The Issue The issue in this case is whether Respondent, Arnaldo Carmouze, P.A., committed violations of Chapter 458, Florida Statutes (2001), alleged in an Administrative Complaint filed with Petitioner on February 25, 2004, in DOH Case Number 2002- 16502, as amended; and, if so, what disciplinary action should be taken against his license to practice as a physician assistant in Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians and physician’s assistants licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Arnaldo Carmouze, P.A., is, and was at the times material to this matter, a physician's assistant licensed to practice in Florida, having been issued license number PA 9100713. Mr. Carmouze's address of record at all times relevant to this matter is 6545 Southwest 95th Avenue, Miami, Florida 33173. No evidence that Mr. Carmouze has previously been the subject of a license disciplinary proceeding was offered. Mr. Carmouze's Supervising Physician. At the times relevant Mr. Carmouze worked under the supervision of Dr. Manuel Fernandez-Gonzalez, a physician licensed to practice medicine in Florida. Dr. Fernandez-Gonzalez, who has practiced emergency medicine, holds Florida medical license number ME 17907. Dr. Fernandez-Gonzalez currently practices family medicine at 9600 Southwest 8th Street, Miami, Florida. Prior to April 2002, Dr. Fernandez-Gonzalez and Mr. Carmouze worked together in Miami, providing emergency room care and seeing patients at a nursing home. The emergency room services were provided pursuant to employment contracts that both had entered into with a company providing emergency room services at the hospital in south Florida where Dr. Fernandez- Gonzalez and Mr. Carmouze provided services. Mr. Carmouze's Assignment to Weems Memorial Hospital. The company for which Mr. Carmouze was employed also provided emergency room services for Weems Memorial Hospital (hereinafter referred to as "Weems"). Weems is located in Apalachicola, Florida, located in the Florida Panhandle, approximately 520 miles from Miami. Weems is a rural hospital, licensed under Chapter 395, Florida Statutes. It does not have 24-hour, on-site ancillary services such as X-ray, laboratory, and respiratory therapy. These services are available to the emergency room on an on-call basis after business hours. At the times relevant, Malvinder Ajit, M.D., a Florida licensed physician, was the Director of the Emergency Department at Weems. Dr. Ajit has not provided any documentation to the Department indicating that he has ever acted as supervising physician of record for Mr. Carmouze. Mr. Carmouze was assigned by the company by which he was employed to work in the emergency room at Weems in April 2002 and again in June 2002. He worked in the emergency room at Weems as a physician's assistant for part of April 2002, and part of June 2002. While at Weems, Mr. Carmouze provided emergency room medical services to more than 100 patients. While working at Weems, Dr. Fernandez-Gonzalez, who remained in Miami, continued to act as Mr. Carmouze's supervising physician. Mr. Carmouze did not notify the Department that he was practicing as a physician's assistant at Weems in April or June 2002. The evidence, however, failed to prove that Mr. Carmouze was working for, and thus "employed," by anyone different from the employer that he worked for in Miami. The only evidence on this issue proved that Mr. Carmouze continued throughout the relevant period to work for Dr. Fernandez-Gonzalez and the company that provided emergency room services at Weems. Dr. Carmouze's Treatment of Patient A.M. On June 7, 2002, Patient A.M., an 84-year-old female, was brought to the emergency room (hereinafter referred to as the "ER"), at Weems by ambulance. She arrived at approximately 23:24 hours (11:24 p.m.). A.M.'s medical history included congestive heart failure, coronary artery disease, and atrial fibrillation. She presented to Mr. Carmouze in apparent respiratory distress (respiratory rate of 36 to 40), had no measurable blood pressure, and a pulse rate of 100 to 108. While being transported to the ER from her home, A.M. was given oxygen by rebreather mask. During her transport, her oxygen saturation level improved from 68% to 91%. Mr. Carmouze assessed A.M.'s condition, obtained her medical history, ordered lab work and other tests, and ordered and initiated nebulizer treatments for her. She was alert, oriented and had a Glasgow score of 15/15, indicating she was responding to verbal and pain stimuli. Mr. Carmouze ordered nebulizer treatments with albuterol and atrovent to assist her breathing. Additionally, A.M. received 100% oxygen through a nonrebreather mask. Mr. Carmouze also determined that A.M. was "dry," meaning that her fluid volume was depleted and, therefore, she was dehydrated. As a result, her blood pressure was low. In an effort to treat this condition, Mr. Carmouze ordered an I.V. with 0.9 normal saline. He also ordered a Dopamine drip to increase A.M.'s heart rate in an effort to increase her blood pressure. Mr. Carmouze appropriately denied a request from a nurse to administer Lasix to A.M., because A.M. was "dry." Lasix is a diuretic used to decrease fluid volume. It opens the arteries and reduces fluids, thereby lowering blood pressure. Lasix was contraindicated for A.M. and contrary to the appropriate efforts initiated by Mr. Carmouze to treat A.M.'s low blood pressure. Despite Mr. Carmouze's treatment of A.M., her condition continued to deteriorate. At or near 23:50 hours (11:50 p.m.), approximately 25 minutes after A.M. had arrived at the ER, an ER nurse contacted A.M.'s primary physician by telephone and obtained an order to administer Lasix to A.M. The Lasix was administered immediately. A.M.'s oxygen saturation level was 81%, down 10 points since her arrival, when the Lasix was administered. Within half an hour, at 0:18 hours (18 minutes after midnight) on June 8, 2002, A.M.'s oxygen saturation level had dropped another 10 points, to 71%. A.M. then "crashed and coded." Mr. Carmouze initiated appropriate emergency measures when A.M. coded, including initiating Cardio Pulmonary Recitation and endotracheal intubation. A.M. was given epinephrine, atropine, and a CVP line was placed. These actions by Mr. Carmouze were appropriate. Mr. Carmouze did not attempt or order that A.M. be intubated prior to 0:18 hours when she coded. A.M.'s primary physician, Dr. Sanaullah, arrived at the ER. Shortly after she coded, Dr. Sanaullah continued the same efforts initiated by Mr. Carmouze. A.M., however, did not recover, expiring at 01:00. The "Standard of Care" for Treating A.M. Four expert witnesses testified in this matter, rendering opinions as to whether Mr. Carmouze's treatment of A.M. was consistent with "that level of care, skill, and treatment which is recognized by a reasonably prudent similar [physician assistant] as being acceptable under similar conditions and circumstances. . . " (hereinafter referred to as the "Standard of Care"). The expert witnesses who testified were Dr. Fernandez-Gonzalez, Dr. Julio Lora, Dr. Harry W. Lee, and James L. Cary, P.A. Dr. Fernandez-Gonzalez's testimony as to whether Mr. Carmouze treated A.M. within the Standard of Care is rejected for lack of credibility. Dr. Fernandez-Gonzalez's testimony has been found to lack credibility for the reasons explained by Petitioner in paragraph 25 of Petitioner's Proposed Recommended Order. That paragraph, except for the last two sentences, is hereby adopted. Additionally, Dr. Fernandez- Gonzalez's testimony is rejected because, in the undersigned's judgment, he made too much of an effort to give the answers that he appeared to conclude that Mr. Carmouze wanted him to give. The testimony of Dr. Lora on the other hand is found to be credible. Dr. Lora, testifying as an expert in cardiology and internal medicine, offered convincing explanations as to why Mr. Carmouze did not violate the Standard of Care in his overall treatment of A.M. and, in particular, in not attempting to intubate A.M. earlier than he did. Dr. Lee's testimony, while corroborating Dr. Lora's testimony, was cumulative and of little weight. A.M. was reported to be awake, alert, and oriented. She was breathing, albeit with difficulty, on her own. Therefore, it was appropriate for Mr. Carmouze to attempt the other measures to assist her breathing he instituted. Mr. Cary's testimony, while credible, was not convincing, especially given Dr. Lora's expert opinions. Mr. Cary's testimony was taken during a discovery deposition by Respondent and, as a result, the benefit of his testimony to Petitioner's case was limited. The evidence failed to prove that Mr. Carmouze violated the standard of care: In his treatment of A.M.; By failing "to contact his supervising physician, the ED director, and/or Patient A.M.'s primary physician for assistance in treating Patient A.M."; By failing "to identify a treatment plan for Patient A.M."; and By failing "to consult his supervising physician prior to ordering Demerol, a controlled substance, for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M." Mr. Carmouze's Treatment Plan and Medical Records for Patient A.M. Mr. Carmouze, as the Department has conceded in Petitioner's Proposed Recommended Order, paragraph 13, page 20, did identify a treatment plan for Patient A.M. Having found that Mr. Carmouze did not err when he did not initiate intubation of A.M. earlier than he did, the evidence failed to prove that "he failed to maintain medical records that justified the course of treatment in that he failed to record a reason for not intubating sooner in an attempt to address Patient A.M.'s respiratory distress." There is no indication in Mr. Carmouze's medical records for A.M. that Mr. Carmouze attempted to contact Dr. Ajit or Dr. Fernandez-Gonzalez. The medical records do indicate, however, that A.M.'s primary physician, Dr. Sanaullah, was "notified and arrived for code." While the evidence did not prove who notified Dr. Sanaullah, Petitioner failed to prove that Mr. Carmouze was not responsible for Dr. Sanaullah's notification. Mr. Carmouze failed to identify himself by name or professional title in A.M.'s medical records. He also failed to include Dr. Fernandez-Gonzalez's name and title in A.M.'s medical records. