation to the patient. The following self-reported patient safety incidents (week of December 12 to 18, 2012) illustrate the impact and frequency of attribution-related incidents: o "RNs are consistently unable to page providers in a timely manner. This has been an issue for quite some time. Due to providers not routinely being on call, interns aren't consistently with residents, they switch back and forth, our posters are not up to date, and providers aren't notifying RNs of schedule. RNs have to page multiple providers to get to the right provider. This delays care especially in emergency situations. Patient developed atrial fibrillation with heart rate in the 150's. It took three pages to the Intern and two to the Resident over 25 minutes to get appropriate orders (Intern never called back but put in orders). Neither the Intern nor Resident came to see patient before placing orders." o "Urology case in the Operating Room. Presence of faculty surgeon confirmed via cell phone before patient brought to room. Message from faculty given to Residents at 08:40 requesting them to call faculty. Faculty not present in OR until after 11:00 and several phone calls, page and escalation to Urology Chief. Faculty denies getting any phone calls or page although states he was in his office." p a y j S f e K I ) TAG: A-G064 Standard: Care o f P a t i e n n : P( .02.n2.0i (?P I. 2, h'S.0.101.03 tEV Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Documentation of Teaching Physician and Resident Notes The Parkland Hospital Chief Medical Information Officer (CMIO) conducted an audit for the Parkland Medical Executive Committee (MEC) of about 800 charts, from November 2011 to December 2011 (during the time of the ICE Survey), for the following parameters: All Elements of Triage Documentation are Complete; Medical Screening Exam (MSE); Triage Bounce Back; MOT (Memorandum of Transfer) for Patient transferred from Parkland; Nursing Documentation in Open records; Nursing Documentation in Closed records. We reviewed the audit results, and noted that the only findings were occasional delays by Orthopedic and Urology Attending Surgeons who were in the OR and unable to respond in a timely manner. There were instances in which the Attending Teaching Physicians co-signed Resident orders (as evidence of oversight), but signed the Resident progress notes in "batches", typically on the day of or after discharge while they (Attending Teaching Physicians) were dictating patient discharge summaries. Conclusion As most physician care at Parkland is delivered through Residents and Interns, it is essential to have close and effective supervision of the care by Attending Teaching Physicians. Residents must know when to escalate issues to their Attending Physicians. Residents must only perform procedures for which they have been properly trained and concurrently supervised. Late night or early morning non-urgent procedures by Residents who lack full competence in the procedure or without proper oversight should be avoided. Because multiple Residents may care for a patient during the course of a patient's inpatient stay, it is essential for there to be complete and appropriate "hand-offs" of patients between Residents between shifts or between services (e.g., Emergency Department to Medicine.) Failure to have proper hand-offs with appropriate communication can result in delays in patient care or patient injury. Parkland should review all procedures and training for hand-offs and should regularly audit and monitor compliance with hand-off procedures. Nursing and support staff need to know at all times who is the Attending Physician and Resident Physician. Parkland should re-evaluate its Resident call procedures to ensure that Nursing and support staff can quickly locate the patient's Resident Physician and Attending Physician. Given the issues noted above with: o o o o Patient hand-offs between Residents and Attending Physicians Late night procedures with adverse outcomes, where an issue was not escalated by a Resident to an Attending Physician or a Chief Resident Documentation errors by Residents Repeated delays in properly identifying the Resident or Attending Physician in charge of a given patient At Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 114 / We believe that the current operation o f Parkland's Resident training program is contributing to (he Hospital's d e f i c i e n c i e s in meeting all standards o f the Conditions o f Participation. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 el. seq.. this information is confidential and privileged. I 15 Ak 2.7.5 Mcdication M a n a g e m e n t Medication management plays a critical role in Parkland's delivery of safe patient care for palliative, symptomatic, and curative treatment of many diseases and conditions. Because medications are also capable of causing great harm if the incorrect dose or medication is administered to a patient, the Hospital must develop a monitoring program to eliminate any potential harm that could be caused by errors. Our survey found deficiencies in the management of medications across a broad spectrum. We have categorized these deficiencies according to issues. At this time the Hospital does not have a consistently effective and safe medication management system as evidenced by our survey findings. Medication Management Oversight From reports provided at patient safety meetings, in departmental surveys, and from patient chart reviews, we noted frequent medication errors at Parkland. Medication reconciliation is not performed on a consistent basis and there were instances of mislabeled medications. Our analysis also indicated there was a lack of effective and safe medication management involving multiple services and disciplines working together. Additionally, the medication management system does not include consistent mechanisms for reporting potential and actual medicationrelated errors and a process to improve medication management processes and patient safety b a s e d o n t h i s i n f o r m a t i o n . ?MS2.21 1AG: A-0267 Standard: Projmim Scope. J4S2.23cc(4) f AG: A-0410 Standard: Preparation and A dm in is ?ration o ? Dnsg?o SIMOX.ol (I P Uj q) ? I.P : 6. ' J ) o mt.OS Ul.ft'J fP.P-2) - Pl.Of.Ol.O! For the inpatient medication process, the physician enters an order in Epic. There are times where the physician overrides the Epic ranges in the order set, but the Pharmacy Department does not consistently query the physician on the override. All concerns, issues or questions, for example, about proper dosing and drug substitutions should be clarified with the individual prescriber by the Pharmacy before dispensing. Parkland does not query all physician overrides of acceptable dosage limits and document those instances where the physician continued with the override and the reason for doing so. These override events are not currently reviewed on a case by case basis and should be tracked for trending. ?482.25 FAG: A-049>> Condition of Participation: Pharmacy Services: 1.1X04.0!.(17 (EP Pi. The Hospital docs not have policies and procedures to actively identify potential and actual adverse drug events. Proactive identification could include: direct observation of medication administration, review of patients' clinical records, identification of patient signals that would warrant immediate review of patient's medication therapy and implementation of medication use evaluation studies. As stated above, all concerns, issues or questions regarding a particular drug or dose should be clarified with the individual prescriber by the Pharmacy before dispensing. ?48A25(bK6) FA O: A-?0508. Standard: ! >divery of Services: MVf.f?J ?i di o,?>' 4j i I >.04 04 01 (EP 4) Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 116 A&M reviewed Parkland's policy regarding timely delivery of medication administration orders primarily regarding the "30 minute rule" in which treatments must be completed within 30 minutes after the ordered time. During the course of our review CMS issued reference S&G-1205 Hospital regarding HSLiSb?) on November 18, 2011, and removed the reference to the "30 minute rule" which had established a uniform window before or after the scheduled time for all scheduled medication administration. In response to this change, Parkland policy RC P-2A, WD 07-2011, RD 12-2011 was updated and now states that, with regards to stat orders received, "medication will be administered within an hour after themedication is available in the patient care area." The Hospital is also in the process of adopting and updating its medication administration policies and procedures to take into account the nature of the prescribed medication, specific clinical applications, and overall patient needs. The policy should also identify those medications that require exact or precise timing of administration, and those medications that are not eligible for scheduled dosing times. For medications that are eligible for scheduled dosing times, the Hospital will distinguish between those that are time-critical and those that are not and establish the new medication administration policy governing timing accordingly. Drug Storage There is currently an internal program at Parkland to reduce the incidence of expired medications. However, our survey found expired medications in the inpatient psychiatric unit, the outpatient community clinics and the outpatient campus clinics. fi8'.?.25{hK.*)TA??: 0505. Swj$s*tl: D e l k e r y o1 S e r v i c e ; A'L\UKkftf.(?l f?PS?/ Our review also found that the refrigerator for Malignant Hyperthermia (MFI) medications had not been checked for seven days. Staff did not follow through on daily assignments and management failed to ensure that assignments were carried out per Parkland's policy. ?48?. i i t b i i / K i f T A O : A-U?05. Siantjarci: Delivery of-fcivk-cs: SMOXt?i Of (LPSi In the Ambulatory Surgical Center (ASC) on November 29, 2011, Anesthesia medications were left unattended on the anesthesia cart in OR#5 by the Certified Registered Nurse Anesthetist (CRNA). This was a failure to follow Parkland policy. It is important to remain attentive and aware to ensure that medications are secured at all times. $4S2.23(cX2Xi) 'l-ACi: A-0407. Standard: Preparation ami A d m ? u s n m ? e a * f Drugs; Hi .20.03.0? ff.P 4, 5) MM.04,01.01 f F i ' 6). /1 M An incident o f d r u g diversion occurred in the clinic at the Medlock Adolescent Center because drugs had not been secured and stored as required by Hospital policy and regulatory requirements. In that case, 12 bottles of Schedule II drugs were stolen by one of the juvenile residents because the drugs were not locked in the controlled substance cabinet. Additionally, staff did not consistently perform a count of the Schedule II drugs by shift and as additional staff came on duty, this particular diversion was not discovered until the next day. Following this event and an investigation of the drug diversion and theft, administration leaders responsible for Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 117 the Medloek Clinic changed their policy to institute and require multiple counts of Schedule II drugs, in addition to monitoring security to ensure the drugs are locked in the secure cabinet after administration. ? j a a U i u n I AG; A-0491 ?482.25 ^tandar<<>>- I'wj.-Mtitiun and uj.niH>>:':!iaiH.-fi ofDmy-: /i vd.v ul'niiihn.-'iht ooo>' .;/ U! I tt-i 2/ ?!!(iJ" 6i .oipfjUcubltf.li! W S'wsg*. > ''i o 'Oil.: A7_" j j j ' t SmtuUrtli />>ww v. 5l{h?(>>j ! \k.\:A~C>W Siair?trd: I f c l i v m o f Services; PC.HS.OUC (i'P IJ Over sedation is not consistently reported in an accurate manner. In an example noted by an A&M surveyor, a patient was given sedation and experienced respiratory arrest. In some patient safety reports over sedation was not clear nor mentioned as a possible source for the patient's negative outcome. For example, a patient was given 2mg Versed and 50 mg of Demerol, intramuscularly (IM), prior to a procedure. It was reported that the patient's blood pressure dropped significantly, and that the patient was severely short of breath and that the resuscitation team was called. The safety report was completed and reasons given for the arrest were related to not having a second intravenous line and patient not wearing a hospital gown. After interviewing the Attending Physician it was noted that the patient may have been over sedated due to the poor physiologic state of the patient In violation of Parkland Policy Admin 6-16. ? 1X2.5! U1 >f 6 j TAG: A U503 Mandar?: Delivery of Services: MM.iiV Of.tij (BP 3/ IJlO-ijiiJH ?FJ 4,hj Medication Reconciliation Medication Reconciliation is the formal process of obtaining a complete and accurate list of each patient's current medications and then comparing the prescriber's (MD, PA or APRN) admission, daily, transfer, and discharge orders to that list. Discrepancies or safety issues are identified by the prescribcr and, if appropriate, changes made to the orders. Any resulting changes in orders are documented and communicated to the Pharmacy, caregivers, patient, and the next provider of care. The examples of non-compliance were cited in the section of this report entitled Nursing Provision of Care, Section 2.5. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 121 Conclusion In order to deliver s a f e and e f f e c t i v e care, medication management must be adhered to throughout the care process. Parkland should d e v e l o p a safe medication management system that addresses the organization's medication processes to include the following: o o o o o Medication Management Oversight Safe Storage o f Drugs Sale Delivery o f Medications Medication Reconciliation Verbal Orders Parkland d o e s not currently meet several Conditions o f Participation and standards related to medication management. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. 2.7.6 Infection Control The July 2011 and August 201 I, CMS surveys cited Parkland for several violations of Conditions of Participation related to infection control. Findings included: staff not properly disposing of soiled gloves; infectious waste in patient rooms not being properly disposed of; not washing hands after removing gloves; and staff food items sitting in patient treatment areas, which led CMS to determine that Parkland's infection control violations created an "immediate jeopardy" situation and "put patients at risk of severe infection and possibly subsequent death." Our review found that the Parkland Infection Prevention Department has not yet been effective in changing the infection control and prevention environment at Parkland. Infection control guidelines for procedures as fundamental as hand hygiene are not followed consistently throughout the Hospital. During our review, we identified areas within the Hospital that disregard the infection control processes, while other departments are unaware of proper processes. This indicates that the Department has not demonstrated its effectiveness with: 1) enforcing policy and 2) educating staff. At present, the Infection Prevention Department does not effectively identify areas of non-compliance, create action plans to correct non-compliance or use its authority to enforce Hospital policies and CMS regulations. The Infection Prevention Department has technical expertise and understands the principles of infection prevention, however, it is often reluctant to exercise the Department's authority to enforce standards or recommended practice, policy and procedure. Infection Prevention staff conduct rounds within the Hospital utilizing a 24 point tool. During the Infection Control rounds conducted first quarter FY 2012, there were direct observations of violations in 23 of the 24 areas of focus hospital-wide. However, scorecards for the divisions and the roll up for the Hospital show an overall compliance score of 93%. When 23 out of 24 monitors are in non-compliance in the Hospital, significant intervention by Infection Control staff is required. We did not see evidence of a corrective action plan resulting from these rounding scorecards. There appears to be a significant disconnect between the Department's statistical findings versus actual observations. This disconnect is supported by the A&M ICE team observations detailed in this report. We observed significant inconsistency in infection control practices throughout the Hospital. Departments have their own practices and do not follow nationally recommended standards. In certain restricted areas of the Cath Lab and IR, staff were not following national standards and were not wearing hospital-issued scrubs. After pointing out this deficiency in the Cath Lab and Interventional Radiology (IR) during our review, the practice was instituted and, as of the report date, all areas which require scrub attire appear to be following the national standards. We will monitor future compliance with adherence to the scrub attire policy. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Direct observations of the environment are additional evidence of a lack of a strong infection prevention culture. We observed waste bins in patient rooms that were over flowing, staff throwing trash at the waste bin in patient rooms, missing the can and making no effort to pick up the trash and dispose of the trash properly. During our rounds on the inpatient units, blood, excrement and trash were observed in patient rooms. ?1K2.41 lAG: \ 0?0) Condukm of Partkipaiion: In the Catheterization Lab, improper sterile gowning was observed along with a lack of vigilance in maintaining the sterile field and a lack of knowledge of the traffic flow and the sterile field parameters. There are many areas in the hospital and clinics where walls and furniture are in disrepair. ; Pi.'AT! I \ik v-0 i 7 c onduion 01 Participation: iaiecuon t uirtrul; A' OJ ol fit ti:Jo 1 h > In Labor and Delivery (L&D) and the OR, terminal cleaning is not in compliance with national standards and requirements. Floors and other intense cleaning requirements were not properly performed. i" ! \(\ Ao 07A Cimdkion fAPnoAipaiusii: Pslbction Control ; A ' Oi 0} uj it" During our survey, we observed L&D utilizing a large compartmentalized delivery system for simultaneously transporting up to six infants (referred to internally by staff as the "six-pack") with only approximately eight to ten inches between infants separated by a metal partition. This transportation method presents a cross-contamination and infection risk for infants. After pointing out this deficiency during our review, the Hospital ceased the utilization of this method of transporting infants. We will monitor continued compliance with the infant transportation practices. Elsewhere, our report cites observations of improper hand hygiene in various areas of the hospital: Medical/Surgical Inpatient Units: Staff was routinely witnessed moving from room to room with inappropriate hand washing techniques. The organizational focus on this issue has resulted in staff using the antibacterial chargers virtually in lieu of hand washing. The Parkland policy states that staff must wash their hands upon arrival for duty and after 3 uses of the antibacterial chargers. >A8A42 'TAG: \ 0 747 ( omikioo of Participation: Infection Control; /f.fl/ ft? Of 'El' A A/Aa, A- 07 a I {! Fl M o Inconsistent hand hygiene practices were observed among clinicians in the Main OR. Primarily, the anesthesia providers and two circulators were not following proper hand hygiene protocol. It was observed, at times, when gloves were removed, hand washing or using hand sanitizers was not occurring. In a follow up evaluation of this unit, anesthesia providers were performing correct hand hygiene along with the RN circulators. However, a surgical Resident made several hand hygiene infractions primarily when removing gloves and not using the hand sanitizer. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 124 o Inadequate hand hygiene procedures were observed within the Physical Therapy Department, especially during clinical delivery of care between patients. Primarily, Physical Therapists, in the gym setting, have a routine whereby they move from patientto-patient rendering clinical care without appropriate hand hygiene procedures being followed. There are no sinks in the care area. The staff has wall mounted hand hygiene stations in the large gym venue. Nevertheless, they did not consistently use this method of hand sanitizing between patients. o All areas of the Hospital should have a minimum of two infection control surveys per year, with additional attention given to those areas of high concern. It is imperative to engage the department manager, and appropriate hospital executives to specifically point out infractions. The infection control staff should be prepared to offer corrective actions at the time to stop the infraction and when appropriate, require implementation immediately. While CMS requires that a person or persons be designated as infection control officers, it is not a single departmental function, but instead a house-wide function. The Infection Prevention Department should solicit assistance from other departments that can help to affect change, such as Human Resources and Environmental Services. Follow up should occur consistently to ensure the correction is being sustained. Departments such as Environmental Services or Facilities can be additional support systems in promoting a house-wide infection control program. Leadership must support the efforts of Infection Prevention, and if non-compliant behavior persists, disciplinary actions should be taken. Quality Assessment and Performance Improvement (QAPI) The CMS standards require that the hospital-wide quality assurance and improvement programs address problems identified by the infection control officers. Parkland's Infection Control Department's specific QAPI program is not integrated into the overall QAPI program, and this structure has led to disparate practices throughout the Hospital. Additionally, infection Control policies and procedures arc not enforced similarly across the system. In order to promote consistent practice across the system, regardless of the service, a centralized process of policies and procedures is needed to mandate the infection control standards for Parkland. -S-:iS2..2i TAG: A U2CM Conditions of Participation: Qua! it) Assessment and Performance iiriproystnetu Program: i.D.O ? tO.OJ ifrP I) In reviewing Environmental Services (EVS) practices, each manager of each department, along with EVS and Infection Control, should be involved in policing the Hospital's infection control policies and ensuring a clean care environment. There is a lack of understanding or oversight, however, among departments and managers, as we found numerous gaps in cleanliness and appearance across the Hospital. In many hospitals it is a leading practice to have continual joint reviews by infection control staff and EVS leaders for infection control issues. As of now, an Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. effective infection control surveillance throughout the Hospital is not being conducted. ? > > 52 <' '!' VG: v-6717 i ondaka'i of !o'a: iivipatioiK iniccik<<>> Qanroi: ft U2 gQ.Oj t-'.P 2} Conclusion Going forward, Infection Prevention should model enforcement behavior to all managers to demonstrate the urgency and criticality of the needed corrective actions. Ongoing evaluation by Infection Control must occur in a structured and consistent manner. Infection Prevention should solicit key leaders in the organization to participate in environmental rounds, to both point out issues and concerns, as well as to demonstrate leadership's commitment to infection control. Leaders should also confront issues "on the spot" to enforce corrective actions. Leadership must support this activity in its entirety with escalation and consequences as needed to gain full compliance. Infection Prevention should develop and implement surveillance schedules that accounts for all departments with more frequent surveillance for problem areas. To summarize, key actions required: o Infection Control staff should review all areas a minimum of two times a year, with increased rounding on problematic areas and high risk areas. o o o The Infection Control staff completing the reviews must be fully aware of corrective action to rectify any findings immediately, Follow-up must occur to assure that corrective action is taken; the issue must be elevated if corrective action is not taken. Infection Control Department specific QAPI programs should be incorporated into the overall QAPI program. o o The current silo nature of Parkland's organizational structure has led to many disparate practices. Increased attention by EVS to overall cleanliness of the house. o (We note that during house rounds by the A & M ICE team on January 5, 2012, results of the new EVS director were visible through significantly cleaner patient care areas on floors we toured.) o A Centralized review of all IC Policies & Procedures throughout the PHFIS system for consistency and compliance and then properly distributed throughout the Hospital. Utilize staff from other areas (such as EVS, departmental managers, and executive leadership) for ongoing monitoring. o Engage the Human Resources Department to ensure that repeated Infection Control violations result in disciplinary actions. Following our discussion of preliminary findings with the Infection Prevention Department, the Department presented several ideas to improve Infection Control and Prevention practices across the organization all of which will be reviewed by the A&M ICE team in devising an Action Plan for Infection Control and Prevention improvements to meet the Conditions of Participation. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 126 Currently, h o w e v e r , Parkland d o e s to Infection Control. not m e e t all C o n d i t i o n s o f P a r t i c i p a t i o n and s t a n d a r d s A related Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1/101el. seq., this information is confidential and privileged. 2.7.7. Environment of Care The Hospital must provide a safe, clean and functional environment of care. Leadership is accountable for the oversight, management of potential risks, and safety of the building and equipment as well as the cleanliness to ensure patient safety and infection control. Environmental Services Environmental Services (EVS) provides cleaning services for all of the Parkland campus and facilitates patient throughput by cleaning and sanitizing patient rooms in a timely manner. The Hospital recently engaged an outside contract service to manage the Environmental Services operations. The Contractor cleaning staff is given detailed cleaning duties as well as the frequency in which tasks are to be completed. Supervisors monitor their assigned departments for timeliness and effectiveness of cleaning. While there are staff assigned to specific areas of the Hospital, EVS supervisors can reassign staff on an urgent basis if there is a surge in room turnover requests. EVS has a target of 40 minutes from the time of notification for cleaning until the bed is ready. From November I, 201 1 through January 12, 2012, average turnaround time averaged 58 minutes. A Teletracking system allows for concurrent tracking of turnaround time, therefore delays in service can be identified more readily. In reviewing the turnaround report of the over 16,000 clean requests, there were also approximately 5,100 room cleaning cancellations. Twenty-eight percent of the cancellations show a cancellation reason that the patient is still in the room, and another 38% show the room was already clean. While the automated system is an effective method to manage multiple communication hand offs, there are still gaps in the system that can contribute to delays in admissions, such as patient room cleaning. Cancellation rates relating to a patient still in room, or the room is already cleaned indicate the system is not being used effectively. While these processes are representative of EVS practices in most hospitals, the general state of cleanliness of the campus indicates that something is not working in the cleaning assignment or inspection processes. Throughout the survey multiple areas were not clean to a "reasonable person's standard". These areas included patient units, patient rooms, ancillary departments and common areas of the Hospital, as well as off campus locations. In many cases, extremely unclean conditions were observed in patient rooms and common shower rooms. Trash cans were found to be overflowing in many patient rooms. Dirty linen piled on patient room floors and in chairs was regularly observed. Interviews with unit staff indicated dissatisfaction with the process and frequency of the housekeeping services. ?482.4 Ha> I' U>: A -0701 Standard: Ouildings. S ??C.42 f A O A- f t / 1 ? Condition ol'Participatfcm: Infection Control: /-,< <<2 06,0! (hPjj} ICQ i 03 01 (!-:!> 2j IX .04.01.03 tf.P 2? - Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Terminal cleaning does not appear to be performed correctly in Labor and Delivery (L&D) and the general operating rooms. The cleaning process in these areas did not meet the accepted infection control standards for sterile areas which includes flooding the floors of the OR when performing terminal cleaning. N e w l y hired staff in the L & D operating rooms was unfamiliar with and uninformed about the policies regarding terminal cleaning. The Hospital does not have adequate equipment in the main operating rooms for cleaning each area, so that cross contamination will not occur. Pantries and refrigerators used for patient food throughout the Hospital require general cleaning. Pantries are over-crowded with items and in general disarray. Immediate attention should be given to these areas. Refrigerators (both staff and patient) are in need of cleaning and defrosting. Pantry cabinets should be cleaned and properly wiped down and properly organized to facilitate easy location of expired and needed items. ?4f>\421 A>nil.iin >.\; l-'A ',02,04.&L 'Ei'-ii We observed chairs, stretchers, and equipment in hallways which create obstruction to clear pathways. If an item must be left for longer than 30 minutes in the hall, it is essential that the items be only on one side which is designated. ?482.4 Mai TAO A-O'?0l Standard: Buildings: EC.02M.Ql (U* I! The Hospital's main operating room is 57 years old. The physical plant is under-sized for the complexity of technology needed for current day surgeries. Overall, the physical environment is cluttered and the corridors are obstructed by equipment, case carts and stretchers. Repairs are needed to ensure the environment of care is safe and maintains infection control standards. The current state of the environment is a result of a lack of knowledge of and inattention to the entire environment of care requirements. Specific observations include the following: o o o o o o o o Observed in OR# 11, hole in wall covered by duct tape with a bundle of coaxial cables Broken electrical cover plate in OR//11 Several critical red electrical outlets covered with tape OR doors to OR#l 1 do not completely close Several OR doors open during cases and when rooms are not in progress Sharps container obstructing an OR door Medical gas shut off valve boxes obstructed by tables in front of boxes (OR Room 12 & 13) Sharp boxes open with foot pedal and therefore syringes, needles and other used sharps are accessible. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 130 A&M reviewed the most recent Medicare validation survey and corresponding corrective action plan with members of the Life Safety and Engineering staff The corrective actions are well documented. Corrective actions to specific deficiencies identified by the CMS surveyors were directed to all areas of the Hospital versus the particular area of the citation. Physical Environment The majority of the areas of the Hospital and outpatient clinics were surveyed by the ICE Team. The size and age of this facility creates a difficult environment, however, there are multiple areas of disrepair in the Hospital that require immediate attention. The floors in the Hospital are in particular need of attention. The Hospital needs to prioritize their current resources to clean and burnish floors on a regular basis to assure that they are maintained. Outpatient clinics appear to be low on the priority list. Walls and floors require repair in patient care and common areas. AlsA-i 1;>>) Physic;;! LnviroumdStt: BuiMinas. FAG: A-0701, fC.di fit QfilJ'bt There are numerous unlocked supply cabinets in all areas of the Hospital. This practice places supplies at risk for pilferage and unauthorized persons gaining access to restricted areas. Many of the supplies are expensive and caution should be taken to assure they are available when needed. JWiAT I,-\?i. V0721 fx '.QZ.M.M 5n In both inpatient and outpatient areas of the Hospital we observed unattended, unlocked phlebotomy carts that were accessible to the public. Phlebotomy carts are filled with needles, syringes, and other items that can create harm to a visitor or unauthorized person. This practice places the Hospital out of compliance. ?482.-1) ibX2) TAG: AAV/24 - F.G.02.0UT! (F.P i) Conclusion While Parkland's current facility may show wear and tear due to its age, it does not have to be unclean. With an appropriate, thorough and regularly cleaned, serviced and maintained facility, even the oldest facility can maintain an appearance and standard of cleanliness appropriate for patient care. The Hospital conducts weekly "Environment of Care" tours with one member of the Life Safety, EVS, IC, and the Facility team. The tour targets a different area every week and that area is not advised of the tour in advance. The intent of the tour is to identify areas of concern regarding environment of care, infection control, life safety and physical plant. Results of tours are well documented and are reported back to appropriate department. Follow-up by responsible parties to correct issues identified in the reports needs to occur on a more consistent basis. Follow-up on Environment of Care issues is essential to a safe, clean, functional plant. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 131 / Al present, Parkland is not in compliance with several Conditions of Participation or with all elements of standards related to Environment of Care. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 132 2.7.8 Discharge Planning and Case Management Case Management (CM), Discharge Planning (DP) and Social Work (SW) are the three methods used throughout a hospital to coordinate care among interdisciplinary teams, advocate for the patient and to ensure a smooth and complete continuum o f c a r e from admission to discharge to post-discharge transfer to home or other sub-acute care settings such as nursing homes or long term care facilities. Starting at a patient's admission, Case Management should promote high quality, cost effective treatment. Discharge Planning and interventions by Social Workers provide for the patient's next level of care. Like Case Management, Discharge Planning and Social Work interventions need to begin on the first day of a patient's hospital stay. This will ensure that the patient's transition out of the acute setting to home, or to another care delivery site, will adequately meet the needs for their recovery. These departments must also have a collaborative relationship with the community resources that will work with the Hospital and patient post-discharge. Organization Department/ Groups Case Management, Discharge Planning and Social Work at Parkland reside in the Hospital's Care Management Department. The mid-level leadership in this group is very new to the role and docs not have a strong management background. The delivery model is a hybrid of unitbased and services-based care management. Our review of the Case Management/Discharge Planning function consisted of interviews with the Case Management Director and staff, review of the Policies and Procedures, and review of both active and closed charts. Our survey of cases showed that Case Management and Discharge Planning did not adequately meet the required level of inpatient intervention and post-hospital ization discharge planning. Presently, the Department is not provided with some critical information needed to carry out its daily functions such as information on: daily census, admissions, or Average Length of Stay (ALOS) by payor, and patient's observation status. Communication within the Department between Case Managers and Social Workers is not adequate and Case Managers do not identify and advise Social Workers of "hard to place" cases that will require intensive discharge planning. This creates delays in discharges, which slows the opening of vital beds for ED patients pending admission. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 133 The following show a low to average Case Mix Index and higher than average Length of Stay, both of which combine to create delays in bed availability. Payor Case Mix Index Medicare Overall 1.6473 1.10 Payor Medicare Medicaid Commercial Charity Self Pay Average Length of Stay 6.20 4.95 6.43 5.00 3.49 Case Management During interviews on the floors and care units, nursing staff could not locate or identify the discharge planning screen in an initial assessment within Epic and stated that they do not commonly refer patients to discharge planning. This is consistent with the feedback from the Case Management department that referrals from nursing based on the initial nursing assessment are infrequent. A timely start to discharge planning is required for well being of the patient as well as for the success of the department. Parkland needs to increase nursing awareness of case management elements and use of the discharge screens on the initial nursing assessment. The Hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge. g482.43(a) TAG: A-0800 Standard: Identification of Patients in Nc.c Standard: Discharge Planning L valuation: PC.04. Ol.UJ (EE In the Parkland Emergency Department, Case Management is currently limited to only utilization review. Case Managers in the Emergency Department were not proactively involved in managing care and only get involved once a bed has been assigned. Case managers can play a proactive role in reviewing cases continually and providing input as to appropriate patient bed type, e.g., inpatient vs. observation admission criteria, etc. :j4S2.43{a) TAG: A -0800 Standard: fSe'iiiiilcilikifl-^rPStioiSs*- in KVcdafOischaise Planning PC,04.01.03 ;bP l j The Care Management Department as a whole is challenged by the placement of patients with no funding and those who are not eligible for any type of public assistance. While Social Workers actively search for charity sources, this is not always possible or timely. As a result, some patients stay in the Hospital for protracted periods of time as there is no discharge placement available. The Hospital has not allocated funds to pay for some of the resources that would affect a discharge. Given the continual bed shortage at the Hospital, being able to discharge these types of patients could have a very positive effect on patient care and patient flow. Many safety net hospitals have entered into agreements such as leasing beds in a Skilled Nursing Facility (SNF), reduced rates for Durable Medical Equipment (DME) and home oxygen, long stay hotels, etc. that can be utilized to facilitate discharges. We also recommend reaching out to community resources, extended service agencies and religious organizations that may provide additional resources in this effort. The Hospital's Utilization Management Officer has been involved recently in the creation of a not-for-profit DME supplier in Dallas that will accept, refurbish and sterilize used and usable D M E for free distribution to indigent patients. ?182.43{a) TAG: 4-0800 Standard: Identification of Patients in Need of Discharge Planning: Pi '.02.0i 01 (EE ?1 PC.04.0l.oS (BP Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 135 Social Work Services The Social Work function at Parkland often operates under adverse conditions with high patient volumes. Calls from physicians are frequently received stating the patient "needs to go home today and needs after care" (such as Skilled Nursing Facility (SNF), Home Health). This lack of early identification and communication of cases between Case Management and Social Work and Physicians and nurses can cause delays in appropriate discharges. Another frequently noted occurrence is when substantial placement work has been completed based on the initial plan and then that placement is changed on the day of discharge. This requires complete re-work and can delay the patient's discharge adding to LOS, patient dissatisfaction and house-wide bed availability. <48 >. '.o.{bisaffACi: A-0810 Slam!<<*.!: nitttkirgc Pfenning ami Evaluation: PC.u-4.iU.ui ,H> I Jj Another issue frequently encountered by Social Work is a conflict between physicians regarding disposition of patients. This was particularly observed in the surgery units. The disagreement between physicians can create delays in discharge, and is an inefficient use of time by social workers. The Hospital should develop a multidisciplinary process that includes physicians, nursing case management and social work to ensure a collaborative approach to patient care management and discharge planning. lAii: A-oy|o Standard: DAcha^e Planning arid I.A aiimiiro;; I o('.<>o{ Hi /. 4) Quality Assessment and Performance Improvement (QAPI ) The Care Management department does not have a department level QAPI plan and they do not track the effectiveness of their discharge planning process. The Flospital should have a mechanism in place for ongoing reassessment of its discharge planning process. Baseline data will need to be collected on all elements of the process and they should begin reporting any indicators to the QAPI Quality of Care Committee (QCC). ?4?2<2I Tag: A-OAv Oualin Assessing>> and Perthr-nano. impu m n . - n i Program: SH/!2 Is2 PJ -f-'.P / 6) - U\t/l>>o!.()! tl'P I j The Hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, datadriven quality assessment and performance improvement program. The Hospital's governing body must ensure that the program reflects the complexity of the Hospital's organization and services; involves all Hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The Hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. A y m M Conclusion The Care Management group, including Case Management, Social Work, and Discharge Planning require considerable re-organization and improvement. Case Management must work in more collaboration with Utilization Review in order to coordinate efforts regarding admissions and continued stays. The entire Care Management program should be restructured to ensure a collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services to meet an individual's and family's comprehensive health needs through communication and available resources to promote quality, cost effective outcomes. Following our discussion of preliminary findings, the Care Management Department presented some ideas to restructure its Case Management, Social Work and Discharge Planning efforts, including: 1. Restructuring Case Manager/Social Work roles and defining criteria for identification of patients likely to suffer adverse health consequences upon discharge without adequate discharge planning at an early stage of hospitalization. 2. Transitioning the Department to a clinical case management model /collaborative that will consist of teamwork between Case Manager, Utilization Review Specialist and Social Worker and defining the screening, assessment, discharge planning process for identified high risk patients. 3. Restructuring the ED Case Manager role to screen all patients who present to the ED for admission criteria, evaluate each patient's condition to determine medical necessity, and communicate with the physician regarding medical necessity for appropriate level of care determination. 4. Produce an Extended Stay High Cost Outlier Report to identify inpatients that could safely move to a post-acute care setting if funding permitted. These efforts, if accomplished, could help to improve the Case Management and Discharge Planning processes at Parkland, but at present Parkland is not meeting all the Conditions of Participation and standards related to the obligation to have effective Case Management and Discharge Planning. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 137 2.7.9 Ut i I iza t?o n Rev i evi' A hospital's Utilization Review (UR) function is intended to focus upon: whether patients meet the required admitting criteria, how long a patient stays in the hospital for a given diagnosis, and how a hospital's treatment and usage patterns of its patient population compare to state or national benchmarks. A UR plan should provide for the review of admissions, duration of stays and professional services furnished including imaging, laboratory, drugs and biologicals. The UR department can also be a valuable resource in detecting and monitoring physician practice patterns to improve the efficient use of resources such as inpatient days, pharmacy, imaging and laboratory services. UR Group Organization The UR group at Parkland resides in the Clinical Quality Management Department (Quality Department). The group currently focuses upon the reduction of readmissions for three conditions: Congestive Heart Failure (CFIF), Myocardial Infarction (MI), and Community Acquired Pneumonia (CAP). Starting in January 2012 the UR group said it will begin reviewing high risk diabetes patients. The UR group appears to be performing a modified form of disease management for these three conditions and docs not appear to be engaged with Case Management or Discharge Planning. However, the UR group believes that it is performing more than a "disease management function", and that it is using nationally recognized transitional care techniques and are interacting with Parkland Case Management on reviews of patients other than the three conditions of CHF, MI and CAP. The current Parkland UR plan does not provide for the review of admissions for the Behavioral Health Services patient population, which is a large percent of the diagnosis seen at Parkland. The only reviewed data is on the duration of stays and professional services furnished including drugs and biologicals on a very small selection of patients. The UR plan should include a delineation of the responsibilities and authority for those involved in performing UR. The plan should also establish procedures for the review of the medical necessity of admissions, the appropriateness of the setting, the medical necessity of extended stays, and the medical necessity of professional services, including drugs and biologicals. While the UR Plan currently provides for the review of extended stays, the minutes of the UR Committee meetings do not contain the required information to improve utilization. The UR group believes that it is actually currently conducting reviews for medical necessity of admissions, appropriateness of care setting and medical necessity of extended stays on behalf of the Case Management Department, although that work is not reflected in the UR Committee minutes. The UR group indicates that work has been done to reduce inappropriate Emergency Department visits as well as to enhance the review of high risk diabetes patients, although the Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. UR Committee minutes do not reflect these activities. ?482.30 Condition od'arrkipatton: IItilte&tioin Review. f A O : A-0652. ?