The Issue The issues in this case are whether Respondent violated Section 458.331(1)(m), and/or (1)(t), Florida Statutes (Supp. 1996), and, if so, what discipline should be imposed.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings of fact are made: Findings regarding the parties The Board of Medicine (Board) is the regulatory board within the Department of Health that is responsible for the regulation of the practice of medicine in Florida. Respondent is, and was at all times relevant to this proceeding, a licensed physician, Board-certified in plastic surgery. His license number is ME 0030449. At all times relevant to this proceeding, Respondent practiced at the Florida Center for Cosmetic Surgery (FCCS), which was an office surgery center in Ft. Lauderdale, Florida. Respondent performed cosmetic surgery at FCCS about two to three days a week while still maintaining his own office surgery center in Winter Park, Florida, where Respondent currently practices. From the beginning of the professional relationship between Respondent and FCCS, it was contemplated by all concerned that the relationship would be a part-time, short-term relationship; Respondent was merely providing plastic surgery services and follow-up care on a temporary basis until FCCS could make a more permanent arrangement with a plastic surgeon who wanted to work full-time for FCCS. Respondent never had any role in the business practices of FCCS, never had any managerial role at FCCS, and never had any ownership interest in FCCS. The agreement between Respondent and the principals at FCCS included an understanding that all patients who sought services at FCCS were patients of the clinic; not patients of the individual surgeon who performed the surgery on a patient. Consistent with that understanding, FCCS also insisted that it was entitled to custody and control of all of the medical charts, and Respondent was not allowed to remove any medical charts from the premises of FCCS. Respondent performed surgery at FCCS for approximately six weeks. General findings about the relevant surgical procedures A brow lift is a cosmetic surgery procedure that involves an incision in the patient’s scalp. The incision goes quite deeply into the forehead. After the incision, the scalp is dissected and loosened all the way down to the eyebrows, with the intent of this procedure being to raise up the eyebrows to some degree to give a rejuvenated appearance to the forehead. The incision in the scalp bleeds easily. In order to minimize the scalp bleeding, an electrocautery device is used for cauterization at the site of the bleeding. An electrocautery device may either be monopolar or bipolar. A monopolar cauterization device utilizes a “grounding plate” or a “grounding pad” to ground the electric current. The grounding plate or pad is attached to the patient on a fleshy part, typically along the side of a patient’s thigh or on a patient's buttock, away from any bony prominence. "Bovie" is the trade name of a major brand of monopolar cauterization devices. The grounding plate or grounding pad for a monopolar cauterization device is commonly referred to as a "Bovie pad." In contrast, a bipolar cauterization device does not need and does not have a grounding pad. Liposuction is a medical procedure in which fat is removed from an area of a patient's body by means of a suction device. A cannulus, which is a narrow tube with a sharp tip, is inserted into the desired areas of the body. The cannulus is connected to a vacuum-like device and once the cannulus is inserted into the operative area, it is manually maneuvered by the physician to remove the fat within reach of the cannulus with vacuum suction. General findings about Patient F. V. This case arises from surgical procedures performed by Respondent on February 6, 1997, on a patient identified in the record of this case as Patient F. V. Patient F. V. is a white female, who at the time of the relevant surgery was 43 years old. Patient F. V. wished to improve her facial features and wished to reduce the fat in her thighs. She went to FCCS to seek cosmetic surgery for those purposes. Patient F. V. had previously undergone cosmetic surgery performed by Dr. Myron Persoff, also at FCCS, on August 23, 1995. Pre-operative contact between Patient F. V. and FCCS On January 28, 1997, Patient F. V. contacted FCCS (probably by telephone) and someone at FCSS filled out a consultation form about that contact. The form listed the requested procedures of a facelift/browlift and liposuction. The form also noted a prior facelift by Dr. Persoff, a plastic surgeon also with FCCS. Finally, the form indicated a confirmation note of January 29, 1997, for an appointment date and time of January 30, 1997, at 3:00 p.m. On January 30, 1997, Patient F. V. went to FCCS for consultation regarding cosmetic surgery. On that date, Patient F. V. filled out a “Patient Information” form. The form asked Patient F. V. basic questions relating to her medical history and relating to her social history. Patient F. V.’s next visit to FCCS was on February 3, 1997. February 3, 1997, was the first and only time that Respondent met with Patient F. V. prior to the surgery on February 6, 1997. On February 3, 1997, a presurgical and anesthesia evaluation form was completed by Certified Registered Nurse Anesthetist (CRNA) Charlotte Filip. This form detailed some history of Patient F. V. and listed the prior surgery to the breast, face, and eyes. The Patient and Nurse Filip signed the form. During Patient F. V.’s February 3, 1997, visit to FCCS, Respondent conducted an initial physician/patient consultation. During the course of the consultation on February 3, 1997, Respondent conducted a thorough pre-operative consultation with Patient F. V. His activities during that consultation included taking a history and conducting a physical examination. Respondent discussed with Patient F. V. what she wished to have done, and he also discussed with her the risks and benefits of the proposed procedures. During the course of that consultation Respondent made a plan for the surgical procedures to address Patient F. V.'s concerns and desires. Thereafter, Respondent approved Patient F. V. for a brow lift and thigh liposuction. At the conclusion of the consultation on February 3, 1997, Respondent dictated a pre-operative report. The transcription of that dictation is not in F. V.'s medical chart maintained at FCCS. The fate of that dictated pre- operative consultation report is presently unknown.6 At the time of the Patient F. V.'s 1997 surgery, it was the practice of FCCS to prepare, and to maintain in the patient's medical records, a financial check list. For reasons not explained in the record in this case, the financial check list for Patient F. V.'s 1997 surgical procedures is missing from Patient F. V.'s medical chart at FCCS. At that same time, it was also the practice at FCCS for the physician to either provide the patient with pain medications or with a prescription for pain medications prior to surgery, and to document such delivery of medications or prescription for medications in the patient's medical chart. For reasons not explained in the record in this case, such documentation is missing from Patient F. V.'s medical chart at FCCS. At the time of Patient F. V.'s 1997 surgery, it was also the practice at FCCS to provide each patient with a pre- surgery instruction sheet listing numerous things the patient should do prior to surgery, as well as things the patient should not do prior to surgery. It was also the practice of FCCS to place a copy of the instruction sheet in the patient's medical chart. For reasons not explained in the record in this case, the copy of the instruction sheet given to Patient F. V. is missing from her medical chart at FCCS. At the time of the pre-operative consultation on February 3, 1997, FCCS was experiencing delays with the transcription of dictated reports. Such transcriptions often took as long as one or two weeks. Some of the information generated at the pre-operative conference needed to be promptly communicated to the financial staff at FCCS so that the costs of the procedures to be performed could be determined and so that arrangements for payment could be made with the patient. In some manner not presently remembered, Respondent provided the FCCA financial staff with the information they needed to make the necessary financial arrangements with Patient F. V.7 Patient F. V.’s medical records at FCCS do not contain adequate documentation of Respondent’s pre-operative consultation on February 3, 1997, with Patient F. V. Further, Respondent could not produce any adequate documentation of his February 3, 1997, consultation with Patient F. V. Day of Patient F. V.’s surgery Respondent performed surgery on Patient F. V. on February 6, 1997, which consisted of a brow lift and liposuction of her thighs. Before Respondent began the surgical procedure, CRNA Filip (Nurse Filip) conducted her own physical assessment of Patient F. V. for her purposes as the anesthetist. Nurse Filip also documented the results from the lab tests. Nurse Filip documented her results by hand writing notes on the bottom left portion of the Pre-Operative Checklist. As evidenced by the anesthesia record in Patient F. V.’s records, Nurse Filip also performed her duties as the anesthetist for the surgery and documented her pre-operative care of Patient F. V. In the anesthesia record, Nurse Filip documented information including a cursory patient history (allergies, medication being taken, and blood pressure), date, type of surgery, and surgeon. Respondent had no part in documenting any information on the anesthesia records. The anesthesia records for Patient F. V.'s surgery on February 6, 1997, appear to be complete. The circulator who participates in a surgical procedure has the recordkeeping responsibility of creating an operating room record, which should include a detailed description of the equipment used during the surgical procedure, as well as an itemization of all significant events from the time the patient enters the operating room until the patient goes to the recovery room. During 1997 it was the practice of FCCS to keep the circulator's operating room records in the patient's medical chart. For reasons not explained in the record in this case, the circulator's operating room record is missing from Patient F. V.'s medical chart at FCCS. The progress note for the day of surgery, February 6, 1997, is a de minimus notation that lists little more than the type of surgery performed, the surgeon's name, the weight of the patient, the names of the scrub nurse, the circulating nurse, and the CRNA, and the total amount of fat removed. This de minimus progress note is not in Respondent's handwriting.8 In addition to a progress note summarizing the basic details of a surgical procedure, once the surgery is complete the surgeon should also prepare a detailed operative report which describes in detail the manner in which the surgical procedure was performed, including all significant events that occurred during the surgery. Such an operative report should include a description of the type of liposuction and the type of brow lift performed. Such an operative report should also detail the manner in which the surgery was performed and should note any burns, injuries, or other complications arising from the surgery. A sufficiently detailed operative report is especially important in the event of post-operative complications, because details regarding the methods and techniques employed during the surgery can often facilitate an understanding of, and facilitate treatment of, any post- operative complications. There is no clear and convincing evidence as to whether Respondent did or did not prepare a detailed operative report of the type described in the immediately preceding paragraph. What is clear is that such an operative report is missing from Patient F. V.'s medical chart at FCCS.9 Respondent's recollection of the details of the subject surgery on February 6, 1997, is not very good. Although he seems to have a clear recollection of some details, he does not appear to recall some other equally important details. He does, however, remember that after the surgery he wrapped Patient F. V.'s forehead with Ace wrap and placed a strip of tape along the forehead to immobilize the Ace wrap. He also applied Ace wrap to the patient's thighs at the conclusion of the surgery. The Ace wraps on the thighs were also secured with strips of tape. At the conclusion of the surgical procedures on February 6, 1997, there were no visible blisters at the locations where blisters were visible on February 7, 1997. During the surgical procedures performed on February 6, 1997, on Patient F. V., Respondent did not use a monopolar catherization device. Therefore, no grounding pads were used during that surgery. Findings regarding post-operative care FCCS’s post-operative policy in effect in February of 1997 required the patient to return for post-operative follow up as follows: one day, one week, two weeks, and one month. Patient F. V. returned the next day, February 7, 1997, and was seen by Respondent. On February 7, 1997, the patient’s head dressing was removed, the bandages on the patient's thighs were removed, and the patient was advised to follow up in 5 days to have sutures removed. Respondent’s notes for this visit included a notation that the patient was "doing great," and that the patient should return for staple removal. Respondent's notes also mention a "forehead blister" which is noted to be "clean," and a "tape blister" on the left thigh. On February 7, 1997, Patient F. V. had a blister on her left thigh. This thigh blister was located on the front of the thigh, a few inches above the kneecap. On February 7, 1997, the patient also had a smaller blister on her forehead above her left eye.10 Respondent’s post-operative progress note of the February 7, 1997, visit does not document a treatment plan for the injuries on the forehead or the thigh. However, in this regard it must be noted that there is no evidence that either blister required treatment on February 7, 1997, or that either blister appeared to require any future treatment other than follow-up observation.11 Patient F. V. returned to FCCS on February 13, 1997, and was seen again by Respondent. The written progress note for that day recorded her weight, but no other