North Carolina Department of Health and Human Services Division of Health Service Regulation Pat McCrory Aldona Z. Wos, M.D. Governor Ambassador (Ret.) Secretary DHHS Drexdal Pratt, Director HAND DELIVERED NOTICE ADMINISTRATIVE ACTION ANBULATORY SURGERY CENTER LICENSE TO: Lorraine Cummings, MD, Owner FEMCARE, Inc. 63 Orange Street Asheville, 28801 FROM: Azzie Y. Conley, RN Section Chief Acute and Home Care Licensure and Certification Section SUBJECT: Summary Suspension of Your License to Operate Certificate No. AS0004 FD) No. 943170 DATE: July 31, 2013 Pursuant to North Carolina General Statutes N.C.G.S. the Division of Health Service Regulation (DHSR), North Carolina Department of Health and Human Services (DI-H-IS), HEREBY SUSPENDS YOUR CERTIFICATE TO OPERATE FEMCARE, Inc., an ambulatory surgery facility. YOU ARE HEREBY DIRECTED TO CLOSE FEMCARE, Inc, BY NO LATER THAN 5:00 P.M. ON July 31, 2013. AGENCY FINDINGS This Summary Suspension is based on this agency's findings that conditions at FEMCARE, Inc., presents an imminelit danger to the health, safety and welfare of the clients and that emergency action is required to protect the clients. This agency has identified the facility failed to be in substantial compliance with Rules for which they are licensed. this Acute and Home Care Licensure and Certification Section 'fir l1ttp:/ /WWw.nccihlis.gov/d11sr/ Phone: (919) 855-4620 Fax: (919) 7i5-3073 Mailing Address: 2712 Mail Service Center Raleigh, Nortll Caroiina 27699-2712 A Location: 1205 Umstead Drive (Lineberger Building) Dorothea Dix Hospital Campus Raleigh, N.C. 27603 An Equal Opportunity Affirmative Action Empioyer Dr. Lorraine Cummings, Owner FEMCARE, Inc. July 31, 2013 Page Two of Four On July 18, 2013 through July 19, 2013, staff with the Acute and Home Care Licensure and Certification Section surveyed FEMCARE, Inc. Therefore, it is the finding of this agency that the facility has neglected to provide the services to assure the health, safety and welfare of the clients. As a result of the survey findings, the Section substantiated Rule violations that include: 10A NCAC 1 3 .03 0 Governing Authority 10A NCAC 13C .030 l(b) Governing Authority 10A NCAC 13C .030l(c) Governing Authority 10A NCAC 13C .03 03 Administrative Records 10A NCAC 13 .03 05(a) Personnel 10A NCAC 13C .0305(e) Personnel 10A NCAC 13C .03 06(a) Quality Assurance 10A NCAC 13C .03 06(b) Quality Assurance 10A NCAC 13C .0306(d) Quality Assurance 10A NCAC 13C .0401(b) Medical Services 10A NCAC 13C .0403 Emergency Cases 10A NCAC 13 .05 02 Equipment 10A NCAC 13C .0801 Drug Dispensing 10A NCAC 13C .090 1(a) Nursing Administration 10A NCAC 13C .0901(b) Nursing Administration 1 0A NCAC 13C . 1 0 1 (0) Operating Suite 10A NCAC 13C .l20l(a) General 10A NCAC 13C .1301 General 10A NCAC 13C .1302(a) Sterilization Procedures 10A NCAC 13C .l302(b) Sterilization Procedures 10A NCAC 13C .13 02(c) Sterilization Procedures 10A NCAC 13C .l302(d) Sterilization Procedures 10A NCAC 13C .1303 Housekeeping Review of survey findings revealed a potential imminent threat to the health and safety of patients. Based on the survey findings, the facility failed to have an organized and operational governing body. The facility failed to have policies and procedures current with standards of practice; failed to ensure anesthesia was administered to patients in a safe manner; failed to have a contract with an anesthetist; failed to have a contract with a pharmacist; failed to ensure staff were trained in the operations of the defibrillator to manage emergency situations, failed to have a Director of Nursing and organized nursing staff; failed to ensure staff were trained in infection control standards; failed to ensure equipment was appropriately sterilized and monitored; and failed to implement a quality improvernent program. Observations during the survey of July 18, 2013 through July 19, 2013, revealed facility staff failed to ensure the nitrous oxide gas delivery system was functioning appropriately. Observations revealed nasal masks used for the administration of nitrous oxide were torn and not intact, tubing was taped in layers at all connection sites, and no evidence of preventative maintenance on the nitrous oxide delivery system. The facility's failure to maintain a fully functioning nitrous oxide delivery system could affect the amount of the nitrous oxide delivered to the patient. Therefore, the patient would 11ot receive the intended dosage of nitrous oxide medication as ordered by the physician for surgical abortion procedures. Thereby, the liealth, safety, and welfare of all patients is at risk of not being fully sedated during surgical procedures leading to pain and movement resulting in harm. Thereby, placing any patient who receives nitrous oxide at risk. Dr. Lorraine Cummings, Owner FEMCARE, Inc. July 31, 2013 Page Three of Four The Report of Survey upon which the agency's decision is based is enclosed. During the onsite survey, deficiencies were identified and discussed with facility staff on July 19, 2013 and via telephone July 31, 2013. Therefore, it is the finding of this agency that the facility has neglected to provide the services to assure the health, safety and welfare of the patients. APPEAL NOTICE You have the right to contest this summary suspension of your certificate by filing a petition for a contested case hearing with the Office of Administrative Hearings (OAH) within sixty (60) days of your receipt of this letter. For complete instructions on the filing of petitions, please contact OAH at (919) 733-2698. The mailing address for OAH is as follows: Office of Administrative Hearing 6714 Mail Services Center Raleigh, NC 27699-6714 N.C.G.S. 15013-23 provides that you must also serve a copy of the petition on all other parties, which includes The Department's representative for such actions is Ms. Emery Edwards Milliken, General Counsel. This person may receive service of process by mail at the following address: Ms. Emery Edwards Milliken, General Counsel NC Department of Health and Human Services Office of Legal Affairs 2005 Mail Service Center Raleigh, NC 27699-2005 Ifyou do not file a petition within the sixty (60) day period, you will lose your right to appeal this Summary Suspension. In addition to your right to file a petition for a contested case hearing, NC. Gen. Stat. l50B-22 encourages the settlement of disputes through informal procedures. In keeping with this law, this office remains readily available for discussion or other informal procedures to assist in resolving any dispute you may have with our findings and action. Please note that the use of informal procedures does not extend the sixty (60) days allowed to file for a contested case hearing as explained above. Should you have any questions regarding any aspect of this letter, please do not hesitate to contact me at the Department of Health and Human Services, Division of Facility Services,.Acute and Home Care Licensure and Certification Section, 2712 Mail Service Center, Raleigh, North Carolina 27699-2712 or contact me at (919) 855-4646. cc: Drexdal Pratt, Director, Division of Facility Services Cheryl Quimet, COO, Division of Facility Services Emery Edwards Milliken, General Counsel, Department of Health and Human Services File Dr. Lorraine Cummings, Owner FEMCARE, Inc. A uly 31, 2013 Page Four of Four STATE OF NORTH CAROLINA COUNTY OF DURHAM This Notice of Administrative Action, dated July 31, 2013, was hand delivered on July 31, 2613. The document was delivered in person by Paul D. William, MT, with the Acute and Home Care Licensure and Certification' Section on July 31, 2013. Signature of Recipient Signature of Section Representative Date Dr. Lorraine Cummings, Owner FEMCARE, Inc. July 31, 2013 STATE OF NORTH CAROLINA COUNTY OF DURHAM This Notice of Administrative Action, dated July 31, 2013, was hand delivered on July 31, 2013. The document was delivered in person by Paul D. William, MT, with the Acute and Home Care Licensure and Certification Section on July 31, 2013. Signature of Recipient Signature of Section Representative Date North Carolina Department of Health and Human Services Division of Health Service Regulation 'e Pat McCrory Aldona Z. Wos, M.D. Governor Ambassador (Ret.) Secretary Drexdal Pratt, Director VIA EMAIL NOTICE OF INTENT TO REVOKE AMBULATORY SURGICAL FACILITY LICENSE TO: Dr; Lorraine Cummings, MD, Owner - Femcare, Inc. 63 Orange Street Asheviile, NC 28801 - FROM: Azzie Y. Conley, RN Section Chief Acute and Home Care Licensure and Certification Section SUBJECT: Intent to Revoke Your License to Operate AS0004 . l)A'l'E: July 26, 2013 PROPOSED AGENCY ACTION The North Carolina Department of Health and Human Services, Division of Health Service Regulation, Acute and Home Care Licensure and Certification Section, has determined that you have substantialiy failed to comply with the provisions of Article 6 Part 4 of Chapter ?l31E-145 of the North Carolina General Statute and the rules promulgated under that Part based on the survey conducted by the Licensure and Certification Section on July 18, 2013 through July 19, 2013. The Department, therefore, intends to revoke your Ambulatory Surgical Facility license. This amendment is based on the failure to comply with the following: 4% 10A 10A 10A 10A 10A 10A 10A 10A 10A 10A NCAC NCAC NCAC NCAC NCAC NCAC NCAC NCAC NCAC NCAC 13C .0301(a) Governing Authority 13 .030 103) Governing Authority 13C .0301(c) Governing, Authority 13C .0303(a) Administrative Records 13C .0305(a) Personnel 13C .0305(e) Personnei 13C .0306(a) Quality Assurance 13C .0306(b) Quality Assurance 13C .0306(d) Quality Assurance' 13C .040 (19) Medical Services :31: Acute and Home Care Licensure and Certification Section http:/ Phone: (919) 855-4620 Fax: (919) 715-3073 . Mailing Address: 2712 Mail Service Center Raleigh, North Carolina 27699-2712 Location: 1205 Umsteaci Drive (Lineberger Building) Dorothea Dix Hospital Campusnv Raleigh, N.C. 27603 An Equal Opportunity Affirmative Action Employer Page 2 Dr. Lorraine Cummings, Owner July 26, 2013 6 10A NCAC 13C .0403(b) Emergency Cases 9 10A NCAC 13C .0502 Equipment 0 10A NCAC 13C .0801 Drug Dispensing 10A NCAC 13C .0901(a) Nursing Administration 10A NCAC 13C .090 Kb) Nursing Administration 0 10A NCAC 13C .ll01(c) Operating Suite 6 10A NCAC 13C .1201(a) General 0 10A NCAC 13C .1301 General 9 10A NCAC 13C .1302(a) Sterilization Procedures 6 10A NCAC 13C .1302(b) Sterilization Procedures at 10A NCAC 13C .l302(c) . Sterilization Procedures 0 10A NCAC .l302(d). Sterilization Procedures 0 10A NCAC 13C. 1303 Housekeeping NOTICE OF OPPORTUNITY TO DEMON STRATE COMPLIANCE WITH LICENSING LAWS AND RULES Pursuant to N. C. General Statute you are hereby given an opportunity to show compliance with all lawful requirements for retention of your license to operate Femcare, Inc. If you believe that you have substantially complied with the licensure rules for ambulatory surgical facilities, you may submit a written statement to this agency. The statement should clearly set out all of the reasons showing that you contend compliance. . . You may attach supporting documents to your statement. Send your written statement and any supporting documents to the attention of: Azzie Conley, Section Chief Division of Health Service Regulation Acute and Home Care Licensure and Certification Section 2712 Mail Service Center Raleigh, NC 27 699-2712 In order to be considered, your written statement must be received by this agency within 10 calendar days after you receive this notice. CON SEQUENCE OF FAILURE TO SUBMIT WRITTEN STATEWNT If the agency does not receive a written statement from you within 10 calendar days after you receive this notice, the agency will revoke your license. If the agency receives a written statement within the time specified, the agency will carefully review the statement and any documents submitted with it. Following the review, the agency will decide to amend your license. Any person aggrieved by this decision may file a petition for a contested case hearing in accordance with G5. 