OY¥-129¢ STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA NO. 2008001451 Return Receipt Requested SANCTUARY SURGICAL CENTRE, INC. 7002 2410 0001 4236 0400 d/b/a SANCTUARY SURGERY CENTRE, 7002 2410 0001 4236 0417 Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “AHCA”), by and through the undersigned counsel, files this Administrative Complaint against Sanctuary Surgical Centre, Inc. d/b/a Sanctuary Surgery Centre (hereinafter “Sanctuary Surgery Centre”) pursuant to 28-106.111 Florida Administrative Code and Chapter 120, Florida Statutes hereinafter alleges: NATURE OF THE ACTION 1. This is an action to impose an administrative fine in the amount of two thousand ($3,000.00) dollars pursuant to Section 395.1065(2) (a) Florida Statutes (2007). JURISDICTION AND VENUE 2. This court has jurisdiction pursuant to Section 120.569 and 120.57 Florida Statutes and Chapter 28-106 Florida Administrative Code. 3. Venue lies in Palm Beach County, pursuant to 120.57 Florida Statutes (2007) and Chapter 28, Florida Administrative Code PARTIES 4. AHCA is the enforcing authority with regard to Hospital licensure law pursuant to Chapter 395, Part I, Florida Statutes (2007) and Rules 59A-5, Florida Administrative Code 5. Sanctuary Surgery Centre is am _ ambulatory surgical center, located at 5503 N. Federal Highway, Boca Raton, Florida 33487 and is licensed under Chapter 395, Part I, Florida Statutes (2007) and Chapter 59A-5, Florida Administrative Code. COUNT I SANCTUARY SURGERY CENTRE FAILED TO MAINTAIN A SURGICAL DEPARTMENT WHICH IS ORGANIZED UNDER WRITTEN POLICIES AND PROCEDURES RELATING TO SURGICAL STAFF CLINICAL PRIVILEGES 59A-5.0085(1), Florida Administrative Code {SURGICAL SERVICES) 6. AHCA re-alleges and incorporates (1) through (5) as if fully set forth herein. 7. During complaint investigation conducted on February 1° and 4‘, 2008, and based on the review of facility records, patients clinical records and interview, it was determined the facility failed to ensure patient care is provided in a safe manner by failing to maintain a surgical department which is organized under written policies and procedures relating to surgical staff clinical privileges, physician's orders, discharged patients and patient consents. The facility failed to ensure their practicing professionals were credentialed and granted privileges to perform procedures. Sanctuary Surgery Centre failed to ensure that all anesthesia was administered by an anesthesiologist or by a certified registered nurse anesthetist, under the on-site medical direction of a licensed physician, with credentials at the facility. The facility did not have physician admission orders on all clinical records reviewed. Furthermore, Sanctuary Surgery Centre failed to have properly executed informed consents prior to all surgical procedures.. This violation was observed for 21 of 21 sampled patients. (Patient's #1 - #21) 8. During an interview with the Director of Nursing/Administrator/Risk Manager (RM) on 2/01/08, at approximately 1:00 PM, he/she stated that they have not obtained any delineation of clinical privileges for the physician's at the facility. A review of the physician's credentialing files confirmed the interview. There was only one chiropractor who had a certificate for training in Manipulation Under Anesthesia hereinafter (MUA's), but he/she did not have any clinical privileges in the credentialing file to perform the procedure at the facility. MUA's are a routinely performed procedure in the facility. The DON reported that there is one physician (physician #1) who oversee's all of the MUA procedures and "just stands there." The DON reported, physician #1 does not perform any procedures and therefore did not need any delineation of clinical privileges. This information contrasts sharply with the written document on file at the facility. Physician #1 is documented as the "Surgeon" on the handwritten operative reports, signed the patient's history and physicals, and dictated the operating reports for 21 sampled patients. Physician #1 also supervises the Certified Nurse Anesthetists during these procedures. 9. A clinical record review revealed that the facility records were inconsistent as to whether the prescribing chiropractor was present during the performance of these procedures (MUA's). In the twenty-one patient records reviewed, the prescribing chiropractor did not have clinical privileges at the facility. 10. During an interview with the Director of Nursing (DON) on 2/01/2008, at approximately 9:30 AM, he/she stated that most of the chiropractors don't want to do the procedure. The DON reported that the chiropractors have submitted credentials, but have contracted with another physician, physician #2, to do the procedures for them. The DON further stated, physician #3 has not done any procedures at the facility, and does not have MUA training. Physician #4 is another chiropractor who does not perform MUA's. Physician #2 performs MUA’s for several chiropractors. 