The Issue The issue in this case is whether Respondent, Park Imaging, Inc., was obligated to file a report and pay an indigent care assessment pursuant to Section 395.1015, Florida Statutes, (1991) and, if so, whether Respondent should be fined or otherwise sanctioned for its failure to do so.
Findings Of Fact Based upon the oral and documentary evidence presented at the final hearing and the entire record in this proceeding, the following findings of fact are made: At all times pertinent to this proceeding, Park Imaging owned and operated a fixed-site diagnostic imaging center in Coral Springs, Florida. Park Imaging also owned and operated a mobile diagnostic service which is described in more detail below. Since 1984, hospitals in Florida have been required to pay an assessment based on net operating revenue to the Public Medical Assistance Trust Fund ("PMATF") for the funding of health care services to indigent persons. See Chapter 84-35, Laws of Florida, codified at Section 395.101, Florida Statutes (1989). Effective July 1, 1991, the statutory requirement to file a report with the AHCA and pay the PMATF assessment was expanded to include certain additional health care entities including "diagnostic imaging centers." See, Section 177, Chapter 91-112, Laws of Florida, codified at Section 395.1015, Florida Statutes (1991). For the health care entities that fell under the 1991 statute, the first reporting period began July 1, 1991 and ran through December 31, 1991. The report was due on or before March 31, 1992 and the assessment was to be paid by April 30, 1992. Park Imaging filed the required report and paid the applicable assessment for its fixed-site diagnostic imaging center. Park Imaging did not file a report or pay any assessment regarding its mobile diagnostic service. Except for diagnostic imaging centers, all of the "health care entities" that were required to file a report and pay an indigent care assessment pursuant to Section 395.1015, Florida Statutes, are licensed or registered by the State. Thus, there was no question as to the need for those entities to comply with the statute. Diagnostic imaging centers, on the other hand, are not licensed or registered and, consequently, there was less certainty as to the types of providers or services that fell into this category. Park Imaging has a separate medical care provider number for its mobile operation. The AHCA has treated the two operations as separate entities and sent Park Imaging separate reporting forms with different identifying numbers for each of the operations. Park Imaging's mobile operation consists of the transportation of ultrasound equipment in vans to private physicians' offices. No services are performed within the vans. The equipment is off-loaded from the van into the physician's office. The physicians utilize the equipment for their patients. All power necessary to operate the equipment is provided by the physician's office. The equipment can be plugged into a standard electrical wall socket in the physician's office. During the period from July 1, 1991 to December 31, 1991, Park Imaging's diagnostic operation provided ultrasound service primarily to cardiac and obstetric patients. In all cases, a physician ordered the test and defined the protocol to be followed during the test. Park Imaging provided technical expertise, including an onsite employee of the company. Park Imaging's technician provided the expertise necessary for running the equipment and executed the protocol established by the physician. The physician was responsible for interpretation of the test results and for managing the outcome of the results of the test and communicating the results to the patient. Section 395.1015, Florida Statutes (1991) defined "diagnostic imaging centers" that were subject to the reporting and assessment requirements as follows: Diagnostic imaging centers that are free- standing outpatient facilities that provide specialized services for the identification or determination of a disease through examination and also provide sophisticated radiological services such as computed tomography scans and magnetic resonance imaging, and in which services are rendered by a physician licensed by the Board of Medicine under Section 458.311, Section 458.313, or Section 458.327, or by an osteopathic physician licensed by the Board of Osteopathic Medical Examiners under Section 459.006, Section 459.007, or Section 459.0075. Park Imaging contends that its mobile operations do not have a "facility" upon which an assessment can be levied under Section 395.1015, Florida Statutes, (1991) (subsequently amended and renumbered as Section 395.7015). Park Imaging also contends that its mobile operations did not provide "sophisticated radiological services" as that term is used in Section 395.1015, Florida Statutes. In this regard, Park Imaging argues that the equipment utilized in the