subjective or objective complaints were noted. The progress note mentions a "possible tape blister" on the patient's upper left thigh. On this occasion the top of the thigh blister had come off and an unprotected layer of skin was at that site. The thigh blister needed treatment to prevent infection. The progress note also mentions that Bacitracin, an antibiotic, was applied to the thigh blister and that the blister site was covered by a 4” x 4” piece of gauze held in place by a small piece of paper tape. There are no notes concerning the lesion on the forehead. In this regard it must again be noted that there is no evidence that the forehead blister required any treatment at the time of this visit.12 Patient F. V. was advised to come back in one week to have the staples removed. The next entry in the progress notes states that Patient F. V. returned three days later, on February 16, 1997. Although the matter is not entirely free from doubt, the visit recorded as having occurred on February 16, 1997, probably actually took place on February 17 or 18, 1997.13 The progress note for that visit first notes that the patient was happy. It also notes that the stitches and the staples were removed. The progress note concludes with the following: "Script given for Silvadene 1% due to burn on leg and forehead." It is not clear from the progress notes who saw the patient at this visit, but it was probably one of the physicians (other than Respondent) who worked at FCCS, inasmuch as a prescription was written during this visit. Both Bacitracin and Silvadene were appropriate antibiotics for the patient's thigh and forehead lesions. Silvadene has a more penetrating quality to it and can penetrate scabs better. On February 24, 1997, Patient F. V. called the FCCS regarding the lesion on her leg. A dermatologist friend of hers had advised her to discontinue the Silvadene cream and to contact her physician about the lesion. Patient F. V. wanted Respondent to see her. She was advised to come in the next day to see one of the other physicians employed at FCCS. The next day (February 25) Patient F. V. returned to FCCS for further follow up treatment. She was seen by Dr. Alexander, one of several physicians employed by FCCS, who advised her to leave the lesion dry and see how it heals. The lesion on the thigh was described as "dry and scabbed." The patient was very unhappy during this visit. On February 26, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing very well “except for left leg burn.” Respondent also noted as a possible cause of the lesion on the patient's left leg: “probable ground plate sensitivity.” There are no subjective complaints recorded. The record also does not contain any type of plan concerning the left leg burn. In this regard it should be noted that on the previous day Dr. Alexander had advised the patient to leave the burn dry and see how it heals. In all probability, during the following 24-hour period there was no change to the lesion on Patient F. V.'s thigh that required any additional treatment plan other than the "wait and see" plan noted by Dr. Alexander the day before. Photographs were taken on the visit of February 26, 1997. There are several post-operative photographs of the left leg lesion. On March 20, 1997, Patient F. V. returned to FCCS and was seen by Respondent. Respondent noted that she was doing better and that her leg lesion was improving. There are no clearly documented objective or subjective complaints. There is no plan documented other than return ASAP. Respondent’s medical record of March 20, 1997, does not document a plan for the course and scope of treatment for Patient F. V. Although Respondent documents a concern with the forehead, he did not document what concerns he had or how he planned to treat the concerns.14 After the visit of March 20, 1997, Patient F. V. did not return to the FCCS for over a year. On June 4, 1998, Patient F. V. was seen by two physicians at FCCS. Both physicians examined Patient F. V. and then prepared progress notes reporting what they had observed and proposing a plan to address what they had observed. Respondent discontinued his professional relationship with FCCS on or about April 1, 1997. Prior to leaving FCCS, Respondent reviewed all of his charts and had the opportunity to make sure all the histories and physicals were complete. To the best of Respondent's recollection, when he left FCCS there were no charting problems in any of the medical charts of any of the patients who had been treated by Respondent at FCCS. Patient F. V. returned to FCCS on June 4, 1998, and was seen by Dr. Alexander. Dr. Alexander was another plastic surgeon who worked at FCCS. Following his examination of Patient F. V. on June 4, 1998, Dr. Alexander prepared a progress report reading as follows: "6/4/98. Depressed area above the left eye on the forehead, dime size. Second degree burn, one- inch long depigmented burn scar left medial thigh. Also two- inch wide scar, medial forehead lift scar. Plan, revise all scars." On June 4, 1998, patient F. V. was seen by another physician identified in progress notes as "Dr. H."15 Following his examination of Patient F. V. on June 4, 1998, the second physician ("Dr. H") prepared a progress note reading as follows: Dr. H, 6/4/98 1.7 x .8 centimeter hypopigmented scar with surrounding hypopigmentation 2mm. flat non-tender .8 x .6 centimenter thin skin left upper forehead appears like lower dermis mobile to touch but doesn't animate on her own. Can't really see scar - just notice conture deformity. Rec - Excise leg scar vertically. ? Alloderm under depressed scar left forehead. Discuss with patient. G.L.A.D. Patient F. V. has elected not to have scar revision surgery. When Respondent discontinued his professional relationship with FCCS, he left all of the medical records concerning his care and treatment of Patient F. V. in the possession and custody of FCCS. Respondent did not take any copies of any medical records concerning Patient F. V. when he discontinued his relationship with FCCS. It was not until the latter part of 1999 that Respondent first obtained possession of a copy of the FCCS medical records concerning Patient F. V. He obtained those copies by means of a discovery request. As of the time of the final hearing in this case, several documents were missing from the medical records concerning Patient F. V. maintained by FCCS. The missing documents included the following: a detailed pre-operative report; a detailed operative report prepared by Respondent or prepared by someone acting pursuant to Respondent's direction and control; a financial check list; written documentation of medications provided to or prescribed for the patient; and a sheet of pre-surgery instructions regarding what the patient should and should not do. At several times during the period from 1998 through 2002, the medical records at FCCS concerning Patient F. V. were searched in an effort to locate a detailed pre-operative report and/or a detailed operative report. Such documents could not be found in the FCCS records on those occasions. Without an operative note (or some other form of detailed information regarding the manner in which the surgical procedures at issue were performed) it is virtually impossible to reach a reliable determination as to what caused the injuries on the patient's left thigh and forehead. On the basis of the record in this case, the causes of the forehead and thigh lesions observed on Patient F. V. on February 7, 1997, are unknown. Because the causes are unknown, it is also unknown whether such lesions were caused by act or omission by Respondent. And, because no specific act or omission by Respondent has been identified as the cause of either lesion, it is impossible to determine whether any such unidentified act or omission, if any, might or might not have constituted a departure from the applicable standards of care. There is no clear and convincing evidence that Respondent "fail[ed] to properly administer liposuction, causing full-thickness burns to Patient F. V.'s left thigh area." There is no clear and convincing evidence that Respondent "fail[ed] to properly perform the brow lift, causing full-thickness burns to Patient F. V.'s forehead." There is no clear and convincing evidence that Respondent "improperly plac[ed] or fail[ed] to appropriately supervise the placement of the grounding pads of the Bovie unit." There is no clear and convincing evidence that Respondent did "not adequately maintain[ ] his surgical equipment relating to liposuction and brow lift procedures." There is no clear and convincing evidence of Respondent's "failing to properly document Patient F. V.'s preoperative consultation." There is no clear and convincing evidence of Respondent's "failing to properly document a post-operative report of the procedures." There is no clear and convincing evidence of Respondent's "failing to complete or create an appropriate operative report for the procedures."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine issue a final order in this case dismissing all parts of both counts of the Amended Administrative Complaint because none of the violations alleged in the Amended Administrative Complaint have been proved by clear and convincing evidence. DONE AND ENTERED this 31st day of December, 2003, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of December, 2003.
The Issue The issue is whether Respondent properly denied Petitioner's application for approval as an office surgery accrediting organization pursuant to Section 459.309(3), Florida Statutes, and Florida Administrative Code Rule 64B8-9.0092.
Findings Of Fact In Florida, physicians who perform certain surgical procedures in their offices are required to register the office with DOH. Additionally, DOH must inspect such offices unless a nationally recognized accrediting agency or an accrediting organization approved by the Board inspects and accredits the offices every three years. See § 458.309(3), Fla. Stat. and Fla. Admin. Code R. 64B8-0.0091. Florida Administrative Code Rule 64B8-9.0092, entitled "Approval of Physician Office Accrediting Organizations," purports to establish requirements that FLACS must meet in order to achieve the Board's approval to operate as an accrediting organization. FLACS is a not-for-profit corporation, organized for the following purposes: (a) to promote office safety through its accreditation activities; (b) to promote cosmetic surgery; and (c) to provide continuing education courses related to office surgery. FLACS was formed in 1999 and, since that time, has participated actively in office surgery issues considered by the Board. The Board approved FLACS as an accrediting organization early in 2001. In January 2003 FLACS filed a complete renewal application, seeking the Board's approval to continue operating as an office surgery accrediting organization. The Board denied the application and, after a formal administrative hearing, entered a Final Order denying FLACS's application. See Florida Academy of Cosmetic Surgery, Inc. v. Board of Medicine, Case No. DOH-04-0661-FOF-MQA (Final Order, June 18, 2004)(adopting Recommended Order in DOAH Case No. 03-3349, April 15, 2004.) FLACS filed a new application for approval as an office surgery accrediting organization on July 12, 2004. The Board never advised FLACS whether its application was complete or incomplete. There is evidence that a member of the Board's staff, Melinda Grey, reviewed the application, finding it incomplete in many respects. On August 5, 2004, Ms. Grey prepared a spreadsheet entitled "Board of Medicine Staff Issues Regarding FLACS Application." The spreadsheet compared the application with the requirements of the applicable provisions of the Florida Administrative Code, including Florida Administrative Code Rule 64B8-9.0092. Larry McPherson, the Board's Executive Director, was aware that Ms. Grey was reviewing FLACS's application. She did not tell Mr. McPherson that the application was incomplete. Instead, she informed the Board's legal counsel that FLACS had filed the application. Subsequently, Ms. Grey placed the application on the agenda for the Board's next scheduled meeting. On August 7, 2004, the Board voted to deny the new application. On August 23, 2004, the Board entered an Notice of Intent to Deny FLACS's new application on the following grounds: When participating in accrediting activities in the past, the applicant violated Section 458.331(1)(nn), Florida Statutes, by failing to comply with rules of the Board in the following manner: The applicant failed to provide copies of accreditation reports and corrective action plans to the Board office within 30 days of completion of accrediting activities in violation of Rule 64B8- 9.0092(4)(e), Florida Administrative Code. The applicant failed to immediately report to the Department conditions in physicians' offices that posed a potential immediate threat to patients in violation of Rule 64B8-9.0092(4)(f), Florida Administrative Code. When inspecting and accrediting facilities the applicant ignored its written accreditation standards and failed to provide the Board office with accreditation standards under which it was actually operating. Such facts reveal that the applicant operated in violation of Rule 64B8-9.0092(4)(g), Florida Administrative Code. When inspecting the facilities, the applicant operated with inadequate or applied inconsistently its quality assurance program in violation of Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate quality assurance program as required by Rule 64B8- 9.0092(4)(a), Florida Administrative Code. The applicant failed to provide evidence of an adequate ongoing anesthesia related accreditation and quality assurance processes as required by Rule 64B8- 9.0092(4)(c), Florida Administrative Code. The applicant failed to submit copies of all incident reports filed with the state that originated at FLACS accredited facilities as required by Rule 64B8-9.0092(4)(f), Florida Administrative Code. Uncorrected "Prior Errors" After FLACS submitted its January 2003 "renewal" application, the Board's staff met several times with FLACS to discuss and "work out" problems that the Board had with FLACS's office surgery accrediting procedures. These meetings, which took place between January 2003 (when FLACS filed its renewal application) and August 2003 (when the Board denied the renewal application,) were supposed to