15013, Article 3, as amended. This petition must be filed with the Omce of Administrative Hearings, P.O. Drawer 27447 Raleigh, North Carolina 27611- 7477 within sixty (60) days of receipt of this notice. G.S. 150-B-23 provides that a party filing a petition must also serve a copy of the petition on all parties to the petition. Therefore, if you file a_.petition for a contested case hearing,_ you must serve a copy of the petition on the Department of Health and Human Services by Inhihng a copy of your petition to: 2 Emery E. Millikan General Counsel Office of Legal Affairs Adams Building Room 111 2005 Mail Service Center . Raleigh, NC 27699-2005 We will notify the appropriate agencies by copy of this letter. Piease -contact our office if there are any questions about this process. Please McCarty, urse Consultant at (919) 8554620 or me should -you have questions or need additional information regarding this notice or your right to show compliance with all lawful requirements for retention of your home care license. Pat McCrory North Carolina Department of Health and Human Services Division of Health Service Regulation Aldona Z. Wos, M.D. Governor Ambassador (Rot) Secretary DHIIS Drexdal Pratt, Director July 26, 2013 Lorraine Cummings, M.D., Owner Femcare, Inc 63 Orange Street Asheyille, NC 28801 Re: Licensure Survey Dear Dr. Cummings, Thank you and your staif for the assistance and cooperation extended during the licensure survey at Femcare, Inc in Asheville, NC from Iuly 18, 2.613 through July 19, 2013. The investigation was conducted in order to determine the facility's compliance with the NC Rules Governing the Licensure of Ambulatory Surgical Facilities. As discussed in the exit conference, deficiencies' were in the area of 10A NCAC 13C NC Rules Governing the Licensure of Ambulatory Surgical Facilities. 1 Enclosed please find CMS Form 25 67, "Statement of Deficiencies and Plan of Correction," containing the cited deficiencies. A plan of correction for the deficiencies must be submitted and should include the following: A description of the corrective action(s) and the systems that have been or will be implemented to correct the deficiency. A description of the monitoring system that has been or will be implemented The date by which all corrective actions will be completed and the monitoring ,.An original of the enclosed form CMS 2567, with the plan of correction added, must be returned to this office, SIGNED AND DATED, VVITMN 10 CALENDAR DAYS OF We are unable to accept e<<-mailed or faxed reports at this time. A response will be" sent ONLY if the plan of correction is not approved Please retain a copy for your files. Ifyou have any questions, please feel free to contact me hy caliing (919) 855- 4620. Debbie McCarty, RN Nurse Consultant Acute and Home Care Licensure and Certification Section Enclosures: State Form Statement of Deficiencies 41% as Acute and Home Care Licensure and Certification Section Phone: (919) 855-4620 Fax: (919) 715-3073 Mailing Address: 2712 Mail Service Center Raleigh, North Carolina 27699-2712 Location: 1205 Urnstead Drive (Lineberger Building) Dorothea Dix Hospital Campus Raleigh, NC. 27603 An Equal Opportunity I Aflirmative Action Employer .4 - . -. Division of Health Service Regulation PRINTED: FORM APPROVED STATEMENT OF AND PLAN OF CORRECTION (Xi) IDENTIFICATION NUMBER: 29130055 (X3) DATE sunvsv COMPLETED MULTIPLE CONSTRUCTION A. BUILDING: B-WW3 0711912013 NAME OF PROVIDER OR SUPPLIER INC STREET ADDRESS, CITY. STATE, ZIP CODE 63 ORANGE STREET ASHEVILLE, NC 2880'! (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) PLAN OF CORRECTION PREFIX (EACH CORRECTIVE ACTION SHOULD BE TAG CROSS--REFERENCED TO THE APPROPRIATE DEFICIENCY) (X5) COMPLETE DATE 000 INITIAL COMMENTS An unannounced licensure survey was conducted on JuIy18, .2013 through July 19, 2013. Based . on the survey findings, violations of the rules were identified. The facility failed to follow standard infection control practices as recommended by Centers for Disease Control and Prevention. Review of the CDC (Centers for Disease Controi and Prevention) guidelines for the sterilization of surgical instruments reveaied the sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic. status of the processed items. Survey findings revealed no mechanical. chemical, and biological indicators were used for monitoring the sterilization process. The failure to ensure proper sterilization of surgical instruments could result in infections. Pursuant to North Carolina' General Statutes N.C.G.S. the Division of Health Service Regulation (DHSR), North Carolina Department of Health and Human Services A (DHHS), HEREBY INTENDS TO REVOKE THE LICENSE TO OPERATE FEMCARE, INCL, an ambulatory surgical facility.- .0301 (A) GOVERNING 3C.O301 The facility's governing authority shall adopt bylaws or other appropriate operating policies and procedures which shall: (1) specify by name the person to whom responsibility for operation and maintenance of the facility is delegated and rneihods established by 000 Q111 Division of Health Service Regulation LABORATORY OR REPRESENTATIVES SIGNATURE TITLE (X6) DATE smre FORM 6899 If continuation sheet 1 of 41 . PRINTED: FORM APPROVED Division of Heaith Service Regulation STATEMENT or (X1) enovloan/sUPPLlERrcLIA (X2) MULTIPLE oonsrnucnon (x3) DATE SURVEY AND PLAN or CORRECTDN IDENTIFICATION NUMBER: COMPLETED A. BUILDING. 20130055 3- 07/1 912013 NAME or PROVIDER on sueetran STREET ADDRESS, crrv, STATE, ZIP cops 63 ORANGE STREET ARE INC FE ASHEVILLE, no 23301 (X4) "3 SUMMARY STATEMENT or: in PLAN or (X5) (EACH DEFECIENCY MUST BE i=Rr-gceoso av FULL PREFIX (EACH SHOULD BE coMI=i.E.Te TAG REGULATORY on Lso EDENTIFYING TAG TO THE DATE 1 111 Continued From page 1 111 the governing authority for holding such individuals responsible; (2) provide for at least annual meetings of the governing authority if the governing authority consists of two or more individuals. Minutes shall be maintained of such meetings; (3) maintain a policies and procedures manual which is designed to ensure professional and safe care for the patients. The manual shall be reviewed, and revised when necessary, at ieast annuaiiy. The manual shall include provisions for administration and use of the facility, corn plianoe, personnel quality assurance, procurement of outside services and consultations, patient care poiicies and services offered; and (4) provide for annual reviews and evaiuations of the facility's policies, management, and operation. This Ruie is not met as evidenced by: Based on review of the facility's poiicies and procedures and physician interview, the . governing authority failed to ensure annual review of policies was conducted. The findings include: Review of the facility's policies and procedure manual on 07/1 8/2013 revealed the most recent review of poiicies was March 1990. interview on 07/19/2013 at 1440 with Physician A (owner) revealed the physician was a solo practice and she was the governing authority for the facility. The physician interview revealed there were a number of poiicies that were not I Division of Health Service Regulation STATE FORM 5899 9M'iG'l'l if continuation sheet 2 of 41 .. 2. ::or - - =r . In Division of Health Service Regulation PRINTED: 07/29/2013 FORM APPROVED 10A-13C.03D1 When services such as dietary, iaundry, or therapy services are purchased from others, the governing authority shall be responsible to assure the supplier meets the same local and state standards the facility would have to meet if it were providing those services itself using its own staff. This Rule is not met as evidenced by: Based on observation during tour of the facility, review of agreements and staff and physician interviews, the facility's governing authority failed to ensure oversight of housekeeping services. The findings include: Review of a "Cleaning Contract" signed revealed 'Tuesday: down bottom or operating room beds; Sweep entire building; hallways, bathrooms, exam rooms, kitchen. and operating room area; Mop entire building with gerrnicide; Miscellaneous indoor cleaning: down walls in operating rooms every other week; Dust and clean light fixtures . or as needed." Observation on 07/18/2013 at 1740 during tour of' the operating room #1 revealed a thick layer of dust that roiled up when touched that was I . covering the top of the crash cart that was located lathe operating room (OR). Observation further STATEMENT or (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE AND PLAN or coaeecnou NUMBER: A. COMPLETED 201 30055 5- WW9 0711912013 NAME or PROVIDER or: suppose sri-tear ADDRESS, crrv, STATE, zip cone 1 63 ORANGE STREET ASHEVILLE, NC 23301 . (X4) SUMMARY STATEMENT or DEFICIENCIES PLAN or: CORRECTION . (X5) PREHX (EACH DEFECIENCY MUST es Pesceoeo BY FULL PREFIX (EACH CORRECTIVE SHOULD BE TAG REGULATORY OR TAG CROSS-REFERENCED TO THE APPROPREATE DATE DEFICIENCY) 111 Continued From page 2 111 current and did not represent current practice. interview confirmed March 1990 was the last review of the facility policies. 112 .0301 (B) GOVERNING AUTHORITY 112 Division of Health Service Regulation STATE FORM 6 B99 9M1 if continuation sheet 3 of - .Division of Health Service Regulation PRINTED: 07/29/2013 FORM APPROVED STATEMENT OF DEFICEENCIES AND PLAN CORRECTION NAME OF OR SUPPLIER VFEIVECARE, INC (X1) NUMBER: 20130055 B. WING (X2) MULTIPLE A. BUILDING: (X3) DATE SURVEY COMPLETED 63 ORANGE STREET NC 23301 0711 9/2013 STREET ADDRESS, STATE, ZIP CODE (X4) ID PREFIX TAG SIJMMARY STATEMENT OF (EACH DEFECIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE PLAN OF CORRECTION (X5) COMPLETE DATE DEFICIENCY) 112 Q113 Continued From page 3 revealed a thick layer of dust on the surface of the suction machine and nitrous oxide machine located in the OR. Observation revealed athick layer of dust located on the surface of the suction machine and nitrous oxide machine in OR Physician A confirmed the observation. interview on 07/19/2013 at 0907 with staff #3 (non--iicensed staff) revealed the facility staff ctean between patients including wiping down the operating room beds and any blood spills. interview revealed the staff do not mop floors between patients. interview revealed surgical procedures are scheduled on Wednesdays, Fridays and Saturdays. The staff member stated there was a person that comes to the facility on Tuesday evenings that does the "big cleaning" including mopping. Staff #3 stated housekeeping comes on Wednesday and Friday evenings, but the staff member was unsure if the floors are rnopped on those days. interview on 07/19/2013 at_144O with Physician A revealed the physician did not know if terminal cleaning of the operating rooms was being done. interview revealed the physician did not know how often floors were being mopped in the operating rooms. Interview confirmed there was no documentation of terminal cleaning of the operating rooms and no monitoring of housekeeping duties. interview confirmed there was a think layer of dust located on the equipment and horizontal surfaces in the operating rooms. interview revealed the physician did not know if the housekeeping staff I had any training in infection control prevention. .0301 (C) GOVERNING AUTHORITY I I C1112 'I'i3 Division of Health Service Regulation STATE FORM B599 (311 if continuation sheet 4 of 41 .. . . Ila . . . . . . . .