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on A.M.'s medical records. While the quality of Mr. Carmouze's medical records for A.M. was correctly characterized as "minimally acceptable" by Mr. Cary, the evidence failed to prove clearly and convincingly that those medical records were not adequate. This finding is based upon the lack of an unequivocal opinion from Mr. Cary concerning the adequacy of the medical records and a comparison of Mr. Cary's opinions with those of Dr. Lee in support of Mr. Carmouze's medical records for Patient A.M. Mr. Cary, on the one hand, made the following negative comments about Mr. Carmouze's medical records for A.M: "[T]he record isn't really clear on what did happen because he did not write down any times on intervention of what he did." Petitioner's Exhibit numbered 1, page 14; "[W]hen you look at this face sheet here you don't get a picture of what happened and at what time, there's no real times there, no progression of the treatment." Petitioner's Exhibit numbered 1, page 67. Mr. Cary stated that there was no time noted in Patient A.M.'s history/physical section, and that a portion of that section was illegible. Petitioner's Exhibit numbered 1, page 21 and 25. On the other hand, Mr. Cary stated that "[the medical record for A.M.] is minimally acceptable, it just doesn't give a good clear picture of the sequence of events." Petitioner's Exhibit numbered 1, page 68. Mr. Cary also stated the following when asked if he thought Mr. Carmouze maintained medical records that justified the course of his treatment regarding Patient A.M.: "There were medical records that were there, I think they could have been more complete and more detailed . . . ." These statements, taking into account the fact that Mr. Cary was able to read almost all of Mr. Carmouze's medical record pertaining to A.M. on direct examination by counsel for Mr. Carmouze, reduces the effectiveness of his other opinions. Finally, it is noted that all of Mr. Carmouze's experts, along with Mr. Cary, were able to read Mr. Carmouze's notes, other than a word or two. Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Patient C.M. On April 23, 2002, Patient C.M., a 20-year-old male presented to Mr. Carmouze at Weems' ER. C.M. complained of a server headache. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient J.S. On April 24, 2002, Patient J.S., a 37-year-old female presented to Mr. Carmouze at Weems' ER. J.S. complained of a burn. In pertinent part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril. Patient B.M. On April 24, 2002, Patient B.M., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. B.M. complained of a headache of two-days' duration. In pertinent part, Mr. Carmouze ordered 25 milligrams of Demerol administered to B.M. at the ER. Mr. Carmouze noted in the medical record for B.M. a diagnosis of scabies/headache cluster, severe. This is the only diagnosis made at Weems' ER for B.M. Patient R.M. On April 24, 2002, Patient R.M., a 73-year-old male, presented to Mr. Carmouze at Weems' ER. R.M. complained of abdominal pain and constipation of several days’ duration. In patient part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to R.M. at the ER. Mr. Carmouze noted in the medical record for R.M. a diagnosis of abdominal pain, impaction. This is the only diagnosis made at Weems' ER for R.M. Patient M.F. On April 25, 2002, Patient M.F., a 34-year-old female, presented to Mr. Carmouze at Weems' ER. M.F. complained of left-flank pain. In relevant part, Mr. Carmouze ordered 50 milligrams of Demerol and 50 milligrams of Vistaril administered to M.F. at the ER. Mr. Carmouze noted in the medical record for M.F. a diagnosis of left-flank pain, left nephrolithiasis. Patient G.C. On June 7, 2002, Patient G.C., a 20-year-old male, presented to Mr. Carmouze at Weems' ER. G.C. complained of right-flank pain. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Patient G.B. On June 7, 2002, Patient G.B., an 83-year-old female, presented to Mr. Carmouze at Weems' ER. G.B. complained of wrist, knee, and leg pain, secondary to a fall. In relevant part, Mr. Carmouze ordered two separate doses of Demerol, 50 milligrams each, and Vistaril, 50 milligrams each. Mr. Carmouze noted in the medical record for G.B. a diagnosis of chest contusion, leg edema, and right Colles' fracture. This is the only diagnosis made at Weems' ER for G.B. Patient K.S. On June 8, 2002, Patient K.S., an 18-year-old female, presented to Mr. Carmouze at Weems' ER. K.S. complained of lower back pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.S. a diagnosis of intractable back pain, trauma to spine. This is the only diagnosis made at Weems' ER for K.S. Patient C.W. On June 8, 2002, Patient C.W., a 46-year-old female, presented to Mr. Carmouze at Weems' ER. C.W. complained of headache and dizziness. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for C.W. a diagnosis of headache and anemia. This is the only diagnosis made at Weems' ER for C.W. Patient M.A.C. On June 9, 2002, Patient M.A.C., a 49-year-old female, presented to Mr. Carmouze at Weems' ER. M.A.C. complained of pain in the lower right abdomen and back. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for M.A.C. a diagnosis of diabetes mellitus and abdominal pain. This is the only diagnosis made at Weems' ER for M.A.C. Patient R.S. On June 9, 2002, Patient R.S., a 34-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of shoulder pain. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for R.S. a diagnosis of right shoulder tendon tear. This is the only diagnosis made at Weems' ER for R.S. Patient K.M. On June 11, 2002, Patient K.M., a 52-year-old male, presented to Mr. Carmouze at Weems' ER. R.S. complained of wrist pain secondary to a fall. In relevant part, Mr. Carmouze ordered Demerol, 50 milligrams, and Vistaril, 50 milligrams. Mr. Carmouze noted in the medical record for K.M. a diagnosis of a Colles' fracture. This is the only diagnosis made at Weems' ER for K.S. Facts Common to Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. Mr. Carmouze did not note in his medical records for Patients C.M., J.S., B.M., R.M., M.F., G.C., G.B., K.S., C.W., M.A.C., R.S., and K.M. (hereinafter referred to jointly as the "Pain Patients "), that he had consulted with Dr. Fernandez- Gonzalez or Dr. Ajit prior to ordering Demerol for the Pain Patients. Demerol is a controlled substance. Dr. Fernandez-Gonzalez' testimony regarding alleged consultations he had with Mr. Carmouze concerning the Pain Patients and other patients seen by Mr. Carmouze while at Weems is rejected as lacking credibility for the reasons explained, supra. Mr. Carmouze also failed to note in the medical records for the Pain Patients his name and professional title. His name was stamped on the Emergency Room Record he completed for Patients M.A.C., G.M., and R.S. His name was also written into the space under "Time/Initials" on the Emergency Room Record for Patients M.A.C., C.W., R.M., and J.S. None of these records, however, included his title of "physician assistant." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the Pain Patients. Mr. Carmouze failed to ensure that the signature of Dr. Fernandez-Gonzalez or Dr. Ajit was included in the medical records of the Pain Patients. The Other "106 Patients". While at Weems ER, Mr. Carmouze provided medical services, in addition to A.M. and Pain Patients, to 106 other patients at issue in this case (hereinafter referred to as the "106 Patients"). Petitioner's Exhibit numbered 4 is a composite exhibit of medical records for the 106 Patients. There are approximately two patients for whom more than one medical record has been included in Petitioner's Exhibit numbered 4. The foregoing findings relate to the 108 medical records for the 106 Patients. Mr. Carmouze failed to note in most of the medical records for the 106 Patients his name and professional title. Of the approximately 108 records, Mr. Carmouze's name does not appear in any fashion on 48 of them. The rest either include his name (but not title) either stamped on the record or written into the box titled "Time/Initials." On two of the medical records both Mr. Carmouze's name and "P.A." have been written into the box titled "Time/Initials." Mr. Carmouze failed to identify Dr. Fernandez-Gonzalez or Dr. Ajit by name and professional title in the medical records of the 106 Patients. Mr. Carmouze did not ensure that either the signature of his supervising physician or Dr. Ajit was included on the medical records of the 106 Patients.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that, Arnaldo Carmouze, P.A., has violated Subsections 458.331(1)(m) and (v), Florida Statutes, as described in this Recommended Order; issuing a reprimand; placing Mr. Carmouze's license on probation for one year; requiring that he pay an administrative fine of $5,000.00; requiring that he perform five hours of CME in a subject(s) determined appropriate by the Board; and suspending his license for six months (with the suspension stayed provided he complies with probation). DONE AND ENTERED this 13th day of December, 2006, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 13th day of December, 2006. COPIES FURNISHED: Irving Levine Matthew Casey Assistants General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Julie Gallagher, Esquire Greenberg Taurig, P.A. 101 East College Avenue Tallahassee, Florida 32301 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Dr. M. Rony François, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
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's medical license should be disciplined for alleged violations of Chapter 458, Florida Statutes.
Findings Of Fact Respondent is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued license number ME 0027368. Respondent is board certified in family practice; however, he is not board certified in emergency medicine. On May 30, 1994, Dr. Dulay was on call in the hospital emergency room at Madison County Memorial Hospital (MCMH) in Madison, Florida. On May 30, 1994, Patient T.H. an obese, forty-eight year-old male was found unconscious on the floor of the bathroom by his brother, Wallace. T.H. had an arteriovenous malformation (AVM) in his brain. An AVM is a weakened area of a blood vessel which can fill with blood, expand and/or burst. AVMs located in the brain are very dangerous since a ruptured AVM can damage the brains tissue. The amount of damage depends on the amount and rapidity of the bleeding. Under any circumstances, a ruptured AVM is an emergency medical condition where time is of the essence in diagnosing and treating usually with some neurosurgical intervention. On May 30, 1994, at approximately 4:56 a.m., Carol Wells a Madison County 911 Operator received an emergency call regarding T.H. The call was originally received as a fall. An Advanced Life Support (ALS) ambulance was dispatched to T.H.'s location in Cherry Lake Garden Trailer Park. An ALS unit is intended to be a mobile critical care unit, able to render critical care and stabilization to a patient enroute to an appropriate hospital. An Advanced Life Support unit contains equipment needed for insertion of a chest tube, a lab, and an x-ray, as well as equipment and medications for cardiac emergencies. The equipment and medications needed for T.H.'s case were