result in changes to FLACS's inspection procedures and to alleviate the Board's concerns about FLACS' renewal application. Apparently FLACS successfully implemented some changes between the time that the Board denied FLACS's renewal application in August 2003 and the time that the Board issued the June 2004 Final Order in DOAH Case No. 03-3349. There is no evidence in the instant case that FLACS committed the following prior violations: (a) failed to provide DOH with accreditation reports and corrective action plans required by Florida Administrative Code Rule 64B8-9.0092(4)(e); and (b) awarded accreditation retroactive to the inspection date. Despite FLACS's effort to make needed changes in its inspection processes, it failed to do so on several occasions. First, on May 23, 2004, FLACS inspected the office of Anthony Rogers, M.D. Even though Dr. Rogers had one crash cart deficiency (missing the drug isuprel), FLACS's facility inspection form indicates that Dr. Rogers passed the inspection. FLACS did not receive confirmation that Dr. Rogers was in 100 percent compliance with the Board's rules regarding the mandated crash cart medications until May 27, 2004. FLACS accredited Dr. Rogers on that date based on a packing slip/boxed content list, showing receipt of the isuprel. Second, FLACS inspected the office of Rodolfo Binker, M.D., on May 22, 2004. FLACS's facility inspection form indicates that Dr. Binker passed the inspection even though he was missing intubation forceps (McGill). FLACS did not receive confirmation that Dr. Binker's monitoring and emergency equipment included intubation forceps (McGill) until May 24, 2004. FLACS accredited Dr. Binker that same day based on an invoice, showing that the forceps had been ordered and shipped to Dr. Rogers. The invoice does not indicate the date that Dr. Rogers received the forceps. Third, FLACS prefers for physicians who fail an inspection to verify compliance with the Board's rules by providing FLACS with a packing slip, showing receipt of the missing drugs or equipment. However, the evidence indicates that one of FLACS's inspectors sometimes accepts purchase orders/invoices, which do not show actual receipt of the missing items. Fourth, there is no evidence that FLACS failed to advise DOH about conditions in any physician's office that posed potential immediate jeopardy to patients as required by Florida Administrative Code Rule 64B8-9.0092(4)(f). FLACS's application states that "[a]ll deficiencies, including those which pose potential immediate jeopardy, will be immediately reported to the Department of Health and the Board." However, as a practical matter, FLACS does not believe it is necessary to make such a report as long as it notifies the Board by telephone for any circumstance that it believes constitutes an "immediate threat" to a patient and provides the Board with copies of all inspection materials, facility surveys, and compliance materials on all FLACS accreditations. In other words, unless a patient is in immediate danger, FLACS will leave it to DOH and the Board to review all documentation and determine whether a physician's office poses a "potential immediate threat." Finally, Bruce Hirshman, D.O, is an anesthesiologist who participates in FLACS's ongoing anesthesia-related accreditation and quality assurance processes. At some point in time, FLACS accredited Dr. Hirshman's office surgery facility. As of June 3, 2003, FLACS was aware that Dr. Hirshman had not registered with the Board of Osteopathic Medicine and advised him to do so. FLACS took no further action regarding Dr. Hirshman's failure to register until May 2005. FLACS's May 5, 2005, letter to Dr. Hirshman, stated as follows in relevant part: As of April 28, 2004, the Florida Academy of Cosmetic Surgery was informed by Ms. Rina Palladino at the Florida Board of Osteopathic Medicine that you had not registered with the Florida Board of Osteopathic Medicine to perform office surgery. The Florida Academy of Cosmetic Surgery is withdrawing your accreditation . . . . Rule 64B8-9.0092(2)(f)--Adverse Incident Reports Florida Administrative Code Rule 64B8-9.0092(2)(f) requires an application for approval as an office surgery accrediting organization to include copies of all incident reports that accredited physicians file with the state. The incident reports are defined by Section 458.351(4), Florida Statutes, which reads as follows: (4) For purposes of notification to the department pursuant to this section, the term "adverse incident" means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. 1. The performance of a wrong- site surgical procedure; The performance of a wrong surgical procedure; or The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed- consent process if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. The incident reports are further defined by Florida Administrative Code Rule 64B8-9.001(1)(a), which states as follows in relevant part: . . . an event over which the physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries: The death of a patient. Brain or spinal damage to a patient. The performance of a surgical procedure on the wrong patient. The performance of a wrong-site surgical procedure, the performance of a wrong surgical procedure; or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in the paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient. A procedure to remove unplanned foreign objects remaining from a surgical procedure. Any condition that required transfer of a patient to a hospital licensed under Chapter 395, Florida Statutes, from any facility or any office maintained by a physician for the practice of medicine which is not licensed under Chapter 395, Florida Statutes. FLACS understood that the "incident reports" referenced in Florida Administrative Code Rule 64B8-9.0092(2)(f) are the same as the "reports on adverse incident" defined by Section 458.351, Florida Statutes, and Florida Administrative Code Rule 64B8-9.001(1)(a). FLACS's application specifically references adverse incident reports as defined by Section 458.351, Florida Statutes. FLACS provided two such adverse incident reports with its new application: (a) one filed by Fabio Arturo Castro, M.D., from an incident that occurred on November 24, 2003; and (b) one filed by Kurt S. Dangl, M.D., from an incident that occurred on September 25, 2003. The new application did not include the following incident reports that FLACS included with its January 2003 renewal application: (a) one filed by Robert Gregory Smith, M.D., from an incident that occurred on August 16, 2001; and (b) one filed by Rafael A. Fleites, M.D., from an incident that occurred on March 9, 2002. As of July 12, 2004, DOH had received a total of nine (9) office incident reports from doctors' offices that are, or were at the time the incidents occurred, accredited by FLACS. FLACS's accredited physicians did not provide it with the following incident reports: (a) one filed by Michael Patipa, M.D., from and incident that occurred on March 29, 2004; (b) one filed by Constantino F. Mendieta, M.D., from an incident that occurred on February 2, 2004; (c) one filed by Edward J. Gross, M.D., from an incident that occurred on July 22, 2003; (d) one filed by Timothy Fee, M.D., from an incident that occurred on November 11, 2003; and (e) one filed by Ramiro Morales, Jr., M.D., from an incident that occurred on April 9, 2002. The Board's staff discovered that FLACS's application did not provide copies of these five incident reports by reviewing individual physician office registration files. FLACS has several methods to use in collecting incident reports. First, FLACS requires its accredited physicians and office surgery facilities to attest and acknowledge that they are required to provide FLACS with any and all adverse incident reports related to or following surgery in the accredited offices. Second, FLACS requires the staff of accredited offices to perform self-evaluation surveys after the first and second year of accreditation, said surveys to include such incident reports. Third, FLACS watches for information about adverse incidents as reported by news media or complaints from the public. Most important, FLACS can make quarterly public record requests for the reports even though the state system of record keeping for adverse incident reports is not computerized. There is no persuasive evidence that FLACS ever made an oral or written public records request for copies of incident reports related to its accredited physicians and office surgery facilities. There is no statutory or rule requirement for physicians to file copies of incident reports with their accrediting organization. However, at least two of the nationally recognized accrediting agencies, Joint Commission on Accreditation of Healthcare Organization (JACHO) and American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF), have provisions in their accreditation manuals related to adverse incidents. JACHO's "Accreditation Manual for Office-Based Surgery Practices," Second Edition (2005), defines a "sentinel event" as follows: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error, and not all errors result in sentinel events. JACHO requires each accredited practice to define "sentinel event" for its own purposes in establishing mechanisms to identify, report, and manage these events. JACHO encourages, but does not require, its clients to report "sentinel events" to the accrediting agency within 45 days of the event or of becoming aware of the event. The report should include a root cause analysis and an action plan. If JACHO becomes aware of an unreported "sentinel event," JACHO will advise the accredited practice to prepare and submit the report within a certain timeframe. If the accredited practice fails to file an appropriate report within that time frame, JACHO will not revoke accreditation, but will place the accredited practice on an "Accreditation Watch" list. AAAASF's "Standards and Checklist for Accreditaion of Ambulatory Surgery Facilities" contains forms for accredited surgery facilities to use in reporting "unanticipated sequela." The forms refer one to AAAASF's "Quality Assurance and Peer Review Manual" for questions relative to their completion. The record indicates that "unanticipated sequela" are the equivalent of adverse incident reports, including but not limited to, events that result in unplanned hospital admissions. In Florida, physicians are required to file adverse incident reports with DOH's Consumer Services Unit (CSU), which is part of DOH's Medical Quality Assurance Program. On at least a quarterly basis, the Board's staff requests CSU to provide it with copies of adverse incident reports filed during a certain timeframe. The staff of the CSU has access to medical consultants who review the incident reports to determine whether there might have been a violation of law or a violation of a standard of care. If so, the matter is referred for further investigation, determination of probable cause, and possible disciplinary prosecution by the Board. The Board's staff places the incident reports in physician registration files and in office surgery inspection/accreditation files. The Board's staff also places copies of incident reports involving physicians or facilities in the respective file of their accrediting agency or accrediting organization. The Board's staff provides copies of adverse incident reports to DOH's state inspectors before they make office inspections of non-accredited facilities or facilities formerly accredited by a national agency or FLACS. The state inspector/risk manager uses the incident reports during inspections to recommend improvements so that such incidents can be avoided in the future. The Board's Surgical Care Committee, uses the incident reports for statistical purposes. The Surgical Care Committee reviews the reports to determine whether changes need to be made in administrative rules, including but not limited to, rules related to standard of care or physician registration. It is important for FLACS to be aware of adverse incident reports filed by its accredited physicians and office- surgery facilities. Such reports are an essential part of any accreditation program. Without such knowledge, FLACS cannot be assured that its accredited physicians and offices are taking steps to prevent such incidents in the future. Moreover, if FLACS is not aware of the adverse incidents occurring in the offices it inspects, FLACS cannot implement changes in its own policies to improve the accreditation process. The Board has no policy or practice for routinely sharing incident reports with accrediting organizations. Nevertheless, requiring FLACS to file copies of incident reports with the Board could alert the Board to incidents that were known to FLACS but never reported to the state and vice versa. As stated above, FLACS could make routine public records requests for copies of reports filed with the Board but not reported directly to FLACS. Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) Florida Administrative Code Rules 64B8-9.0092(4)(a) and 64B8-9.0092(4)(c) were declared invalid in Florida Academy of Cosmetic Surgery, Inc. v. Department of Health, Board of Medicine, DOAH Case No. 05-0402RX (Final Order, August 8, 2005). For the reasons set forth below in the Conclusions of Law, it is unnecessary to report facts related to a mandatory quality assurance program or the ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board issue a Final Order denying FLACS's application for approval as an office surgery accrediting organization. DONE AND ENTERED this 9th day of August, 2005, in Tallahassee, Leon County, Florida. S SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of August, 2005.
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a licensed medical doctor. By means of a two-count Administrative Complaint, the Respondent is charged with violations of Sections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, by allegedly failing to keep written medical records justifying the course of treatment of a patient, and by failing to practice medicine with the required level of care, skill, and treatment. The Respondent denies the violations charged in the Administrative Complaint, and also asserts that the Administrative Complaint should be dismissed by reason of the Petitioner's failure to timely investigate and prosecute the subject charges.
