Findings Of Fact The following Findings of Fact are based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to section 20.43, and chapters 456 and 459, Florida Statutes. At all times material to these proceedings, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 8729. Respondent's address of record at the time of filing the Administrative Complaint was 11950 County Road 101, Suites 101, 102, and 103, The Villages, Florida 32162. Respondent's current address of record is 13767 U.S. Highway 441, Lady Lake, Florida 32159. Respondent currently holds no board certification in any specialty area, and did not complete any residency other than in emergency medicine. Respondent attended Michigan State University, College of Osteopathic Medicine. In 2002, he began full-time practice as an emergency room physician at Munroe Regional Medical Center in Ocala, Florida. He worked as an emergency room physician until he opened Exceptional Urgent Care Center (“EUCC”). At all times material to this complaint, Respondent owned and operated EUCC. Treatment Provided to Patient J.K. On March 15, 2018, J.K., along with his wife, presented to EUCC with complaints of a sore throat and fever. This was the first of two visits to the clinic. J.K. reported his medications as Amlodipine, Warfarin, Tamsulosin, and Dofetilide (unless otherwise indicated, hereinafter referred to by its trade name "Tikosyn"). J.K. was prescribed these medications by his cardiologist at the William S. Middleton Memorial Veterans Hospital (“V.A. Hospital”) in Wisconsin, his home state. Relevant to this matter, Tikosyn helps patients maintain a normal heartbeat rhythm. Tikosyn was prescribed to keep J.K.'s heart in rhythm as he had atrial fibrillation. J.K. was treated by a nurse practitioner, who ordered a chest x-ray and a flu swab. The flu swab returned negative, and the chest x-ray showed no focal pneumonia. J.K. was prescribed Tamiflu and Naproxen. J.K. elected not to fill the Tamiflu due to the “expensive cost.” Respondent was not involved in J.K.'s treatment on this date. On March 16, 2018, J.K. and his wife K.K. returned to EUCC as J.K.’s symptoms had not improved. On this visit, J.K. saw Dr. Im. Dr. Im evaluated J.K. and ordered two tests. Dr. Im ordered a Prothrombin Time International Normalized Ration ("PT INR") test to determine J.K.'s coagulation and he ordered a CT scan of the chest. The PT INR results were within the therapeutic range. The CT scan showed shattered ground- glass opacification in the posterior right lower lobe and the medial left upper lobe. The CT scan findings were interpreted as "non-specific, may represent hypoventilatory change or an infectious inflammatory process (acute or chronic).” Respondent advised J.K. and K.K. that the CT scan appeared to show the start of pneumonia, and he was going to prescribe three medications: Levaquin 750 mg, Prednisone 20 mg, and Zyrtec 10 mg. K.K. testified that she asked Respondent if the Levaquin, Prednisone, or Zyrtec were contraindicated with any of J.K.'s current prescriptions, specifically Tikosyn. K.K recalls that Respondent replied that he was not familiar with Dofetilide (Tikosyn), and advised them to check with the pharmacist to see if there were any contraindications. Although Respondent initially advised J.K. and K.K. that he was not familiar with Tikosyn, Respondent testified that he advised J.K. and K.K. of the possible interactions between Levaquin and Tikosyn and told her that the interaction was very rare. He testified that he advised J.K. and K.K. that the pharmacist is a safety net, and the pharmacist would call him to discuss the prescriptions if he missed anything. K.K. credibly testified that Respondent did not counsel J.K. or K.K. on any risks regarding the medications Dr. Im prescribed or provide them with any alternatives during the visit on March 16, 2018. J.K. and K.K. left EUCC and went to Publix to fill the prescriptions. K.K. asked the pharmacist if any medications would interfere with any of J.K.'s prescribed medications. Upon advice of the pharmacist that Levaquin was contraindicated with Tikosyn, K.K. declined to fill the prescription for Levaquin. On behalf of J.K., K.K. then called EUCC and asked for a different antibiotic that would not interact with Tikosyn. However, she was instructed to contact J.K.'s cardiologist. K.K. then contacted the cardiology staff of the V.A. Hospital in Wisconsin, who instructed K.K. to follow the advice of the pharmacist and (tell J.K.) not to take the Levaquin. K.K. called EUCC a second time to confirm whether J.K. had an infection and she was told that J.K. did not have an infection. Respondent recalls that he had a personal conversation with K.K. during a courtesy telephone call placed the next day (March 17, 2018). Respondent testified that during that call, he explained Levaquin was the drug of choice, other medications would not cover J.K.'s pneumonia, the potential interactions were very rare, and J.K. needed to take the Levaquin. By his own admission and his medical records, Respondent did not provide J.K. or K.K. with any specific alternative antibiotics and insisted that J.K. needed to take the Levaquin. K.K. disputes that Dr. Im spoke with her or J.K. at any point after the March 16, 2018, visit. She clearly recalled that she spoke with a woman each time she spoke with staff at Dr. Im’s office. Overall, J.K. and K.K. clearly and convincingly testified that Respondent never advised them of the risks of using Levaquin with Tikosyn or provided any alternatives to the Levaquin. Expert Testimony Petitioner offered the testimony of Dr. Anthony Davis, who testified as an expert. Dr. Davis has been licensed as an osteopathic physician in Florida since 1995. Dr. Davis attended Kirksville College of Osteopathic Medicine and completed an internship in family practice. He has been board certified in family medicine by the American Board of Osteopathic Family Physicians since 2001, and board certified in emergency medicine by the American Association of Physician Specialists since July 2003. He is also affiliated with professional organizations including the American College of Family Practice and Florida Osteopathic Medical Association. Dr. Davis was accepted as an expert in emergency and family medicine. Dr. Davis relied upon his work experience, his training, and his review of the medical records for J.K. to render his opinion regarding the standard of care related to treating J.K. The standard of care requires an osteopathic physician treating a patient similar to J.K. to: (1) provide and document their justification for why Levaquin was the appropriate drug of choice; (2) note the patient’s acknowledgment that there are interactions with Tikosyn; (3) ensure the patient understands the risks and benefits of combining Tikosyn and Levaquin; (4) explain to the patient that there are limited alternatives to Levaquin; and (5) provide the reason for prescribing a potentially dangerous drug. Levaquin is a medication that comes with a black box warning that requires physicians to counsel patients on the risks associated. When a drug is designated as contraindicated and has a category X for interaction, the standard of care requires that the physician clearly explains to the patient why they are using the drug and defend how it is going to be safe. Tr., p. 70. Dr. Davis opined there were multiple treatment options available for J.K., such as supportive care or an antibiotic with a lower risk of interaction with J.K.'s existing medication. Moreover, Dr. Davis testified that there were safer alternatives to Levaquin that would effectively treat pneumonia, such as doxycycline, if J.K. actually had pneumonia and an antibiotic was necessary. Respondent provided literature from the Infectious Diseases Society of America related to community-acquired pneumonia in an attempt to prove that X-Ray or other imaging techniques are required for the diagnosis of pneumonia and to support his claim that Levaquin was the drug of choice for J.K. However, Dr. Davis credibly pointed out that the article, published in 2007, is no longer accurate.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medicine enter a Final Order as follows: Finding that John Joseph Im, D.O., violated section 459.015(1)(x), by committing medical malpractice, as defined in section 456.50, as alleged in the Administrative Complaint; Issue a letter of concern against Respondent’s license to practice osteopathic medicine; Requiring completion of a prescribing practices course; and Imposing an administrative fine of $2,500. DONE AND ENTERED this 16th day of December, 2019, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN 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 16th day of December, 2019.