- 07/29/2013 FORM APPROVED Division of Health Service Regulation STATEMENT or oeI=IcIENcrEs (X1) Paovioes/suePI.rEeIcLIA (X2) CONSTRUCTION (X3) DATE SURVEY PLAN or CORRECTION NUMBER: BUILDING, COMPLETED 20130055 5- WW5 0711912013 NAME OF PROVIDER on SUPPLIER smear Aooness, CITY, STATE, ZIP cops 63 ORANGE STREET WFEMCARE, INC ASHEVILLE, NC 28801 (X4) ,9 SUMMARY STATEMENT or-" in Peovicees i?l.AN oI= (x5) (EACH MUST BE PRECEDED av FULL PREFIX (EACH CORRECTIVE AcrIoN SHOULD ea COMPLETE TAG REGULATORY on 1.30 IDENTIFYING il\lFORlv'lATl0N) me CROSS-REFERENCED ro THE APPROPRIATE GATE DEFICIENCY) 113 Continued From page 4 113 10A-130.0301 The governing authority shall provide for the selection and appointment of the A professional staff and the granting of Clinical privileges and shalt be responsible for the professional conduct of these persons. This Rule is not met as evidenced by: Based on policy review, Credentialing file review and physician interview, the governing authority failed to ensure privileges were delineated for 1 of 1 physician tiles reviewed (Physician A). The findings include: Review of "Quality Assurance Guidelines" policy revised Aprii 2002 revealed committee composed of (name of two physicians and a certified nurse midwife) shalt meet quarterly to review the policies, appropriateness of procedures, quality of Care rendered in the outpatient surgicai facitity, tissue review, establish infection control and approve additional services. Ali staff members of the surgical facility shalt be board certified or qualified in Obstetrics and Gynecology. They will be a member of the active staff of (iocal hospital)!' Further review revealed a procedure that inciuded "10. Credentials will be reviewed every two years consistent with the hospital protocols." Review of Physician A's file revealed a "Request for Privileges" form with blanks to check "requested" and "granted" privileges. The procedures listed included "first and second trimester abortion and suction evacuation); sterilization via laproscopy both cautery and clips; and Iiltrasounciing." Further review of the form reveaied "Completed by Division of Health Service Regulation STATE FORM 5399 If continuation sheet 5 of 41 . .. . .. Division of Health Service Regulation PRINTED: 07/29/2013 FORM APPROVED STATEMENT OF AND PLAN OF CORRECTEON NAME OF PROVIDER OR SUPPLIER INC (X1) IDENTIFICATION NUMBER: 20130055 (x2) MULTIPLE CONSTRUCTION A. BUILDING: B. WING STREET ADDRESS, CITY, STATE, ZIP CODE 63 ORANGE STREET NC 28801 (X3) DATE. SURVEY COMPLETED 0711 912013 (X4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIIENCIES (EACH DEFICEENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATHDN) ID PROVIDERS PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD era TAG cnoss-nesenenceo TO THE APPROPREATE DATE (X5) COMPLETE I -.. J. Q113 Continued From page 5 Physician" and "Compieted by Medical Director" both signed by Physician A and dated 07/01/2013. Further review or' the form revealed the "Procedures requested and granted" were blank with no checks indicating which procedures were requested and approved. Interview on 07/19/2013 at 0905 with Physician A revealed there was no quality assurance committee and no process for reappointment or granting privileges. Interview revealed the physician was a soio practice and she just signed the form as requesting and approving privileges. The physician reviewed the form and immediately checked the requested and granted priviieges as approved. Physician A confirmed the procedures requested and approved was blank and stated she forgot to check the procedures. .0303 ADMINISTRATIVE RECORDS The following essential documents and references shall be on fits in the administrative office of the facility: (.1) appropriate documents evidencing control and ownerships, such as deeds, teases, or corporation or partnership papers; (2) bylaws of poiicies and procedures of the governing authority; (3) minutes of the governing authority meetings if applicable; (4) minutes of the facility's professional and administrative staff meetings; (5) a current copy of these regulations; (6) reports of inspections, reviews, C2113 115 Division of Health Service Reguiation STATE FORM 5899 If continuation sheet 6 of 41 . 4 - I n' I.-Division of Health Service Reguiation PRINTED: FORM APPROVED and corrective actions taken related to iicensure; and (T) contracts and agreements reiated to licensure to which the facility is a party. All operating licenses, permits and certificates shall be appropriately displayed on the licensed premises. This Rule is not met as evidenced by: Based on review of policies and procedures, meeting minutes and physician interview, the facility failed to maintain evidence of bylaws of the governing authority, minutes of governing authority meeting minutes or staff meeting minutes and faiied to have a current copy of the NC Rules Governing the Licensure of Ambulatory Surgical Facilities. The findings iriciude: Review of facility policies and meeting minutes revealed no evidence of governing authority byiaws, governing authority meeting minutes or staff meeting minutes for the past year. Further review revealed no current copy of the NC Rules Governing the Licensure of Ambulatory Surgical Facilities. interview on 07/19/2013 at i420 with the physician and owner of the facility (Physician A) revealed there was no governing authority meeting as she was a soio practioner. interview revealed there were no staff meetings and no meeting minutes. The physician stated there may have been some bylaws years ago, but she was not aware of any bylaws that could be provided. The physician stated "They (the bylaws) might have been in another book, but i think I threw that STATEMENT or DEFICIENCIES (X1) (x2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN or CORRECTION IDENTIHCATION NUMBER: A COMPLETED 20130955 3- 07/19/2013 NAME cs PROVIDER on STREET ADDRESS, cmr, STATE, ZIP cops 63 ORANGE STREET INC ASHEWLLE, NC 28801 (X4) "3 SUMMARY STATEMENT or csricienciss is PLAN OF (X5) (EACH DEFICIENCY MUST BE PRECEDED sv FULL PREFIX (EACH connective ACTION SHOULD BE COMPLETE 1-Ag REGULATORY on LSC IDENTEFYING -mg; GROSS-REFERENCES TO THE APPROPRIATE DATE DEFICIENCY) 115 Continued From page 6 115 Division of itealth Service Regulation STATE FORM 6899 9lVi'l G11 If continuation sheet 7 of 41 PRINTED: 07/29/2013 FORM APPROVED Divisionof Health Service Regutation STATEMENT or cenciewcias (xn PRDVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE surzvev AND PLAN or CORRECTION IDENTIFICATION NUMBER: A. BUILDING: COMPLETED 20130055 5- 0711912013 NAME PROVIDER OR SUPPLIER INC STREET ADDRESS. CITY, STATE, ZIP CODE 63 ORANGE STREET ASHEVILLE, NC 28801 Personnel Records (1) A record of each employee shall be maintained which includes the foilcwingz (A) employee's identification; (B) resume of education and work expenence; (C) verification of valid license (if required), education, training, and prior employment experience; and (D) verification of references. (2) Personnel records shall be confidential. (3) Notwithstanding the requirement found in Subparagraph of this Rule, representatives of the Department conducting aninspection of the facility shalt have the right to inspect personnel records. This Rule is not m_et as evidenced by: (staff The findings include: was processing (sterilizing) the surgical Based on personnel file review and staff and physician interview, the facility failed to have a personnel tile for 1 of 5 employee files reviewed interview on 07/ 19/201 3 at 0907 with staff #3 (non--licensed) revealed she was the person that instruments. interview revealed staff #3 did not (X4) :3 SUMMARY STATEMENT or DEFECIENCEES in PROVIDERS PLAN or CORRECTION (x5; PREFIX (EACH DEFICIENCY MUST BE r-eacscso av FULL PREFEX (EACH CORRECTIVE ACTION SHOULD BE COMPLETE TAG REGULATORY on LSC TAG TO THE APPROPRIATE DATE DEFICEENOY) Q115 Continued From page 7 C2115 book out. I am not really sure." The physician stated she did not have a copy of the NC Rules Governing the Lioensure of Ambuiatory Surgical' Facilities. 0 117 PERSONNEL 117 Division of Health Service Regulation STATE FORM G899 9iVl1G'l'l lf continuation sheet 8 of 41 -.- - - . . . . PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Recuiation STATEMENT or (X1) PRDVIDERISUPPLIERICLIA (X2) MULTIPLE (x3) DATE sunvev Ana PLAN or coanecrrou NUMBER: A BUELDWG: COMPLETED 20130055 3- WING 07/19/2013 NAME OF PROVEDER OR SUPPLIER VFEMCARE, STREET ADDRESS, CITY. STATE, CODE 63 ORANGE STREET ASHEVILLE, NC 2880'! (X4) 11) SUMMARY STATEMENT OF DEFICIENCIES PREFIX TAG (EACH DEFICEENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC INFORMATION) ID PREFIX TAG -- CROSS-REFERESNCED TO THE APPROPRIATE PROVIDERS PLAN or CORRECTION . (X5) (EACH CORRECTIVE Ac'noN SHOULD as comma-rs DATE DEFICIENCY) 117 Continued From page 8 the instruments. available. stated there was no application, resume, staff Interview confirmed the job processed surgical instruments prior to staff #4 was trained to process surgical competency checks available. 119 PERSONNEL 10A 13C .0305 Orientation shall be provided to familiarize each new ern ployee with the facility, its usually process the surgical instruments and was filling in for the regular person who was on vacation. interview revealed the regular person'- that processed the surgical instruments was a volunteer (staff interview revealed staff #4 (volunteer) had been processing the instruments for about a year. Interview revealed staff #3 had been trained by staff #4 regarding how to process Review revealed there was no personnel file and no evidence of training or checks regarding processing surgical instruments for staff Review revealed there was no evidence of the volunteer employee's application, resume, prior work history and verification of references Interview on 07/19/2013 at 1430 with Physician A revealed staff #4 was a volunteer and there was no personnel file for staff The physician history or verification of references available for responsibilities for staff #4 included processing the surgical instruments. Interview revealed staff #4 had no medical background and had not volunteering at this facility. interview revealed instruments by a former employee. Interview' confirmed there was no evidence of training or work Q119 Division of Health Service Regulation STATE FORM B899 if continuation sheet 9 of 41 . .. 4 -.-. .2 PRINTED: 07/29/2013 FORM APPROVED Division of Heaith Service Regulation STATEMENT or DEFICIENCEES (X1) (X2) MUi.'l'iPl.E consrnucnon (X3) DATE sunvsv AND PLAN on CORRECTEON NUMBER: BUILDING: COMPLETED 20130055 B-WW9 0711912013 NAME OF PROVIDER OR SUPPLIER VFEMCARE, INC 63 ORANGE STREET ASHEVILLE, NC 28801 STREET ADDRESS. CITY, STATE, CODE policies, and job responsibilities. Ail persons having direct responsibility for patient care shall be at least 18 years of age. All other employees working in the facility shail be not less than 16 years of age. The governing authority shall be responsible for insuring health standards for employees which are consistent with recognized professional practices for the prevention and transmission of communicable diseases. This Rule is not met as evidenced by: Based on review of policies, employee file review and physician interview, the governing authority failed to establish written protocol for health standards for em pioyees. The findings include: Review of poiicies revealed no policy or procedure that established'-guideiines for employee health. Review of employee fiies revealed TB testingor screening was not completed in the past year for 1 of 2 RN files reviewed (RN Interview on 07/19/2013 at 1430 with Physician A revealed there were no policies established regarding surveillance of communicable diseases such as T8 and hepatitis in employees. interview revealed TB testing or screening should be conducted annuaily for all employees. The physician confirmed RN #1 's TB testing had not been completed within the past year and was delinquent. 19 SUMMARY STATEMENT or' so Pnovrosns PLAN or (X5) (EACH DEFICIENCY MUST BE PRECEDED sv FULL (EACH snouun es COMPLETE TAG REGULATORY on LSC me, TO THE APPROPRIATE BATE . 119 Continued From page 9 119 Division of Health Service Regulation STATE FORM B889 9M'iG'l'1 If continuation sheet 10 of 41 PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Requiation STATEMENT OF DEHCEENCIEZS (X1) (x2) MULTIPLE constnucnon (X3) sunvav AND PLAN oi= connection IDENTIFICATION NUMBER: . COMPLETED A. BUILDING. 20130955 3- WW3 07/1 912913 NAME OF PROVIDER OR SUPPLIER INC STREET CETY, STATE, ZEP CODE 63 ORANGE STREET ASHEVILLE, NC 28801 . - - -0- 10A-130.0306 The governing' authority shalt estabiish a quality assurance program for the purpose of providing standards of care for the facility. The program shalt include the establishment of a committee which shall evaluate: appropriateness and necessity of surgical procedures performed, and (2) compliance with facility procedure and policies. The committee shall determine corrective action if indicated. The committee shall consist of at ieast one physician or dentist (who is not an owner), the chief executive officer (or his designee), and other health professionals as indicated. There shall be at feast one meeting of the committee quarterly. The functions of the committee shalt include development "of policies for selection of patients, review of credentials for staff privileges, peer review, tissue review, establishment of infection control procedures, and approval of additional surgical procedures to be performed in the facility. Records shall be kept of the activities of the coinmittee. These records shall include as a minimum: (1) reports-made to the governing authority; (2) minutes of committee meetings including date, time, persons attending, description and resuits of (X4) "3 SUMMARY STATEMENT OF DEFICIENCJES ip Pnovioens PLAN OF CORRECTION (EACH MUST as PRECEDED BY FULL - PREFIX (EACH SHOULD as COMPLETE TAG REGULATORY on ENFORMATION) -me cnoss-nesenswceo TO THE APPROPRIATE DEFECIENCY) 120 Continued From page 10 120 120 .0306 QUALITYASSURANCE 120 Division of Heaith Service Reguiation STATE FORM B899 9MtG'l'l If continuation sheet 'ii of 4% .