Findings Of Fact Findings stipulated by the parties4 The Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida. The patient R. C. presented with a history of diabetes and hypertension. The Respondent did not attempt or make any contact with the primary care physician of patient R. C. Brevital was administered intravenously to the patient R. C. without the use of an IV pump. Resuscitative drugs and equipment should always be immediately available. There is no documentation of respiratory monitoring during the administration of anesthetics and the surgical procedure performed on patient R. C. It is well below the standard of care to both administer a general anesthesia and perform the surgical procedure. Findings based on evidence At all times material, the Respondent has specialized in urology. The Respondent is not board certified in urology. At all times material to this case, the Respondent was associated with a clinic named Instituto Latino Americano de Impotencia y Diagnostico (ILAID). One or two days each week, the Respondent would see patients at ILAID that were potential candidates for penile implant surgery. At all times material to this case there were at least two other licensed physicians associated with ILAID who often were the first physicians to see patients who came to ILAID with complaints of impotency. The subject patient (Patient R. C.) went to ILAID for the first time on May 24, 1993. On that day the patient signed a form titled "Patient Information," which contains little more than patient identification information, and a form titled "Patient's Declaration and Agreement."5 The patient probably saw a physician at ILAID on May 24, 1993, because a blood sample was taken from the patient that day and the results of the blood tests were reported back to ILAID on May 25, 1993. However, there is no documentation that the patient was seen by a physician at ILAID on May 24, 1993. Specifically, there is no medical chart documenting that on that day a physician took a history from the patient, examined the patient, evaluated the patient, ordered any tests of the patient, or otherwise treated or cared for the patient. At all times material to this case, the routine practice and procedure of ILAID regarding patients who went to ILAID with complaints of impotency was to have the patients seen by a physician associated with ILAID. It was also the routine practice and procedure at ILAID for the physician who first saw the patient to prepare a-medical record documenting the patient's visit. Such a medical record would routinely document a patient history, an examination of the patient, the physician's evaluation of the patient, and any treatments given or tests ordered by the physician. The impotency patients at ILAID were also routinely put through an evaluation procedure to determine the extent of and the nature of their impotency before implant surgery was recommended or performed. The results of the evaluation procedure were also routinely documented in the patient's medical chart. The Respondent first saw the subject patient on July 13, 1993, at the ILAID facility. On that date there were no patient records regarding the subject patient prepared by any other physician associated with ILAID for the Respondent to review. In the absence of any medical documentation, the Respondent apparently assumed that the patient had been through the normal routine at ILAID and proceeded to go forward on that assumption. On July 13, 1993, the Respondent took a brief, limited history from the patient and conducted a limited physical examination of the patient. The physical examination was limited to the patient's abdomen and urogenital area. Based on that limited history and examination, the Respondent concluded that penile implant surgery was an appropriate course of treatment, subject to the patient receiving medical clearance for the surgery. The Respondent did not perform any objective tests for impotence on the patient. The Respondent did not obtain a detailed medical history from the patient. The Respondent did not obtain a detailed history regarding the nature, extent, or duration of the patient's impotence. The Respondent did not conduct a complete physical examination of the patient. Prior to performing penile implant surgery, a physician should perform objective tests to determine if the surgery is indicated. Two objective tests that should always be performed are blood tests to determine the patient's testosterone level and prolactin level.6 Depending on the details elicited during the patient history, other objective tests may also be indicated. The Respondent failed to have tests done to determine the testosterone level and the prolactin level of the patient. The failure to perform these two objective tests is a departure from acceptable standards of medical care recognized by a reasonably prudent similar physician. Prior to performing penile implant surgery, a patient's condition must be assessed by a physician to determine whether surgery is indicated. The surgeon does not have to personally perform all aspects of the assessment of the patient's condition, but the surgeon must at least verify that an adequate assessment has been performed by another physician, and that the assessment has been documented in the patient's medical records. Adequate assessment of a patient's condition requires, at a minimum, a detailed medical history, a complete physical examination, and the performance of any objective tests indicated by the history and physical examination. The performance of surgery without either performing an adequate assessment of the patient's condition or verifying that such an assessment has been documented by another physician is a departure from acceptable standards of care recognized by a reasonably prudent similar physician. The Respondent did not obtain a detailed medical history from the patient, did not perform a complete physical examination of the patient, and failed to order at least two objective tests that were indicated by the patient's complaints. The Respondent also failed to verify that documentation existed which showed that any other physician had obtained a detailed medical history from the patient, had performed a complete physical examination of the patient, and had ordered the objective tests indicated by the patient's complaints. If the Respondent had attempted to verify the existence of such documentation, he would have discovered that the documentation did not exist. The Respondent's performance of surgery on the patient without performing an adequate assessment of the patient's condition, or without verifying that such an assessment had been documented by another physician, was a departure from acceptable standards of medical practice. The Respondent made arrangements for additional blood tests and for an EKG to be administered to the patient. The Respondent also believed that he had made arrangements for one of the other physicians at ILAID to medically clear the patient for surgery. Anticipating no problems regarding the medical clearance, the Respondent also contacted the director of ILAID, Rogelio Medel, and asked him to arrange a location for the implant surgery. In view of the patient's financial circumstances and his lack of medical insurance, it was decided that the surgery would be done in an operating room at a physician's clinic, which would be somewhat less expensive than performing the surgery in a hospital operating room. Rogelio Medel contacted Dr. Francisco A. Prado and arranged for the use of one of the operating rooms at Dr. Prado's clinic. Rogelio Medel had made similar arrangements with Dr. Prado twice before. The arrangement with Dr. Prado was that Dr. Prado would provide not only the use of the operating room, but would also provide all necessary supplies (including the anesthesia medications), as well as the services of a nurse anesthetist, Eduardo Perez, who worked for Dr. Prado on a regular basis. The surgery was scheduled for early in the afternoon on July 16, 1993. Unbeknownst to Rogelio Medel and to the Respondent, Eduardo Perez was not a licensed nurse anesthetist. The Respondent did not inquire of Eduardo Perez regarding the latter's qualifications or licensure status. Rather, relying on the representations of Dr. Prado, the Respondent assumed that Eduardo Perez possessed the necessary qualifications and licensure to function as a nurse anesthetist. While it is clear that Eduardo Perez was not licensed as a nurse anesthetist, there is no clear and convincing evidence in the record as to whether Eduardo Perez was or was not trained in the use of anesthetics, was or was not trained in the use of respiratory and cardiac monitoring equipment, or was or was not trained in the use of resuscitative drugs and equipment.7 The Respondent assumed that Eduardo Perez was trained in these matters, based on the assumption that Eduardo was a licensed nurse anesthetist. In view of the representations of Dr. Prado, it was reasonable for the Respondent to make that assumption.8 The Respondent was not trained in the techniques and procedures of advanced cardiac life support. The Respondent was not trained in the use of a defibrillator. The Respondent was not trained in the use of anesthetics. Prior to performing surgery on the subject patient, the Respondent had received a copy of the laboratory results dated July 16, 1993. He had also received a copy of the EKG report prepared by Dr. Freddie Rodriguez. Prior to performing the surgery, the Respondent had not received any written medical clearance for the patient to undergo the planned implant surgery. The Respondent never received any written medical clearance for the patient to undergo surgery, because the patient was never medically cleared. The Respondent did not receive any telephonic verification that the subject patient had been medically cleared for surgery, because no other physician had cleared the patient for surgery.9 Prior to performing surgery, it is the responsibility of the surgeon to verify that the patient has been medically cleared for the proposed surgery. Under similar conditions and circumstances, a reasonably prudent similar physician would not perform surgery without verification that the patient had been medically cleared for the proposed surgery. It is a departure from minimum standards of medical practice for a surgeon to perform surgery without such verification. Early in the afternoon on July 16, 1993, the Respondent performed penile implant surgery on the subject patient. The surgery was conducted in one of the operating rooms at Dr. Prado's clinic, as previously arranged with Dr. Prado. During the surgery the patient was anesthetized with the anesthetic agents Versed and Brevital. These anesthetic agents were administered by Eduardo Perez, who was functioning as a nurse anesthetist. Eduardo Perez was present during the entire surgical procedure, during which time he monitored the administration of the anesthetic agents, monitored the patient's vital signs, and otherwise performed the functions that would be performed by a nurse anesthetist. At all times material, the Respondent believed, based on the representations of Dr. Prado, that Eduardo Perez was a licensed and qualified nurse anesthetist who regularly worked in that capacity for Dr. Prado. When the surgical procedure had been completed, the Respondent left the patient in the care of Eduardo Perez while the Respondent left the operating room to change clothes. When the Respondent left the operating room the patient appeared to be normal. When the Respondent returned to the operating room a few minutes later, he noticed that the patient had become pale and sweaty. The Respondent also noticed that the patient had very little pulse or blood pressure. The Respondent and Eduardo Perez initiated cardiopulmonary resuscitation and also called fire rescue for assistance. The Respondent and Eduardo Perez continued their cardiopulmonary resuscitation efforts until the fire rescue personnel arrived a few minutes later. The fire rescue personnel initiated advanced cardiac life support measures and subsequently transported the patient to a hospital emergency room, where further efforts were made to resuscitate the patient. Shortly thereafter the patient was pronounced dead in the emergency room. Following an autopsy and investigation into the cause of death, the Dade County Medical Examiner was of the opinion that it could not be stated with any degree of medical certainty that the death of the subject patient was caused by the surgery. In order to have medical records sufficient to justify penile implant surgery, a physician must have written medical records that document at least the following matters: (a) a detailed patient history; (b) a complete physical examination of the patient; (c) a consideration of alternative therapy options; and (d) a pre-operative medical clearance. With regard to the subject patient, the Respondent does not have, and never did have, written medical records documenting any of the four matters itemized immediately above. By failing to keep written medical records documenting such matters with regard to the subject patient, the Respondent failed to keep records justifying the course of treatment of the patient.10
Recommendation On the basis of all of the foregoing it is RECOMMENDED that a Final Order be issued in this case concluding that the Respondent has violated Sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, imposing a penalty consisting of the imposition of administrative fines totaling $6,000. 00, and the suspension of the Respondent's license to practice medicine for a period of 90 days. DONE AND ENTERED this 23rd Day of September, 1998, in Tallahassee, Leon County, Florid __________________________________ MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 1998.
The Issue Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, he then had an "emergency medical condition," as defined by Section 395.002(8)(a) F.S. Whether, when the patient J.B. presented to the Emergency Department of Munroe Regional Medical Center (MRMC) on May 22, 1995, MRMC provided to the patient appropriate "emergency services and care," including an appropriate "medical screening, examination and evaluation," as defined by Section 395.002(9) F.S., and as required by Section 395.1041 F.S., and if not, how shall MRMC be disciplined?