present. The ALS unit arrived at T.H.'s location at 5:19 a.m. Jimmy Kent was an EMT and driver of the ALS unit that responded to the 911 emergency call on T.H. Richard Kline was the paramedic on the ambulance. Mr. Kline was trained in ALS care and could administer certain drugs, including Procardia without a physician's order. Paramedic Kline found patient T.H. on the floor of the trailer. He observed T.H. to be comatose, unresponsive to painful stimuli, and exhibiting snoring-type respirations. His skin was hot and dry, and his face was red. T.H. scored a three on the Glasgow Coma Scale, the lowest possible score. T.H.'s vital signs were blood pressure estimated at 300 plus over 150, respiratory rate of 40, heart rate "tacking" at approximately 170, with raspy breathing. T.H. was considered in critical condition. At the scene, Paramedic Kline was having problems with his cardiac monitor, which became non-functional due to battery problems. However, patient T.H. could still be adequately monitored manually. Additionally, within twenty-five minutes of beginning the run, the cardiac monitor on the ALS unit was non- functional due to failure of the primary and back-up batteries. The lack of the units equipment did not significantly impact the paramedic's ability to monitor or treat T.H.'s condition. Paramedic Kline was informed by T.H.'s family that he had a history of Arterial Venous Malformation, paralysis on the right side, and strokes. T.H.'s sister was called and she advised that T.H. not be brought to Madison County Memorial Hospital (MCMH) because they usually don't have a doctor available. She wanted T.H. to go to South Georgia Medical Center (SGMC) in Valdosta, Georgia. The paramedic thought that they needed to take T.H. to MCMH because of the serious vital statistics that T.H. had. The paramedic felt T.H. could go into cardiac arrest. After being advised by the paramedic that T.H. needed immediate assistance at MCMH, T.H.'s sister agreed to have T.H. taken to MCMH. There are two hospital emergency facilities to choose from when transporting an emergency case in the Madison, Florida, area, MCMH and SGMC. In driving terms MCMH is slightly, but not significantly, closer to Cherry Lake Garden Trailer Park than SGMC. However, the facilities are very different in the services each can offer in an emergency situation. MCMH is not a trauma center. MCMH does not have any neurosurgical facilities, neurosurgical consults, diagnostic MRI's, diagnostic CT scans, or cerebral monitoring equipment available. MCMH cannot treat a cerebral vascular accident or bleeding in the brain. On the other hand, SGMC is a tertiary care facility. It has neurosurgical facilities, neurosurgical consults, diagnostic CT scans, and cerebral monitoring equipment available. SGMC can treat a cerebral vascular accident and is the closest facility which can provide such care. The ambulance was en route to MCMH when it contacted the hospital by radio; Joanie Cruce, R.N., spoke to the ambulance driver over the radio. Paramedic Kline informed Nurse Cruce of T.H.'s history, including the presence of T.H.'s AVM and vital signs. He also informed Nurse Cruce that he was bringing the T.H. to MCMH. Nurse Cruce relayed T.H.'s information to Joe Jaime, R.N. Nurse Jaimie was on the telephone to Dr. Dulay who was in another room at the hospital. Nurse Jaimie relayed over the telephone to Dr. Dulay the information Nurse Cruce gave her. At no time did Dr. Dulay speak directly with the paramedic. Dr. Dulay was informed that the patient had high blood pressure, was unconscious, and had a history that included an arterial venous malformation. Due to the patient being unconscious, he suspected a cerebral vascular accident/stroke (CVA). At approximately 5:40 a.m., while en route to MCMH, the paramedic asked for advice on whether to administer Procardia. Procardia is used to reduce blood pressure. Respondent advised that it was appropriate to administer 10mg of Procardia. There was some uncertainty in the testimony as to whether the administration of Procardia was requested by the paramedic and approved by Dr. Dulay, or ordered by Dr. Dulay. Either person could have authorized the use of the drug. In any event, 10mg of Procardia was the appropriate medication for the patient's condition and met or exceeded the appropriate standard of care for an emergency room physician under the circumstances. At some point, Dr. Dulay advised the ambulance to have T.H. taken to the nearest appropriate facility. The ALS unit was one to two miles from MCMH when Joanie Cruce, R.N., advised the ambulance driver to take T.H. to the nearest appropriate facility. Either Nurse Cruce misspoke and said Tallahassee or Richard Kline misunderstood her to say Tallahassee. Richard Kline questioned the direction to take T.H. to Tallahassee. He told nurse Cruce that the family wanted T.H. to go to the hospital in Valdosta. The information was passed to Dr. Dulay. He agreed that SGMC was an appropriate facility for T.H. and in fact SGMC was the closest appropriate facility for T.H.'s condition. Dr. Dulay never informed the nursing staff that T.H. could not be brought to MCMH and indeed the nurses thought that the ambulance was on its way even after the conversation about Valdosta. Patient T.H. was not in respiratory or cardiac arrest at the time the ambulance was turned around to go to Valdosta. After the change of direction, which is always within the discretion of the ambulance crew, there was no further contact with MCMH. Therefore Dr. Dulay was never informed of the results of the Procardia. Additionally, T.H. was never admitted to MCMH and never became a patient of Dr. Dulay or the hospital. Therefore, since T.H. was not a patient of the hospital no transfer from one facility to another facility occurred. While en route to SGMC, the ambulance contacted SGMC's emergency room. The staff advised the paramedic to give T.H. sodium nitroprusside. However, the ambulance did not carry sodium nitroprusside. Instead the paramedic was advised by SGMC staff to administer Lasix IV and nitroglycerine. Patient T.H. suffered respiratory arrest just outside the city limits of Valdosta. Efforts to intubate and revive him were unsuccessful. Patient T.H. arrived at SGMC in full arrest. The ambulance arrived at SGMC at 6:25 a.m. Attempts to revive the patient at the hospital were unsuccessful. T.H. was pronounced deceased shortly after his arrival at SGMC. T.H.'s cause of death was cardiopulmonary arrest with an underlying cause of intracranial hemorrhage, probably due to an aneurysm. In short, all of T.H.'s symptoms were caused by a rapidly expanding and bleeding cerebral vascular incident from his AVM. T.H.'s condition was not due to a cardiac problem. The medical condition of T.H. at the time he was transported by Madison County ALS was indicative of an intracranial hemorrhage. Such a condition could only be evaluated for surgical treatment through the utilization of an MRI and CT scan, and required the immediate consultation of a neurosurgeon. None of which were available at MCMH. Moreover, it would generally be preferable to transport a patient with a score of three on the Glasgow Coma Scale to a trauma center. SGMC was the closet facility to Cherry Lake at which a neurosurgical consult was available, and which had the capability of treating an intracranial hemorrahage; therefore, patient T.H. was appropriately diverted to that facility. Dr. Dulay did not open a chart on T.H., and could not recall whether he made written notes during T.H.'s emergency. However, it is not customary practice that a medical chart be opened for an emergency case when consults are made via radio and the person is diverted or otherwise delivered to a separate facility. Generally, neither the hospital nor the doctor know the name of the person being transported. If the person does not arrive at the hospital, that facility has no information on which to open a patient record. Under such circumstances, the person's history, vital signs, and medication administration are recorded in the ALS run sheet, which accompanies the person to his or her ultimate destination. The radio communications are recorded by audiotape. In this case, the history, vital signs, and medication administration to T.H. were in fact recorded in the ALS run sheet. The run sheet appropriately accompanied T.H. to SGMC. The radio communications were recorded by audiotape. These documents are adequate records in emergency situations. Given these facts, there was no deviation by Dr. Aldolfo Dulay from the applicable standard of care for a physician under the circumstances presented in this case or that there was a failure to keep adequate written medical records justifying the course of treatment of the patient.
Recommendation Based upon the findings of fact and conclusions of law, it is, RECOMMENDED: That the Board of Medicine enter a final order finding that Adolofo Dulay, M.D. did not practice below the accepted standard of care in his handling of the diversion of patient T.H. to a tertiary care facility, that there was no transfer of patient T.H. and that the records maintained were appropriate under the circumstances and that the Administrative Complaint be dismissed. DONE AND ENTERED this 2nd day of June, 1998, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 2nd day of June, 1998. COPIES FURNISHED: John Terrell, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Richard B. Collins, Esquire Ryan Garrett, Esquire Collins and Truett, P.A. 2804 Remington Green Circle, Suite 4 Tallahassee, Florida 32308 Angela T. Hall, Agency Clerk Department of Health Building 6, Room 136 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Pete Peterson, Esquire Department of Health Building 6, Room 102-E 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health Building 6, Room 306 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Dr. Marm Harris, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether proposed rules 59B-15.001 through 59B-15.007 are an invalid exercise of delegated legislative authority.