-. - - - .. - - . A I . . . Lu07/29/2013 . . --..- .. FORM APPROVED Division of Health Service Regulation STATEMENT OF (X1) (X2) MULTIPLE consrnucnon (X3) cprre suavev AND PLAN OF CORRECTION NUMBER: A BUELDING, 20130055 3- WW9 07/19/2013 NAME OF OR eraser ADDRESS, crrv. sr/are, ZIP coca 63 ORANGE STREET ASHEVILLE, NC 28801 (X4) in SUMMARY srnremenr OF in PROVIDERS PLAN OF CORRECTION (x5) (EACH MUST ea PRECEDED av FULL PREFIX (EACH ACTION SHOULD ea TAG, REGULATORY OR INFORMATION) -{Ag DATE 120 Continued From page 11 120 cases reviewed; and recommendations made by the committee; and (3) information on any corrective action taken. Appropriate orientation, training or education programs shall be conducted as necessary to correct deficiencies which are uncovered as a result of the quality assurance program. This Rule is not met as evidenced by: Based on review of policy, quality assurance meeting minutes and physician interview, the governing authority failed to have a quality assurance program. Review revealed no monitoring of the quality of care and services provided, no evidence of meeting minutes and no evidence of a non-physician owner present on a quality committee. The findings include: Review of "QualityAssurarice Guidelines" policy revised April 2002 revealed committee composed of (name of two physicians and a certified nurse midwife) shall meet quarterly to review the policies, appropriateness of procedures, quality of care rendered in the outpatient surgical facility, tissue review, establish infection control and approve additional services. All staff members of the surgical facility shall be board certified or qualified in Obstetrics and Gynecology. They will be mernber of the active staff of (local hospital)." Further review revealed a procedure that included review of sampled medical records for procedures that are performed at the facility including compiicaticns. The procedure includes "10. Credentials will be reviewed every two years consistent with the STATE FORM Division of Health Service Regulation 6899 if continuation sheet 'l2 of 41 . - - .- -- PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation STATEMENT OF DEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (x3) DATE SURVEY AND PLAN OF NUMBER: BWLDING: COMPLETED 20139055 8- 0711912013 NAME or: PROVIDER on STREET ADDRESS, CITY. ZIP CODE 63 ORANGE STREET mc ASHEVILLE, Nc 23301 (X4) 19 SUMMARY STATEMENT OF DEFICIENCIES in PROVIDERS PLAN OF coRRec'noN (x5; (EACH DEFICIENCY MUST BE PRECEDED sv FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE compusre TAG REGULATORY DR LSC INFORMATIDN) my TO THE APPROPRIATE DATE DEFICIENCY) Q1120 Continued From page 12 C1120 hospital protocols." Review of the facility's quality assurance (QA) committee meeting minutes revealed the most recent QA meeting was January 25, 2007. interview on 07/19/2013 at 1440 with Physician A revealed there was not a QA committee and there had not been any quality reviews of medical records since 2007. interview confirmed there was not a non-owner physician member that was part Of a QA committee. interview with the physician confirmed there was no CIA program or functions in place currently or since 2007. 121 .0401 MEDICAL SERVICES 121 10A-13C.D401 All patients admitted to the facility shall be under the direct care of a physician or dentist. The facility shall haveavailabie an anesthetist and he or she shall be available to administer regional or general anesthesia. Any patient undergoing general or regional anesthesia shall, prior to surgery, have a history and physical examination, relative to the intended procedure, performed by a licensed physician Or a dentist who has successfully completed a postgraduate program in oral and maxiliofacial surgery accredited by the American Dental Association. Results of the _i examination and the preoperative diagnosis shail be recorded in the patients chart prior to surgery. The attending physician and dentist. prior to surgery, shall Division of Health Service Regulation STATE FORM 6399 G11 if continuation sheet of 41 PRINTED: FORM APPROVED Division of Health Service Regulation STATEMENT or (X1) PRQVIDERISUPPLEERICLIA (X2) MULTIPLE consrnucrion (X3) DATE sunvev AND PLAN or CORRECTION NUMBER: COMPLETED A. BUILDING. 20130055 B-WW8 0711912013 NAME OF PROVIDER OR SUPPLIER VFEMCARE, ENC 63 ORANGE STREET ASHEVILLE, NC 2880'! STREET ADDRESS. STATE, ZEP CODE (X4) in PREFSX TAG SUMMARY STATEMENT OF DEFICEENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) ID PREFIX TAG CROSS-REFERENCED TO THE APPROPRIATE PLAN or CORRECTION 9:5) CORRECTIVE ACTION SHOULD BE compme DATE DEFSCIENCY) I C1121 C2123 Continued From page obtain written, informed consent of the patient or iegai guardian for surgery and shaii record this in the patient's medical record. The facility shall have the capability of obtaining blood and -blood products to meet emergency situations. This Rule is not met as evidenced by: Based on review of the facility's contracted services and physician interview, the facility failed to have an anesthetist avaiiable. The findings include: Review of the facility's contracted services on 07/19/2013 revealed no agreement and/or contract for anesthesia services. interview on 07/19/2013 at 1430 with Physician A revealed the facility does not currently have an agreement andlor contract' with an anesthetist or anesthesiologist. The interview revealed the physician was not aware of the requirement. .0403 EMERGENCY cAsEs 10A-130.0403. Each shall have a written plan for the transfer of emergency cases to a nearby hospitai when hospitalization becomes necessary. There shall be procedures, personnel and suitable equipment to handle medical emergencies which may arise in connection with services provided by the facility. (cl There shall be a written Q121 123 STATE FORM Division of Health Service Regulation 5599 If continuation sheet 14 of 41 -33PRINTED: FORM APPROVED . Division of Health Service Recrulation STATEMENT or DEFICJENCIES (X1) (x2) MULTIPLE CONSTRUCTION (X3) cm: sunvev AND PLAN OF CORRECTEON NUMBER: BUILDENG: COMPLETED 20130055 5- WW 0711912013 NAME OF Pnoviosn on SUPPLIER ADDRESS, CITY. sr/we, ZIP cops 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4) ID sumunnv smrsueur OF in PLAN OF (x5; PREHX (EACH MUST BE PRECEDED ev FULL (EACH CORRECTIVE ACTION SHOULD es COMPLETE ms REGULATORY on TAG CROSSREFERENCED TO THE APPROPRIATE DATE osncasmcv) 1223 Continued From page 14 123 agreement between the facility and a nearby hospital to facilitate the transfer of patients who are in need of emergency care. A facility which has documentation of its efforts to establish such a transfer agreement with a hospital which provides emergency services and has been unable to secure such an agreement shali be considered to be in compliance with this Rule. This Rule is not met as evidenced by: Based on policy review, Observation and staff and physician interviews, the facilityfailed to ensure emergency equipment had weekly checks performed according to policy to ensure the equipment was suitable for use in patient care. The findings include: Review of "Emergency Preparedness and Equipment" policy dated as revised January 1989 revealed "l\/lust be available and in working order at all times the following: Suction machine with clean suction catheter 12. Review of a "Crash Cart" policy revised 1990 revealed crash cart drugs and equipment are__to be checked weekly. Review of "Nursing Policy Responsibilities in the Operating Room" (not dated) revealed "The and RNs will be responsible for functions in the operating room. They will perform the foiiowing responsibilities: Check the crash cart each surgery day prior to the initiation of the procedures." Division Of Heaith Service Regulation STATE FORM B899 if continuation sheet $5 of 41 flPRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation STATEMENT or (X1) (x2) consraucnon (x3) DATE sunvsv AND PLAN or CORRECTION :osNrincArioN NUMBER: BUWNG: COMPLETED 201 30055 3- WW 0711912013 NAME or PROVJDER on suramsn srnesr ADDRESS. crrv, cops 63 ORANGE STREET FEMCAR ASHEVILLE, NC 28801 (X4) in SUMMARY STATEMENT or in PLAN or CORRECTION (X5) MUST as sv FULL PREHX (EACH CORRECTNE ACTION snouua BE COMPLETE me REGULATORY on LSC ENFORMATIDN) TAG To run APPROPRIATE DATE 123 Continued From page '15 123 Observation during tour of the operating room on 07/1 8/201 3 at 1545 revealed a crash cart with a Medironic Physio-Control LifePac 9 defibrillator - located on top of the crash cart. Observation revealed medication and supplies on the crash cart were not secured with a locking mechanism. interview with Physician A during the tour revealed there was no log or evidence of dates when the crash cart medications and equipment were checked. interview revealed the defibrillator was not checked by staff to verify it was functioning properly. Interview with the physician revealed she was not aware of the need to check the defibrillator periodically. The interview revealed the facility had a user manual for the defibrillator. Review of the user manual for the Physio--Controi LifePac 9 defibrillator revealed "Section 7 Maintaining the Equipment" was missing from the manual. Further observation revealed a suction machine on top of the crash cart. interview reveaied staff did not check the suction machine for proper functioning. interview on 07/ 1 9120i 3 at"? 1045 with staff #2 (registered nurse) reveaied the nurse did not check the crash cart. The nurse stated "l do not know how to do a defibrillator check or trouble shoot the machine. I do not do checks." Interview on 07/19/2013 at 1115 with staff #1 (registered nurse) revealed the nurse did not perform any monitoring of the crash cart to ensure medications, supplies and equipment were not expired, availabie and in working order when needed. interview revealed the nurse did not know the procedure to perform checks on the defibrillator to ensure it was functional. interview on 07/19/2013 at 1430 with Physician A revealed there was no process in place to check Division of Health Service Reputation STATE FORM 5599 If continuation sheet of 41 . .. 07/291201 3 FORM APPROVED Division of Health Service Regulation smramanr OF DEFECIENCEES (X1) (X2) (x3) DATE sunvsv AND PLAN or CORRECTION NUMBER: . . COMPLETED A. suitozns. 20130055 07/19/2013 NAME OF PROVIDER OR SUPPLIER INC 63 ORANGE STREET ASHEVELLE, NC 28801 STREET ADDRESS, CITY, STATE, ZIP CODE (X4) iD PREFEX TAG SUMMARY STATEMENT OF DEFECIENCIES (EACH DEFJCIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC INFORMATION) ID PREFIX TAG PLAN OF CORRECTION (EACH CORRECTEVE ACTION SHOULD BE CROSS--REFERENCED TO THE APPROPRIATE (X5) COMPLETE DATE Q123 C2125 Continued From page 16 the defibrillator and suction machine on the crash cart to ensure there were in working order when . needed. The physician confirmed the defibrillator had not been checked according to manufacturer's recommendations. interview confirmed the physician was not sure how to perform the defibrillator checks and the manufacturer's user manual was missing the section that provided guidance with maintaining the equipment. Review of "Medtronic Physio--Control LifePac 9 User Manual Section 7 Maintaining the Equipment" obtained via computer search by facility staff after requested by surveyor on 07/19/2013 revealed Physio-Control recommends a minimum program of routine maintenance and testing for ciinical personnel. Recommended maintenance and testing for ciinical personnel: Check all necessary supplies and accessories are present (gel, paper, cables, electrodes, etc.) daily and whenever necessary; Operational tests, monitorfunction, discharge function with standard paddles, adaptors or paddle options daily and whenever necessary; Verify paddles are clean Additional preventative maintenance and testing such as electrical safety tests, performance testing and calibration should be performed routineiy by biomedical personnel..,." .0502 EQUIPMENT 3C.0502 equipment for the administration of anesthetics shall be readily available, kept clean or sterile, and maintained in good working condition. Q1123 C1125 STATE FORM Division of Health Service Regulation 6899 9M1 G11 ll contlnuallon sheet 17 of 41 . -2-acne.