11. During a telephone interview with physician #3 on 2/05/08, at approximately 4:00 PM, he/she stated that he/she performs MUA's at the facility. When asked by the surveyor if the physician had -credentials for the procedure, the physician refused to answer the question, and stated,”I didn't know who I was calling back, I am with a patient." Physician #3 reported he/she would call the surveyor back at a later time. 12.. During the review of the 21 patient records, it could not be determined which chiropractors were performing the MUA's on each of the patients. 13. The handwritten surgical reports and the anesthesiology reports do not reflect the presence of physician #1. The dictated surgical reports, however, identify the chiropractor performing the procedure, a non- prescribing physician, (physician #1), as the attending physician, and the prescribing physician is documented as a co-attending physician. The 21 patient records consistently reflect a physician other than the physician who prescribed the procedure as performing the procedure. 14. The patient informed consent forms do not contain a physician signature, nor do they indicate that the physician who would be performing the procedure is a physician other than the patient's prescribing physician. There was no documentation that would indicate that the patients undergoing such procedures were aware of the second chiropractic physician who was performing procedures. The facility staff did not provide any records that reflected the patients knowledge of this practice. 15. A review of the surgical schedule for the months of March, April, and May of 2007, and of January 1/24/08- 1/26/08, did not document the name of the chiropractor who performed all twenty-one procedures. The prescribing chiropractors were documented. The DON was asked to provide to the surveyors a list of the chiropractors who performed the MUA procedures at the facility on 2/01/08. After two additional attempts to get the information, the DON faxed a form to the Agency for Health Care Administration on 2/05/08, which documented 44 chiropractors were currently performing MUA procedures at the facility. There was no documentation provided that any of these chiropractors had delineation of privileges or credentials at the facility, and only one had a certificate to perform an MUA procedure. 16. During the clinical records reviewed for service on 1/24/08-1/26/08, the records included documentation that there were 11 patients seen at the facility each day. It was determined, the MUA procedure is a three-day consecutive treatment. These same patients came each day. The timeline for these cases are as follows for 1/24/08: Patient case load, start surgery time stop surgery 1. Patient #7 7:19 AM 7:26 AM 2. Patient #1 7:29 AM 7:37 AM 3 Patient #2 7:40 AM 7:51 AM 4. Patient. #3 7:55 AM 8:03 AM 5. Patient #8 8:11 AM 8:20. AM 6. Patient #4 8:17 AM 8:24 AM 7. Patient #5 8:28 AM 8:34 AM 8. Patient #9 8:44 AM 8:51 AM 9. Patient #6 8:51 AM 8:58 AM 10 Patient #10 9:08 AM 9:16 AM 11 Patient #11 9:23 AM 9:30 AM 17. In approximately 2 hours and eleven minutes, the facility had performed 11 MUA procedures on the 11 patients. These procedures lasted from 5 minutes to 11 minutes in duration. 18. The patients were all in the recovery room for ten minutes and then discharged. There were 10 different prescribing physicians documented performing the procedures at the facility on the handwritten operating reports. All ten of these chiropractors are not credentialed by the facility, nor do they have documented training to perform MUA's at the facility. Physician #3 documented on the handwritten Operating Reports for all 11 patients that day. Physician #3 signed all of the history and physical evaluations performed on that day, and dictated all of the operating reports. 19. The dictated reports documented that the attending physician for all 11 patients seen on 01/24/08 was physician #2. The timeframes documented on the clinical records had overlapping times on two of the patients, patients #4 and #8, and did not document sufficient time between cases to clean and sterilize the room for the next patient. The documentation for the next two days was similar to the documentation provided for 1/24/08. 20. During a review of the twenty-one clinical records, there was no documentation indicating that the patients were discharged in a safe manner and in the company of a responsible adult. The patient's discharge instructions documented that the patient was unable to drive for 24 hours. 21. The discharge notes in patient #20's clinical record documents that patients who have undergone manipulation under anesthesia are maintained for ten (10) to fifteen (15) minutes in the patient recovery area, and then instructed to wait in the facility reception area. This patient's record documents, "Patient driving home. Instructed to wait in lounge until fully awake." 