Findings Of Fact The State Center for Health Statistics (State Center) within the Agency collects and disseminates data from hospitals and ambulatory surgery centers. One of the responsibilities of the State Center is to produce comparable and uniform health information and statistics through a Comprehensive Health Information System. § 408.05(3), Fla. Stat. The State Comprehensive Health Information System Advisory Council (CHIS) is established within the Agency to assist the State Center in reviewing the Comprehensive Health Information System and to recommend improvements for the system. § 408.05(8), Fla. Stat. In conjunction with CHIS, the agency is to develop and implement a long-range plan for making available performance outcome and financial data that will allow consumers to compare health services. § 408.05(3)(l), Fla. Stat. In 2004, Section 408.061, Florida Statutes, was amended to require health care facilities to submit hospital emergency department data, data on hospital-acquired infections as specified by rule, and data on readmissions as specified by rule. On October 20, 2004, a meeting of CHIS was held, and a discussion was held on the collection and dissemination of data relating to infection rates. A motion was approved to consider the adoption of Surgical Infection Prevention (SIP) measures and to form a Technical Workgroup for Hospital Acquired Infections (Technical Workgroup) to make recommendations to the Agency on how to report SIP measures, to review the current systems of reporting infection rates, and to determine the appropriate infection measures to report. On December 1, 2004, CHIS met and heard recommendations from the Technical Workgroup concerning the collection and reporting of SIP measures. The recommendations included developing draft rules. The agency assigned Carolyn Turner, a Government Analyst II with the Agency, to draft rules relating to the collection of SIP Measures. Ms. Turner began drafting the rules in December 2004. Ms. Turner drafted the Proposed Rules. On January 13, 2005, the Agency held a rule development workshop, which had been noticed in the Florida Administrative Weekly on December 30, 2004. During the workshop and subsequent to the workshop, the Agency received comments and suggestions for modifications to the Proposed Rules, and, as a result, the Agency made some changes to the Proposed Rules. The Proposed Rules were published in the Florida Administrative Weekly on March 11, 2005, and a public hearing was held on the Proposed Rules on April 4, 2005. The Proposed Rules provide: 59B-15.001 Purpose The rules in this section describe the requirements for reporting Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) for the purpose of providing comparative information to consumers. 59B-15.002 Definitions "Hospital" means an entity that is licensed per Section 395.002(13), Florida Statutes. "Reporting period" means a calendar quarter. "Eligible patient" means a selected surgical patient 18 years of age or older with no prior evidence of infection as specified by the Center for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. 59B-15.003 Exclusions State-operated hospitals. Psychiatric hospitals with no licensed acute care beds other than licensed psychiatric or substance abuse beds. Specialty rehabilitation as defined in subparagraph 59A-3.52(1)(c)2. F.A.C. Intensive Residential Treatment Programs for Children and Adolescents as defined in paragraph 59A-3.252(1)(d), F.A.C. 59B-15.004 Reporting Requirements Hospitals shall report Surgical Infection Prevention (SIP) Measures to the Agency for Health Care Administration (Agency) quarterly due on or before December 1, 2005 for the period April 1, through June 30, 2005. Thereafter, data shall be reported for each calendar quarter due 150 days following the end of the quarter. Hospitals shall report the following measures for all eligible patients regardless of type of payer. Prophylactic antibiotics received within 1 hour prior to surgical incision; Prophylactic antibiotic selection for surgical patients; Prophylactic antibiotics discontinued within 24 hours after surgery end time. The methodology used to prepare the measures shall meet the standards specified by the Centers for Medicare and Medicaid Services (CMS) in the Specifications Manual for National Hospital Quality Measures available on the CMS website at: www.cms.hhs.gov/quality/hospital. CMS standards include submission of SIP data to the Quality Improvement Organization Clinical Warehouse, providing records required for reabstraction activities, and compliance with other data quality standards as specified by CMS. Hospitals shall use the SIP methodology specified by the CMS for the applicable reporting period to determine the SIP measures reported to the Agency. If the hospital uses sampling, the hospital must follow the sampling protocol specified by CMS. Hospitals shall report the population size, rate numerator value, and denominator value as specified by CMS for each type of surgery to include coronary artery bypass surgery (CABG), cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, vascular surgery, and for all of the above surgeries overall. Hospitals shall report data separately for each location consistent with Rule 59E-7.012, F.A.C. unless reporting separately would be contrary to CMS specifications. If a combined report is submitted, report the name of the hospital and AHCA hospital identification number required in subsection 59B-15.005(1), F.A.C. for each of the hospitals included in the report. The data shall be submitted in a text file, using a tab between each data element. Start a new line for each type of surgery and for each measure. Order the rows of data by type of surgery as listed in subsection (5) with three consecutive rows of data for each measure in subsection (2) above reported for each type of surgery. Each line of data shall state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of surgery or state all of the above surgeries overall as in subsection (5) above and state the name of the type of measure as in (2) above. The rate shall be reported as a decimal number greater than or equal to zero (0) and less than or equal to one hundred (100) using the format X.XX, XX.XX, or XXX.XX as required. Report hospital contact information required in Rule 59B-15.005, F.A.C. in the order specified starting a new line beginning with contact name and contact telephone number. Hospital contact information should be reported at the beginning of the document. (8) Hospitals shall send the SIP measures by electronic mail to SIPReport@ahca.myflorida.com or, if requested in writing by the hospital and approved by the Agency to the Agency's mailing address using a 3.5" diskette or CD- ROM. The mailing address of the Agency is: Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop #16, Tallahassee, Florida 32308 with the statement, "Attention: State Center for Health Statistics." If the hospital has a vendor send the SIP measures to the Agency, the hospital will direct the vendor to copy (cc) the hospital contact when the report is e- mailed to the Agency. 59B-15.005 Hospital Contact Information. Each hospital shall include the following contact information when submitting a report required in this section to the Agency for Health Care Administration: Name of hospital; AHCA hospital identification number; Reporting year in four digits; Reporting quarter as a 1, 2, 3, or 4 where 1 corresponds to the first quarter of a calendar year; Contact name; Contact title; Contact address; Contact direct telephone number; Hospital telephone number; Contact e-mail address; Contact FAX number. The hospital contact information shall be reported in a text file as described in Rule 59B-15.004, F.A.C., using a tab between each data element. 59B-15.006 Certification Each hospital shall provide certification of the accuracy of the Surgical Infection Prevention Measures including all data required in this section as provided in Section 408.061(1)(a), Florida Statutes. The certification shall be submitted to the Agency for Health Care Administration (Agency) using the Certification of Surgical Infection Prevention Measures from SIP-1, dated 2/01/2005, incorporated by reference. The certification shall be submitted to the Agency for Health Care Administration (Agency) quarterly prior to or concurrent with the submission of the Surgical Infection Prevention Measures as provided in Rule 59B-15.004, F.A.C. The Certification of Surgical Infections Prevention Measures Form will be available from the Agency website at www.ahca.myflorida.com. The signed Certification of Surgical Infections Prevention Measures may be submitted electronically to SIPReport@ahca.myflorida.com. using a pdf file with a scanned signature or mailed to the Agency address provided in Rule 59B- 15.004, F.A.C. If a combined report is submitted per subsection 59B-15.004(6), F.A.C., a separate Certification of Surgical Infection Prevention Measures Form SIP-1 must be submitted for each hospital included in the report. 59B-15.007 Administrative Penalties Failure to report as required in this section in whole or in part is subject to administrative fines as provided in Section 408.08(2) and 408.08(5), Florida Statutes, unless the hospital has been granted an extension of up to 30 days by the Agency for Health Care Administration for reasons of extraordinary or hardship circumstances such as a natural disaster or emergency event impacting the hospital. Hospitals must request the extension, in writing, prior to the due date specified in Rule 59B-15.004, F.A.C. The Proposed Rules provide that the specific authority for the promulgation of the Proposed Rules is Subsection 408.06(1)(a)2., Florida Statutes, and the law implemented by the Proposed Rules is Subsection 408.05(3)(l)1., Florida Statutes. Dr. McKalip is a neurological surgeon practicing in St. Petersburg, Florida. He has hospital privileges at Bayfront Medical Center (Bayfront) and St. Anthony's Health Care (St. Anthony's). Both hospitals would be required by the Proposed Rules to report SIP Measures to the Agency. SIP Measures would be required to be reported only on the following surgical categories: coronary artery bypass surgery, cardiac surgery, hip arthroplasty, knee arthroplasty, colon surgery, hysterectomy, and vascular surgery. Dr. McKalip performs vascular surgery of the brain, vascular bypass surgery in the neck, and, as part of his board certification, is required to be able to perform carotid artery surgery in the neck. These procedures would be included under the category of vascular surgery in the ICD-9 codes as other (peripheral) vascular shunt or bypass VASC SHUNT and BYPASS NEC.2 The Proposed Rules do not require Dr. McKalip to report the use of SIP measures; they require the hospitals in which he performs the procedures to report the SIP measures. The Proposed Rules do not require the hospitals to implement SIP measures, merely to report whether the SIP measures were implemented. Some hospitals, including Bayfront and St. Anthony's, have developed policies which require physicians practicing in those hospitals to implement the SIP measures. Data collection relating to SIP measures is not a new concept. The Centers for Medicare and Medicaid Services (CMS) have developed a methodology to collect data on SIP measures, and some hospitals are currently voluntarily reporting the use of SIP measures for certain surgical procedures. The Proposed Rules adopt the methodology developed by CMS. The Proposed Rules are supported by the Florida Hospital Association; Florida Medical Quality Assurance, Inc.; and CMS. The use of SIP measures is supported by many medical societies and organizations. The Agency views the collection of the SIP measures as the first step in a three-step process for collecting and reporting hospital-acquired infection data. The second step will involve the collection of infection rates that are acquired in the inpatient setting, and the third step will involve reporting the infection rates by physicians.