The Issue The issue is whether the osteopathic medical license of James E. Mhoon, D.O., (Mhoon) should be revoked or otherwise penalized based on the acts alleged in the Amended Administrative Complaint.
Findings Of Fact James E. Mhoon, D.O., is a licensed osteopathic physician in the State of Florida, having been issued license number 050001142. He practices at 1502 Roberts Drive, Jacksonville Beach, Florida, and has practiced in Florida since 1958. Between January 25, 1982, and June 19, 1985, Mhoon treated Mrs. Vernon (Vee) Howard for osteoarthritis, degenerative disc disease, and osteoporosis. Throughout this time period, Mhoon prescribed a Schedule II narcotic, Nembutal, to Mrs. Howard. Specifically, between January 1, 1984, and March 7, 1985, Mhoon prescribed 800 Nembutal to the patient. Mrs. Howard first saw Mhoon on January 25, 1982, at age 63. Mhoon hospitalized her and referred her to a neurologist. She was already taking Nembutal prescribed by another doctor, although Mhoon's records do not indicate who that doctor was. According to Mhoon, she was seen by a neurologist, referred to University Hospital to a neurosurgeon, and ultimately had disc surgery in March, 1982; however, Mhoon's records do not contain any documentation of these events. Nembutal, according to the Physician's Desk Reference (PDR), is a hypnotic agent and is appropriate for short-term treatment of insomnia. Mhoon explained that he used Nembutal in this patient because it was an extremely strong sedative hypnotic which also potentiates the narcotic analgesic medication he gave her (Percodan). He prescribed it because Mrs. Howard had constant severe pain and was unable to sleep. He believed that this was the only choice for this patient because he could use these drugs to relieve her pain and allow for sleep while risking addiction or he could allow Mrs. Howard to die. No other viable surgical or medical alternatives existed. Dr. Lloyd Gladding acknowledged that Nembutal was useful in conjunction with Schedule II analgesics in the long- term management of severe pain. According to Gladding it would be useful if other alternatives were not available. Duane L. Bork, M.D., also agreed that the use of Nembutal with this patient was appropriate considering her chronic problems with severe pain. Mhoon's medical records on Mrs. Howard do contain multiple references to her chronic pain and associated sleep disturbance. They also contain numerous references to Mrs. Howard's severe alcoholism, including one hospitalization for an overdose of Percodan and alcohol. In these respects, the medical records are adequate to justify the course of treatment. Mhoon treated a patient, Roy Landrum, from March, 1971, until June, 1985, for hypotension and anxiety as well as other injuries and illnesses. Throughout this time Mhoon prescribed Seconal, a Schedule II drug. While Mhoon prescribed Seconal throughout the time he saw Landrum, specifically between January 30, 1984, and June 5, 1985, he prescribed and the patient received 5450 milligrams of Seconal or approximately 500 milligrams per day (10 50 mg. capsules per day). Seconal has the side effects of confusion, disorientation, and drowsiness, and is addictive. According to the PDR, the recommended dosage of Seconal is between 50 and 100 milligrams daily for short periods. According to Mhoon's testimony, he first saw Landrum in 1971 at age Landrum had been receiving Seconal for 38 years from another doctor for treatment anxiety. Mhoon claims he counselled with Landrum in an attempt to get Landrum to give up the drug and seek detoxification. Landrum refused to abandon Seconal because he believed it worked well for his anxiety. Mhoon claims he allowed Landrum to have 10 capsules daily because Landrum's wife died unexpectedly. None of this information is in Mhoon's medical records on Landrum. Landrum's wife died in July, 1984; however, Mhoon prescribed 5450 mg. of Seconal between January, 1984, and June 5, 1985, six months before and one year after Landrum's wife died. Accordingly, little weight is given to Mhoon's explanation for this prescribing of massive amounts of Seconal. Mhoon did appropriately monitor Landrum for side effects and organ damage from the massive doses of Seconal. According to Thomas A. Michelsen, D.O., allowing Landrum to have 10 capsules of Seconal daily is excessive even allowing for some variance from the PDR. Seconal is recommended for treatment of insomnia for a 2-3 week period. It is not recommended for anxiety, and lower scheduled drugs, such as Restoril, Dalmane, and Halcion, are appropriate and recommended. Dr. Michelsen reviewed Mhoon's records and opined that the records are inadequate and fail to justify the course of treatment. Lloyd D. Gladding, D.O., stated that Seconal was inappropriate because better medication was available for treatment of anxiety. Dr. Bork testified that Seconal was the drug of choice for treatment of anxiety for most of the 38 years before Landrum came to Mhoon. It was replaced by the benzodiazepines such as Valium and Librium, however it is still listed in Rakel's Textbook of Family Practice as an anti-anxiety drug and it is still appropriate in some cases. Bork believes Mhoon's treatment of Landrum was appropriate, however he bases his opinion on the medical records and detailed discussions with Mhoon. Harry Curtis Benson, M.D., saw Landrum twice in 1986 and reviewed Mhoon's records and discussed the matter with Mhoon and Landrum. Because Landrum had done very well on the Seconal and because he refused to change, Benson thought Mhoon's prescribing was appropriate, even considering the large amounts for 1984 and 1985. The opinions of Dr. Bork and Dr. Benson are credited because their opinions are based on more than a simple review of the PDR and Mhoon's records. Accordingly, it is found that Mhoon's prescribing to Landrum was not excessive or inappropriate. It is, however, found that Mhoon's medical records fail to justify the course of treatment. Mhoon also treated three patients for narcolepsy. Narcolepsy is a disorder which is treated with a range of central nervous system stimulants. These drugs are subject to abuse. Narcolepsy is primarily diagnosed by a detailed patient history and clinical observation of the patient. Mhoon treated Kathryn Tackett from September, 1981, until July, 1985, for, among other things, narcolepsy. There is no indication in the medical records of her first visit with Mhoon that she had symptoms of narcolepsy. According to Mhoon, Tackett told him that she had suffered from narcolepsy and that her previous physician prescribed Ritalin and Fastin. She also advised that she had been treated for narcolepsy by a neurologist in Jacksonville, Dr. McCullough. Mhoon's medical records do not contain any medical records from these other physicians confirming the diagnosis of narcolepsy. Mhoon claims that he did a thorough workup and took a detailed patient history on Tackett. Mhoon's medical records do not contain any notations of patient history regarding symptoms of narcolepsy or of physical examination findings or clinical observation which relate to narcolepsy findings. Mhoon prescribed Ritalin and Fastin for Tackett throughout the four years he saw her. Ritalin is a commonly used drug for narcolepsy. Fastin is a sympathomimeticamine and is chemically and pharmacologically related to Ritalin and the amphetamines, but is a weaker central nervous system stimulant. The PDR recommends Fastin as an anorectic drug to be used for weight reduction in abuse patients. The PDR recommends a dosage of one capsule per day. Mhoon continued to give Fastin to Tackett because it was sufficient stimulation to control her narcolepsy at times and was a less dangerous drug than Ritalin and the amphetamines. Dr. Michelsen disapproved of the use of Fastin simply because it was not in the PDR for treatment of narcolepsy. Michelsen did not understand the relationship between Fastin and the amphetamines. Dr. Gladding initially disagreed with the use of Fastin because it was not listed as a drug indicated for use in narcolepsy. He did finally agree that Fastin was a weaker stimulant than the indicated drugs. Dr. Bork agreed that Fastin is a central nervous system stimulant that is considerably safer than the amphetamines. Bork found Mhoon's treatment and prescribing to Tackett to be appropriate. Dr. Bork's opinion is accepted in this regard and it is found that the use of Fastin was appropriate for narcolepsy. Dr. Bork also testified that Mhoon's records were adequate to justify the course of treatment. However, when questioned further, he was unable to reference the records to support his opinion. Both Dr. Michelsen and Dr. Gladding found the medical records to be inadequate to justify the course of treatment given by Mhoon to Tackett. A review of the medical records supports these opinions. It is found