->S5. Standard: Scope and ! -eq\. m -v oi A .o a jS '.A0(0 t \ G : A -ft 38 Sum:i<-nd: R r v A w o f l ' i c l c s aontd iocs, ill 0! (?P i(TM) The UR Committee must review professional services provided, to determine medical necessity and to promote the most efficient use of available health facilities and services. Currently, cases that are questionable for admission or continued length of stay are taken by Parkland Care Management to the Chairman of the UR Committee for review. The Chairman of the UR Committee, who is also the head of the UR group, indicated that he personally conducts admission reviews, admission status reviews, concurrent reviews, unsafe discharge reviews, preop day reviews and extended stay reviews and that he maintains a written case log for cases reviewed other than Code 44 cases. Some admission and continued stay reviews are documented in a "CareWeb" software program. The minutes of the UR Committee meetings, however, do not contain information regarding these case reviews or interactions with Case Management or any trending data with respect to these reviews. The UR group believes it needs additional analytic resources that can provide refined data and analysis to the UR Committee. In Peer Review committee minutes and cases brought forward for peer review, as well as the indicators for review, there is not a provision for the review of providers who may have trended unfavorably in these categories such as medical necessity of admissions, Length of Stay (LOS) or unsafe discharges. This information should be used for Ongoing Professional Practice Evaluations (OPPE). Utilization Review should be presenting trending data to the UR Committee on how it works with Care Management to coordinate efforts regarding admission and continued stays. Until these elements are actively reviewed the UR function is not in compliance with C M S C o P . Commaed Slavs. i \G-0605A Standard: Determination Regarding Admissions or Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 139 Currently the metrics used by Case Management (Milliman and Roberts) are limited and exclude other methods such as geometric mean LOS. Though the Case Management department holds a weekly meeting on identified problematic cases, these cases are not discussed at the UR Committee. Only raw data is presented regarding extended LOS. No analysis or trends are presented nor are any recommendations for actions contained in the UR Committee meeting minutes we reviewed. In order to comply with the CoP, extended stays should be analyzed by the UR Committee and actions should be taken as appropriate. Findings need to be discussed at the UR Committee, tracked and trended and should be referred to peer review as indicated. JJ482..H) (c)(2) FAG: A-057. Standard: hxtonded Stay Revicsv. i IX04 01.oi (!J> ? F, }n, Conclusion Overall, the UR Committee and group needs to ensure that proper data is collected, analyzed and trended for all the required elements. Trends need to be referred to Medical Staff Peer Review as necessary and the focus of the UR function needs to expand past the current "Transitional Care" management focus. The UR Plan does not include all the elements required by the CMS CoP. It should contain a delineation of the responsibilities and authority for those involved in the performance of UR activities. It should also establish procedures for the review of the medical necessity of admissions, the appropriateness of the setting, the medical necessity of extended stays, and the medical necessity of professional services. While the Hospital's UR Plan does provide for the review of extended stays, the minutes of the UR Committee meetings do not contain discussions surrounding this element. The UR group indicated that it engages on a daily basis with the Case Management/Discharge Planning function, however, the UR Committee minutes and our interviews and review of documents did not document that the UR group and the Case Management/Discharge Planning function are working collaboratively to develop goals for the current Parkland patient population. Following our discussion of preliminary findings with the UR group, the group presented clarifying information regarding its functions and services as well as an outline of activities for the UR Committee to focus upon in the coming year, all of which will be reviewed by the A&M ICE team in devising an Action Plan for Utilization Review, Case Management and Discharge Planning improvements to meet the Conditions of Participation. At this time, however, Parkland is not meeting all of the Conditions of Participation and standards related to Utilization Review. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 140 2.S Quality and Performance Improvement Program (QAPI) As part of our engagement, under the Systems Improvement Agreement (SfA), A&M was asked to conduct an analysis of the Hospital's current Quality Assessment and Performance Improvement (QAPI) program. The purpose of the QAPI analysis is to evaluate the Hospital's current QAPI program in terms of its ability to meet the requirements of 42 C.F.R ? 482.21 for an effective, hospital-wide, data-driven QAPI program that is used to develop and implement performance improvement activities and projects that improve the timeliness and quality of care and the safety of patients at Parkland. The QAPI analysis is to include an evaluation of the adequacy of Parkland's QAPI resources, the qualifications of the QAPI staff, and the level of engagement of the Parkland Board of Management, administrative official and medical staff in the QAPI program. In accordance with the SIA, as amended, the QAPI analysis report will be delivered to CMS by A&M no later than February 10, 2012. However, because the effectiveness of Parkland's QAPI touches upon nearly every aspect of the provision of patient care at Parkland that is otherwise discussed in this report, we wanted to provide some preliminary and thematic comments in general about Parkland's quality and performance improvement. Our fuller analysis of the QAPI program will be delivered in our February 10, 2012 report. Hospitals must work to guarantee not only a safe patient experience, but a care experience that is also cost efficient and consistent with best practices. Through the ICE survey and interview process a number of trends emerged relating to how quality is viewed at Parkland. "Quality" at Parkland is often viewed as a "Department" or "Building" -- Support Building B in this case where the Department is housed -- which is responsible for "quality" rather than quality being an institutional and cultural trait as well as a imperative for all staff and employees. The primary challenge for Parkland, even before addressing quality program issues, is to instill a sense that quality belongs to everyone. Overall Parkland's QAPI program is not as effective as it should be. It does not capture all quality related issues, events and initiatives and does not adequately prioritize and appropriately deploy resources as needed. The program does not engage in enough data analysis or trending studies, or share information gleaned from that data across the organization. The Parkland QAPI program often views quality through the lens of reported "adverse events." But too often adverse events are viewed as isolated incidents as Parkland, rather than symptoms of a systemic problem within the organization. Non-compliance with policies, procedures or standards at Parkland often stems from lack of knowledge and not an intention to willfully disregard rules and regulations. As such, the QAPI program must include continuous education on quality standards across the house. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 141 Organization wide, Parkland's QAPI program does not effectively integrate into each Hospital department and unit, and as noted throughout this report, few if any, Hospital departments have department specific QAPI plans, as required by the Medicare Conditions of Participation. Even within the Quality of Care Department (Quality Department), which is responsible for Parkland's QAPI program, there is a high degree of siloing as units within the Quality Department do not interact effectively and share information with one another. Recent organization changes in the Quality Department to fold together the Performance Improvement group and Continual Readiness group -- the group that assists the Hospital in understanding Medicare and Joint Commission standards and policies -- have already begun to improve the Hospital's effectiveness in responding to state and federal surveyors and investigating adverse patient events. Parkland's QAPI program, as currently organized, is also limited with respect to its collaboration with other organization-wide functions that should also be focused on care quality such as the Compliance, Internal Audit and Legal departments. Recently the Interim Chief Executive Officer (CEO) launched a project to better align the work of these four key departments: Quality, Compliance, Internal Audit and Legal. Better alignment of those four functions will be part of the QAPI improvement process. Finally, because of the belief that "quality" is a department or building at Parkland, rather than a cultural trait, Parkland's QAPI program needs to convey a consistent message throughout the organization on its purpose and how each employee must own the quality of all of the work they perform as well as the work of their colleagues. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 142 A Section 3: Department and Unit Specific Finding 3.1 Emergency Services Introduction Parkland's medical and psychiatric emergency services have been under close scrutiny by the Centers for Medicare and Medicaid Services (CMS) and Texas Department of State Health Services (DSHS) following significant allegations of unsafe patient care. In May 201 1, following complaints regarding the care of three psychiatric patients at Parkland, CMS conducted a complaint survey that led to a "Condition Level Deficiency" for violations of patient rights. A full CMS survey in July 201 1 and a follow-up survey in August 2011 identified additional patient care issues in the Parkland's Emergency Services Department (Department or ED or ESD). These surveys resulting in findings of EMTALA (Emergency Medical Treatment and Labor Act) violations, including: o o o Failure to provide Medical Screening Exams (MSEs) by Qualified Medical Personnel (QMPs). Failure to provide patients, who were transferred from the ESD to other acute care facilities, with required "stabilizing treatment" or an appropriate transfer. Failure to have policies and procedures in place to assure EMTALA compliance including policies to ensure that emergency services were available to meet the needs of individuals with emergency medical conditions after the initial examination to provide treatment. While Parkland has taken some steps to address some of the issues raised in the CMS surveys, during our ICE survey period we continued to witness or be advised of adverse patient care events in the ESD. We observed instances of delayed patient intake, delayed patient care, problems in properly monitoring patients under 1:1 observation and problems with patients eloping without being seen or being treated, which we further outline in this section. Parkland's ESD is clearly challenged with issues similar to those confronting emergency departments of other large public hospitals across the nation. These challenges include: hospital over-crowding; community ambulance diversion; boarding of patients; limited access to primary care services; reduced reimbursement from public and private insurers; high rates of uninsured individuals; and undocumented aliens displaced from the health care system. Parkland's ESD is an extremely busy service, with over 200,000 patient visits in 2011. The ESD is the front door for most of Parkland's patients and accounted for 85% of the Parkland's hospital admissions in 2011. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 143 But sheer volume alone eannol justify lapses and gaps in patient care and continuing failure to meet several of the CMS Conditions of Participation. As part of our ICE survey we tried to determine the root causes behind delays in intake, triage, screening and treatment in the ESD as well as incidents of patients eloping, and leaving without being seen or treated. We also sought to understand why some patients with special needs have been left unattended or improperly "handed o f f ' between caregivers or service areas. We also examined the frequency of patients being "boarded" in the ED and why some patients have been discharged without proper direction or assistance. Many of the adverse patient care episodes experienced in Parkland's ESD can be traced in whole or in part to some of the following issues and weaknesses in Parkland's ESD organization and operation: o o o o o o o o o o o Multiple and fragmented portals of entry into Parkland's ESD. Frequent movement of patients between far-flung ESD care settings. Inadequate physical plant and undersized registration, triage, treatment and waiting areas. A partial and unsuccessful effort to introduce a "split flow" model to improve care and efficiency. A Pod-based treatment setting that restricts patient flow to available care sites. Nurse staffing based on grids instead on patient acuity. Ineffective discharge planning and case management. Inefficient Hospital inpatient bed management that leads to delays in assigning patients to an inpatient bed and causes high rates of "boarding" in the ESD. Transformation of the Urgent Care Center in the ESD from an emergency services department to essentially a walk-in, primary care clinic with full EMTALA obligations. Lack of consistent community resources - dialysis, substance abuse treatment - for uninsured, undocumented immigrants. Staff accountability and institutional cultural issues. All of these issues must be addressed as a whole in order to resolve continuing issues around access, delays, hand-offs, boarding, elopements, patient observation and safety that continue to cause adverse patient care events. Parkland ESD - "Split Flow" System and Other Through-put Problems Three years ago, in an effort to improve patient flow, the Hospital redesigned the ESD by implementing a "split flow" system. A split flow system tries to separate patients who are expected to be treated and released into an area of the ED separate from those patients who are more urgently ill, and who are expected to be admitted to the Hospital. This model of emergency care "splits" the flow of patients who can be treated and released from patients who Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. must be seen and admitted. It appears that physical plant restraints at Parkland led to a compromise in the design of the split flow system. In order for a split flow system to work effectively, a "fast track" feature must be introduced for those patients who can be examined, treated and released expeditiously. The redesigned Parkland ESD did not include a "fast track" area in the ESD for low acuity patients. Rather an Urgent Care Center (UCC) was established on the other side of the Hospital from the ESD. A separate area designed to provide for patients of moderate acuity illness - an "Intake Area" -- was omitted from the ESD and instead the flow was designed to place those patients in the hallways and chairs of the Pod areas. The Pod areas are those parts of the ESD intended to care for the sickest patients. The ESD also continued to maintain operation of specialized and separate areas for psychiatric and Ob/Gyn emergencies, moving patients between the Main ESD, UCC and other points of Hospital entry to the Psychiatric Emergency Department (PED) and the (Women's) Intermediate Care Center. This emergency department reorganization at Parkland created multiple portals of patient entry into the Parkland's various Emergency service areas. The complexity of this division and the physical layout of patient flow between the various emergency areas have resulted in: 1. Redundant transferring of patients between various services areas of the Department; 2. Errors in patient flow supervision, and 3. Severe delays in the completion of the conduct of an MSE and the provision of stabilizing treatment as required under EMTALA. The triage areas in both the Main ESD and the UCC are overcrowded and unsafe. The Main ESD waiting room and triage areas are often filled in excess of seating capacity. Nursing visibility of the patient areas is poor and compromises the ability of nurses to safely monitor patients in the waiting area. Additionally, the provider culture of the ESD has not assumed complete responsibility for maintaining an environment in which all patients seeking medical care for emergencies are encouraged, rather than discouraged, to remain in the ESD and undergo evaluation and treated in a timely manner. The complexity of the triage process at Parkland's ED is contrary to the split flow model on which the Parkland ESD was originally designed, and therefore creates safety risks and delays for persons presenting to the Hospital for evaluation and stabilizing treatment of emergency medical conditions. The Parkland ESD as a whole is over-crowded with staff, patients and visitors moving in and out of the Department without supervision. This also leaves the ESD vulnerable to elopements by patients with and without their consent. The rate of patients at Parkland who leave without being seen by a provider qualified to meet the EMTALA obligations o f t h e Hospital averaged 5.2% in Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. 2011, twice the national average, with an astonishingly high peak rate of 15.1% in September 2011. The ESD patient How is further compounded with the number of patients who are brought to the Hospital under Apprehension of Peace Officer Without Warrant (APOWW) or some other means of police custody. The absence of a dedicated intake area for patients of moderate acuity illness has created an unsafe environment for patient care in the "Pod area" of the Main ESD. Patients are crowded in hallway chairs and stretchers, placing them and their physicians in a situation that lacks privacy, proper nursing supervision, and the facility to accommodate proper examination by a qualified medical professional, all in violation of EMTALA as well as the timely provision of care required under the Medicare Conditions of Participation. The capacity of the ESD to meet the demand of patients who come to the Hospital seeking emergency care is also severely impacted by upstream constraints in the Hospital patient flow process. A great deal of these bed shortages are caused by ineffective case management and discharge planning, which is discussed elsewhere in this report, or by inefficient Environment Services (EVS) housekeeping services that delay access to beds. "Holding" patients designated for admission, boarding admitted patients awaiting bed assignment, as well boarding and patients awaiting hemodialysis leads to a severe loss of functional beds in the ESD, long patient queues for service, and diversion of ambulance patients away from Parkland Hospital. The Urgent Care Center has many parallel deficiencies in design of the triage process, patient throughput, and functional capacity, creating an environment that violates the Medicare Conditions of Participation. Taken together, the current overall organization of the Parkland ESD services with its many points of entry and disparate care areas, coupled with a partial attempt to institute a split flow treatment model, has created a fragmented emergency services delivery system that is contributing to, or in some cases directly causing: delays in triage, examination and treatment; errors in hand-offs and transfers; patient elopements; and general patient safety issues. Organization and Structure of Parkland's Emergency Services - General The Department of Emergency Services (Department) is comprised of four discrete Emergency Service areas in Parkland Hospital: the Main Emergency Service Department (Main ESD), (Women's) Intermediate Care Center (ICC), Urgent Care Center (UCC), and Psychiatric Emergency Department (PED). In addition, the Department has oversight for persons arriving to Labor & Delivery (L&D) Triage. The patient populations served by each Emergency Service Area and L&D Triage are outlined below. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 146 /h ff I M Arrival/Location Main Emergency Services Department (Main ESD) Urgent Care Center o o o o Patient Population Medical complaints in patients over the age of 18 Trauma over the age of 14 Pediatric burn patient Psychiatric Emergency Department o o (Women's) Intermediate Care Center o o o o o o o o o Patients over the age of 18 with: o Moderate acuity (ESI Level 3) illness with stable vital signs (excluding chief complaint of abdominal pain) o Low acuity (ESI Level 4 or 5) and no open lacerations or acute surgical problems Adults, and voluntary or involuntary adolescents ages (13 -17), presenting with a guardian or police, with the following conditions: o Suicidal ideation o Homicidal ideation o Auditory and/or visual hallucinations o Delusions o Dystonic reactions o Eating disorders o Psychiatric medicine refills o Either or both Drug and Alcohol Abuse or Dependence N o patients referred from the Jail can be sent to the Psychiatric Emergency Department Gynecologic chief complaint after age of menarche o Without traumatic injuries less than 96 hours old Pregnant patients less than 24 weeks gestation Alleged criminal assault on female patients age 14 and above Alleged criminal assault on female patients age 14--16 when the alleged assailant is not a family member Females presenting with abdominal pain below the umbilicus. Gynecological oncology patients with any complaint, unless they have unstable vital signs Vaginal bleeding and/or discharge Vaginal /perineal sores in female patients Postpartum complaints post vaginal delivery or cesarean section within six weeks Females of all ages greater than 24 weeks gestation for any complaint except trauma less than 96 hours old All pregnant asthmatic patients of any gestational age Labor and Delivery Triage o o Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 147 Physical Structure of Emergency Services Persons arriving to Parkland requesting emergency care currently present to one of five areas in which an EMTALA obligation exists, along with the attendant requirement for a Hospital Qualified Medical Professional (QMP) to conduct a Medical Screening Examination (MSE), to determine the presence or absence of an Emergency Medical Condition (EMC) and provide Stabilizing Medical Treatment or Transfer (SMTT) as indicated. These five areas are located widely distant from each other and on three different floors of the Hospital. Parkland does not have a pediatric emergency service area. Pediatric emergency care is provided at the Emergency Department of the Children's Medical Center of Dallas (CMCD), operating under a separate facility license. The interior of the C M C D Emergency Department is immediately adjacent to the interior of the Parkland ESD, separated only by a short hallway and accessible doorway. The main exterior entrances to each respective emergency department are widely separated in two different hospital buildings. Presently, all pediatric patients presenting to the Parkland ESD require an MSE and transportation to the C M C D Emergency Department. For the last twelve months, an average of 24 pediatric patients per month have presented to the Parkland ESD, the monthly range for the period was a minimum of four patients and a maximum of 54 patients. During the period of the ICE survey, there were no observed or reported instances of pediatric transfers from Parkland Hospital to CMCD without prior completion of an MSE. On chart review, it was noted that one pediatric patient was transferred to CMCD without transfer certification. The patient presented to the Hospital ESD at which time a QMP performed an MSE and determined that Stabilizing Treatment required transfer to CMCD. The patient was appropriately transferred with informed c o n s e n t by w h e e l c h a i r to C M C D : $4*2.! 2 TAG: A-0W2; ?482.55 TAG: V-iOO. /lis The existence of multiple portals of patient entry into the Department's various emergency service areas, as well as the complexity in the physical layout of patient flow between the various Department services areas or L&D Triage, increases the process variation and the probability of error in the Hospital's efforts to meet its EMTALA obligations. The ICE Team observed that persons who present to the check-in or triage area of one Emergency Service area in the Hospital are frequently transported or accompanied to another Emergency Service area, e.g., from the UCC to the ESD. It is not uncommon for a patient to undergo transportation back and forth between two different areas of the ESD, e.g., a person evaluated by the ESD Check-In nurse could be transported to the UCC, where an MSE by the UCC physician determines that the treatment indicated for the patient's Emergency Medical Condition requires that the patient be transported immediately back to the ESD. A patient evaluated at one service area will be returned to ESD for further evaluation and treatment if they: a) are found to have additional EMCs unrelated to the service Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 148 area initially assigned; b) are found to have an EMC with a higher level of acuity than identified at the time of initial triage; c) arrive to the assigned service area at a time of day near or after the assigned service area's closing time (further discussed in the UCC section of this report). The redundant transferring of patients between the Main ESD and UCC and back adversely impacts patient flow through the Department in several ways: a) it directly delays care; b) frustrates the patients and increases the likelihood that a patient will defect and leave the Department either without completing treatment or against medical advice; c) it requires a nurse to make manual changes in the Department computerized patient tracking system, increasing the incidence of user errors or omissions that cause patients to "drop out" of the system and negatively affect nursing's ability to care for them. $482.55 O G \-l 100.< edition-.;nflHuiieipaiton: kfnerueiK,). Services S482.55f.aM2) f A t i : A-1105 Stand*)<t Waiting Areas The Main ESD waiting room and triage areas are often filled in excess of seating capacity. The waiting area has 70 seats, which, using a benchmark of 1.7 visitors per ESD patient, exceeds capacity on average when there are 42 or more patients in the waiting area. ESD administration reported several days within the ICE survey period in which there were over 50 patients waiting to be seen in the waiting areas, plus accompanying family members or friends. During periods of peak patient arrivals, people are constantly moving in and out of the Triage area. Patients are not distinguished from visitors by any visual means. Portions of the waiting rooms are not visible to triage staff so that patients can be adequately monitored. The physical layout of the waiting area obstructs visualization between the two ED waiting rooms; a nurse in one waiting room cannot observe patients in the other waiting area of the Main ESD. Patients seated in the triage waiting room are not visible to either the Checlc-ln Nurse or the Dallas County Health Department Police Officer (DCflD PD) officer posted at the entry. There are blind spots obscuring parts of the main waiting area from the Check-In nursing station. ?4SQA 1. TAG 0700 Ondiiioii oil'anicip.ttion: Ph\:s< -il I m ? f o m e n t . x'iS.: ! o i A C VOi I.*- Condition ofpHuicipStuDn: Paticsn Rjf.hu>; i.C 02 J ^ 01 il-.P !>o !U,opt}! Uf. ,-?/> <41 EMTALA, Medicare and Compliance Hotline signage specifies, in clear and in simple terms both in English and in Spanish language, the rights of individuals with emergency conditions and women in labor who come to the Department for health care services; and that Parkland Hospital participates in the Medicaid program. The signs are posted in places likely to be noticed by all individuals entering each of the Emergency Service Areas. In Lhe waiting area, there is no signage instructing patients to alert nursing if the patient's condition changes or worsens. There is no signage informing patients of the process they should follow if they decide to leave Against Medical Advice (AMA) or to leave without being seen by a physician. The Medicare Hotline number is missing from signage in the Main ESD area. Treatment rooms do not have required E M T A L A s i g n a g e . $489.20 <"q)< 11 Basic Commitments Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 150 Facility Layout The Main ESD was reconstructed from a conventional "racetrack" configuration into a podbased split-flow ED system in 2009. The Main ESD occupies about 42,000 square feet on the ground floor of Parkland Hospital. The Main ESD has a total capacity of 88 beds (patient care areas), including the designated patient chairs in the pod hallways. The pods are the core units of care in the Main ESD. The Main ESD treatment area is divided into two wings (East and West) which collectively hold five pods of 12 beds each (60 beds) plus partitioned hallway stretchers and chairs designated for patient care. The Trauma Service in Pod 3 consists of six enclosed specialized care rooms. The pods include nine critical care rooms fully equipped to manage life-threatening emergencies. Pods are designed to function as self-sufficient modular units, each with its own supplies, tracking screens, physician and nurse charting stations, and other resources required for emergency care. There are wall unit hand sanitation dispensers in various areas of each pod as well as at the doorway of each patient bed in the pod. Bottled hand sanitizers are present on countertops in various nursing and physician areas of the pod workspace. 22 beds have cardiac monitoring connected into a central monitor located at the nursing station. Other specialized rooms of the Main ED include decontamination room and nine rooms with negative ventilation (east wing), one orthopedic room comprised of three beds, and one ophthalmology room. Infection Control/Environment of Care The ICE Team observed chairs, stretchers and equipment in the inter-Pod hallways, creating obstruction to clear pathways. Shipping boxes were present in patient care areas while staff was S t o c k i n g P y x i s . ?482.41 ( a ) ' ! >\Q: \ o< ?J The ICE Team observed numerous incidents of inadequate hand washing or sanitizing by staff between patients, for example, when a nurse or tech left the patient's room or assigned area, and entered another patient room or bedside without performing hand hygiene. ? 4 8 2 . 4 2 . TAG A - 0 7 4 ? Cno^frtfrt of fomcipptiofi: I n f o a w n Oogirol: (('01 OS 01 tf-.P "j t\TS(> 07.0?.Of d'P 2, 3i Ancillary Resources Information Technolog)> and Deficiencies Medical Information Privacy in Maintaining a Central Log and Safeguarding The Main ESD uses "Epic ASAP ED," a information management system. Epic modules are used in all Hospital clinical areas with the exception is Ob/Gyn. Epic is a Certification Commission for Healthcare Information Technology (CCHIT) and Meaningful Use certified solution-software system that integrates all IT functions required for ED IT management; Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Electronic Medical Record (EMR); a decision support Computerized Physician Order Entry (CPOE), database and management reports, prescription writer, email/page messaging, radiologic image viewing, and results reporting for Pathology and Diagnostic Imaging. The Emergency Department central log is maintained through the database of the Epic system. During our survey of the Main ESD, the Nursing Supervisors on duty were not able to access or create an emergency department "central patient log" or analogous report using the Epic Emergency Department Information Systems (EDIS). An "Emergency Department," as defined in ?489.24(b), is required to maintain a central log of individuals who "come to the emergency department," seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. The purpose of the central log is to track the care provided to each individual who comes to the Hospital seeking care for an emergency medical condition. In accordance with CMS Interpretative Guidelines, each hospital has the discretion to maintain the central log in a form that best meets the needs of its patients. The central log should include, directly or by reference, patient logs from other areas of the hospital where a patient might present for emergency services or receive a medical screening examination instead of the main emergency department. At Parkland that would mean including within the central log information about patients who presented directly to the UCC, PED or the Labor & Delivery Unit in WISH. If additional logs are kept by those other areas -- UCC, PED or L&D - those logs must be available in a timely manner for surveyor review and they must be incorporated by some method into the central log. $4rra??: V0M7. - ?Mf?.'V! Of .\()9 (EPij A nursing home patient presenting to the ED, suffering from a traumatic brain injury (TBI) was left unattended in soft restraints in the Main ESD, fell off of his chair and sustained possible head i n j u r i e s . 34H2 :.>Coit2i ! AG; A*!OA! StaiiHer<<'.:, Pattern Ridir*; 1*1'QJ "S tri thJ*h We also noted multiple instances of patients not receiving intake, triage or a medical screening examination (MSE) in a timely manner. In one incident on a weekend evening shift our surveyor observed a mother with her young child lying under the water fountain in the Main ESD waiting area. The intake nurse was unaware of the mother or child's presence or status in the waiting area and in fact was reading homework materials when interviewed by our surveyor. In another incident on the day shift (described in more detail later in this section) we observed a patient in distress in the Main ESD triage waiting area, seated in a waiting chair with an IV bag being held by the patient's friend. The Intake Nurse was unaware of the patient's presence or the patient's distress. In third incident (also described in more detail later in this section) a Main ESD patient had been triaged and given an MSE but was kept waiting for an additional 14 hours before it was noticed by a staff member that the patient's care had not been completed. ?4iJ9.2"K4}ii): Special Responsibilities of Medicare Hospitals in btncr&ency Cases Another patient who presented to the Main ESD intake nurse reporting suicidal thoughts was sent to a waiting area un-escorted and was not covered by a one-to-one sitter or immediately escorted to a physician or nurse for triage. The patient eloped after approximately 30 minutes of waiting. Following an intensive search and dispatch by the Parkland Police Department, the patient was ultimately recovered at his apartment and returned to the Hospital for treatment. During our survey we also observed a patient who presented during the evening shift under a Apprehension of Peace Officer Without Warrant (APOWW) legal hold. This patient was not placed in 1:1 observation with a Patient Care Attendant (PCA) as required by Departmental policy until the 23:00 shift started. The nurse responsible for the patient was told by the admitting team that the patient did not need a PCA even though the patient was APOWW. The Lead Pod Nurse assigned to the patient for the ensuing night shift was aware of the Department p o l i c y a n d a s s i g n e d a P C A t o t h e p a t i e n t . 5482,:. UhjG'i TAG: A-0295 Standard: Staffing a ml Dcliven of ( are ."<' *0 ' n?. 01 ;h.P / , A ' OS 0 )Jil h Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Five A P O W W patients (high risk elopement according to the ESD Policy F-4) in a pod in ESD West were observed to be under supervision of two PCAs. The ESD policy requires 1:1 ratio between PCAs observing patients under legal holds. ?482.13(c)(2) TAG: A-0I44 FX'.02.01.01 (LP I) An ICE study did not demonstrate a relationship between ESD Staffing and the occurrence of three adverse events in the ESD that were each subject to an ICE case study. The ICE study reviewed four consecutive weeks beginning November 15, 2011 through December 06, 2011. During the period under review three adverse events reported by the ICE team occurred. The chart below represents a weekly bar chart constructed from ESD data showing patient census by hour of day (left Y-axis) for each day of the week. The red line represents the combined number of nurses and unit techs (Caregivers) staffing the ESD at each hour of the day (right Y-axis). These events, described in detail elsewhere in this report, are labeled on the chart as A, B, and C, connected by a line arrow to the staffing level at the time and date of occurrence. A brief description of each event is provided below the chart. The analysis revealed that: a) the number of caregivers staffing the ESD correlated with the ESD census by hour of day; and b) caregiver staffing was adequate at the time of day when each of the three events occurred. The analysis did not reveal a correlative relationship between insufficient caregiver staffing and the occurrence of the reportable adverse events during the time period under study. 160 EDS Census and FTEs 140 Event A 120 Event B 100 25 ma 12/06/2011 WB12/07/2011 80 60 15 20 raw 12/08/2011 m12/09/2011 <<12/10/2011 12/11/2011 12/12/2011 20 oAug FTEs 40 o- o 1:00 2:00 3:00 4:00 5:00 6:00 7:00 8:00 9:00 . o 10:0011:0012:0013:0014:0015:0016:0017:0018:0019:0020:0021:0022:0023:00 Event A: 12/6 - Patient arrived by EMS in the waiting room without active treatment. Event B: 12/7 - ESRD Patient Underwent Hemodialysis w/o physician order Event C: 12/10- Individual found under water fountain intake; nurse was doing homework Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 158 Main ESD Patient Flow Processes The Parkland ESD uses a "Split Flow" model, which is a patient flow plan that stratifies patients into separate groups based on the severity of their conditions, in order to parallel process triage and registration and have patients seen by a qualified emergency provider as quickly as possible. A commonly-accepted severity-based triage system (Emergency Severity Index or "ESI") is used to clinically stratify patients into five groups, from least (ESI 5) to most (ESI 1) acutely ill, according to patient acuity, chief complaint, and resource needs. The ESI score is then used to segment incoming patients to different ED areas (ESD, UCC, PED, ICC). Nursing staff in the Main ESD is required to demonstrate proficiency in determination of the ESI. Patient Inflow Design Immediately upon entering the ED through the ambulatory entrance patients or their family members encounter an information booth with an administrative clerk who issues visitor passes and provides minimal patient information to family and visitors. Ambulatory patients then proceed through a metal detector (posted by a DCHD Police Officer) into the main Triage Area. Cheek-In and Triage The Triage Area serves as the primary point of entry for ambulatory patients into the Main ESD. Ambulatory persons who arrive to the ESD are initially greeted by a Check-In Nurse. The purpose of the Check-In process is to identify persons who on presentation appear to be either or both an ESI 1 or 2 or who are eligible for a limited number of high-severity expedited protocols for either chest pain or stroke. The Check-In Nurse obtains identifying information, chief complaint, and performs visual observation of the patient. When the Check-In nurse encounters a high-severity patient, he or she uses a hand radio to contact the EMS desk. A transporter or a nurse meets and transports the patient to the bed assigned them by the EMS nurse. Patients judged by the Check-In nurse to be acutely ill are placed in a wheelchair and transported directly back to the Main ESD Pod area for assessment and treatment. Patients not immediately placed in Main ED are assigned a place in the queue for Main ED Triage. Patients in queue for Triage wait in the general ESD Waiting Area, which is located immediate to the area of the Check-In nurse. Patients presenting at the ESD with complaints appropriate for treatment in the UCC, ICC, PED, or L&D (exclusive of labor or pregnancyrelated complaints) are first triaged in ESD, and then walked or transported to the assigned Emergency Service Area. Patients in labor or with pregnancy-related complaints are transported immediately to L&D. Patients assigned to the Main ESD after triage wait in a Triage Waiting Area for placement in the ESD. After being triaged patients are escorted or transported by ESD staff (nurses or aides according to protocols) to the Main ESD or one of other Emergency Service Areas, i.e., PED, UCC, or ICC. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. The complexity of the Parkland ESD triage process creates safety risks and delays for persons presenting to the Hospital for evaluation and stabilizing treatment of emergency medical conditions, too much time is used to collect information unnecessary at this triage point in the process, and to move patients to the areas where they will actually receive care. Delays in triage, even before an MSE is performed, can lead to delays in the identification of patients who have EMCs, and increases the time needed to begin stabilizing treatment or transfer (when indicated). ?4$2.!3tcK2i i \ G : Jv-0144 Standard: P m a c y and Safely. Triage's assignment of patients into the two Main ESD areas (pods and chairs) creates safety risks and delays for persons presenting to the hospital for evaluation and stabilizing treatment of emergency medical conditions. G!$243io;t2) TAG: A-0144 S a n d a r d : Privacy and S a f H y : E( u!.0!.0!( EE j , ICE Team surveyors frequently observed patient queues for triage as evidenced by the presence of a high volume of patients in the Triage Waiting Area (numerous patients standing in the Triage Waiting Areas with every scat occupied by a patient). The insufficient capacity of the Main ESD Triage system (staff, triage beds/chairs, and providers qualified to conduct either MSE or Triage exams) creates safety risks and delays for persons presenting to the Hospital for evaluation and possible treatment of emergency medical conditions. ?482.1 He) TAG: A-0722 /.(',02, ao.OJ Nurses who were interviewed acknowledged that patients in waiting areas of ESD, UCC and PED leave without being seen or without being treated. Ten nurses performing triage were asked if they had a duty to do the following: inform the physician(s) on duty about patients who intend to leave (or who apparently have left) the Main ESD; make an effort to counsel patients about the benefits of staying for evaluation and treatment versus the risks of leaving before being seen or treated by a physician; and to provide documentation of their efforts to conduct the previously described activities. Four of the ten nurses interviewed stated that they did not know if they were required to perform all of those activities for patients who have left or who intended to leave the department before completion of the examination or treatment. The Department has no nursing policy that directs nurses to instruct patients to alert their nurse if patient's condition changes, worsens, or if the patient wishes to leave without being seen (LWOB). <;>>l82.35ioii.>)TAG: 4-0305 /'< \6f V2M-EE The potential for failure in the ED Intake and Triage systems is evidenced by several cases we observed or were made aware of during our survey period. A patient presented to the ESD with a chief complaint of suicidal thoughts. The patient was directed to wait in the open Triage Waiting for an available nurse. The patient was not immediately put on a 1:1 PCA watch or immediately escorted for triage either in the Main ESD or Psychiatric Emergency Department. The patient waited for approximately 30 minutes and then left. It was only sometime later that the Intake Nurse realized that the patient had eloped. DCHD Police were dispatched in order to Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. find the patient. The patient was ultimately located at the patient's residence and was returned to the Hospital for treatment. As a result of this event, the Hospital instituted a Psychiatric patient protocol for check-in. If a person presents to the Check-In nurse with a complaint of suicidal or homicidal ideation, or who displays a significantly altered mental state, the protocol now requires the Check-In nurse to: a) request the immediate presence of an ED Tech to provide 1:1 observation of the patient throughout the triage process; b) obtain and start handwritten documentation on a Psychiatric Monitoring Tool; and c) expedite the patient to the triage nurse as promptly as possible. We will continue to monitor the ESD for compliance with this new protocol to validate that these procedures are being followed. ?48123( ,0! i>2.03 OH' 2. Jj During our survey period we also observed several gaps in "hand-offs" of patients between caregivers. We observed a patient presenting to ESD who was deemed a significant enough risk for suicide by the triage nurse to require an RN for transport to PED. The patient was accompanied by the RN to the PED waiting room where responsibility for care was transferred from the RN to the PED Unit Clerk (HUC) at 11:15. Patient was observed by ICE Survey Team at 13:15 and seen by a QMP at 13:17. There was no report or handoff witnessed between clinical providers as required by policy. Patient Throughput: EMS Desk and Pod Assignment Patients assigned to Pods by the Triage nurse are placed in a Pod location by the RN at the EMS (ambulance under control of Emergency Medical Services) desk, based on the number and acuity of patients presently in each of the Pods. Patients are assigned to either Pod beds or unnumbered chairs distributed in the hallways between the Pods. Workload among the five ESD Pods is balanced using the assumption that triage has effectively segmented the patients assigned to ESD, that is, random assignment of ESI 1, 2, or 3 patients results on average in an equallydistributed workflow among the Pods. Physician and Nursing staff report that on occasion this "round robin" patient distribution method results in an unbalanced workload between Pods. The workload in a Pod can change when one or more patients in the Pod experience: a) a worsening of their condition; b) a new complication of their present illness; or c) prove to have a more severe and acute condition than was apparent at the time of triage. The absence of a "charge nurse" continually monitoring all the Pods, and with the authority to manually alter patient assignments, decreases the ability to adjust Pod work stream in response to changes in patient severity of illness. Ambulance Arrivals and the EMS Desk The Nurse at the EMS Ambulance desk assigns a Pod location to the following types of patients: patients who arrive to the Main ESD by ambulance; patients who are transferred between the Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 161 Main ESD and die other Emergency Service Areas (Urgent Care Center, Intermediate Care Center, Psychiatric ED); psychiatric patients who arrive to the PED under legal hold APOWW, Order of Protective Custody (OPC), or a Mental Illness Warrant (MIW). Patients who arrive by ambulance are triaged inside their assigned Pod. The medical screening exam (MSE) is conducted by a Qualified Medical Professional (QMP) in the Pod treatment area to which the patient was transported after assignment by the EMS Desk Nurse. Interviews with nursing staff posted at the EMS Desk and in the Main ESD Pods revealed that nurses are not uniformly aware of a receiving hospital's obligations to report EMTALA violations by transferring hospitals. ?482.20-. ?482.30 on) The nurses were not uniformly aware that a hospital such as Parkland has the obligation to report to the State CMS survey agency any time it has reason to believe it may have received an individual who has been transferred in an unstable emergency medical condition from another hospital in violation of the requirements of ?489.24(d). The receiving Hospital is obligated to report any transferring hospital that a) fails to contact the receiving hospital in advance to accept the transfer; b) ensures that the receiving hospital received appropriate medical records; c) effected the transfer with qualified personnel, transportation equipment and medically appropriate life support measures and; d) ensured that the receiving hospital had available space and qualified personnel to treat the patient. 