22. A second patient, patient #12's record documents that anesthesia was ended at 11:15 AM. The record further documents that the patient was discharged from the facility five (5) minutes later at 11:20 AM. 23. Twelve of the discharged patients have documentation that they were discharged either to home or with transportation. They do not contain a name of the responsible adult they were discharged to. 24. A review of the Governing Board Membership Qualifications policy and procedure, documented that applicants to the medical staff would be approved by the board of directors upon recommendation by the medical advisory committee. The initial appointment would be probationary for six months. After that period of time, the appointment would be for the remainder of the two year term, subject to the bylaws of the medical staff. There was no evidence in the physician's credential files, or provided by the facility that any physicians went through the appointment process or that any subsequent reviews were done by the facility. There were no meeting minutes provided by the facility for the governing board or medical staff. The policy further documented that an applicant for surgical admitting privileges must have hospital co-admitting privileges in a local accredited hospital. There was no documentation provided by the facility to ensure that any of the physicians had admitting privileges at an area hospital. The medical staff credentials did not contain any signed forms that they were aware of the bylaws of the facility, as required in the policy and procedure for membership qualifications. 25. The clinical records reviewed did not contain any physicians orders. During an interview with the DON on 2/01/08, at approximately 12:00 PM, he/she stated that they should have standing orders in the clinical records. The DON returned with a copy of the standing orders which pertained to the recovery room nurse. There were no physician orders provided for the care of the patients from pre-op to surgery. The recovery room standing orders were not signed or contained in any clinical record reviewed. The policy and procedure for treatment orders documented that all orders were to be in writing, and authenticated by a physician within 24 hours. Each patient admitted to the facility shall have specific admission orders provided by the admitting physician. Standing orders for specific physicians or groups may be submitted for center usage. Orders will be submitted to the medical staff quality assurance for review and approval. Printed orders must be validated by the attending physician. The facility failed to provide any evidence that the standing orders were approved by the medical staff quality assurance, and there was no standing orders for care, or admission orders signed by the attending physician for patients #1 thru #21. 26. During an interview with the DON on 2/01/08, at approximately 10:00 AM, he/she stated that the Anesthesiology services for the facility are performed by Certified Nurse Anesthetists. A doctor supervises the administration of anesthesiology to patients by the nurse anesthetists. Facility records do not, however, reflect that this supervising physician has been credentialed to supervise anesthesiology services or that the physician has received training adequate to supervise the Certified Nurse Anesthetist. 27. The policy and procedure for consents documented that the request form for surgery and/or the administration of anesthesia must be obtained by the appropriate physician. Both the physician and the patient must sign the forms and include the date. The forms must be obtained prior to surgery. The twenty-one clinical records reviewed contained consent forms for the prescribing physician and the admitting physician to perform the MUA procedure. The 11 consents) were signed by the patient, but not by any Physician. The consents for anesthesia were signed by the patient but not by the anesthesiologist. During an interview with the DON on 2/01/08, at approximately 2:00 PM, he/she stated that the consents were not signed by a Physician or Anesthesiologist and agreed it should have been. There is no area on the consent for the physician to sign the form. 28. The facility failed to ensure that the surgical procedures performed at the facility were carried out ina safe manner. The patients were not informed which physician was. performing the procedure. The facility did not follow their policy and procedures to grant clinical privileges to the physicians at the facility, to properly execute informed consents, to discharge patients safely post-op, and to ensure physician's orders were obtained for the patient's care. 29. Based on the foregoing, Sanctuary Surgery Centre violated Rule 59A-0085(1), Florida Administrative Code. The fine assessed is $1,000.00 COUNT II SANCTUARY SURGERY CENTRE FAILED TO OBTAIN PROPERLY EXECUTED INFORMED CONSENTS PRIOR TO A SURGICAL PROCEDURE Rule 59A-5.0085(1) (c), Florida Administrative Code (SURGICAL SERVICES) 30. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 31. During the complaint investigations conducted on 12 February 1° and 4™, 2008 and based on patient clinical records and staff interviews, the facility failed to obtain properly executed informed consents prior to a surgical procedure. This affected 21 of 21 sampled patients. (Patient #1 - #21) 32. The policy and procedure for consents documented that the request. form for surgery and/or the administration of anesthesia must be obtained by the appropriate physician. Both the physician and the patient must sign the forms and include the date. The forms must be obtained prior to surgery. The twenty-one clinical records reviewed contained consent forms for the prescribing physician and the admitting physician to perform the MUA procedure. The consents were signed by the patient, but not by any physician. The consents for anesthesia were signed by the patient but not by the anesthesiologist. During an interview with the DON on 2/01/08, at approximately 2:00 PM, he/she stated that the consents were not signed by a physician or Anesthesiologist and agreed it should have been. There is no area on the consent for the physician to sign the form. 33. Based on the foregoing, Sanctuary Surgery Centre violated Rule 59A-5.0085(1) (c), Florida Administrative Code. The fine assessed is $1,000.00. COUNT III SANCTUARY SURGERY CENTRE FAILED TO PROVIDE A SAFE AND SANITARY ENVIRONMENT, RESULTING IN AN IMMEDIATE AND SERIOUS DANGER TO THE PUBLIC HEALTH Rule 59A-5.0085(1) (g), Florida Administrative Code (SURGICAL SERVICES) 34. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 35. During the complaint investigations conducted on February 1% and 4°, 2008, and based upon observation, interview and record review, the facility failed to provide a safe and sanitary environment, resulting in an immediate and serious danger to the public health, safety and welfare of patients. 36. The facility failed to ensure potentially dangerous uncapped used needles were secured; medical equipment was sterilized appropriately; medications were appropriately labeled and secured; staff wore the correct surgical attire in the appropriate area's of the operating room (OR), the traffic flow of materials in the OR were unidirectional; the OR rooms and floors were clean and an infection control program was maintained in the facility. 37. During a tour of the PACU (Post Anesthesia Care Unit) with the Director of Nursing (DON) on 02/01/2008 at 11:00 AM, the surveyor observed an uncovered, garbage can sized sharps container, approximately one eighth full of uncapped, used needles, juxtaposed next to a patient 14. recovery chair. The DON informed the surveyor that the container should not have been located next to the chair. 38. During a tour of the Medication Room with the DON on 02/01/2008 at 11:10 AM, multiple bottles of Botox were observed in the refrigerator. The bottles were marked June 10 but there was no indication if the 10 stood for a day or year. Upon inquiry, the DON could not confirm whether the 10 stood for the day or the year. 39. During a tour with the DON on 02/01/2008 at 11:15 AM of the facility’s dirty equipment and sterile storage areas, the doors to the facility's dirty equipment room were observed to be propped open with biohazard containers. One door opened into the sterile storage room and the other door opened onto a central hallway. Used bloody = surgical instruments were observed on the counter in the equipment room. Sitting next to the used bloody surgical instruments were three uncovered Styrofoam cups filled with ice and beverages. It was uncertain if the beverages were intended for staff or patients. Upon seeing the cups among the used surgical instruments, the DON agreed that cups of beverages should not be on a counter with used surgical instruments. In the sterile storage room, the surveyor noted that breast implants, surgical drapes, surgical gowns, and surgical light covers, were either not dated to reflect the date of sterility or the date had expired. The surveyor also noted 15 that the autoclave, which was located in the sterile storage room, was operating but that the temperature dial was not in the green zone, indicating that the autoclave was not functioning at the proper operating temperature. 40. On 02/01/2008 at 11:20 AM, the surveyor returned to the sterile storage room as the Operating Room Technician (OR Tech) was opening the door to the autoclave. Hair was observed sticking out from the bottom and sides of the OR Tech's hairnet. An oven mitt was observed sitting on top of the autoclave. Upon closer inspection, the surveyor and the OR Tech were not able to find an inspection sticker.on the autoclave. The surveyor asked the OR Tech if the instruments inside the autoclave were sterilized. The OR Tech said, "It just. finished." She/He informed the surveyor that it takes 20. minutes to sterilize. She stated that she sets the timer and it does not start ticking until the autoclave has reached the proper temperature. 