that Mhoon's records regarding Tackett contain inadequate documentation to support a finding of narcolepsy or to support the course of treatment. Mhoon treated Mildred Lockwood for narcolepsy from May, 1974, until June, 1985. Mhoon testified that he took a long detailed history from the patients regarding her narcolepsy. Mhoon's medical records do not reflect such a patient history. Mhoon also claims that the patient had been treated by Dr. Faris for narcolepsy and that he called Dr. Faris and confirmed the diagnosis. Again, Mhoon's medical records do not mention Dr. Faris or any contact with him. The medical records reflect only that the patient said she had narcolepsy. Subsequently, in 1987, Mhoon sent Lockwood to a neurologist who, according to Mhoon, agreed with his diagnosis and treatment of Lockwood. Dr. Bork also concurred with the diagnosis and treatment of Lockwood. A review of the medical records shows that the records are inadequate to justify the course of treatment given to Lockwood because they contain no detailed patient history, no clinical observations, and no confirming opinions. Mhoon treated Glen Burke for narcolepsy from October, 1974, until June, 1985. In Burke's case, Mhoon had a neurological consultation report from a Paul W. Jones, M.D., from February 2, 1971, which contained a detailed patient history, a record of an EEG, and a diagnosis of narcolepsy. The medical records of Dr. Jones, which reflect his treatment of Burke for narcolepsy from February, 1971, until September 6, 1974, show a history of successful treatment with Benzedrine and Dexedrine. Mhoon treated Burke with Benzedrine and Dexedrine. He also followed Burke on a regular basis and adjusted his medication as necessary. Dr. Bork opined that the treatment and records of Mhoon for Burke are appropriate and adequate. In 1986, Mhoon referred Burke to a neurologist, Dr. R. L. Hudgins. Dr. Hudgins examined Burke and determined that Mhoon's diagnosis, treatment and medications for Burke are correct and appropriate. It is found that Mhoon's diagnosis and treatment of Burke are appropriate and that the medical records justify the course of treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Professional Regulation, Board of Osteopathic Medical Examiners, enter a Final Order and therein: Find the Respondent, James E. Mhoon, D.O., guilty of violating Section 459.015(1)(n), Florida Statutes (1985), now Section 459.015(1)(p), Florida Statutes (Supp. 1986), as charged in Count II of the Amended Administrative Complaint, as it relates to patients Landrum, Lockwood and Tackett. Dismiss all other charges contained in the Amended Administrative Complaint. Order the Respondent to attend continuing education courses to improve his record keeping and documentation. Reprimand Respondent for these violations. Impose a fine of $1,000.00. Case No. 86-1710 DONE AND ENTERED this 2nd day of March, 1988, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of March, 1988. APPENDIX TO THE RECOMMENDED ORDER IN CASE NO. 86-1710 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted by the parties in this case. Specific Rulings on Proposed Findings of Fact Submitted by Petitioner, Department of Professional Regulation, Board of Medical Examiners Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 1 & 2 (1); 3 & 4 (2); 8 (29); 9 (30); 10 (29); 11 (8); 12 (8); 13 (9 & 10); 15 (11 & 14); 16 (34); 19 & 20 (20); 21 (21); 22 (23); and 24 (28) Proposed findings of fact 5, 6, and 7 are subordinate to the facts actually found in this Recommended Order. Proposed finding of fact 17 is unsupported by the competent, substantial evidence. Proposed finding of fact 18 is unnecessary. Specific Rulings on Proposed Findings of Fact Submitted by Respondent, James E. Mhoon, D.O. 1. Each of the following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 4 (2 & 4); 6 (5); 7 (6); 8 (7); 13 (14); 14 (14); 16 (16); 17 (16); 18 (17); 22 (34); 23 (37); 24 (21); 25 (25); 30 (32); and 32 (32) 2. Proposed findings of fact 5, 10, 11, 12, 15, 19, 20, 21, 26, 27, 28, 29, and 33 are subordinate to the facts actually found in the Recommended Order. Proposed findings of fact 1, 2, and 3 set forth in the Procedural Matters section of this Recommended Order and are not necessary as findings of fact. Proposed finding of fact 9 is rejected as being argumentative and conclusionary. Proposed finding of fact 31 is rejected as being unsupported by the competent, substantial evidence. The exhibit upon which it is based was not admitted in evidence. COPIES FURNISHED: Francine Landau, Esquire Inman and Landau 2252 Gulf Life Tower Jacksonville, Florida 32207 Harry L. Shorstein, Esquire 615 Blackstone Building Jacksonville, Florida 32202 Susan Branson, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Respondent, Alexandra Konowal, D.O., violated Subsections 459.015(1)(x) and (o), Florida Statutes, and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed osteopathic physician in the State of Florida, having been issued license number OS 7169. Petitioner is the state agency charged with regulating the practice of osteopathic medicine pursuant to Section 20.42, Florida Statutes. On July 20, 1998, Respondent first saw Patient B. M., a 75-year-old female, at Eye Health of Fort Myers, for a complaint of poor vision and cataracts. Respondent scheduled cataract surgery for July 30, 1998, at an outpatient surgery center. On Thursday, July 30, 1998, at approximately 10:30 a.m., Respondent performed the surgery, removing the lens of Patient B. M.‘s left eye and replacing it with an implant. Patient B. M. was discharged from the surgery center at 11:17 a.m., with instructions to go to Eye Health of Fort Myers for follow-up examination that afternoon. On Saturday, August 1, 1998, Patient B. M. telephoned Eye Health early in the morning complaining of inability to see from the left eye and severe pain in the left eye. At about 9:00 a.m., August 1, 1998, Patient B. M. was examined at Eye Health of Fort Myers by James Campbell, an optometrist with Eye Health. Dr. Campbell found residual cortex in the left eye, with corneal edema, but observed no pus in the eye. Dr. Campbell changed the antibiotic eye drops for the patient. At approximately 10:00 a.m., on August 1, 1998, Dr. Campbell had a telephone conference with Respondent and Dr. Franz to discuss the symptoms of Patient B. M. At approximately 4:45 p.m., on August 1, 1998, Patient B. M. again called Eye Health complaining of unbearable pain. Dr. Campbell, in turn, called Respondent at approximately 5:00 p.m. to advise her of Patient B. M.’s complaints. During the 5:00 p.m. telephone call from Dr. Campbell to Respondent, Dr. Campbell discussed the possible diagnosis of endophthalmitis. At 5:36 p.m., August 1, 1998, Respondent spoke with Patient B. M. on the telephone for nine minutes. During the 5:36 p.m. telephone call, Patient B. M. reported shooting pains in her eye and that her vision was bad. During the 5:36 p.m. telephone call, Respondent advised Patient B. M. that she needed to be evaluated. When Patient B. M. said she could not come in, Respondent advised of the possible risks including damage to the optic nerve from excessive pressure and infection. Respondent suggested going to the emergency room and offered to provide transportation, but Patient B. M. refused. During the 5:36 p.m. telephone call, Respondent recommended that Patient B. M. take Percocet that the Patient already had for the pain; Respondent would call in a prescription for erythromycin ointment and told the patient to call back if the eye didn’t improve. Following the 5:36 p.m. telephone call, Respondent did phone in a prescription for erythromycin to a Walgreens Pharmacy near Patient B. M.'s residence. It appears the patient did not pick up this prescription. The "standard of care" expert witness offered by Petitioner found it "difficult to answer" a hypothetical question directed to the "standard of care" of Respondent's care of Patient B. M., incorporating all relevant facts set forth hereinabove in these Findings of Facts and, essentially, failed to render an opinion incorporating all relevant facts; therefore, Petitioner has failed to prove by clear and convincing evidence that Respondent failed to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances as alleged in this matter. Respondent prepared an office note dated August 1, 1998, 7:30 p.m., as a record of Respondent’s telephone call to Patient B. M. This note was, in fact, prepared on the morning of August 3, 1998. The note reads in its entirety: 8/1/98 7:30 PM Spoke with patient. States having pain in left eye. Recommended artificial tears for shooting pain, and continue using Ocuflox and Pred Forte. Patient states she has been taking Percocet every four hours with no relief, but she takes Percocet