548123(b)!3s TA( i: A-0395 Condition of Participation: Nursing Services. Staffing and Deliver) of f a r e : P( (12.01 .C2t PC 02.02 a I (KP / , ?j Patients who arrive by ambulance may be placed in the ESD Triage Waiting Area if the clinical care Pods of the Main ESD are "cappcd" (reach patient bed capacity). This type of delay was observed when a patient brought in by EMS at 15:51 in acute distress, crying and rocking to-andfro from abdominal pain while seated in a chair in the Main ESD waiting area, with her family member standing next to her holding the patient's IV infusion bag by hand overhead. The family member explained that she placed the papers and padding observed underneath the patient's chair because the patient was incontinent of urine. The Check-In Nurse assigned to the waiting room was unaware of patient's condition. Patient was assigned a room at 16:02 after intervention by ICE Assessment Team. A PGY3 Emergency Room Resident evaluated the patient at 16:12, and the patient was then formally triaged by the nurse at 16:27. ?48,,-.(3(c}(2s TAG: V>>JM i. u>i A..-,' Pri\acy and Safety: B. < fit A,/' h < The EMS Desk nurse was interviewed and explained that ambulance crew was directed to wait outside the waiting area until space could be made for the patient in the Main ESD, which was full to capacity at the time of the patient's arrival. The ambulance attendants erroneously delivered the patient into the waiting area. There is insufficient nursing oversight of the overall ESD as well as insufficient control of patient flow and tracking and monitoring patients who may leave the waiting and/or treatment areas. The EMS Desk assigns ambulatory patients to the Pod area chairs; however, individual Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. chairs are not clearly designated as patient location/assignment areas. The Epic tracking system does not assign patients to individual chair locations, instead patients in each Pod tracking screen are designated under a common category of "Pod Assigned". Pod Physicians and nurses cannot clearly track patients assigned to the chairs in their respective Pod. On December 12, 2011, we observed an example ofpatients not being tracked within the ESD, which led to delays in patient care and assessment. In that case the patient arrived and checked into the ESD at 15:45. The patient was triaged at 16:26, and documentation of nurse reassessment occurred at 20:09. The patient was placed in a Pod chair at 23:27 but a review of the case revealed that the patient was not in the Pod patient tracking screen and was not reassessed or evaluated by clinical professional until 06:08 the following morning. ?4<<2.23{b)(3) '! -Hi- A-{K5*75.Sumi>>r' Patient Flow and Provision of Care in the Pod Areas The Pod chairs and hallway stretchers serve as the intake area for ESI level III patients. ESI Level III patients directed to the Main ESD are placed in either Pod stretchers, or hallway stretchers and chairs located between the Pods. At Parkland, the practice of treating ESI Level III patients in Pod hallways rather than in areas designed for this challenging class of patients may be creating unnecessary risks in patient safety and care. Level III ESI patients can be the most challenging segmentation of the emergency patients. The highest level of medical liability risk and regulatory noncompliance risk occurs in the ESI Level III population. Level I and II patients are easily identified as acutely ill and in need of both prompt action and emergency resources. Patients that present as ESI Level 4 and 5 are by definition not urgently ill or not ill at all, do not require the resources present in an emergency department, and could otherwise be provided for at a doctor's office. Patients in the Level III segment, however, sometimes have a serious illness in evolution that has not yet declared the severity of its nature, for example, patients with Level I or II acuity may be assessed as a Level III at the time they present to the ESD, only to decompensate over time, after their initial triage assessment. In emergency departments with fully implemented "Split Flow" patient process systems include are "Intake Rooms" used to accommodate ESI Level III patients. These Intake Rooms have beds that are temporarily occupied by patients in order to provide greater privacy than hallway chairs, facilitate more accurate patient interviews, and enables complete physical examinations. These Intake areas typically have point of care labs for immediate testing results. In the current Parkland ESD arrangement, nurses and physicians in the Pod areas do not have the means to identify, at a glance, the current status of a person sitting in a hallway chair. The chairs are not specifically designated as 'Patient Care' areas. Both patients and their accompanying visitors can be in the hallways. Patients in the pod area chairs are not distinguishable from visitors or from other patients walking through the area. There are no indications to allow staff to know if a vacated chair indicates a patient who has left (or "defected") from the Pod Area or Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Main ESD. Some chairs and hallway stretchers are not readily visible from the nursing and physician workstation areas. Supervising nurses and physicians are frequently unaware of patients in the chairs and hallways of the ESD. The physicians and nurses in the ESD are not consistently aware of, or accountable for, patients in their assigned areas. These patients frequently leave without being seen, leave without completion of treatment, or may be waiting for excessive periods of time for treatment or nursing assessment. Many of these patients who leave (or defect) from the ESD are patients who were either in the triage waiting areas or the Pod hallways. We observed an example of such an unattended patient leaving the ED on December 1, 2011. The patient arrived at 10:04 and placed in an ESD Pod at 10:39. The patient was assessed by an RIM at 10:58, and an IV was started at 1 1:13. At 15:29 the Emergency Medicine Resident, an EM PGY 2, noticed that the patient was not in his assigned Pod. The patient was called for on the intercom at 15:37 and 16:14 with no response. The patient was assumed to have Left Without Treatment (LWOT) with a peripheral IV still in place when he departed from the ESD. In this example, there was a four hour and 33 minute time delay between the last RN assessment and the first call to find the absent patient. Departmental nursing policy requires the treating nurse to reassess patients at two hour intervals, and in this case that policy was not followed. MHCj j %ci: A-r.'<>f< : - S4??2J;!>}s.>5 '{ \(i: fY-OW? ?i*n aK Parkland Hospital ESD Patient Defection Rates 16 0% 15.1% 11.0% 12.0% 10.0% 8.0% 6.3% 6.0% LWBS % -LWOBS Rate 5.2% 2011 AMA % 4.0% 3.2% '33% 2.0% 0.4% 0.0% Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-ll Sep-11 Oct-11 Nov-11 Dcc-11 0.4% 0.654 0.6% 0.6% 0.5% ?'7% 0 J % ? 1 % 0.5% 0.5% 0.7% The chart shows that the ESD Left Without Being Seen (LWOBS) rate for 2011 was 5.2%, approximately twice the national average of about 2.3% for all emergency departments. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 164 In other observations by the ICE Survey Team, Nursing Plans of Care were not found in the Epic ESD nursing documentation module or on patient chart reviews. ?232.23 stsH-1) TAG: A-03% Coitibiou of Gidteipiuiou Ktn-sijg .Vc.icc-: Maflau.- mulTteliverv o f C a r e . W.(12 1)2.0/ ?LP 4} a PC.ntMi t F P .1 2 J 13 ? SR.02Ji2.02 tPP Additionally, the Department of Nursing Administration was unable to produce a unit-specific performance improvement process or plan for the improvement of patient care delivery and care outcomes in the ESD. Our survey found no unit-specific nursing standards ofcare for the ESD. ?482,(R)(?VI)5 TAG A-f 10G Condi lHan oi?piircici|i<2.13fb) TAG: A~ 0 1 4 1 - JH 02.01.iU '?/\v> UCC Patient Flow The UCC was designed to function as part of a split flow system for the Emergency Services Department, in which patients identified as having low resource needs and low acuity illness are split off from the main flow of patients in the Main ESD. The purpose of a UCC is to serve as the "Fast Track" area in which patients with similar levels of resource needs are placed in a standardized care environment designed to expedite their care. Patients suitable for this care Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 169 environment are on an unscheduled, walk-in basis, primarily for an injury or illness that requires immediate care but is not serious enough to warrant a visit to an emergency department. The Urgent Care Center was not designed as an urgent care clinic intended to provide primary patient care. The UCC, however, has apparently evolved into a service that now serves many patients as a quasi-primary care clinic. Because the UCC is part of the Parkland Emergency Services Department, it is obligated to follow the EMTALA patient screening, examination and treatment rules. In response to its EMTALA obligations, the UCC created an unduly complex triage process, which creates safety risks and delays for persons presenting to the hospital for evaluation and stabilizing treatment of emergency medical conditions. The Check-In Nurse role adds an additional step in the triage process, delaying completion of the triage process and the MSE. Delays in triage, even before an MSE is performed, can lead to delays in the identification of patients who have EMCs, and increases the time needed to begin stabilizing treatment or transfer (when indicated). i i SJHV.u! ResponsibilitiesofMotlicarc- ?Hospiiais in emergency Cases ICE Surveyors observed patient registrars obtain and provide payment information from patients in the ESD, PED and UCC waiting areas before these patients had received MSE and stabilizing treatment. Registration personnel had been instructed to use the long patient waiting times to be seen and allow patients to complete registration for their visit. We advised the Hospital of this observation, and they indicated that they would change the process on acquiring payment information from patients until the time of discharge from the UCC. ?4'!9.24. special Responsibilities o f X-Mliearr 1 lospitak in Smcrginey C<>i3?bH<>.'? oi (!-.!' Psychiatric Services - Emergency Department (PED) The Parkland Psychiatric Emergency Department (PED) has a capacity of 19 patients, but patients are diverted to other facilities in the area when the census reaches 25. Based on interviews with the Nursing Director, the patient population is described as both voluntary and involuntary patients. Seventy percent of the patient population is involuntary (Apprehension by a Peace Officer Without a Warrant - A P O W W ) and 30% of the patient population is voluntary. Involuntary patients access the PED through a separate entrance and are screened for safety including the use of hand-held wands to detect metal on patients. The voluntary population accesses the PED through the Main Emergency Department triage where they are now escorted by a representative from Parkland, or by direct access of the PED public entrance. The Director stated that the "direct access" volume represents a very small percentage of the total, that being 1%. It is estimated by the Director that 70% of the PED patient population has a substance abuse co-morbidity. Eighty percent of the PED population has an actual psychiatric diagnosis. The PED can hold an involuntary patient for 48 hours in order to assess the patient's condition and provide appropriate, safe disposition. Voluntary patients can be held for four hours. Physical plant is a significant issue in this Department. The current layout provides for limited dayroom space when the PED reaches capacity and minimal room is available to navigate, creating a challenge to staff in order to maintain a safe patient and staff environment. The current staffing ratio utilized is 8:1 patients to nurse. The P E D staffing plan is three Registered Nurses and four Psychiatric Technicians per shift, one for each major area of the PED. Staffing models are not based on acuity. The Department is staffed with one to two Attending Physicians, one Social Worker and a Substance Abuse Counselor. First and second year physician Residents as well as medical students are also assigned and stationed in this space-challenged Department. P/jji oi v-i >jv Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 177 The Medical staff in the PED is contracted through University of Texas Southwestern Medical Center (UTSW). There is no core team of consistent Attending Physicians, as most doctors from UTSW are assigned a small percentage of time for clinical care. This creates a break in the continuum of care for the psychiatric patient and does not allow for proper communication or follow through on policies and procedures among the physician clinical staff. At this time, the PED Medical Director is creating a new staffing model to provide two providers on a more consistent basis and to provide more consistent coverage. The Department does not have a permanent Nursing Director or Nurse Manager. The Interim Nurse Manager who was covering both the inpatient unit and the PED resigned December 17, 2011 and as stated, the Medical Director is newly hired. Staff has been in a state of flux caused by a significant number of RN and Tech terminations/resignations since the inception of the SIA, and the Department struggling to care for patients in a safe and comprehensive manner. The Psychiatric Emergency Department policies were reviewed. We found them to be difficult to understand, very general and did not address specific issues which would guide the Department in decision making processes. In a high-risk patient care area the staff must have both knowledge of, and access to, pertinent polices to ensure the delivery of safe patient care and regulatory compliance. Psychiatric Services - Inpatient Unit (8 North) The Inpatient Psychiatric service is an eighteen bed locked unit. The patient population was described by the Nurse Manager as being comprised of both voluntary and involuntary patients I 8 years and older. The payer mix is predominantly Medicare, out of county Medicaid or single agreement arrangements. The unit provides services to medically compromised patients that other local psychiatric facilities will not accept for admission. Concurrent medical issues of the inpatient unit population include chronic dialysis, IV therapy, and OB patients. The majority of the patients admitted to the inpatient unit are transferred from the PED. The most common diagnoses of patients admitted include: schizoaffective disorder, schizophrenia, and bipolar disorder. The Manager also stated that the ALOS in the unit is 8.8 days. Based on hospital statistics received by the ICE Team, the average daily patient census in the inpatient unit in November 201 1 was 12.7. The current staffing ratio utilized is 8-9:1 ratio of patients to Registered Nurse. A ratio of 6:1 that can be adjusted for acuity is a more leading practice. The staffing patterns include two RNs and two Psychiatric Technicians per shift except on the night shift when there is only one Psychiatric Technician scheduled. Medical staffing includes the availability of an Attending Physician and a Resident. The inpatient unit does not staff to acuity. There are two health care teams which can provide care for up to nine patients. One Nurse, one Attending Physician, one Resident, a medical student, and a social worker comprise each team. Nurse staffing does not vary based on acuity or the number of patients, it is fixed at 1 RN per team. At the time of our Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 178 survey, the unit did not have a designated Occupational Therapist or Therapeutic Recreation Specialist as a part of the interdisciplinary team which is generally a component of an inpatient psychiatric plan of care. Social work support is not available on Saturday and Sunday, therefore patients are not discharged on weekends. Pi 0-1 <<>/ .o>,' ;LP 2at Psychiatric Services - Outpatient Clinic (Chase) The clinic is located approximately five miles from the main campus and is open Monday through Thursday, 7:30 am to 5:00 pm, and Friday 7:30 am to 4:00 pm. Based on interviews with the clinic manager, the following information provides an overview of the outpatient clinic. There are approximately 600 visits per month, with six patient groups per week, including depression, schizophrenia, and brain/behavior disorders. These groups are facilitated by Physician Residents, Social Workers, and Psychologists. Most of the Inpatient Psychiatric Unit patients are referred to the Behavioral Health Clinic for outpatient treatment. The manager defined the patient population to be one-third diagnosed with dementia, one third depression, and the remaining third, schizoaffective disorder. Clinic referral sources were described as being approximately 5% from the PED, 15% from the inpatient unit, and 80% from Parkland or other area hospitals. Staffing for the outpatient clinic is: 1 RN, .6 FTE Psychiatric Technician, 3 Clerks, 1 Social Worker, and 3 Psychologists. MDs and residents rotate days of coverage. In reviewing clinic medications, it was noted that there were only three long acting intramuscular anti-psychotic medications available to be prescribed, demonstrating the potential for a lack of individualized care and treatment. Based on interviews with the Medical Director and outpatient manager, it was found that these three medications were the only available long-acting medications available on the Parkland formulary. Prior to this issue being raised by the ICE Team consultant during the initial review, the limited number of medications had not been questioned. Based on some of our preliminary findings presented to the Department, the medical director has explored the addition of a more effective drug for patients who have compliance issues in routinely taking medications. The new medication can be administered once per month instead of every two weeks as in the case with the other medications. During environmental rounds the clinic refrigerator was found to not have an alarm system to alert management if there was a power outage. Based on some of our preliminary findings presented to the Department, on a follow up visit, we were told that an alarm has been ordered that will send a page to the outpatient manager's cell phone alerting her of an outage. ?482,25 \AQ: \-U:-i)>> SUIUMHSS: t)e liven o f S m A - - ' : F.C.Qi.ViJil (LP ti A fan was also present that had not gone through safety checks by the bio-med department. This fan was in the patient care areas which also presents a potential infection control hazard. o/o lAA:l mil) TAG: A-0724 Standard; facilities: F<"o2 01 oid-.P h Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. As in the case of other psychiatric services a comprehensive quality improvement program is not in place for the clinic. The Department is planning to develop a quality initiative to respond to and proactively manage patients with medical co-morbidities, as it is estimated by the staff that approximately 80% of patients have medical co-morbidities. ?4B2.'i I (CK + Miii I A'U; 4*0285, PI uj.w HI 01' 1) I'OKU >FJ> /, J/. Psychiatric Liaison Services The psychiatric liaison service is a consult service for Parkland inpatients. The consult liaison service is broken into four separate teams consisting of a Psychiatric Attending Physician, three Psychologists, a Resident, a Psychology Intern, Medical Student, and a rotating RN and Social Worker. The RN and Social Worker make rounds with one team per week, rotating to each team. On weekends, the Social Worker is not available as was the case on the inpatient unit. The Medical Director reports that this causes the Residents to focus more on social work functions for the patient versus functioning in their role as a physician. The liaison RN triages referrals made to the service by Parkland physicians and refers patients to one of the teams or a Psychologist based on the patient's needs. Per the Medical Director, an average of 40 patients are seen per day, including an average of ten new patients per day. The most common diagnoses are depression and delirium. The Director stated that all A P O W W patients are seen as well. Maintaining continuity of care within the Parkland system is challenging as only 5% of the patients needing acute psychiatric care are referred to the inpatient unit This is due, in part to the fact that Parkland does not participate in the Northstar Medicaid managed care plan. Competencies/Staffing Effectiveness During the review, concerns were identified regarding staffing competencies specific to the psychiatric population. The nursing staff was unable to articulate specific competencies required for the unit. Two mandatory two-day training sessions were given to the PED staff, but they did not follow up with competency testing to monitor the effectiveness of the training. In addition, it was observed that the nursing staff failed to identify or assess a patient who was in ETOH (alcohol) withdrawal. By not ensuring staff has met proper competency requirements. Staffing levels in the PED unit are not adequate to ensure this high risk patient population is cared for in a consistent comprehensive manner. Patient staffing models are not based on acuity or changes in patient volume. A review of staffing schedules reflected an inadequate number of staff is present to manage the overall fluctuations in patient volume in a safe manner. Staffing grids reflect the same number of staff for all volumes of patients. There is also no mechanism to account for patient acuity. This is critical as patients frequently require 1:1 coverage in the instance of seclusion. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Social Worker staffing levels are not consistent with established core staffing patterns. Social worker staffing resources are not adequate to cover PTO and weekends, which leaves shifts uncovered. The PED does not meet CMS standards for staffing and is out of compliance with (';o ; j ami v-iu 'Uh) \mvna Sonne--. Since our initial review of the PED staffing and our meeting with PED leaders, there have been several changes. Temporary agency RNs and social workers have been hired and a recruitment plan for filling vacant positions has been initiated. The staffing grid has been changed to account for increases in patient volume as well as patient acuity. Additionally, efforts have been made to cap census of the PED to 12 patients and to coordinate with the Dallas police department to limit APOWWs. On multiple occasions during the survey period, it was observed that psychiatric technicians who were specifically assigned to patient areas were not physically in those areas. Psychiatric technicians routinely leave their assigned patient care areas to transport specimens to the lab or escort patients to other areas of the Hospital. I AG: A o m Standard: OraanCaiioio /../) ,').>' Hi) 01 (PP 31 Patient Care Based on interviews with PED staff, there is a lack of focus on the patient's individualized plan of care. Physicians, Nurses, and Social Workers could not articulate that an individual plan of care existed for each patient. Chart reviews confirmed that documentation within patient medical records did not reflect the integration of patient strengths and limitations when planning patient care. Additionally, in several inpatient charts we reviewed, the plan of care was not consistently revised to address a patient's change of status. The lack of an adequate plan of care and/or documentation of a plan is a deficiency. ?482.23 (b)(4) !\\0: A-0396 Condition olTattieipaiion: Nursing Services. Staffing and Deliver;.- of C are: Ml 0 : rC.Ol (LP 3} Pi' 01 03 03 (HP 3, P) P( '.Qi.o3.0l (LP o :.?.>> In one record review, a patient's plan of care referenced use of restraints before the patient demonstrated behavior to require use of restraints. IR2.13(0*3)'! AC*: A-016 \ foulard: Patient Rights; /'i' 03 03 0! (hp 3 a P( .03 03.oj /PPP Inpatients do not receive the required benefit of a complete interdisciplinary team which includes therapeutic services such as occupational therapy and therapeutic recreation. Occupational therapy and therapeutic recreation are common services for patients in the inpatient setting. While every patient may not benefit from the service, it should be available to patients who need those types of therapy. Occupational therapy is available in the Hospital, but has not been readily utilized on the inpatient unit. We could not determine the purpose of a Current Events group session for inpatients that we observed. The session was held from 4:15pm to 4:35pm (20 minutes) and was led by a Psychiatric Technician. The group meeting was not listed on the schedule. The group meeting ended early due to some patients leaving the group for other reasons (watching TV, etc). The Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 181 group meetings should be conducted for their full length as long as a single patient remains with the group. There are no objectives for the scheduled groups, and individual patient care plans do not list groups a patient should attend, based on therapeutic appropriateness. In observing RNs, there is limited interaction with patients. Much of their time is focused on medication administration and other medically related issues. RNs are minimally involved in leading groups and there is very minimal psychosocial involvement between RNs and patients. At the time of the survey, Social Workers in the PED were assessing all involuntary patients, but voluntary patients were assessed only if an immediate need was identified by other staff. All patients should be assessed by a Social Worker upon admission to the unit. This function should not be based on voluntary or involuntary presentation as there is no correlation to how a patient presents and the patient's psychosocial needs. Chart reviews revealed a lack of consistency in performing patient assessments. The PED does not perform a formal fall risk assessment as required by Parkland policy. In addition, fall risk indicators such as a colored wrist band are not utilized. o We observed an admission process on the inpatient unit given by a new staff member where a de-escalation screening did not take place. This new staff was being overseen by a preceptor. o Per interviews and chart reviews, we substantiated that patients lack face-to-face provider assessments within one hour after initiation of restraint on the inpatient unit. A physician must be available to conduct a face-to-face assessment within a one hour time frame of restraint initiation. o Chart reviews for PED patients revealed a lack of follow-up to pain assessment prior to patient discharge. Patient had a pain assessment score of five (5) and was treated with Tylenol. N o follow up assessment was conducted prior the patient's discharge from PED. o Based on both chart reviews and direct observations, we substantiated that skin assessments are not being performed consistently on patients in the PED per Parkland policy. 2 i sj !!o':; i . ' , - 0 ) " ( ' W o? 01 a.i ! i. 2P. Although Hospital policy mandates nurse to nurse patient hand-offs, during the ICE survey, hand-off communication was observed to be inconsistent and/or not performed between the PED and other departments. It was observed that there was a lack of proper hand off between the Main ED and PED which resulted in a patient elopement. All patients who present with psychiatric complaints should be escorted from one department to the other by trained clinicians. Patients should never be left unaccompanied by staff. We also observed that patient hand offs from the Main ED to PED were not RN to RN, which is in violation of Parkland policy. At this writing, procedures were enhanced so that patients being transferred to or from the Main ED are Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 182 escorted by a nursing staff team member. The ICE Team will continue to validate this change in procedure. < '.v i AC: A-iW-sO. Supxiaffl Medical Su>>{T. MXtO Oi Ui >/?P J) I'i JU.02M (U'h The PED does not use a coordinated discharge planning process. Additionally, handoffs to external providers are not routinely conducted. Chart review revealed a lack of discharge planning; e.g. "dial 911" as a discharge plan. It is critical to develop a process to address all aspects of discharge planning including communication with outside providers, family and/or significant others. The discharge plan must be individualized, and based on the patient's plan of care. All clinical disciplines involved in the patient's care must be coordinated and should include medication reconciliation. t>i ' ;pnjT> l'( :U(f! i . - S f r j i o<<;: A-<*(R)e Standard: Idenflifkstion of Patten-, in Need of i?i oo/ t' I. 4 ?0 H> Environment of Care / Patient Safety During the survey, we observed that windows on the seclusion doors in both PED and the inpatient unit were inadequate to allow 100% visualization of the patient. Based on some of our preliminary findings presented to the Department, PED doors have been refitted with larger windows that now allow visibility of the patient in all areas of the seclusion room. for 100% visibility becausc of the room's physical design. As previously stated, the PED is limited by physical space. Based on a recent Dallas Fire Marshall report, the number of patients who can be safely treated in the PED day room is 19, which includes patients in the three private rooms and the staff observing patients. We have frequently observed a census in the PED which exceeds the stated fire code. Another area in the PED of great concern is the seclusion hallway. This is very small area used for admission interviews and lab specimen collection and is cluttered with equipment, a movable sharps receptacle, boxes, a phlebotomy carl, and at one point we observed patient food placed on top of the soiled linen bins. The spacc is adjacent to the seclusion rooms which are used for violent patients; therefore this presents a safety hazard to patients and staff. Review of a surveillance tape confirms staff movement was hindered during a violent patient incident due to clutter in the hallway. Based on some of our preliminary findings presented to the Department, as of this writing, the Hospital has complied with the recommendations and the hallway has remained free of obstructions. The inpatient rooms on the psychiatric unit are equipped with unsafe bathroom sinks and faucets for ligature risk. The Hospital is in the process of upgrading the bathrooms in patient rooms with replacement sinks and faucets that do not pose a potential safety risk to the patient. Bathroom doors in patient rooms are equipped with sensors to determine any additional weight placed on the door. It was observed that extreme pressure was required to activate these sensors and we recommended that the Hospital inspect the sensors to ensure they are operating properly. It was also noted that bathroom doors in the PED are not equipped with these weight-detecting sensors However, after replacement of the door, the seclusion room door in the inpatient unit still does not allow Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 183 and should be. The bathrooms in the PED are equipped with lights outside the closed door which indicate to staff if patients are moving within the bathroom. These movement sensor lights do not operate properly and are ineffective, therefore do not ensure patient safety since no movement could indicate patient harm has resulted. Additionally, we noted the following infection control risks in the nourishment room on the inpatient unit: o o o Large wet stains on ceiling tiles Rusty ceiling tile braces Calcium build-up on ice machine \4"> ! \f, A-nTC; < ondkion o f f ?nieip;;tion: infection Control ?4S?.,.| I I AG A-0700 Condition of Paiik-ip^bn: Physical ? f>>vin>mm n;; !( <>i 0< <>! ,/o/<; : a. iC.'KOS 0] (/o'/- 4r : i,,C0? 01 Oi (&>L J> Patient Rights / Privacy As stated previously, the PED has significant physical space limitations; however private interview rooms are available for issues requiring patient privacy. Clinicians perform physical exams and engage in verbal interactions with patients in the PED community day room. The Psychiatric Technician "report o f f ' to the next shift is being conducted in the day room where the clinical discussions can be heard by patients in the day room. Additionally, it was observed that a patient was being examined in the day room by a Clinical Nurse Specialist after a patient fall, while other patients were present in the day room. Patient property is not consistently checked and secured in the PED. The Hospital safety reports confirmed a consistent problem with mishandling patient belongings and Psychiatric Technicians are not following Hospital policy. p4H; : : ; A' \ ()i }< c e;ujiy,;;j of Participation: Patient RAha- Organization / Leadership As previously stated within this report, the Psychiatric Department has undergone many personnel changes from the director to technician level. Staff was unable to articulate the chain of command for problem resolution. There is a lack of supervisory oversight to facilitate adequate staffing and safe delivery of care. As previously referenced interim nurse managers have been placed on the inpatient unit and PED as a short term solution and as a mechanism to provide closer oversight and support for staff. Psychiatric Technicians are not properly supervised as evidenced by direct observation of a Psychiatric Technician allowing a patient to self administer his own medications without authorization from a Nurse. Report offs between Technicians is very informal and unsupervised by RNs. The Psychiatric Technicians play an important role in the monitoring they provide to patients. Their input and observations should be sought out in understanding patient status. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 184 Additionally, the RN is responsible for providing direct oversight to the technicians and to provide assistance in caring for patients. The role of the Charge Nurse is vital to the coordination and integration of care among the other patient care team members. During interviews with staff and management, it was noted that there is an inconsistent knowledge of the role of the charge nurse in the PED. The new interim manager for the PED is spending time mentoring and modeling the role of the Charge Nurse. Additionally, the nurse educators are also assisting in the mentoring subject to ICE review. Documentation Chart audits revealed incorrect documentation of restraints and seclusion. Orders for "patient holds" and seclusion are written as one order. Hospital policy requires an individual order for each episode of restraint and seclusion, therefore two separate orders and two separate sets of documentation are required for a patient hold that results in seclusion. During inpatient chart reviews, it was noted in multiple records that the consent for psycho-active medications were signed by the patient, but not the Physician. S4X . H i o%(} \-0i 15 Standard: Notia of Rights; H! t>i Of >>! Infection Control Maintaining a sanitary environment in the Hospital is essential to avoid sources and transmission of infections and communicable diseases. The findings described below were observed in the Psychiatric Department: o We repeatedly observed patient nourishments in the PED nursing station, which required refrigeration, e.g., milk and sandwiches. Additionally, we observed numerous times open containers of muffins on counter in the nourishment room on the inpatient unit. o o The refrigerator in the inpatient nourishment room used for patient food is not consistently monitored for proper temperature. The inpatient Charge Nurse was observed entering the nurses' station wearing gloves and carrying a container of wet wipes. When asked why he was wearing gloves, he stated that he had just cleaned a wheel chair in a patient room. o o PED staff in the seclusion room hallway removed gloves and proceeded through a doorway without washing hands after removing gloves. Bathrooms in the PED lack soap dispensers. After bathroom use, patients leave the bathroom and proceed to find a Psychiatric Technician for hand sanitizer. Based on observation, patients can leave bathroom without receiving hand sanitizer. o Observed a lack of separation between clean and dirty linen in the PED. Additionally a soiled utility area is not identified. Clean and dirty utility rooms on the inpatient unit are properly designated with signage and staff is confused about the purpose of each room. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. see/., this information is confidential and privileged. 185 o Recjiners in the P B D dayroom are not properly and consistent Iy cleaned. i \< t \ 074? t cmtRtion (MPnitu'ipaiinn liiftciiun Control: i 182.41 TAG A-U7IH) Condition of Parudpaiion: Physiol tin* ironmoni, /C.Ol H3.M ! iCftlllZM i/8>Jj; KUt.Oi >H t/ PI. J. dr. IC til fit 'II tl-.t'l Jr. rt ftl.tVi.Di (A/71 Quality Assessment and Performance Improvement (QAPD Psychiatric Services docs not have an individual formal QAPI program. Performance improvement projects and initiatives are not well coordinated, although the inpatient unit has identified areas for performance improvement including the decrease o f the use o f seclusion, proper hand washing and improved hand off procedures. Based on supplied quality data, the seclusion rate of patients in N o v e m b e r w a s 2% which decreased 13% in one year. I i \< i: < Auditions ol'P;iiueipmu) - 1 OJ' I 0-1<2 Standard: Staffing and Delivery of Care; W> !H #4.(73 t f . P h Staffing In the WISH service line, there are 17 inpatient locations, divided on two floors. In the current configuration, the disjointed layout creates a need for more staff due to lack of efficiency. This inefficiency creates direct supervision issues, lack of available support and geographical barriers. The chart below provides a summary of each area with the number of actual beds for occupancy, average daily census and staffing based upon staffing the grid, not actual staffing, for the 4 th quarter of 201 1. Staffing to ADC budgeted to average daily Staffing Area 4 East 3 West 3 North 3 East 4 South Unit Postpartum Postpartum Postpartum Postpartum L&D Triage Beds 28 28 26 28 5 ADC 16.33 16.99 16.89 17.28 3.65 .5 .5 .5 .5 .5 UM 4 5 5 5 2 RN 1 1 1 1 0 PCA 1 1 1 1 1 HUC Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. p'i A 'Voi '. .oo< Staffing Beds ADC 15.98 15.80 23.29 26.39 22.02 14.37 24.16 33/per day .5 1 1 1 1 1 2 1 ^l PCA HUC 1 1 1 0 M Area 4 North 4 West 5 South NNICU NNICU NNICU Nursery L&D Unit Postpartum GYN/ONC Antepartum CAN CCN ICN Well baby L&D UM 4 4 3 9 6 RN 1 2 1 0 2 0 3 5 26 20 27 45 20 25 102 48 8-10 6RN/1LVN 27 0 2 4 There are discrepancies between actual staffing as reported by the House Nursing Supervisor, what is demonstrated through Hospital reports, and what is visualized on the units. It is difficult to make management decisions with inaccurate and disparate information. A total of 20 positions were open as of September 2011 in L&D. In anticipation of forecasted low census, the Hospital did not fill these positions. The anticipated low census did not occur, occupancy reached 100% and at times surpassed 110% and resulted in insufficient nursing staff. On January 9, 2012, Hospital leadership approved a request to fill 26 positions to cover the vacancies, expiring traveler contracts and any other vacancies created through additional attrition. S-i;-;:: hh; i U-, \ O.iO ! Si;?iui>nd: S.al'iws; md i><:ii\ctv t< Oi 01 0.) tt'Ph I f ) 01 06 Oi WISH staff was unable to clearly articulate the competencies they were expected to maintain. Competencies should be clearly understood by staff, and they should be able to verbalize what they are and why they do them. For the areas in WISH, they should be very extensive and reflective of the tasks and care they are expected to provide. These competencies drive staffing decisions and must be available to whoever is making assignments. In addition, there is a need for competencies on newborn resuscitation or immediate response in the event of a critical situation with an infant. These competencies are essential for safe performance in this area. The staff within the Postpartum unit are currently not certified in the Neonatal Resuscitation Program (NRP). This should be an essential competency for the staff on this unit as well as the Nursery unit. Following our debrief with WISH leadership on our preliminary findings, training is now underway for assuring competency of the postpartum staff in neonatal resuscitation. We will continue to monitor to validate completion and continuance of this and other competencies training. m.H f ?482. 'Afh){:A TAG. A-029 7 StarKferd: Staffing ami Dei'verv of Care; MR.Oi.02.Ol fi'P h - 0 < <>! f p p h Delivery of Service Labor and Delivery has five points of access. Labor & Delivery patients can come from Clinics, the Emergency Department, Walk-in, EMS and transfers from other facilities for a higher level of care. Patients are taken directly to Triage for observation of labor and evaluation for indications of admission. Active labor patients are admitted to L&D immediately. Patients deliver infants in delivery rooms, LDRs and L&D operating rooms for C-Sections and over capacity deliveries. Post-delivery patients that delivered in other than a LDR are moved to a recovery room. If the recovery rooms are at capacity, patients may recover in the L&D classroom, in the hallway or on the post partum unit if beds are available. The chart below depicts this flow process through L&D to Postpartum. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 192 L&D to Postpartum Flow Chart Labor & Delivery _ VV: [_o_ :1 ' ; 1 Delivery Room o LDSR I Labor & Delivery OR Recovery Room i luW-< 0 Postpartum patients are admitted from L&D. Volume in postpartum is frequently over 100% capacity. Overcrowding forces patient back-up in the L&D area. A classroom on the L&D unit is used for holding patients on this unit until a bed is available. During peak census periods (several times a week since A & M arrival on site) patients are seen recovering in the hallways to provide for cleaning a labor room for waiting laboring patients. Overcrowding in the recovery room during high volume forces patients to postpartum prior to full recovery or before control gained is of patients on magnesium sulfate. Staffing ratios for these patients are 1:1 or 1:2. Placing them on the postpartum units puts them in a staffing mix of Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 193 ] :4 to 1:6 or higher. Staffing at this higher level is unsafe and also leads to different levels of care fortius population. The high patient volume frequently forces overcapacity situations. The closure of the 4 South postpartum unit has only led to worsened overcrowding. The census in this area has increased above pre-closure levels rather than decreased as expected. elective procedures in overcrowded conditions. This is an exceptionally busy service with overflow capacity reached regularly. The same is true for the Recovery Room where patients are pushed to the postpartum area for recovery and management of extremely complicated patients that require 1:1 or 1:2 cares. The postpartum areas are not staffed according to acuity but rather to census. This lack of staffing to acuity places the patients and nurses at risk. Several issues were identified by our survey team through observation and interview in the WISH service line. Staff could not convey the frequency in which the nursing assessments should be completed. The staff assesses the patient hourly for a focused assessment and every four hours for a full assessment. While practice is in full compliance, staff were unclear in their answers. This uncertainty of the assessment practice could be problematic in a survey environment. Each staff member should be able to verbalize clearly the competencies necessary for their position and why they are critical elements, e.g., high risk low volume procedures, and how they were selected. ? ;$2 23 (h)(4s f AG: A-og% Condition of Participation: Nuking Sendees. Staffing and Deliver} of (Arc; \K(>2 02 Of >? 0 ' ,TJ' h Pi'Of OSJ) J (hP 5. 22 23; In staff interviews staff was unable to clearly describe the process for the development and implementation of the plan of care. Plan of care development is an integral part of the patient care process and a core part of training for every nurse. The absence of this information is an unacceptable clinical practice leading to poor communication of patient needs and the potential for gaps in care. r. u? Hj ;h -AA J, 2 \ g.g Five adverse patient events in WISH were reviewed by ICE Team. Three involved uterine ruptures and two involved infants. After review by the ICE Team and medical review by the Hospital, the ruptures were deemed to be physiologic in nature with no harm caused. The infant incidents were also found to be unpreventable. The follow up was prompted by the ICE Team and is an example of Parkland not consistently recognizing the need to ensure that all cases of this nature have prompt and thorough reviews. There arc many issues surrounding transporting infants. A "six-pack" (a phrase used in WISH for the cart), is a large compartmentalized delivery system for six infants to be transported simultaneously. The cart separates the infants with approximately 8 to 10 inches separating each infant from each other and is labeled with a hand written piece of tape to identify the infant. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 194 In addition, elective and scheduled procedures are not closely monitored and restrictions should be put in place for scheduling This piece of tape is pulled off and replaced every time the infant in the cart change. The observation of this "six-pack" in use led to the recognition of significant issues with overcrowding on the postpartum area: o o o o o o o Lack of available appropriate space to move moms immediately post-delivery, Inability to resuscitate infants on postpartum, Frequent movement and transport of infants from the nursery to the moms several times a day, Difficulty with training for staff for this area Safety of the infants Potential for cross-contamination Risk of infant mix-up secondary to identification practices. After our initial survey, the hospital ceased the utilization of the "six pack" transport. However, the practice of moving babies back and forth several times a day remains a high risk practice and increases the risk of misidentification of a child and a possible mismatch with mom. ?4?2.421,4.0 A- O'M " Confirm of I'afiK'ipanon: lufbcu'on Cocauk 4 ; N2.S I (ft) TAG vtKCi Guriditwn of Puiflcifialiun: Compliiniet with i-tftJcrul. Staic and I ?wtal I.av.s: f,C OJ 06,111 ?i-.P i j - /< *./>/ ili. Hi {HP i j j U>.04.01.01 (KP-h There is no census or activity sheet used in the nursery to track the whereabouts of each infant at any given time. It is important that the staff is fully aware of who is in the nursery, who is with mom, and any infants who might be elsewhere. The unit should demonstrate the census of all infants by name, medical record number, the time they entered the nursery, the time they were transferred out of the nursery, where they went, time of return, and any movement to other departments. In part, the reason for the frequency of transport is to attempt to accommodate the mother and baby remaining together (rooming-in). Rooming-in fosters breast feeding, facilitates motherbaby bonding, and family interactions with the new infant. To comply with The Joint Commission guideline on breast feeding, there is a need to offer consistent rooming in. Currently, the infant must spend time in the nursery which does not provide for on-demand feedings. This standard is relatively new and will be challenging to meet with the current overcrowding. For mothers who are saving breast milk and freezing it, a practice of heating the water from where the baby bottles is placed in the microwave was observed. This inappropriate method of heating milk in this manner results is unpredictable heating and potential burns to the infant. If heating breast milk, temperatures must be monitored and within the appropriate temperature range. A safety risk regarding placement of emergency equipment for resuscitation was observed and identified. In the event of a needed resuscitation, a nurse must physical transport the infant 50- Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. 