Findings Of Fact At all times relevant hereto Respondent was licensed as a physician in the State of Florida having been issued license number ME0040318. Respondent completed a residency in internal medicine and later was a nephrology fellow at Mayo Clinic. He was recruited to Florida in 1952 by Humana. In 1984 he became associated with a Health Maintenance Organization (HMO) in an administrative position but took over treating patients when the owner became ill. This HMO was affiliated with IMC who assimilated it when the HMO had financial difficulties. At all times relevant hereto Respondent was a salaried employee of IMC and served as Assistant Medical DIRECTOR in charge of the South Pasadena Clinic. On October 17, 1985, Alexander Stroganow, an 84 year old Russian immigrant and former cossack, who spoke and understood only what English he wanted to, suffered a fall and was taken to the emergency Room at a nearby hospital. He was examined and released without being admitted for inpatient treatment. Later that evening his landlady thought Stroganow needed medical attention and again called the Emergency Medical Service. When the ambulance with EMS personnel arrived they examined Stroganow, and concluded Stroganow was no worse than earlier when he was transported to the emergency Room, and refused to again take Stroganow to the emergency Room. The landlady then called the HRS hotline to report abuse of the elderly. The following morning, October 18, 1985, an HRS case worker was dispatched to check on Stroganow. Upon arrival, she was admitted by the landlady and found an 84 year old man who was incontinent, incoherent, and apparently paralyzed from the waist down, with whom she could not engage in conversation to determine his condition. She called for a Cares Unit team to come and evaluate Stroganow. An HRS Cares Unit is a two person team consisting of a social worker and nurse whose primary function is to screen clients for admission to nursing homes and adult congregate living facilities (ACLF). The nurse on the team carries no medical equipment such as stethoscope, blood pressure cuff, or thermometer, but makes her evaluation on visual examination. Upon arrival of the Cares Unit, and, after examining Stroganow, both members of the team agreed he needed to be placed where he could be attended. A review of his personal effects produced by his landlady revealed his income to be above that for which he could qualify for medicaid placement in a nursing home; that he was a member of IMC's Gold-Plus HMO; his social security card; and several medications, some of which had been prescribed by Dr. Dayton, Respondent, a physician employed by IMC at the South Pasadena Clinic. The Cares team ruled out ACLF placement because Stroganow was not ambulatory, but felt he needed to be placed in a hospital or nursing home and not left alone with the weekend approaching. To accomplish this, they proceeded to the South Pasadena HMO clinic of IMC to lay the problem on Dr. Dayton, who was in charge of the South Pasadena Clinic, and, they thought, was Stroganow's doctor. Stroganow had been a client of the South Pasadena HMO for some time and was well known at the clinic as well as by EMS personnel. There were always two, and occasionally three, doctors on duty at South Pasadena Clinic between 8:00 and 5:00 daily and, unless the patient requested a specific doctor he was treated by the first available doctor. Stroganow had not specifically requested to be treated by Respondent. When the Cares unit met with Respondent they advised him that Stroganow had been taken to Metropolitan General Hospital Emergency Room the previous evening but did not advise Respondent that the EMS squad had refused to return Stroganow to the emergency Room when they were recalled for Stroganow the same evening. Respondent telephoned the Metropolitan General Emergency Room and had the emergency Room medical report on Stroganow read to him. With the information provided by the Cares unit and the hospital report, Respondent concluded that Stroganow needed emergency medical treatment and the quickest way to obtain such treatment would be to call the EMS and have Stroganow taken to an emergency Room for evaluation. When the Cares unit arrived, Respondent was treating patients at the clinic. A clinic, or doctors office, is not a desirable or practical place to have an incontinent, incoherent, and non-ambulatory patient brought to wait with other patients until a doctor is free to see him. Nor is the clinic equipped to perform certain procedures that may be required for emergency evaluation of an ill patient. At a hospital emergency Room such equipment is available. EMS squads usually arrive within minutes of a call being placed to 911 for emergency medical treatment and it was necessary that someone be with Stroganow when the EMS squad arrived. Accordingly, Respondent suggested that the Cares team return to Stroganow and call 911 to transport Stroganow to an emergency Room for an evaluation. Upon leaving the South Pasadena clinic the Cares team returned to Stroganow. Enroute they stopped to call a supervisor at HRS to report that the HMO had not solved their problem with Stroganow. The supervisor then called the Administrator at IMC Tampa Office to tell them that one of their Gold-Plus HMO patients had