regularly for neuropathy. Told to use two every four hours and call if no improvement. While the August 1, 1998, office note records a great deal of relevant information, Respondent's testimony revealed it does not reflect Patient B. M.'s refusal to come in for evaluation, Respondent's warnings regarding the risks of not being evaluated, an offer of transportation to an emergency room, or a prescription order for Erythromycin. Petitioner's expert witness testified on deposition that, "I'm not sure what the standard of care is" for charting weekend telephone calls. When he receives a telephone call at home from a patient, he makes notes on "a scrap of paper" and later records the note in the patient's record. Respondent testified that she now keeps a book at home in which she records every conversation when patients call her at home; she then brings the book to her office for reference in recording the entire conversation in the patient's record. However, she does not believe that anyone in her practice does it the way she now does. There is no standard procedure in the practice of osteopathic medicine for memorializing conversations in the patient's record between a physician and patient which occur outside the office or hospital setting. On August 3, 1998, Patient B. M. returned to Respondent’s office complaining of no vision and sharp pain. Respondent’s examination revealed Patient B. M.’s left eye to be swollen and with hypopyon (internal pus). Respondent diagnosed endophthalmitis and immediately referred Patient B. M. to a retinal specialist. On August 3, 1998, Patient B. M. was seen by the retinal specialist who found near total hypopyon, so that neither the iris nor any posterior detail could be visualized. Ultrasound showed dense mobile vitreal opacities, primarily anteriorly. The specialist recommended a vitrectomy with injection of antibiotics, and discussed at length the possibility of loss of vision, loss of the eye and uncertainty of any visual benefit. He performed the surgery for Patient B. M. the night of August 3, 1998. Endophthalmitis is a recognized complication of cataract surgery that occurs in less than one percent of patients, but does not presumptively indicate a departure from the standard of care. The standard of care required Respondent see Patient B. M. and treat her for endophthalmitis on August 1, 1998, or to warn Patient B. M. on August 1, 1998, of the serious consequences of endophthalmitis if Patient B. M. did not have an examination. The evidence revealed that Respondent warned Patient B. M. of the serious consequences of her failure to go to the clinic or an emergency room for treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, that the Department of Health, Board of Osteopathy, enter a final order finding that Respondent, Alexandra Konowal, D.O., is not guilty of violating Subsections 459.015(1)(x) and (o), Florida Statutes, and dismissing the Administrative Complaint filed in this matter. DONE AND ENTERED this 18th day of December, 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 18th day of December, 2001. COPIES FURNISHED: Bruce A. Campbell, Esquire Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 39A Tallahassee, Florida 32399-0450 Bruce M. Stanley, Jr., Esquire Henderson, Franklin, Starnes & Holt 1715 Monroe Street Post Office Box 280 Fort Myers, Florida 33902-0280 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Department of Health 4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times relevant hereto Lawrence D. Urban was a licensed osteopathic physician in Florida having been issued license number OS 001232. From January 1983 through at least March 17, 1984, Respondent maintained offices in Clearwater and Zephyrhills. He practiced in the Clearwater office on Monday, Wednesday and Friday of each week and in the Zephyrhills office on Tuesday, Thursday and Saturday. Respondent employed Wendell Bloom to work in the Zephyrhills office as a business manager and assistant to Respondent. Bloom had no medically related license such as physician's assistant, nurse, technician, etc. As an assistant to Respondent, Bloom drew blood, performed vascular analyses, mixed IV solutions, and administered IV solutions. He worked at the Zephyrhills office Monday through Friday. Bloom had standing orders from Respondent that if a new patient came in Bloom would draw a blood sample, send it to the lab for analysis and make an appointment for the patient to see Respondent when the results of the blood analysis was received. Respondent described his practice in Zephyrhills as holistic, involving nutrition, chelation, and cancer therapy using laetril. Chelation treatment involves the intravenous injections of solutions containing EDTA (Ethylenadiaminetetracetic acid), vitamins, including B12, B complex and C, and the minerals, calcium and magnesium. On many occasions Bloom commenced IV chelation injections containing EDTA before Respondent arrived at the office and completed some of these after Respondent had left the office. On at least five (5) occasions Bloom injected patients with IV solutions containing EDTA without Respondent being present any time during the procedure. Drawing blood without a doctor present in the office constitutes the practice of medicine. Injecting IV solutions in patients constitutes the practice of medicine without a doctor present. In the Zephyrhills office Respondent referred to Bloom as Dr. Bloom in the presence of patients. No sign or disclaimer was posted in the office that Bloom had no prior medical training and was not licensed in any medically related health professional field in Florida. Respondent knew that patients might believe Bloom to be a medical doctor. In administering an IV solution to a patient there is always a danger of an allergic reaction or an anaphylactic reaction, even if a patient has previously tolerated the treatment. Respondent acknowledged that serious side affects would result to a patient receiving an IV solution containing EDTA if the patient suffered kidney failure. Bloom also operated the vascular analyzer machine in the office. As described by Bloom, by attaching clips from the machine to the fingers and toes the machine will tell you if there is any kind of clotting or obstruction any place within the cardiovascular system. Further, by putting transmission gel on the clip and holding it over an artery, transmissions from the clip with the return echo is transformed onto a chart which will denote the elasticity of the artery. This machine is not universally accepted in the medical profession. By Final Order entered August 26, 1983 (Exhibit 1) the Florida Board of Osteopathic Medical Examiners found Respondent guilty of filing false reports, fee splitting, and abetting an unlicensed person to practice osteopathic medicine. He was sentenced to a reprimand, placed on probation for six (6) months and directed to report to the Board at the end of the probationary period. If, at this time, Respondent's report on the status of his practice satisfies the Board that the financial aspects of his practice is in accordance with the law, the reprimand will be withdrawn. Terms and conditions of the probation were not delineated. Respondent appeared before the Board at its March 17, 1984 meeting. After Respondent reported that the financial aspects of his practice were poor, but in conformity with the law, one of the Board members inquired if Respondent was working with any non-osteopathic physicians in his practice, which was one of the accusations for which he was reprimanded and placed on probation. At this point Respondent told the Board that he had a helper who was a "non- anything" who was drawing blood, doing vascular analyses of patients, giving IVs to patients undergoing chelation therapy and whatever Respondent told him to do. (Exhibit 2) After hearing these disturbing facts the Board voted to extend the Respondent's probation while an investigation of his practice was conducted. The charges considered at this hearing were those resulting from that investigation.