41. The surveyor informed the OR Tech that the autoclave was not at the proper operating temperature five minutes ago. The OR Tech replied, "It had to have been." With bare hands, she then reached into the tray of instruments in the autoclave to retrieve a test strip from the bottom of the tray. Upon realizing that the surveyor was observing her touch the newly sterilized instruments with her bare hands, the OR Tech replied, "Oh, I shouldn't 16 be touching it? I should wear gloves?" The surveyor asked the OR Tech to describe the proper procedures for running the autoclave. The OR Tech then told the surveyor that the timer on the autoclave should be set for 10 minutes to sterilize instruments "but I put it at 18." When asked about her training and experience, the OR Tech stated that she used to be a scrub tech at two hospitals but that she did not perform sterilization of surgical equipment at those facilities. She informed the surveyor that she had just started doing sterilization when she was hired by this facility and that she had never received any training on sterilization. The DON confirmed that the OR Tech had not received any training on sterilization. A review of the personnel file for the OR Tech, conducted on 02/04/2008, failed to reveal any documentation that the OR Tech had ever received any training, or had previous experience in sterilization. 42. Upon request, the facility was unable to provide the surveyor with documentation that the autoclave had ever been inspected. 43. On 02/01/2008 at 2:30 PM, the surveyor attempted to tour the first of two surgical suites. While observing staff entering and leaving the surgical area, it was noted that the traffic flow from the operating suite flows from the suite to the sterile area and then the soiled area. No barriers protect the sterile area from contamination from the other areas. It. was also noted that staff entering and exiting the sterile storage room and the operating room did not wear scrub gowns or masks. In addition, staff did not indicate to the surveyor that protective gear must be donned prior to the tour of the surgicdl suites. The surveyor asked the OR Tech for protective equipment and the OR Tech indicated that she was not sure where the protective equipment was located. She said, "I think there's some in the men's locker room." She/He then reached over to a rack in the sterile storage room and handed the surveyor a gown and a mask. When the OR Tech did not offer the surveyor protective foot covering, the surveyor requested that the facility provide foot covering. The OR Tech left the room and returned a few minutes later with foot covering. 44, During the tour of the first operating room, the following observations were made: (a) Four (4) feet from the operating table was an equipment cart with magazines strewn amongst the surgical equipment. Also in a drawer of the surgical equipment cart was a comb, its tines encrusted with what appeared to be dandruff, sitting next to an open and undated vial of Lidocaine. . (b) Medications were observed to be littered on the equipment cart, including open undated bottles of Atropine and Labetalol, and drawn syringes - two (2) containing Ketamine, two (2) containing Ephedrine, and one (1) containing Epinephrine. The syringes were not dated and the concentrations of the medications were not listed. A Nurse Anesthetist (CRNA), preparing equipment for the next patient, removed the syringes from the equipment cart and stated, "These should be thrown out." It was noted that the CRNA was preparing equipment with bare hands and was not wearing a surgical mask. (c) A table in the operating room was soiled with a dried yellow substance, an apparent spill. A blue foam leg holder device sat atop the table and was covered with a similar dried yellow substance. (d) The floor of the suite under and near the operating table was stained with a yellow substance. (e) Even though the surveyor had been told by the CRNA and the OR Tech that the operating room had been cleaned and was ready for the next patient, vacuum tubing, a roll of gauze, and several electrodes were observed on the floor of the operating room. 46. During the tour of the second surgical suite, the surveyor observed that a desk in the suite served as a shelf for the following medications: five open, undated bottles of Lidocaine, an open, undated bottle of Marcaine, four open, undated bottles of sodium bicarbonate, an open, undated bottle of Kenalog, an open bottle of Betadine dated September 5, 2007, and a container of 10-20-4% ointment marked "Refillable until 6/12/2007." 47. During an interview with the DON on 02/01/2008 at 3:10 PM regarding infection control practices, the DON confirmed that he was the individual at the facility responsible for both infection control and risk management. Upon request, the DON was unable to provide the surveyor with minutes of meetings related to an infection control program. Upon request, the DON was unable to provide the surveyor with minutes of meetings concerning reports to the governing body addressing the infection control program. Upon request, the DON was unable to provide the surveyor with an infection control log or similar documentation regarding tracking and investigating infections. The DON informed the surveyor that there was no need to track infections .because no cases of nosocomial infection had ever occurred in the eight years that the facility has been operational. 