an emergency situation which was not being property handled. Respondent left the South Pasadena Clinic around noon and went to IMC's Tampa Office where he was available for the balance of the afternoon. There he spoke with Dr. Sanchez, the INC Regional Medical Director, but Stroganow was not deemed to be a continuing problem. By 2:00 p.m. when no ambulance had arrived the Cares Unit called 911 for EMS to take Stroganow to an emergency Room. Upon arrival shortly thereafter the EMS squad again refused to transport Stroganow. The Cares team communicated this to their supervisor who contacted IMC Regional Office to so advise. At this time Dr. Sanchez authorized the transportation of Stroganow to Lake Seminole Hospital for admission. Although neither Respondent nor Sanchez had privileges at Lake Seminole Hospital, IMC had contracted with Lake Seminole Hospital to have IMC patients admitted by a staff doctor at Lake Seminole Hospital. Subsequent to his meeting with the Cares team Respondent received no further information regarding Stroganow until well after Stroganow was admitted to Lake Seminole Hospital. No entry was made on Stroganow's medical record at IMC of the meeting between Respondent and the Cares Unit. Respondent was a salaried employee whose compensation was not affected by whether or not he admitted an IMC Gold-Plus patient to a hospital.
The Issue Whether Respondent, Guy Hendricks, III, R.Ph., is subject to discipline pursuant to Subsection 465.016(1)(e), Florida Statutes, for violating Rule 64B16-28.120(2), Florida Administrative Code.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made: Respondent, Guy R. Hendricks, III, R.Ph., is a Florida-licensed registered pharmacist, so licensed in 1972; he was licensed as a consultant pharmacist in 1974. Registered pharmacists typically dispense medications at a community pharmacy, for example, Eckerds and Walgreen's. Consulting pharmacists oversee a pharmaceutical distribution system in a long-term care nursing home facility with a Class I institutional permit. In addition to his employment at the Arbors in Orange Park (the Arbors), Respondent is engaged in the development of "cutting edge consultant computer programs" and "research and development in the field of software platforms which will lead to a fully integrated consultant software package." (Respondent's vita, Petitioner's Exhibit 2) On August 1, 1996, Respondent became the consulting pharmacist for the Arbors. The AHCA survey, which is the genesis of the allegations of the Amended Administrative Complaint in this case, was conducted later that same month. The Arbors is a sub-acute care facility which has a Class I institutional pharmacy permit. Florida Statutes and Florida Administrative Code rules restrict the type of medicinal drugs and drug preparations allowed in Class I institutional pharmacies. One of the consulting pharmacist's responsibilities is to see that the applicable Florida Statutes and Florida Administrative Code rules are followed within the Class I institutional pharmacies, subject to pharmacist's control. The Arbors utilized a Baxter SureMed Dispensing Machine (SureMed machine) which is a computerized dispensing machine that stores medications and allows the pharmacist to track when medications are taken from the machine, by whom they are taken, what dosage is dispensed, and to whom the medication is administered. It has a complete computerized tracking system. It is a "modern tool of pharmacy" used to provide a high level of pharmaceutical care for nursing home residents. Florida Statutes and Florida Administrative Code rules require that nursing homes, such as the Arbors, provide "reasonable and consistent quality of life for residents" and that "reasonable efforts be made to accommodate the needs and preferences of residents to enhance the quality of life in a nursing home." Florida Administrative Code rules allow the Arbors to adopt policies and procedures regarding drugs to meet the needs of residents and to maintain an Emergency Medical Kit(s), the contents of which shall be determined by the facility's medical director, director of nursing, and pharmacist, and "it (the medical kit) shall be in accordance with facility policy and procedures"; the "emergency medical kit" may contain medicinal drugs and drug preparations which are not otherwise allowed within Class I institutional pharmacies. Respondent testified that the SureMed machine was being used as one of the Emergency Medical Kits of the Arbors. The drugs contained in the SureMed machine were determined by the Arbors staff before Respondent was employed as consulting pharmacist. During the August 27-28, 1996, AHCA Survey, the surveyor concluded that the SureMed machine was being used inappropriately by the Arbors. The survey revealed that the SureMed dispensing unit was used as an emergency medication kit. Review of the SureMed Policy and Procedure stated "Medications stored in SureMed are intended for emergency stat orders, late admission first dose, new orders and missing doses" (part of Petitioner's Exhibit 5) contrary to the approved use of medicinal drugs used in facilities with a Class I Institutional Pharmacy Permit. An inventory list provided by the facility revealed in excess of 300 medications in the SureMed unit and this unit had been accessed 