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Each of the petitioners and intervenors are owners, operators and/or applicants for acute care hospital facilities in Florida. Prior to the challenged proposed rule, HRS had no separate rule setting forth the criteria or methodology to be utilized when reviewing applications for new or expanded osteopathic hospitals. By memorandum dated March 1, 1984, the then Deputy Assistant Secretary for Health Planning and Development for HRS informed the HRS Acting General Counsel that because there were four applications for osteopathic hospitals should be reviewed and addressed, "it would be to our advantage to have a written policy in place within the next week." An Assistant General Counsel prepared a four-page document dated March 7, 1984, which analyzed the appellate decision in Gulf Coast Hospital, Inc. v. HRS, 424 So.2d 86 (Fla. 1st DCA, 1982) and three administrative orders involving Certificate of Need applications for osteopathic hospitals. HRS rules, particularly those dealing with the Certificate of Need program, are generally prepared by the Office of Comprehensive Health Planning. In this instance, Mr. Eugene Nelson, the Administrator of the Office of Community Medical Facilities, prepared and drafted the challenged rule. Prior to the preparation and approval of the proposed rule, which, according to the notice appearing in Volume 10, No. 18 of the Florida Administrative Weekly (May 4, 1984), was accomplished on April 6, 1984, HRS held no public workshops, formed no task force to study osteopathic bed need, and did not consult with or receive any input from the Statewide Health Counsel, local health councils, existing osteopathic or allopathic facilities or professional associations. After publishing the proposed rule on May 4, 1984, HRS did hold an informal public hearing and received written comments. Neither the transcript of the hearing nor the written comments had been reviewed by Mr. Nelson as of the date of the instant rule challenge hearing. The proposed rule adds a new subsection to existing Rule 10-5.11, Florida Administrative Code, which contains the criteria for evaluating applications for Certificates of Need. Proposed rule 10-5.11(28) sets forth the criteria for evaluating osteopathic acute care need, and provides as follows: "Osteopathic acute care hospital" or "osteopathic hospital" means, for the purposes of administration of the Health Facilities and Health Services Planning Act (Sections 381.493 - 381.499, Florida Statutes), a hospital which: Has or proposes to have licensed doctors of osteopathy (D.O.s) in the capacities of Chief of Staff, Medical Director, chiefs of each medical department, and director of any residency or training program; and Has or proposes to have, on its premises, facilities and equipment to perform osteopathic manipulative therapy. Notwithstanding the above, nothing in this paragraph shall apply to osteopathic hospitals in existence prior to the effective date of this rule. Identification of such hospitals shall be consistent with the current inventory of osteopathic acute care hospitals as shown in reference material filed with the Department of State. Applications for proposed osteopathic acute care hospital beds will be reviewed according to relevant statutory and rule criteria. A favorable need determination for proposed osteopathic acute care hospitals beds will not normally be given to an applicant unless a bed need exists according to paragraph (28)(c) of this rule. A favorable need determination may be made when the criteria, other than as specified in (28)(c), as provided for in 381.494(6)(c), Florida Statutes, and the remainder of Rule 10-5.11, Florida Administrative Code, demonstrate need. The need for osteopathic acute care hospital beds shall be calculated in conjunction with Rule 10-5.11(23) and analyzed on a service district level only. The need for such beds in a service district shall be five percent of that service district's total acute care bed need as determined by Rule 10-5.11(23), notwithstanding the supply of existing and approved non-osteopathic acute care hospital beds in the service district. In determining whether a need exists for additional osteopathic acute care hospital beds, however, the department shall consider the supply of existing and approved osteopathic acute care hospital beds in the service district and shall deduct this supply from the calculation of bed need in making such determination. In addition to the methodology contained in (28)(c), the department shall consider the following criteria and standards in reviewing proposals for additional osteopathic acute care hospital beds: The historical and current utilization of all existing osteopathic acute care hospital beds in the service district; The number of licensed and approved osteopathic acute care hospital beds in the service district; The supply of licensed D.O.'s in reasonable proximity to the location of the proposed osteopathic hospital; The historical and current utilization by D.O.'s of all non-osteopathic hospitals in the service district, except in those instances where discrimination against D.O.'s has regularly occurred. An applicant who cites discrimination in the granting or denial of hospital staff membership or professional clinical privileges as a reason for the application shall include, as part of the application, evidence that the remedies provided for in s.395.006(1), Florida Statutes, have been followed. Each proposed new osteopathic hospital must be accredited by the American Osteopathic Association (AOA) within two years of initial operation. Each existing hospital proposing additional osteopathic acute care hospital beds must be AOA- accredited; and meet the requirements under sections (a)1. and 2. In no event shall historical and current utilization of all hospital beds by all physicians be used to determine need for osteopathic acute care hospital beds. All existing and approved osteopathic acute care hospital beds shall be included in the department's inventory of total existing and approved acute care beds. Subsection (a) of the proposed rule basically defines an osteopathic hospital in terms of its staff and facilities and then "grandfathers" those osteopathic hospitals which are in existence prior to the effective date of the rule. Such hospitals are to be identified by the "current inventory of osteopathic acute care hospitals as shown in reference material filed with the Department of State." According to Mr. Nelson, the inventory referred to in the proposed rule is a directory of osteopathic hospitals prepared by the Florida Osteopathic Medical Association (FOMA). Mr. Nelson had no knowledge of the criteria which FOMA utilized to develop this list, nor did he scrutinize each hospital to determine if it was, indeed, an "osteopathic" facility. At least one hospital, Humana Hospital of the Palm Beaches, was removed by HRS from the FOMA list based on a Recommended Order from a Hearing Officer in a Certificate of Need proceeding finding that Humana was no longer an osteopathic hospital. Humana was not a party to that proceeding. The FOMA list does not include those hospitals whose medical staffs are comprised of a large percentage of osteopathic physicians. Acute care hospitals are licensed by the HRS Office of Licensure and Certification as either "general" or "special" hospitals. They are not licensed as "osteopathic" or as "allopathic" hospitals. The appointment or election of medical staff positions within a hospital are internal matters for each facility and HRS has no authority to control such matters. Florida's Hospital Licensing and Regulation Law does prohibit a licensed facility from denying staff privileges to an individual based upon the individual's status as a Doctor of Osteopathy, a Doctor of Medicine, a Doctor of Dentistry or a Doctor of Podiatry. Section 395.011, Florida Statutes. Subsection (f) of the proposed rule requires accreditation by the American Osteopathic Association (AOA) within two years of initial operation of new osteopathic hospitals and before existing hospitals propose additional osteopathic acute care beds. Both Mr. Nelson and the Director of the Office of Licensure and Certification were unaware of AOA accreditation requirements. There are no statutory requirements for AOA accreditation for osteopathic hospitals. Utilizing the FOMA list of osteopathic hospitals, osteopathic beds comprising approximately five percent of the total number of licensed acute care hospital beds in Florida. The number of osteopathic physicians licensed in Florida, without regard to the nature of their practice or the location of their residence, is approximately five percent of the total number of allopathic physicians licensed in Florida. These two factors form the basis for the quantitative osteopathic bed need methodology set forth in subsections (b) and (c) of the proposed rule. The rule provides that need for osteopathic beds in a given HRS service district is five percent of the total number of acute care hospital beds shown to be needed for such District pursuant to the acute care bed need formula contained in Rule 10 5.11(23), Florida Administrative Code. The acute care bed need formula set forth in Rule 10-5.11(23) basically employs statewide utilization rates to determine each District's bed allocation and then adjusts each District's allocation based upon that District's specific historical utilization experience. The District's gross osteopathic bed need, as determined by the five percent formula