48. The surveyor inquired as to the facility procedures for following up with patients to detect post- surgery infections. The DON confirmed that the facility does not perform any infection related follow-up. Upon review with the surveyor, the DON agreed that by not conducting follow-up, the facility failed to provide for the 20 surveillance, prevention, and control of infection among patients. The DON also agreed that the facility had failed to establish a viable system for identifying, reporting, evaluating and maintaining records of infections and for conducting ongoing reviews and evaluations of aseptic, isolation and sanitation techniques. During an interview with the Chief Operating Officer (CEO)/Physician Owner on 02/04/2008 at 11:45 AM, the CEO informed the surveyor that there was no need for infection tracking and trending because no infections had ever occurred in the facility. 49. During a review of personnel files, conducted on 02/04/2008, it was noted that multiple files contained laboratory reports, dated 10/25/2007, documenting that nasal cultures revealed heavy staphylococcus species. It was determined the facility failed to follow its policies and procedures. 50. In stark contrast to its actual practices, the facility’s policies and procedures are documented below. (a) The facility's policy on Sterilization and Monitoring documents as follows: (1) Only sterilizers with properly functioning temperature and exposure time indicators and printouts or graphs may be used to sterilize items. When a discrepancy exists between a sterilizer's set temperature and exposure time and the temperature and 21 exposure time indicators, times processed in that sterilizer must not be dispensed to the sterile field. Temperature and exposure time records shall be retained indefinitely. All sterilizers shall be serviced at least yearly and documented evidence of service shall be maintained indefinitely. 51. The facility's policy on sterilization and Disinfection Principles and Methods documents as follows: (a) Thermometer gauges and computer tape printout should be checked periodically to detect faulty sterilization. Computer tape printouts should be dated, numbered and kept for one (1) year to detect faulty autoclaves. All packs should contain sterility indicators to indicate they have been subjected to the sterilization process. Change in indicators or autoclaves or autoclave tape do not necessarily assure sterility. All wrapped supplies must be re-autoclaved every thirty (30) days. 52. The facility's policy on Terminal Sterilization documents as follows: (a) Maintain sterility of the contents after sterilization. Requirements: Adequate temperature; proper timing. 53. The facility's policy on Outdated Sterile Supplies documents as follows: 22 (a). All sterile supplies shall be marked with an expiration date. Checking for outdates will be done on a monthly basis. 54. The facility's policy on Sterile Central Supply documents as follows: (a) Traffic flow of all materials will. be uni- directional from decontamination to processing, and finally, to sterile storage. Each item will have an expiration date on it. Expiration dates will be checked when they are delivered for use and all shelves will be checked for outdates at the first of each month. Any outdated packages will be returned for reprocessing. 55. The facility's policy on Traffic Control documents as follows: (a) Prescribed patterns to control the flow of personnel, patients, and materials to, from, and within the operating room will be strictly adhered to. All. workflow, staff and patient traffic patterns, and materials handling must follow an unidirectional course from an unsterile to an aseptic environment state. 56. The facility's policy on Operating Room Attire documents as follows: (a) All personnel entering the semi-restricted and restricted areas of the operating room are required to wear appropriate apparel. Purpose: To provide a safe 23 environment for surgical patients by minimizing external sources of contamination. Proper attire in the restricted area of the operating room shall include a mask. 57. The facility's policy on Universal Safeguards in the Operating Room documents as follows: (a) Masks, shoe covers, and head covering are worn in accordance with routine operation room attire policies. 58. The facility's Infection Control Program documents as follows: (a) Certain patients in a health care setting (hospital, outpatient day surgical care units) may acquire infections during their hospitalization. These infections are known as nosocomial infections. The Infection Control Program is responsible for all aspects of the spread of infection within the health care setting. Activities included in the Infection Control Program are the documentation of nosocomial infections in patients, the recognition and investigation of outbreaks of infection, the recognition of patients at risk for developing nosocomial infection, and intervention where possible to prevent infection. 