100 yards to the nursery where emergency equipment is kept. This practice was placing the nurse at risk for a fall with resulting injury to self and the infant. Treatment rooms on the units and the availability of resuscitation equipment for these rooms are critical in responding in a timely manner to any infant resuscitation need. Action on correcting this issue was started immediately; however ICE Team has not verified progress. SAG o f i u ; vovoo < undidon of Pamcipmion. Pin Mrfe 1 nGronmeno IX J>A.fK>J) i U-.P I . During a tour of the recovery room area, we observed a patient being transported from the recovery room through a doorway which did not accommodate the width of the stretcher unless the rails were lowered, instead of utilizing the proper door with the required width. This practice could lead to patient harm. ?-182.4i ! \Q- A 0700 Condhion of IVlicipntion: Physical bnviromneirt: We also identified an event where a patient had requested a treatment be discontinued and her request was not respected by a caregiver. State law and Medicare Conditions of Participation require that patient's rights be respected on accepting or declining medical treatment. Failure to recognize the rights of a patient is a CoP violation. A 82.1A 'f AG: a- 0! 15 ( ondition of Participation: (R) ' Patient's Rights.; RL01.01.0i HiP IA) The use of handheld transmitters should be replaced with the use of phones to avoid clinical conversations being overheard as persons walk by. Patient privacy should be respected at all times possible. AA >4 o ! A> A o 01 If ( ondnAn uA'anieipunon; lAiuuif^ ?dAiA- /A <0 'U ;o/ >'ip Li, The Diabetic Antenatal program provides day passes for patients to attend to personal needs. They are admitted as inpatients and the Hospital and physician retain full responsibility while they are out on pass. The patients should be admitted as an observation patient to eliminate risk. Expired sterile items were found on the neonatal resuscitation board. The reason for checking sterile supplies is to assure that equipment and supplies used for individual patients is safe and appropriate. Failure to do so is a violation of Infection Control standards. $ 4 8 2 -12 T A G A- 0 7 4 7 WISH Staff follows a practice of setting up sterile delivery tables in advance of deliveries. Once set-up and covered, the sterility of the items on the table cannot be guaranteed over a period of time due to room traffic and possible contamination by visitors when staff is out of the room. This practice was stated to be a workaround due to the absence of available personnel to assist during the delivery process. $482. =2 I AG -V 0747 Condition ofPaiticipalion: Infection Control; f{ 01 OJ 01 1 (F.P 2! Point of care testing supplies were observed in a specimen refrigerator on the same shelf as specimens. Although the two can reside in the same refrigerator, the specimens must be below the reagents on a separate shelf, f A ; P A\A a- 07-17 Condiiion ??f PnrtK ipA.ion; SnAeuon Control.; /{ :o;/ pa n< n-.p Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 196 The specimen log was identified to be incomplete with inconsistent information entered. This is a violation of Parkland L&D policy 17-01 "Sending Specimens to Pathology". If a policy exists, it must be followed. If the policy is not applicable, it should be removed or retired. The Department reports that specimens and testing supplies are separated as of 12/12/11 - subject to ICE Review. Environment of Care Order and cleanliness as a whole in WISH areas is problematic and needs immediate attention. The unit is cluttered with equipment in the hallways such as desk chairs, IV pumps, monitors, wheel chairs, stretchers and medical carts. This issue is a symptom of the overall space issues. If the situation precludes clearing the halls, then attention must be given to assuring that items/beds are on one side of the hall and the other side remains unobstructed. The floors are littered and appear to have not been cleaned as required. The walls and floors are soiled and in some places stained. Holes in the wall, chipped paint, torn and worn furniture, clutter, cardboard boxes on the floor and paper plastered around the units lead one to believe that the area is not clean. Patient soiled items are left in the rooms and trash cans are not attended to resulting in an overall appearance of untidiness. In addition, low lighting enhances the appearance of uncleanliness of the unit. The lack of cleanliness is a house-wide issue. The contract for Environmental Services should be examined to evaluate compliance. ?482.4101) 1 AG: A-0705 Condition of Participation: Physical J-nvironmum: ? 1 .m i r o i w e n t : t'l P IJ We observed the terminal cleaning process in L&D ORs and found them to be out of compliance with the required standards. Floors were not flooded and cleaning equipment was not specific to a single area. The floor cleaner was being shared between the Main ORs and L&D ORs. This practice is in direct violation of infection control standards. This process must be monitored by Infection Control to a s s u r e safe practice. ?482.42 TAG A- 074? Condition of Participation: infection Conttel; H ' Oi 0.101 f?F 2i Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 197 Material Safety Data Sheets (MSDS) need to be readily available in NNICU where staff are cleaning equipment and routinely using harsh chemicals. Laminated MSDS sheets should be readily available in the event of an exposure accident. Although the sheets are available on the computer, they are not readily available in case of an eye injury due to delay. In the Intermediate Care Clinic, the dirty utility room was identified to be in violation of Infection Control standards with clean and dirty in the same area. We advised WISH leadership that this issue was spotted on repeated survey visits. A plan of correction was developed by WISH to correct this issue immediately, but remediation of this issue consistently has not been validated by A & M . $482.43 'I AG Medication Management We observed deficiencies in securing medications used by both nursing and anesthesia. Anesthesia medication trays were observed being stored unsecured in a sterile supply room as well as in an unlocked anesthesia box in a patient room. Erythromycin ointment and Vitamin K are stored in the patient rooms but accessible to all nurses. For security, they should be placed in the Pyxis and removed when the patient arrives for delivery. 25(a) TAG: A-0491 ;yiS2.25(a'K.V> T A G : MM Management and Admmwtratioji.ofDru.ai>: MM.0iPJ.01 o.EE >EP 3) LDJM.oWP 0747 Comfitwn^fttffl'cifMictn:Infection Contfd: iC.fi Ufa 01 (EP 21 Nurses were observed failing to use two patient identifiers when administering medications. This lack of using two patient identifiers can lead to medication administration errors. Additionally, there are a large number of name alerts needed with similarities of names requiring a heightened awareness. KPSG.??.?I.O! ? j'?;/- > XI o'.oIs Pain Assessments Assessment and re-assessment are the ongoing evaluations of a patient to identify that patient's response to provided treatment and care, their physiological condition and any new issues that may have developed since the last assessment. Pain assessment is a critical component in the assessment and re-assessment process. This information drives the plan of care and nursing intervention. An example of these issues was a 14 year old burn patient's plan of care for the use of restraints which was identical to the plan of care of a 60 year old patient. Additionally, during Hospital rounds, we found the same issues in open medical records. $482.23(b}M) i \G:A-03% Standard: Stalling and Delivery of Care; PCMt.OJ.O" (EPi. J) Focused chart review of open medical records on 2 East, 2 West, 7 North, 8 West, 9 North, 10 West, 7 South, 7 South South, and 9 East found incomplete pain assessments and reassessments post medication. In reviewing records on patient rounds, there was also a lack of documentation regarding the use of PRN ("pro re nata" or "as needed or as circumstances require") medication orders and the need for continued pain assessments and re-assessments. AG: \-?c.% SiamDrd: Stuiiiig; and O e l t v s g of Care ; / ' ( f>{ u: (K KP I .?.' Restrai nts The use of restraints is a critical issue in the Medical Surgical Units. The intent of a restraint is to protect the patient and staff from harm and to avoid removal of medical devices. The decision Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. to utilize restraints should not be driven by diagnosis but a comprehensive individual patient evaluation. The evaluation should include a physical assessment to identify medical problems that may be causing behavior changes in patient. Addressing these medical issues may eliminate or minimize the need for the use of restraints. When a restraint is ordered for a patient exhibiting violent behavior, the Epic system only allows the Medical/Surgical nurse to choose non-violent restraint orders. In addition, an order for nonviolent restraints requires less staff intervention and assessment than might be required for a patient exhibiting violent behavior. In review of another medical record, a patient was described as requiring restraints for patient safety. The patient had a physicians order for wrist restraints for several days, then a second order for ankle and wrist restraints several days after that. There was no documentation of the patient's continued behavior or the required intervention for a less restrictive method to manage the patient. The order was repeated for four days. $452.1 Joik I s ("AG: -\-0! 17 Standard: Medice o f Rt^huo HIJit Ol Ol <>{<<-o) TAG:A~0!54 Standard: Restraints and Seclusion; In order to evaluate compliance with Joint Commission documentation standards relevant to restraints, we conducted an audit of several medical records and found that even though the mandated actions appear as if they arc in compliance, the standardized process in Epic fails to meet the content needs of the standard. The electronic record choices make all of the treatment Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 202 plans look the same and not individualized to each patient. Restraints may be mentioned in the treatment plans but they are not specific to the patients' individual issues, age or other factors. As mentioned earlier, we found a 14 year old burn patient's plan of care for restraint use identical to that of a 60 year old m a n . Pi'. Hi a 5.0! il-.P i. t) ?48 - . 1 3 << ) ?A> I AU-.A0I67 Standard R^straim* and Srchisioti. PC oXQS.ol (I. P ,'i Review of the daily restraint log for a six-week period of time ( 2 - 3 days per week) indicated an average of 60-70 patients are in restraints each day. Utilizing 65 patients as an average, this equates to 10% of the entire Hospital census and 17% if WISFI census is removed. An article in The Journal of Nursing Scholarship, 2007, 39(1)30-7, identified a use rate of 50 episodes per 1,000 patient days or 5%, in a review of 40 acute care facilities. Utilizing this study, Parkland's rate is twice the expected rate. Infection Control and Environment of Care We observed a lack of communication between units regarding patients being transported with confirmed infectious disease. The lack of communication from the Emergency Department to the admitting unit regarding patients with confirmed infectious disease status is problematic. This lack of communication results in improper room preparation and potential exposure during transport and to the other patients in the rooms where the infected patients are placed. In multiple areas (transport, nursing, lab, x-ray) staff are exposed to infectious disease as well. This is an essential component of the hand-off between units and needs to be included in both the written n o t e s a n d t h e v e r b a l h a n d - o f f . ?4S2.42 I AC: A-07-f? Condition of pyrficipatMm: infection Control: f( o 01 Hi 01 !hP I. A j! Staff were routinely witnessed moving from room to room with inappropriate hand washing techniques. The organizational focus on this issue has resulted in staff using the antibacterial chargers virtually in lieu of hand washing. The Parkland policy states that staff must wash their hands upon arrival for duty and after 3 uses of the antibacterial chargers. ?452.42 TAG: A-O/47 Commiosi of Participation: tiifceiion Contrai; CAS'G 0- Oljsi 482.42 TAG: A-0747 Condition of Participation: Infection C ontroi: IC 01,03, Oi fU* /. 2. 3j Order and cleanliness as a whole is problematic on the Medical/Surgical units and needs attention. The areas are cluttered with papers on the floor and taped to the walls. Multiple pieces of equipment are left in the hallways such as IV pumps, monitors, wheel chairs, stretchers and medical and cleaning carts. This practice blocks the required egress and prompt cleaning of needed equipment. ?4X2.42TAG: A-0747 Condition ftf Participate i$n: Infection Control ?482.41 I \ G : \-0700 Condition of Participation: Physical linvinflfittwrnt: 1X202:1)6.01 (L;P 1 The Medical Surgical areas are littered and appear to have not been cleaned as required. The walls and floors are soiled and in some places stained. We also observed holes in the wall, chipped paint, torn and worn furniture, clutter, cardboard boxes on the floor and paper posted on walls. Patient soiled items are left in the rooms and trash cans are not attended resulting in an overall appearance of untidiness. During patient interviews on 7SS, 7S and 9S patients stated that their rooms were not cleaned on the weekends. We observed Medical/Surgical units with spilt urinal contents, discarded food and used dressing material on the floors in patient rooms. The lack of cleanliness is house-wide. The contract for Environmental Services should be examined to evaluate compliance. Renovated units such as 7 North and Neurosurgery, however, were c l e a n e r a n d l e s s c l u t t e r e d . ?482.41 fa) TAG: A-0701 Condition oi'Participation: Physical Environment; I (-.02.06.01 Q: IC.0ijl3.01 Environmental cleaning carts with hazardous materials present are consistently left unsecured and unattended in public areas, placing visitors, patients, and employees at risk for exposure to hazardous chemicals. fl8"VUt<> 18 764 130 17.242 583 83,004 2,262 382.802 13 3,437 447 72,971 654 116,032 4 224 1,052 158,761 1,386 252,988 1,290 322,242 203,283 1,827 131 130,182 19,366 617 334 56,115 479 86,486 762 113,430 920 111,191 1,192 175,755 2,778 416,868 40 872 1 18 287 45,346 900 139,425 107 300 17,337 41,167 181 23,200 278 31,259 537 94,470 807 121.766 144 19,858 385 58,550 6,608 1,019,436 15,391 2,295,822 PACU Cases 10 430 2,814 508 2 1,173 1,737 221 407 336 2,460 15 676 116 136 710 204 11,955 PACU Phase 11 Phase II Mins Cases Mins 630 12,592 92 32,587 196,214 8 1,045 37.763 322 45,119 199 495 71,589 93,557 132,041 532 86,104 389 21.183 3 29,920 290 45,236 79,119 21,409 790 197,628 501 69,303 792 1 210 45,300 205 27,117 24 3,596 10,778 1 1,204 165 20,368 52,410 307 44,537 14,901 91 18,279 898,516 3,826 524,603 The Day Surgery Unit (DSU) consists of 21 beds and is located on 2 South. The hours of operation are five days a week, Monday - Friday from 05:00 to 20:30. DSU provides Phase II recovery when the patient returns from the PACU or directly from the Main Operating Room and is also responsible for discharging the surgical patient following the PACU. The Main PACU provides Phase I and II recovery nursing care to all patients who have undergone general or regional anesthesia. The PACU consists of twenty-six bays and one Isolation Room, and is open 24 hours a day, seven days a week. The Holding Area is located within the PACU to facilitate patient assessment prior to transfer to Operating Room for the patient coming from an inpatient unit. It is staffed by the post anesthesia nurses. The Sterile Processing Department (SPD) is under the leadership of a Director who possesses a depth of knowledge and experience in sterile processing and is supported by a Manager and Supervisor. SPD is responsible for reprocessing, sterilization, and processing of sterile supplies and instruments for all Hospital patient care areas including the Main OR and ASC. SPD is staffed 24 hours per day, seven days per week. In 2011, SPD reprocessed, sterilized and distributed 75,010 instrument trays and 144,288 single instrument sterile peel packages for the entire house. The Ambulatory Surgery Center (ASC) is an outpatient surgery facility, located across the street from the main Hospital. The ASC provides care for patients who have elective surgeries and outpatient surgeries and procedures. The facility is open Monday through Friday 06:00 to 17:00. The unit is staffed by post anesthesia registered nurses in preoperative holding and the recovery area. The operating room is staffed by registered nurses and scrub techs along with support staff. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 207 A\% M I M Below is a chart summarizing Parkland's 2011 ASC volume: ASC 2011 (1/1/11-12/31/11) Dny Day Surgery Surgery ANES ANES PACK OR Mfns . Cases Miits Cases Cases Mlns 1.783 41 2.483 41 1,783 3 271 5 259 5 271 3 6,092; 56 5.022 56 6.092 55 106.724 2.752 177.726 2.752 106.724 4 91.800 97,062 1.046 1,046 91,800 999 11,038 332. 15,883 332 11,038 142.522, 1,977 176,026 142.522 1.977 1.953 8.852 6.542 93 93 8.852 89 87.326 1.511 129,697 1,511 87,326 71 105,598 792 68,093 792 105,598 759 320 10 592 10 320 702 81.677 58.386 702 644 81,677 10,252 168 12,778 168 10,252 163 654,255 9,485 750,549 9,485 654,255 4,743 OR Case Service ; Volume i ANESTHESIOLOGY 41 EGS 5 ENT 56 GASTROENTEROLOG / 2.752 GEN 1.046 GI SURGERY 332 GYN 1,977 OMFS 93 OPHTHALMOLOGY 1.511 ORTHO 792 PAIN 10 PLASTICS 702 URO 168 Grand Total 9.485 PACU Phase 11 Phase !f Cases Mins Mtns 122 40 2,397 91 5 223 2.490 56 2.977 81 2,721 121,003 46,479 992 55,216 319 13,860 86.478 1.930 121.417 4,253 90 4,903 3,283 1,482 67,409 37,477 776 43,469 10 590 32,523 687 37,390 164 9,428 6,488 219,765 9,272 480,282 The Unit Manager of the Pre-Anesthesia Evaluation Clinic (PAEC) also manages Preoperative and PACU at the ASC. PAEC receives all elective same-day surgery or same-day admits. Patients with an Anesthesia Scoring Assessment (ASA) of 3 and 4 must complete "PreAnesthesia Evaluation" prior to the proposed surgery. Patients with an ASA score of 1 and 2 may be screened prior to the day of surgery for anesthesia work-up on arrival. The Pre-Anesthesia Evaluation Clinic at the ASC provides nursing and medical care for the surgical patient to include: o o o o Preoperative admission nursing assessment Preoperative evaluation by Anesthesia Provider Preoperative patient education Financial clearance is also accomplished at this venue The Department of Anesthesia provides services in multiple areas of the Hospital including, but not limited to, the Main Operating Room, ASC, Interventional Radiology, GI Lab (Endoscopy) and MRI. The anesthesia providers include Attending Faculty, Residents, CRNAs and support staff. The Department of Anesthesia provided 49,168 hours of coverage between the Main OR and the ASC. Environment of Care The Main Operating Room is 57 years old. The physical plant is under-sized for the complexity of technology needed for a contemporary surgical environment. Overall, the physical plant is cluttered and obstructed by equipment, case carts and stretchers. Repairs are needed to ensure Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 208 the environment of care is safe and maintains infection control standards. Individuals within the department stated they did not know the standards or regulations for proper environment of care requirements. Following are examples of seen environment of care issues observed in the Main OR. o Observed in OR# 1 1, hole in wall covered by duct tape with a bundle of coaxial cables. Broken electrical cover plate in OR#l 1. Several critical red electrical outlets covered with tape. o OR doors to OR#l 1 do not completely close. Several OR doors open during case and when cases are not in progress. Sharps container obstructs OR door. On a follow up survey, the OR door from ante room to OR#l 1 was opened and not able to be closed. Locking mechanism was removed. The air exchanges are affected when the doors are left opened allowing potential for bacterial growth. o o o Medical gas shut off valve boxes obstructed by tables in front of boxes (OR Room 12 & 13). Sharp boxes open with foot pedal and therefore syringes, needles and other used sharps are accessible. Paper signs, business cards and tape applied on surfaces in patient care areas therefore not allowing for proper cleaning of surfaces and creating a fire hazard and difficult to wash. jA-G-o ci) o Oxygen tanks improperly stored in medical gas cabinets in each Main OR corridor. Oxygen tanks in Main OR and PACU were not clearly identified as full or empty. Upon a follow up survey of the Main OR, oxygen tanks were still not clearly identified as to full or empty although the storage cabinet was clearly marked. o Carbon dioxide tanks not well secured and not identified as full or empty as well as improperly stored in ante room connected and opened to O R # l . Several environment of care issues were observed in the PACU. o Oxygen tanks in main PACU were found not clearly identified as full or empty or secured. Upon a follow up survey of the PACU area, the oxygen tanks were found to be secured in a rack; however, the tanks were still not properly labeled or placed to properly identify full or empty. o Isolation room door was propped open with an empty cart and the Personal Protective Equipment (PPE) cart, outside isolation room, partially obstructed the doorway. A broken chair was found, In the follow up visit by the survey team, the empty cart was moved into the Isolation Room. PPE cart was moved around the corner from the room. The rolling chair was removed. o The manager stated she was unaware of the environment of care requirements. ?482.42 I AG A-0747 Conditio>> of Participation: Infection Control, ?482,4! TAG A-0700 Condition of Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 209 A & M oiirivirurnnent: f{' 01.0J. Participation: EC 02.01.0! 'EE 1, 2K EC.O2.06.O1 fl'-Elj. 3): tCO2.02.Ot 0> d.K H-03.OI.0i t? Jr Infection Control Inconsistent hand hygiene practices were observed among clinicians in the Main OR. Primarily, the anesthesia providers and two circulators were not following proper hand hygiene protocol. It was observed, at times, when gloves were removed, hand washing or using hand sanitizers was not being performed. In a follow up survey visit, anesthesia providers were performing correct hand hygiene along with the RN circulators. However, a surgical resident made several hand hygiene infractions primarily when removing gloves and not using the hand sanitizer. ?482.42 f AG: A-0 7 47 Condition offlfalifcipalton: infection Controi: \f>$(i 02 01 0} fl.P 2. 3i The surgical and anesthesia staff and providers are confused regarding when to perform hand hygiene regardless of the number of educational activities provided in the past year. It appears that the confusion is due, in part, to the high frequency of changing gloves and when to sanitize while in the OR and exiting the OR. It may also stem from the fact that there may not be sufficient number of sanitizers or they are inconveniently located in the OR. The Fire Marshal, an Infection Control RN Practitioner and the OR Associate Director conducted an environmental tour to determine if additional sanitizers could be installed in identified locations and the tour resulted in a plan to install twenty-four additional units. <S( ?\P~.0J fit'jEP 2. Bj The Neurosurgery storage cabinet was placed near the scrub sink and sterile trays and supplies were in danger of the sterile items being contaminated by water. The OR staff stated they did not have an awareness of the potential for contamination from water. The follow up visit revealed the sterile supplies and trays were removed and placed in the ante room connected to OR #11 (Neurosurgery Suite) and away from the potential of splashing water. S482.4'.i i'AG: A-0747 Condition of Paitrcipauoa: intact ion Control: K ' 02.01.Of CkP h All the red large sharp containers were placed outside each OR. During and after each OR case, the staff would carry the sharps outside the OR to throw away the sharps. Sharp containers need to be near the area of use to ensure they are not unnecessarily transporting contaminants outside the OR. Upon resurvey, it was observed, the sharps containers were moved to a convenient place inside the OR. > ! R 2 . a A T , \ u : A-0747 < s .mi it ion o f Participation: Infection Control: JC.O2.01.O! (EE 1} It was observed that the RN circulators were removing the tops of medication vials and contaminating the rim of the vial and therefore contaminating the solution when it was poured into a sterile medication cup that is on the sterile field. The vial does have an aluminum pull off tab to access the solution. However, many times the tab breaks off and the RN uses an unsterile bottle opener or nurse's scissors to remove the vial top therefore contaminating the rim of the vial. At the follow up survey, the OR was evaluating devices to remove solutions from vials in a sterile manner. >MX2.42 TAG: A-0747 Condition of Participation: Infection Control; tC.02.0i 01 {EP i ) Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Shipping boxes were found in the ASC patient supply cabinets. The items in the boxes were patient supplies and the external shipping boxes were not removed prior to placing the supplies in the cabinets. External corrugated cardboard shipping boxes may have insects and may have been exposed to unknown outside substances and then be a source of contamination to the sterile supplies in the cabinet. There is a lack of knowledge regarding infection control measures with regards to handling and storing sterile supplies. There does not seem to be a strong environment of care program in the ASC. Following up with the ASC Associate Director and Director of Perioperative Services the corrugated boxes were removed and future external shipping boxes will be removed prior to entering the supply room and the cabinets. ?482.-;": I AG: A-074? Condition of Phtlicijwiioti: Infection ( ontfoi: K ?>2.0,: t>! 0:P 3) During the survey, there were several instances where sterile supplies in OR rooms were opened on a sterile field in preparation for a surgical procedure and no one was attending the room to ensure the sterile supplies and field were not compromised. An observation of this practice was noted on three different occasions in the Main #OR 3, 9, 13 and ASC OR #5. There is a lack of accountability or support by some clinical staff to adhere to recommended practices and to following policy and procedures after a number of announcements from leadership for adherence to the standard of practice. Upon the last follow-up survey visit in the OR that we conducted on December 23, 2011 all rooms were attended where sterile supplies were opened on the sterile f i e l d a n d s u r g i c a l p r o c e d u r e w a s n o t in p r o g r e s s . ?482.42 TAG: A-0747 Condition of Participation: Infection Control; li '.02 0IJ>f (l-'P h Upon checking the emergency airway cart in the Main OR, the laryngeal blades were not obviously or clearly identified as clean. The blades were not packaged and did not have any identifying language as to their sanitary status. / / * : -ti TMi -i-o-'dl Condition of Participation: Building 1C !<; ( j . o h In the ASC PACU Nourishment Room, a closed pitcher of fluid (assumed to be water) was not labeled nor dated. The staff and leadership stated they were not aware of requirements for ensuring that the food item is safe and fresh. Follow up with the Associate Director of the ASC confirmed the pitcher of water in the ASC PACU area is now refilled daily, labeled as water and d a t e d w h e n it w a s f i l l e d . ?482.42 TAG: A-0747 Condition of Participation; Infection Control: fC.Ut.03J>! Review of the SPD loan/borrow log revealed missing elements in the documentation when reprocessing/sterilization had been deferred due to an emergency situation. At times, the Flospital will borrow instruments from outside facilities that are not a part of Parkland. When sterile trays arrive from outside facilities, reprocessing and sterilization must be performed except for emergency procedures. In these emergency situations, the sterile trays from outside facilities may be used as long the surgeon is aware and accepts the sterile instruments and the quality testing from the outside facility. The log must reflect the reasons for deferring reprocessing. At the follow up discussion, the loan/borrow log form was revised and now allows Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. for documenting reasons for deferring reprocessing, S UYl. 1l \ \G: A . 0 / 4 7 <'oflSkhm of Participation: Asepti-ware(TM) solution must be stored in an environment of less than 85 degrees per manufacturer's recommendations. The SPD department staff was observing the temperature in an adjacent room and assuming the temperature was the same in the room as the Asepti-ware(TM) was being stored. The manager and staff did not make the connection about proper product storage and monitoring temperature regulation when manufacturers have recommendations on temperature ranges. During a follow up survey visit, the room where the Asepti-ware(TM) solution is being stored now has a temperature gauge and a daily temperature log that is being maintained. .?4?.'.42 I AC>>: A-lV/4? Conditio<< of Participation: infection Control: H '(>202 01 (FP-h Within the SPD area, a hole in wall the size of four inches by three inches was found near the sprayer over the SPD decontamination wash sink. Holes in walls are a source for insect infestation or mold or mildew especially when in a wet environment. The leadership and Facilities/Maintenance function should check all surface (wall, floor and counter tops) integrity in their routine environmental surveillance rounds. In a follow up call to the Associate Director it was stated the hole was repaired on December 12, 201 1. ;; A : 1 ' AG: \ <;?<<<< 1 ondirCn of Signage identified clean and contaminated instruments in the SPD decontamination room. The left side was identified "clean" and right side was identified as "dirty." With further inquiry the "clean" side was actually devices that were new and not reprocessed items and not "clean" items. These items were needed to refill trays after gross washing and before the trays were placed in the large washers. The signage is misleading and needs to be changed to reflect the actual state of the "new" and not reprocessed items area. ;; AC\4 - ;.\G: 0/4? ( o:nii<! if p/j Several infection control issues were identified in the PACU patient care area. The floors and shelving areas in the patient bays and floors were dusty. Dust was found on the shelves, under the crash carts, emergency carts and patient stretchers. The unit walls were posted with nonwashable paper signs, which is a tire hazard. The Unit Manager stated there was a change in the environmental services vendor and routine environmental cleaning was not being done well in the Main PACU. Infection control issues items were found in the Main PACU patient supply room. o Several corrugated cardboard boxes were found in the patient supply closet. External shipping cartons/boxes are considered to be "dirty" because they have been exposed to unknown and potentially high microbial contamination. Also, cardboard shipping boxes serve as generators and reservoirs for dust and can potentially house vectors such as roaches. o Rolls of used and dirty medical grade tape were found in the drawers of a supply cart containing sterile supplies. Tape should not be used from patient to patient and should not be stored in sterile supply drawers as it is a source of transferring contaminants from one patient to another. o Supplies were found to impede the 18 inch ceiling and 8 inch minimum to floor clearance. Manager and staff have a lack of knowledge regarding the requirements for infection control for storage conditions of patient supplies. A!A2. !7 i \G: AA AI7 Condition of Pautcipalimi: Infcetion Control; The sign for the soiled utility room in the PACU was missing. Management was unaware of the signage needed for staff to ensure identifying the proper room for the temporary storage of "dirty" equipment. ?482.12 TAG: A-07-17 Condition of Participation; infection Control; IC 02 02 OlfFP-i) Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 214 Medication Management Anesthesia agents (Sevofluare, Isoflurane and Suprane) were found in two unsecured stainless steel anesthesia prep carts in the OR corridor. Anesthesia providers and support staff should be responsible for securing the anesthetic agents, AUG 25(bK2)i,o f \G: a a g o > standard Delivery o f The refrigerator for Malignant Hyperthermia (MM) medications had not been checked for seven days. Staff needs to follow through on daily assignments and management should ensure assignments were carried out as per policy. ?4A\2a fas T u>: VO i'A stamfaiif; Pharmacy Mnsnuxinenl ,t'id \dndmsu'a!ion: \l\li>J 01 0} (> p 3s In the ASC, on November 29, 2011, Anesthesia medications were observed to be left unattended by the Certified Registered Nurse Anesthetists (CRNA) on the anesthesia cart in OR#5.. The CRNA failed to follow Parkland policy. Medications must be secured at all times. 51A2G5(b)iGiij 1 \G \ 0:-0,' SnnGaidGeiAerv oi'Seivices: M\}0'i 0! 01 tEP ji We observed an Attending Anesthesia physician preparing medications for an impending patient. Medications were removed from their original container, a vial, to a syringe and not immediately given to the patient and placed on the cart for future use. The label was applied as the name of the medication, but not dated. The Attending Anesthesia Physician prepared the medications but the CRNA relieving the Attending Anesthesia provider and did not correct the labels. \'PS(> Oj 0} 01 ?1 f j! During the walk through at the ASC, it was noted that IV start trays were left unattended and accessible to the public who walk past the desk of the ASC Preoperative Nurse station. An IV catheter was left on the bed table in ASC Preoperative assessment room #10. IV solutions (no added medications) are spiked the same day, however, the IVs were left unattended and not secured in patient Preoperative holding assessment rooms. IVs should not be left unattended in empty rooms. 5 ?8 2;'5ib)i?KU '! AG: AAGiQ Maridssul Dclhcry of"Sen Aes; ,1/1/03 0< 0i (EP 3/ During observations with RNs, it was noted that a Main P A C U R N and DSU RN administered medications to patients without using two patient identifiers, and that the Main DSU RN administered pain medication without using patient identifiers. The RNs stated they identified the patients upon admission to the unit and did not think further patient identifications were needed to administer medication. A -,t .a a- o i.aoo An A A.,-. oAn proGdan; ireainicnl and r-crvices, ! ieoiviso <>a-! Anii.mo- G if loo poMoso M,,nAAs:, v-An: admisG.H ria" oicdii-auos - blo<;d or idood In subsequent follow up surveys, additional medication management issues were noted: o In the Main OR, a Lidocaine ointment tube was found opened in a cart and not dated with an expiration date. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. o o Ancef was drawn in a syringe with an Ancef label; however no dosage was documented on label. In OR#12, a label was applied to a syringe marked as "Mar". The medication was 2% Marcaine. The scrub tech improperly labeled the syringe using an inappropriate abbreviation and did not have the strength written on the label. o o o o In OR# 15, a syringe labeled Neostigmine was found on top of an anesthesia tray and not secured. No surgery was in progress and no staff or anesthesia providers were in the OR. Boxes containing medications in two unlocked anesthesia fiberoptic carts were left sitting in the OR corridors. A Pharmacy cart containing used anesthesia medication boxes, in the vicinity of OR#12, was found unlocked. Several Plasmalyte IVs were hanging on Hotline IV poles in ORs where surgery was not in progress, and IV bags were found in OR corridors that were not dated or secured. A torn wrapper on a 3000cc bag of sterile water was found on cart. The wrapper protects the integrity of solution. [,? - . o *..< > : : , , Patient Rights Tissue product order with patient information was left in an empty OR on December 1, 2011. Patient information was not secured and was accessible to unauthorized personnel. ?4S2.r4(d'H l t TAG: 0147 Standard: Confidentially of Patient Records; RJ.tfl 01.Hi (nP 7J-1M .02.01 0! W ' .y A patient was called into PACU assessment room and two people accompanied the patient. The nurse proceeded to conduct the assessment talcing vitals on the automatic monitoring system. One of the individuals looked at the display on the vital sign monitor. The nurse did not validate who these individuals were, nor did the nurse ask the patient if the two people could be included in t h e i n t e r v i e w . ?482.l3(dK 1) I AG: 0147 Standard; Confidentially of Patient Records: R I . 0 P o i . 0 I t E P 7) IMiipo/jU f?P 2 ?i Patient charts are stored overnight in open cart in the ASC registration office. The office is cleaned in the evening and charts are accessible to unauthorized personnel. ?482.1 ."MX' J TAG: 0147 Standard. C o n f i d ^ u i a f h of Patient Records: ki.01.01 01 -!<> I Starufeml: t%r>cy Management and Administration: MHOS. oi.Oi iHP 3j The difficult airway cart checklist shows that cart has not been regularly checked. For several days the cart was not checked when it was checked prior to September, which contained the last entry check date. The anesthesia tech staff must perform the daily check and document that the check was performed. For all surgical procedures, a count of sponges, needles (and other sharps), and instruments are counted at the start of closing an incision. The closing count ensures that patients have minimal risk for retained foreign objects in the surgical wound. A closing count was not conducted during incision closure on first wound, medial wound on ankle procedure, within the required time frame in OR# 15 07:30 case on November 15, 2011. This procedure had two incisions where the first incision was closed and the surgery proceeded for another two hours with the second wound on the lateral side of the ankle. When multiple sites/stages of an operation are Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. performed, separate counts are done for each site or stage. There was a lack of awareness between the scrub tech and RN circulator to conduct the closing count on the first wound. Association of P e r i o p e r a t i v e Registered N u r s e s , ( A O R N ) Standards, R e c o m m e n d e d Practices, and Guidelines. Burns from Elcctrosumical Unit (ESU) Over the last 29 months there have been 15 patient safety reports submitted at Parkland on patients sustaining burns from the clectrosurgical unit cautery pencil. The electrosurgical unit is a device that surgeons use to manage homeostasis or bleeding. Through a cautery pencil that is equipped with a metal tip, the device delivers an electrical current to the tissue and cauterizes the blood vessel to stop bleeding. It also can deliver current through the pencil to cut tissue. The ESU cautery pencil has two buttons or switches that a surgeon touches to generate the current through the pencil. The cautery pencil is placed on the operative field in a protective holster that is attached to the surgical drapes. The surgeons, depending on the type of procedure, use the cautery pencil throughout the surgical procedure. The holster is attached to the surgical drapes in a convenient place for the surgeon to easily retrieve the cautery pencil from the holster. After using the pencil, the surgeon should return the pencil to the holster. However, as the surgeon progresses through the surgery he/she is focused on the surgical procedure and anatomy, and at times, the pencil may not be returned to the holster. The scrub tech is to either return the pencil to the holster, if it can be reached without disturbing the surgeon, or a reminder is audibly given to the surgeon to return the pencil to the holster. Electrosurgical burns occur in various ways. If the pencil is left unprotected or out of the holster, it is possible for the switch to be inadvertently activated, thus generating the current onto wherever the pencil is located, and at limes, it is lying on the patient's skin or on the drapes. Once the pencil is activated, the current transmits energy to whatever it touches and creates a burning effect. The inadvertent activation of the pencil can cause a burn on the patient's skin or on the drapes if the current is activated for a prolonged period. Prolonged contact with drapes causes a melting effect. The drapes lie on the patient and if the pencil is activated for a prolonged period, this melting effect may also cause a burn on the patient. Burns can be sustained by user error. When surgeons use the cautery pencil, extra caution must be taken to ensure the pencil tip or blade does not touch any adjacent tissue inadvertently. This unintentional cauterization on adjacent tissue may happen, more often, with inexperienced surgeons. In reviewing the 15 safety reports, there were 8 accidental activations and 7 user errors. In both situations, the patient sustained varying degrees of burns. The incident on December 2, 2011 resulted in a full thickness burn. Soon after that incident, an awareness program was initiated to alert staff and providers to "holster" the ESU pencil at all times, when not in use. On January 5, 2012, an accidental activation of the ESU pencil occurred when an attending surgeon, after the Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 218 scrub tech repeatedly warned the surgeon to holster the pencil, leaned on the upholstered cautery pencil and the patient sustained a superficial burn. ?482.13(c)(2) TAG: A-01-14 Standard: Privacy and S a f a ; : Pi.05 01.01 if-.P 2j Documentation and Resident Oversight During the Pre-anesthesia evaluation at the ASC, the CRNA was reviewing the history and physical (H&P) that was performed by a Neurology Clinic Resident. The CRNA found a very complex patient with several medical events that had occurred within the last year. The H&P was vague and confusing in the sequence of the medical events for this patient. The CRNA evaluated the patient and found the information in the H&P was incorrect at times. For example, the history in the chart indicated the patient had a tracheostomy. The patient was asked and examined for a tracheostomy incision. The patient denied having a tracheostomy and no visible scars were seen upon examination. The patient had experienced several medical events over the year, however, information was vague on the chronological order of when these medical events occurred. Additionally, the history of the medical conditions was vague in description. For example, the patient had a history of chest surgery but the H&P did not provide any additional description w h a t c h e s t s u r g e r y w a s p e r f o r m e d , ?482.2 He) > \ G : A-0449 Standard: {"ontcul o f Record; RC.Of Ot.fiULP Conclusion Surgical, Perioperative Services and Department of Anesthesia failed to meet all of the Conditions of Participation as specified by the Centers for Medicare and Medicaid Services in a number of areas including: o o o o o o Environment of Care Infection Control/Prevention Medication Management Patient Rights Delivery of Service Information Management Some deficiencies were addressed on an incident-by-incident basis, however upon resurvey, it was evident that the remedial actions taken did not lead to sustainable compliance with the CoP. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 219 3.5.2 E n d o s c o p y The Endoscopy Unit is comprised of six procedure rooms. The average volume for CY2011 was 492 procedures per month. The Unit Manager has oversight of 11.2 RN FTEs, 5.6 GI Tech FTEs and 2.0 Support Staff FTEs. Over 80% of the procedures are upper GI endoscopies and colonoscopies. The physical space is small and not conducive to patient flow. The Endoscopy Unit has a public corridor and interferes with patient throughput although the staff works well with the interrupted space. Procedures in the Department were observed, and interviews with key staff were conducted. Medication Management It was observed that the RN circulator and GI Tech did not exchange any communication when the circulator poured Normal Saline solution into a container onto the sterile field. There was a failure to exchange the information audibly and visually regarding the medication name, strength and expiration date. This is a failure to follow the Parkland policy PS 04 - 33. "2. DISPENSE THE MEDICATION ONTO THE STERILE FIELD. Pharmaceutical Services The staff was unaware of the Parkland policy on dispensing medications on and off the sterile field. This policy should be a house-wide policy for all procedural areas and staff should be educated regarding proper procedure. It was observed that syringes and sharps were not secured in a locked drawer or cabinet. The Hospital should manage risks related to hazardous materials and waste. The GI Unit has a corridor where the public has easy access to the procedure areas, which poses a risk for access. The staff was unaware of these potential risks. i482.25ib)i2^iil I'AG: A-0502 Stsmdard .Deliver* of Services: WiV fti tit!.Of t W J j Record of Care Hand off communication was not being documented in the nursing record. The hand off communication was conducted correctly from the procedure area to the recovery area, however, the nurses were unaware that a note needs to be documented that a hand off was conducted and w h o w a s i n v o l v e d in t h e h a n d o f f . ?482.2.*)(.G TAG: -G0395 Condition of Participation; Nursing Services. Staffing a m i ! JeliVfry | f < i u v / ' O O 01 ?C /A 0 ill f?i> /. ?j Conclusion The Endoscopy Unit (GI Lab) does not meet all of the related Conditions of Participation. The unit operates primarily in a silo and is not synchronous with other procedural areas of the Hospital with regard to house-wide policies and procedures. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1/101el. seq., this information is confidential and privileged. 3.5.3 Catheterization Lab The Catheterization Laboratory (Cath Lab) is comprised of three procedure rooms; one Electrophysiology (EP) and two catheterization labs. Hours of operation are 0700 to 1730, Monday through Friday. The physical space is clean and technology is in good repair. The team does practice excellent radiation safety evidenced by proper protective equipment and knowledge of radiation hazards. The Cath Lab and EP volumes for 201 1 were 970 IP and 635 OP. The unit manager oversees 16.8 PTEs. Currently, there is an active search for another Attending Cardiologist to replace an outgoing Attending Physician. Three procedures were observed: two catheterizations and an insertion of an Implantable Converter Defibrillators (ICD) device. We conducted interviews with the unit manager and staff RNs regarding practice in the unit. The staff RNs (primarily agency RNs) were not consistently informed on Parkland policy and procedures regarding traffic flow and scrub attire. When asked to define proper traffic flow in a sterile environment, nursing and the medical staff were misinformed or misunderstood the sterile environment practices. Additionally, the Cath Lab staff exhibited a general lack of knowledge surrounding infection control policies and procedures. Environment of Care Electrical strips in the procedure rooms were not in compliance with CoP and do not meet Parkland policy on electrical safety, Parkland policy #10-05. A follow up discussion with the Cath Lab Manager stated all extension cords were replaced with the proper extension cords based on Parkland policy #10-05, following our observation. J482.4 u'ai i AG: A-070) Standard; Infection Prevention A Cardiology Fellow scrubbed in for a catherization procedure was not wearing protective eyewear. There was a failure to follow Parkland policy Surgical Attire in Semi-Restricted and Restricted Areas and OSHA requirement I910.1030(d)(3)(x) Masks, Eye Protection, and Face Shields. Masks. The staff does not enforce Hospital policy on a consistent basis in regards to the physicians wearing proper protective equipment. This demonstrates that the Cath Lab team does not possess a depth of the invasive procedure environment as it relates to sterile and aseptic techniques. All of the staff need a thorough understanding of the requirements to maintain the "restrictive" environment. In the procedure rooms, paper business cards were taped on supply carts. Paper surfaces are not washable. There is a lack of awareness among the management and team regarding what needs to be a part of a routine surveillance in a restricted and non-restricted environment. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. An Attending Physician self gowned and contaminated the cuffs of the sleeves when the physician pulled their hands out through the sleeves. Hands must remain inside the cuffs until the sterile gloves are donned. The Attending Physician dropped a sterile gloved hand below waist during the operative procedure resulting in contaminating the gloved hand. Improper attire was worn by a housekeeper when cleaning a restricted area. When in restricted areas, Hospital-issued surgical scrubs must be worn and all hair must be covered by a disposable bonnet/cap. The leadership and team were unaware of procedures to ensure all aspects of patient care and the care environment are taken into consideration when changes in care are made. In direct observation, a Cath Lab RN, Circulator, "popped" or removed the tops of the medication vial using a bottle opener and compromised the sterile integrity of the top of vial. The medication was poured into the medication cup on the sterile operative field. The RN failed to follow Parkland policy PS-04-33. The team and leadership failed to evaluate or question all i n f e c t i o n c o n t r o l p r a c t i c e s . i-l;C.-fc2 r.-xG: A-S847 ( < miiik>>; of JHtrtieipaiioa: !rH<>ft Control; If'.OS bl.Qt Medication Management We observed an unlabeled syringe at the sterile field and on the sterile back table. A sample of blood was drawn by the Attending at the field and left on the operative field because there wasn't a person to readily available to hand the specimen to. A label with the patient name and type of specimen must to be applied to specimens and syringes. SPSC.0i-.iM.01 A medication label was not properly labeled on back table in the procedure room. The label only had the name of the medication and not the strength. The process puts the patient at risk for receiving either the wrong medication or dosage. This action violates Parkland policy Admin 63 3 . SPSC OS.0-Ko! There was no audible communication or visual inspection between the RN circulator and Scrub Tech when a medication was poured into the medication cup on the back table during a procedure. Audible communication and visual inspection between circulator and tech did not occur when transferring medications from an original container to another container and when passing off medications between two people. The circulator must communicate audibly and show the original medication container to the Scrub Tech. Communication between the two involved individuals must cite the name of the medication, strength, if applicable, and expiration date. These actions failed to follow Parkland policy PS 04-33 Medications On/Off the Sterile Field. The Cath Lab staff was unaware of the policy of proper dispensing of medication from the original container and transferring the medication to another person. In direct observation, a Cardiology Fellow communicated a verbal order to the RN who was in the Cath Lab procedure. The verbal order (Paxil 600 mg.) was for a patient in the preoperative holding area of the Cath Lab. The RN in the procedure communicated the order to the RN in Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 222 A & M Preoperative holding. A verbal order cannot be communicated from RN to RN. The order-was not documented as a verbal order in the medical record. Delivery of Service A Time Out procedure was incorrectly executed prior to a procedure. The participants in the Time Out procedure did not use two sources for patient identifiers. The RN Circulator did not use the patient consent as one of the sources for identification. Staff failed to follow Parkland Admin 6-30 policy. The team lacked knowledge of the policy and proper execution of the Time Out procedure. ('P 01 05 Oi <:FJ\ fl It was observed that a patient site marking was not performed for an insertion of an Implantable Cardiac Defibrillator (ICD). The Parkland policy for exempted procedures did not specify whether ICDs are exempt or whether a site marking must be performed as it is an invasive procedure. There was a failure to follow policy Parkland 6-30. l P.oi.OJ oi An ICD procedure involves a wound where a pocket is created to insert the ICD implant. The procedure calls for sponges, needles and other sharps, therefore creating a potential risk for retained foreign objects. It was observed that sharp and sponge counts were not conducted for the ICD procedure, which is required practice according to Parkland policy PS 04- 43. The Cath Lab has only recently become aware of the requirements for the condition of their environment for invasive procedures for maintaining a sterile environment with each procedure room. The staff is on a learning curve with their understanding of providing patient care in a sterile environment (restricted area). There is a knowledge deficit among the staff regarding the proper practices in restricted areas and the Parkland policies and procedures and the standards for the sterile environment. Conclusion The Cath Lab does not meet all of the Conditions of Participation as required by the Centers for Medicare and Medicaid Services in the following areas: o o o Infection Control/Prevention Medication Management Delivery of Services The leadership, physicians and staff are not well informed on standards of care relevant to invasive Cath Lab procedures in restricted environments. This lack of education and monitoring of infection control practices needs to be corrected through education and the development of departmental performance improvement. Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. 3.6 Clinics 3.6.1 Outpatient Specialty A&M surveyed several on-campus clinics, targeting a sample of high volume, heavy traffic clinics as well as specialized, lower volume clinics. Findings were discussed with staff at the time of survey and a preliminary set of findings was discussed with clinic management. Observations were similar in the several clinics we surveyed. We also returned for follow-up surveys on a sample basis. The clinics reviewed were: o o o o o o o o o o o Gastroenterology Specialty Clinic Transplant Clinic Surgery Clinic Dermatology Clinic Primary Care Internal Medicine Clinic (PC1N) ENT and Oral Surgery Clinic Hematology / Oncology Clinic Lab Clinic Urology Clinic Neurology Clinic Internal Medicine Specialty Clinic Medication Management In a review of the Transplant Clinic, expired supplies and medications were found. An expired multi-dose vial of Lidocaine was found in the cupboard of the treatment room. Additionally, an e x p i r e d I V c a t h e t e r w a s f o u n d in a d r a w e r . of ?2.V. . MM 06 iH.O! ?-.fb,? 4 8 2 . : - t e n \ G : \-04tM Standard: Preparation Administration Upon review of a patient chart in the Gastroenterology Specialty Clinic, it was noted that the RN did not enter documentation for the time of administration of a vaccine. This occurrence places the Flospital out o f c o m p l i a n c e with C o P ?482.21 ) Content of Record. Medication reconciliation is an issue throughout the Parkland system. There is no clear delineation of agreed upon responsibilities between physicians and nurses to ensure effective medication reconciliation. The current set-up of the electronic medical record (EMR) system and lack of education contribute to this issue. Physicians are unable to view removed medications in the Epic system, and therefore cannot make a determination on drug status. Providers do not feel they should make a decision to reorder or discontinue medications that other providers have prescribed. Nurses do not enter or discontinue medication lists in the Epic system because they perceive they are writing orders. This dysfunctional system results in Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Ah duplication of orders and orders that are not timely, thus medications are not reconciled. M'S(l iij.06.rti/ Environment of Care / Infection Control During a review of the Surgery and Dermatology Clinics, it was observed that the cytology lab was operating with inappropriate work space. Microscopic viewing of cytology specimens occurs in the area where employees and Residents perform computer work. Specimens are stored where Residents are working on computer work stations. This creates a potential for crosscontamination. While surveying the ENT and Oral Surgery Clinic, we observed that access to the medical gas shut-down panel was obstructed by a patient cart. Medical gas panels should be accessible at all times. As reported throughout this report, the clinics have a general lack of cleanliness. common deficiencies in the clinics related to the environment of care: o o o o o o o o o o o o o o o o o We observed Overall lack of cleanliness Observed Dental lab floor and surfaces are covered with dental composite dust and adhesive Observed dried blood on floor of phlebotomy area in Lab Clinic Dental composite materials not labeled and left on counter surfaces in Dental Lab Oral rinse solution found in soiled utility room in Oral Surgery Clinic Oily brown substance found in storage cabinet under the ice machine in Oral Surgery Clinic Paint peeling from walls Torn/taped chairs Signs are push-pinned and taped to walls and other surfaces Shipping boxes observed in sterile and patient care areas Patient privacy drapes are not laundered and are in disrepair Bottom shelves in sterile supply storage areas do not meet proper clearance from floor Top shelves in supply areas with sprinklers do not meet 18" clearance requirements Inconsistent equipment Carpeted floors in sterile supply areas do not provide for proper cleaning Clean/dirty areas are not separated appropriately Inadequate placement of signage. IC.02.O2.01 {V.P 4k lC.Q3.0i ?482.42 TAG ,4-0747 Condition cif Participation: Infection 2. 3i; 1131'!. 3j; ?3C.02M.0l (El'lj Control; ?482.41 PAG A-0700 Condition of Participation: Physical Environment; K 01.03 01 ill'I. 01 (EPI. 2. 4;: PCJU.Ol.OJ or missing preventative maintenance labeling observed on medical Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 225 Patient Rights / Privacy Patient paper charts were discovered in an unlocked cabinet in the Transplant clinic. These records were not secured and were accessible to unauthorized personnel. Patient EKG findings were observed on a shelf in an unsecure area. We also observed a list of patient names on the printer in an unsecured area which was accessible to unauthorized personnel. On re-survey, the Transplant Department reported that all documents with patient health information had been properly removed and stored. We will revalidate this finding on future surveys. ?4$2.i3{bxi) T \C \ OS-PVamhrd SMivctfijp of Services:. MMtiS.OlMl if I' 3j Staffing A common theme in our report is the lack of demonstrated competencies of staff. In many clinics, staff could not articulate competencies for crash carts and AEDs. Staff should be trained on emergency equipment within the Department and appropriate competencies should be developed. Nursing staff must have specialized qualifications and competence to meet patient n e e d s . 0 S 2 . 2 3 i b ) ( 5 ) TAG: A-0397 Standard: Staffing and Delivery o f Care: HR iH.02.al rfP I) i f f 0 ftR 0! 06.0? Quality Assessment/Performance Improvement (QAPP We observed unit specific QAP1 plans in Urology, Transplant, and Primary Care Internal Medicine (PCIM) clinics. Other specialty clinics lacked an adequate plan. An overall outpatient quality plan should address opportunities to improve care to the population served by the clinics. 3483.21 TAG: A-0263 Conditions of Participation: Quality Assessment and Performance Improvement Program. ?482.23 TAG: A-0385 Conditions of Participation: Nursing Set vices. ?-1S2.23(ai TAG. A>>0.g% Standard: Organization: SR.02 02.01 [ I f f g 6i o LP 04 Of?l i f f if Patient Care In the ENT and Dermatology Clinics, the Time-out procedure was reviewed with staff. Nursing staff assigned to the procedure do not consistently participate in the time out. Additionally, only the providers document the time out; nursing should make a documentation entry on whether proper time out procedure was performed. ( PJU.03,01 i f f 1) Conclusion There were similar trends in deficiencies noted in both the Community and campus-based Clinics. These trends provide the Hospital with the opportunity to focus on key areas to improve care. These areas include medication management, environment of care, staff competencies, QAPI and proper signage. In brief the outpatient clinics did not fully meet all relevant Conditions of Participation. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 226 Ai 3.6.2 Community Clinics Parkland's Community Health Care Centers were established in 1987. The Community Oriented Primary Care (COPC) facilities are under the direction of the Executive Vice President, Community Medicine. COPC includes a network of 11 primary health centers, 11 school-based clinics and homeless medical services. They provide pediatric, adolescent and adult primary care, women's health and senior care services. The Women's Health clinics are under the direction of the WISH department. These clinics are located within the COPC clinics, and are stand-alone clinics. All physicians in the COPCs are employed physicians. Wait time for appointments vary by clinic. The adult and geriatric average wait time is 106.3, days but for adults alone it is 175.7 days, based on Parkland statistics from October 1, 2010 through December 30, 2011). The Pediatric case load has a much shorter average wait time of 4.5 days on average. Pediatrics is able to maintain a low third day available appointment backlog (usually one to three days) per the Hospital report provided. The adult/geriatric population can have wait times ranging from two to three days to as high as 422 days. The OP clinic leadership is exploring a variety of options to expand access, but all remain in the planning phase. Parkland and the Dallas Independent School District collaborate to create health care facilities on various school campuses for students and children of students. These clinics provide care to students and their families. Services and programs provided to patients include: acute care, management of chronic illness (such as Asthma, Obesity, Diabetes, etc.), physicals, immunizations, specialty care referrals, STD and HIV testing, health education, Class D Pharmacy, DPS programs, family therapy, family planning, M H M R and Social Work. There are 11 of these clinics throughout the Dallas County area. Parkland serves both adult and juvenile facilities for the Dallas County Jail System. The Medlock Adolescent Center is a locked, secure facility for adolescent males ranging in age from 1 1 - 1 7 . The average daily census averages 85-90 residents per day. The average length of stay is 6 to 9 months. The clinic in the facility provides nursing services 13.5 hours per day, seven days a week. Providers are on site two days per week. Henry Wade Juvenile Detention Center serves as an initial process center for two of the other adolescent facilities. The center is one of the largest in Texas with a capacity of 480 adolescents and houses youths 10-17 years old who have been arrested or been charged with an offense that breaches probation. Nursing services are provided 24 hours per day, with eight hours of provider coverage Monday - Friday and on-call provider availability on off hours and weekends. Youth Village, with a capacity of 88, is a residential care facility for youths between 10-17 years old who require supervision ordered by the court. The average length of stay is 6 to 9 months. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 227 The clinical services include 13.5 hours per day by nursing, seven days per week. Providers are onsite two days per week. The Letot short-term program has a shelter capacity for 40 youth referred by law enforcement for runaway, truancy and class C misdemeanors. The Letot program aims to reunite runaways with their families whenever possible. Nursing medication administration is provided two hours per day, seven days per week. Medical provider services are onsite three days per week. The Dallas County Jail system has an average census of 6,301 inmates. The clinic performs an initial assessment on each inmate as part of the intake process. Fifty percent of inmates have an acute or chronic medical and/or mental health condition. Health services include: health screening for all inmates upon arrival & yearly; TB screening for all inmates upon arrival & yearly; acute and intermediate medical inpatient care; crisis stabilization; suicide prevention program; acute & intermediate mental health inpatient care, as well as clinic services such as OB and GYN, HIV, dermatology, dental, dialysis, and infectious disease. A&M surveyed several off-site clinics, unannounced. We targeted high volume, heavy traffic clinics, sampled school clinics, correctional facility clinics, and mobile clinics for homeless patients, women's clinics. Findings were discussed with staff at the time of the survey and a report was issued to management. Because we surveyed a broad sample of clinics, it was our premise, and we reported to Parkland, that these findings should be construed as clinic-wide issues. Our observations were similar in the several clinics we surveyed. We also returned for follow-up surveys on a sample basis. Clinics that we surveyed included: o o o o o o o o o o o East Dallas Health Center Southwest Dallas Health Center Garland Health Center HOME Mobile Clinic Bridge Homeless Clinic Maple Plaza Women's Clinic Lakewest Women's Health Center Red Bird School Clinic Seagoville School Clinic Medlock Adolescent Center Parkland Services at Dallas County Jail Medication Management During the surveys, we observed several instances of medication management deficiencies in the medication log area. Logs were not properly completed. We noted one clinic did not track medications removed from storage area, which deviates from the standard method used to track Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 228 medications removed from the cabinet. Nurses use ditto marks instead of filling out each field. One log we observed noted that an outdated medication had been used. The use of ditto marks does not compel the nurse to properly document correct medication, dose and expiration date on the log. During chart review, we observed patient charts without a vaccine administration time. A change to Epic Medication Administration was made after our survey visit to install a hard-stop to ensure medication administration time is accurate. In the COPC Clinics, medication rooms, cabinets and carts were properly locked with the exception of medication carts in Jail infirmaries and clinics. However, keys to medication cabinets/closets/refrigerators were not adequately secured; nurses keep keys in an unlocked drawer, on top of desk, or take keys home. On re-survey we noted the locations that were cited for unlocked cabinets initially did not have a re-occurrence of the issue, however the practice of unsecured keys remains an issue. The Hospital should ensure the policies and procedures address specific issues related to securing keys for medication storage. TAG; \-<>5fl0 MVt.fO.OLOI OiP .5.6} In the Medlock Adolescent Center, medication room security was not maintained and was accessible to residents. Controlled substances were not placed in locked cabinets within the medication room, and a controlled substance reconciliation was not being performed at the end of this shift. An unlocked medication cart was accessible to residents. These practices were in violation of Parkland policy. Failure to follow security and reconciliation procedures at the Medlock Adolescent Center by Parkland staff led to a theft and diversion of drugs by Metlock juvenile resident. Several residents wound up ingesting the stolen drugs, suffered adverse reactions and had to be treated in the Parkland Emergency Services Department. ?4^.25fb)i2)iis TAG:A*(I500 MMOAOi.OJ t! F L 6 ) Hospital policy is not followed when labeling pre-drawn medications and multi-use vials. We noted improper labeling such as missing dates, incorrect dates, and an un-standardized format. Clinic staff is confused regarding the proper way to label medications. We observed an opened 1 L. NaCl in the medication closet in the Maple Plaza Women's Clinic that was labeled as good for 30 days. The Normal Saline solution is used in a procedure that comes in contact with a patient, rendering it contaminated. This is in violation of Hospital policy. To avoid cross contamination and ensure sterility of the solution, the use of a saline solution should be one-time use. Medication reconciliation is an issue throughout the Parkland system. There is no clear delineation of agreed upon responsibilities between physicians and nurses to ensure effective medication reconciliation. The current set-up of the Electronic Medical Records (EMR) system and lack of education contribute to this issue. Physicians are unable to view removed medications in the Epic system, therefore cannot make a determination on drug status. Providers Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 229 do not feel they should make a decision to reorder or discontinue medications that other providers have prescribed. Nurses do not enter or discontinue medication lists in the Epic system because they perceive they are writing orders. This dysfunctional system results in duplication of orders and orders that are not timely, thus medications are not reconciled. Additionally in the Medlock clinic, pharmacy staff does not provide oversight and validation of physician medication orders. Because of separate IT systems, the pharmacy does not receive copies of physician orders to serve as a "source of truth" for order validation. ?48 225{h){2){i) TAG; A-"0502 Standard Delivery of Services; \-l\f.G3 01.0} (BP it Environment of Carc/Infection Control We observed common deficiencies in the clinics related to environment of care. These areas have a general lack of cleanliness and the physical plants show a lack of care. Environmental deficiencies included: o o o o o o o o o o o o o o o o Holes in walls, torn wallpaper, torn upholstery Broken electrical outlet face plates Ceiling tiles in disrepair Signs are push-pinned and taped to walls and other surfaces Bottom shelves in sterile supply storage areas do not meet proper clearance from floor Top shelves in supply areas with sprinklers do not meet 18" clearance requirements Cardboard shipping boxes observed in patient care areas and sterile supply areas Empty and full oxygen tanks are not properly secured, stored and labeled Rusted cabinetry - This deficiency was related to the Bridge Clinic. The cabinet was removed upon re-survey Staff food in nursing work areas Refrigerators and freezers need to be cleaned and defrosted Inconsistent or missing preventative maintenance labeling observed on medical equipment Patient privacy drapes are dirty and in disrepair. Although some clinics have a cleaning schedule with EVS, it is not a house-wide practice. Carpeted walls and floors in sterile supply areas do not provide for proper cleaning, this was observed in several clinics (This issue in Bridge Clinic was resolved upon re-survey) Clean/dirty areas are not separated appropriately I n a d e q u a t e p l a c e m e n t o f s i g n a g e . ?>482.42 I' VG A 0 7 4 / Condition ofPafticipatiftn: Infection Control; ;: 182 4! TAG A-0700 C ondi'fiou of Participation: Physical Environment; K'MlMOt a\t>:at )(5j Staff should be trained on emergency equipment within the department. Age appropriate competencies should be developed. Nursing staff must have specialized qualifications and competence to meet patient needs per C M S C o P S t a f f i n g and Delivery of Care. ji482..2Jib)(5): TAG A -0.T>7 Standard: Staffing and Delivery of Care; HH Of (>2 01 rlfPp HRjifM.Of if-P t j Quality Assessment and Performance Improvement CQAPI ) An overall outpatient quality plan should address opportunities to improve care to the population served by the clinics. The Clinics do not meet the CoP requirements involved in a performance improvement program that is integrated with the hospital. J4S2.2I TAG: A-026> Conditions of I'artieij-ndon: Quality A>>*>>sm<; P(\tn.o.Of t1 /*;(j Conclusion Outpatient clinics are not currently meeting all Conditions of Participation in areas of: medication management, medication reconciliation, environment of care, quality assurance and performance improvement. The clinics are managed by a capable staff, and they were responsive to consultant recommendations. Hospital facilities and EVS departments should focus on bringing the clinics to the required standard. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 231 3.7 Physical Medicine and Rehabilitation Background The Physical Medicine and Rehabilitation Department (PM&R) is comprised of outpatient and inpatient services. The outpatient arm of the Department provides physical, occupational and speech therapy and wound care within the Hospital, and one outpatient physical and occupational therapy clinic at the nearby Ambulatory Surgery Center. The current outpatient volume is approximately 121,000 visits annually. The inpatient unit has 17 beds. The Department also oversees an Orthotic Lab within the Hospital. The Director oversees 136 PTEs including seven direct reports. The Clinical Chair of PM&R and the Medical Director of the inpatient unit are both contracted physicians through University of Texas Southwestern Medical Center (UTSW). The survey included interviews and observations in both the inpatient and outpatient care settings. In addition, chart audits were performed to determine adequate levels of patient care, documentation and Resident oversight. Initial findings were reported to the Department on December 1, 2011. A follow-up survey of the areas was conducted on December 20, 2011. Upon initial review, there was a backlog of approximately 1,800 outstanding appointments for outpatient physical therapy, occupational therapy, and speech therapy treatments. The process for prioritizing patients for appointments is subjective and there is inconsistent practice in contacting referred patients in a timely manner. Patients who need immediate care are not being seen in a timely manner, while other patients who may have reached maximum medical improvement are being referred again for maintenance programs and are filling valued appointment slots. There are physical plant constraints causing a rate limiting factor on appointment availability. There is no plan or use of flexible staffing to increase staffed hours in order to meet demand. The Department does not have access to a PRN or staffing pool that can be used to meet flex up to address the wait list. The hours of operation for the unit are 8:00 to 16:30, Monday through Friday, and the unit is closed on weekends. While the problems have likely resulted from a lack of education regarding patient prioritization, there is a lack of physician leadership engagement in this Department and therefore inadequate direction to staff. As noted below, the UTSW physician acting as the Medical Director has minimal involvement in the operations of the Department. ?4X2.54 r \ G : A -1076 C ondition of Pafncipalion: ?u?patieiU Services. : f P> 0? 03 01 HOP 3). ?3D O i 03 01 (PP !j Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 232 Infection Control During observations in the wound care area, a lack of sterile technique was witnessed during a debridement procedure. There was no utilization of a sterile barrier to place any removed unhealthy tissue. Instead, it was observed that the tissue was placed on a white towel from the laundry cart and the debridement instrument then reentered the wound area. Dust, lint and other contaminants from the towel could be passed to the wound increasing the chance of infection. Appropriate infection control practices should be enforced to protect each patient during procedures. This practice is not in compliance with Medicare Conditions of Participation. $482.42 ?'AC!: A-0747 Condition of Participation: Infection Control: K'.Oi.tH.O! lEP 2. Sj Inadequate hand hygiene procedures were observed within the Physical Therapy Department, especially during clinical delivery of care between patients. Primarily, Physical Therapists in the gym setting have a routine whereby they move from patient-to-patient rendering clinical care without appropriate hand hygiene procedures being followed. There are no sinks in the care area. The staff has wall mounted hand hygiene stations in the large gym venue; nevertheless they did not consistently use this method of hand sanitizing between patient care. This practice is a d e f i c i e n c y o f t h e M e d i c a r e C o P ?4S2A2 I A ( i : \ - >> 7 4 7 Condition ^ P a r t i c i p a t i o n : Infection Control: ft. 01 05.0! tF.P ?/; \PS(1 m.Ol 01 (LP 2 $>. Plans of Care / Documentation Chart audits conducted by A & M revealed the following deficiencies in the Medicare Conditions of Participation: o Patients were not consistently assessed for pain per Parkland policy. ?482,54 '! A Condition of Participation: Outpatient Services a n d ?4S2.24(c}(2)iiiij T A G : A-0458 Standard: Content of Record. o Discharge summaries were not consistently completed. ?482.43(a) FAG: A-OSOW Standard: Identification of Patients in Need of Discharge Planning: ?482.43(1.00}: T A G : A-4806 Standard: Discharge Planning Evaluation. o o Patients were not consistently re-assessed after 30 days or 10 treatments per Parkland p o l i c y , g i g g . v i "'ooo< ; V !'G76: Condition of Participation: Outpatient Services. Plans of care relating to long term goals, duration of treatment, frequency of treatment and type of treatment were not consistently followed. f \G: A - i 076: Condition of Participation: Outpatient Services. The Hospital policy does not specify admission criteria for the Inpatient Rehabilitation unit and therefore the medical staff admits patients to this unit without proper justification. Documentation to support continued hospitalization and support of the diagnoses were not in compliance with C o P requirements. ?482.24fc>> Tag A-0449 Standard: Content of Record; ?482.30; dj.'Iag A -fW>56 Standard: Determination Regarding \dmission> or Continued Stags, Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Further, the Inpatient Rehabilitation unit does not consistently perform a complete nursing assessment in a timely manner ,which is a CoP deficiency. Chart audits revealed a stroke patient who was admitted who did not have a sensory assessment performed by nursing on the relevant upper extremity until 16 days AFTER admission. >:48.:G3(h>( > ) TAG: A-0395; A \0i,01',0j, During the survey, many of the non-compliance issue were found to stem from a lack of education of providers with regard to policies and procedures. In some cases this is because a policy does not exist, and in other cases, the policy may exist, but is not easily accessible. The staff does not act in accordance with said policies as part of the care routine. This could be a reflection of the "siloed" organization structure and perhaps a deficiency on the part of leadership and governance. Compliance with Laws and Regulations Parkland does not hold a Durable Medical Equipment (DME) license, yet they dispense DME such as canes, crutches and walkers. The Department noted that the DME was dispensed without charge to patients. The institution also has an orthotics lab which manufactures custom back braces and post-operative braces as prescribed by the surgeons. Because Texas Administrative Code #25-Medical Device Manufacturers and Distribution License requires an application to be submitted to the Texas Regulatory Licensing Unit for licensing to dispense Durable Medical Equipment, the Hospital is out of compliance with Medicare CoP S4S2. 11 (t>)('2] FAG: A4S022 Comliiion o f Partioipatiori: Compliance with federal. State and Local Laws: /./.'>. 04.0!Ml i'W I). Parkland does not issue Advance Beneficiary Notice (ABN) forms to patients who receive DME supplies. The Flospital does not have a policy regarding the dispensing of DME supplies, therefore patients are not treated consistently; funded patients may not receive DME supplies from the hospital, and may be given a list of DME suppliers, while unfunded patients may receive free DME supplies. Custom compression garments are supplied to Parkland HEALTHplus (PHP) covered patients only, even though PHP does not cover compression garments. The Department Medical Director's role is primarily focused on the Inpatient Unit - and has little to no involvement in the oversight of outpatient services. The Director is committed and focused on UTSW and therefore docs not dedicate adequate time to Parkland PM&R. Therefore, the Department functions without the required oversight. This Department has little to no medical representation in any committee structures or forums where physician representation can work collaboratively to address quality of care issues. jj482.56 >: 4 AG: .4-0724; I ( ' 0/JU.01 si. V j). The staff in the critical care units draws blood from existing patient lines. The specimens are transported to the lab by the staff or pneumatic tube (some specific exceptions apply) to the lab, are received, and sent to the appropriate location in the lab for processing. The laboratory information system is utilized for the reporting of results. For critical results, the Cerner system produces an audible alarm when a result is in the defined critical range. We reviewed the log book in which staff notifications of critical results are recorded. The time, date, patient, test, results, and the name of nursing staff to which results were called were noted. In reviewing patient safety reports from September 2011 through November 2011, in the laboratory-related categories, there was one incident reported in which there was a three-hour delay before critical results were reported. There were two additional incidents reported in which there was a misunderstanding on the nursing s t a f f s part on what result was within the range of critical values. Dialogue with Nursing would be variable to ensure the results from the annual review and establishment of critical values are communicated, would be useful. Additionally, during our survey, an incident occurred where false positives for vancomycinresistant enterococcal infections (VRE) were reported on more than 14 patients in the Neonatal Intensive Care Unit (NNICU). The microbiology section had recently changed reagents for their VRE surveillance program. The reagent instructions state the time of incubation and the assurance that results do not need confirmation. However, they were reporting results by patient, which made this a clinical, not surveillance test, which would require confirmation. The Hospital held meetings regarding this issue and CMS CLIA regulators reviewed the situation as well. As a result, the Laboratory will no longer use this reagent, and will perforin surveillance only on an Confidential for investigation anil review by quality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code anil 42 USC 1 /101 el. seq., this information is confidential and privileged. Ai anonymous basis, and will not provide "interim" results on cultures of this type. The Laboratory is preparing a formal plan of correction under CLIA on this event. The Anatomic Pathology section recently had a sentinel event where the wrong specimens were reported out for the wrong patient. A plan of correction has been instituted by the Department. During the review and observation in Anatomic Pathology and Cytology, no breaks in the revised process were observed. During this review, we observed that the physical condition of the Anatomic Pathology Grossing Room needed to be thoroughly cleaned; including floors and all environmental surfaces. Phone covers had tissue, blood and other substances on them. This physical state places the organization out of compliance with the CoP - ?482.42 Condition of Participation: Infection Control. l(ai TAG: A-0701 Condition of Participation: Physical haviromrmni; ?('10106.01 (FP I) Blood bank blood type and cross-matching procedures and controls were reviewed for potential gaps that could create safety risks for patients. Blood onsite is stored by type and by expiration When orders date, with a "first in, first out" method to minimize having to waste expired blood. are received for a type and cross-match, each order is worked individually to avoid potential errors in specimen labeling and matching. The typing and cross-matching is an automated process. This helps reduce the potential for the "human" error component in that portion of the procedure. The required quality controls for the device used to type and cross-match are done per manufacturer requirements. Blood is picked up by nursing staff and joint verification of the correct blood-type and patient are done by the laboratory and nursing staff. N o deficiencies or patient safety risks were identified in the blood bank review. The Laboratory has a unit based Quality Assessment and Performance Improvement (QAPI) program. It contains many of the elements needed for the program. The Laboratory must implement quality assurance (QA) monitors on each of its contract services and needs to report its QAPI results not only through the Pathology/Medical Staff route and Transfusion Committee but also through the Hospital wide QAPI QCC committee. These changes are needed for the tEP IJ LP),04.04 05 i.EJ1 Laboratory to be in compliance with the QAPI related CoP: ?482.2! TAG: A-0263 Condition of Participation: Qua) it) A s s e ^ m a o l and PeitbnnanW Improvement Proliant; PC O.lPt.O/ /> Laboratory leadership was not aware of the reporting chain and requirements and were educated in these elements during the review. As part of our survey, we reviewed the operations of the Fine Needle Aspiration Clinic and noted the following deficiencies: o The floors in the procedure rooms were very dirty on the day of the survey. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 238 o The time out on a patient was done well in advance of the actual procedure. Other preprocedure activities were performed after the time out was performed. The time out is to be done just before the procedure as a final patient safety check. l.'P.O/.ai01 H I j. K 1,01.01 03 (CP It. There was no nursing support for any patient seen in the clinic. Only the Faculty and Resident Physician attended the patient. $432.23(100) TAG; .-G0.195 ^ HO2.03. ol (LP "j. Autopsies The wording in Parkland's Policy and Procedure Admin 4-01 regarding autopsies meets the CMS standard. On review of five charts for which an autopsy was performed, the following was found: o o o None of the charts contained an order for an autopsy, Only one chart contained a note in the progress notes indicating that an autopsy was offered and the family agreed, In two of the charts, a note indicated that an autopsy was offered and the family refused; subsequently an autopsy was performed but the note was not amended to reflect the family's agreement, o o The autopsy reports indicated that the Attending Physician was notified but does not name the Attending Physician, There were no notations in the nursing notes to indicate that pathology had been notified that an autopsy had been requested. These deviations from Hospital policy place the organization in noncompliance with the CoP ? 4 8 1 2 2 TAG: A0-0364 Condition of Participation: Medical Staff and ?4 82.22(d) Standard; Autopsies: MS.o5.0l (EP 9> 01 Other than the above-noted deficiencies, the Laboratory appears to be in general compliance with most of the CMS Conditions of Participation. They are active in identifying issues for improvement and take action in a timely manner. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 239 At 3.8.2 Pharmacy The Pharmacy function provides pharmaceutical dispensing and clinical pharmacy consultative services for Parkland patients and employees who are seen within the Hospital. There are eight Class A pharmacies (at ambulatory sites), three Class C pharmacies (at Parkland Hospital, Lew Sterrett Justice Center and the Ambulatory Surgery Center), and twenty-five Class D pharmacies that are located within the clinics. A Class A pharmacy license (community pharmacy license) is issued to a pharmacy dispensing drugs or devices to the general public pursuant to a prescription drug order. A Class C pharmacy license (institutional pharmacy license) is issued to a pharmacy located in a hospital or other in-patient facility that is licensed under the Texas Hospital Licensing Law (Article 4437f, Vernon's Texas Civil Statutes) or Chapter 6, Texas Mental Health Code (Article 5547-1 et seq., Vernon's Texas Civil Statutes), or to a pharmacy located in a hospital maintained or operated by the state. A Class D pharmacy license (clinic pharmacy license) is issued to a pharmacy dispensing a limited type of drugs or devices pursuant to a prescription drug order. The Inpatient Pharmacy operates from the Main Pharmacy and several satellite locations in the Hospital such as the Operating Room. All of the satellite locations distribute medications to patients. The physical areas in which the Inpatient Pharmacy are located are of sufficient size for the level of activity, with the exception of the need for additional clean rooms. The Pharmacy manages a high volume and high acuity demand. There is an extensive Intravenous (IV) program. The Pharmacy processes all Total Parenteral Nutrition (TPN) orders and mixes the TPN within the Pharmacy. There is adequate space in the "clean" room for processing chemotherapy agents due to the additional space recently opened. There are numerous Continuous Renal Replacement Therapy (CCRTs) orders processed each day. The Department uses pre-mixed bags for CCRT. The Pharmacy provides medications for the Dallas Special Weapons and Tactics (SWAT) teams who accept full responsibility for the medications. The Pharmacy does not oversee the use of these medications. In addition, the Centers for Disease Control (CDC) provide drugs for the regional disaster program. The Pharmacy does not oversee this drug program. The storage rooms for these medications are secure and alarmed to CDC. The eight Class A licensed retail sites are located within the service area. Each area is appropriately staffed with a pharmacist and at least one technician. Each area fills orders in its location. The organization is evaluating a centralized fill operation with mail out and/or centralized pick-up. The Class D pharmacies have a centralized re-packaging operation that supports the program. The 340(b) drug program is utilized to support both the Class A and the Class D pharmacy operations. Drug security was observed to be adequate at the sites A&M visited. 1 lowever, as noted elsewhere in this report (Medication Management, Section 2.7.5 and Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 240 Ai Patient Safety/Patient Rights, Section 2.7.1), during our survey period an incident of drug diversion occurred in the clinic at the Medlock Adolescent Center because drugs had not been secured and stored as required by Hospital policy and regulatory requirements. In that case, 12 bottles of Schedule II drugs were stolen by one of the juvenile residents because the drugs were not locked in the controlled substance cabinet. Additionally, staff did not consistently perform a count of the Schedule II drugs by shift and as additional staff came on duty, so this particular diversion was not discovered until the next day. Following this event and an investigation of the drug diversion and theft, administration leaders responsible for the Medlock Clinic changed their policy to institute and require multiple counts of Schedule II drugs, in addition to monitoring security to ensure the drugs are locked in the secure cabinet after administration. ?4B2.1 t -SG: o U4v i >;--!? <:7 /r , Y V; j<<4 Stand;!!<<: P h t n n a c y Marta ttc meat and Adinhnurmivn of&tug*>: .1/1/ 03.01 01 f.n o-u / $ t n> 4} The class A pharmacy at Garland Clinic serves an enormous volume of patients in the community. The space in the pharmacy is undersized and does not stage the medication preparation area apart from the incoming shipments of drugs. There is a great opportunity for cross contamination between the preparation area and the shipping boxes. The storage bins in the pharmacy are dusty and require a regular cleaning schedule. The supplies impede the 18 inch clearance requirement from the ceiling. The Pharmacy utilizes the Epic Willow software for inpatient pharmacy management and the Cerner Retail and Symphony System for the ambulatory pharmacy management. Epic provides an adequate program for monitoring drug/food interactions. A report is generated in nutritional services which provide alerts that the patient is on a medication that may be impacted by certain foods. The pharmacy system automatically alerts when a drug is ordered for which potential drug/drug interactions exists. Physicians write medication orders for inpatients in Epic. The Parkland leadership stated there are times when the physician overrides the pre-established ranges in the order set, and the Pharmacy does not consistently question/investigate the physician's order on the override to ensure acceptable dosage limits are understood. Documentation is required to track and trend instances where physicians continue to use the override and the justification for such. j 482.25(b) T \G: A-0500. MMOi.Ol.Oi W n s s m c m anti Periom-.atwe improvement; PtJjJ (>! 01 ?i-.Pl) fl j ' G f l ) . QS.HI.Ol Drug Utilization Evaluations (DUE) are in effect but do not include the major patient populations being served as the process excludes neonatal intensive care patients and specific psychiatric patients. The Pharmacy leadership did meet with the Medical Directors of the departments not represented and chose D U E ' s for those areas immediately after this issue was brought to their a t t e n t i o n . ?4S2.2I V.\0 Pi 0.