The Issue The issue for consideration was whether the Respondent's license as a physician in Florida should be disciplined because of the alleged misconduct outlined in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the allegations contained herein, the Respondent, Moheb Ishad Girgis El-Far was licensed as a physician in Florida under license number ME 0026895, and the Board of Medicine was the state agency responsible for the licensing and monitoring of physicians in this state. At all times pertinent to the issues herein, Respondent practiced medicine with a specialty in obstetrics at his clinic located a 401 East Olympic Avenue, Punta Gorda, Florida. Patient 2, C.L., first went to see Respondent at his office in Punta Gorda in January, 1989 because she was pregnant and had heard he was delivering babies in his office. She was referred to the Respondent by the Sarasota Health Department when she indicated she wanted to have her child in a birthing center. During that first visit, the doctor and patient agreed on a treatment plan which would culminate with the baby's being delivered in his office and C.L. paid for this pursuant to their agreement. During the period of the patient's prenatal care with the Respondent, he told her her baby was due on August 30, 1987, and when labor began, she was to come to his office and bring her own sheets. On August 24, 1987, C.L. began her labor and went to Respondent's office as agreed. By the time she got there, she was about ready to deliver and a few minutes after her arrival, she did so in a birthing room with her husband present. At the time of the delivery, both Respondent's wife and Ms. L.'s boss, neither of whom played any part in the proceedings, were standing in the doorway to the birthing room. No nurse was present and C.L. cannot recall seeing any sterilization or resuscitation equipment in the room. C.L. experienced little pain during the delivery, which appeared to go smoothly. Afterwards however, Respondent told her she had sustained an inverted uterus and when Respondent attempted to remove the afterbirth, she started to hemorrhage. When this happened, Respondent gave her a shot and towels with which she was to try to stem the bleeding while he tried to correct the uterine problem. He was unsuccessful and thereafter called the paramedics who came to his office and took C.L. to St. Joseph's Hospital in Punta Gorda for treatment. Respondent did not treat her at the hospital because he had no hospital privileges. While there she required 6 units of blood and 2 units of plasma. At no time during the course of her prenatal care did Respondent advise her to go to the hospital. She fully recovered. C.L. was shown pictures of Respondent's office taken by Department investigators at some time subsequent to her delivery. With the exception of the fetal monitor which she had seen in his office, the pictures she saw bore little similarity to the condition of the office whenever she was there. Though the office was not as messy as the pictures show, she was, nonetheless concerned about its condition at the time of her delivery. The carpet was dirty and so was the aquarium. She could not do anything about it at that time, however, and it was not so bad as to cause her to feel unsafe. S.K., Patient 1, first went to the Respondent for her pregnancy care in November, 1987 on a referral from a friend. They agreed on a fee of $1600.00 for prenatal care and delivery in his office. During these initial discussions, Respondent did not discuss in detail with the patient the possibility of complications. He stated only that if there were complications, they could probably be treated in the office. S.K. went to Respondent's office about 6 times after that initial visit. During this period, on an early visit, Respondent gave her some medicine samples and a prescription for vitamins. When she asked about the cost, he said he would include the cost of the samples when he billed her insurance company. During these visits, she also saw his personal office, an examining room, and a small room where the patient's blood pressure was taken. She noted that the office was not as clean and orderly as others she had seen, and in fact, was usually in a state of disarray. On one occasion when Respondent examined her, he was wearing a wrinkled shirt with a blood spot on it. The next time she went for a visit, Respondent was wearing the same shirt. S.K. was shown pictures of Respondent's office taken by investigators and several were similar to conditions she observed there. His personal office was not well organized and there was clutter about but not as aggravated as appears in the photos. Based on her experience with other doctors, Respondent's office was far more untidy and in disarray but not necessarily nonsterile or unsafe. On February 5, 1988, S.K. went to Respondent's office because she was having pains and thought she was in labor. When she called him and explained her symptoms, he told her to come in and he examined her when she did. He gave her something to calm her and to try to stop her labor in an attempt to save her baby. He gave her a shot of demerol and put her in an examining room to lie down. She slept there for quite a while with her husband present. When she awoke she again began to have pains but Respondent would not give her any more medicine. After a while, the baby spontaneously delivered while Respondent was sleeping in another room. He was called but by the time he came in, the baby was dead. He asked S.K. if she wanted to see the fetus but she declined. After a period of recovery, she was released to return home. When this patient came into the office that day and it appeared she was going to deliver, her husband asked Respondent if he thought she should be in the hospital. Respondent replied that it was up to her because the baby, if delivered, was too premature to survive. The decision not to go to the hospital was hers. Respondent did not try to dissuade her from going. In fact, in most ways she considered Respondent's treatment of her to have been satisfactory. During the period she was in his office Respondent was in and out of the room checking on her. The only complaint she has relates to his handling of the fetus she delivered. About 2 weeks after delivery she again went to see Respondent at his office where he showed her her baby which he had preserved in a jar of formaldehyde. This was a strange and sad experience for her. Mr. K. basically confirms that testified to by his wife. While she was in labor or sleeping prior to the delivery, he wandered about the building into other parts of the clinic. He also rested in one of the examining or birthing rooms and observed the general state of cleanliness of the facility was poor. For example, the floor and rugs were spotted throughout with a dark stain and the examining table also had a dark stain on it. These stains looked to him like blood. In addition, the hallway carpets were dirty, there were bags off debris laying out, spare pieces of wood were stacked in the halls, and medical instruments were left out in the birthing and examining rooms. In his opinion, many of the pictures shown to him displayed scenes similar to what he saw when he was there with his wife. Both Dr. Borris and Dr. Marley agreed that Respondent's treatment of Ms. K. had no relationship to her miscarriage. By the same token, neither claims that his treatment of Ms. L.'s inverted uterus was inappropriate. Both agree, however, that other factors in Dr. El Far's operation of his practice as regards both patients failed to conform to generally accepted standards of care in providing obstetrical services. Specifically, he failed to have a nurse present during the delivery; he failed to have emergency equipment in the form of resuscitative and lifesaving equipment available to handle potential surgical complications which might have arisen; he had no emergency backup care available; and he had no hospital privileges in Punta Gorda, the area in which he was engaged in an obstetrical practice. Without those privileges, it was not prudent for him to undertake a delivery in the office. While the prenatal care of patient 1 was within standards, the balance of Respondent's practice was below standards because: the patient was not monitored while in the office; if the conditions as appearing in the pictures existed at the time he was seeing patients, he did not meet sanitation standards because of the general disarray.; he attempted a delivery in his office when a hospital was only 1.5 miles away, (not prudent in light of the patient's condition when there was no emergency to justify it); and his records were not complete. The standard of a reasonably prudent physician is the same regardless of the locality. Acceding to the wishes of a patient, when to do so is not in the patient's best interests, is not necessarily acceptable medical care. Mr. Cook, the Department's investigator, inspected Respondent's office on September 16, 1988, in the company of investigator Clyne, as a result of a call he received from an agent of the Florida Department of Law Enforcement who was then on the premises. When they arrived, they observed a female sitting on the couch in the waiting room changing a baby's diaper. From conversation he had with Respondent at the time, Mr. Cook inferred the lady was a patient. In addition to the previously mentioned lady and the state investigative personnel, Cook also noticed two children, who Respondent indicated were his, running freely about throughout the building. Cook examined the patient log maintained by Respondent for that day and noted that two patients were scheduled. Nonetheless, while he was there, there were no nurses, receptionists or office staff present. Though Respondent claims he did not have any patients that day, and though Cook did not see any other than the lady aforementioned, from the patient log and the fact that at least one patient was there, it is found that Respondent was engaged in at least a minimum practice and was available to see patients. Mr. Cook observed conditions in Respondent's office on the day in question that were inconsistent with a proper medical practice. Trash was not contained, food was left open, and dust and dirt were in evidence, all in the area where