STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs, , . CaseNo, 2010008361 GLADIOLUS SURGERY CENTER LLC d/b/a GLADIOLUS SURGERY CENTER, Respondent, ; / ADMINISTRATIVE COMPLAINT COMES NOW the Agency For Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against Gladiolus Surgery Center LLC d/b/a.Gladiolus Surgery Center (hereinafter “Respondent”), pursuant to | Sections 120.569 and 120.57; Florida Statutes (2010), and alleges: | NATURE OF THE ACTION This is an action to impose upon the Respondent an administrative fine in the amount of three thousand dollars ($3,000.00), pursuant to Section 395.1065(2)(a), Florida Statutes (2010), based upon the Respondent’s violation of the rules adopted by the Agency under Chapter 395, Part I, Flotida Statutes (2010), | JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to Sections 120.60 and 395.003, Florida Statutes (2010). 2. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code (201 0). PARTIES | 3. The Agency is the regulatory authority responsible for licensure of ambulatory surgical Filed January 20, 2011 8:00 AM Division of Administrative Hearings centers (hereinafter “ASC”) and enforcement of applicable state statutes and rules governing ASCs pursuant to Chapters 395, Part I, and 408, Part II, Florida Statutes, and Chapter 59A-5, Florida Administrative Code. 4, Respondent operates a licensed ASC located at 7431 Gladiolus Drive, Fort Myers, Florida 33908, License number 1144. 5. Respondent was at all times material hereto a licensed ASC under the licensing authority of the Agency, and was required to comply with all applicable rules and statutes. COMMON FACTUAL ALLEGATIONS 6. That on July 23, 2010, patient number five (5) was taken into the operating room at 8:00 AM for a podiatric procedure. 7, That the surgery start time is documented at 8:36 AM. 8. That patient number five (5) was positioned on the operating table in a prone position and was receiving monitored anesthesia care; 9. That patient number five (5) was not intubated, but did have oxygen via a nasal canula in place. 10. That patient number five (5) was intubated during the procedure at about 9:15 AM and anesthesia records reflect that the patient’s condition continued to deteriorate, 11, That Petitioner’s representative interviewed Respondent’s anesthesiologist number one (1) on July 30, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): a. The procedure began about thirty (30) minutes late; b. About thirty 30) minutes into the case, 9:06 AM, he observed that the patient was having trouble breathing; c. The patient’s oxygen saturation was decreasing; d. About 9:10 AM, the patient’s condition was not improving and he informed the operating surgeon that the patient needed to be flipped to the supine position; e, The patient was turned on the back at around 9:12 AM and was intubated; f. Cardiopulmonary resuscitation was started at approximately 9:45 AM when emergency medical personnel arrived; g, Inresponse to questioning, the anesthesiologist could not recall any equipment failure; h. He believed the pad for the defibrillator and the defibrillator paddles functioned properly; i. The alarms on the anesthesia monitoring equipment were turned off during the procedure and he saw only flashing lights on the monitors; j. The anesthesia monitoring equipment was old and he did not know how to activate the alarms on the equipment; k. He did not need the crash cart when the patient was turned supine as he was managing the patient with medications, 12. That Petitioner’s representative interviewed Respondent’s operating surgeon number one (1) on July 30, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): a. Thirty (30) minutes into the procedure anesthesiologist number one (1) informed him that the patient was having trouble breathing and the case needed to be cancelled; . The procedure was just about finished and the patient was flipped to the supine position and intubated; . He could not see what was occurring at the head of the table; , He was able to complete his portion of the surgery rather rapidly after the " patient was turned. That Petitioner’s representative interviewed Respondent's circulating nurse one (1) on July 29, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): a. She was asked a little after 9:00 AM to get a stretcher so the patient could be flipped to the back because the patient was having breathing problems; . She did not hear any alarms go off on any of the anesthesia monitoring equipment; ) . After the patient was flipped to the back, the patient “pinked up” a little after the patient was intubated and a scrub technician was hand bagging the patient; . .The anesthesiologist was asked on several occasions if he wanted a crash cart and he responded that he did not need the crash cart. That Petitioner’s representative interviewed Respondent’s scrub technician number one ~ (1) on July 30, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): “I was at the foot of the table with the surgeon, [Anesthesiologist number one (1)] asked us to turn the patient over. I ran and got the stretcher. He tubed [the patient] and told me just to ‘bag’ [the patient] as fast as I can, [The patient] was real blue when we turned [the patient] over but [the patient] pinked up when I was bagging [the patient]. I don’t remernber times, it just seemed like a long time. We asked about the crash cart, but [anesthesiologist number one (1)] said no. [The patient] will be okay. I just wish he hadn’t waited so long to do something. The patient was sweating; the leads not reading. [Anesthesiologist number one (1)] giving lots of meds from his cart. The nurses finally brought - the crash cart in. Wish I had gone and got it myself earlier.” 