-. .- Cl. .. . . PRENTEID: 07/29/2013 FORM APPROVED Division of Heatth Service Regulation STATEMENT DEFICIENCIES (Xi) Ixz) MULTIPLE CONSTRUCTION (x3) DATE suavsv AND PLAN OF NUMBER BWLDING: COMPLETED 29130055 5- WW3 07/19/2013 NAME OF PROVIDER on SUPPLIER srnesr ADDRESS. cnv. STATE. ZIP CODE . 63 ORANGE STREET NC 28801 (X4) SUMMARY STATEMENT oI= oer=IcIsIv_cIEs In Pnoviosns PLAN OF Ix-5; (EACH DEFICIENCY MUST as PRECEDED av FULL pagpgx (EACH connective ACTION SHOULD BE COMPLETE REGULATORY on ENFORMATION) mg. cnossinsrensmoso To THE APPROPRIATE DATE 125 Continued From page 125 This Rule is not met as evidenced by: Based on medicai record review, observation and staff and physician interview, the nitrous oxide - gas delivery systems were not maintained in good working condition. The tindings include: Closed record review of 16 patients that had surgical abortion procedures performed between January 2013 and Juiy 2013 revealed 100% (all 16 patients) had nitrous oxide gas administered at a 30% nitrous oxide, 70% oxygen mix as per the facility's standing orders. Observation on 07/1 8/2013 at 1805 revealed a nitrous oxide deiivery system in OR Observation revealed tubing was taped at all connections with layers of tape. Observation revealed the tubing was taped with iayers of tape where the tubing connected to the wall oxygen, where two tubes connected to the delivery control machine, where tubing connected to the nasal mask and where the reservoir bag connected to the system. Observation revealed the nasal mask was torn down the center. Observation of OR #2 revealed another nitrous oxide delivery system. Observation revealed tubing was taped at all connections with layers of tape just as it was observed in OR Observation revealed the nasal mask was torn down the center. I Observation on at 1620 revealed the tape had been removed by facility staff on the tubing that connected the nasai mask to the nitrous oxide delivery system in OR Observation revealed the tubing was gaping open after the tape was removed. Division of Heaitn Service Regulation STATE FORM 5399 9lVi'lG1i If continuation sheet 18 of 41 r--H -. - PRINTED: 07129/2013 FORM APPROVED Division of Health Service Requlation STATEMENT or DEFICIENCIES (X1) Pnovloenrsupmee/cLiA (x2) CONSTRUCTION (x3) ores sunvsv AND PLAN or EDENTIFICATION NUMBER: A. COMPLETED 20130055 3- WW9 0711912013 NAME OF PROWDER OR SUPPLIER INC STREET ADDRESS, CITY, STATE, ZIP CODE 63 oRANes STREET ASHEVILLE, no 28801 PLAN OF CORRECTION Interview on 07/19/2013 at 1045 with staff #2 (registered nurse) revealed the nurse assisted - Physician A in the operating room and was responsible for administering the nitrous oxide during the surgical procedure. The nurse stated staff #1 had trained her on the use of the nitrous oxide gas. interview revealed the nurse did not check the nitrous oxide machine or hoses for leaks. interview revealed the nitrous oxide tubing is taped between the connections and the nasal mask has a large tear across the top that prevents the mask from making a secure fit. Interview on 07/ 1 9/201 3 at'O9D7 with staff #3 (non~|icensed staff) revealed there had not been any maintenance checks on the nitrous oxide machines in the last nine years. interview revealed the hoses had not been replaced in nine years. The staff member stated she did not remember the nose mask ever being replaced. Interview on 07/19/2013 at 1115 with staff #1 (registered nurse) reveaied she did not know what the manufacturer's recommendations for maintenance and safety checks were for the . nitrous oxide delivery system. The staff member stated "I'm not doing any checks and I do not know what the recommendation are." The nurse further stated "The hose is cracked where we, have it taped. The nasal mask is ripped. it should be replaced." Further interview revealed the nitrous oxide machine has not had any preventative maintenance performed. Physician interview during tour on 07/18/2013 at 1805 revealed there was no users guide for the nitrous oxide delivery system. interview revealed no preventative maintenance had been performed on the equipment. The physician (X4) ID SUMMARY STATEMENT or DEFICIENCIES in (X5) (EACH DEFICIENCY MUST as PRECEDED av FULL Pentax (EACH CORRECTIVE ACTION SHOULD BE comm:-re TAG REGULATORY on LSC IDENTIFYING TAG TO THE APPROPRIATE WE DEFECIENCY) 125 Continued From page 18 125 STATE FORM Division of Health Service Regulation 5899 It continuation sheet 19 of 41 -- - - . . .. . . . . .- PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Reguiation STATEMENT OF oe=:clENciEs (X1) (x2) MULTEPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION rosNnr=IcATrON NUMBER: COMPLETED 20130055 3- WW9 07/19/2013 NAME OF PROWDER OR SUPPLIER STREETADDRESS, STATE, ZIP CODE 63 ORANGE STREET ASHEVILLE, No 20001 (X4) [9 SUMMARY STATEMENT OF I9 PLAN OF CORRECTION (EACH MUST as PRECEDED av FULL (EACH CORRECTIVE ACTION SHOULD BE COMPLETE TAG REGULATORY oR INFORMATION) TAG CROSS-REFERENCED To THE APPROPRIATE DATE - aer=IcieNcY) (2125 Continued From page 19 125 stated "We have cracks. We need new (nitrous oxide) tubing. I don't know if it is leaking or not. I can't be sure it is functioning with the proper mix. I have not had it tested." Further interview on 07/19/2013 at 1500 with Physician A revealed "Yes, there must be a better system. We don't know if the nitrous oxide is leaking or if the patient is getting the correct amount of gas. Yes, it (the tubing and nasal mask) is cracked and the taped tubes are not a safe way to do this." C1132 .0801 DRUG DISPENSING 132 10A--'l 3C.0801 The governing authority, with the advice of a registered pharmacist, shall assure that there are appropriate methods, procedures and controls for obtaining, dispensing, and administering drugs and biologicals. This Rule is not met as evidenced by: Based on contract reviews, and physician interview the facility leadership failed to have a contract or written agreement with a registered pharmacist to assure appropriate methods, procedures and controls for obtaining, dispensing, and administering drugs and bioiogicais are being implemented by the staff. The findings include: On 07/18/2013 at 0930, a request was made to the facility administration to provide a list of at! contracts related to patient care services. Review of the contracts revealed no avaiiable documentation of a written contractor agreement between thearnbulatory surgical center and a registered pharmacist for providing advice to the Division of Health Service Reguiation STATE FORM 5599 (311 If continuailorl sheet 20 of 41 .- . L. I32 . Division of Heaith Service Regulation PRINTED: 07129201 3 FORM APPROVED STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION NAME OF PROVHDER OR INC (X1) IDENTIFICATION NUMBER: 20130055 B. WING (X2) MULTIPLE coNsTRuc'rioN A. BUILDING: DATE SURVEY COMPLETED 63 ORANGE STREET ASHEVILLE, NC 28801 0711 912013 STREETADDRESS, CITY, STATE, ZIP CODE 4) ID PREFIX TAG SUMMARY STATEMENT OF DEFICIENCEES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSO IDENTIFWNG INFORMATION) ED PREFIX TAG CROSS-REFERENCED TO THE APPROPRIATE PLAN OF CORRECTION I (X5) (EACH CORRECTEVE ACTION SHOULD BE COMPLETE DATE DEFICIENCY) . E. Q132 C1134 Continued From page 20 facility to assure appropriate methods, procedures and controls for obtaining, dispensing, and administering drugs and biologicals are being implemented by the facility staff. Observation on 07/1 9/2013 at 1120 of medications revealed prepared envelopes of medication envelopes labeled "Methergine 0.2 mg (miliigram)." Interview with staff during tour revealed the medication was labeled and packaged by staff and dispensed by the physician. interview with staff confirmed the medication was taken from larger bottles of the pills and placed in the packets. Interview confirmed the label did not have a lot number and expiration date on the envelope. Interview on 07/19/2013 at 1510 with Physician A revealed the does not have a registered pharmacist on staff. Further interview revealed the facility does not have a written contract or agreement with a registered pharmacist to provide consuitation to the'-facility. Interview revealed a registered pharmacist does not provide oversight or perform periodic audits/visits at the facility. interview revealed the medical director was over the pharmaceutioai services provided at the faciIity.. .0901 NURSING ADMINISTRATION 10A-130.0901 The facility shall have an organized nursing Department under the supervision of a director of nursing who is currently ticensed as a registered nurse and who has and accountability for allnursing services. Q132 C1134 Division of Health Service Regulation STATE FORM BBI-39 9iVI'iG'l'i If continuation sheet 21 of 41 .11.. PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation or (X1) (X2) comsmucnon (x3) DATE surzvev AND PLAN or NUMBER: A. BUILDING: commerce 20139055 B-WW9 07/19/2013 NAME or on SUPPLIER STREET ADDRESS, cnv, srms, CODE 63 ORANGE STREET ASHEVILLE, NC 23301 (X4) in summer STATEMENT or DEFICIENCIES Pnoviosn-s PLAN or connacnon (X5, (EACH oerlciencv MUST BE PRECEDED sv FULL PREFIX (EACH CORRECTIVE SHOULD as comers TAG REGULATORY on LSC ENFORMATION) mg DATE 134 Continued From page 21 The director of nursing shall be responsible and accountable to the chief executive officer for: provision of nursing services to patients; (2) developing a nursing policy and procedure manual and written job descriptions for nursing personnel. This Rule is not met as evidenced by: Based on review of job description, personnel files and staff and physician interview, the facility failed to have a director of nursing responsible and accountable for all nursing services. The findings include: Review of a "Job Description for Director of Nursing" (not dated) revealed "The Director of Nursing must be a registered nurse in the State of North Carolina. The Director of Nursing will report directly to the Medical responsibilities: 1. She will oversee and direct ail nursing functions in (facility name). 2. duties and responsibilities on surgery 3. She will be responsible for training new RNs and new LPNs in (facility name) protocols and record such training in personnei files. 4. She wili be responsible to see that the crash carts and portable oxygen units are functioning. 5. She will attend QualityAssurance meetings. 6. She will inventory medical supplies and needs and submit for Review of the personnel files for staff #1 and staff' #2 (registered nurses currently on staff at the facility) revealed no evidence the registered nurses (RNs) were identified as a Director of Nursing position. Review revealed staff #1 and staff #2 files contained staff RN job descriptions. Division of Health Service Regulation STATE FORM 5599 If continuation sheet 22 of 41 . 51' I . . - Division of Health Service Regulation PRINTED: 07/29/2013 FORM APPROVED STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION 20130055 NAME OF PROVIDER OR INC (X1) NUMBER: (X2) MULTIPLE CONSTRUCWON A. BUILDENG: (X3) DATE SURVEY COMPLETED 07/19/2013 CITY. STATE, ZIP CODE 63 ORANGE STREET ASHEVILLE, NC 28801 (X4) .3 SUMMARY STATEMENT DEFICIENCEES PREFIX TAG (EACH OEFECIENCY MUST BE PRECEDED BY FULL REGULATORY OR 1.80 INFORMATION) PROVIDERS PLAN OF CORRECTION PREFIX (EACH CORRECTIVE ACTION SHOULD BE TAG CROSS-REFERENCED TO THE APPROPRIATE DEFICEENCY) (X5) COMPLETE DATE 134 Continued From page 22 with any surgical procedures. member reported directly to Physician A. 139 .1101 OPERATING SUITE 10A-13C.1101 Each operating suite shall be adequately equipped for the types of procedures to be performed. Each recovery area shail be adequately equipped for the proper care of post anesthesia recovery of interview on 07/19/2013 at 1115 with staff #1 (registered nurse) revealed the staff member-is a registered nurse.