medical services were or would be rendered. Mr. Cook took photos and a video tape of the condition of Respondent's office. The photos were those shown to the two patients who testified herein and to Mr. K. Though he looked throughout the office, Mr. Cook could find no sterilization equipment, no general anesthesia equipment, no blood transfusion equipment, and no emergency resuscitation equipment. When asked about his sterilization capability, Respondent stated his "heater" was broken and in for repairs. When during a visit to Respondent in October, 1988, Ms. Clyne told him he needed sterilizer equipment, he indicated it had recently been purchased. On that visit, Respondent had a patient in the office. Ms. Clyne again went to Respondent's office on February 15, 1989 and observed it to be still in a state of disarray. Ms. Hampton, another Department investigator, visited with Respondent in his office on January 11, 1989 and found it to be unsatisfactory. The waiting area was cluttered, the carpet was dirty, the walls stained, and magazines were laying around. The clinic area was piled up with mail leaving no counter space. Respondent took Ms. Hampton on a tour through the office during which she observed the computer, patient records, and the typewriter to be unclean. Her examination of the halls, examining rooms, birthing rooms, and the like revealed that in one room, a sink had an unclean speculum in it and others were lying about. The paper on one examining table was soiled and when Respondent saw that, he quickly tore it off. The spread in one of the birthing rooms was soiled and the floor needed sweeping. Trash cans were not lined and needed cleaning. The covering on the baby examining table was soiled and there were bloody cotton balls on a table in the room. She, too, saw no evidence of any sterilization, anesthesia, or emergency resuscitation equipment. On this visit, Respondent indicated he was not seeing any new patients; only those former patients who were still pregnant. Respondent indicates that during the period from July 4 through September 16, 1988 he had closed up his office for an extensive vacation and was living in his office on that latter date. He does not deny that his office was in the condition as depicted in the photos when they were made but contends he has since cleaned it up and put new carpet down. During the period his office was closed, he referred his patients to other doctors and has not been actively practicing while waiting for his malpractice insurance to come through. Respondent also does not deny that the Certificate of Education form he signed and submitted to the Board was in error. He contends, however, that at the time he signed it he believed it to be a certificate of regular continuing education hours, not a certification used for approval for dispensing drugs. He also claims that at no time did he intend to defraud the Board, and when Ms. Clyne brought the error to his attention, he wrote to the Board explaining what had happened. He contends that when he affirmed the statement that he had the appropriate hours, he considered the "a" in "affirm" to be a negative prefix indicating he did not have the required hours. This contention is both ingenuous and unbelievable. It is found that Respondent well knew the meaning and effect of the certification he signed and his affixing his signature thereto was both false and with intent to mislead.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license to practice medicine in Florida be suspended for two years and that he thereafter be placed on probation for an additional period of three years under such terms and conditions as are imposed by the Board of Medicine. RECOMMENDED this 30th day of October, 1989, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 89-1507 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings Fact submitted by the parties to this case. For the Petitioner: 1.- 3. Accepted and incorporated herein. Accepted and incorporated herein. Rejected in so far as it editorializes on the condition of the clinic. While below standard, there was no evidence of health hazard to patients. 6.-8. Accepted and incorporated herein. 9. & 10. Accepted and incorporated herein. 11. & 12. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein Accepted and incorporated herein. Accepted. & 18. Accepted and incorporated herein. 19. Accepted. For the Respondent: 1. & 2. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. Rejected as contra to the weight of the evidence. Rejected as contra to the weight of expert testimony. Rejected as contra to the weight of the evidence. Accepted in so far as it finds that Respondent's performance of medical procedures was within standard. Rejected as to the finding that overall care and practice was within standards. Accepted. COPIES FURNISHED: Larry G. McPherson, Jr., Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 David K. Oaks, Esquire The Professional Center 201 West Marion Avenue Suite 205, Box 3288 Punta Gorda, Florida 33950 Kenneth E. Easley General Counsel DPR 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dorothy Faircloth Executive Director Board of Medicine DPRB 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue to be determined in this proceeding is whether Respondent, Babak Saadatmand, M.D. (Respondent or Dr. Saadatmand), has violated section 458.331(1)(m) and (t), Florida Statutes (2013), as alleged in the Administrative Complaint.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and the entire record of this proceeding, the following findings of fact are made: The Parties Petitioner, the Department of Health, is the agency charged with the regulation of the practice of medicine pursuant to chapters 20, 456, and 458, Florida Statutes. Respondent, Babak Saadatmand, M.D., is a medical doctor licensed by the Board of Medicine. Dr. Saadatmand holds Florida license number ME 114656. Respondent graduated from the University of Maryland, College of Medicine, in 1988, and completed his residency at Case Western Reserve. He then completed a residency in emergency medicine at Cook County Hospital in Chicago, Illinois. Respondent was board-certified in internal medicine, but no longer holds that certification because at the time it was due for renewal, he was no longer eligible because his practice was devoted to emergency medicine as opposed to internal medicine. He remains board-certified in emergency medicine. Respondent has held positions that required him to supervise residents and give lectures at Yale University, New York College of Medicine, and Indiana University. Dr. Saadatmand chose to practice emergency medicine as a traveling physician for the last three years, because of the financial benefits available by doing so while he gained additional experience in emergency medicine. However, he has since or now accepted a position as the assistant program director of the emergency medicine residency program at Jackson Memorial Hospital in Miami, Florida, where his job responsibilities will include the supervision of residents. Dr. Saadatmand holds a medical license in several other states in addition to Florida, and has not been disciplined in any state where he is licensed. Dr. Saadatmand’s Treatment of R.D. In June and July of 2014, Respondent was working as a traveling physician at Parrish Medical Center in Titusville, Florida. While most of his assignments in various emergency facilities have been six months long, the assignment at Parrish Medical Center was for approximately one month. Respondent treated patient R.D. on June 27, 2014, at Parrish Medical Center emergency room. R.D. was accompanied by his wife, C.D. R.D. was a 52-year-old male when he presented to Parrish Medical Center. He had a history of T-cell lymphoma and had been treated for his cancer through the Space Coast Cancer Center. Just days before his presentation to the emergency room on June 27, 2014, he had been cleared to return to his place of employment. However, on June 27, 2014, R.D.’s supervisor called R.D.’s wife, C.D., and asked her to come get R.D. as he was too ill to be at work. R.D. arrived at Parrish Medical Center in the early afternoon, and was triaged by a nurse at approximately 2:13 p.m. The notes from the triage nurse’s assessment recorded, among other things, R.D.’s vital signs upon arrival; his chief complaint, including its duration and intensity; a brief medical history; a list of his current medications; and a drug/alcohol use history. Registered Nurse Sharon Craddock was the emergency room nurse who completed the initial assessment, or triage assessment, of R.D.’s condition. According to her triage notes in the Parrish Medical Center records, R.D.’s chief complaint upon arrival was constipation, which was described as constipation for three days, with bilateral abdominal pain. The pain was described as aching, pressure, shooting, and throbbing, and R.D.’s pain level was reported in Ms. Craddock’s notes as being an eight on a ten-point scale. Her description of his abdomen was “soft, non-tender, round, and obese.” Nurses are directed to record the pain level reported by the patient, and not to alter the pain level based on the nurse’s observation.1/ R.D.’s vital signs were taken upon his arrival at Parrish Medical Center and were recorded in the electronic medical records as follows: temperature, 98.4F; pulse, 127H; respiration, 20; blood pressure, 120/70; and pulse oximeter, 95. The only abnormal reading reflected in R.D.’s vital signs was his pulse, which was above 100, considered to be the upper limit of normal. R.D. reported that he had a medical history which included T-cell lymphoma and that he did not smoke or drink. His current medications were listed as aspirin, Zyrtec, Amaryl, Metformin, Prilosec, Percocet, Pravastatin, and a multivitamin. The Percocet dosage was listed as one tablet, three times daily, as needed for pain. Ms. Craddock also recorded a nursing note for R.D. at 3:37 p.m., and she was in the room when Respondent first went in to see R.D. Ms. Craddock’s nursing note indicates, “Pt with a hx of stomach CA with a recent ‘clean bill of health’ presents with ABD pain and constipation. Occasionally takes Percocet for pain. Wife at BS. Pt. sleepy, states he normally takes a nap this time of day. Pending MD eval with orders.” The Parrish Medical Center chart documents that R.D. was calm, cooperative, and asleep at 15:37 hours (3:37 p.m.). This presentation is generally inconsistent with a patient who is in severe abdominal pain. Dr. Saadatmand saw R.D. at approximately 3:56 p.m. Consistent with the custom at Parrish Medical Center, he worked with a scribe who took Respondent’s dictation for notes during his visit with the patient, and then loaded those notes into the electronic medical record. Respondent would