22 times in the 24 hours prior to surveyor review. Further review of the usage log revealed that an unsampled resident received Norixin from the SureMed unit on 8/26/96 at 23:04, 8/27/96 at 22:21 and 8/28/96 at 22:21 instead of receiving a resident specific labeled medication from the provider pharmacy. Respondent suggests that a "typographical error" may have occurred in the facility's SureMed policy and procedure in that, if the word "not" is inserted after the words "emergency stat orders," the policy and procedure would conform to the limitations proscribed for Class I institutional permitees. While this explanation is plausible, it is not accepted as credible. This portion of the Arbors' SureMed policy and procedure, referenced by the AHCA surveyor, does not follow Florida law. If the foregoing policy and procedure language is the only language considered, the surveyor's conclusions may be justified; however, the surveyor failed to note the following language which immediately follows the quote from the same SureMed policy and procedure. "SureMed is not intended to be a routine source of medication. The pharmacy must be informed of all new admissions, new orders, refill orders, and missing doses." When a nursing home resident is first admitted to the Arbors, the admittee does not bring medications but brings new prescription orders which must be filled by the provider or back-up pharmacy. Home Care Pharmacy in Orlando, Florida, provides medications to the Arbors; it is 140 miles from Orlando to Orange Park. Deliveries are made two times a day. There were occasions in 1996 when patients were out of medication or Home Care Pharmacy was not delivering as ordered. While the Arbors has only a Class I institutional permit which limits drugs readily available to residents, the facility accepts residents who are "sub-acute" care patients, for example, patients with chronic disease, post-surgical patients, and patients with "super" infections, all of whom require continuity of pharmaceutical therapy. Frank May, a registered pharmacist and certified HCFA surveyor for AHCA, testified that while the Arbors' SureMed policy and procedure were "out of compliance," nevertheless, it was appropriate to "take a drug out of the machine or out of the emergency medication kit if it cannot be provided by the provider pharmacy or if that provider pharmacy is a long way off or by a back-up pharmacy in a timely manner for the next dosage of that medication." May also testified that "there is nothing wrong" with utilizing the SureMed machine as an emergency medical kit or maintaining drugs, otherwise not permitted in a Class I institution permit, in the machine. May further testified that without examining each instance wherein the SureMed machine was accessed immediately prior to the AHCA survey, it would be impossible to determine whether or not an "emergency" existed warranting the use of the particular drug obtained from the SureMed machine. May testified that in 1996, the use of automated drug dispensing machines was becoming very prominent in nursing homes; and problems, such as addressed in this case, were "fairly prevalent." Respondent maintains that the facility's use of the SureMed machine was on a bona fide emergency basis only. The Arbors' SureMed policy and procedure were changed immediately following the August 1996 survey. Respondent sent AHCA a July 20, 1997, letter in response to the AHCA licensure investigation in which he identified the SureMed machine as a "computerized emergency system," a "modern tool of pharmacy," and "our only solution" "to treat our residents' sub acute conditions" when "some local pharmacies . . . could not provide medications." The SureMed machine was removed from the Arbors in November 1996.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges against Respondent in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. JEFF B. CLARK 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 28th day of March, 2001. COPIES FURNISHED: Guy Hendericks, III Post Office Box 4173 Sebring, Florida 33871 Lawrence F. Kranert, Jr., Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
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 Whether Department of Health and Rehabilitative Services ("HRS") Rules 10- and 10-17.005 (originally published as 10-16.001, 10-16.005), Florida Administrative Code, constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Standing Humana is a corporation engaged in the business of constructing and operating hospitals in Florida. It has applied to HRS for a certificate of need to construct and operate a 100-bed acute care hospital to be located south of the St. Johns River in the area known as Mandarin, in Duval County, Florida. The challenged Subdistrict Rule places this area in Subdistrict 3 of HRS District IV. Humana's (Mandarin) application for a certificate of need (CON) was denied by HRS on February 23, 1983, and Humana requested a formal Section 120.57(1), hearing. The case was then transferred to the Division of Administrative Hearings and assigned Case Number 83-934. The final hearing in that CON case began on September 6, 1983, and recessed on September 7, 1983. In the instant case--on Humana's request, and without objection by HRS--official recognition was given to the transcript of that