STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, AHCA NO: 2003007463 vs. TAMPA OUTPATIENT SURGERY JOINT VENTURE,, LTD., d/b/a TAMPA OUTPATIENT SURGICAL FACILITY Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “AHCA”), by and through the undersigned counsel, and files this Administrative Complaint against Tampa Outpatient Surgery Joint Venture, Ltd., d/b/a Tampa Outpatient Surgical Facility (hereinafter “Respondent”) and alleges: NATURE OF THE ACTION 1. This is an action to impose an administrative fine on Respondent in the amount of five hundred dollars ($500) pursuant to Section 395.1065(2) (a), Florida Statutes (2002). 2. The Respondent is cited for the deficiency set forth below as a result of a survey on or about August 28, 2003. JURISDICTION AND VENUE 3. This Court has jurisdiction pursuant to Section 120.569 and 120.57, Florida Statutes (2002) and Chapter 28-106, Florida Administrative Code (2002). 4, Venue lies in Hillsborough County, Division of Administrative Hearings, pursuant to Section 120.57, Florida Statutes (2002), and Chapter 28, Florida Administrative Code (2002). PARTIES S. AHCA, Agency for Health Care Administration, State of Florida is the enforcing authority with regard to the licensing of ambulatory surgical centers pursuant to Chapter 395, Part I, Florida Statutes (2002) and Rules 59A-5, Florida Administrative Code (2002). 6. Respondent is an ambulatory surgical center located at 5013 N. Armenia Avenue, Tampa, FL 33603. Respondent, is and was at all times material hereto, a licensed ambulatory surgical center under Chapter 395, Part I, Florida Statutes (2002) and Chapter 59A-5, Florida Administrative Code, having been issued license number 942. COUNT I RESPONDENT FAILED TO ENSURE THE REGULAR AND SYSTEMATIC REVIEWING OF ALL INCIDENT REPORTS, INCLUDING FIFTEEN DAY INCIDENT REPORTS, FOR THE PURPOSES OF IDENTIFYING TRENDS OR PATTERNS AS TO TIME, PLACE OR PERSONS. Fla. Admin. Code R.59A-10.0055 (3) (2002) 7. AHCA re-alleges and incorporates paragraphs (1) through(6) as if fully set forth herein. 8. On or about July 2, 2002, a survey was conducted at Respondent’s facility. 9. Based on staff interviews and record review, it was determined that the Risk Manager did not conduct an investigation of an incident to determine trends or causal and risk factors for one (#1) of one report reviewed. Findings: Review of a code fifteen report and patient #1's clinical record revealed an investigation had not been conducted. An approximately eighty-five year old patient presented to the facility on May 22, 2002, at 11:35 A.M., for elective excision and repair of the left lower lid, conjunctiva, and tear duct with possible insertion of a lacrimal stent secondary to cancer. Review of the physician's history and physical, dated May 22, 2002 revealed the patient's medications included Aspirin and a history of an angioplasty. Review of the anesthesia and nursing evaluation, dated May 22, 2002 revealed the patient's medication included Aspirin and Coumadin and had a history of an irregular heart beat. The documentation revealed the patient had been off the Coumadin for four days prior to surgery. Review of the EKG, dated May 22, 2002 revealed atrial fibrillation with Ventricular response of 81. Review of the operative report, dated May 22, 2002 revealed Monitored Anesthesia Care (MAC) was utilized, 0.5% Marcaine with Epinephrine was injected into the operative site (no strength or amount was documented), and surgery was performed from 12:17 P.M. to 1:52 P.M. without complications. Review of the surgical nursing documentation, dated May 22, 2002, revealed 0.5% Marcaine with Epinephrine, 1:100,000 units had been injected by the physician (no amount documented) . Interview with two Surgical Nurses and an Anesthesiologist on July 2, 2002, at approximately 12:20, 12:45 and 1:00 P.M. respectively, and observation of the medication vials, revealed that the facility had premixed vial of 0.5% Marcaine with Epinephrine 1:200,000, and Xylocaine with Epinephrine, 1:100,000. The Surgical Nurse’s interview revealed that the surgical nurse is responsible for documenting the type, strength, and amount of solution injected by the surgeon into the Operative site. Review of the Post Anesthesia Care Unit (PACU) nursing documentation, dated May 22, 2002, at 2:20 P.M., indicated that the patient suffered a nose bleed, the patient indicated he/she had had them before, and that he/she was on coumadin. The documentation revealed that the patient was discharged at 2:57 P.M. and the nose bleed was resolved. The clinical record did not contain evidence of the surgeon being notified of the nose bleed. Review of the Medical Examiner's report, dated May 23, 2002, indicated that the patient was found expired, by a family member at home on May 23, 2002, at 8:30 A.M.. The report indicated the patient was found in the bathroom slumped over the tub with vomitus in the tub and on the bed. There was no evidence of an autopsy being performed and the death was classified as natural causes. Interview with the Administrator on July 2, 2002, at approximately 11:00 A.M. and 13:45 P.M., revealed the record had been reviewed, an investigation was conducted, and no changes resulted from the incident. The interview revealed no changes had been implemented and a root causal analysis of the incident had not been conducted secondary to the cause of death