then have the opportunity to review the notes as transcribed and direct the scribe to make any necessary changes. Dr. Saadatmand’s notes indicate that R.D. presented with abdominal pain, and was experiencing moderate pain that was constant with cramping. The description of R.D.’s pain as moderate was based upon Dr. Saadatmand’s observation of R.D. The chief complaint listed was constipation. Dr. Saadatmand took a history from R.D., who reported that he had been diagnosed with gastric lymphoma in 2013, and was treated with radiation and chemotherapy. R.D. and his wife, C.D., reported to Respondent that they feared his cancer might be returning, as his current symptoms were similar to those he experienced when his cancer was first diagnosed. He had returned to Space Coast Cancer Center for some additional screening two to three weeks before the emergency room visit, which included a CT of the abdomen and an upper and lower endoscopy. R.D. and his wife both believed that the results of the screening were normal. Respondent recorded this conversation in the electronic medical record as “[R.D.] had a recent follow up with Dr. Rylander and had normal EGD and colonoscopy. [R.D.] had recent CT scan with cancer center.” Space Coast Cancer Center does not use Parrish Medical Center to perform its CT scans or other testing, so the results of the recent CT scan were not available for Respondent to view. Respondent believed that R.D. and C.D. had followed the directions of R.D.’s oncologists, and R.D. had been a compliant patient. Respondent asked R.D. about his use of Percocet. He did not ask how much he was taking, but how often and whether the use had changed. He considered the answer to this question to be important, because a change in the use could indicate a change in R.D.’s pain intensity. R.D. did not report any change in the amount that he was taking, which was generally an “every other day thing for him.” Respondent testified that, given that the type of Percocet that R.D. was prescribed was an extra-strength as opposed to a standard version of Percocet, it was highly likely that R.D. would suffer from opioid-induced constipation. R.D. reported to Respondent that he had not attempted any laxatives. R.D. also denied having any nausea or surgical history. The lack of a surgical history is significant because patients with a recent surgical history and abdominal pain may be experiencing complications related to the surgery, which would account for the patient’s pain. There is no reference to R.D.’s diabetes in either the nursing triage notes or Dr. Saadatmand’s notes. The only reference in the past medical history is the report of cancer. The list of medications R.D. was taking at home includes Metformin HCI. No evidence was presented to establish whether Metformin is a drug prescribed only for diabetes or whether it is an accepted treatment for other conditions. Moreover, there is no evidence presented to establish how Respondent was to know that R.D. was diabetic if R.D. did not report the condition. In addition to taking R.D.’s medical history, Respondent performed a review of systems and a physical examination, including palpation of his abdomen. In his chart, the electronic medical record states under “review of systems,” “All systems: Reviewed and negative except as stated.” Under the category “Gastrointestinal,” the record indicates “Reports: Abdominal pain, Constipation. Denies: Nausea, vomiting, Diarrhea.” In the physical examination section of the electronic medical record, it is noted that R.D. was alert and in mild distress. The cardiovascular examination indicates that R.D. had a regular rate, normal rhythm, and normal heart sounds, with no systolic or diastolic murmur. With respect to his abdominal exam, Respondent indicated, “Present: Soft, normal bowel sounds. Absent: Guarding, Rebound, Rigid.” The notation that the abdomen was soft with normal bowel sounds is another way of noting that the abdomen is non-tender. Because R.D. was tachycardic upon presentation to the emergency room, Dr. Saadatmand noted R.D.’s anxiety about the possibility of his cancer returning, and checked his pulse a second time. When Respondent checked R.D.’s pulse, it had slowed to 90, which is within a normal range. In light of R.D.’s normal vital signs, normal abdominal examination, and the length of his pain and constipation, Respondent determined that the most likely cause for Respondent’s pain was constipation, and communicated that determination to R.D. and C.D. He asked whether R.D. had used a laxative and was told he had not. Dr. Saadatmand told R.D. and his wife that the pain medication that he took could be a source for his constipation, and that it would be prudent to try a laxative and see if that produced results before considering any further diagnostic tests. Respondent did not order any lab tests for patient R.D. on June 27, 2014, because his vital signs and abdominal examination were normal. He did not order an EKG for R.D. because there were no symptoms to indicate a cardiac issue. Respondent also did not order a CT scan of the abdomen or pelvis for patient R.D. on June 27, 2014. He felt that, in terms of R.D.’s concern about cancer recurrence, there were tests available to R.D.’s oncologist that would be more useful in detecting any recurrence of R.D.’s cancer that are not available through an emergency room visit. For example, a PET scan would be the most helpful, but is not something that Respondent could order through the emergency room because it is not considered an emergent study. The Department has not alleged, and the evidence did not demonstrate, that R.D. suffered from any emergency condition that additional testing would have revealed and that went undetected by Dr. Saadatmand. Respondent did order a prescription-strength laxative, i.e., Golytely, for R.D., which is a laxative commonly used to treat constipation and to prepare patients for a colonoscopy. Dr. Saadatmand communicated his recommendation to R.D. and C.D., who seemed relieved that the problem might be limited to constipation. He also advised them to return to the emergency room should R.D.’s symptoms get worse or if he developed a fever, because those developments would indicate a change in his condition. R.D. received discharge instructions that are consistent with Dr. Saadatmand’s discussion with R.D. and his wife. The discharge instructions referred R.D. to his primary care physician, noted the prescription for Golytely, and provided information related to the community health navigator. The Patient Visit Information sheet received by R.D. specifically noted that the patient was acknowledging receipt of the instructions provided, and stated, “I understand that I have had EMERGENCY TREATMENT ONLY and that I may be released before all my medical problems are known and treated. Emergency medical care is not intended to be a substitute for complete medical care. My Emergency Department diagnosis is preliminary and may change after complete medical care is received. I will arrange for follow-up care.” R.D. also received printed materials about constipation and how to address the problem. These instructions stated that the patient should contact his or her primary care provider if the constipation gets worse, the patient starts to vomit, or has questions or concerns about his or her condition or care. It also instructed the patient to return to the emergency room if he or she had blood in his or her bowel movements or had a fever and abdominal pain with the constipation. R.D. signed the acknowledgment that he had read and understood the instructions given to him by his caregivers. The acknowledgment specifically referenced the instructions regarding constipation. The written instructions are consistent with the verbal advice provided by Respondent. R.D.’s Subsequent Treatment Unfortunately, R.D.’s symptoms did not improve. He developed a fever and his pain level increased significantly. As stated by his wife, his pain the following day was “way worse” than when he saw Dr. Saadatmand. After a call to her niece, a nurse that worked in the emergency room at Parrish Medical Center, C.D. took R.D. back to the hospital on June 28, 2014, at approximately 6:30 p.m. At that point, he had a heart rate of 125, a temperature of 101.6 degrees, and tenderness in the lower left quadrant of his abdomen. Testing indicated that R.D. had intra-abdominal masses and small collections of extra-luminal gas that suggested the possibility of a contained micro-perforation. There is no allegation in the Administrative Complaint that the micro- perforation existed at the time R.D. saw Respondent. R.D. died on August 23, 2014, as a result of end-stage T-cell lymphoma. The Expert Witnesses The Department presented the expert testimony of Annie Akkara, M.D. Dr. Akkara is board-certified in emergency medicine and has been licensed to practice medicine in Florida for approximately nine years. All of her practice has been in the greater Orlando area in the Florida hospital system. She worked full-time for one year when she first moved to Florida, and since that time approximately 80 percent of her practice has involved reviewing medical charts for Veracode Associates, to determine whether diagnostic codes are fully supported in the medical records. She takes emergency room shifts on an as-needed basis, and has supervisory responsibility over patient extenders, such as nurses and physicians’ assistants, but not over other physicians. Dr. Akkara has never served on any committee for a medical staff at a hospital or helped develop protocols for an emergency room, and has not conducted any type of medical research. Although her position requires her to review electronic medical records, she was not familiar with the program used by Parrish Medical Center. Dr. Akkara reviewed the medical records for the emergency room visits for both June 27 and 28, 2014, as well as the records from the inpatient admission after the June 28 visit. She also reviewed the expert witness reports of Drs. Orban and Smoak. Dr. Saadatmand presented the expert testimony of David Orban, M.D. Dr. Orban practices emergency medicine in the Tampa area. He attended medical school at St. Louis University and completed residencies in orthopedics and emergency medicine. Dr. Orban has been licensed to practice medicine in Florida since 1982 and has been board-certified in emergency medicine since 1981. Before he practiced in Florida, Dr. Orban served as an instructor in surgery at the Washington University School of Medicine, and from 1970 through 1983, was an assistant professor of medicine at the University of California, Los Angeles (UCLA). In that position, he supervised residents in the emergency medicine program and helped to develop the program’s curriculum. Dr. Orban left