(RN) that has worked at the facility since 2003. interview revealed ail staff report to Physician A. Interview further revealed that a Certified Nurse Midwife (CNIVI) was the director of nursing a couple of years ago. interview revealed the CNM currently examines patients for gynecological appointments one day a week in the office practice and is not involved Interview on 07/ 19/2013 at 1045 with staff #2 (registered nurse) revealed there was no director of nursing and alt staff reported to Physician A. interview on 07/19/2013 at 0907 with staff #3 (non-licensed staff) revealed there was not a director of nursing. Interview reveaied the staff Interview on 07/19/2013 at 1545 with Physician A revealed the physician functions in the rote of the director of nursing and all the facility staff report to the physician. Interview revealed the CNM was the director of nursing in the past. interview revealed the facility staff all report directly to Physician A. Interview confirmed there had not been a director of nursing for over a year. C1134 C1139 Division of Health Service Regulation STATE FORM 5399 QMI G11 If continuation sheet 23 of 43 PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation . STATEMENT OF DEFICIENCEKS (X1) (X2) CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: BUILDING: COMPLETED 20130055 B-WW 07/19/2013 NAME OF PROVIDER OR SUPPLJER STREET ADDRESS, CITY, STATE, ZIP CODE 63 ORANGE STREET NC ASI-EEVILLE, NC 28801 (X4) 33 SUMMARY OF DEFECIENCEES ID PROVIDERS emu OF CORRECTION (X5) PREFIX (EACH DEFICIENCY MUST BE PRECEIIJEIZ) BY FULL (EACH CORRECTWE ACTION SHOULD BE COMPLETE TAG REGULATORY on INFORMATION) TAG TO THE APPROPRIATE DATE 139 Continued From page 23 139 surgical patients. (C) The following equipment shall be available in the operating suite and recovery area: (1) cardio-pulmonary resuscitation drugs and iniubation equipment, (2) cardiac monitor, (3) resuscitator including oxygen and suction equipment, (4) suitable surgical instruments customarily available for the planned surgical procedure, (5) defibrillator, and (6) tracheostomy set. This Rule is not met as evidenced by: Based on observation and physician interview, the facility faiieci to have a resuscitator availabie. The findings inciude: Observation during tours of the facility on 07/18/2013 at 1730 revealed there was no resuscitator available for use. Interview on 07/18/2013 at 1730 with Physician A during the tour confirmed there was no resuscitator avaiiable. Interview reveaied the physician was not aware that a resuscitator was required. - . Q141 .1201 GENERAL - Q141 The governing authority shali develop written policies and procedures designed to enhance safety within the facility and on its grounds and minimize hazards to patients, staff and visitors. Division of Health Service Reguiatlon STATE FORM 5599 9M1 G11 If continuation sheet 24 of 41 A - -5. .I.t . . - . .V. PRWTED: FORM APPROVED Division of Health Service Requlation STATEMENT or (X1) (X2) MULTIPLE cowsrnucrron (X3) one susvev AND PLAN or= CORRECTION NUMBER: BUILDWG: COMPLETED 20130055 3- WW 0711912013 NAME. OF PROVIDER on SUPPLIER smear ADDRESS. crrv, STATE, ZIP cops 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4) 53 SUMMARY STATEMENT or In -. PROVIDERS PLAN os coaascnon (X5) (EACH DEFICIENCY MUST as PRECEDED sv FULL (EACH ACTION SHOULD BE COMPLETE TAG necsmronv on LSC TAG cnosseesenenceo TO THE DATE DEFICIENCY) 141 Continued From page 24 141 The policies and procedures shall inciude estabiishment of the following: (1) safety rules and practices pertaining to personnel, equipment, gases, 'liquids, drugs; (2) provisions for reporting and the investigation of accidental events regarding patients, visitors and personnel (incidents) and corrective action taken; (3) provision for dissemination of safsty--related information to employees and users of the facility; and (4) provision for syringe and needle storage, handiing and disposal. Smoking shail be permitted only in designated areas which shall not include patient care and treatinent areas. This Rule is not met as evidenced by: Based on policy reviews, observation, staff and physician interviews, the facility failed to ensure fire safety drills were conducted. The findings include: Review of a "Fire Plan" policy revised 1939 reveaied the facility should conduct fire drills quarterly. Review of the facility's "Fire Driils and Fire Alarm 9 System" log revealed the most recent fire drill was conducted May 25, 2011. interview on 07/19/2013 at 0907 with staff #3 (non--licensed staff) revealed there had not been any fire drills conducted in several years. Division of Health Service Regulation STATE FORM 5599 9M1G11 If continuation sheet 25 of 41 - . .. -. . . - - Au - PRINTED: 07/29/2013 -4: . FORM APPROVED Division of Health Service Reculation smremenr cs DEFJCIENCIES (X1) (x2) MULTIPLE consrnucnon (x3) om: sunvsv AND or IDENTIFECATION NUMBER: . CCIMPLETED A. BUILDING. 20130055 3- WW9 0711 912013 NAME OF PROVIDER OR SUPPLEER INC 63 ORANGE STREET ASHEVILLE, NC 28801 STREET ADDRESS, CETY, STATE, Zi? CODE (x4) ID PREFIX TAG SUMMARY STATEMENT OF (EACH MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFWNG ID PREFIX TAG CROSS-REFERENCED TO THE APPROPRIATE PROVIDERS PLAN OF CORRECTION I (X5) (EACH CGRRECTTVE ACTION SHOULD BE DATE DEFICEENCY) Q1-44 Continued Frorn page 25 Interview on 07/ 1 9/201 3 at with staff #2 <<(registered nurse) revealed the nurse had worked at the facility for one and one half years. The staff member stated she had never participated in a fire drill since she had worked at the facility. Interview on 07/19/2013 at 115 with staff #1 (registered nurse) revealed no fire drills had been conducted at the facility in the past two years. Interview on 07/19/2013 at '?545 with Physician A confirmed the East fire drill conducted at the facility was May 25, 2011. .1301 GENERAL 10A 130 .130'! The governing authority shall employee procedures to minimize sources and transmission of infections. Professionally recognized surveillance methods shall be used. The governing authority shall provide space, equipment and personnel to assure safe and aseptic treatment and - protection of all patients and personnel against cross-infection. This Rule is not met as evidenced by: Based on review of policies, culture results, meeting minutes, Centers for Disease Control' and Prevention (CDC) guidelines, observation and staff and physician interviews, the failed to have an active infection control program. The findings include: Review of an "Infection Control" policy revised 1992 revealed infection control policies are established and reviewed by the Quality Q141 C2144. Division of Health Service Regulation STATE FORM 6699 9M'l (311 If continuation sheet 26 of 41 -, . -. .. .- . .- . . . . PRINTED: 07/29/2013 .3. FORM APPROVED Division of Heaith Service Regulation STATEMENT or (X1) (X2) MULTIPLE comsmucnon (x3) SURVEY AND PLAN or coReec'noN NUMBER: A BUWNG, COMPLETED 20130055 3- WW9 0711912013 NAME or on SUPPLIER srnaer ADDRESS, CITY, STATE. ZIP cops 63 ORANGE STREET ENC ASHEVILLE, NC 2880'! (X4) 19 SUMMARY STATEMENT or= DEFICIENCIES an PLAN or: (x5) prqfipgx (EACH MUST BE eREcEeEo av FULL (EACH ACTION SHOULD ea COMPLETE mg on LSC INFORMATION) osoSs--REi=EnENcEo ro THE DATE DEFICIENCY) 144 Continued From page 26 144 Assurance Committee. Review revealed patients identified with communicable diseases and employee exposures are to be tracked and reported. Further review of the policy revealed the operative sterile trays are to be cultured annuaily. Operating room floors are to be mopped daily and walls cleaned bi--week|y. Review of the most recent result of a cultured sterile tray revealed a negative growth report dated 2011. Review of facility documents revealed no evidence of infection control monitoring or meeting minutes. 1, Review of "Operating of Peiton and Crane Autoclave" policy revised January 1989 revealed a procedure for steam sterilization of surgical instruments. Review of the policy revealed no procedure for the use of chemical or biological indicators during the sterilizing process. Review of the CDC (Centers for Disease Control and Prevention) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008; Healthcare infection Control Practices Advisory Committee (HICPAC) revealed "sterilizing Practices Overview. The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycEe' for the toad contents, and other aspects of device reprocessing. consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping Division of Health Service Reguiatlon FORM 6899 9iVl'iG'l'l lf continuation sheet 27 of 41 - . . PRINTED: FORM APPROVED Division of Health Service Regulation STATEMENT or DEFICEENCIES (X1) (X2) (x3) DATE suavev AND PLAN OF CORRECTION NUMBER: BUILDING, ICOMPLETED 20139055 3- WW9 07/1 9/2013 NAME or PROWDER on SUPPUER smear ADDRESS, crrv. STATE, ZIP cops 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4) .9 SUMMARY STATEMENT OF in Pnoviceas PLAN or CORRECTION PREHX (EACH DEFICIENCY Must as PRECEDED sv FULL PREFIX (EACH ACTION SHOULD as COMPLETE "mo neoumronv on IDENTEFYING INFORMATION) mo TC) "rue DATE DEFICIENCY) 144 Continued From page 27 144 instruments, loading the sterilizer, operating the sterilizer, and monitoring of the entire process. The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. Chemical indicators are convenient, are inexpensive, and indicate that the item has been exposed to the sterilization process. Chernical indicators should be used in conjunction with biological indicators, but based on current studies should not replace them because they indicate sterilization at marginal sterilization time and because only a biological indicator consisting of resistant spores can measure the microbial killing power of the sterilization process8-47, 974. Chemical indicators are affixed on the outside of each pack to showthat the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the iriside of each pack to verify sterilant penetrationi other sterilization systems, the steam cycle is monitored by mechanical, chemical, and biological monitors. Steam sterilizers usually are monitored using a printout (or graphically) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobaciilus stearotherrnophilus (formerly Bacillus stearothermophilus). Positive spore test results are a relatively rare event 838 and can be attributed to operator error, inadequate steam delivery 839, or equipment malfunction. I n' Division of Health Service Regulation STATE FORM 5999 9M1 G11 If continuation sheet 28 of 41 . I-I . -, 07/29/2013 FORM APPROVED Division of Heaith Service Regulation STATEMENT or DEFECIENGIES (X1) (x2) CONSTRUCTION (xs) DATE suave: AND PLAN or IceNrIr=icATIoN NUMBER: A I COMPLETED 29130055 3- WW3 0711912013 NAME OF PROVIDER on SUPPLIER eraser ADDRESS, crrv, STATE, CODE 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4) .9 SUMMARY STATEMENT OF DEFICIENCIES in Paoviorars PLAN oI= CORRECTION (X5) PREFIX (EACH oEi=IcIEr~Icv MUST as PRECEDED av FULL (EACH ACTEON SHOULD BE COMPLETE TAG REGULATORY on me INFORMATION) TAG cRoss--RereaeI~zceo TO THE APPROPRIATE DATE DEFICIENCY) ':44 Continued From page 28 144 items that become wet are considered contaminated because moisture brings with it microorganisms from the air and Further review of the geideiines revealed "16. Monitoring of Monitor each load with mechanicai time, temperature, pressure) and chemical (internal and external) indicators. if the internal chemical indicator is visible, an externai indicator is not needed. d. Use biologicai indicators to monitor the effectiveness of sterilizers at least weekly with an DA-cleared commercial preparation of spores Geobacillus stearothermophiius for steam) intended specifically for the type and cycle parameters of the Observation on 07/18/2013 at 1810 during tour of the sterile processing area revealed a ceiling tile (drop down ceiling) that was missing above the autociave area where clean sterile packs were processed. The area was open to the pipes and air flow above the ceiling. Observation of the top of the autociave revealed excessive dust that rolled Lip when touched. interview during the tour with Physician A reveaied the facility had a leak last week and the tile had to be removed. Interview confirmed the top of the autociave was covered with a layer of dust Observation on 07/18/2013 at 1815 reveaieci a cart with instrument packs located on the cart. interview with Physician A during the tour reveaied these packs were and available for use. Observation revealed three packs with beads of moisture located inside the clear packs. Physician A stated "Yes, there is condensation inside the packs. It will be okay tomorrow. I don't think there is a problem with that." I Division of Health Service Regulation STATE FORM 5399 9M1 G11 If continuation sheet 29 of 41 -t - FORM APPROVED Division of Health Service Requiaticn STATEMENT OF (X1) (x2) (X3) DATE SURVEY AND PLAN OF CORRECTION NUMBER: BUEWNG: COMPLETED 29130055 B-WW9 0711912013 NAME OF Pnoviosn on suPPusn srnesr ADDRESS, omr, STATE, cOcE 63 ORANGE STREET INC ASHEVILLE, NC 2880? (X4) in SUMMARY STATEMENT OF In Peoviosns PLAN or CORRECTION (x5; PREFIX (EACH DEFICIENCY MUST BE PRECEDED av FULL pagmx (EACH CORRECTIVE ACTEON SHOULD ea COMPLETE TAG REGULATORY on IDENTIFYENG -mg TO THE DATE 144 Continued From page 29 3' 144 interview on 07/19/2013 at 0907 with staff #3 (non-iicensed staff) revealed she was the person that was processing (sterilizing) the surgical instruments. interview revealed staff #3 did not usualiy process the surgical instruments and was filling in for the regular person who was on vacation. Interview revealed the regular person that processed the surgical instruments was a volunteer (staff interview reveaied staff #4 (voiunteer) had been processing the instruments for about a year. interview revealed staff #3 had been trained by staff #4 regarding how to process the instruments. Further interview revealed the staff member stated she "pulied the instruments out Of the autoclave too early yesterday and caused the condensation." The staff member stated she was not aware that it was a problem to remove the packs before the drying cycle was completed and she was trying to get all of the packs done. Staff #3 revealed there was a leak in the ceiling above the autoclave about a week ago and the ceiling tile was removed. interview confirmed the ceiling tiie opening was located above the area where clean instruments were processed. Staff #3 stated she was not aware of a facility policy for cleaning or sterilizing surgical instruments. The staff member expiained the procedure that she followed to sterilize surgical instruments. The process that she explained was consistent with the facility policy. The staff member stated there was no chemical indicator strip placed inside the instrument packs prior to The staff member stated she was taught to use the sterilizer tape on the outside of the pack to determine appropriate sterilization of the instruments. The staff member further stated there was no method of tracking the surgical instruments that were sterilized. Division of Health Service Regulation STATE FORM 559" 9M'l (311 if continuation sheet 30 cf 41 PRENTED: 07/29/201 3 FORM APPROVED Division of Health Service Regulation . . STATEMENT on SEFICIENCIES (X1) (x2) MULTIPLE cousrnucnow (xs) one sunvsv :1 AND PLAN or CORRECTION IDENTIFICATION NUMBER: A BUILDENG, COMPLETED . ti 20130055 3' Wt"? . . 0711912013 NAME or PROVIDER on sunpusn ADDRESS. ZIP CODE 63 ORANGE smear INC ASI-EEVILLE, NC 28801 in :3 in SUMMARY STATEMENT or DEFICEENCIES in Pnovioens PLAN or-' '3 PREHX (EACH osncisncv MUST as ensceoso sv FULL enarix (EACH CORRECTIVE ACTION SHOULD as coMPLs'rE. TAG necumronv on TAG TO THE APPROPRIATE DATE DEFICIENCY) 144 Continued From page 30 Review of staff #3's personnel file revealed no evidence of training or com petency checks =5 regarding processing surgical instruments.' Review revealed there was no personnel file and no evidence of training or competency checks regarding processing surgical instruments for staff interview on 07/19/2013 at with Physician A revealed staff #4 was a volunteer and there was f; no personnel file for staff interview confirmed I the job responsibilities for staff #4 included i processing the surgical instruments. interview revealed staff #4 had no medical background and 3 had not processed surgical instruments prior to volunteering at this facility. Interview revealed staff #4 was trained to process surgical instruments by a former employee. interview confirmed there was no evidence of training or competency checks available. Interview on 07/19/2013 at 1545 with Physician A revealed she was not aware of a practice of using chemical indicators inside the surgical packs when sterilizing and did not use biological (spore) testing when sterilizing. The physician was not 9 aware of a need to have a system in place for 2 tracking surgical instruments when sterilizing the packs. Interview further reveled that the observation of the condensation on the sterile packs meant that the packs were removed from the sterilizer too soonand not allowed to dry . properly. The physician stated she was not aware that it was a problem to have condensation' inside the sterilized pack. The physician confirmed the facility's policy for sterilization of instruments had not been revised since The physician did not know what source or reference was used to develop the policy for Division of Health Service Regulation STATE FORM 5599 9M1 G11 lf continuation sheet 31 cf 41 PRINTEDFORM APPROVED Division of Health Service Reguiation STATEMENT or DEFICIENCIES (X1) (X2) MULTIPLE (X3) SATE sunvsv AND PLAN or connection nuusen BUWNG: COMPLETED 20130055 3- WW3 07/19/2013 NAME oI= PROVIDER on SUPPLEER Accnass, crrv, coca 63 ORANGE smear -AFEMCARE, INC ASHEVILLE, NC 28801 (X4) ,9 SUMMARY STATEMENT or DEFECIENCEES In PLAN or (xs) PREFIX (EACH Musr BE PRECEDED sv FULL przapgx (EACH SHOULD as counters me. REGULATORY on LSO IDENTIFYING TAG CROSSREFERENCED TO THE APPROPRIATE DATE DEFICIENCY) 144 Continued From page 31 144 sterilization and was not aware of using nationatty 'recognized infection control guidelines for policy 'development. - - i 2. Observation of the sterile processing area on 07/19/2013 at 1150 revealed clean supplies (scalpels and gauze) that were placed on the counter of the room next to the sink where dirty equipment is placed for cleaning after use. Interview with staff during the tour confirmed the finding. interview on 07/19/2013 at 1545 with Physician A reveaied that the clean surgicai supplies that were observed on the counter next to the sink where the dirty instruments were placed was not appropriate and the staff shoutd not be mixing the clean supplies with dirty instruments. The physician confirmed there were no policies regarding cross contamination of clean and dirty supplies. 3. Observation on 07/19/2013 at 1150 of a glucometer machine revealed a low control that expired 11/2009. Observation and staff interview revealed there were no high controls available. interview with staff during the tour reveaied the staff would use the machine if needed. interview revealed the staff would wipe the machine down between patient use. Review of policies revealed no policy regarding the use and cleaning of the glucometer between' patients. Interview on 07/19/2013 at 'i545 with Physician A revealed there was no policy and -procedure for care and use of the glucometer. The physician stated "l don't even know why it is here. We don't use it. We have the patient bring their machine from home if we need a glucometer." The physician confirmed the glucorneter was iocated Division of Health Service Regulation STATE FORM 5599 9M1G11 ll' continuation sheet 32 of 41 - PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation OF (X1) Pnovioen/suPPl_1en/cLiA (X2) CONSTRUCTION (X3) DATE sunvsv AND PLAN OF CORRECTION SDENTIFICATION NUMBER: . COMPLETED A. 20130055 8- 07/19/2013 NAME OF PROVIDER OR SUPPLIER INC STREET ADDRESS, CITY, STATE, ZIP CODE 63 ORANGE STREET ASHEVILLE, NC 28801 (X4) io PREFIX TAG SUMMARY STATEMENT OF (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC INFORMATEON) ID PREFIX TAG Paoviosas PLAN on CORRECTION (EACH coanracnva ACTION SHOULD BE TO THE APPROPFHATE (X5) COMPLETE GATE Q144 'i-45 Continued From page 32 in the laboratory and available for patient use. 4. Observation on 07/18/2013 at 1730 reveaied-a Yankauer suction and suction tubing that was removed from the sterile packaging and left open in a drawer that was available for patient use. Interview with Physician A during the tour confirmed the finding. 5. Observation of the operating rooms and on 07/19/2013 at 1150 revealed large amounts of dust that covered the tops of the suction machines and rolled up when touched. Observation revealed the top of the crash cart that was located in OR #1 revealed dust that rolled up when touched. Interview with staff during the tour confirmed the finding. Interview on 07/19/2013 at 1115 with staff #1 (registered nurse) revealed the staff member is a registered nurse (RN) that has worked at the facility since 2003. The nurse stated there was no infection control training provided at the facility. Interview on 07/19/2013 at 1545 with Physician A revealed there is no infection control program. The physician stated "We don't have any infection surveillance monitoring." .1302 STERIUZATION PROCEDURES 10A-130.1302 Policies and procedures shall be established in writing for storage, maintenance and distribution of sterile supplies and equipment. . Steriie supplies and equipment shall not be mixed with unsterile (3144 C2145 Division of Heaith Service Regulation STATE FORM B899 9M'lG'['i If continuation sheet 33 of 41 -- -. .: a .1. -.-.- ..-- PRINTED: FORM APPROVED Sivision of Health Service Regulation . STATEMENT on (X1) (X2) MULTIPLE CONSTRUCTION (xs) DATE SURVEY AND PLAN OF CORRECTION NUMBER: A. QUWNG, COMPLETED 20130055 3- WW3 0711912013 NAME OF PROVIDER OR SUPPLIER STREET AooREss, crrv, STATE, ZIP CODE 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4, ,9 SUMMARY STATEMENT or= ossicimcies in PLAN (X5, PREFIX (r.=.AcH DEFICIENCY MUST es PRECEDED BY FULL (EACH CORRECTIVE ACTION SHOULD BE COMPLETE TAG REGULATORY OR IDENTEFYING mg CROSS-REFERENCED To THE APPROPRIATE DATE 145 Continued From page 33 145 supplies, and shall be stored in dust proof and moisture free units. They shall be properly labeled. (C) Sterilizing equipment shall be available and of the necessary type and capacity to sterilize instruments and operating room materials, as well as laboratory equipment and supplies. The sterilizing equipment shall have design control and safety features intact. The accuracy of instrumentation and equipment shall be checked quarterly by any professionaliy recognized method and periodic calibration and preventive maintenance shall be provided as necessary, and a fog maintained. The date of expiration shall be marked on all suppiies sterilized in the facility. This Rule is not met as evidenced by: Based on policy review, Centers for Disease Control and Prevention guidelines review, observation, personnel file reviews, staff and physician interview, the facility failed to maintain supplies and equipment for use in the surgical suite. The findings include: Review of "Operating of Patton and Crane Autoclave" policy revised January 1989 revealed" a procedure for steam sterilization of surgical instruments. Review of the poiicy revealed no procedure for the use of chemical or biological indicators during the sterilizing process. Review of the CDC (Centers for Disease Control and Prevention) Guideiines for Disinfection and I I I Division of Health Service Reguiation STATE FORM 6399 git/|1G11 if continuation sheet 313 of 41 . -1- J- E. - -J PRINTED: FORM APPROVED Division of Health Servlce Regulation or (X1) (X2) MULTIPLE consraucnou (xa) DATE sunvev AND PLAN oI= CORRECTION EDENTIFICATION NUMBER: A COMPLETED 20130055 3- WW9 0711912013 NAME or: oR SUPPLEER ADDRESS, crrv, srATe, ZIP CODE 63 ORANGE STREET INC ASHEVILLE, NC 28801 (X4) 11) SUMMARY STATEMENT or oEr=:cIENciEs in Pnovioens PLAN or (x5) DEFICEENCY MUST BE I=nEcEoEo av FULL PREFIX (EACH CORRECTIVE as COMPLETE TAG on LSC TAG TO THE APPROPRIATE DATE 145 Continued From page 34 145 Sterilization in Healthcare Facilities, 2008; Healthcare Infection Control Practices Advisory Committee (HICPAC) revealed "Sterilizing Practices Overview. The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycle for the load contents, and other aspects of device reprocessing. consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, ioading the sterilizer, operating the sterilizer, and monitoring of the entire process. The sterilization procedure should be monitored routinely by using a combination of mechanicai, chemical, and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items. Chemical indicators are inexpensive, and indicate that the item has been exposed to the sterilization process. Chemical indicators should be used in conjunction with, biologicai indicators, but based on current studies should not replace them because they indicate sterilization at marginal sterilization time and because only a biological indicator consisting of resistant spores can measure the microbial killing power of the sterilization process847, 974. Chemical indicators are affixed on the outside of' each pack to show that the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration. other sterilization systems, the steam cycle is Division of Health Service Regulation STATE FORM 5599 Qil/l'1G'l'l if continuation sheet 35 of 41 . . . -- *v-.3 PRINTED: FORM APPROVED Division of Health Service Regulation . STATEMENT or-' DEFICIENCIES (X1) (X2) MULTIPLE cousrnucnou (X3) DATE sunvsv Awe PLAN or coareecnow IDENTIFICATEON NUMBER: BUILDNG, COMPLETED 20130055 B-WW3 07/19/2013 NAME OF PROVIDER on SUPPLIER ADDRESS. cnv, STATE, ZIP CODE 63 GRANGE STREET INC ASHEVILLE, NC 28801 (X4, ,9 SUMMARY STATEMENT or DEFICIENCEES in PROVIDERS PLAN or (EACH MUST BE av run. PREFIX (EACH conaacnva ACTION SHOULD as COMPLETE TAG REGULATORY on TAG CROSS-REFERENCED TO THE APPROPRIATE WE 145 Continued From page 35 145 monitored by mechanical, chemical, and biologicai monitors. Steam sterilizers usually are monitored using a printout (or graphicaiiy) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into. the pack to monitor the temperature or time and temperature. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacilius stearotherrnophiius). Positive spore test results are a reiatively rare event 838 and can be attributed to operator error, inadequate steam delivery 839, or equipment malfunction. items that become wet are considered contaminated because moisture brings with it microorganisms from the air and Further review of the guidelines reveaied "16. Monitoring of Sterilizers Monitor each load with mechanical time, temperature, pressure) and chemical (internai and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed. ci. Use biological indicators to monitor the effectiveness of sterilizers at ieast weekiy with an FDA>>-cleared commercial preparation of spores stearothermophilus for steam) intended specifically for the type and cycle parameters of the Observation on 07/18/2013 at 1810 during tour of the facility's sterile processing area revealed a ceiling tile (drop down ceiling) that was missing above the autoclave area where clean siariie packs were processed. The area was open to the pipes and air flow above the ceiling. Observation of the top of the autociave revealed excessive dust that rolled up when touched. interview during the tour with Physician A I I Division of Health Service Regulation STATE FORM 9599 (311 if continuation sheet 35 of 4'i - -. . .. . - NTED: 07/29/2013 FORM APPROVED Division of E-ieailth Service Regulation STATEMENT OF (X1) (X2) (X3) DATE SURVEY AND FLAN OF NUMBER BUILDWG: COMPLETED 20130055 07/19/2013 NAME oF PROVIDER on SUPPLIER STREET ADDRESS. cm', coDE 63 ORANGE STREET -AFEMCARE, INC ASHEVILLE, NC 23301 (X4) "3 SUMMARY STATEMENT OF in PRovioER's PLAN or CORRECTION (xs; (EACH MUST as Raecsoso av FULL PREFIX (EACH CORRECTIVE SHOULD BE COMPLETE TAG REGULATORY OR LSC -me. CROSS-REFERENCED TO THE APPROPRIATE DATE 145 Continued From page 36 145 revealed the facility had a leak last week and the tits had to be removed. interview confirmed the top of the autoclave was covered with a layer of- dust Observation on 07/18/2013 at 1815 revealed a cart with instrument packs located on the cart. Interview with Physician A during the tour revealed these packs were sterilized and available for use. Observation revealed three packs with beads of moisture located inside the clear packs. Physician A stated "Yes, there is condensation inside the packs. It will be okay tomorrow. i don't think there is a problem with that." interview on 07/19/2013 at 0907 with staff #3 (non--iicensed staff) revealed she was the person that was processing (sterilizing) the surgical instruments. interview reveaieci staff #3 did not usually process the surgical instruments and was filling in for the regular person who was on vacation. Interview revealed the regular person that processed the surgical instruments was a voiunteer (staff interview revealed staff #4 (volunteer) had been processing the instruments for about a year. interview reveaied staff #3 had been trained by staff #4 regarding how to process the instruments. Further interview revealed the staff member stated she "pulled the instruments out of the autoclave too early yesterday and caused the condensation." The staff member stated she was not aware that it was a problem to remove the packs before thedrying cycle was completed and she was trying to get all of the packs done. Staff #3 revealed there was a leak in the ceiling above the autoclave about a week ago and the tile was removed. Interview confirmed the ceiling tile opening was located above the area where clean instruments were I Division of Health Service Regulation STATE FORM 5599 (311 if continuation sheet 37 of 41 -. - - . - I PRINTED: FORM APPROVED Division of Health Service Reculation STATEMENT OP DEFIOEENCIES (X1) Paovroen/sur=PLIEa/OLIA (X2) DATE suavev AND PLAN OF NUMBER: A. I COMPLETED 29130055 B-WW9 07/19/2013 NAME or PROVIDER oa SUPPLEER STREET CITY, STATE, CODE (53 ORANGE STREET WFEMCARE, INC ASHEVILLE, NC 28861 (X4, "3 SUMMARY STATEMENT OF I9 PRovIoraR's PLAN OF (x5) MUST era Pneceoeo ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETE TAG REGULATORY OR LSC TAG CROSS-REFERENCED To THE APPROPRIATE DATE DEHCIENCY) 145 Continued From page 37 145 processed. Staff #3 stated she was not aware of a facility policy for cleaning or sterilizing surgical instruments. The staff member explained the procedure that she followed to sterilize surgical instruments. The process that she explained was consistent with the facility policy. The staff member stated there was no chemicai indicator strip placed inside the instrument packs prior to sterilizing. The staff member stated she was taught to use the sterilizer tape on the outside of the pack to determine appropriate sterilization of the instruments. The staff member further stated there was no method of tracking the surgical instruments that were sterilized. Review of staff #3's personnel fiie revealed no evidence of training or competency checks I regarding processing surgicai instruments. Review revealed there was no personnel file and no evidence of training or com petency checks regarding processing surgical instruments for staff A interview on 07/1 9/201 3 at with Physician A revealed staff #4 was a volunteer and there was no personnel tile for staff Interview confirmed the job responsibilities for Staff #4 included 'processing the surgical instruments. interview - revealed staff #4 had no medical had not processedsurgical instruments prior to volunteering at this facility. interview reveaied staff was trained to process surgical instruments by a former em pioyee. interview confirmed there was no evidence of training or competency checks avaiiabie. interview on 07/19/2013 at 1545 with Physician A reveaied she was not aware of a practice of using chemical indicators inside the surgical packs I Division of Health Service Regulation STATE FORM 6899 9M'iG1'l if continuation sheet 38 of 41 .. .. -PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation STATEMENT OF DEFICIENCEES (X1) neovioen/suPPLIea/cLiA (X2) MULTIPLE (X3) oprre sunvsv AND PLAN OF coeaecnon ioENTii=icATicr~i NUMBER: A BUILWG: COMPLETED 20130055 3- WW9 07I19I2013 NAME OF PROVIDER on SUPPLIER STREET ADDRESS, CITY, STATE, cops 63 ORANGE STREET ASHEVILLE, NC 28801 (X4) in SUMMARY STATEMENT OF psncisncias Ta PROVIDERS PLAN OF CORRECTION (EACH DEFICIENCY MUST ea PRECEDED sv FULL PREFIX (EACH conaacrivs ACTION SHOULD BE COMPLETE 'me REGULATORY on 1.30 ENFORMATION) TAG cnoss~nsrEnaNceo 'ro THE oaieciencv) 145 Continued From page 38 145 when sterilizing and did not use biological (spore) testing when sterilizing. The physician was not aware of a need to have a system in place for tracking surgical instruments when the packs. Interview further reveled that the observation of the condensation on the sterile packs meant that the packs were removed from the sterilizer too soon and not allowed to dry properly. The physician stated she was not aware that it was a problem to have condensation inside the sterilized pack. The physician confirmed the facility's policy for sterilization of instruments had not been revised since 146 .1303 HOUSEKEEPING 146 10A-13C.1303 Operating rooms shall be appropriately cleaned in accordance with estabiished written procedures after each operation. Recovery rooms shall be maintained in a clean condition. This Ruie is not met as evidenced by: Based on review of facility policy, review of :3 housekeeping contract, observation and physician and staff interview, the facility failed to ensure terminal cleaning of the operating rooms. The findings include: Review of an "Infection Control" policy revised 1992 revealed operating room floors are to be mopped daily and walls cleaned bi-weekly. Review of a "Cleaning Contract" signed 08/05/2003 revealed "Tuesday: down bottom or operating room beds; Sweep entire building; hallways, bathrooms, exam rooms, Division of Health Service Regulation STATE FORM 5599 9lVl1G*i1 lf continuation sheet 39 of 41 .. -. . A - .-.- .. . . .. . .- i. A PRENTED: 07/29/2013 . FORM APPROVED Division of Health Service Regulation STATEMENT OF DEFICIENCIES (Xi) (X2) MULTIPLE CONSTRUCTION (X3) DATE suavsv AND PLAN OF CORRECTION IDENTIFECATION NUMBER: A BWLDINGI COMPLETED 20130055 3- WW3 0711912013 NAME OF PROVIOER OR SUPPLEER INC 63 ORANGE STREET ASHEVILLE, NC 28801 STREET AQDRESS, STATE, CODE kitchen and operating room area; Mop entire building with germicide; Misceiianeous indoor cieariing: down walls in operating rooms every other week; Dust and clean light fixtures or as needed." Observation on 07/18/2013 at 1740 during tour of the operating room #1 revealed a thick iayer of dust that rolled up when touched that was covering the top of the crash cart that was located in the operating room (OR). Observation further revealed a thick layer of dust on the surface of the suction machine and nitrous oxide machine located in the OR. Observation revealed a thick layer of dust iocated on the surface of the suction machine and nitrous oxide machine in OR P_hysician A confirmed the observation. interview on 07/19/2013 at 0907 with staff #3 (nonulicensed staff) revealed the facility staff Clean between patients including wiping down the operating room beds and any blood spills. interview revealed the staff do not mop floors between patients. lntervieiiv revealed surgical procedures are scheduied on Wednesdays, Fridays and Saturdays. The staff member stated there was a person that comes to the facility on Tuesday evenings that does the "big cieaning" including mopping. Staff #3 stated housekeeping comes on Wednesday and Friday evenings, but the staff member was unsure if the fioors are mopped on those days. interview on 07/19/2013 at 1440 with Physician A revealed the physician did not know if terminal cleaning of the operating rooms was being done. interview revealed the physician did not know how often fioors were being mopped in the operating rooms. interview confirmed there was noidocumentation of terminal Cleaning of the (X4) in SUMMARY STATEMENT OF oei=iCiENciEs in PLAN OF CORRECTION . (X5) (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTNE ACTION SHOULD BE compuars TAG REGULATORY on ioeinir-"vine INFORMATION) 1-AG CROSS--REFERENGED To THE APPROPRMTE DATE DEFICIENCY) 1463 Continued From page 39 145 A Division of Health Service Reguiation STATE FORM 5599 9M'lG'l'l ii continuation sheet 40 of 41 PRINTED: 07/29/2013 FORM APPROVED Division of Health Service Regulation STATEMENT OF OEFICIENCIES (X1) (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN oe coRRec'noN NUMBER: . COMPLETED A. eumeime. 20139055 WW9 0711912013 NAME OF PROVIDER OR SUPPLIER INC 63 ORANGE STREET ASHEVILLE, NC 28801 STREET ADSRESS, CITY. STATE, ZIP CODE operating roomsgand no monitoring of housekeeping duties. interview confirmed there was a think layer of dust located on the equipment and horizontal surfaces in the operating rooms, interview revealed the physician did not know if the housekeeping staff had any training in infection control prevention. (X4) .9 SUMMARY STATEMENT OF To PLAN OF CORRECTION (x5) (EACH oEEicIENcv MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTEON SHOULD BE COMPLETE mg REGULATORY oR LSC INFORMATION) TAG CROSS--REFERENCED TO THE APPROPREATE DATE 146 Continued From page 40 146 Division of Heatth Sen/Ice Regutaiicn STATE FORM B399 9M'iG'i'i if continuation sheet 41 of 41