15. That Petitioner’s representative interviewed Respondent’s circulating nurse two (2) on July 29, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): . She entered the operating room after circulating nurse one (1) came out of the operating room to get a stretcher at around 9:15 AM; . The patient was cyanotic when the nurse entered the operating room; . She heard anesthesiologist number one (1) say the airway was occluded; _ The anesthesia monitor was not showing any vital signs at the time; . Scrub technician two (2) asked if a crash cart was needed; and anesthesiologist one (1) replied “No” In response to a question as to why the anesthesia monitor was hot reflecting vital signs, she indicated the belief that it was because the patient was diaphoretic and the leads were not making good contact with the patient’s skin; . In response to a question as to whether the anesthesia monitors were on, she responded “No” and that the monitor’s alarms were turned off; . After the patient was transferred to the hospital, she turned the anesthesia monitor alarms back on; i. The defibrillator was brought into the operating room at around 9:45 AM; j. The pads on the defibrillator did not work and they could not get any heart rhythms or other vital signs utilizing the defibrillator pads. . 16. That Petitioner’s representative reviewed Respondent’s policy and procedure number SA-011 entitled “Alarm System” and noted that the “Policy” section of the document provides “All patient care equipment alarm systems will be functional and used as intended by the manufacturer of the device for which the alarm was designed. This policy is not intended to cover environmental alarms such as fire, gas, leak, eto.” 17, That Petitioner’s representative interviewed Respondent’s operating room manager on July 29, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): ) a, She entered the operating room when circulating nurse one (1) came out to get a stretcher at around 9:12 AM; b.. The patient was blue when she entered the room; c, The patient’s airway was somehow obstructed; d, When the patient was hooked up to the defibrillator at around 9:40 AM, the device did not work properly and the pads on the defibrillator were not providing the heart rhythm as expected; . e, According to circulating nurse two (2), the heart monitor was not working; f. No cardio pulmonary resuscitation was started on the patient until emergency medical services arrived. 18, That Petitioner’s representative interviewed Respondent’s pre-operative nurse one (1) on July 29, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient tuber five (5): a. She entered the room when circulating nurse one (1) came out to get the stretcher to flip the patient; , She went out and got a crash cart around 9:45 AM . When she came back into the room she started recording the code process; . She observed that the defibrillator did not work properly; . No chest compression was started by staff; The chest compression of the patient was commenced by emergency medical staff. 19, That Petitioner’s representative interviewed Respondent’s pre-operative manager on July 29; 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): She entered the operating room when the patient was being “bagged” by the scrub technician; _ . She asked if the crash cart was necessary and the anesthesiologist one (1) replied “No” She told pre-operative nurse one.(1) to get the crash cart; . Nocardiopulmonary resuscitation was initiated until emergency medical staff arrived; . When the defibrillator pads were placed on the patient they could not obtain any heart thythms; f. She tried to shock the patient but the defibrillator did not discharge using the pads; g. The pads were taken off and the defibrillator was recharged to 200 joules; _ h. The defibrillator paddles worked when the pads were not used. 20. That on July 30, 2010, Respondent’s pre-operative manager indicated that she believed the failure of the defibrillator to fail on July 23, 2010 was because the pads were not working properly. 21, - That Petitioner’s representative interviewed Respondent’s administrator on July 30, 2010 who indicated as follows regarding the procedure of July 23, 2010 for patient number five (5): a. She was not at the facility on the day in question; b. When asked if the same defibrillator was still in use, she indicated “Yes” c. When asked what other action was taken by Respondent, she indicated that an incident report had been completed, the risk manager and quality - assurance coordinator had been notified, the facility was conducting a root cause analysis, and a new defibrillator had been ordered; d. When asked if any in-service training had been conducted related to what measutes staff could or should have been implemented to assure a better outcome, she answered that no in-services had been conducted. 