Findings Of Fact At all times material, J.B. was a 42 year old male employee of an Ocala music store. In that capacity, he had been moving pianos for years. As a result, he had experienced neck, shoulder and back pain off and on for years. The pain and stiffness was worst upon awaking in the mornings and frequently required two days' bed rest before he could return to work. In the week preceding Monday, May 22, 1995, J.B.'s neck and shoulder pain had intensified. On Friday, May 19, 1995, J.B. went to a walk-in clinic, CARE-ONE, because his primary care physician was out of town. He was examined by a physician; x-rays were taken; he was issued a soft cervical collar; and he was prescribed a muscle relaxer and pain medication, both of which are "scheduled" drugs. The CARE-ONE physician also advised him to see a neurosurgeon for further evaluation and treatment. Despite his use of the prescribed drugs, J.B.'s pain intensified further over the weekend, to the point he was weeping and vomiting on occasion. He also had new pain in his left arm. At all times material, Respondent MRMC in Ocala, Florida, was licensed as a Class I general hospital with an emergency department. MRMC's emergency department handles upwards of 40,000 patient visits annually. At 8:15 a.m. on Monday, May 22, 1995, J.B.'s wife, L.B., took him to the MRMC emergency department. The term, "triage", generally refers to a means of sorting and prioritization of patients based on a superficial initial examination to determine how rapidly they will be seen in a mixture of patients who have differentiated complaints. Emergency department Board-certified physicians established MRMC's medical triage protocols in 1989. In so doing, MRMC has melded the concept of initial patient evaluation and "triage" into one process, and has authorized registered nurses, among other health care professionals, to perform both functions. MRMC's emergency department staff numbers 75 FTEs at all times, plus physician and physician assistant components. Physicians are available on the premises 24 hours a day for any consultation that may be required. At all times material, Geraldine Sweeney was an MRMC Clinical III Emergency Department Triage Nurse. As such, she maintains 24 hours of continuing education units per years (twice the number required to maintain her R.N. license). She also regularly participates in in-service training in emergency department nursing. These courses regularly include neurological topics and she has encountered and assessed numerous neurological cases over her 16 years in MRMC's emergency department, six of them as triage nurse since MRMC established its dedicated triage system in 1989. Ms. Sweeney has both an associate of arts and an associate of science degree in nursing; is a fully licensed Registered Nurse; and has never had any disciplinary action taken against her license. She was accepted as an expert in hospital emergency nursing. At formal hearing, J.B. did not remember being seen by any health care professional at MRMC on May 22, 1995. His wife, L.B., was attending to registration procedures with an MRMC admittance clerk in a different room and was not present when J.B. was assessed at MRMC's emergency department on that date, but she knew he was taken to a different room by a female hospital employee whom L.B. presumed to be a nurse. Geraldine Sweeney, R.N., did not recognize J.B. at formal hearing. She has "triaged" at least 1,000 patients since May 22, 1995. However, despite these three witnesses' lapses in memory or lack of opportunity to observe and/or lack of independent recollection, MRMC's documentation for May 22, 1995, in Ms. Sweeney's handwriting and bearing her signature, shows that Ms. Sweeney is the only MRMC health care professional who performed its initial, and only, assessment of J.B. at MRMC on May 22, 1995. Ms. Sweeney's contemporaneous documentation of her examination of J.B. shows he arrived at MRMC's emergency department at 8:15 a.m. and was "triaged" at 8:15 a.m. She wrote down that subjectively, he presented with a "history of neck problems with spasms; now has pain into left arm; seen at CARE-ONE Friday; had x-rays; given valium and lortab; advised for neurosurgeon." His objective vital signs were recorded by Ms. Sweeney as, "temperature 36.4 C., pulse 62, respiration 20, blood pressure 130/75." No weight was recorded. The only other significant objective triage data Ms. Sweeney recorded was, "Wearing soft collar; ambulates well; grips equal." Ms. Sweeney classified J.B. according to MRMC's physician-established protocols as "Class I, not requiring immediate attention," and he was released from the MRMC emergency department at 8:25 a.m., just ten minutes after his arrival. At that time, he was provided with a written list of other treatment locations to which he could go, including CARE-ONE again, and his personal physician. This list did not name any other hospital emergency department. Richard S. Slevinski, M.D., is Board-certified in emergency medicine and is director of the emergency department at Baptist Hospital in Pensacola, Florida, which includes a Level II Trauma Center. He was accepted as an expert in emergency and general medicine. Dr. Slevinski and Nurse Sweeney testified that a loss of function is a significant phenomenon that should have been recorded in a proper evaluation. Ms. Sweeney testified that if J.B. had identified loss of function as a symptom to her or if she had discovered a loss of function during her examination, she would have noted that and followed up with additional tests, but J.B. did not subjectively describe loss of function and she did not objectively observe any loss of function. Dr. Slevinski and Nurse Sweeney testified that a change in function or location of pain, increase in intensity of pain or recent onset of pain are subjective indicators that should be recorded if related by the patient during an examination and evaluation. Ms. Sweeney testified that she would have recorded any of these subjective symptoms if J.B. had related them to her, but he did not. Nurse Sweeney also testified that none of the objective vital signs she recorded during her examination of J.B. on May 22, 1995 indicated severe or intense pain. This was corroborated by neurosurgeon Dr. Barry Kaplan. (See Finding of Fact 32) I accept Dr. Slevinski's expert opinion that as a medical physician, he has found that if a service was provided in an emergency department it should be documented, and that it is the duty of the emergency department professional who performs patient screenings, examinations and evaluations to inquire adequately of a patient to find out what is going on with him or her and to make a chart so that later someone else can read the chart and see what the examiner did, and I reasonably infer from this expert testimony that, absent some strong evidence to the contrary, if a service has not been documented, the service has not been performed. This analysis, however, does not support a finding that J.B. actually told Nurse Sweeney on May 22, 1995 that his overall pain or his left arm pain was newly onset, that his pain had intensified, or that his pain was more localized in his left arm. J.B. has described his pain as chronic or recurring over a long period of time in testimony and when he saw Dr. Kaplan, a neurosurgeon, on June 1, 1995 (see Findings of Fact 27, 29), and J.B. can remember nothing about what he told Nurse Sweeney on May 22, 1995. Therefore, this is a situation in which Nurse Sweeney's testimony about what J.B. did not tell her is unrefuted, rather than the classic situation, described by Dr. Slevinski, in which a patient testifies as to what symptoms he told a health care professional and the chart shows the health care professional failed to record what the patient said. However, upon the evidence as a whole, it is found that no full neurological evaluation of J.B. was done by anyone at MRMC; that Nurse Sweeney did not individually feel each of his fingers to ascertain if he had sensation and similar temperature in each; and that she did not administer any muscle resistance tests. Rather, she had J.B. perform a "grip test". This "grip test" is performed by having the patient lift and cross his arms and reach out to the examiner. It tests whether the patient is able to maneuver both his own hands forward and grab onto the examiner's fingers with equal pressure, thereby indicating lack of loss of arm function. The test permits skin to skin contact so that any loss of sensation in the patient's hands or any change or inequality of skin temperature in the patient's hands or digits can be noted by the examiner. Upon her education, training, and experience, Nurse Sweeney thereby determined that J.B.'s grips were equal and his skin was a normal temperature, indicating no loss of function, sensation, or failure in circulation. Dr. Slevinski testified that, if J.B. had presented his CARE-ONE x- rays to her, Ms. Sweeney should have had the CARE-ONE x-rays read by a qualified physician, preferably a neurologist. Ms. Sweeney denied that J.B. brought his x-rays with him to MRMC, stating that if he had done so, she would have recorded that on the assessment form and would have had them read by a qualified physician instead of just recording, "had x-rays," which she had meant to show that J.B. had had x-rays taken the Friday before at CARE-ONE. J.B.'s testimony is clear on this single point to the effect that he had his wife take him to get the CARE-ONE x-rays and had them with him at MRMC. Marion Community Hospital documented that J.B. had the CARE-ONE x-rays with him at that facility at 9:23 a.m. (See Findings of Fact 24-25) This is corroborative of J.B.'s testimony on this issue. I therefore find that Ms. Sweeney overlooked those available CARE- ONE x-rays as part of her evaluation of J.B. Dr. Slevinski opined that MRMC, through Nurse Sweeney, did not provide an adequate medical screening examination for J.B.'s presenting complaint on May 22, 1995 because he was not given an appropriately sophisticated neurologic assessment or examination of the involved extremity (left arm) by a physician, preferably a neurologist; because the CARE-ONE x-rays J.B. brought with him were not reviewed by a qualified person; and because his pain was not stabilized. Specifically, Dr. Slevinski faulted Ms. Sweeney's use of a "grips" examination instead of an examination of J.B.'s status of sensation, strength of fingers, or reflex capabilities. He opined that Ms. Sweeney's examination, as documented, was insufficient to rule out that J.B. had a condition that was going to cause him further damage. It was Dr. Slevinski's opinion that "triage", as generally understood by the community of health care professionals, without more, cannot constitute an adequate or appropriate medical screening, examination, and evaluation. In Dr. Slevinski's view, severe pain alone qualifies as an emergent or emergency condition until an adequate examination proves that it is not. However, Dr. Slevinski conceded that pain is highly subjective and is only an "emergency medical condition" if the absence of immediate medical attention could reasonably be expected to result in serious jeopardy to the patient's health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. Upon further questioning, Dr. Slevinski opined that in general, a medical screening examination or evaluation need not always be done by a physician; that it can be done by a nurse or even a psychological case worker in the appropriate circumstances; and that in some, but not necessarily all patient presentations, there is no reason a triage nurse, within the scope of her license, if authorized to do so by the hospital, cannot perform a medical screening examination simultaneously with triage, although that is not his preference and although that was not appropriate in this case or in all cases. Dr. Slevinski commented also that a failure to correctly diagnose and treat after an appropriate screening, examination, or assessment might subject a hospital or individual health care provider to civil liability but would not violate Chapter 395 F.S. After J.B., still in pain, had been returned from the examining room, that is, only after Nurse Sweeney had already finished her evaluation of him and determined that he did not have an emergency medical condition requiring further emergency treatment and care, and while J.B. was standing beside L.B. facing the administrative clerk in the registration area of the MRMC emergency department, L.B. handed her insurance card to the clerk. The clerk then told L.B. that J.B. could not be treated at MRMC because he did not have either a referral from his primary treating physician or a life-threatening condition. An argument ensued, and L.B. demanded to know where else she could get treatment for J.B. She then drove J.B. directly to Marion Community Hospital's emergency department upon the suggestion of MRMC's admissions clerk. J.B. was clocked-in at 9:23 a.m. at the emergency department of Marion Community Hospital a/k/a "Columbia" or "HCA", where he was kept for about five hours. He was examined by an in-house neurologist who performed a limited "hands on" physical examination and a neurological examination. His vital signs were taken. He was injected intramuscularly with 30 milligrams of toradol, a "scheduled" pain killer. He was observed and re-evaluated after several hours. Additional x-rays were taken and reviewed by a radiologist who also reviewed the CARE-ONE x-rays J.B. had brought with him. J.B.'s valium and lortab prescriptions were refilled. He was released from Marion's emergency department with instructions to call and schedule an MRI and also to see his own physician and a neurosurgeon. The only medical "treatment" J.B. received at Marion was for pain. The final result after Marion's extensive and expensive screening examination and evaluation was the same as had occurred at MRMC: that he was released because he had no emergency medical condition requiring further emergency medical treatment in that facility at that time. Barry Kaplan, M.D., is the Board-certified neurosurgeon who eventually performed successful surgery on J.B. Dr. Kaplan first saw J.B. in his office on July 1, 1995. The length of this visit is not clear on the record. J.B.'s general description to him was that of chronic pain. Apparently J.B. had gone back to work for part of the time between May 22, 1995 and seeing Dr. Kaplan on June 1, 1995. On June 1, 1995, Dr. Kaplan did a complete neurologic examination, which included testing J.B.'s muscle actions against resistance. He also felt all of J.B.'s fingers, individually, while asking about sensation in each. These tests revealed only mild weakness or dysfunction in the bicep muscle of J.B.'s left arm and only mild numbness or dysfunction in his left arm. Dr. Kaplan also reviewed an MRI taken of J.B. on May 31, 1995 which demonstrated a chronic arthritic condition of J.B.'s neck, with bone spurs pressing the nerves running to his left arm and spinal cord, which resulted in J.B.'s pain. In Dr. Kaplan's opinion as an expert in neurosurgery and general medicine, J.B.'s condition on June 1, 1995, could not have developed measurably within the time elapsed since his visit to the MRMC emergency department on May 22, 1995 or even within the last month, because on June 1, 1995, J.B. had no acute symptoms of sufficient severity that he then had immediate need of treatment, nor was there any reasonable expectation that lack of treatment could be expected to result in serious jeopardy to his health, serious impairment to his bodily functions or serious dysfunction to his bodily organs or parts. On June 1, 1995, Dr. Kaplan believed that J.B.'s condition could be left alone for another four to six months before any permanent injury would occur to his spinal cord, but due to J.B.'s intense and chronic pain and relative youth, he recommended elective surgical removal of certain discs. Dr. Kaplan did the recommended elective surgery at J.B.'s request on July 12, 1995 at MRMC. J.B. has been pain-free since recovery. Dr. Kaplan's opinion also was that none of the objective vital signs recorded by Nurse Sweeney on May 22, 1995 would be consistent with severe pain. Although he was aware that Nurse Sweeney did not record giving a numbness test, weakness test, or reviewing x-rays on May 22, 1995, Dr. Kaplan also opined that, "Unless somebody has quadriparesis or complete dysfunction of a part from a cervical disc problem, then it is not an emergent condition . . . . Unless they have severe weakness or numbness to go along with the pain, there's no indication for emergency intervention." Dr. Kaplan's opinion also was that no serious jeopardy could have been incurred by J.B. not receiving further emergency services and treatment beyond MRMC's initial assessment on May 22, 1995. No health care witness set a minimum time necessary to conduct an appropriate examination. All indicated that the time involved and appropriate tests varied from case to case.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the administrative complaint herein. RECOMMENDED this 17th day of December, 1996, at Tallahassee, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1996. COPIES FURNISHED: Thomas W. Caufman, Esquire Agency for Health Care Administration 7827 North Dale Mabry Highway No. 100 Tampa, Florida 33614 Thomas D. Watry, Esquire 1500 Marquis Two Tower 285 Peachtree Center Avenue Northeast Atlanta, Georgia 30303 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue The issues in this case are whether Petitioner committed the alleged violations and, if so, should her paramedic license be revoked.