59. The facility's policy on Nosocomial Infections: Follow-up of Discharged Patients documents as follows: (a) It is the policy of (the facility) to maintain a survey program of discharged patients which reflect as accurately as possible the rate of nosocomial infections which develop after release from the Center. This survey will allow for the development of a true picture of any problem areas which may develop in the facility and/or among personnel. Post-discharge nosocomial rates will be monitored for cluster patterns, isolate, procedure, etc., and will be reported to the Medical Staff Quality Assurance Committee. The physician will be ultimately responsible for reporting nosocomial infections which develop after discharge. The Infection Control Coordinator and/or designee will be responsible for trends, etc., which may. develop and for reporting the findings to the Medical Staff Quality Assurance Committee. 60. The facility's policy on Infection Control Quality Assurance documents as follows: (a) The Infection Control Program will have an active Quality Assurance Program (hereinafter QA) to ensure infection control practices are done. The Quality Assurance Program will identify problems or related concerns in the care of the patient. Provide a system for monitoring the quality of care, technique and procedures. Q.A. is the process of looking at patient care problems pertaining to Infection Control. Q.A. monitors, surveillance and walk- 25 throughs are done on a monthly and quarterly timeframe. All results are reported to the Infection Control Committee to take appropriate action if necessary. 61. Based on the foregoing, Sanctuary Surgery Centre violated Rule 59A-5.0085(1)(g), Florida Administrative Code. The fine assessed is $1,000.00 PRAYER FOR RELIEF WHEREFORE, AHCA intends to: A. Assess against Sanctuary Surgery Centre an administrative fine of $3,000.00 for the violations described in Counts I, II and III in accordance with Section 395.1065 Florida Statutes. B. Award the Agency for Health Care Administration reasonable attorney’s fees, expenses, and costs. Respondent is notified that it has a right to request an administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statues (2007). Specific options for administrative action are set out in the attached Election of Rights and explained in the attached Explanation of Rights. All requests for hearing shall be made to the Agency for Health Care Administration, attention Agency Clerk, 2727 Mahan Drive, Mail Stop #3, Tallahassee, Florida 32308. Telephone (850) 922-5873. 26 RESPONDENT IS FURTHER NOTIFIED THAT FAILURE TO RECEIVE A REQUEST FOR A HEARING WITHIN TWENTY-ONE (21) DAYS OF RECEIPT OF THIS COMPLAINT, PURSUANT TO THE ATTACHED ELECTION OF RIGHTS, WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. IF YOU WANT TO HIRE AN ATTORNEY, YOU HAVE THE RIGHT T jf Assistant General Counsel Agency for Health Care Administration Spokane Building, Suite 103 8350 N.W. 52°¢ Terrace Miami, Florida 33166 (305) 470-6802 Copies furnished to: Diane Reiland Field Office Manager Agency for Health Care Administration 5150 Linton Boulevard, Suite 500 Delray Beach, Florida 33484 Elizabeth Dudek Deputy Secretary Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Finance and Accounting Revenue Management Unit Agency for Health Care Administration 27 2727 Mahan Drive, MS #14 Tallahassee, Florida 32308 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing was mailed (Return Receipt Requested) to Gina Melby, CEO, Sanctuary Surgery Centre, 5503 North federal Highway, Boca Raton, Florida 33487, and to Guy D. Sperduto, Registered gent, 8982 Taftf Street, a Florida 33024 on Lud gle 2008 28 R: PLETE TH TION COMPLETE T TI R SENDER: COMPLETE THIS SEC ™ Complete items 1, 2, and 3. Also complete tem 4 if Restricted Delivery is desired. . ™@ Print your name and address on the reverse so that we can return the card to you, — _ ll Attach this card to the back of the mailpiece, or on the front if space permits. D. Is delivery address different from item 1? ©] Yes 1, Article Addressed to: If YES, enter delivery address below: [1 No SS OZ Me YL Fedivcek legs Sore Mal Cl Exes Mal —— Woe FLO I¢F 7 C1 Registered m Receipt for Me L ae pielort, ‘ Clinsured Mal ~=1C.0D. 4. Restricted Delivery? (Extra Fee) » ransfor trom service lab 7002 2410 o001 423b 041? + PS Form 3811, February 2004 Domestic Return Recei 102595-02-M-1540 ; : ' , y SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY AW al ) / © Agent ! On, B. Received by (Printed Name) ™ Complete items 1 2, and 3. Also complete item 4 if Restricted Delivery is desired. ® Print your name and address on the reverse Cc D. Is delivery address different from item 1? Lee If YES, enter delivery address below: C1 No 3. Service Type tified Mail CJ Express Mail OC Registered 1-Retum Receipt for Merchandise O insured Mail =O C.0.D. 4. Restricted Delivery? (Extra Fee) 2. Article Number (Transfer trom service labo 7002 2410 Oo04 4234 0400 PS Form 3811, February 2004 Domestic Return Receipt 102595-02-M-1540

Docket for Case No: 08-001396