22, That Petitioner’s representative interviewed Respondent’s staff as to whether the anesthesiologist was in the operating room the entire time of the procedure of July 23, 2010 for patient number five (5) or if they were aware of anesthesia ever leaving the operating room when patients were under anesthesia and they responded as follows: Circulating nurse number one (1) indicated that sometimes the director of anesthesia, anesthesiologist number two (2), leaves the room when . patients are under anesthesia; Circulating nurse number two (2) indicated that she has watched the anesthesia monitor for the director of anesthesia, anesthesiologist number two (2), on occasion and in response to questioning indicated that she was uncomfortable with the practice; The operating room manager indicated that she had heard that the director of anesthesia, anesthesiologist number two (2), will leave the room for a short period of time; The pre-operative manager indicated that she was aware of the director of anesthesia, anesthesiologist number two (2), leaving the operating room for short periods of time and will interview the next patient. 23. That Petitioner’s representative interviewed Respondent’s director of anesthesia, anesthesiologist number two (2), on July 30, 2010 who indicated as follows: a, b. He does come out of the operating room to go to the bathroom; He occasionally will come out of the operating room to assess a patient in post anesthesia recovery; | He does not leave the operating room to assess other patients while a procedure is in process. 24, That Petitioner's representative reviewed Respondent’s policy and procedure number AN-009 entitled “Intraoperative Monitoring” and noted the following: a. The section entitled “Purpose” provides: “To provide guidelines for safe efficient monitoring of patients receiving all levels of anesthesia in. compliance with Florida State regulations. To determine that monitoring activities remain in accordance with ASA standards for Basic Intraoperative Monitoring.” . | b, The section entitled :Policy” provides: “Qualified anesthesia staff will be continuously present in the operating room throughout the administration of all general anesthetics, regional anesthetics and surgical procedures | | with monitored anesthesia care to monitor and provide anesthesia care.” 25. That Respondent continued offering surgical services to patients after the procedure on patient number five (5) until voluntarily discontinuing surgical services on or about July 30, 201 0, COUNTI 26. The Agency re-allegés and incorporates Paragraphs one (1) through twenty-five (25) as if fully set forth herein. 27. That pursuant to Florida law, emergency equipment shall be provided as needed commensurate with the services of the facility, maintained in functional condition, and capable of providing at least the following services: 1. Inhalation and therapy; 2. Defibrillation; 3. Cardiac monitoring; 4. Suctioning; 5, Maintenance of patient airway. Rule 59A-5.0085(1)(f), Florida Administrative Code. | 28. That the above reflect Respondent’s failure to meet the minimum requirements oflaw where: a, Respondent failed to ensure that, prior to procedures conducted on July 10 23, 2010, its defibrillation equipment was maintained in functional condition; . ' b, Respondent knowingly failed to ensure that, subsequent to the procedure coriducted on July 23, 2010 on Patient number five (5), its defibrillation equipment was maintained in functional condition while Respondent continued to conduct surgical procedures on other patients; c. Respondent’s failure to ensure that, prior to the procedure conducted on July 23, 2010 to patient number five (5), its anesthesia monitoring ‘equipment was maintained to ensure the equipment’s alarming systems were operational as mandated by law and Respondent’s policy and , procedure, 29, That the Respondent’s failure to ensure that its equipment was maintained and functional for procedures undertaken by Respondent is in violation of the minimum requirements of law . and places patients at increased and unnecessary risk in the event of emergent conditions. 30, That the Petitioner cited Respondent for its violation of the provisions of Rule 59A- 5,0085(1), Florida Administrative Code. WHEREFORE, the Agency intends to impose an administrative fine in the amount of one thousand dollars ($1,000.00) against Respondent, an ambulatory surgical center in the State of Florida, pursuant to Section 395.1065(2)(a), Florida Statutes (2010). COUNTIL | 31. The Agency re-alleges and incorporates Paragraphs one (1) through twenty-five (25) as if fully set forth herein, li 32. That pursuant to Florida law, anesthesia services shall be organized under written policies . and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls. (a) A qualified anesthesiologist, or certified registered nurse anesthetist, certified pursuant to Section 464.012, F.S., shall be responsible for coordinating the functions, equipment and supplies of the service, (b) All anesthesia shall be administered by an anesthesiologist or