Findings Of Fact At all times relevant to this proceeding, Petitioner was employed as a paramedic by the City of Gulfport and worked as a paramedic for the Gulfport Fire Department. In this capacity, Petitioner worked under the auspices of the medical director for Pinellas County Emergency Medical Services (Pinellas County EMS). Petitioner was a paramedic from 1997 until March 2003. Prior to that time, from 1991 until 1997, she worked as an emergency medical technician (EMT). On February 20, 2003, Petitioner, along with Lt. Brian Campbell and Firefighter/EMT Dennis Jackson, were called to respond to the scene of a shooting. Petitioner was the only paramedic on the scene and, therefore, the only person on the scene certified by the Office of the Medical Director (OMD) to provide advanced cardiac life-saving treatment. Petitioner received the call at 12:22 a.m., and arrived at the patient's side at 12:30 a.m. When Petitioner arrived at the patient's side, she observed a white male, approximately 20 years old, lying on his back in the street. His skin color was ashen, his mouth and eyes were wide open, and his pupils were fixed and dilated. Upon physical examination, Petitioner could not detect a pulse and observed two small holes in the patient's trunk. At that point, Petitioner did not know whether the two holes represented two separate entry wounds or one entry and one exit wound. Petitioner observed a trail of blood, at least a block long, leading to the patient, but there was not a lot of blood around the patient. Petitioner attached an electrocardiogram (ECG) monitor to the patient to monitor the electrical activity of his heart. When Petitioner first turned on the ECG monitor, she observed four ticks of electrical activity within a 14-second span. Petitioner testified that based on her observation and physical examination of the patient, she believed that the electrical activity exhibited on the ECG monitor was not pulseless electrical activity (PEA), but rather "artifact" caused by her manipulation of the patient. Petitioner further testified that, thereupon, she stopped touching the patient and observed that the ECG read-out went mostly flat, showing only occasional ticks. Petitioner testified that these occasional ticks, as observed on the ECG monitor, indicated to her that the patient was in asystole. Shortly thereafter, Petitioner declared the patient dead. After Petitioner declared the patient dead, she prepared a Patient Care Report (Report or Patient Care Report) while still on the scene. In the Report, Petitioner wrote that she found a white male laying on the ground with an apparent small entrance wound in his upper chest and a possible small exit wound near his back rib. She further noted that the patient's temperature was normal, that his eyes were fixed and dilated, that he was not breathing (apneic), and that he had no discernible pulse. Petitioner also noted in the Report that the patient was in asystole within one minute after the ECG pads were attached, but she failed to note the initial four ticks she observed, which may have represented PEA. In the Report, Petitioner noted that at 12:30 p.m., the patient was hooked up to the monitor; at 12:31 p.m., he was asystolic; and at 12:32, she confirmed the patient dead. Upon completing the Report at the fire station, Petitioner attached to the Report the last of several ECG strips she had intermittently printed while at the patient's side. The ECG printout that Petitioner attached to the Report depicted a classic "flat line" indicative of asystole or no electrical activity. Petitioner discarded each of the ECG strips that contained some indicia of electrical activity. A Patient Care Report is a legal document that Petitioner is required to complete by law. By signing the Report, Petitioner acknowledged that the information contained in the Report was true and accurate. Later, on the morning of February 20, 2003, when the employees' shifts at the fire station were changing, Petitioner and Toni Lanahan (Lanahan), a firefighter/paramedic coming on duty, talked about the shooting incident. That such conversation occurred is undisputed. However, there was conflicting testimony as to what Petitioner told Lanahan during that conversation. According to Lanahan, Petitioner told her that when she (Petitioner) arrived at the scene, the patient looked dead but she hooked him up to the ECG monitor, that he had a rhythm but she did not work him, and that she turned off the monitor. Petitioner testified that she did not tell Lanahan that the patient had a heart rhythm, but only that the patient "was dead" and that she did not work him.1 About two hours after her conversation with Petitioner, Lanahan retrieved stored ECG code summary data of the patient described above.2 When Lanahan reviewed the ECG code summary, she saw that the patient had a presenting ECG rhythm showing approximately 40 beats per minute of PEA with gradually slowing PEA for the entire seven minutes depicted in intervals on the ECG summary. Based on her review of the ECG record of the gunshot wound patient, Lanahan believed that in this situation, the OMD protocols mandated that immediate resuscitative treatment be administered. Lanahan then reported these concerns to her emergency medical services (EMS) Coordinator, Lt. Marenkovic, who in turn, reported the incident to Gulfport Fire Chief Brian Brooks. Chief Brooks notified the OMD of the possible violations of its protocols by Petitioner. The OMD initiated an investigation, which included reviewing the written statements of Petitioner, Lt. Campbell, and EMT Jackson; the ECG code summary for the incident; Petitioner's Report; and the transcripts of the sworn interviews of Petitioner, Lt. Campbell, and EMT Jackson taken by the Gulfport Fire Department. After reviewing the above-referenced documents, Dr. Laurie Romig (Dr. Romig), the medical director of the Pinellas County EMS, decided to revoke Petitioner's certification. This decision was based on Dr. Romig's determination of the following: (1) Petitioner violated numerous protocols in the Medical Operations Manual, both administrative and direct patient care protocols; and (2) Petitioner attempted to make the situation appear differently from what it turned out to be, and that, apparently, she did that on purpose. Specifically, Dr. Romig charged Petitioner with violating Pinellas County Emergency Medical Services Protocol 2.3, Sections 5 and 6, and Protocol 10.8 and the following Pinellas County Emergency Medical Services Rules and Regulations: Sections XIII-3-b, related to falsification or inappropriate alteration of emergency medical services records; XIII-3-e, related to theft or dishonesty in performance of duty; XIII-3-i, related to demonstrated ability, failure or refusal to adhere to established protocols and standards as established by the authority; and XIII-3-k, related to just cause, including unbecoming behavior or unprofessional conduct reflecting a poor system image. The Pinellas County emergency protocols are written requirements that paramedics must follow when administering emergency treatment to patients. The protocols are published in a document entitled Pinellas County Medical Operations Manual, which is approved by the medical director and distributed to all Pinellas County EMS paramedics. Petitioner received a copy of the most recent medical operations manual in January 2003. EMS Protocol 5.10 prescribes treatment for patients presenting with PEA. As defined in Protocol 5.10, PEA is "any semi-organized electrical activity that can be seen on a monitor screen although the patient lacks a palpable, radial, brachial, or carotid pulse." When PEA is present in a patient, Protocol 5.10 mandates that immediate life-saving treatment be implemented. The patient initially had electrical activity. Nonetheless, Petitioner did not follow Protocol 5.10. According to Petitioner's testimony, she believed that the patient was asystolic and, thus, the protocol related to PEA was inapplicable to the shooting victim. Petitioner's belief was not supported by the ECG report. Protocol 5.4 delineates the procedures to be followed in the treatment of asystole. In the book utilized for Pinellas County EMS paramedic training, "asystole" is defined as a cardiac arrest rhythm associated with no discernible electrical activity on the ECG ("flat line"). Significantly, Protocol 5.4 and Protocol 5.10, discussed in paragraph 21, require that resuscitative efforts be started immediately and that such resuscitative efforts and treatment be terminated by the paramedic only "after 10 minutes of continuous asystolic arrest with appropriate interventions." Even if Petitioner's assertion that the patient was asystolic is accepted, she failed to provide the required resuscitative efforts and/or treatments prescribed by Protocol 5.4. Petitioner did not prematurely terminate resuscitative efforts, she never implemented them. Protocol 5.15 prescribes the treatment and transport considerations for "patients with cardiac arrest secondary to trauma, regardless of presenting cardiac rhythm." The protocol provides that such patients should be transported to the closest hospital emergency facility. Contrary to the requirements in Protocol 5.15, the patient was not transported to a hospital emergency facility. Protocol 2.3 requires paramedics, when possible, to contact and consult with On-line Medical Control (OLMC) in any case in "which a deviation from protocol has been made intentional or otherwise." The OLMC is a system which allows paramedics to contact the OMD and consult with a medical doctor regarding a situation in the field. Petitioner clearly deviated from Protocols 5.4 and/or 5.10, by failing to initiate and implement the resuscitation procedures required by both protocols, and Protocol 5.15, by failing to have the patient transported to a hospital emergency facility, yet she never contacted the OLMC as mandated by Protocol 2.3. Petitioner acknowledged that she did not follow either Protocols 5.4 or 5.10, both of which required immediate resuscitative efforts. Petitioner testified that instead, she followed Protocol 10.8, which provides an exception to the protocols that require initiation of resuscitative efforts. Petitioner contends that Protocol 10.8 provided the basis for her withholding resuscitation from the patient. Protocol 10.8 requires that cardiopulmonary cerebral resuscitation (CPCR) be initiated "in all cases when the patient is found in cardiopulmonary arrest unless one of the exclusion or special situation criteria applies." The exclusion criteria provides that CPCR may be withheld if the patient has, "in conjunction with apnea, pulselessness and asystole on the ECG," an "obviously unsurvivable trauma." If CPCR is withheld, Protocol 10.8 requires that exclusion criteria be fully documented and described. Protocol 10.8 does not define "obviously unsurvivable trauma." However, according to Dr. Romig, the term connotes catastrophic injuries observable by an untrained eye. Dr. Romig, an expert in emergency medicine and traumatic cardiac arrest, testified that nothing about this patient, based on her review of the records and documents, indicated that the patient had suffered an "obviously unsurvivable trauma." Also, Lt. Campbell, an EMT certified for 12 years, who was at the scene, testified that although the patient "looked dead," he could not say that the patient suffered an "obviously unsurvivable trauma" because the patient showed only a small bullet wound to the chest and a "little bit" of blood on his (the patient's) clothing. The weight of the evidence showed that the patient had not suffered an obviously unsurvivable trauma. However, even accepting Petitioner's testimony that she believed that the patient had suffered an obviously unsurvivable trauma, she failed to comply with Protocol 10.8. If Petitioner, in fact, relied on Protocol 10.8 in deciding to not administer CPCR, she was required to document and describe the exclusionary criteria, which was the basis of her decision to withhold CPCR. Petitioner failed to provide any such documentation and, thus, violated Protocol 10.8. In addition to violating the above-noted protocols, Petitioner was dishonest in the performance of her duties as a paramedic and also falsified EMS records. The ECG summary showed that despite the patient's having electrical cardiac activity of at least 40 beats, Petitioner turned off the ECG machine and pronounced the patient dead. After pronouncing the patient dead, she then turned the ECG machine on again, and intermittently printed activity on four separate occasions until