< l(J V ' o LP! i A-02fG Conditions AAAnicipatjon: Quality Assessment ami Performance improvement: 1 iPP It l.i)M.i)i. The Pharmacy stated that there is a limited concern with physicians ordering drugs for other than FDA approved usage or literature supported for off label use. However, not all the drugs being Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 242 prescribed "off label" have gone through the vetting process in the P&T Committee. ?482.21 T>\0 V-0363 Co(#iStMis of Participation: Quality A ^ e ^ m e m aod Pcrformaisec improvement:: Pl.Oi.O! 01 tif i!J 'o>! ?PP h Parkland has a universal formulary for the health system. Restrictions are built into the EMR for the outpatient setting and providers will only see the drugs they can order depending on the setting in which they are practicing. They can still order drugs that are not on the list but they have to take additional steps to access the entire formulary. Compliance with the formulary is described as good to excellent. There is a well-documented drug review for drugs being considered for addition to the formulary. The P&T Committee considers the following elements when they evaluate drugs for the formulary: o o o o o o o o o o o An evaluation of clinical studies A list of other drugs in the therapeutic category A cost comparison of alternate drugs The cost impact of allowing the new drug on the formulary Potential deletions if the drug is added The formal recommendation from the sub-committees that re multi-professional in composition An evaluation of look-alike, sound alike potentials Availability of the medication Training required to add the drug How long the drug has been on the market and the safety profile of the drug Any requirements of special populations -e.g., neonates There are processes in place that assist in controlling drug therapy costs: o o o o There is an automatic generic substitution program for the majority of drugs. There is a policy for single generic equivalents for each drug. There is a policy regarding which doses of each drug will be stocked in the pharmacy. Physicians are required to justify the use of a non-formulary drug. The pharmacy completes a special form regarding this request. The pharmacist contacts each physician when he or she orders a non-formulary drug, and suggests substitutions. Prescribers are not monitored for excessive use of non-formulary drugs. They do, however, look at the drugs being ordered off formulary. o o The current formulary does group drugs into therapeutic categories. The formulary is routinely evaluated for ineffective or obsolete drugs Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 243 The P&T Committee has approved automatic stop orders for certain drugs. All orders are stopped when the patient has surgery. Orders are discontinued when the patient transfers into or out of a specialty unit. The Committee has instituted a policy that limits the duration of prophylactic antibiotic therapy. Therapeutic categories that contain high risk, high volume or expensive drugs are reviewed regularly to reduce therapeutic duplicates and minimize drug therapy problems. Drugs are removed from the formulary if they provide no unique benefit. Xigris (used for sepsis), Factor 7, and other certain drugs are in a restricted drug category as they are either expensive or highly toxic. The ordering and dispensing are tightly controlled. The total cost of a course of therapy is on the antibiogram. However, this has not curtailed their use. The pharmacy is starting a stewardship program to try to reduce the utilization of these medications. All efforts should be made to reduce the utilization of these as first line antibiotics. The P&T committee has established microbial-sensitivity reporting mechanisms that reflect costeffectiveness criteria. The committee reviews the antibiogram yearly. TPN is reviewed for appropriateness and cost. Inappropriate chemotherapy ordering is not a problem at the Hospital. High cost antibiotics are an issue. The Pharmacy does not formally monitor ordering patterns for these items. The restrictions are in the authority level to order these items. There is a policy in place regarding P&T Committee member activities and potential conflicts of interest on an individual basis. There are policies in place regarding appropriate activities of pharmaceutical manufacturer representatives within the organization and pharmaceutical industry sponsorship of presentations within the organization. There are few problems with enforcement of this policy. physician is working. The P&T Committee reviews the documentation on drug administration errors, adverse drug reactions and incompatibilities but these also need to be reported through QCC to the Parkland Board of Managers. anrnv.u. nsiTa: il.il3 ?482.21 1 A G A-0.AG ( omlnita>>; of Pimisipation: Quality Aascx-mcatt ami iNrfoitnanee LD 03. <>/ 01 (Li* JJ 01.01 (hi'h Few drug representatives go directly to the department in which the In addition, the pharmacy utilizes the Institute for Healthcare Improvement tool to validate Parkland Adverse Drug Reaction (ADR) trends against national trends. However, based on a number of adverse patient safety events and upon our further investigation, there is room for improvement in this area. For instance, when two babies had a known adverse reaction to a vaccination, the staff relayed that other babies had the same reaction, but did not know if the event should be reported as an ADR (per discussion with Pharmacy Director). This sequence of events indicates that additional education and training is needed. Even if the reaction is a known Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 244 side effect of the drug, it must be reported. This is not an uncommon theme in hospitals and requires f r e q u e n t r e i n f o r c e m e n t and education. ?4S2J5(bX6) TAG: A-0508. Standard: Delivery of Services: ! L\i>-(Jit'.O i CP -,'.< Clinical Services The clinical pharmacy services have been in place at for a number of years. They have an integrated clinical model and pharmacists routinely round with physicians and are active on the nutritional support team. The Pharmacy and the P&T Committee ensures that the following are part of the clinical program: o o o o o Drug evaluations are conducted to identify problem areas and determine the costeffectiveness of drugs Criteria are developed for evaluating the benefits of all drugs Assessment of the cost of drug therapies Physician education regarding the cost of drug therapy including, but not limited to educational newsletters, grand rounds, and feedback on individual prescribing activity A program for targeted drugs that control the use of expensive and/or toxic drugs that includes criteria for appropriate drug use, daily review of patient profiles for use of targeted drugs, alternatives to the identified drugs, specific follow-up with physicians who prescribe drugs regarding appropriateness o o o o o o o o Pharmacokinetic services on an automatic basis for some drugs and on a requested basis for other drugs There are Pharmacy initiated IV to oral/IM therapies Effectiveness of IV therapy including staff education on a limited basis. Utilization of TPN Utilization of laboratory data to evaluate the efficacy of drug therapy and to anticipate toxicity or adverse effects Pharmacy participation in discharge planning/case management on a limited basis. Pharmacy participation in infection control activities They may utilize comparative performance measures on a regional and national basis, i.e., Lazarus, HBSI, and MedPar data Security and Diversion Precautions There is a diversion prevention program that consists of staff from the Pharmacy, Human Resources, and Parkland Police. One person has sole responsibility to investigate potential drug diversions. Amounts of controlled substances purchased are compared with amounts dispensed on a daily basis. Amounts dispensed are compared with amounts administered and recorded in the patient's chart. The Pharmacy now does a daily manual report on this element and provides information Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 245 on the drug, amount ordered, unit amount taken from Pyxis, amount charted, amount wasted and any discrepancies in any of these line items. The report includes all Pyxis users, not just nurses. Everyone with Pyxis access is on the report. The Pharmacy runs a report weekly on traveling nurses that details the days worked, the doses administered and verifying any outliers. This report is also run for regular staff on a quarterly basis which lists all staff that are more than two standard deviations off the normal standard. A manual log is kept and compared to the computerized log for checks and balances. There is a focus to monitor "street sale potential" drugs. The Pharmacy has developed a team to deal with continual drug shortages and communicate to the Physicians conversion guidelines. There is an internal process to identify and track potential and actual shortages and there have not been many interruptions of service due to these shortages. As noted elsewhere in this report, however, some substitution drugs placed on the crash carts did not match up with the crash cart stocking list when we observed a crash cart audit. Also, as noted above in this report, during the period of our survey there was an incident of theft and diversion of drugs at the Metloclc Adolescent Center because drugs had not been secured and stored as required by Hospital policy and regulatory requirements. Conclusion Although the Parkland Pharmacy Department largely meets the elements of the Medicare CoP related to pharmacy operations, the Pharmacy must be involved with Hospital-wide efforts to: improve medication management, reduce medication errors and ensure that medication errors, adverse drug reactions and all incompatibilities are reported to the Quality of Care Committee (via the P&T Committee) and up through the Parkland Board of Managers. Additionally, specific deficiencies in the areas noted above on - infection control, documentation, QCC reporting, drug utilization evaluations (DUE), tracking off-label use - should be addressed and remediated by the Pharmacy Department. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 246 /Is 3.8.3 Radiology The Parkland Diagnostic Imaging Services includes a comprehensive suite of imaging modalities across the System. In addition to the diagnostic services within the Hospital, there are imaging services available in six of the Community Oriented Primary Care (COPC) sites, a satellite in the Ambulatory Surgery Center (ASC), primarily for the orthopedic clinic, and a mobile mammography van to supplement the Breast Center for screening mammography and community outreach. There is dedicated a Computed Tomography (CT) and a diagnostic x-ray room for the Emergency Department. Services are provided at multiple locations throughout the Hospital. The equipment profile demonstrates that the Hospital has funded current technology. The Department has four diagnostic rooms and a chest room. They also have four fluoroscopy suites. The ED has a diagnostic room and a 64 slice CT. The ASC has two diagnostic rooms, three C-arms and two portable units. MRI has four magnets at the Hospital. Three are 1.5 Teslas and one is a 3.0 Tesla. One of the magnets has a larger bore (70 cm) so it approximates a more "open" field. One of the units can accommodate bariatric patients up to 500 pounds. They have a large bore 1.5 Tesla at the Breast Center. They have purchased Siemens and GE magnets. CT has four units in the main department. Currently they have three Toshiba 64-slice units and a 16-slice GE LiteSpeed. They have one open room. This room is being modified to accommodate a Philips 256 slice instrument. Once it is installed, they will replace the 16 slice instrument with another 256 slice unit. Nuclear Medicine has three SPECT CT units, a DEXA scanner, a dual head unit and a thyroid uptake unit. The Hospital also has two units in Cardiology, both are dual head units but one is a Spectrum Dynamics E-SPECT which speeds up the scanning time from 45 minutes to 10 minutes. Ultrasound (US) has eight rooms. One is dedicated to sonography/vascular and a second unit is dedicated to sonography/biopsies. They have a portable US for Neonatal Intensive Care Unit (NNICU). Interventional Radiology has one BiPlane and two single plane rooms and two sonography rooms. Mammography has four digital diagnostic towers, two sonography rooms, one core biopsy room and a mobile van with a digital tower. Each of the COPC clinics has one diagnostic room (Bluitt, East Dallas, Deharo, Irving, Garland and Southeast). Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant to Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. 247 Nursing supports multiple areas in Diagnostic Imaging. Nursing support is provided 24 hours a day, seven days a week. One nurse is on call on the night shift to provide additional support if needed. In addition to the RN's, there is one Nurse Practitioner who supports the Department. The nursing staff provide support for interventional radiology (3 RN's), any biopsy location (1 RN), and MRI (1 RN 24 hours/day). In CT a processing station and three IV stations are staffed. The nurses perform intake for all CT patients and order laboratory tests and hydration per protocol. Of note, CT will be drawing and processing Point of Care testing for Creatinine to reduce the turn-around times in the very near future. The nurses in the IV stations start the IV's or place the capped IV for the procedure. Nursing staffs an 8-bay (soon to be 11-bay) preparation and recovery area and provides Phase II post anesthesia care. They adhere to American Society of PeriAnesthesia Nurses (ASPAN) guidelines. When there is an anesthesia case, the anesthesia provider remains with the patient until they are extubated and appropriate for the level of recovery provided in this unit. Anesthesia and Respiratory Therapy transfer all patients that are to remain intubated directly to the lCU. All nurses are Advanced Cardiac Life Support (ACLS) certified. Staffing is on a 1:4 nurse to patient ratio, which is appropriate for the activities. All nurses certified in the Department are certified to attend moderate sedation. It was stated that they are following the rules for moderate sedation and do not perform any other activities except the administration of the medications and monitoring of the patients during the procedure. The Radiologists read the images throughout the day and dictate their impressions. The Department is staffed with both Faculty and Residents/Fellows. Radiology Residents are present in the Department 24 hours per day. A Faculty member is on call if needed after hours. The Emergency Department (ED) Physicians do preliminary readings of ultrasounds and the Radiologists perform confirmatory reading of these images. The radiology information system (RIS) is Epic Radiant and Picture Archival and the Communication System (PACS) is McKesson. The system can customize reading lists for the reading physician. The viewer for the referring physician has not been well received. Philips iSite has been supplemented for the referring physicians so they can get better views. The Radiology Department only rarely has to retrieve old films as they have had PACS for eight years. The only studies they may need to pull are old comparative mammography films. They digitize any films if they are brought over from Iron Mountain and destroy the old files - except for mammography films which must be retained for 21 years in original form. The Department schedules all their own exams utilizing the Epic Cadence system. Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 248 Transcription is 100% voice recognition. The reports are filed in the PACS and in the EMR. There is daily follow-up with patients regarding the need for further examinations. Follow-up is conducted physician to physician with the ordering physician contacting the patient. Imaging protocols have been built into the Hospital's electronic medical record system, Epic. When a physician orders a radiology procedure, Epic automatically defaults to a screen that affirms the use of the imaging protocol as established for the study. Physicians are not compelled to make a cognitive decision to change their own orders. Because of this process, radiology staff members can and do change physicians' orders and then use the order set protocol without an order to change. Physicians must approve the use of the protocol and cancel the original order. Failure to obtain a change of the physician order results in non-compliance with the COP. S4'S2.24(c};Ji: 1 SO A-'0406. JriSfMW.O/ (?P Lh. Bone Densitometry Bone density is offered on the Hospital campus. It was previously located at the Breast Center, where space was constrained. Waiting times for routine appointments times for the last 13 months have been a low of two days to a high of four days with the average being 2.44 days. Ultrasound A full range of non-cardiac ultrasound (US) services is currently available in the Hospital. US guided core breast biopsies are performed at the Breast Center. US services are also provided in the OB/GY1M Clinic of WISH. Diagnostic Imaging does not oversee the US services at WISH. The Department is staffed 24 hours a day, seven days a week. Residents read throughout the Lengthy wait times may be resulting in the delay of treatment. Overall for the service the waiting time for an appointment averaged 16 days for the last 13 months. $482.2(>(a) Tag A-0529 a -aaLui: Radioloaic Services Ultrasound Waiting Time Study Renal, Venus and Doppler US of the Pelvis US of the Abdomen US Biopsies Overall Waiting times Low 0 5 8 11 High 2 39 45 32 Average 0.85 21.38 22.85 19.05 16 Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 249 Mammography Services include both screening and diagnostic mammograms at the Breast Center. The Department performs stereotactic biopsies with a core table. They perform the needle localizations prior to Operating Room (OR) excisional biopsies. The patient is discharged from the Breast Center and travels in a Parkland campus shuttle bus back to the Hospital or ASC and registers again for seed placement and further surgery. The service is staffed from 7:30 to 16:30, Monday through Friday. There are occasional weekend hours to provide additional capacity for screenings. Waiting times for routine appointments are tracked by type of service. For screening mammography the range of waiting times for the last 13 months has been a low of 2 days and a high of 143 days with an average of 39.6 days. The Director and Manager stated that they have corrected the contributing factors for the lengthy waiting times for screening mammography. This is validated by the data for waiting times for the last three months (6, 3 and 2 days respectively). Delays in diagnostic mammography may contribute to a delay in treatment. iatS2.26{a> l a g A - 0 5 2 << . W . O l O J . O ! ( W h Mammography Waiting Time Study Diagnostic Mammography Low 29 High 102 Average 72.9 General Radiology General, fluoroscopy, interventional, mobile and intra-operative services are provided by the main Radiology Department 24 hours per day/365 days per year. The service covers all patient types: inpatient, outpatient, and Emergency Department patients. Waiting times for routine appointments for fluoroscopy services are tracked by type of service. Fluoroscopy Studies Waiting Time (in Days) Low High Study Intravenous Pyelogram (IVP) Barium Enema, Upper GI, Barium Swallow *13 m o n t h period d a t a Average 6.55 6.77 3 1 19 18 It is important during any radiology procedures completed that there be consistency in practice based on Hospital policy in patient management and in the use of protective gear for staff safety. Variance in practice was noted in the Operating Room when the mini-fluoroscopy unit was used. Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to A\t Some of the OR staff and physicians were not wearing protective X-ray attire. There was a failure to meet Parkland Policy G - l . This failure of not using appropriate personal protective equipment was primarily a result of misinformed staff and unawareness of the Parkland policy. The failure also is a result of the radiology staff not enforcing the requirements of personal protective equipment for mini fluoroscopy. In the fluoroscopy procedure, CoP standards related to safety were not met. .26 ib) CD I AC: A <<534. 33' 0 J l>kVJ ) Open dressings not used during a procedure were left on an anesthesia cart after a procedure. After IR procedures, open dressings must be disposed of regardless of whether the dressings are used. :Gl! '41. I G: tC'.'i OS f | a P G During procedures in the Interventional Radiology Department, it was observed that medication labeling was not properly performed in various patient care situations. In one case, the RN failed to date medications drawn up in syringes for administration during the procedure. This Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 252 inaccurate labeling of the syringe is a failure to follow Parkland Policy NSG 20-01. The inaccurate labeling also violates PHR-D-003, Medication Vials or Ampoules Use by Nursing & Pharmacy. SPSd.oi.Gj.oi iPP /, J. o/, 5, 6 ,G.An IR technician was observed drawing up a medication for the sterile field. The tech communicated audibly but did not visually show the physician the vial of medication that was being placed in the sterile cup on the sterile field. This is a failure to follow the Parkland Policy PS 04-33. "2. Dispense the Medication onto the Sterile Field." Additionally, the physician drew up the medication in an unlabeled syringe. All medications that are removed from their original container and not immediately administered must be labeled with medication name, strength and date. SPSG OS.04.01 (P.P E 2. 3. -t. 3. 6, Sj. The Time Out procedure is an important protocol to ensure that the correct procedures are being performed in the right site on the correct patient. As a part of the procedure, all core team members of the procedure team are expected to participate in the process immediately before the procedure. The team conducted the Time Out outside the procedure room. The Attending Physician noted that the A&M consultant did not witness the Time Out procedure and offered to repeat the Time Out. The second Time Out was conducted in the procedure room. During this Time Out procedure, the patient's procedure consent was not used as one of the two identifiers. There was a failure to follow Parkland Policy Admin 6-30 Universal Protocol. A Time Out is performed before the procedure commences however it should be done in the procedure room immediately before the procedure. XPSO.OI.iH.Oi. Use of two patient identifiers when providing care, treatment and services. UM . It was observed that the Preoperative and Recovery staff are ordering trays for patients in bulk and re-thermalizing them for patients when they were ready to eat again. The food needs to be served immediately to avoid bacterial growth. Radiology Statistics and Staffing Studies Diagnostic Radiology Ultrasound MRI Invasive Radiology CT Nuclear Medicine Mammography Administration and Support Nursing 2011 Actual *A >> Staff (Paid FTE's) 65.2 17.6 22.3 7.2 27.8 9.1 19.1 29.8 21.4 Worked Hours/Test 0.61 0.97 2.19 1.35 0.64 2.03 0.64 197,911 33,677 18,872 8,883 80,634 8,302 54,629 Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 253 A & M Quality Assessment and Performance Improvement (QAPI") The Department does have some departmental indicators, primarily surrounding radiation safety. The Radiation Safety Committee determines which staff will be required to wear badges to monitor radiation exposure. The Director stated that there are no staff members nearing maximum thresholds. The Diagnostic Department and Nuclear Medicine need to expand and incorporate their quality program into the hospital-wide QAPI program. ?4821(1-HI xiij. SAG: .4-0285. pfjsi.Oi 01 (LP li Pl.O-'l 0-1 01 iJJ'l, J) Conclusion Although the Parkland Radiology Department meets many of the elements of the Medicare CoP related to radiology operations, they must address and remediate the specific deficiencies noted above including: o o o o o o o Physician orders for imaging services. Wait times for some services, such as ultrasound and mammography. Use of protective equipment by staff. Staff credentialing for certain procedures. Infection control. Securing and properly dispensing drugs during procedures. Developing department-based QAPI indicators and plans. Confidential for investigation and review by quality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information or designated agent(s). Pursuant is confidential and privileged. to 254 3.8.4 Respiratory Therapy Respiratory Care provides service 24 hours a day, seven days a week to all inpatient areas of the Hospital as well as the Emergency Services. The Respiratory Care Department reports administratively to clinical support services. Respiratory Care staff participates in teaching at University of Texas Southwestern Medical Center (UTSW). Staffing consists of licensed Respiratory Care practitioners and pulmonary technicians. Equipment/transport technicians and clerical staff act in the capacity of support personnel. In reviewing a three-month period of patient safety reports, Respiratory Care represented 6.4% or 163 occurrences. Of these occurrences, 72% were missed treatments with the primary reason of "respiratory therapy too busy" or "therapist was unavailable". The Department must develop mechanisms to increase its staff flexibility in order to respond to changes in Department workload and to reduce and eliminate incidences of patients not receiving required respiratory therapy treatment on a timely basis. o''. i u", *-s!.-: /. > a ; ( i j * 3 , Staffing levels within the Department have been reviewed internally by the Operational Excellence Department. In response to A & M ' s preliminary findings on respiratory therapy, which were shared with the Department, the Department has proposed increasing staff flexibility through the hiring of a Respiratory Care practitioner to serve as a "floater" so that surges in workload can be better managed. The addition of an equipment technician was also recommended by the Department in order to provide more direct patient care time for the practitioners. Lastly, the Hospital's Operational Excellence Department has recommended that allocation of staff between shifts should also be reviewed. We will continue to review the Department's efforts to respond to changing workloads and to ensure that patients receive therapy on a timely basis. Patient Care The CMS survey in August 2011 found a deficiency related to a used nebulizer that had not been removed from an Emergency Department (ED) room. As a corrective action to the deficiency, the Department now requires the respiratory therapist to remain with the patient until the treatment is complete so they may immediately dispose of the equipment. Our review did not reveal any new incidents of this nature during observations performed in the ED. Disposable equipment and supplies in the ED were observed without proper labeling. The patient's name, date, time of day, and dosage were not labeled on a used medication nebulizer. ypsa 0104.011/J' 3). As of this writing, the Respiratory Therapist assigned to the ED was instructed to label each medication used as outlined above, however, we have not validated that this change in procedure is being adhered to. Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant to is confidential and privileged. 255 A&M reviewed medical records of several patients to determine appropriate patient care and proper documentation. The chart review showed documentation inconsistencies relating to key elements in documenting responses to treatment. G;82.?7(b)fd)'TAG \-l 164. R< 'Ji2.0l.tU (HP lh Examples of documentation inconsistencies included: o In one case, the tidal volume of a patient had dropped from 1600-to-800 over three treatments but there was no documentation of any physician contact or attempts to address the 50% drop with appropriate follow up. Documentation was inconsistent in recording key vital signs pre and post treatment as well as observations and professional assessments related to treatments being administered. Patients' ongoing progress and response to medications and treatments were also not documented on a consistent basis. o o In reviewing this finding on documentation errors with key leaders in the Respiratory Care Department, leadership concurred that documentation improvement is needed. The survey team recommended that the Department should provide additional education for proper documentation. Additionally we recommended the implementation of an audit process to review charts for adequate documentation. Management has reported that an educational document has been developed, but there is no evidence that an audit procedure has been implemented. The educational materials have not been verified by the survey team. Environment of Care. Safety and Infection Control One of the most significant issues, which was identified as a house-wide issue, was the storage of full and empty oxygen tanks, primarily on the medical-surgical nursing units. On our initial surveys, oxygen tanks were inappropriately stored throughout the Hospital. Tanks were propped against doors and walls within nursing units, stored in combustible areas, and not placed in properly labeled holders. 482.4 l(t>>{l) (i). Tag -07 i 0 Standard: i.iffe Safely from Fire Following our survey findings on the tank storage, the Department surveyed all areas that use oxygen to determine proper storage needs. The Department ordered 30 holding tank racks that will be deployed to a specific location at each nursing station that currently does not have a storage area. The Department said they would be labeling and designating tanks as full or empty. The Respiratory Care Department, in conjunction with Nursing Services, has removed all empty tanks from the nursing units and now has a complete current inventory. The Executive Vice President and Chief of Hospital Operations has also issued a house-wide communication which has greatly increased awareness and responsibility to secure loose oxygen tanks in a spirit of cooperation and patient safety between Respiratory Care and Nursing. We will continue to monitor adherence to these new procedures and whether on subsequent rounding whether all oxygen tanks are properly stored and labeled. Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 256 As part of our survey, we reviewed the cleaning and storage process for equipment. Supplies and equipment were checked and equipment and supplies in the inventory were found to be current. There was no temperature gauge found in the cleaning solution to assure that it was at or above the manufacturer's recommended temperature range for proper cleaning. As of this writing, the Department has a portable electronic thermometer and log in place to assure the cleaning solution is at 68 degrees or higher, meeting the manufacturer's specifications. Upon resurvey, the new practice was observed and the temperature reading on December 21, 2011 was within manufacturer's recommendations. Medication Management We reviewed the Department's policy regarding timely delivery of medication administration orders primarily regarding the "30 minute rule" in which treatments must be completed within 30 minutes after the ordered time. During the course of this audit CMS issued reference S&G-1205 Hospital regarding 42 CFR 482.23(c) on November 18, 2011, and removed the reference to the "30 minute rule" which had established a uniform window before or after the scheduled time for all scheduled medication administration. In response to this change, the Respiratory Department updated policy RC P-2A, WD 07-2011, RD 12-2011 and now slates that, with regards to stat orders received, "medication will be administered within an hour after the medication is available in the patient care area. " Future rounds by A&Mduring the Action Plan period will continue to validate whether this policy update is being honored in practice. The Hospital is also in the process of adopting and updating its medication administration policies and procedures to take into account the nature of the prescribed medication, specific clinical applications, and overall patient needs. The policy should also identify those medications which require exact or precise timing of administration, and those medications which are not eligible for scheduled dosing times. For medications that are eligible for scheduled dosing times, the Hospital will distinguish between those that are time-critical, and those that are not, and establish the new medication administration policy governing timing accordingly. Physician Oversight General medical oversight of the respiratory care services is provided by the designated Medical Director. The Medical Director appears to be actively engaged in medical oversight in the Respiratory Care Department and provides input on: capital expenditures, policy review, staffing, QAPI, and clinical research, particularly with regards to spontaneous breathing testing protocols and decreasing ventilator days inside the Hospital. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. to 257 A & M Conclusion The Respiratory Care Department is not in compliance with all of the relevant Conditions of Participation. Areas o f deficiency include: o o o o o Staffing levels, skill mix, and staff allocation Timeliness o f care Clinical documentation Infection control and environment of care Medication management Quality assurance reviews should be put in place to review compliance with treatment completion and the supporting documentation of the patient's response to the prescribed treatment, both short term and over the course of the hospital stay. Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and Pursuant to privileged. 258 3.8.5 Food and Nutrition Services The Nutrition Services Department provides clinical and full food production services for Hospital patients, visitors, and staff. Nutrition Services has two main components: production and clinical. Production Production includes patient and cafeteria food preparation, tray assembly, tray delivery to the patient, preparation of nourishments and dietary supplements, cafeteria service, special event catering, and sanitation. A conventional cook/serve production system is in use. While some convenience items are used and prepared, vegetables (peeled and sliced) are purchased and the operations manager estimates that the majority of the items are prepared from scratch. The patient meals are on a one week menu cycle and the cafeteria is on a three week cycle. The Department also operates a snack shop that is located in the Cafeteria on a "grab and go" basis. Clinical Support Clinical support includes the Diet Office and the Registered Dieticians (RD). The Hospital has the CompNutrition System. The service employs a significant number of Registered Dieticians as opposed to a mixture of Diet Technicians and RD's. The screening tool for dietaiy consultation contained in the EPIC system is appropriate. However, the majority of the Hospital's patients are referred for consultation by the nursing units. This places an unusual load on the RD. Only those patients who need a consultation should be referred. Nursing should be educated to fill in the screening accurately and only refer those patients in need of a consultation. The majority of the RD's time is spent on the nursing units, in the clinic operations and on the nutritional support team. The clinical services support the nutritional screening and assessment process and the tube feeding/supplement programs. The clinical services collaborate with Pharmacy on Total Parenteral Nutrition. Facilities The main facilities of the Department (production, cafeteria, Snack Shop, and offices) are located on the first floor of the Hospital. The space and equipment are in generally good physical condition. The production area is adequately sized, well laid out, efficiently organized, and maintained to a satisfactory level of sanitation (observed sanitation procedures during the review). The area is Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. to 259 /Is well designed and equipped. The production area is more than adequate to support the Hospital activity and related volume of meals. The storage areas (both cold and dry) and the walk-in refrigerators and freezers were appropriately sized, clean, and well organized. Storage is on both permanent and moveable shelving. There is a combination of gravity feed and regular storage racks in the storeroom. The department has a conveniently located loading dock. Department staff receives the products and transport the orders to the appropriate storage location. basis, with local vendors. The tray delivery system is both a gel pellet system and a hot/cold tray system. The department is converting all trays to the hot/cold system as funding allows. The dish machine is in good working condition. An automatic injection system is utilized to add cleaning chemicals to the dish machine. Dietary staff delivers trays to the patients. Nursing staff retrieve the trays after the patient has eaten and places them in the transport vehicles. It was observed during the review that patient trays were left in the pantry for future use. The trays were not refrigerated. When queried, the staff of the nursing units stated that they re-thermal ize these trays. This practice is not compliant with the CoP. ?482,42 'TAG A-0747. Nutritional services are responsible for monitoring the patient refrigerator temperatures. EVS is responsible for cleaning of the refrigerators. On rounds, it was observed that the temperatures were being monitored appropriately. However, many of the freezers were not monitored. ?481.42 TAG A-0747. The Department is linked electronically with its prime vendor. Food is purchased under a GPO contract and, on a limited The pantry area is stocked by dietary and cleaned by EVS. On rounds, it was observed that both patient food and staff food were stored in ihe same pantry areas. In addition, most of the pantry areas needed to be cleaned. ;Hi:G !o?. I Conclusion Overall, the production and clinical functions of the Department are in compliance with the CMS COP ?482.28 Condition of Participation: Food and Dietetic Services. The areas of nonc o m p l i a n c e a r e f o u n d in C o P - ?48.7.42 T a u A - 0 7 4 7 C o n d i t i o n o f Participation: Infection Control a n d t h e A-074'/ Texas Administrative Code. The Department should cease re-thermalizing trays and should address the other cited infection control issues. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. to 260 3.8.6 Contract Services Parkland engages 711 vendors to provide clinical services directly or indirectly to patients. The contracts not addressed in our review included the following contract types: Employee Benefits, Benefits Analysis (BA), NDA/Confidentiality, Nurse Residencies, Hospitality, HR Search, HR Support, and any contracts related to medical staff credentialing such as reading x-rays in the jail, as these activities require credentialing and privileging. Of the vendor list reviewed, ten contracts were selected for a more thorough review. Areas selected varied from the contract for management of EVS, to clinical services such as vascular technician services. We reviewed a sample of ten contracts for content and compliance with the Conditions of Participation. The contracts were reviewed and the end user departments were interviewed regarding quality data provided by the contracted entity and the internally generated quality monitors against which the services were evaluated. All of the reviewed contracts were written in a manner that met the requirements of the CoP. All reviewed contracts contain a provision for the contracted entity to provide quality monitoring and data to the organization on a regular basis. However, many of the end user departments are either not requesting the data, not receiving the data, or are not reporting the data through the QAPI process. In addition, few of the departments have their own department based indicators that are different than those being provided by the contracted service against which they monitor the quality of the service. We noted in one contract that while the Laboratory monitors all of the required elements for quality as defined by the vendor contract, the lab did not have an internal monitor such as turnaround time against which they monitor their performance. Unless a monitor against which the Hospital evaluates contractual and internal performance for each contract (TAT, missed diagnosis, etc.) is initiated as well, they will not meet the full intent of the CoP standard. In addition, both the contractor supplied quality results and the internal monitoring results should flow through the QAPI - process to the Board of Managers and appropriate BOM committees. These quality results should be utilized by the Medical Staff to evaluate and recommend retention or discontinuation of contracted services. Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 261 A M & Conclusion Overall, the contracted services contracts were well written with clear scopes of services, quality metrics and contractor and Hospital responsibilities. The Hospital is not monitoring the contract independently of the quality metrics provided by the contractor (when provided) In addition, the Medical Staff is not considering the Hospital monitors when making recommendations to the governing body, in Parkland's case its Board of Managers, on the retention or discontinuance of the contract. Until the Hospital and BOM consistently monitors all of these contracts for quality of service and documents such monitoring efforts, the Hospital will not be in compliance with the CoP on outsourced and contracted services. Additionally, all of the departments will need to develop these indicators and report the results through the QAPI process. This gap does not represent a failure to include the correct quality elements in the contract itself, but instead it is the monitoring that the Hospital puts in place that needs to be addressed so that both contractual and any other issues the department wishes to monitor are in sync. Until this is accomplished, the organization will remain out of compliance. ?482.1die). M O : A-008.C W 01."li(C) lF.F \ A /. .A: ? W 2 , ! 2 p c H I). I A G ; A - 0 0 S 4 S t a n d a r d : C o n t r a c t e d S e t v i c e s . Confidential for investigation and review by quality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information or designated agent(s). Pursuant is confidential and privileged. to 262 3.8.7 Organ and Tissue The Organ, Tissue, and Eye Procurement service serves only Parkland patients.. Organs and tissue are recovered from donors at Parkland, but transplant is limited to kidneys at this time. Only the procurement portions of the service will be discussed in this report. The Hospital contracts with Southwest Transplant Alliance (Organ Procurement Organization (OPO) for procurement and the University of Texas (UT) for allograft tissue supply. The contracts meet the CoP requirements. The results with Southwest Transplant Alliance have been a 75% conversion rate (January November 2011) based on 16 eligible referrals. This conversion rate has decreased from 2010 (84.6%) based on 26 eligible referrals. One contributing factor may be that a new Level I Trauma Center opened in 20 11 in Piano. The average organs procured per donor at Parkland is 3.23 and transplanted per donor is 3.15. There were 5 hearts, 22 kidneys, 10 livers, 4 lungs and one pancreas recovered in CYTD 2011. Only one organ was discarded (kidney). The Organ and Tissue Procurement policies and procedures meet the requirements of the OPO and UT contract and the CMS CoP. However, the Hospital's governing body, the Board of Managers (BOM), has not formally approved the policies and procedures. Until this is accomplished the organization is out of compliance with the COP ?4<< :.45ta.xn r.\G: A-0R86. The Hospital has a partial QAP1 mechanism in place to ensure that the families of all potential donors are informed of their options to donate organs, tissues, or eyes, or to decline to donate. This issue is discussed in the Organ Collaborative Committee (OCC), but the results of the evaluation are not taken through the OCC committee and therefore are not reported to the BOM. ?482.45(ftX3) TAG: A-088S. Only designated requestors can approach the family to inquire about organ donation. In the majority of the cases this is a representative from Southwest Transplant Alliance. A designated requestor is an individual who has completed a course offered or approved by the OPO that has been designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation. As part of the contract monitoring, Parkland should have a copy of the training program and records or a listing from the Southwest Transplant Alliance or UT stating that the persons identified as the designated requestors have completed this training program and the program specifically addresses the use of discretion. The Hospital does not have a copy of the OPO or UT training program content to verify that this element is in compliance The Hospital has requested this i n f o r m a t i o n . ?4t;2.4ofy}i4} FAG: 12;c). 1AG: A-OtJ&i Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to The Department has mechanisms in place to ensure that all appropriate staff have attended an educational program regarding donation issues and are knowledgeable in working with the OPO, tissue bank, and eye bank. The records documenting the various educational and training sessions do not indicate that the education provided was mandatory for what specific groups, i.e., if the education is mandatory for R N ' s but not for patient techs or unit secretaries. As the sign in sheets include all categories of staff (both on-line sheets and paper sheets) it might be interpreted that not everyone who was supposed to complete the training had done so. Therefore, the sheet should identify this clearly on the "completed" list. The Department's policies and procedures on record-keeping indicate the mechanisms to ensure that all required individuals have received the training. The Department needs to be able to produce irrefutable documentation of the execution of this policy. Until this documentation can be provided, they will not be in compliance with the CoP. :;482ai5!3>i5). T\G: A-0891. The Hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues. Death records are reviewed to improve identification of potential donors and maintain potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place. The effectiveness of protocols and policies is monitored as part of the Hospital's QAPI. The results of the Organ Collaborative Committee are only taken to the Critical Care Committee. These results are not routed through QCC. i;48_\1.Ma;f5> f \u: a-0891. In addition, as these evaluations are part of the Hospital's QAPI process, the proceedings must be confidential. The confidentiality of the actions of this committee is not assured. The minutes do not indicate that the discussions are protected information used for Quality Improvement. The kidney transplant service was surveyed by CMS in 2010 and U N O S in July 2011. Deficiencies were cited by U N O S related to verifying blood type and compatibility between donor and recipient. A Plan of Correction (POC) has been prepared and submitted to UNOS. The POC was reviewed and as of this date, the Director stated that this has been implemented. Therefore the organization should be in compliance with CMS CoP ? 182.45(b)Standard: Oryan Transplant;< 2).. Chart entries may be made by "smart scripts" embedded in Epic. The physicians are utilizing this primarily for Resident supervision attestation. The physician is actually going into the Resident's note with these scripts so it does not have a unique authentication date and time. Other clinical staff have their own scripts. These are not vetted for appropriateness and can be changed even if "approved" as originally written. The practitioner must have a computer generated authentication or utilize the actual date and time on the computer in the note so that it reflects actual date and time. The Hospital's Compliance Department is reviewing the scripting to determine if additional authentication is required in the current Epic configuration. ?<>'AO: A - 0 4 6 7 . RCAl Hf 01 .7.7' ? ! Epic has been the EMR for the Emergency Department since 2007, the community clinics since 2009, the inpatient areas since late 2009 and the specialty clinics since the fall of 2009. The findings related to omissions should not be related to the utilization or user friendliness of the EMR. Conclusion Overall, the HIM department is functioning in an effective manner. The deficiencies observed are based on the actions of personnel outside the HIM department or a potential deficiency in the EMR format. However, the CoP deficiencies noted related to proper and complete chart documentation - which were noted in other areas of this report as well -- must be addressed on a house-wide basis among Physicians, Residents, nursing and other care staff. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant Section 160.007 of Texas Occupations Code and 72 USC 11ItiIet. set/., this information is confidential and privileged. to 268 Conclusion, Next Steps and Action Plan Submission Although this report is perhaps longer and more detailed than many anticipated it would be when we accepted our assignment under the Systems Improvement Agreement (SIA), we hope that it sets the fact base for understanding the current situation at Parkland Health & Hospital System. With this report and its findings in hand all of Parkland's constituents - patients, employees, medical staff, board members, government regulators and residents of Dallas County - can be fully informed on the current conditions at Parkland and understand the steps that need to be taken, not only to bring Parkland back into full compliance with all of the Medicare Conditions of Participation (CoP), but to improve significantly the quality of care experienced by every patient who comes to Parkland. We appreciate the assistance and support we have received from so many Parkland employees and physicians and the time they have spent with us over the last few months. And we thank the Parkland Board of Managers (BOM) for giving us broad access to all of Parkland's facilities and employees. Our report has identified critical gaps in many areas of Parkland's compliance with the Medicare Conditions of Participation including serious problems with: o o o o o o o o o o o Timeliness and quality of patient care Patient rights and patient safety " H a n d - o f f ' and continuity of patient care Role and organizational structure of nursing and nursing practice Case management and discharge planning Infection prevention and control Medication management Supervision of Medical Residents Emergency medical treatment, particularly psychiatric emergency treatment Quality Assessment and Performance Improvement (QAPI) functions; and Progressive discipline and accountability. These gaps put all of Parkland's patients at significant risk and could easily lead to a situation likely to cause serious injury, harm, impairment or death to a patient. Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to Our survey found that Parkland failed or had deficiencies in multiple Medicare Conditions of Participation. Significant deficiencies exist in the following CoP: o 42 CFR ? 482.13 - Patient Rights o o 42 CFR ? 482.13(c) - Privacy and Safety 42 CFR ? 482.13(e) - Restraint or Seclusion A 42 CFR ? 482.21 - Quality Assessment and Performance Improvement Programs 42 CFR ? 482.13.22 - Medical Staff o (Conduct of Ongoing Professional Practicc Evaluation (OPPE)) 42 CFR ? 482.23 - Nursing Services 42 CFR ? 482.25 - Pharmaceutical Services 42 CFR ? 482.30 - Utilization Review 42 CFR ? 482.41 - Physical Environment 42 CFR ? 482.42 - Infection Control 42 CFR ? 482.43 - Discharge Planning 42 CFR ? 482.55 - Emergency Services 42 CFR ? 489.20 - Emergency Medical Treatment and Active Labor Act (EMTALA) Deficiencies were also noted in the following COP; 42 CFR ? 482.12 - Governing Body 42 CFR ? 482.26 - Radiologic Services 42 CFR ? 482.27 - Laboratory Services 42 CFR ? 482.51 - Surgical Services 42 CFR ? 482.54 - Outpatient Services 42 CFR ? 482.56 - Rehabilitation Services 42 CFR ? 482.57 - Respiratory Care Services The number of deficiencies found creates overall concerns about the safety of the care environment at Parkland. If the deficiencies catalogued in this report are not addressed and fixed, Parkland could not pass a CMS hospital survey and would not continue as a Medicare and Medicaid participating hospital. And if these deficiencies are not addressed timely and effectively, "trigger events" that could result in significant patient harm will likely continue to occur. In reviewing the current situation at Parkland, Dallas County Judge Clay Jenkins has said: "Parkland can be a great hospital, but before it can be a great hospital it must be a safe hospital." We agree. "Safety First" must become the bywords for every member of Parkland's staff and be embedded into the organization's culture. Confidential for investigation and review by finality assurance/improvement committees or designated agent(s). Pursuant Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information is confidential and privileged. to 270 The next step in this process under the SIA will be our submission of an Action Plan to CMS, which will identify specific actions that must be taken, including milestones, and which should lead to substantial compliance with all of the Medicare Conditions of Participation for acute care hospitals and full compliance with all EMTALA requirements As we draft this Action Plan, we will continue to meet with Parkland's Board of Managers, senior leadership team, employees and physicians to obtain feedback on this report in order to craft an Action Plan that every Parkland associate can stand behind and support. Making Parkland a place for safe, effective and quality patient care will be the touchstone of the Action Plan we propose. The Action Plan will require commitment, effort and dedication from the B O M and leadership team, physicians, all of the employees of the Parkland System and to some extent, the community at large. The most significant change required is in the level of individual accountability and commitment to quality and safety. There is no doubt that there is a strong commitment to patient care, but the individualized attention and compassion needs to return to Parkland's care model. The change will require a fundamental restructuring of Hospital organization, leadership, policy and procedure, process and work flow, and metrics for monitoring performance and compliance. Strategic and operational issues related to access and throughput will need to be addressed to ensure the patients are able to access and receive timely care in the right setting. Models of care delivery will need to be streamlined so that the individualized plan of care and compassion can be maintained in fast paced, high volume care settings such as Emergency Services and some already taxed outpatient and ambulatory services. Some people may be asked to take on more and/or different tasks, roles or assignments. Some may decide they are equipped for the change in accountability, some may decide to leave of their own accord, and some may be challenged to meet the requirements of the new culture and standards. But, everyone must be held accountable to ensuring a safe environment and providing high quality patient care. The BOM and Hospital leadership will need to commit to providing the resources, education and support for this operational and cultural "turnaround". The changes and corrective work necessary to restore Parkland's status with all of its regulators - and with all of its patients and the public - is dependent upon the work of all of the people of Parkland. The work necessary to fix Parkland cannot be accomplished by a single department or just a few Parkland staff members. Everyone must be involved and all must take ownership. In two years Parkland hopes to make only its second move in its history to a new hospital facility. While this will be yet another significant achievement in Parkland's history and another demonstration of faith in public health care by the citizens of Dallas County, Parkland's future achievements should not be bound alone by bricks and mortar. For a hospital is not just bricks Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to and mortar. As this report lias hopefully demonstrated with vignettes of actual patient care experiences, fundamentally, hospitals are people. "People whose education and training are sound. perceptive. People whose actions are. deliberate People whose judgment is calm and and definitive. Our pride is not that we were swept up by tlte whirlwind of tragic history, but that when vcc were, we were not found wanting. " Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant to is confidential and privileged. 272 At APPENDIX Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 273 M fi Independent Consultative Expert (ICE) Members and Backgrounds Peter Urbanowicz is a Managing Director with Alvarez and Marsal Healthcare Industry Group in Washington, D.C. He leads the firm's healthcare compliance practice. Formerly Deputy General Counsel of the United States Department of Health and Human Services and later Executive Vice President and General Counsel of Tenet Healthcare Corporation (NYSE: THC), Mr. Urbanowicz has over 20 years of experience in addressing challenging healthcare issues in government and private industry. Mr. Urbanowicz received his Bachelor of Arts and Juris Doctor Degrees from Tulane University. He is admitted to the bars of the District of Columbia, the United States Supreme Court and the Louisiana Supreme Court and is a member of the American Law Institute. Kathleen Murphy is a Managing Director with Alvarez and Marsal and leads the Healthcare Industry Group's process improvement practice. She has a background in Human Resources and Organizational Development, which has provided a foundation for consulting in the areas of effective organizational design, deployment of human capital, and staffing models. Her experience includes: assessments and implementation of performance improvement projects for Emergency Services, Periopcrative/Surgical Services, Ancillary and Support Services Departments in hospitals as well as Ambulatory Surgery Centers and Imaging Centers. Ms. Murphy received her Bachelor's Degree in Human Resources from the State University of New York at Old Westbury. Diane Rafferty is a Senior Director with Alvarez and Marsal Healthcare Industry Group. She previously served as the Executive Vice President/Chief Administrative Officer for Brotman Medical Center, which she joined while the facility was in Chapter 11 restructuring. While responsible for day-to-day operations, her leadership, direction and strategic initiative improved overall operational performance, helped restructure operations, provided cost effective care, and produced positive margins over a 12-month period. She previously served as a Surveyor/Clinical Investigator with The Joint Commission; CEO of San Ramon Regional Medical Center/Tenet Healthcare; an independent consultant providing expertise on compliance, medical malpractice and healthcare litigation; Chief Operating Officer of USC University Hospital and West Hills Medical Center/HCA; and Chief Nursing Officer of UniHealth, Northridge Hospital Medical Center. She most recently served as the Interim CEO of University Physicians Hospital in Arizona to assist the hospital to regain their deemed status from CMS. Ms. Rafferty earned a Bachelor of Science, Nursing from the State University of New York. She also earned a Master's in Healthcare Administration from the University of La Verne. Dan Dourney is a Senior Director with Alvarez & Marsal Healthcare Industry Group. With more than 25 years of healthcare experience, Mr. Dourney specializes in operations and management in the ambulatory service sector. His primary areas of concentration are analytics, Confidential for investigation and review by quality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 USC 11101 et. seq., this information or designated agent(s). Pursuant is confidential and privileged. to 274 activity-based costing, change management, revenue enhancement, operational due diligence, strategy planning, performance improvement, improved customer experience design and optimal service delivery. Mr. Dourney's notable assignments include an operational turnaround of the HeallhSouth Outpatient Division following a public fraud scandal. Mr. Dourney earned a Bachelor's Degree in Physical Therapy from S U N Y at Syracuse, New York. He is a past member of the American Physical Therapy Association (APTA), American College of Healthcare Executives (ACHE), Assisted Living Federation of America (ALFA) and a Fellow of The Society of Orthopedic Medicine (SOM). Dr. Francis L a M o r t e is a Director with Alvarez and Marsal Healthcare Industry Group. Prior to joining A & M , he was executive chairman of EMX, L.P. one of the nation's largest privatelyheld emergency medicine practice management firms. As compliance officer for eight years, he developed the c o m p a n y ' s risk control systems and training programs for the firm's 600 employees in the areas of E M T A L A and HIPAA obligations. Dr. LaMorte was an attending ED physician with St. Barnabas Medical Center for more than 20 years and served as president of the System's Independent Physician Association. He was Chairman of the St. Barnabas Health Care System's Utilization Management Committee from 2002 to 2006. Dr. LaMorte earned a Bachelor's Degree from Princeton University, and received his Doctorate in Medicine from the Robert Wood Johnson Medical School. He holds a Master's Degree in Business Administration from the Yale University School of Management. Jim McLarty is a Director with Alvarez and Marsal Healthcare Industry Group. He specializes in operations improvement, productivity enhancement, patient throughput and other healthcare provider improvement opportunities. In addition to consulting experience, Mr. McLarty has experience as a registered nurse and practiced in critical care and cardio-thoracic surgery. He later served in hospital administration Most recently, as C h i e f N u r s i n g Officer/VP o f p a t i e n t care services in tertiary and community hospitals. As a CNO he led internal organizational preparation for two successful TJC surveys. medical staff. Mr. McLarty has a Bachelor's of Science in Nursing from West Texas A & M University and a Master's of Science focusing on healthcare administration from Texas State University. Louise Kenney is a Director with Alvarez and Marsal Healthcare Industry Group. She has led operational improvement teams on projects that specifically address organizational structure, CMS and Joint Commission deficiencies, staff productivity and competency, and standardization of the delivery of care. She has served as a nurse executive and surgery center administrator as he led the development and rapid implementation of an OPPE/FPPE program for a hospital's Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to well as a consultant in various roles focused on operational efficiency and clinical outcomes. She has also served in several management positions for inpatient, ambulatory, pediatric and adult facilities within academic and community based hospitals and as a perioperative nurse. Ms. Kenney received her BSN at Alverno College and Master's of Science of Management at Cardinal Stritch University. Tain ra Aloi is a Director with Alvarez and Marsal Healthcare Industry Group. As a reimbursement specialist, she is experienced with government compliance reporting. She is an experienced Medicare cost report preparer and has been involved in many CMS audits relating to cost reporting. As a consultant, she has led and worked on engagements related to access and throughput for hospitals focusing on perioperative, emergency services, imaging, ambulatory/clinics and admitting/registration and other intake functions. Ms. Aloi earned a Bachelor's Degree in Business, with a concentration in Accounting from the University of Texas in Dallas. Ainel Hammad is a Senior Associate with Alvarez & Marsal Healthcare Industry Group. She brings over ten years of diverse healthcare experience. Recent experience includes providing interim financial management services to management companies for groups of assisted living facilities, and assisting in the turnaround of the largest N e w Jersey hospital system implementing operational initiatives totaling $150 million as well as assisting in the strategic assessment of the organization's strategic plan. Prior to joining A&M, Ms. Hammad performed management and financial consulting services for hospitals, long-term care facilities and ambulatory care centers. Ms. Hammad earned a Bachelor's Degree in finance from Saint Joseph's University Haub School of Business in Philadelphia, Pennsylvania. Eliza Medearis is an Associate with Alvarez and Marsal Healthcare Industry Group with a diverse healthcare experience including information technology, decision support and finance in hospital, government and group health benefit consulting environments. Her recent experiences include developing and administering annual department operating, project and capital budgets for a cancer research center; strategic planning for a large national cancer center; and developing a new hospital database to evaluate and appropriately modify patient length of stay, system wide, on a regular basis. Ms. Medearis received her Bachelor of Arts Degree in Economics from Brand?is University and will receive her Master's of Health Administration Degree from Johns Hopkins Bloomberg School of Public Health in the spring 2012. Ellen Intcrlandi has more than 30 years of healthcare leadership experience as demonstrated by roles in institutional, community, association and consultant settings. She specializes in Patient Safety, Quality, Regulatory Operational issues, service line management, staffing and operations Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to Ai, efficiency and leading cultural change. Recent experiences include opening the first freestanding Women's Hospital in New Mexico, combining cultures of closed physician/staff/health plan and open community physician hospital model to create a center of excellence and developing a Patient Safety collaborative for the State Hospital Association, spearheading statewide patient safely initiatives, determining and publishing state-wide best practice, developing tools and resources for hospitals, and promoting targeted, short-term patient safety practice improvements. Ms. Interlandi received her Bachelor of Science Degree in Nursing from Rush University in Chicago, Illinois, and her Master's of Health Management Degree from Saint Thomas University in Miami, Florida. She also holds a Bachelor of Arts Degree in Spanish Literature from Knox College in Galesburg, Illinois. Kathleen Millgard has worked with Alvarez and Marsal Healthcare Industry Group for more than ten years. Ms. Millgard has more than 30 years of healthcare operational experience. Her managerial experience began as a clinic department head and progressed to the level of CEO/COO in hospitals ranging from 59 to 600 beds. Her experience includes acute care, psychiatric and teaching facilities in both domestic and international settings. She has personally designed and successfully implemented numerous Plans of Correction to allow the hospitals to continue to participate in Medicare and Medicaid. Ms. Millgard received her Bachelor of Science Degree in Nursing from University of the State of New York, and her Master of Health Administration Degree from Georgia State University. She also received her Master of Business Administration Degree from Georgia State University. Cathie Abrahamsen has been a healthcare practitioner and consultant in the health care field for over 30 years. She has held numerous clinical, administrative and advisory positions in both public and private health care organizations. Recently, Ms. Abrahamsen served as a director of nursing, and has worked as a corporate clinical consultant for over seventeen hospitals across the country. In addition, she has served on the faculties of Northwestern University and Elmhurst College in the Schools of Nursing. Ms. Abrahamsen served as Joint Commission Surveyor for fifteen years in the hospital and behavioral programs. She designed and presented regional and custom educational programs for the Joint Commission. She attended and received a Bachelor and Master's degree of Nursing from Northern Illinois University in DeKalb, Illinois. Joyce Berry has over 25 years of experience as a health care practitioner, leader and consultant. She has held numerous positions from hospital operations to executive leadership roles in primary care based acute services. Ms. Berry has focused primarily on regulatory compliance audits, continuous quality improvement and productivity and operations analysis. Other notable Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to 277 positions include her work as the Senior Operations Executive with Cambio Health and multiple high-level compliance positions. Ms. Berry received her Bachelor of Science Degree in Nursing from the University of Texas at Galveston and her Master's in Nursing Administration from the University of Texas at Arlington. Ms. Berry is a licensed nurse in both Texas and Florida. Katherine Cardone Nelson has nearly 30 years of experience in healthcare clinical and leadership roles. Ms. Cardone Nelson led a number of different services at Georgetown University Hospital including inpatient psychiatric, emergency department, and cancer services. Her recent consulting work focuses on helping organization ensure readiness for both Department of Health and Joint Commission on Accreditation of Healthcare Organization surveys. Ms. Cardone Nelson has been a member of the Georgetown University Medical Center Institutional Review Board (IRB) for the past eight years. Ms. Cardone Nelson received her Bachelor of Science Degree in Nursing and her Master's of Science in Administration of Nursing Services from Georgetown University in Washington, D.C. Cynthia Tang has over 25 years of experience in the health care industry as a health information management (HIM) expert and coding consultant. Ms. Tang previously served as a healthcare consultant for a Big Six accounting firm and as regional director of health information and quality resource management for two of the nation's largest healthcare organizations. She has conducted 1IIM operations assessments in over 150 hospitals. P a t r i c k Coonan is presently Dean and Professor at the School of Nursing at Adelphi University in Garden City, N e w York. He has had a long history of service in nursing leadership, administration and education. He has held senior patient care management positions at major medical centers in the metropolitan New York area, including as Chief Nursing Officer in an academic medical center. He was a Fellow in the Johnson & Johnson - Wharton Fellows Program in Management for Nurse Executives at The Wharton School, University of Pennsylvania. He is certified in Nursing Administration, Advanced from the American Nurses Association and is a Fellow in the American College of Healthcare Executives. Dr. Coonan received his Ed.D and M.Ed from Columbia University, a Master's in Public Administration / Health Care Administration (MPA) from Long Island University and a B.S. in Nursing from Adelphi University. Confidential for investigation and review by finality assurance/improvement committees Section 160.007 of Texas Occupations Code and 72 USC 11 Iti I et. set/., this information or designated agent(s). Pursuant to is confidential and privileged. 278 At Exhibit A - Systems Improvement Agreement (SIA) Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to SYSTEMS IMPROVEMENT AGREEMENT This Systems Improvement Agreement ("SIA" or "the Agreement") between the Centers for Medicare & Medicaid Services ("CMS"), a division of the United States Department of Health and Human Services ("DHHS"), and Dallas County Hospital District d/b/a Parkland Health & Hospital System ("PHHS")(collectively, "the parties") is being executed and will be implemented to further the objectives of Titles XVIII and XIX of the Social Security Act, to facilitate the delivery of quality hospital services to the community served by PHHS, and to promote consistent compliance by PHHS with all the Medicare Conditions of Participation for Hospitals at 42 C.F.R. ??482.11 - 482.57 and all the requirements of the Emergency Medical Treatment and Labor Act (EMTALA) at 42 C.F.R, ?489.20 and ?489.24. This agreement is in effect for the time period beginning September 30, 2011 through April 30, 2013, unless voluntary withdrawal or termination of the Medicare Provider Agreement occurs, or the terms of the Agreement are fulfilled earlier, in accordance with the provisions contained in this Agreement. All timeline referenced in this agreement will be calendar days. Rccitals Whereas, on May 12, 2011, a CMS Complaint Survey of PHHS found non-compliance with one of the Medicare Conditions of Participation ("CoPs") for Hospitals (42 C.F.R. ? 482.13 Patient Rights), which included significant deficiencies that affect or had the potential for affecting the health and safety of patients. Whereas, on May 23, 2011, CMS issued a Letter to PHHS removing the deemed status of the hospital and notifying the hospital the state survey agency would soon complete a full survey of the hospital. Whereas, on July 21, 2011, the first CMS Follow-up survey of PHHS found non-compliance with five of the Medicare Conditions of Participation ("CoPs") for Hospitals (42 C.F.R. ?? 482.11, 482.12, 482.23, 482.42 and ?489.20) and EMTALA requirements which included deficiencies that represented immediate jeopardy to patient health and safety. Whereas, on August 9, 2011, CMS issued a Termination Letter to PHHS terminating the Medicare Provider Agreement effective September 2, 2011. Whereas, on August 31, 201 1, a Follow-up Survey of PHHS, found continued non-compliance at condition level with five of the Medicare Conditions of Participation for Hospitals (42 CFR ?? 482.11, 482.12, 482.23, 482.24, and 482.55) and E M T A L A requirements which included deficiencies that represented immediate jeopardy to patient health and safety. Whereas, on September 1, 2011, CMS issued a letter to PHHS extending the termination date to September 30, 2011. 1 Whereas, on September 9, 2011, CMS issued a Termination Letter to PHHS terminating the hospital's Medicare Provider Agreement, effective September 30, 2011. This letter transmitted the August 31, 2011 survey findings. Whereas, on August 31, 2011, a substantial allegation survey conducted concurrently with the Follow-up Survey of PHHS and completed on September 9, 2011 found non-compliance at condition level with two of the Medicare Conditions of Participation for Hospitals (42 CFR ?? 482.43,482.54). Whereas, on September 21, 2011, CMS issued a letter to PHFIS transmitting the September 9, 2011 substantial allegation survey findings. Whereas, CMS has determined that, in view of the impact PPIHS' termination would have on the community, affording the hospital an additional opportunity to achieve and maintain substantial compliance with all the Medicare Conditions of Participation and E M T A L A is in the best interest of the Medicare program in particular and the community served by PHHS generally. THEREFORE, in the interest of avoiding termination of PHHS' Medicare Provider Agreement on September 30, 2011 and in bringing PHFIS into full compliance in a timely manner with all regulatory Conditions of Participation for hospitals at 42 C.F.R. ??482.11 - 482.57 and EMTALA, the Parties agree as follows: CMS agrees to stay the scheduled termination action during the pendency of this Agreement by written notice to be executed and delivered to PHHS within 24 hours of execution of the Agreement. In consideration for C M S ' stay of the scheduled termination action, PHHS agrees to do the following at its own expense: I. Obtain Independent Consultative Review: PHHS will obtain an independent expert onsite review that will provide the following: a comprehensive hospital-wide analysis of its current operations compared to industry accepted standards of practice to ensure compliance with all the Medicare Conditions of Participation for acute hospital provider and EMTALA requirements related to the timely provision of care and services; recommendations for hospital-wide changes and improvement to ensure compliance with all the Medicare Conditions of Participation for acute care hospitals and EMTALA; assistance in implementing and evaluating such changes and improvement; and implementation of an effective and ongoing hospital-wide Quality Assessment and Performance Improvement program to ensure continued compliance. Further, PHFIS will provide CMS with written information that identifies and details the composition of a proposed group of independent experts with expertise in the design, implementation, management and evaluation of hospital services, including, but not limited to, the following: 2 leadership and management supervision and accountability; quality and appropriateness of services, including emergency services, provided to patients in accordance with the Medicare Conditions of Participation for acute care hospitals and EMTALA; infection prevention practices; protection and promotion of patient's rights; discharge planning; outpatient services, qualified and supportive staffing resources; staff training and education; and quality assessment and performance improvement, as discussed in Section 2 below. The information will include the curriculum vitae and other information pertinent to the qualifications and credentials of each expert proposed for retention. PHHS will not retain the services of any of the proposed experts until CMS concurs. At a minimum, the team of experts will have expertise and national certifications, as appropriate, related to their respective field and area of expertise. Unless otherwise approved in writing by CMS, no one who currently is, or in the past 12 months has been, an employee of, or affiliated with, PHHS or Dallas County or has any other conflict of interest (as defined in Attachment A hereto), may be included in the group of independent experts. Further, the experts may be obtained from a variety of sources rather than one consulting group. a. The independent consultative experts will identify, in writing, areas of improvements in PHHS' performance and conduct a root cause analysis (See Attachment A for definition of term). The report should provide details of identified obstacles and system failures that are preventing or inhibiting PHHS from attaining or maintaining safe and acceptable standards of practice to ensure compliance with all the Medicare Conditions of Participation at 42 C.F.R. ?? 482.11 - 482.57 and with EMTALA. The analysis must include, but is not limited to, review of the following: leadership/management accountability and supervision; quality and appropriateness of services, including emergency services and outpatient services, provided to patients in accordance with the Medicare Conditions of Participation for acute care hospitals and EMTALA; infection prevention practices; discharge planning process; qualified and supportive staffing resources; staff training and education; and quality assessment and performance improvement as discussed in Section 2 below. The written report will be submitted to CMS for review prior to issuance to PHHS, and will be accompanied by an oral briefing, at the discretion of CMS, on the report's findings. This report will be due to CMS no later than 60 days after CMS has approved the proposed independent consultative experts. CMS may require the independent consultative experts to revise the report, at PHHS' expense, before CMS will accept the report. If CMS accepts the report, the independent consultative experts will issue the accepted report to PHHS no later than 5 days after the date CMS accepts it. No later than 5 days after receipt of the report PHHS must notify CMS in writing that it has received the report. 3 b. The independent consultative experts will develop a detailed written plan identifying specific actions to be taken, including milestones, which will lead to substantial compliance with all the Medicare Conditions of Participation for acute care hospitals and EMTALA. The action plan will be due to CMS no later than 30 days after CMS has accepted the analysis report. CMS may require the independent consultative experts to revise the action plan, at PHHS' expense, before CMS will accept the action plan. If CMS accepts the action plan, the independent consultative experts will issue the accepted action plan to PHHS no later than 5 days after the date CMS accepts it. 1. N o later than 15 days alter receipt of the action plan, PHHS must notify CMS in writing that it has received the action plan and is committed to implementing the action plan. If PHHS refuses to make these commitments to implement the action plan(s) developed by experts without good cause, as determined by CMS, CMS will view this as a breach of the SIA. c. Beginning 30 days after the month in which CMS has accepted the implementation plan, the independent consultative experts will submit monthly reports and updates to CMS through April 30, 2013, on the progression and status of the implementation plan, including identification of problems that may jeopardize the successful implementation of the plan and actions underway to address those problems. Updates shall be due by the 10th day of each month. The reports and updates will then be forwarded to PHHS no sooner than five days after submission to CMS. At the discretion of CMS, these reports may be followed by face-to-face or telephone conference discussions between the independent consultative experts and CMS as needed, and at the expense of PHHS. 2. Acquire Expertise in the development and implementation of an effective Quality Assessment and Performance Improvement (QAPJ) program: PHHS will engage the services of individual(s) with national expertise and credentials in the development and implementation of effective Quality Assessment and Performance Improvement (QAPI) programs to work with PHHS to design and implement a comprehensive, hospital-wide, and effective QAPI program no later than 60-days after the date that CMS approved the proposed consultative experts. No one who currently is, or in the past 12 months has been, an employee of, or affiliated with, PHHS or Dallas County or has any other conflict of interest (as defined in Attachment A hereto), may be considered for this position. At a minimum, the expert(s) would conduct the following activities: a. Conduct an analysis of the hospital's current QAPI Program in terms of its ability to meet the requirements of 42 C.F.R. ? 482.21 for an effective, 4 ongoing, hospital-wide, data-driven QAPI program that is used to develop and implement performance improvement activities and projects that improve the timeliness and quality of care and the safety of patients at PHHS. The analysis will include, but not be limited to, evaluation of the adequacy of the QAPI program's resources, the qualifications of the QAPI staff, and the level of engagement of P H I I S ' s governing body, administrative officials, and medical staff in the QAPI program. The QAPI program expert's analysis is to be included in the report referenced in Section 1 a above. b. Provide recommendations and a detailed implementation plan, including milestones to close any gaps identified in the analysis. The QAPI program expert's plan is to be included in the plan referenced in Section 1 b above. c. Develop a monthly report and update, consistent with the requirements of Section 1, c., above. 3. On-Site Expert: In addition to engaging independent consultative experts, PHHS will engage the services of an independent, full-time, on-site Compliance Officer. The Compliance Officer will provide oversight and coordination of PHHS's compliance efforts in accordance with the reports and plans as required pursuant to this Agreement and provide ongoing feedback to the parties about PHHS's improvements and compliance with all the Medicare Conditions of Participation for acute care hospitals and EMTALA. The Compliance Officer will work directly with the Chief Executive Officer, the Chief Medical Officer, and P H H S ' Corporate Compliance Officer to coordinate the QAPI program with accountability for specific goals and objectives. The Compliance Officer must have knowledge of clinical policies and procedures and the ability to choose among a number of alternatives in overseeing and monitoring the development and implementation of the QAPI program. a. PHHS will engage the Compliance Officer for the duration of this Agreement. b. As part of the oversight, as the independent compliance expert, the Compliance Officer will conduct quarterly comprehensive reviews of the QAPI program activities and status of the hospital's compliance with the Conditions of Participation and EMTALA, and will provide the results to PHHS and CMS. 4. Selection of Consultants: Within 45 days after the effective date of this Agreement, PITHS shall provide CMS with information that identifies and provides the 5 qualifications (i.e. curriculum vitae) about one or more proposed Independent Consultative Experts, QAPI Expert Consultant, and On-Site Compliance Officer. For all approvals of individuals or companies required under this Agreement by CMS, PHHS shall submit the names and qualifications of the designated individuals or companies via electronic mail or overnight mail. Within 10 days after receiving the information about the proposed consultants, CMS will approve one or more of the professionals proposed to serve in each capacity. CMS shall not unreasonably withhold approval 5. Surveys: CMS will authorize a Medicare certification survey of all the Medicare Conditions of Participation for acute care hospitals and E M T A L A no sooner than 180 days and no later than 365 days from the date that CMS accepts the consultative experts' written implementation plan as provided in l.b. 6. The parties further understand and agree: a. Notwithstanding any provision of this Agreement, or any document generated pursuant hereto, CMS and its agents retain full legal authority and responsibility to investigate credible complaints and otherwise evaluate compliance with Medicare participation requirements, and to this end, may survey, or authorize its agents to survey, PHFIS and take enforcement action including, but not limited to, termination o f P H H S ' s Medicare provider agreement, in accordance with the procedures set forth at 42 C.F.R. ? 489.53 and more fully at State Operations Manual sections 3010 and 3012. CMS will, however, provide PHHS with the opportunity to provide information about any deficiencies identified during the survey and to meet with CMS to discuss the findings/deficiencies. CMS may, at their discretion, provide the Independent Consultant Experts with information acquired during the course of this Agreement that may be relevant to the development or implementation of their action plan. b. In the event that the survey referenced in Section 5 herein demonstrates that PHFIS is substantially in compliance with all Medicare Conditions of Participation and EMTALA, CMS will promptly rescind the pending termination. PHHS will be released from the survey jurisdiction of the Texas State Agency and CMS will restore the deemed status of PHHS. c. In the event that the survey referenced in Section 5 herein demonstrates that PHHS is found with Condition-level non-compliance in one or more of the Medicare Conditions of Participation for acute care hospitals or any 6 requirements of EMTALA at 42 C.F.R. ?489.24, CMS will promptly notify PHHS of these findings and set a date for termination of the hospital's Medicare provider agreement, consistent with the notice requirements at 42 C.F.R. ? 489.53(d) and more fully at State Operations Manual sections 3010 and 3012. CMS agrees that this termination decision will be based solely on the findings from the Medicare certification survey referenced in Section 5. 7. PHHS shall remain solely responsible for achieving and maintaining substantial compliance with all applicable Medicare requirements and may not transfer this responsibility to any third party. 8. CMS is not responsible for providing either PHfIS, or its outside expert consultants, with technical advice in meeting its obligations under the existing Medicare provider agreement. 9. All reference to number of days herein refers to "calendar days" rather than "business days." Any deadlines or time parameters referenced in this Agreement may be extended for good cause at the sole discretion and approval of CMS. In the event of the need to extend any deadlines, PHHS shall send written notice to CMS detailing the reasons for the requisite extension and indicating the additional time needed to meet the referenced deadline or time parameters. 10. PPIPIS waives all rights to administratively or judicially challenge in any forum and for any purpose the legal or factual validity of the findings set forth in the Statements of Deficiencies (Form CMS 2567) from the surveys described in the Recitals. Further, PHHS shall neither file nor submit any action or suit against the United States, DHHS, CMS (including its officers, employees, and agents), Texas Department of State Health Services ("DSHS"), or any other component of the Federal Government in any administrative or judicial forum with respect to any matter related to the Medicare surveys described in the Recitals. This paragraph shall survive the termination of this Agreement for any reason stated here. 11. Phis Agreement sets forth the full and complete basis for the resolution of this matter by the parties. Each party shall be responsible for its own costs including attorney fees associated with this Agreement. 12. This Agreement will be executed with duplicate originals signed by both parties. 7 13. All reports and notices referenced in this Agreement are to be submitted to the parties as follows: For CMS: Ginger Odle, Manager Non-Long Term Care Certification & Enforcement Branch Division of Survey & Certification Centers for Medicare & Medicaid Services 1301 Young Street, Room 832 Dallas, TX 75202 Ginjj.er.Odl e@cms .hhs.gov For PHHS: Ron Anderson, M.D., Chief Executive Officer Parkland Health and Hospital System 5201 Harry Hines Blvd Dallas, TX 75235 Ron.Auderson@phbs.org With a copy to: Paul S. Leslie Executive Vice President & General Counsel Parkland Health and Hospital System 5201 Harry Hines Blvd Dallas, TX 75235 Paul .Leslie@phhs.org 14. if PHHS wishes to dispute any action taken by or on behalf of CMS under this Agreement, excluding possible termination at the end of the Agreement based on continued non-compliance with one or more Medicare Conditions of Participation or EMTALA, it may submit a written statement with supporting evidence to CMS within ten (10) days of receiving written notice of such action. CMS will review such submission and promptly issue a written final determination. 15. The terms of this Agreement shall be binding on the parties hereto, including their successors, transferees, administrators, heirs, executors, designees, assigns, agents and contractors. 16. Each person executing the Agreement in a representative capacity on behalf of either party warrants that he or she is duly authorized to do so and to bind the party he or she represents to the terms and conditions of the Agreement. 8 17. This Agreement may be amended by the written agreement of both parties. Any terms of the Agreement not met by the provider will constitute a breach of the Agreement, and may result in CMS exercising its right to proceed with the termination of the Medicare provider agreement. 18. The Parties hereby agree that all documents, information and data produced or prepared in accordance with this Agreement are subject to applicable federal and state law privacy protections including, but not limited to, 5 U.S.C. ? 552(b), 45 C.F.R. ?? 5.61- 5.69, and Texas statutes protecting the privilege and/or privacy of medical records, quality assurance, patient safety, peer review, and performance improvement activities. THE FOREGOING PROVISION'S ARE HEREBY AGREED TO ON THE DATE(S) INSCRIBED BELOW For Dallas County- Hospital District For the Centers for Medicare & Medicaid Services By: _ _ Gerar ite Regional Administrator Division of Survey & Certification CMS Dallas 9 Attachment A: Definitions: Conflict of Interest: A situation in which a person has a financial, private, or personal interest that may adversely affect or influence or appear to adversely affect or influence the professional and objective exercise of his or her duties and obligations as set forth in this Systems Improvement Agreement by and between CMS and PHHS. Root Cause Analysis: An analysis that includes problem identification and definition; investigation for gathering information; identifying root causes; implementing solutions; and monitoring these solutions to ensure they continue to prevent the original problem identified. Minimum Scope of Gap Analysis and Written Action Plan: At a minimum, the following areas must be addressed by the independent consultative experts: The analysis report must include the following: 1. comprehensive analysis of the hospital's current operations compared to industry accepted standards of practice that ensure PPIHS's compliance with all the Medicare Conditions of Participation for acute care hospitals and EMTALA related to the provision of patient care and sendees, including, but not limited to, leadership/management accountability mechanisms, quality and appropriateness of services, including emergency services and outpatient services, provided to patients, infection prevention practices, discharge planning process, patient's rights protection, qualified and supportive staffing resources, staff training and education, and, per D below, Quality Assessment and Performance Improvement (QAPI); root cause analysis of process and system failures; and recommendations for changes and improvement to ensure full compliance with all the Medicare Conditions of Participation for acute care hospitals and EMTALA. 2. 3. B. The action plan must include the following: 1. identification of actions to correct identified deficiencies in each service/functional area; and identification of detailed milestones, including completion dates, related to each deficiency. 2. 10 The independent consultants must provide : 1. Monthly written update to CMS regarding: a. b. c. 2. progression and status of implementation plan problems that may jeopardize successful implementation of plan; and actions taken to address identified problems. Face-to-face or telephone conference to discuss monthly updates as needed. The analysis and action plans must also contain a section that specifically addresses the hospital's QAPI program, including: 1. Assessment of the Hospital's current QAPI program, including, but not limited to a. b. c. d. e. Effectiveness of the program in achieving increased patient safety and improved quality of care; Whether it is ongoing and has adequate resources; Whether the hospital's leadership (including its Board of Managers) is appropriately engaged in the program; Whether it is hospital-wide; Whether it is data-driven, including the process for determining the selection of tracking measures that comply with the requirements of 42 C.F.R. ?482.21, definitions of adverse events and methods to identify them; Adequacy of data collection and analysis; and Process to develop, implement and evaluate performance improvement activities and projects. f. g. 2. Recommendations and action plans to address identified weaknesses in the QAPI program, including detailed milestones and timelines for completion. 