hearing, as filed with the Division of Administrative Hearings. Prior to the CON hearing in Case Number 83-934, on August 12, 1983, HRS published proposed Rules 10-16.001 and 10-16.005 ("Subdistrict Rule") at Volume 9, Number 32, pages 1952 through 1957, Florida Administrative Weekly. (Petitioner's Exhibit No. 1) After the CON hearing recessed, and after a public hearing on the proposed Subdistrict Rule, HRS published changes to the rule on September 23, 1983, at Volume 9, No. 38, page 2475-2476, Florida Administrative Weekly. These changes were made in response to comments which HRS received at a public hearing held on the proposed rule. (Petitioner's Exhibit No. 2) On September 26, 1983, HRS filed the Subdistrict Rule with the Department of State for adoption, effective October 16, 1983. (Petitioner's Exhibit No. 3) Thereafter, the Bureau of Administrative Code, Department of State, informed HRS that since other rules were already numbered in Chapter 10-16, Florida Administrative Code, the Subdistrict Rule would be published in Chapter 10-17, Florida Administrative Code. (Petitioner'S Exhibit No. 28) At the CON hearing, Humana attempted to introduce evidence which HRS challenged as inconsistent with Rule 10-5.11(23) the state-wide acute care bed- need rule, and the Subdistrict Rule--then a proposed rule not yet adopted by HRS. The presiding hearing officer, acknowledging the "proposed rule" status of the Subdistrict Rule, sustained HRS objections to the admission of evidence proposing a methodology, or subdistrict bed-need allocations, inconsistent with those contained in the (proposed) Subdistrict Rule. He did, however, rule that the two non-agency parties could offer evidence for the purpose of showing that HRS, or the local health council in conjunction with HRS, had developed bed-need formula or techniques for subdistricts beyond, or inconsistent with, the proposed Subdistrict Rule and the underlying local health council's district plan. (DOAH Case No. 83-934, pp. 220-221, Transcript of Hearing). II. The Rule Adoption Process In response to Section 381.494(7)(b), Florida Statutes (1983), requiring local health councils to develop district plans using a "uniform methodology," HRS transmitted to the councils written guidelines for designating and allocating bed-need among various subdistricts. (Petitioner's Exhibit Dos. 9 and 10) The statute does not express or imply that the word, "methodology" should be given a meaning other than that assigned by ordinary and common usage. Webster's Seventh New Collegiate Dictionary defines the term as: "a body of methods, rules and postulates; a particular procedure or set of procedures." A methodology is not necessarily a mathematical formula. These guidelines, transmitted to the local health councils in early 1983, describe the relationship between HRS and the councils, the format and content elements of district health plans, and the requirements for stating district health care policies and priorities. Examples are provided. The guidelines require that local plans contain a district health profile--an overview of the area's population characteristics, community health status and prevailing health related attitudes and behaviors. Components are also required, including detailed information on the district's health care resource inventories, costs and utilization patterns, analysis of local services as well as recommendations and priorities for future health systems development. For at least three types of existing health care facilities--acute care hospitals, nursing homes, and psychiatric specialty hospitals information must be provided on current capacity, physical status, service areas, and recommendations for future developments. A time frame is imposed for accomplishing each phase of the plan development, with the final phase adoption of the local health plan--to be accomplished by December, 1983. Finally, the guidelines, at page 15, point out the statutory requirement that HRS adopt, by rule, those elements of the approved district plans necessary for review of applications for certificates of need: Adoption Into Rules Section 7(b) of Chapter 381.493 states that "Elements of an approved district plan necessary to the review of any certificate of need application shall be adopted by the Department as a part of its rules." This should be kept in mind through- out the plan development process. Local policies and priorities are the items most pertinent to certificate of need review since information on bed need and capacity are either determined at the state level or must be updated to the time of certificate of need application, review and appeal. There- fore, the local health council will be ex- pected to develop a separate submission of their policies and priorities in the proper format for rule promulgation within thirty days of the adoption of the local health plan. State agency staff will assist in the development and refinement of these documents. (Petitioner'S Exhibit No. 9) HRS interpreted its responsibility under Section 381.494, as one of assuring that district health plans were consistent with the state-wide uniform bed-need methodology prescribed in Rule 10-5.11(23). Under subparagraph "d" of that rule, local health plans must designate subdistricts according to HRS guidelines. Subparagraph "e" requires that beds be allocated to designated subdistricts consistent with the total number of beds allocated to the district under the rule, and consistent with subparagraph "i," which contains geographic accessibility standards. Rule 10-5.11(23) * * * * * Acute Care Service Subdistrict Designation. Acute care service sub- district designations shall be adopted, as necessary, by each Local Health Council as an element of its local health plan according to guidelines developed by the State Health Planning Agency. Designations will become effective for the purposes of this rule upon the filing of the adopted local health plan acute care subdistricting elements with the Secretary of State. Subdistrict Bed Allocations. Subdistrict bed allocations by type of service shall be made by the Local Health Councils consistent with the district total acute care bed allocation as determined by the methodology contained in paragraph (f) below, as well as any adjustments to the allocation as determined by the provisions of paragraphs and (h) below. Such allocations shall also be consistent with the provisions 9f paragraph (i) and the requirements of Section 381.494(7)(b) , Florida Statutes. * * * * * Geographic Accessibility Considerations. Acute care hospital beds should be available and accessible within an automobile travel time of 30 minutes under average travel conditions to at least 90 percent of the population residing in an urban area subdistrict. Acute care hospital beds should be available and accessible within a maximum automobile travel time of 45 minutes under average travel conditions to at least 90 percent of the population residing in a rural area sub- district. The elements of the District IV health plan contained in the Sub- district Rule are consistent with the uniform methodology prescribed in Rule 10-5.11(23) and HRS guidelines. In response to these guidelines, the District IV health council adopted and transmitted to HRS, on July 7, 1983, the acute care component of the district health plan. After the district council approved this component and allocated beds to the various subdistricts, HRS supplied updated population figures resulting in an increase in the total number of beds allocated to the district. The council's staff then adjusted the number of beds allocated to the subdistricts on a pro rata basis. These adjustments were consistent with the council's policy, as reflected by its approval of the acute care component. No evidence has been presented to show that the council's staff lacked authority to make these adjustments. (Petitioner's Exhibit No. 7) In addition to allocating district wide bed-need among the subdistricts of District IV, the acute care component contains detailed information and analysis concerning acute care bed-need. This information is pertinent but not necessary to the review of CON applications in District IV. (Petitioner's Exhibit No 7) The challenged Subdistrict Rule simply designates subdistricts and allocates bed-need among them; other data and analysis contained in the acute care component are not included. HRS, however, is now drafting an addition to the Subdistrict Rule (Section 10-17.005), titled "subsection (3), Acute Care Policies and Priorities," which incorporates additional portions of the district plan for use in reviewing CON applications in District IV. This draft rule allows exceptions based on local conditions: When there are more than one widely separated hospital service areas located within a single subdistrict, such as St. Augustine in South Duval Subdistrict 3, Bunnell and Daytona Beach in Subdistrict 4, and unforeseen growth, change and makeup of population, or other circumstances cause a significant increase in the demand for inpatient care within one of the service areas, the State should make exception to the District Health Plan when it is reasonable and logical to do so. (Petitioner'S Exhibit No. 34) This provision was contained in the district plan at the time HRS adopted the Subdistrict Rule. (Petitioner'S Exhibit No. 7) The Subdistrict Rule, with the exception of St. Lukes' Hospital, allocates beds among the subdistricts on the basis of the number of patient-days currently utilized by the hospitals in each subdistrict, projected for 1988. St. Lukes' Hospital, now located on the north side of the St. John's River in Subdistrict 1, will move to the south side of the St. John's River in Subdistrict 3, the subdistrict where Humana seeks to build its Mandarin hospital. This move from north to south is accounted in the subdistrict allocation by assuming that 34 percent of the current (north) St. Lukes' Hospital patient-days will come with the hospital when it moves from Subdistrict 1 to Subdistrict 3, and that the remainder will come from Subdistrict 3 (south) patients. With 66 percent of St. Lukes' bed capacity allocated for Subdistrict 3, there will be no additional bed-need in that subdistrict for years. HRS prepared an economic impact statement (EIS) in connection with its adoption of the subdistrict rules, including the Subdistrict Rule under challenge. The EIS addresses the agency's cost to implement the proposed rules, the cost or economic benefit to persons directly affected, and the affect on competition. The data and methods used in preparing the EIS are also briefly summarized.