by a certified registered nurse anesthetist, under the on- site medical direction of a licensed physician, except for local anesthesia administered by a podiatrist, and except for local anesthesia administered by a dentist, and such other anesthesia administered by a dentist in accordance with Section 466.017, F.S., and Chapter 59Q-14, F.A.C, (c) An anesthesiologist or other physician or a certified registered nurse anesthetist under the on- site medical direction of a licensed physician, shall be in the ambulatory surgical center during the anesthesia and post-anesthesia recovery period until all patients are alert or discharged. (d) At least one registered professional nurse shall be in the recovery area during the patient’s recovery period. (e) Prior to the administration of anesthesia, patients shall have a history and physical examination including laboratory analysis when indicated. (£) Written policies and procedures relative to the administration of anesthesia shall be developed by the anesthesia service, approved by the medical staff and the governing body, and be reviewed annually, dated at time of each review, revised as necessary, and enforced. (g) Anesthetic safety regulations shall be developed, posted and enforved. Such regulations shall include at least the following requirements: 1, All operating room electrical and anesthesia equipment shall be inspected on no _ less than a semi-annual basis, and a written record of the results and corrective actions be maintained; 2. Flammable anesthetic agents shall not be employed in ambulatory surgical centers; 3. Electrical equipment in anesthetizing areas shall be on an audiovisual line isolation 12 monitor, with the exception of radiologic equipment and fixed lighting more than 5 feet above the floor; 4. Each anesthetic gas machine shall have pin-index system or equivalent safety system and a minimum oxygen flow safety device; and 5. All reusable anesthesia equipment in direct contact with the patient shall be cleaned or sterilized as appropriate after each use; 6. At a thinimum the following monitors shall be applied to all patients receiving conduction or general anesthesia: a. Blood pressure cuff; b. A continuous temperature device, readily available to measure the patient’s temperature; c. Pulse Oximeter; and d, Electrocardiogram, e. An Inspired Oxygen Concentration Monitor and a Capnograph shall be applied to all patients receiving | | general anesthesia, Rule 59A-5.0085(2), Florida Administrative Code. . 33. That the above facts reflect that Respondent failed to provide anesthesia services in accord with the provisions of law, including but not limited Respondent’s failure to implement facility policy and procedure adopted to comply with these legal requirements, where: | a. Respondent knowingly allows an anesthesiologist to leave the operating theater during procedures despite a facility policy and procedure mandating the individual’s presence during all procedures; b. Respondent’s failure to ensure that its anesthesiologists to coordinate the functions, equipment, and supplies of anesthesiologist services, including but not limited to the anesthesiologist’s failure to possess the knowledge required to engage alarms on anesthesiology equipment utilized in the procedure on patient number five (5) on July 23, 2010 or alternatively to assure that the equipment alarms were activated. 34. That the Respondent’s failure to ensure that it meets the minimum standards of law and Respondent’s policy and procedure enacted to implement the legal requirement in the operation 13 of an ambulatory surgical center places patients at increased and unnecessary risk in the event of emergent conditions. 35. That the Petitioner cited Respondent for its violation of the provisions of Rule 59A- 5,0085(2), Florida Administrative Code, WHEREFORE, the Agency intends to impose an administrative fine in the amount of one thousand dollars ($1,000.00) against Respondent, an ambulatory surgical center in the State of Florida, pursuant to Section 395,1065(2)(a), Florida Statutes (2010). COUNT IIL 36. The Agency re-alleges and incorporates Paragraphs one (1) through twenty-five (25) as if fully set forth herein, | 37. That pursuant to Florida law, each ambulatory surgical center shall have an ongoing quality assessment and improvement system designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, and opportunities to improve its | performance to enhance and improve the quality of care provided to the public. (a) Such a system shall be based on the mission and plans of the organization, the needs and expectations of the patients and staff, up-to-date sources of information, and the performance of the processes and their outcomes. (b) Each system for quality assessment and improvement, which shall include utilization review, must be defined in writing, approved by the governing body, and enforced, and shall include: 1. A written delineation of responsibilities for key staff; 2. A policy for all members of the organized medical staff, whereby staff members do not initially review their. own cases for quality assessment and improvement program purposes; 3. A confidentiality policy; 4. Written, measurable criteria and