reaching a reading showing no electrical cardiac activity. By engaging in this conduct, Petitioner was dishonest in the performance of her duties. Paramedics are required to truthfully and accurately complete the Patient Care Records of patients for whom they provide emergency medical services. Here, the ECG summary showed PEA of over 40 beats per minute initially and diminished electrical activity for over eight minutes total, six minutes of which were after Petitioner had already pronounced the patient dead. Petitioner initially saw a rhythm of four beats or ticks in a 14-second period, which was a beat rate of 40 and showed on the ECG strip as 42. Although the initial reading of approximately 40 beats and PEA was clearly visible during the entire nearly eight minutes depicted on the six-second intervals shown on the ECG code summary, this was omitted from Petitioner's Report. Petitioner omitted from the patient's Record the ECG readings that showed electrical activity. Instead, Petitioner reported that at the time she declared the patient dead, he was in "asystole" when, in fact, the ECG summary showed PEA. Moreover, Petitioner documented the Report with an asystole ECG strip reflecting a "flat line" reading printed some six or seven minutes after the reported time of death.3 Petitioner admitted during her sworn statement and at this proceeding that she deliberately did not attach to the Report any part of the ECG strip that reflected the interim electrical activity. Petitioner testified that the ECG strips showing interim electrical activity could raise doubts about the propriety of the treatment she gave this patient in a future criminal trial or other investigation.4 The medical director is required by law to ensure that Pinellas County EMS personnel provide quality care and are not a danger to the safety of the county's citizens, residents, or visitors. Here, Petitioner violated the protocols related to the standard of care for patients and completion of reports and rules and regulations related to dishonesty in the performance of duties and to falsification of records. These infractions are a possible threat to public health and safety of residents of and visitors to Pinellas County. As such, they constitute just cause to conditionally revoke Petitioner's Pinellas County Paramedic Certificate. The conditional revocation allows Petitioner to reapply for a paramedic certificate in two years. Such recertification may include a one-year probationary period, with monitoring by the medical director to include a review of all trauma-run reports. Petitioner's Pinellas County Emergency Medical Technician Certification was not revoked and she retains that certification.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that Respondent enter a final order finding Petitioner guilty of the violations alleged in the Notice of Revocation dated March 28, 2003, and upholding revocation of Petitioner's Pinellas County Paramedic Certificate. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of October, 2003.
Findings Of Fact On or about December 13, 1984, Petitioner applied to Respondent for a CON for an ambulatory surgical center (ASC). Respondent assigned CON number 3677 to Petitioner's application. Petitioner seeks to construct a two operating room, free standing ASC at 1710 West Colonial Drive in Orlando, Orange County, Florida. The primary area to be served by this application is Orange County, and the facility as proposed is reasonably accessible to Orange County residents. Orange County is located within Respondent's District VII, which is also comprised of Osceola, Brevard and Seminole Counties. Stuart and Joseph Yachnowitz are owners of Y and S Management and are partners in the application here at issue. Y and S Management will provide medical management services at this facility, as it provides at nine other facilities throughout the country which performed approximately 17,500 outpatient surgical procedures in 1985, primarily gynecological. Two of the facilities managed by Y and S Management are licensed as ASCs under the laws of the states in which they are located. The chief operating officer of Y and S Management, Susan Hill, prepared the CON application which is here at issue. Financing for this project will be provided from the personal funds of Stuart and Joseph Yachnowitz. No funds will be borrowed for this purpose. They have sufficient liquid personal funds to fully finance the project cost of $473,000, as well as operating costs. Petitioner will lease 6,500 square feet on the first floor of a professional building to be constructed at 1710 West Colonial Drive in Orlando from West Colonial Properties, Ltd., at $12 per square foot. This property is owned by Stuart and Joseph Yachnowitz. An abortion clinic known as Orlando Women's Health Center, which they also own, is located next door at 1700 West Colonial Drive. The facility as proposed can reasonably be expected to meet licensure requirements for an ASC. Ambulatory surgical procedures to be performed at Petitioner's facility will include, but not be limited to abortions, tubal ligations, hernia repairs, diagnostic laproscopies, eye surgery for cataracts, hand surgery, plastic surgery, tonsillectomies, and dilatation and curettage. Equipment cost estimates for this project of $161,158 are realistic and complete. Staffing requirement estimates of 11.54 F.T.E., and salary requirements of approximately $182,000 annually are also realistic and complete. Petitioner estimates that for 1987 and 1988, 20% of all cases will be paid by Medicaid, 5% by Medicare, and 75% will be insurance and private pay, with 4% of this figure ultimately being bad debt or indigent care. With total cases estimated for 1987 and 1988 to be 1700 and 2100, respectively, total net revenues for 1987 and 1988 are estimated to be $732,000 and $903,000, respectively. Providing services to Medicaid patients in 20% of its cases would be beneficial to the community since this is a high level of service to patients who are typically underserved. Assuming that 20% of the cases handled at Petitioner's facility have multiple procedures, the projected charge rates for 1987 are $326 per case for Medicare and Medicaid, and $489 per case for private pay and insurance. These are reasonable and competitive charges. The projected charge rate for private pay and insurance is simply 150% of the Medicare and Medicaid rate, which in turn is based on the projected case mix considering the various levels of reimbursement. Petitioner will pay Y and S Management a fee of $50 per case for management services. The financial pro forma prepared for Petitioner demonstrates that using a conservative approach that somewhat overestimates expenses, Petitioner will reach the break-even point at 1400 cases, after allowing for management fees, depreciation and amortization. Using a less conservative, but more typical approach to estimating expenses, Petitioner will break-even at 1100 cases. Need in the service area exceeds the conservative break-even point and Petitioner estimates it will handle 1700 cases in its first year of operation and 2100 in its second. These are reasonable estimates. Respondent has not promulgated a rule setting forth a methodology for determining need for an ASC. However, Respondent has utilized an evolving non-rule policy in evaluating the need for such facilities. Reid Jaffe, Respondent's expert in health care planning, explained the methodology used in this case which resulted in his determining that in July, 1987, there will be a need for additional ambulatory surgical facilities in Orange County sufficient to recommend approval of Petitioner's CON application. Specifically, Jaffe's methodology is as follows: Acquire data from the local health council regarding the number of inpatient and outpatient procedures performed by existing providers, as reported for the current calendar year (1985) by hospitals in the appropriate service district (District VII). Acquire data from the Governor's Office of the population estimate for the appropriate service area (Orange County) for the current and planning horizon years. Using this data, calculate the current overall surgical and outpatient surgical use rates per 1000 population for hospitals in the service area. Using the projected population for the planning horizon year (1987) and the current use rates calculated in (c) above, calculate the projection of overall surgical procedures in the planning horizon year. Multiply projected overall surgeries by 40% to establish total number of out-patient surgeries to be performed in the planning horizon year. Subtract from (e) all outpatient surgical procedures to be performed in hospitals, other ASCs in the service area, as well as the financial break-evens of all CON approved free-standing outpatient surgery centers in the service area. After performing these calculations and subtractions, the number of outpatient surgical procedures remaining are compared to the break-even of the CON applicant at issue. If the remaining number is larger than the applicant's break even, a quantitative need is demonstrated. Applying Jaffe's methodology to this case and applying data he obtained from the Local Health Council of East Central Florida, as reported to it by hospitals in District VII for calendar year 1985, as well as population data for Orange County he obtained from the Governor's Office, it appears that a total of 83,054 surgical procedures were performed in District VII in 1985, with 21,084 of these being outpatient procedures performed in a hospital. Using a July, 1985, population estimate for Orange County of 556,384, the overall surgical use rate for Orange County is 83,054 divided by 556,384 over 1000, or 149.27 surgical procedures per 1000 population; the use rate for outpatient procedures performed in hospitals is 21,084 divided by 556,384 over 1000, or 37.89 outpatient procedures performed in hospitals per 1000 population. Multiplying the overall surgical use rate of 149.27 by 574,599 (projected Orange County population for July 1987) over 1000 and applying a factor of 40% yields a projection of 34,308 outpatient surgical procedures to be performed in 1987. The use rate of 37.89 for outpatient services performed in a hospital is then multiplied by 574,599 over 1000 to obtain 21,722 which is the projected number of outpatient procedures which will be performed in a hospital in 1987. By subtracting this number (21,722) from the projection of total outpatient surgical procedures to be performed in 1987 (34,308) you identify 12,536 procedures which could be performed in ASCs in 1987. The reported number of outpatient procedures being performed in existing ASCs and the break-evens of CON approved facilities are calculated to be 5,488 (Surgical Services 2,693; MediVision 903; AMI Single Day Surgery 1,832; Surgical Associates 60) which is then subtracted from 12,536 to leave a need of 7,048 outpatient procedures which could be performed in ASCs which are not now approved for this service area. Since Petitioner has a conservative break-even point of 1400 cases, and a more typical break-even point of 1100 cases, a quantitative need has been identified which far exceeds Petitioner's break-even point. Jaffe testified that in his experience this is the largest margin between break-even and available procedures he has seen in reviewing CON applications. A need analysis conducted by Howard E. Fagin, Ph.D., who was accepted as an expert in health care planning, facility planning and operations analysis, also confirms that there is a quantitative need for the ASC proposed by Petitioner. The methodology used by Dr. Fagin starts by calculating a target utilization for ambulatory surgical operating rooms. Assuming that a facility operates 250 days/year, 6 hours/day, it takes 1.25 hours/case and that there are 1.2 procedures/case with a utilization rate of 75%, a target utilization of 1,080 procedures/year for an ambulatory surgical room is thereby determined. In 1985 there were 10 approved hospital "dedicated" ambulatory surgical rooms in Orange County, and 9 approved rooms in free-standing ASCs (Surgical Services-5, AMI Single Day Surgery-2, MediVision-2) not counting the 2 rooms approved in CON 3313 for Surgical Associates which are used for no more than 60 cases per year. Multiplying these 19 rooms by the target utilization of 1,080 procedures/year results in a calculation of 20,520 total utilization in available dedicated and free-standing ASC rooms. Data from the Local Health Council of East Central Florida for 1985 indicates that 11,413 outpatient procedures were performed