contained in the proposed rule, is then to be reduced by the number of existing and approved osteopathic beds. The actual supply of existing and approved non-osteopathic acute care beds in the service district is not to be considered in determining the osteopathic bed need. Conversely, existing and approved osteopathic beds are to be included in the inventory of total existing and approved beds. Subsection (h) of the proposed rule. While historical and current utilization of both existing osteopathic beds and the utilization by osteopathic physicians of beds in non- osteopathic hospitals are factors for consideration (subsection (d)1 and 4), HRS may not consider historical and current utilization of all hospital beds by all physicians. Subsection (g) of the proposed rule. The workings of the proposed rule can be exemplified by assuming a hypothetical District with an overall acute care bed need, as determined pursuant to Rule 10-5.11(23), Florida Administrative Code, of 1,000 beds. If no osteopathic beds currently exist in the District, 50 such beds would be approvable under the proposed rule, regardless of the number of occupancy levels of non-osteopathic beds existing in that District. If the District currently has 800 beds, 50 osteopathic beds would be approvable. If the District currently has 1,400 beds, 50 osteopathic beds would still be approvable. If existing non osteopathic hospitals in the District have occupancy rates of 20 percent or 100 percent, this factor is not to be considered. Conversely, the utilization of existing osteopathic hospitals beds is a factor for consideration. Whether the number 50 in this hypothetical District is a minimum, a maximum or just a guideline for the permissible number of osteopathic beds was a subject of confusion among the witnesses who testified at the hearing. Also subject to confusion was whether the proposed rule has the effect of limiting non-osteopathic facilities to ninety five percent of the total bed need as computed under Rule 10 5.11(23), Florida Administrative Code. In determining the need for osteopathic and allopathic beds in a given area, it is the generally accepted practice of health planning experts to consider such factors as historical, current and projected utilization or occupancy rates of existing acute care beds, the average of length of patient stays, and the admission rates of physicians (recognizing the differences in admission practices among specialties and types of physicians). Another useful predictor of need for osteopathic facilities would be the use of such facilities by non-osteopathic physicians and the use of non-osteopathic beds by osteopathic physicians. No attempt was made by HRS to include these health planning techniques in its methodology for determining the need for osteopathic beds. There are eleven HRS service districts in Florida which vary in composition from one county to sixteen counties. Osteopathic hospitals, as determined by the FOMA list, are not evenly distributed throughout the State. Indeed, such hospitals are located in only 8 of Florida's 67 counties. Four of HRS's Districts have no osteopathic beds, while some 80 percent of the total number of osteopathic beds (2,020 out of 2,504) are concentrated in four Districts. There is no evidence that Florida's osteopathic physicians are evenly distributed among the District. Occupancy levels is osteopathic hospitals for the years 1982 and 1983 have, on a statewide basis, been lower than that experienced in non-osteopathic acute care hospitals. For the year 1982, the District osteopathic occupancy rates for those Districts which had osteopathic facilities ranged from 36.4 percent to 88.5 percent, with a statewide average of 54.1 percent. The allopathic occupancy rate for the same year ranged from 66.8 percent to 74.4 percent among all Districts, with a statewide average of 70.2 percent. The range for osteopathic occupancy rates in 1983 was from 33.9 percent to 85.7 percent, with a statewide average of 50.9 percent. The corresponding allopathic occupancy rates were 64.7 percent to 77.7 percent, with a statewide average of 68.2 percent. The optimal occupancy level for acute care hospitals is generally considered to be 80 percent. Pursuant to Rule 10-5.11(23), Florida Administrative Code, the statewide total acute care bed need for the year 1988 is 49,278 beds. Under proposed rule 10-5.11(28), the total osteopathic bed need for 1988 is 2,463 beds. As of March 15, 1984, there were 51,256 licensed and approved allopathic beds and 2,504 licensed and approved osteopathic beds, for a total acute care bed count of 53,760. Thus, under the operation of both rules, for the 1988 planning year, Florida is overbedded by over 4,400 allopathic beds and over 40 osteopathic beds on a statewide basis. Yet, the net result of applying the proposed rules 5 percent formula to each District is to allow the approval of an additional 896 new osteopathic acute care beds. Adding this number to the number of existing osteopathic beds would result in a ratio of osteopathic to allopathic beds of over 6 percent. The operational effect of the proposed rule on a District basis would be to allow an additional 85 osteopathic beds in District 6 (a District already overbedded by 1,029 beds), even though that District already has 193 osteopathic beds operating at occupancy levels of 35.3 percent. Yet, District 7, which shows a surplus of only 170 beds, would received only 64 osteopathic beds in spite of the fact that its osteopathic occupancy level in 1983 was 85.7 percent. District 11 would show a need under the proposed rule for 120 additional osteopathic beds, even though that District is currently overbedded by over 1,500 beds and experienced an osteopathic occupancy level of 56.5 percent and an allopathic occupancy level of 64.7 percent in 1983. The proposed rule would allow 323 osteopathic beds to be established in 3 of the 4 Districts lacking such beds, even though those 3 Districts are currently overbedded by almost 500 beds. Under the proposed rule, an application for osteopathic acute care beds will not normally be granted unless the 5 percent criterion is met. The rule then command HRS to also consider additional criteria: the number of and utilization of existing osteopathic beds, the supply of licensed D.O.s in "reasonable proximity" to the proposed osteopathic hospital and the historical and current utilization by D.O.s of non-osteopathic hospitals, unless discrimination against D.O.s has regularly occurred. The rule contains no indicia of quantification of these additional criteria. The manner in which these factors are to be treated in the Certificate of Need process is not disclosed. Mr. Nelson candidly admitted that at least two of these factors could work either in favor of approval or in favor of disapproval of an application for new osteopathic acute care beds. The Economic Impact Statement (EIS) prepared by HRS for this proposed rule quantifies the publication, printing and mailing costs of the proposed rule for HRS. In the section entitled "Cost or Economic Benefit to Persons Directly Affected," the EIS notes that the rule is "expected to promote an orderly development" of osteopathic hospitals throughout the state and that applicants proposing osteopathic facilities will be able to determine the number of beds available for Certificate of Need approval. The EIS concludes that the additional criteria "are expected to help contain health care costs" and that the rule is expected to provide more equitable access to osteopathic beds for both applicants and patients. As to the impact on competition and the open market for employment, the EIS concludes that applicants, while competing for fewer beds than those that may be available under Rule 10-5.11(23), would not be able to compete on a more equal basis. Finally, the EIS points out that osteopathic physicians able to document discrimination would stand a better chance of a favorable decision on their application. The only data and method listed for making these conclusions was a review and comparison of Rule 10- 5.11(23) and a review of Certificate of Need applications for osteopathic acute care beds. Experience with the Certificate of Need process illustrates that once a bed need is quantified and announced, those beds are rapidly applied for and approved. It is also an accepted principle that decreased occupancy levels in existing facilities generally result in increased health care costs. This is because a hospital's fixed costs must be spread over relatively fewer patients. No attempt was mad in the EIS to assess the impact which the proposed rule may have on acute care bed surpluses sin Florida or on existing allopathic facilities which currently have osteopathic physicians on their medical staffs. No consideration was given to the effect which the propose rule may have upon competition for patients between existing allopathic and osteopathic facilities. Existing utilization or occupancy levels of either osteopathic or allopathic facilities were not considered by the person who prepared the EIS. The economic impact of giving osteopathic beds a preference over allopathic beds (in the sense that the supply of allopathic beds are not to be considered while the supply of osteopathic beds are to be included in the total bed inventory) was not discussed in the EIS.