UCLA in 1983 and moved to Florida, in order to help establish the emergency medicine residency program at the University of Florida. Currently, Dr. Orban is the director of emergency medicine for the University of South Florida (USF), College of Medicine, and the Medical Director Emeritus for the Tampa General Hospital Emergency Room. The USF emergency medicine residency program is a competitive program which receives approximately 1,200 applications each year for ten residency positions. Dr. Orban continues to spend approximately 20-24 hours each week practicing in the emergency room, in addition to his teaching responsibilities. He both sees patients on his own and supervises residents who are seeing patients. He has extensive experience in evaluating non-traumatic abdominal pain in the emergency room.2/ Allegations Related to the Standard of Care Dr. Akkara testified that in her opinion, Dr. Saadatmand’s care and treatment departed from the standard of care in a variety of ways. She agreed that Respondent assessed R.D.’s abdomen, but believed that he erred in not specifically documenting that the abdomen was not tender. In this case, the patient record specifically states, “Abdominal exam: Present: Soft, Normal bowel sounds. Absent: Guarding, Rebound, Rigid.” In Dr. Akkara’s view, the notes should have been more specific, and she found fault with the fact that the notes did not use the words “tender” or “non-tender.” Dr. Orban, on the other hand, noted that Respondent specifically documented the absence of guarding, rigidity and rebound tenderness, and described the abdomen as “soft, with normal bowel sounds.” Dr. Orban testified that assessing an abdomen for guarding, rigidity, and rebound are all forms of checking for abdominal tenderness. He did not hesitate to interpret Respondent’s medical records for R.D. as reflecting a normal exam, meaning no tenderness was discovered. Dr. Orban’s opinion is supported by the differences in the medical records from R.D.’s June 27 and 28 emergency room visits, and what options are provided in the electronic medical record when a positive finding for tenderness is chosen. Dr. Orban’s testimony is credited. The Administrative Complaint alleges and Dr. Akkara opined that Respondent departed from the appropriate standard of care by failing to obtain a complete set of normal vital signs before R.D. was discharged from the hospital. The only vital sign that was ever abnormal during R.D.’s June 27 visit was his heart rate, which upon arrival was 127. Respondent rechecked R.D.’s heart rate when he examined him, and upon re-examination it was 90, well within normal limits. Dr. Orban did not believe that the standard of care required the physician, as opposed to possibly supportive staff, to obtain a complete set of vital signs prior to ordering a patient’s discharge. The evidence established that while there is sometimes a nursing standard in emergency rooms requiring a nurse to obtain a second set of vital signs before a patient is discharged, there is no corresponding standard that requires the physician to repeat all of the vitals as well. Dr. Akkara admitted that while she attempts to get a complete set of vital signs before she discharges a patient, she does not always succeed in doing so. The evidence did not demonstrate a departure from the standard of care for not obtaining a second set of vital signs prior to discharge, especially where, as here, all of R.D.’s vital signs were normal when he arrived at the emergency room, except for his heart rate, and Dr. Saadatmand did, in fact, re-assess R.D.’s heart rate prior to discharge. The Administrative Complaint alleges that Respondent fell below the standard of care by not ordering routine lab work for R.D. The Administrative Complaint does not allege what purpose the routine lab work would serve in the emergency treatment of R.D. Dr. Akkara testified that routine lab work should have been completed before discharge, and that it was a departure from the standard of care not to do so. She stated that the labs were necessary to assess white blood cell count, glucose levels, and kidney function, and in those cases where tenderness was noted in the upper right quadrant of the abdomen, also could indicate issues with the patient’s liver enzymes. Dr. Akkara acknowledged, however, that it is possible for a CBC (complete blood count) to be frequently misleading in patients with abdominal pain, and is often normal with patients with appendicitis. Blood work often cannot distinguish between serious and benign abdominal conditions, and Dr. Akkara admitted that with respect to R.D., given the records from the subsequent admission, any results from a CBC ordered on June 27 would not have altered the treatment of the patient or changed his ultimate outcome. Dr. Orban testified that in the majority of cases where a CBC is ordered in the emergency room, it is not helpful. Ordering a CBC is helpful where a patient has a fever because it would help identify infection, or where a patient appears anemic. Other than those instances, it is not all that useful and is over-utilized. A chemistry panel measures a patient’s serum levels for things like sodium, creatinine, and glucose. Dr. Orban testified that, even with a diabetic patient, unless the patient is experiencing vomiting, mental status changes, blurred vision, frequent urination, or other symptoms associated with diabetes, a blood chemistry panel would not be helpful for assessing a patient with non-traumatic abdominal pain. Records for R.D.’s June 28 visit (the day after Respondent saw R.D.) note that he was diabetic, while the June 27 records do not. However, it was not established that either R.D. or his wife ever told anyone, whether nursing staff or Dr. Saadatmand, that he was diabetic. There is no testimony that his prescription for Metformin was to treat diabetes, as opposed to some other condition, and there was no evidence to indicate that diabetes is the only condition for which Metformin can be prescribed. Dr. Akkara repeatedly referred to R.D.’s diabetes as a basis for her opinions, but never identified the records that formed a basis for her knowledge of R.D.’s diabetic condition. The evidence presented does not establish that ordering a blood chemistry or CBC was required by the appropriate standard of care related to the care and treatment of R.D. in the emergency room on June 27, 2016. Dr. Akkara also testified that Respondent departed from the standard of care by failing to obtain a CT scan of the abdomen and pelvis. Her opinion is based, at least in part, on her belief that Respondent failed to document that R.D.’s abdomen was non-tender. She agreed with Dr. Orban that if a patient has no abdominal tenderness, then a CT scan is probably not warranted. In addition, Dr. Orban testified credibly that over the last ten years, there has been a trend toward over-utilization of CT scans, with the concomitant increased risk of radiation- induced cancer. In this case, R.D. had reported having a CT scan just weeks before this emergency room visit. His abdomen was not tender. In a case such as this one, where the patient presents with non-traumatic abdominal pain and a normal abdominal examination and no fever, a CT scan is not warranted. Dr. Orban’s testimony is credited. There is not clear and convincing evidence to establish that the standard of care required Respondent to order a CT scan under the circumstances presented in this case. Dr. Akkara testified that Respondent also violated the standard of care by not ordering an EKG for R.D. However, she acknowledged that R.D. did not present with any cardiac-related symptoms and denied chest pain. The purpose of an EKG is to explore any cardiac-related symptoms, and R.D. did not present with any. Dr. Akkara did not provide any protocols that dictate when an EKG should be ordered. Dr. Akkara also acknowledged that ordering an EKG would have no impact on the care provided to R.D., and that a patient does not need an EKG just because he or she walks in the emergency room with tachycardia.3/ The Department did not establish that the failure to order an EKG violated the applicable standard of care in this case. The Department also has charged Respondent with failing to arrange for follow-up care and failing to discuss follow-up care, as well as reasons for R.D. to return to the emergency room, if necessary. However, as noted in paragraphs 32-34, Dr. Saadatmand discussed follow-up care with R.D. and told him what circumstances would require a return visit to the emergency room. Dr. Akkara acknowledged that the discharge instructions given to R.D. were adequate. As stated by Dr. Orban, the role of an emergency room physician with regard to the assessment of patients is to identify emergency situations and treat them. Emergency situations are those that are acute, rapidly decompensating, and that require either medical or surgical intervention, with most likely a hospital admission for more definitive care. It is not the emergency physician’s responsibility to manage a patient’s chronic conditions. It is routine to advise patients with non- acute conditions to follow up with their established physicians and to provide written instructions to that effect. Dr. Saadatmand’s actions in providing instructions, both in terms of follow-up and possible return to the emergency room, were consistent with the standard of care. Finally, the Administrative Complaint finds fault with Dr. Saadatmand for not conducting another abdominal examination and not re-assessing R.D.’s vital signs prior to discharge. As noted previously, the only vital sign that was abnormal when R.D. arrived was his heart rate. Respondent did re-assess R.D.’s heart rate prior to discharge, and it was normal. With respect to a second examination of Respondent’s abdomen, the Department did not establish that one was necessary. Here, Respondent’s initial examination was normal, and there was a reasonable explanation for his discomfort that Respondent believed needed to be addressed before going any further. Dr. Akkara offered no protocol or other authority other than her own clinical experience to support the opinion that serial examinations of the abdomen were required. On the other hand, Dr. Orban testified that where, as here, where the first examination was normal and there was no fever or vomiting, no second examination would be required.4/ Dr. Orban’s testimony is credited. In summary, the Department did not establish that Respondent violated the applicable standard of care in his care and treatment of R.D. Further, his medical records, while not perfect, justify the course of treatment provided in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 5th day of December, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of December, 2016.