11 Exhibit B - Glossary of Terms and Abbreviations Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to Confidential f o r investigation and review by quality assurance/improvement committees or designated agent(s). Exhibit B - Glossary of Terms Abbr. / Term 340B Program 340B Pharmacy Program Version Definition / Explanation T h e 3 4 0 B D r u g Pricing Program resulted from enactment of Public L a w 102-585, the Veterans Health Care Act of 1992, which is codified as Section 3 4 0 B of the Public Health Service Act. M a n a g e d by the 1 lealth R e s o u r c e s and Services A d m i n i s t r a t i o n ( U R S A ) O f f i c e of P h a r m a c y A f f a i r s ( O P A ) , the program limits the cost of covered outpatient d r u g s to certain federal grantees, federally-qualified health center look-alikes and qualified hospitals. Participation in the Program results in significant savings, estimated to be 2 0 % to 5 0 % on the cost of p h a r m a c e u t i c a l s for safety-net providers. A&M A l v a r e z and Marsal Healthcare Industry G r o u p A l v a r e z and Marsal Healthcare Industry G r o u p . L.L.C, is a national health care consulting practice, which f o c u s e s on strategy, financial p e r f o r m a n c e , operational effectiveness, clinical quality, m a n a g e m e n t , turnaround and restructuring, transaction and advisory services, c o m p l i a n c e , g o v e r n a n c e , and investigations. financial A B EM A m e r i c a n Board o f E m e r g e n c y M e d i c i n e A B E M a medical specialty certification board, recognized by the A m e r i c a n Board of Medical Specialties, that certifies e m e r g e n c y physicians w h o meet its educational, professional standing, and examination standards. A B E M certification is s o u g h t and earned by e m e r g e n c y physicians on a voluntary basis; A B E M is riot a m e m b e r s h i p association. ABN Advanced Beneficiar/ Notice A report given to M e d i c a r e beneficiaries to let the patient k n o w Medicare is not likely to pay for certain services. The notice must be given to the patient before services are performed. ACGME Accreditation Council for Graduate Medical Education T h e A C G M E is a private, nonprofit council that evaluates and accredits physician residency (i.e., internships, residencies, and fellowships) training p r o g r a m s in the United State. A C L S refers to a set of clinical interventions for the urgent treatment of cardiac arrest, stroke and other life threatening medical emergencies, as well as the k n o w l e d g e and skills to deploy t h o s e interventions. In the United States. A C L S education and certification is sponsored by the A m e r i c a n Heart Association, and is typically provided at hospitals or m e d i c a l schools in a classroom-based course, in out-of-hospital settings trained e m e r g e n c y medical technicians, p a r a m e d i c s or medics typically provide this level of care. In hospitals, A C L S is provided by a designated team of qualified physicians and nurses. A C LS A d v a n c e d Certified Life Support Pursuant to Section 160.007 of Texas Occupations Code and 42 USC 11101 et. seq., this information is confidential and privileged. Page 1 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Temi A c t i o n Plan Version Definition / Explanation Outline of concrete steps that the Hospital should u n d e r t a k e to address all of the M e d i c a r e C o P deficiencies, and m o r e importantly, create sustainable c h a n g e to create an e n v i r o n m e n t for safe, e f f e c t i v e and quality patient care. ACU Acute Care Unit Parkland has a 14 bed acute care unit as well as a N e w b o r n acute care unit and a geriatric acute care unit. T h e s e inpatient units are for patients with medical or surgical conditions. Patients in an A C U receive c o m p r e h e n s i v e care to m e e t i m m e d i a t e and long-term health needs. ADC Admission Order A v e r a g e Dailv C e n s u s T h e average n u m b e r of staffed beds that are occupied each day. T h e a v e r a g e daily census is calculated by dividing the total inpatient d a y s by 365 days. Written order by the treating physician directing patient to inpatient level of care. A d m i s s i o n orders generally guide the overall care of the patient and should include any specific treatments that need to be administered to the patient. ADR ADT A d v e r s e D r u g Reaction A d m i s s i o n Discharges and T r a n s f e r s An adverse drug reaction describes harm associated with the use o f g i v e n m e d i c a t i o n s at a normal dose. A d m i s s i o n , discharge, and transfers represent key status c h a n g e s for patients in their hospital stay - the admission process regardless of their entry into the hospital, discharges which may be to h o m e or another health care facility, and transfer f r o m one n u r s i n g unit or service to another. Each of the c h a n g e s in patient status represent important points in t h e patient stay in w h i c h e f f e c t i v e patient a s s e s s m e n t s a n d c o m m u n i c a t i o n are critical. AUSA A m e r i c a n Healthcare Services Association A H S A is a m e m b e r s h i p organization that provides supplemental s t a f f i n g service f o r hospitals in t h e in the f o l l o w i n g specialties : Nursing, R a d i o l o g y / I m a g i n g , P h a r m a c y , Laboratory. T h e r a p y , Physician. [T. and Medical O f f i c e . A H S A provides no direct staffing, but acts as a single point-of-contact to a n e t w o r k of s t a f f i n g suppliers, that a l l o w s hospitals to avoid h a v i n g to w o r k with multiple agencies o n a daily basis w h e n trying to fulfill s u p p l e m e n t a l s t a f f i n g openings. Allied H e a l t h Professional Clinical health care p r o f e s s i o n s , distinct f r o m dentists, n u r s e s and physicians, that w o r k in support of health professionals by p r o v i d i n g a range of diagnostic, technical, therapeutic and direct patient care. E x a m p l e s of allied health p r o f e s s i o n s include dieticians, E K G technicians, and respiratory therapists. Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). ALOS A v e r a g e Length of Stay T h e average n u m b e r of inpatient d a y s spent in a hospital or other health care facility per a d m i s s i o n or discharge. It represents the average n u m b e r of days patients spend in the hospital per admission. T h e A L O S is calculated by dividing the total inpatient days by the total discharges. ALVIN A M A (disposition status) A M A (organization) A d v a n c e d L a n g u a g e Video Interpreter Against Medical A d v i c e American Medical Association Video interpreting provides interpretative services for e x p l a i n i n g health care information for patients and their families. Term used to report a patient w h o leaves a hospital against the advice of his or her doctor. T h e A m e r i c a n Medical Association ( A M A ) . f o u n d e d in 1847 and incorporated in 1897 is the largest professional association of physicians and medical students in the United States. AN SOS A u t o m a t e d N u r s e S c h e d u l i n g O f f i c e System A N S O S is a centralized electronic scheduling system utilized to schedule nurses. T h e system provides an a u t o m a t e d process to facilitate appropriate staffing levels on n u r s i n g units. AORN Association of p e r i o p e r a t i v e Registered Nurses A O R N is the professional nursing association for nurses practicing in the perioperative area. A O R N also establishes and r e c o m m e n d s standards of practice for perioperative nursing. Pursuant to Section 160.007 of Texas Occupations Code and 42 USC 11101 et. seq., this information is confidential and privileged. Page 1 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term APPOW Expansion / Unabridged Version A p p r e h e n s i o n by a Peace O f f i c e r Without a Warrant Definition / Explanation (a) A p e a c e officer, without a warrant, m a y take a person into custody if the officer: (1) has reason to believe and does believe that: (A) the person is mentally ill; and (B) b e c a u s e of that mental illness there is a substantial risk of serious harm to the p e r s o n or to others unless the person is immediately restrained; and (2) believes that there is not sufficient time to obtain a warrant b e f o r e taking the person into custody. (b) A substantial risk of serious harm to the person or others under Subsection (a) (1) (B) m a y be demonstrated by: (1) the person's behavior; or (2) evidence of severe emotional distress and deterioration in the person's mental condition to the extent that the person cannot remain at liberty. (c) T h e p e a c e o f f i c e r may form the belief that the person m e e t s the criteria for apprehension: (1) from a representation of a credible person: or (2) on the basis of the c o n d u c t of the a p p r e h e n d e d person or the c i r c u m s t a n c e s under which t h e a p p r e h e n d e d person is found. id} A peace o f f i c e r w h o takes a p e r s o n into custody under Subsection (a) shall immediatelytransport the a p p r e h e n d e d person to: (1) t h e nearest appropriate inpatient mental health facility: or (2) a mental health facility d e e m e d suitable by the local mental health authority, if an appropriate inpatient mental health facility is not available. (e) A jail or similar detention facility m a y not be d e e m e d suitable except in an e x t r e m e emergency. ASA Anesthesia Scoring A s s e s s m e n t T h e A S A Physical Status Classification System is a grading system for assessing the degree of a p a t i e n t ' s "sickness" or "physical state" prior to selecting the anesthetic or prior to p e r f o r m i n g surgery. It is comprised of six categorical descriptions of a patients' preoperative physical status, w h i c h are used for recordkeeping, for c o m m u n i c a t i n g b e t w e e n physicians, and to create a uniform system for statistical analysis. T h e g r a d i n g system is not intended for use as a m e a s u r e to predict operative risk. E x a m p l e : A S A PS Category 4: A patient with severe systemic disease that is a constant threat to life. ASC. A m b u l a t o r y Surgery Center A m b u l a t o r y Surgery Centers ( A S C s ) are facilities w h e r e surgeries that do not require hospital admission are p e r f o r m e d . A S C s may perform surgeries in a variety of specialties or dedicate their services to one specialty, such as orthopedic care. Patients w h o elect to h a v e surgery in an A S C arrive on the day of the procedure, have the surgery in an operating room, and recover u n d e r the care of the nursing staff, all without a hospital a d m i s s i o n . Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. f Term ASPAN Expansion / Unabridged Version A m e r i c a n Societv of PeriAnesthesia Nurses Definition / Explanation o A nonprofit professional association for nurses practicing in ail phases of preanesthesia and post anesthesia care, ambulatory surgery, and pain m a n a g e m e n t . A S P A N provides perianesthesia education, n u r s i n g practice, standards and research. A t t e n d i n g Physician An authorized practitioner of medicine, as one graduated f r o m a college of m e d i c i n e or osteopathy and licensed by the appropriate board, who, as a m e m b e r of a hospital staff, admits and treats patients and may supervise or teach house staff, fellows, and students. BLS Basic Life Support BL.S is the level of medical care which is used for patients with life-threatening illnesses or injuries until t h e patient can be given full medical care at a hospital. In the United States, B L S education and certification is sponsored by the A m e r i c a n 1 leart Association, and is typically provided at hospitals in a classroom-based course, designed to teach individuals to recognize several life-threatening emergencies, provide C P U to victims of all ages, and relieve c h o k i n g in a safe, timely and effective m a n n e r . BOM Board of M a n a g e r s Dallas C o u n t y Hospital District (d.b.a. Parkland Health & Hospital S y s t e m ) is governed by a seven m e m b e r B o a r d of M a n a g e r s , all of w h o m are appointed by the Dallas County C o m m i s s i o n e r s Court. M e m b e r s of the B O M are appointed for t w o - y e a r terms, or until a successor is n o m i n a t e d and a p p r o v e d by the C o m m i s s i o n e r s Court. Board m e m b e r s do not receive c o m p e n s a t i o n for their service. T h e B O M is responsible for g o v e r n i n g policies and also has budgetary oversight f o r the Dallas C o u n t y Hospital District. CNA Certified N u r s i n g Assistant A Certified N u r s i n g Assistant, or C N A , is a person w h o assists patients or clients with healthcare needs u n d e r the supervision of a Registered N u r s e ( R N ) or a Licensed Practical N u r s e ( L P N ) . Also known as a N u r s i n g Assistant ( N A ) a Patient Care Assistant ( P C A ) or a State Tested Nurse Aid ( S T N A ) , the individual w h o carries this title also carries a high level of experience and ability: h o w e v e r , issues of liability and legality prevent the C N A f r o m p e r f o r m i n g certain procedtires. CAP College of A m e r i c a n Pathologists C A P is a professional organization c o m p o s e d exclusively of pathologists certified by t h e A m e r i c a n Board of P a t h o l o g y and is considered the leader in laboratory quality assurance. It is also affiliated with the American Medical Association and C A P does accreditation o f laboratories under d e e m e d authority by C M S (Medicare). Pursuant to Section 160.007 of Texas Occupations Code and 42 USC 11101 et. seq., this information is confidential and privileged. Page 1 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr./Term "Capped" Expansion / Unabridged Version Definition / Explanation A term used to describe that a physician or resident has reached the m a x i m u m n u m b e r of hospital admissions for which he or she can care f o r a designated period of time. C-Arro An i m a g i n g s c a n n e r i n t e n s i f i e s so n a m e d because of its c o n f i g u r a t i o n . C - a r m s have radiographic capabilities, t h o u g h they are used primarily for fluoroscopic i m a g i n g d u r i n g surgical, orthopedic, critical care, and e m e r g e n c y care procedures. T h e Certification C o m m i s s i o n for Health. Information T e c h n o l o g y ( C C H I T (R) ) , a nonprofit, 501 (c }3 organization, with the public mission of accelerating the adoption of health IT. Founded in 2004, and certifying electronic health records ( E H R s i since 2006. the C o m m i s s i o n established a definition of w h a t capabilities w e r e needed in these systems. T h e certification criteria were developed through a voluntary, consensus-based process e n g a g i n g diverse health care stakeholders. T h e Certification C o m m i s s i o n has b e e n recognized by the federal government, as a certifying body. C C I I IT Certification C o m m i s s i o n f o r Healthcare information Technology CCN Cerner Continuing: Care Nursery W I S H NN1CU Unit includes a Level 111 C o n t i n u i n g Care Nursery ( C C N ) for n e w b o r n s . A health care information t e c h n o l o g y c o m p a n y that provides systems for medical organizations to m a n a g e and integrate electronic medical records, c o m p u t e r i z e d physician order entry ( C P O E ) . and financial information. Class A P h a n n a c y Class C Pharmacy Class D P h a r m a c y Clean R o o m CMC CM! Children's M e d i c a l Center Case Mix Index A Class A p h a r m a c y license or c o m m u n i t y p h a r m a c y license authorizes a p h a r m a c y to dispense a d r u g or device to the public under a prescription d r u g order. A Class C pharmacy license or institutional p h a r m a c y license may be issued to a p h a r m a c y located in an inpatient facility, hospice, or A S C . A Class D p h a r m a c y license or clinic p h a r m a c y license authorizes the p h a r m a c y to d i s p e n s e a limited type of d r u g or device under a prescriptive d r u g order. A clean r o o m has a controlled level of c o n t a m i n a t i o n that is specified by the n u m b e r of particles per cubic m e t e r at a specified particle size. Children's M e d i c a l Center of Dallas. T e x a s T h e different m i x of all the D R G s in a hospital or hospital d e p a r t m e n t s is called the C a s e M i x Index. It rellects the complexity of the average patient cared for by the hospital. T h e higher the C M I, the greater the complexity of inpatient services provided. Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term CMS CNA C o d e Blue Collateral Expansion / Unabridged Version Centers for Medicare and Medicaid Services Certified N u r s i n a Assistant Insurance P r o g r a m . Definition / Explanation U S federal a g e n c y which administers Medicare, Medicaid, and the Children's Health C N A s are trained and certified to help nurses by providing n o n - m e d i c a l assistance to patients, such as help with bathing, dressing, and using the b a t h r o o m . T h e Parkland Hospital e m e r g e n c y code used to alert staff of a patient requiring resuscitation f r o m a cardiac arrest. T h e portion o f a psychiatric e m e r g e n c y services assessment that includes gathering information f r o m other (non-patient) sources sucli as family m e m b e r s , other medical providers, police officers, f r i e n d s or prior records. Compliance Officer T h e I C E T e a m is required to f u n c t i o n as a c o m p l i a n c e o f f i c e r during the survey, n o t i f y i n g the Parkland Board of M a n a g e r s and C M S when/if Parkland failed to m e e t the r e q u i r e m e n t s of the Action Plan or failed to meet any Medicare CoPs. Condition Code 44 M e d i c a r e billing status c o d e which indicates an inpatient admission that w a s changed to outpatient status after an internal hospital review process d e t e r m i n e d that the services did not m e e t its inpatient criteria. C o n d i t i o n Level Deficiency CoP Conditions of Participation A Condition level deficiency can be n o n c o m p l i a n c e with requirements in a single M e d i c a r e standard that, collectively, result in a severe or critical health or safety breach, or it can be n o n c o m p l i a n c e with several standards within the condition. C o n d i t i o n s of Participation are standards C M S sets forth that health care organizations m u s t m e e t in order to begin and continue participating in the M e d i c a r e and Medicaid p r o g r a m s . T h e s e health and safety standards are t h e foundation f o r i m p r o v i n g quality and p r o t e c t i n g the health and safety of beneficiaries. COPC Core Privilege Plus Viewer COW C o m m u n i t y Oriented Primary Care C O P C describes Parkland's system of eleven primary care centers. On-line system that provides i n f o r m a t i o n about p r o c e d u r e s providers will p e r f o r m at Parkland. A scheduler g o e s into the V i e w e r to c o n f i r m the provider has privileges at Parkland, C o m p u t e r on W h e e l s A portable c o m p u t e r w o r k s t a t i o n in w h i c h the clinical staff d o c u m e n t patient care in the hospital's electronic medical record. It is s o m e t i m e s referred to as a " W O W " , for 'Workstation On Wheels'. CPOE C o m p u t e r i z e d Physician Order Entry T h e process of electronic entry of medical, practitioner instructions for the treatment of patients. Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential f o r investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Terra CPT Expansion / Unabridged Version Current Procedural T e r m i n o l o g y Definition / Explanation T h e C P T code set (maintained by the A M A J describes medical, surgical, and diagnostic services and is designed to c o m m u n i c a t e uniform information about medical services and procedures a m o n g physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. Crash Cart A cart that is readily accessible to health care w o r k e r s and strategically placed in sites in a hospital w h e r e patients c o m m o n l y ' c r a s h ' ( u n d e r g o acute cardiovascular d e c o m p o s i t i o n ) e.g., recovery r o o m . ER, JCU. CRNA CT D&C Certified Registered N u r s e Anesthetists Computed Tomography Dilatation & Curettage A nurse w h o is trained and licensed to give anesthesia. Anesthesia is given b e f o r e and during surgery so that a person does not feel pain. C o m p u t e d t o m o g r a p h y (CT), is a medical i m a g i n g m e t h o d e m p l o y i n g t o m o g r a p h y created by c o m p u t e r processing. A diagnostic g y n e c o l o g i c a l procedure during which dilation ( w i d e n i n g / o p e n i n g ) of the cervix and surgical removal of part of the lining of the uterus and/or contents of the uterus by s c r a p i n g and s c o o p i n g (curettage) occurs. Dallas Health Leadership Team Dallas County Behavioral Health Leadership Team T h e B H L ' f seeks to unite all stakeholders to oversee the Dallas County behavioral health system, including both mental health and chemical d e p e n d e n c y . This organization f u n c t i o n s as a single point of accountability, planning, oversight, and f u n d i n g coordination for all Dallas C o u n t v behavioral health services and f u n d i n g streams. Direct A d m i s s i o n s Patients admitted directly to the hospital inpatient unit without a preceding and initial evaluation in a hospital outpatient unit such as the e m e r g e n c y d e p a r t m e n t or an observation unit. Discharge Care D e v e l o p m e n t of a post discharge care plan, which could include identification of f a m i l y / f r i e n d support for h o m e care, nursing h o m e care, skilled nursing care, h o m e health care, hospice or substance abuse care. C o m p o n e n t s of discharge care plans include education and f o l l o w i n g up with patients after they leave the hospital. Durable Medical Equipment M e d i c a l e q u i p m e n t that is ordered by a doctor (or, if M e d i c a r e allows, a nurse practitioner, physician assistant or clinical nurse specialist) for use in the h o m e . T h e s e items must be reusable, such as walkers, wheelchairs, or hospital beds. DME DRG Diagnostic Related G r o u p Patient classification s c h e m e devised by H C F A (now C M S ) w h i c h p r o v i d e s a m e a n s of relating the type of patients a hospital treats to the costs incurred by the hospital. Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Terra DSHS DSU Expansion / Unabridged Version State of Texas Department of State Health Services Day Surgery Unit Definition / Explanation Texas state department whose mission is to improve health and well-being in Texas. The unit that provides pre- and post-operative care for patients having a surgical procedure in which the patient is able to go home generally after several hours of recovery. An evaluation of prescribing patterns of physicians to specifically determine the appropriateness of drug therapy. Portable o x y g e n tank DUE E-cylinders EKG Drug Utilization Evaluation El echocardiogram A test [hat records the heart's electrical activity. An EKG shows: how fast a person's heart, is beating, whether the rhythm of a person's heartbeat is steady or irregular, the strength and timing of electrical signals as they pass through each part of a person's heart. It can sometimes exhibit changes due to either acute or chronic damage to the heart's muscle. The medical specialty in which physicians care for patients with acute illnesses or injuries which require immediate medical attention. The sudden and unexpected onset of a health condition that requires immediate medical attention, if failure to provide medical attention would result in serious impairment to bodily functions or serious dysfunction of a bodily organ or part, or would place the patients' health in serious jeopardy. EMRs are computerized legal clinical, records created in Care Delivery Organizations (CDOs), such as hospitals and physician offices. EHRs represent the ability to easily share medical information among stakeholders and to allow it to follow the patient through various modalities of care. EM EMC Emergency Medicine Emergency Medical Condition EMR Electronic Medical Record EMS EMTALA EMS is used to reference patient1 arrival at the hospital by ambulance or other emergency transport. Emergency Medical Treatment and Labor Act EMTALA is a federal law that requires any Medicare-participating hospital that operates a hospital emergency department to provide an appropriate medical screening examination to any patient that requests such an examination. If the hospital determines that the patient has an emergency medical condition, it must either stabilize the patient's condition or arrange for a transfer; however, the hospital may only transfer the patient if the medical benefits of the transfer outweigh the risks or if the patient requests the transfer. Emergency Medical Services Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page16of 19 Confidential f o r investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term ENI tpic Epic EDI S Expansion / Unabridged Version Otorhinolarynaoloav Definition / Explanation T h e branch of medicine and surgery that specializes in the diagnosis and treatment of ear, nose, throat, and head and neck disorders. A n electronic medical records ( E M R ) system sold by Epic. Inc. Epic's e m e r g e n c y d e p a r t m e n t information system application, it is s o f t w a r e that includes an E M R as well as applications that track patients' progress in the e m e r g e n c y d e p a r t m e n t , enable providers to enter m e d i c a t i o n orders, write prescriptions, read lab and x-ray reports, and provide m e a n s of secure electronic c o m m u n i c a t i o n s . ESD E m e r g e n c y Services D e p a r t m e n t T h e service area of the Parkland Hospital Department o f E m e r g e n c y Services that provides care f o r (a) patients over the age of 18 with medical complaints; (b) t r a u m a patients over the age of 14; and (c) pediatric burn patients. S o m e t i m e s referred to as the " M a i n ED". ESI E m e r g e n c y Severity I n d e x T h e E m e r g e n c y Severity I n d e x is a five-level e m e r g e n c y d e p a r t m e n t triage algorithm that provides clinically relevant stratification of patients into five g r o u p s f r o m 1 (most urgent) to 5 (least urgent ) on the basis of acuity and resource needs. ESU Electrosurgical Unit High f r e q u e n c y electric currents are used to cut, coagulate, d e h y d r a t e or f u l g u r a t e tissues. In order to avoid or reduce the blood loss d u r i n g surgery, an electrosurgical unit is used. ETOH ETOH withdrawal A shorthand form of ethanol, a chemical c o m p o u n d . It is a term ( s o m e t i m e s E T . O . l l . ) used by E m e r g e n c y Medical T e c h n i c i a n s ( E M T s ) and other first r e s p o n d e r s to describe a patient w h o is displaying s y m p t o m s of o v e r - c o n s u m p t i o n , or withdrawal f r o m , alcoholic beverages. It is also s o m e t i m e s simply used as shorthand for alcohol (e.g. the patient c o n s u m e d 12 shots of E t O H ) . EVS FPPE PTE Gl GU E n v i r o n m e n t a l services F o c u s e d Professional Practice Evaluation Full time equivalent Gastrointestinal Genitourinary T h e d e p a r t m e n t responsible for m a i n t a i n i n g a clean e n v i r o n m e n t that is c o m p l i a n t with regulatory and infection control standards required for hospitals. Evaluation of clinical c o m p e t e n c e for providers, required by T J C - required for n e w providers. An F T E represents a full time position of 40 hours per w e e k . T h e h u m a n gastrointestinal tract refers to the stomach and intestine, and s o m e t i m e s to all the structures f r o m the m o u t h to the anus. T h e organ system of the reproductive organs and the urinary system. Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term GYN H&P Expansion / Unabridged Version Gvnecoloey History and Physical Examination reproductive system. Definition / Explanation G y n e c o l o g y is the branch of medicine that deals with diseases and disorders of the f e m a l e Medical providers are required to c o m p l e t e a medical history and c o m p l e t e a physical e x a m i n a t i o n on patients prior to surgery, on admission to hospitals, and in m a n a g i n g the care of patients. HIM Hospitaiisl HR Health Information M a n a g e m e n t H I M is a hospital d e p a r t m e n t that is responsible for maintaining and facilitating the c o m p l e t i o n of t h e hospital's patient records. A hospital-based general physician. Hospitalists a s s u m e the care of hospitalized patients in the place of patients' primary care physician, H u m a n Resources HR is the hospital's personnel department, which m a n a g e s and facilitates the e m p l o y e e functions of the hospital, such as hiring, benefit m a n a g e m e n t , e m p l o y e e appraisals, etc. HUG Health Unit Coordinator H I J C s m a y also be referred to as unit clerks, ward clerks, or unit secretaries. T a s k s that are usually p e r f o r m e d by H U C s are m a i n t a i n i n g patient charts and records, o r d e r i n g supplies, c o m m u n i c a t i n g with the dietary department, preparing special d o c u m e n t s and coordinating patient activities for the unit. Hygrometer 1AHCSMM ICC H u m i d i t y monitor Internationa! Association of Healthcare Central Service Materiel M a n a g e m e n t Intermediate Care Center An e m e r g e n c y services area at Parkland Hospital, operating u n d e r t h e D e p a r t m e n t of E m e r g e n c y Services, that provides specialized e m e r g e n c y and urgent care f o r w o m e n . ICD Implantable Cardiac Defibrillator An I C D is a small battery-powered electrical impulse generator which is i m p l a n t e d in patients w h o are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. T h e device is p r o g r a m m e d to detect cardiac arrhythmia and correct it by delivering a j o l t of electricity. A & M is the c h o s e n ICE consultant required by the System I m p r o v e m e n t A g r e e m e n t (SIA) b e t w e e n C M S and Parkland Hospital & Health Systems. W I S H N N I C U Unit A situation in w h i c h the p r o v i d e r ' s n o n c o m p l i a n c e with one or m o r e r e q u i r e m e n t s of M e d i c a r e participation has caused, or is likely to cause, serious injury, harm, i m p a i r m e n t , or death to a resident. ICE 1CN IJ Independent Consultative Expert Intensive Care N u r s e r y i m m e d i a t e Jeopardy IM Important M e s s a g e f r o m M e d i c a r e T h e I M is a standard notice that m u s t delivered to all Medicare inpatients on a d m i s s i o n and b e f o r e discharge. Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term Impaired Physician Program indigent Inpatient iou / Unabridged Version impaired physicians. Definition / Explanation A p r o g r a m for the prevention, detection, intervention, monitoring, and treatment of Population e x p e r i e n c i n g extreme poverty. An inpatient is a person w h o has been admitted to a hospital for bed o c c u p a n c y for p u r p o s e s of receiving inpatient hospital services. Generally, a patient is considered an inpatient if formally admitted as inpatient with the expectation that he or she will r e m a i n at least overnight and o c c u p y a bed even t h o u g h it later develops that the patient can be d i s c h a r g e d or transferred t o another hospital and not actually use a hospital bed overnight. IR IV JC. T J C Interventional Radiology Intravenous Joint C o m m i s s i o n interventional radiology is a medical sub-specialty of radiology which utilizes m i n i m a l l y invasive i m a g e - g u i d e d procedures to diagnose and treat diseases. T h e i n f u s i o n of liquid substances directly into a vein. Formerly k n o w n as the Joint C o m m i s s i o n on Accreditation of Healthcare O r g a n i z a t i o n s ( J C A H O ) , t h e Joint C o m m i s s i o n is a United States-based not-for-profit organization that accredits over 19,000 health care organizations and p r o g r a m s in the United State. Joint C o m m i s s i o n accreditation and certification is recognized nationwide as a symbol of quality that reflects an o r g a n i z a t i o n ' s c o m m i t m e n t to m e e t i n g certain p e r f o r m a n c e standards. L&D LDR Ligature I,IP LOD LVN LWOBS Labor and delivery Labor, delivery and recovery room Hospital unit designated f o r the care of w o m e n in labor and f o r childbirth. T h e standard room to give birth in is the s a m e room that a w o m a n will labor, give birth and spend during her i m m e d i a t e postpartum recovery. S o m e t h i n g that is used to bind; specifically : a filament (as a thread) used in surgery. Source: http://www.merriam-webster.com/dictioiiary/Iigature. Licensed independent practitioner Leadership and Organization D e v e l o p m e n t Licensed Vocational N u r s e s Left without b e i n e seen Practitioners w h o can issue certain orders or p e r f o r m certain procedures in the hospital setting (restraints for e x a m p l e ) . A d e p a r t m e n t with t h e H u m a n Resources D e p a r t m e n t of Parkland, responsible for leadership d e v e l o p m e n t . Care for p e o p l e w h o are sick, injured, convalescent, or disabled under the direction of physicians and registered nurses. They provide basic bedside care. Left Without B e i n g Seen is a term o f t e n used by emergency d e p a r t m e n t s to designate a patient encounter that e n d e d with the patient leaving the healthcare setting b e f o r e they w e r e seen by a certified physician. Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Terra LWOT Expansion / Unabridged Version Left without treatment Meaningful Use Definition / Explanation Refers to any patient who leaves the emergency department after having received an MSE (Medical Screening Examination) but before the emergency physician or other type of provider documented completion of treatment. The Medicare and Medicaid EHR Incentive Programs provide a financial incentive for the "meaningful use" of certified EHR technology to achieve health and efficiency goals. The M EC acts as the organizational body which oversees the functions and duties of the medical staff. It is empowered to act for the medical staff and to coordinate all activities and policies of the staff, its departments, and committees. Medicare defines "medical necessity" as services or items reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The process of comparing a patient's medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions. It should be done at every transition of care in which new medications are ordered or existing orders are rewritten. Transitions in care include changes in setting, service, practitioner or level of care. M EC Medical Executive Committee Medical "Necessity Medication Reconciliation MH Malignant Hyperthermia Mi Miman & Roberts MRI Magnetic Resonance Imaging A rare life-threatening condition that is usually triggered by expostire to certain drugs used for genera) anesthesia. Susceptibility to MH is often inherited as an autosomal dominant disorder. Now known as Milliman, Inc., it is a large international, independent actuarial and consulting firm that publishes widely used evidence-based guidelines and software. Magnetic resonance imaging (MR!) is a medical imaging technique used in radiology to visualize detailed internal structures. MR! makes use of the property of nuclear magnetic resonance (NMR) to image nuclei of atoms inside the body. Intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner, and includes information such as physical data (melting point, boiling point, Hash point etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill-handling procedures. MSDS Material Safety Data Sheets Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term MSE Expansion / Unabridged Version Medical Screening Exam Definition / Explanation A medical screening exam is done to determine whether or not an emergency medical, not nursing, condition exists. EMTALA requires the assessment of a patient for the existence of an emergency medical condition before the patient can be transferred or released from the emergency department. The publication Life Safety Code, known as NT PA 101, is a consensus standard widelyadopted in the United States. Despite its title, the standard is not a legal code, is not published as an instrument of law, and has no statutory authority in its own right. However, it is deliberately crafted w ith language suitable for mandatory application to facilitate adoption into law by those empowered to do so. The bulk of the standard addresses "those construction, protection, and occupancy features necessary to minimize danger to life from fire, including smoke, fumes, or panic". M F PA 101 NICU, NNICU Non-Violent Restraints Northstar Medicaid Neo Natal Intensive Care Unit The intensive care unit caring for premature and/or critically ill newborn infants. See "Restraints" The North STAR program is a behav ioral health managed care project led by ValueOptions(R) that serves seven counties in the Dallas/Ft. Worth area. The NorthSTAR program provides an integrated system of care with mental health care and chemical dependency services. Also known as a hospital-acquired infection or MAI, is an infection whose development is favoured by a hospital environment, such as one acquired by a patient during a hospital visit or one developing among hospital staff. Such infections include fungal and bacterial infections and are aggravated by the reduced resistance of individual patients. Northstar Medicaid managed care plan Nosocomial Infections NP Nurse Practitioners A nurse who typically has two or more years of advanced training and has passed a special exam. A nurse practitioner often works with a doctor and can do some things a doctor does such as write prescriptions. Developed and is currently maintained by the American Academy of Pediatrics. This program focuses on the teaching and maintaining basic skills for the resuscitation of neonates. The program is intended for physicians, nurses, midwives. respiratory therapists, and paramedics involved in critical care or transport of neonates. The medical specialty dealing with the care of all women's reproductive tracts and their children during pregnancy (prenatal period), childbirth mid the postnatal period. NRP Neonatal Resuscitation Program OB Obstetrics Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential f o r investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term Obs Expansion / Unabridged Version Observations Definition / Explanation According to Medicare, observation services are furnished by a hospital on its premises, including the use of a bed, periodic monitoring by nursing and other staff, and any other services that are reasonable and necessary to evaluate a patient's condition or to determine the need for a possible (inpatient) admission to the hospital. The OMB's predominant mission is to assist the President in overseeing the preparation of the federal budget and to supervise its administration in Executive Branch agencies. A form of legal hold under Texas State Law. in which a judge or designated magistrate may issue a protective custody order if the judge or magistrate determines thai, a physician has stated his or her opinion that a patient is a chemically dependent person; and the patient presents a substantial risk of serious harm to himself or others if not immediately restrained pending a hearing. Evaluation of clinical competence for providers through peer review, required by TJC. A room equipped for performing surgical operations, it can be part of a hospital, a clinic, or ambulatory surgical center. Written documents that the administration or management of an organization uses to define an outcome (Policy), and to define the means to achieve that outcome (procedure). The Pharmacy and Therapeutics Committee reviews new and existing medications and selects medications to be included in a health plan's formulary based on safety and howwell the drugs work. The committee selects the most cost-effective drugs in each therapeutic class. A person who typically has two or more years of advanced training and has passed a special exam. A physician assistant works with a doctor and can do some of the things a doctor does. The PACU is the nursing unit which recovers patients immediately following surgery. PAEC is clinic in which a patient pre-surgery evaluation is completed by Nursing and Anesthesia. OMB Office of Management and Budget OPC Order of Protective Custody OPPE OR Ongoing Professional Practice Evaluation Operating Room Policies and Procedures P&P P&T Pharmacy and Therapeutics Committee PA Physician Assistants PACU Post Anesthesia Care Unit Pre-Anesthesia Evaluation Clinic PA EC Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term PC A Expansion / Unabridged Version Patient Care A t t e n d a n t Definition / Explanation Attendant who helps persons who are disabled or chronically ill with their activities of dailyliving (ADLs) whether within the home, outside the home, or both, '?'hey assist clients with personal, physical mobility and therapeutic care needs, usually as per care plans established by a rehabilitation health practitioner, social worker or other health care professional. A primary care physician, or PCP, is a physician/medical doctor who provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. The component of Parkland Emergency Services that focuses on those patients that need psychiatric medical care. Positron emission tomography is nuclear medicine imaging technique that produces a threedimensional image or picture of functional processes in the body. Testing performed in the presence or close proximity of a patient, allowing a healthcare professional to obtain quick results to facilitate a better informed decision on patient management. OSHA requires the use of personal protective equipment (PPE) to reduce employee exposure to hazards when engineering and administrative controls are not feasible or effective in reducing these exposures to acceptable levels. Employers are required to determine if PPE should be used to protect their workers. Meaning "as needed" source: httpr/Avww.merriamwebster.com/dictionary/pro%20re%20nata Parkiand's methodology for reporting an event which causes injury or has the direct potential to cause injury or loss of function, and Medical Error, an act or omission that is considered to be an incorrect course of action, with potential or actual negative consequences for a patient. Any time not worked by an employee for which the regular rate, a fixed or a prorated amount of pay, is accrued and paid to the employee. An automated dispensing system supporting decentralized medication management. PCP Primary Care Physician PED PET Scan PHHS POC Psychiatric Emergency Department Positron Emission Tomography Parkland Heath & Hospital System Point Of Care Testing PPE Personal Protective Equipment PR.N PSN Pro re nata Patient Safety Network PTO Pyxis / Pyxis Med Station Paid Time Off Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term QAPI Expansion / Unabridged Version Quality A s s e s s m e n t and P e r f o r m a n c e Improvement Definition / Explanation A quality and p e r f o r m a n c e i m p r o v e m e n t program aimed at providing patient centered care in an e n v i r o n m e n t that p r o m o t e s and demonstrates measurable, i m p r o v e d o u t c o m e s for ail patients. Parkland Hospital's oversight quality c o m m i t t e e Usually referenced in E M T A L A discussions. A Q M P is an individual the hospital has designated as a qualified medical professional through credentialing, etc. T h e process used for investigating and categorizing the root causes of adverse events. Food and nutrition expert w h o has m e t the m i n i m u m a c a d e m i c and professional requirements to qualify for the credentials. Physical restraints are any m a n u a l m e t h o d or physical or m e c h a n i c a l device, material, or e q u i p m e n t attached to or a d j a c e n t to the patients body that the individual cannot, r e m o v e easily which restricts f r e e d o m o f m o v e m e n t or normal access to ones body. C h e m i c a l restraints are any drug used f o r discipline or c o n v e n i e n c e arid not required to treat medical symptoms. A nurse w h o has graduated f r o m a nursing program at a university or college and has passed a national licensing e x a m . Hospitals that serve an essential role in their communities, providing inpatient and outpatient care to ail patients, regardless of abilitity to pay. Outpatient surgery An a g r e e m e n t between Parkland Hospital & Health System and the Centers for M e d i c a r e and Medicaid Services, dated S e p t e m b e r 28. 2011, that allows Parkland Hospital to r e m a i n fully operational while w o r k i n g to correct deficiency f i n d i n g s related to the Center for M e d i c a r e and M e d i c a i d Services Conditions of Participation. QCC QMP RCA RD Restraints Quality of Care C o m m i t t e e Qualified Medical Professional Root C a u s e A n a l y s i s Registered Dietitians RN Safety-net SDS SIA Registered N u r s e Safety-net public hospital S a m e Day Surgery System I m p r o v e m e n t A g r e e m e n t Sitter Patient Care Attendant A "sitter" is the informal term for a Patient Care Attendant, w h i c h is a s t a f f e d position at Parkland Hospital w h o s e function is to assist nurses in patient care. P C A ' s are commonlyassigned to maintain observation over vulnerable patients such as those in restraints, susceptible to falls, or with disabilities. A large c o m p a r t m e n t a l i z e d delivery system f o r 6six infants to be transported simultaneously. Six pack SMTT Stabilizing Medical T r e a t m e n t or T r a n s f e r T r e a t m e n t required under E M T A L A Pursuant to Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term Soft Restraints Expansion / Unabridged Version Definition / Explanation See "Restraints". "Soft" restraints are devices made of material that are designed to safely fit around the wrists, ankles, or chest of a patient to prevent excessive movement. Hospital department responsible for cleaning, preparing, processing, sterilizing, storing, and issuing equipment and instruments and equipment that can be sterilized and re-used for other patients A f o r m o f acquired brain injury, o c c u r i n g w h e n a sudden t r a u m a causes d a m a g e to t h e SPD Sterile Processing Department TBI Traumatic Brain Injury brain. TBI can result when the head suddenly and violently hits an object, or when an object pierces the skull and enters brain tissue. S y m p t o m s of a TBI can be mild, m o d e r a t e , or severe, depending on the extent of the damage to the brain. Teletracking System Termination Notice Thoracentesis Time Out TJC The Joint Commission Patient tracking system; allows for concurrent tracking of turnaround time, therefore delays in service can be identified more readily. Notice from Medicare that the facility is terminated from the Medicare program. A procedure to remove fluid from the space between the lining of the outside of the lungs (pleura) and the wall of the chest. Universal protocol prior to the initiation of a medical procedure done to prevent wrong person, wrong procedure, wrong site surgery. Formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), it is a United States-based not-for-profit organization that accredits over 19,000 health care organizations and programs in the United Stales. Treat-and-release ED visits are those ED visits in which patients are treated and released from the ED (i.e., they are not admitted to the specific hospital in which the ED is located). While the majority of treat-and-release patients are discharged home, some are transferred to another acute care facility, leave against medical advice, go to another type of long-term or intermediate care facility (nursing home or psychiatric treatment facility), are referred to home health care, or are discharged alive but the destination is unknown. The process of determining the priority of pat ients' treatments based on the severity of their condition. In an emergency hospital, the triage nurse to quickly assess patients' condition to determine patients priority of treatment. Treat & Release Triage Triage Nurse Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Confidential for investigation and review by quality assurance/improvement committees or designated agent(s). Abbr. / Term T r i g g e r Event Expansio Definition / Explanation Triggers describe situations that will c a u s e the hospital surveyor to consider if f u r t h e r investigation is needed to d e t e r m i n e the presence of Immediate Jeopardy, per C M S . Triggers arc situations that most likely create j e o p a r d y to an i n d i v i d u a l ' s p s y c h o l o g i c a l and/or physical health a n d safety. ucc UM Urgent Care Center T h e Urgent Care Center at Parkland is a c o m p o n e n t of the Emergency D e p a r t m e n t that is designed to care f o r less acute patients w h o are anticipated to need only outpatient care. Unit M a n a g e r Daily m a n a g e m e n t of unit activities including staff supervision and d e v e l o p m e n t , p l a n n i n g , budget, quality and facility-' operations and coordinating patient services to ensure high quality patient care and optima! o u t c o m e s . US Ultra S o u n d University of Texas Southwest ern Ultrasound refers to s o n o g r a p h y testing which utilizes sound w a v e s to produce pictures of inner structures of the body. U T Southwestern refers to the University of T e x a s Southwestern M e d i c a l School located in Dallas that incorporates U T Southwestern G r a d u a t e School of Biomedical Sciences, and Southwestern School of Health Professions. UTSW V a n c o m y c i n - R e s i s t a n t Entercoccal infections VRE WISH WOW W o m e n Infants and Specialty Services Workstation on W h e e l s V a n c o m y c i n - r e s i s t a n t Enterococcus , or vancomycin-resistant enterococci ( V R E ) , are that are resistant to the antibiotic v a n c o m y c i n . bacterial strains of the genus Enterococcus A c o m p r e h e n s i v e service line at Parkland providing care for w o m e n and infants. Also, " C O W " . A portable c o m p u t e r workstation in which the clinical staff d o c u m e n t patient care in the hospital's electronic medical record. Pursuant t o Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. seq., this information is confidential and privileged. Page 16 of 19 Exhibit C - P a r k l a n d Heath & Hospital System Organizational Chart Confidential for investigation and review by i/uality assurance/improvement committees Section 160.007 of Texas Occupations Code and 42 (JSC 11101 et. set/., this information or designated agent(s). Pursuant is confidential and privileged. to EVP/Chief of Hospital Operations Josh Floren oPsychiatry Svcs oNPC Transition Planning EVP/CNO Miriam Sibley oDirectors of Nursing oNursing Administration <