The Issue The issue to be resolved in this proceeding concerns whether the licensure examination taken by the Petitioner qualifies him under Section 459.007(3), Florida Statutes, for licensure as an osteopathic physician in the State of Florida.
Findings Of Fact The Petitioner, Lawrence Edward Suess, is an osteopathic physician licensed by the Boards of Medical Examiners in Texas, Alabama, and Kentucky. He seeks licensure in Florida, pursuant to Section 459.007(3), Florida Statutes. He is also licensed in Arizona and Texas as a registered nurse, holds BS and MS degrees in child development and nursing and a Ph.D. in nursing. The Respondent, the Board of Osteopathic Medicine (Board), is an agency of the State of Florida, charged with regulating the admission to practice and the practice and licensure standards of osteopathic physicians licensed or seeking to be licensed in the State of Florida. The Board issued an order, as corrected, on November 9, 1995, granting application of licensure to the Petitioner upon the condition that within one year, he successfully complete Part III of the NBOME examination for purposes of licensure in the State of Florida, and not for diplomate status. The Board found in that order that the Petitioner had not passed all three parts of the NBOME examination and had submitted certification of passage of only Parts I and II. The Board found that the “FLEX” examination was not a substantially-similar examination to the required NBOME examination since the FLEX examination did not contain an osteopathic medicine component. The Board also found that the completion by the Petitioner of a Board certification examination was not substantially similar to the NBOME examination because it tested only a single subject matter and not the broad principles contained in Part III of the NBOME examination. On November 13, 1995, a Petition for Formal Hearing was filed by the Petitioner disputing the decision of the Board which precluded him from obtaining licensure to practice medicine in the State of Florida because of failure to complete Part III of the NBOME examination. He contended that he was outside the time period in which he would be allowed to take Part III. He further contended that the FLEX examination was a substantially-similar examination to the NBOME examination. The Petitioner contends that taking the FLEX examination should be sufficient to justify licensure, although he also acknowledged that Part III of the NBOME examination tests osteopathic philosophy and principle; and he acknowledged that the FLEX examination does not, although he was attempting to testify and argue that the FLEX examination was substantially similar to the NBOME examination. He provided no testimony or evidence, however, to establish that the FLEX examination tests osteopathic philosophy and principle. The Respondent presented the testimony of Joseph Smoley, Ph.D. by deposition. Dr. Smoley holds a Ph.D. in educational measurement and has served for ten of the last eleven years as Executive Director of the NBOME. The NBOME is an organization that develops an examination that is independent of the osteopathic medical schools to evaluate osteopathic physicians who are either currently in undergraduate or in graduate medical programs. The NBOME’s main mission is to provide state licensing examinations with an independent assessment of the knowledge base of candidate osteopathic physicians. Dr. Smoley oversees NBOME policy and supervises educational measurement within the osteopathic profession. His oversight responsibilities include the examination section of the NBOME. He provides a constant review of the process of testing for the Board of Directors. The NBOME developed its examination by having questions drafted by faculty members and osteopathic physicians in independent practice. Faculty members may be D.O.’s or Ph.D.’s in the various basic sciences, and there is a multi-tiered process for preparing and reviewing questions. A copy of the bulletin of information concerning the NBOME examinations was attached to and made part of the deposition. Dr. Smoley testified that typically the candidates take Part I as a sophomore during medical school, Part II as a senior, and Part III as an intern in their first post-graduate year. He established that the purpose behind that examination is “the integration of osteopathic principles and practices as well as the philosophy of osteopathic medicine.” No allopathic physicians are involved in the grading process of that examination. Some allopathic physicians associated with osteopathic colleges may submit questions that, after the review process, may be used on the examination. The purpose of the NBOME examination, as shown by Dr. Smoley, is to make sure that each question integrates osteopathic principles and practices in some way and that the entire examination is reflective of the practice of osteopathic medicine. Dr. Smoley is also familiar with the FLEX examination, as well as the current licensure examination for allopathic physicians, the USMLE. The Federation of State Medical Boards (FSMB) does not prepare any complete examination or any additional components for its regular examination concerning manipulation or osteopathic practice and principles. According to Dr. Smoley, there has never been an official comparison or analysis between the NBOME examination and the FLEX examination. Based upon his experience and educational measurement, he has determined that if one examination, the NBOME, contains osteopathic principles and practice and the other examination, the FLEX, does not incorporate those principles and practices, then the two examinations could not be considered equivalent. The NBOME examination is more extensive because it integrates osteopathic principles and practice throughout its content. This osteopathic examination is not simply one that tests manipulation. Therefore, it is not asserted to be appropriate for chiropractors or M.D.’s who have been trained in manipulation but only for persons who have received an osteopathic medical education. The Respondent also presented the testimony by deposition of James R. Winn, M.D. He is Executive Vice President of the FSMB. The FSMB assists state medical boards in conducting their evaluation of physicians regarding their fitness to practice medicine. The FSMB developed examinations which are administered by state boards. Dr. Winn serves as the supervisor for the examination services section of the FSMB. Those examinations are developed in cooperation with the National Board of Medical Examiners. The current examination available from the FSMB is the United States Medical Licensing Examination (USMLE) used since 1992. Prior to that time, the FSMB administered the FLEX examination, which was for the evaluation of all physicians requesting licensure. The FLEX examination did not have a section on osteopathic practice, as shown by Dr. Winn. The FSMB allows all physicians seeking licensure in the United States to take that examination, including graduates of osteopathic medical schools and graduates of foreign medical schools. With the FLEX examination, unlike the NBOME examination, medical students are not eligible, only graduates of medical schools are eligible to take the examination. Dr. Winn is familiar with the examination of the NBOME and its purpose. He is not aware of any side-by-side comparison between the two examinations to determine equivalency. In his expert opinion, there would have to be such an evaluation in order to determine whether the examinations are equivalent. The testimony of Drs. Smoley and Winn was elaborated upon and corroborated by Dr. Morton Morris. Dr. Morris is a licensed osteopathic physician in the State of Florida and is board certified in osteopathic surgery by the American Osteopathic Board of Orthopedic Surgery. He is also certified by the American Board of Quality Medical Assurance and is a fellow of the American College of Legal Medicine. He is Vice-Chancellor for academic affairs in the health professions division at Nova Southeastern University, a Florida osteopathic medical school. Additionally, Dr. Morris is a licensed, practicing attorney in the State of Florida. He practices in the areas of medical malpractice, general