being classified as natural by the medical examiner. The interview revealed the Administrator was unable to locate evidence of a record review or an investigation of the incident. The interview with the administrator revealed that there was no evidence of an investigation being conducted concerning the lack of documentation by the surgeon of the amount and strength of the Marcaine and Epinephrine solution injected into the operative site. The interview with the administrator also revealed that there was no evidence of an investigation concerning the erroneous documentation by the Surgical Registered Nurse, of the amount and strength of the Marcaine and Epinephrine solution utilized by the surgeon. Review of the event file revealed that the facility staff had informed administration of the surgeon being rushed and insisting that the staff process the patient rapidly through the pre- operative process to perform the surgery earlier than scheduled. The file did not contain evidence of the Risk Manager, Administrator, or Medical Director analyzing or implementing corrective action related to the staff concerns. 10. Respondent was provided a mandated correction date of August 2, 2002. 11. On or about August 28, 2003, a survey was conducted at Respondent’s facility. At the time of this survey, the above- listed deficiency remained uncorrected. 12. Based on record review and staff interviews, it was indicated that the Risk Manager did not conduct an event analysis to determine trends or risk factors for one of one record reviewed. Findings: Review of a surgeon’s operative report contained in the medical record of Patient #1 revealed that a laparoscopy with exploratory laparotomy and repair of the left iliac artery and vein was performed on July 9, 2003. Review of a facility record, dated July 9, 2003 by the circulating nurse, and interview with the circulating nurse on August 28, 2003, revealed circumstances concerning operative events which were discrepant with the surgeon’s operative notes. Review of a facility record July 9, 2003, by the scrub technician, and interview with the scrub technician on August 28, 2003, at approximately 11:15 A.M., also revealed circumstances which appeared to be discrepant with the operative notes. Review of records revealed there was no evidence of analysis concerning these discrepancies. Interview with the Administrator/Risk Manager Designee on August 27, 2003, at approximately 4:20 P.M., and Assistant Medical Director on August 28, 2003, at approximately 10:20 A.M., indicated a lack of knowledge concerning the discrepancies in the information. Interview with the Risk Manager on August 28, 2003, at approximately 11:55 A.M., revealed knowledge of the discrepancies, but no evidence of further analysis. 13. The above actions are a violation of Rule 59A- 10.0055(3), Florida Administrative Code (2002), which requires the risk manager to be responsible for the regular and systematic reviewing of all incident reports, including fifteen day incident reports for the purposes of identifying trends or patterns as to time, place or persons and, upon emergence of any trend or pattern in incident occurrence, shall develop recommendations for corrective actions and risk management prevention education and training. Summary data thus accumulated shall be systematically maintained for three years. 14. The above referenced violation constitutes the grounds for the imposed deficiency and for which a fine of five hundred dollars ($500) is authorized, pursuant to Section 395.1065(2) (a), Florida Statutes (2002). 15. Notice was provided in writing to the respondent of the above violation and the time frame for correction. WHEREFORE, the Plaintiff, State of Florida, Agency for Health Care Administration requests the Court to order relief with a fine against the Respondent pursuant to Section 395.1065(2) (a), Florida Statutes (2002), in the amount of five hundred dollars ($500) and all other relief the court deems equitable. NOTICE The Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes (2002). Specific options for administrative action are set out in the attached Explanation of Rights (one page) and Election of Rights (one page). All requests for hearing shall be made to the attention of Lealand McCharen, Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3, MS #3, Tallahassee, Florida, 32308, (850) 922-5873. RESPONDENT IS FURTHER NOTIFIED THAT A REQUEST FOR HEARING MUST BE RECEIVED WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT OR WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. Respectfully submitted, PibtiaD Seay Katrina D. Lacy, Esquire Senior Attorney Fla. Bar No. 0277400 525 Mirror Lake Drive North, #330G St. Petersburg, Florida 33701 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Certified Mail, Return 7003 1010 0003 4303 8524 to Jack Mezrah, M.D., Receipt No. Registered Agent for Tampa Outpatient Surgery, 5013 N. Armenia Avenue, Tampa, FL 33603 dated on November TK 2003. Katrina D. Lacy, Esqujre Copies furnished to: Jack Mezrah, M.D. Registered Agent for Tampa Outpatient Surgery 5013 N. Armenia Avenue Tampa, FL 33603 (Certified U.S. Mail) Maureen F. Martin, Administrator Tampa Outpatient Surgery 5013 N. Armenia Avenue Tampa, FL 33603 (U.S. Mail) Katrina D. Lacy AHCA - Senior Attorney 525 Mirror Lake Drive, Suite 330G St. Petersburg, FL 33701

Docket for Case No: 04-000029