in hospital, non-dedicated, operating rooms. Therefore if we take Jaffe's projection of 34,308 outpatient surgical procedures to be performed in 1987, and subtract 20,520 (total utilization in available dedicated and free-standing ASC rooms) and also subtract 11,413 (outpatient procedures performed in hospital, non-dedicated, rooms), we arrive at a need of 2,375 procedures in 1987 and 3,770 procedures in 1989. Since Petitioner's break-even is conservatively 1400 cases, and again assuming 1.2 procedures per case, Petitioner's conservative break-even is 1680 procedures, which is within the need which will exist in 1987, and well within the need in 1989. The need methodology and opinion of Intervenor's expert, Dr. Deborah Kolb, is rejected because she incorrectly: (a) considered Orange and Seminole Counties as comprising a two county service area; (b) included all existing inpatient hospital based operating rooms, regardless of whether they are dedicated to outpatient surgery, in arriving at her conclusion that there is excess capacity; and (c) assumed all hospital operating rooms are available for outpatient surgery without modification. Ambulatory surgery is typically performed in three types of facilities: hospitals which utilize their operating rooms for both inpatient and outpatient surgery; hospitals which maintain separate "dedicated" outpatient operating rooms, sometimes even in separate facilities adjacent to the main hospital; and free-standing ASCs which are not associated with a hospital. There are definite disadvantages to serving outpatients in hospitals without "dedicated" outpatient operating rooms, including the "bumping" of outpatients in emergencies and increased costs to the patient for services. On the other hand there are advantages and disadvantages to the other two modes of delivering ambulatory surgical services. Hospital based "dedicated" rooms are obviously closer to a hospital in case an emergency develops, and some patients may prefer this proximity to additional equipment and emergency medical staff. On the other hand, costs at a free-standing ASC are generally lower, and some patients prefer to avoid a hospital atmosphere altogether. Surgical procedures performed at ASCs have grown from 10% of all procedures in the early 1970s to 40% currently, and are projected to grow to 50% in the near future. This growth is somewhat the result of a change in Medicaid/Medicare reimbursement policies which now pay 80% for procedures performed in a hospital and require a 20% co-payment by the patient, but which pay 100% for procedures performed in an ASC and require no patient co-payment. The decision to have outpatient surgery performed at one or the other of these types of facilities is primarily the result of patient preference. However, it is clear that the increasing utilization of ASCs is a market force that is driving the cost of hospital outpatient services down. Respondent issued its original notice of intent to deny Petitioner's application on or about May 17, 1985, and on June 14, 1985, Petitioner filed its Petition for Formal Hearing. Thereafter, Respondent reconsidered its position and on March 6, 1986, notified the parties that it intended to grant Petitioner's application. The reason for this reconsideration was that when the initial denial was made, Respondent's projections of procedures were premised on the use of a 30% outpatient surgical factor. Subsequently, the Respondent began using 40% in its projection of the total volume of surgical procedures which might be performed on an outpatient basis. Given the fact that the reason Petitioner was initially denied was due to insufficient procedures, and utilization of the new projection of outpatient volume indicated there would be sufficient volume to support the facility, Respondent determined to support Petitioner's application. The notice of change of position was prepared by Reid Jaffe, who based his testimony at hearing on the 40% factor, and was approved by Robert E. Maryanski, Administrator of Community Medical Facilities, and Marta V. Hardy, Deputy Assistant Secretary for Health Planning and Development. Since Respondent has not adopted a need methodology rule for ambulatory surgical centers, the increase in the factor used to calculate outpatient surgeries from overall surgeries performed was not accomplished through rule-making proceedings. In 1985 Respondent used a factor of 30%, but in early 1986 increased this to the 40% applied in this case.. Intervenor provides services similar to those which Petitioner will perform, and has four free-standing, "dedicated" operating rooms which are used for ambulatory surgery. It also has 17 operating rooms that are used for both in and out-patient surgery. The Intervenor opposes Petitioner's application. In 1985, Intervenor made a profit of $10.9 million on total revenues collected of $184 million; it had an actual total of $37.4 million in uncompensated care which includes partial or no payments, charity, bad debt, and contractual patients. For 1986, it projects an $18.9 million profit on collected revenues of $211 million, with projections of actual uncompensated care of approximately $52 million. In 1985, 2% of Intervenor's costs were for providing indigent care, and this totaled approximately $6 million. Petitioner projects net revenues of approximately $900,000, and it has not been established if this will have any impact on Intervenor's revenues. According to Billie June, Assistant Director of Operating Rooms at Florida Hospital who was accepted as an expert in surgical nursing, and the management and operation of surgical units from a nursing standpoint, Intervenor has had considerable difficulty attracting qualified nursing staff for its operating rooms, and has had to develop its own qualified staff through an internship program. However, Petitioner's facility will not contribute to this difficulty or result in higher salaries. Susan Hill testified based on her experience since 1973 of managing and hiring staff in the Orlando area of the type needed to operate an ASC, that she has had no difficulty obtaining the cooperation of physicians in the area and in attracting fully qualified staff. Based on Hill's experience with other ASCs managed by Y and S Management throughout the country as well as her experience in Orange County, it is found that the staffing needs of Petitioner's proposed facility can be met with nursing and medical staff available in the area. It is found as a matter of fact that there is a need in Orange County for the two operating room ASC proposed by Petitioner, that Petitioner has the ability and will provide quality care, the project is financially feasible, Petitioner will work with and help to meet the needs of health maintenance organizations and will promote cost effectiveness in Orange County. Petitioner's proposal is consistent with the goals, objectives and recommended actions in the 1985-87 Florida State Health Plan and the local health plan. The State Plan encourages the existence of ASCs and the removal of obstacles to the use of outpatient surgery; the local plan provides that applicants for an ASC must demonstrate a willingness to provide services to underserved patient groups and considers the provision of ambulatory surgery to the underserved population to be a desirable objective. In this case Petitioner intends to provide 20% of its cases to Medicaid patients, and another 4% to indigents.
Recommendation Based on the foregoing, it is recommended that the Department of Health and Rehabilitative Services issue a Final Order granting Petitioner's application for CON number 3677. DONE and ENTERED this 23rd day of October, 1986, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October, 1986. COPIES FURNISHED: William Page, Jr., Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301 Chris H. Bentley, Esquire Post Office Box 1739 Tallahassee, Florida 32302 Douglas Mannheimer, Esquire Post Office Drawer 11300 Tallahassee, Florida 32302 E. G. Boone, Esquire Jeffrey Boone, Esquire Gregory Roberts, Esquire Post Office Box 1596 Venice, Florida 34284. APPENDIX Rulings on Petitioner's Proposed Findings of Fact: 1. Adopted in Findings of Fact 1, 2. 2,3. Adopted in Finding of Fact 3. Adopted in Finding of Fact 6. Adopted in Finding of Fact 5. Adopted in Finding of Fact 7. Adopted in Finding of Fact 11. Adopted in Findings of Fact 11, 22. Adopted in Finding of Fact 9. Adopted in Finding of Fact 2. Adopted in Findings of Fact 2, 14. 12,13. Adopted in Finding of Fact 20. Adopted in Finding of Fact 7. Adopted in Finding of Fact 20. Adopted in Finding of Fact 8. Adopted in Findings of Fact 3, 8. Adopted in Findings of Fact 4, 7. Adopted in Finding of Fact 4. Adopted in Finding of Fact 2. Adopted in part in Finding of Fact 15 but otherwise rejected as cumulative and unnecessary. Adopted in Finding of Fact 19. 23-25. Rejected in Finding of Fact 18 and otherwise rejected as irrelevant and not based on competent substantial evidence. Rejected as cumulative and unnecessary. Rejected in Finding of Fact 18. Adopted in Findings of Fact 12-14. Adopted in Findings of Fact 12, 13. Adopted in Findings of Fact 13, 14. 31-35. Adopted in Finding of Fact 15. 36,37. Rejected as irrelevant and unnecessary. 38. Adopted in Finding of Fact 22. 39,40. Adopted in Finding of Fact 23. 41. Rejected as a Finding of Fact since this is a request for further ruling on Petitioner's Motion to Limine which was granted at hearing. Petitioner filed a Motion in Limine on June 11, 1986 to exclude depositions taken of John Hutchens on April 23, 1986 and June 5, 1986. This is the motion dealt with at the prehearing conference on June 23, 1986. The only deposition of John Hutchens offered by Intervenor and admitted was one taken on June 20, 1986 (I-2). Therefore, Petitioner's motion and the prior ruling is moot since the depositions to which the motion was directed were not offered at hearing. 42-45. Adopted in Finding of Fact 22. Rulings on Intervenor's Proposed Findings of Fact, as set forth beginning on page 3: 1. Adopted in Finding of Fact 12. 2-16. Rejected in Finding of Fact 15, and otherwise irrelevant and cumulative. 17,18. Rejected in Findings of Fact 12-14, 22. 19-26. Adopted in part in Finding of Fact 14, but otherwise rejected as contrary to competent substantial evidence. 27,28. Adopted in part in Findings of Fact 12, 13, but otherwise rejected as contrary to competent substantial evidence. 29. Rejected in Findings of Fact 12-15 and otherwise as argument rather than proposed findings of fact. 30-34. Adopted and rejected in part in Finding of Fact 16 and otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 19, but otherwise rejected as irrelevant. Adopted in Findings of Fact 13, 14. 37,38. Rejected as irrelevant. 39,40. Adopted in part in Finding of Fact 16. Adopted in part in Findings of Fact 2, 3 but otherwise rejected as contrary to competent substantial evidence. Adopted in part in Finding of Fact 6, but otherwise rejected as irrelevant. 43,44. Rejected in Finding of Fact 22. 45-47. Rejected in Finding of Fact 7. Adopted in Finding of Fact 7. Rejected in Finding of Fact 7. Rejected in Findings of Fact 3, 5, 7 and 22. Adopted in part in Finding of Fact 3. Rejected as contrary to competent substantial evidence. 53,54. Adopted and rejected in part in Finding of Fact 21. Adopted in part in Findings of Fact 11, 22 but otherwise rejected as irrelevant. Rejected as cumulative and unnecessary. 57-59. Rejected as simply a summation of testimony, irrelevant and contrary to competent substantial evidence. Adopted in part in Findings of Fact 13, 14 and 16 but otherwise rejected as contrary to competent substantial evidence. Rejected as irrelevant. 62,63. Rejected in Finding of Fact 21 and otherwise irrelevant and contrary to competent substantial evidence. Rejected in Findings of Fact 4, 7. Adopted and rejected in part in Finding of Fact 8. Rejected in Findings of Fact 11, 22. Rejected in Finding of Fact 22 and otherwise irrelevant and contrary to competent substantial evidence. Adopted in part in Finding of Fact 20, but otherwise rejected as irrelevant. Rejected as irrelevant. Adopted in Finding of Fact 16; rejected in Finding of Fact 21 and otherwise rejected as contrary to competent substantial evidence. Rejected in Findings of Fact 4, 5 and otherwise rejected as irrelevant. 72-75. Adopted in part in Findings of Fact 19-21, but otherwise rejected in Findings of Fact 21, 22 and as irrelevant. 76-79. Rejected as irrelevant, cumulative argument which does not provide citations to the record contrary to Rule 221-6.31(3), Florida Administrative Code.