health law and administrative law. Dr. Morris is familiar with the NBOME examination, having served as a test item writer for the NBOME. He recognizes Dr. Smoley as one who helps develop the philosophy of the examinations in question. The philosophy of the NBOME is that content concerning osteopathic practice and principles permeates the entire examination. Even when certain questions on their face are not osteopathically oriented, the evaluation and the grading of the responses is carried out from an osteopathic viewpoint and philosophy. The test item writers are directed to draft test questions which include osteopathic philosophy. In the past, the NBOME has agreed to allow a candidate to take only Part III or an equivalent examination and receive the score from the NBOME. In fact, Dr. Morris represented that person in his capacity as an attorney. He worked out the arrangements whereby that candidate could take and pass Part III of the NBOME examination in order to obtain a Florida osteopathic medical license, as the Petitioner seeks herein, even though, since he would not have taken Part III within the required seven years, he could not receive diplomate status with the NBOME. The Board’s order in this case specifically requires passage of Part III of that examination, but it does not require diplomate status. Such an arrangement would thus seem to provide a means to alleviate the Petitioner’s predicament in the instant situation. The Petitioner, in questioning Dr. Morris upon cross- examination, inquired about the possibility of a person taking all three parts of the NBOME examination, even if he had already taken Parts I and II. Dr. Morris stated that that was possible. Page 7 of the Bulletin of Information, in evidence in Respondent’s Exhibit 1, although stating that the candidate cannot take the examination “to attempt to improve his score”, states nothing to indicate preclusion of a candidate taking the entire examination for any other purpose. Dr. Morris stated that the Petitioner could take Part III of the examination and that the NBOME would make arrangements to allow him to do that, with the understanding that if he passed Part III, he would not be able to receive diplomate status from the NBOME (because of passage of time before taking Part III). In making comparisons between osteopathic medical education and allopathic medical education, Dr. Morris acknowledged that in some cases, osteopathic medical colleges use the same textbooks as used by allopathic medical schools. That does not, however, make them similar professions. Although anatomy and physiology may not be different, the philosophy of treating the whole patient is different. Responding to the Petitioner’s contention that having obtained board certification in his specialty area should count as equivalency to the entry level examination, Dr. Morris pointed out that all that the board certification accomplishes is to show that an osteopathic physician is recognized by his or her peers as competent to practice a specialty. It does not mean that the person is osteopathically oriented enough to be eligible for licensure and to be able to pass a minimum competency examination. The Petitioner contends that having passed Parts I and II of the NBOME examination, FLEX should quality him for osteopathic licensure in the State of Florida, in lieu of taking Part III of the NBOME examination, because anything of an osteopathic nature would have already been tested on Parts I and II. Dr. Morris established to the contrary, however, that Part III is the clinical testing, the testing of how the individual puts to use his clinical evaluation in treatment of patients. It is the ultimate test of whether an individual has developed and is able to apply a philosophy of practice sufficient to show that he is competent to be an osteopathic physician. Parts I and II of the NBOME examination do not test clinical skills. The FLEX does test clinical skills, but it does not test for osteopathic practices as to clinical skills. The NBOME requires that a person take Part III within seven years of having taken Part I, if that person wishes to be a diplomate of the NBOME. There is no apparent preclusion, however, in a person arranging to take only Part III, simply for purposes of state licensure. The record is not clear whether a person could take Parts I, II and III within the period of one year. It does seem apparent, however, that the Petitioner could take Part III within a one-year time period, which is all that is required in the Board’s order. Further, the statute requires that a person take all parts of the NBOME examination or a substantially-equivalent examination. What the Petitioner attempts to do is to take two parts of the NBOME examination and then substitute a different examination (FLEX) for Part III. This does not constitute a substantially-equivalent examination for the above reasons. A substantially-equivalent examination would have to be equivalent to all three parts of the NBOME examination. During discussion of the difference between osteopathic and allopathic schools of medicine, Dr. Morris pointed out that many osteopathic physicians use the same modalities that allopathic physicians use. It is just that they also use osteopathic modalities. He gave the example of a cardiac patient whom an osteopathic physician would treat just as a medical doctor would treat the basic condition with appropriate drugs but then would incorporate osteopathic philosophy, such as the “lymphatic pump”, meaning that the osteopathic physician would incorporate muscle techniques of stretching and passive manipulation in order to help the patient. The osteopathic physician would possibly use manipulative techniques on the lymphatic system and not just use drugs or other allopathic techniques. In the context of the NBOME examination, a question might reference a cardiac patient. Although the question would not mention the lymphatic pump, a proper answer might entail a clinical response that would consider that modality of treatment. In orthopedics, Dr. Morris’ specialty, an osteopathic physician can make significant use of manipulative techniques, as well as general surgery, casting and other modalities normally used by allopathic physicians. Use of the FLEX examination, rather than the NBOME examination, would not lower standards for osteopathic physicians. Rather, the FLEX examination simply embodies a different standard than the one used to test for competency in osteopathic principles and medicine. The Petitioner acknowledged that he could have taken Part III of the NBOME examination but chose not to because it was then more convenient for him to take the FLEX examination to continue his training in the State of Texas which required passage of the FLEX examination for osteopathic licensure. The Petitioner contended that if he applied for a Florida osteopathic medical faculty certificate (MFC), the FLEX examination would be acceptable and he would be eligible. That fact, he contends, by analogy, establishes that he is qualified to practice osteopathic medicine in the State of Florida. He has never applied for such a certificate nor has he been offered an osteopathic medical faculty position in the State of Florida. Thus, determination of that issue is not before this tribunal. Even if it were, there are significant differences between a full license to practice osteopathic medicine indefinitely and a medical faculty certificate. With the MFC, the Petitioner would not be allowed to be engaged in private practice of osteopathic medicine and the MFC would only allow him to practice in the academic realm for only two years. Finally, the statutory requirements for an MFC do not require the passage of any licensure examination. Accordingly, to the extent that the Petitioner’s argument and testimony implies some analogy or equivalency between eligibility for the MFC and eligibility for full licensure, such equivalency is not borne out by the greater weight of the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of the Petitioner, Lawrence Edward Suess, D.O., for licensure as an osteopathic physician, without conditions, is denied on the basis that the FLEX examination has not been shown to be substantially similar to the NBOME examination.DONE AND ENTERED this 28th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 28th day of February, 1997. COPIES FURNISHED: Lawrence E. Suess, D.O., Ph.D. Owensboro Psychiatric Institute 1700 Frederica Street, Suite 106 Owensboro, Kentucky 42301 M. Catherine Lannon, Esquire Department of Legal Affairs The Capitol, Room PL-01 Tallahassee, Florida 32399-1050 William H. Buckhalt, Executive Director Board of Osteopathic Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0757 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