norms; 5. A description of the methods used for identifying problems; 6. A description of the methods used for assessing problems, determining 14 priorities for investigation, and resolving problems; 7. A description of the methods for monitoring activities to assure that the desired results are achieved and sustained; and 8. Documentation of the activities and results of the program. Rule 59A-5.019(1), Florida Administrative Code. 38. That pursuant to Section 395.1065(2)(a), Florida Statutes (2010), the Agency may deny, revoke, or suspend a license or impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of Chapter 395, Part I, Florida Statutes, or rules adopted under such part. Each day of violation constitutes a separate violation and is subject to a ’ separate fine, 39, That the above facts reflect Respondent’s failure to maintain and implement a ongoing quality assessment and improvement system designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, and opportunities to improve its performance to enhance and improve the quality of care provided to the public where Respondent: | a. Failed to identify and implement immediate corrective action where Respondent was on actual notice that its defibrillation equipment was not functional and in good working order; b. Failed to identify and implement immediate corrective actions where Respondent was on actual notice that a patient suffered life-threatening conditions during a procedure on July 23, 2010 where Respondent had failed to activate the anesthesia equipment alarm systems; c. Failed to identify and implement immediate corrrective action where Respondent was on actual notice that its staff failed to apply emergency 15 _ treatment, including cardiopulmonary rescusitation, to a patient where the same was indicated; . d. The failure to identify and implement any corrective action to protect patients and staff from potential injury following the July 23, 2010 procedure on patient number five (5) such as, for example, the suspension of surgical services, the re-training of staff, the testing of equipment, the review of the implementation of facility policy and procedure, or the monitoring of staff functions and competencies. . 40, ° That the Respondent’s failure to ensute that its quality assurance and performance improvement functions are implemented in a timely manner when presented with conditions representing an adverse outcome at its ambulatory surgical center places patients at increased "and unnecéssary risk in the event of emergent conditions. 41. . That'the Petitioner cited Respondent for its violation of the provisions of Rule 59A- 5,019(1), Florida Administrative Code. . WHEREFORE, the Agency intends to impose an administrative fine in the amount of one thousand dollars ($1,000.00) against Respondent, an ambulatory surgical center in the State of Florida, pursuant to Section 395,1065(2)(a), Florida Statutes (2010). Respectfully submitted this ( day of October, 2010. . Walsh II Fla. Bar. No, 566365 Agéncy for Health Care Admin. 525 Mirror Lake Drive, 330G St. Petersburg, FL 33701 , 727.552.1947 (office) / 727.552.1440 (fax) 16 Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Specific options for administrative action are set out in the attached Election of Rights, All requests for hearing shall. be made to the attention of: 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 AF INAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE certified mail, return receipt no; 7004 2890 0000 5526 7117 on October , 2006 to Husni A. Charar, Registered Agent, Gladiolus Surgery Center LLC, 8851 Boardroém Circle, Fort Myers, Florida 33919 (U.S. Certified Mail) and U.S. Mail to Lorraine Marie Ambrose, Administrator, Gladiolus Surgery Center LLC d/b/a Gladiolus Surgery Center, 7431 Gladiolus Drive, Fort Myers, Florida 33908. I HEREBY CERTIFY that a true and correct copy of the ite been served by Copies furnished to: Husni A. Charar, Lortaine Marie Ambrose, Administrator Registered Agent Gladiolus Surgery Center LLC d/b/a Gladiolus Surgery Center LLC Gladiolus Surgery Center 8851 Boardroom Circle 7431 Gladiolus Drive Fort Myers, Florida 33919 Fort Myers, Florida 33908 (U.S. Certified Mail) _ (U.S, Mail) Harold D. Williams 7 Thomas J. Walsh II, Esquire Field Office Manger Senior Attorney Agency for Health Care Admin. Agency for Health Care Admin. 2295 Victoria Avenue 525 Mirror Lake Dr., N., #330G Room 340 - St. Petersburg, Florida 33701 Fort Myers, Florida 33901 (Interoffice) (interoffice) 17 NDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY “ i Cimplete items 4, and 3, Also coripleta item 4 if Rastricted Delivery Is desired. @ Print your name and address on the reverse 80 that we can return the card to you. . a Attach this card to the back of the maltplece, or gn the front.if space. permits, 1. Article Addressed to: (usni A. Charar, ny Registered Agent Gladiolus Surgery Center LLC 3851 Boardroom Circle | “ort Myers, Florida 33919 | _ O Agent : EF) Adatesseo | ] 0. ls delivery address diferent fom item 1? OYes If YES, enter delivery adeiress below; 1 No a Reoistered g Insured Mall >8 Form'3841;, February 8004 ” Donveatio Ratu Recalpt : 102695-024-1840 /

Docket for Case No: 11-000263