mobile operations was much less sophisticated than many of the other types of services provided in a fixed setting. The evidence established that Park Imaging's mobile operations provided ultrasound services. There is no evidence that Park Imaging's mobile operations provided computed tomography (CT) scans or magnetic resonance imaging (MRI) or any other services other than ultrasound. CT and MRI equipment could not be transported in a van or off-loaded into a physician's office. CT and MRI equipment require special lead-wall shielding in the structure in which they are used. The investment for CT and MRI equipment is significantly higher than ultrasound as are the government reimbursement rates. Park Imaging's decision not to file the report and pay the assessment on its mobile operations was based upon advice of legal counsel. Park Imaging did not attempt to hid or conceal its decision from the AHCA. In several letters to the AHCA in the fall of 1992, Park Imaging advised the AHCA that it did not believe its mobile operations fell within the scope of the statute. By letter dated September 29, 1992 from Carolyn Turner, who at the time was the Administrator of the AHCA's Ambulatory Health Section, to Joseph Burlandi, corporate counsel for Park Imaging, the AHCA notified Park Imaging that it's mobile diagnostic operations were not exempt from the provisions of Section 395.1015, Florida Statutes (1991) and that Park Imaging would be considered delinquent from that time forward if the report was not filed and the assessment was not paid. This position was subsequently reaffirmed in a letter dated October 30, 1992 from Julia P. Forrester, senior attorney for the AHCA, to Joseph Burlandi. In a letter dated November 23, 1992, the Agency once again reaffirmed its position that Park Imaging 's mobile operations fell within the scope of the statute None of these letters from the AHCA to Park Imaging were sent by certified mail. When Park Imaging continued to refuse to file the report and pay the assessment on its mobile operations, the AHCA issued an Administrative Complaint dated February 22, 1993 seeking to impose penalties against Park Imaging for failure to comply with the requirements of what had subsequently been renumbered as Section 395.7015, Florida Statutes, and Rule 59B-6, Florida Administrative Code, for the reporting period July 1, 1991 through December 31, 1991. At the hearing in this matter, Fran Buie, the current Administrator of the AHCA's Ambulatory Health Section, testified that the AHCA has consistently construed and applied Section 395.1015, Florida Statutes (1991) to mobile facilities. She also testified that her review of the Agency's records confirms that a number of mobile units have complied with the statutory requirements. The evidence did not establish the types of services provided by these other mobile operations.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Healthcare Administration enter a final order requiring Respondent, Park Imaging, Inc. to comply with the provisions of Section 395.1015, Florida Statutes (1991) and establishing a due date for the report and assessment after which a fine should be assessed in accordance with the applicable statute and rules. DONE and ENTERED this 9th day of February 1994, at Tallahassee, Leon County, Florida. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of February 1994.
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida, having been issued license number ME 0055126. On December 4, 1989, D.W. presented herself as a patient at Unity Health Center, where Respondent was employed as a physician. She complained of headaches, insomnia, and jerking of her muscles. She advised that she had had her roof repaired and other repairs done to her home and feared she was reacting to some of the chemicals involved with those repairs. She further advised that the health department had evaluated her home for the presence of formaldehyde, carbon monoxide, and other toxins but none had been detected. Respondent took a minimal, at best, history but performed no physical examination. Yet, Respondent diagnosed the patient as suffering from chemical toxicity. He recommended a holistic diet and prescribed a number of homeopathic or holistic substances. He recommended that the patient return in three weeks to be re-checked. The patient returned to Unity Health Center on December 28, 1989. Respondent recommended an Interro test to check her chemical toxicity levels. The patient submitted to that test, and Respondent used the results of the Interro testing to confirm his diagnosis of chemical toxicity related to chemicals in the patient's environment from the repair of her roof. The Interro machine indicated that the patient had elevated levels of formaldehyde; toxic levels of arsenic, lead, and mercury; and a sensitivity to mold and yeast. Respondent prescribed additional homeopathic or holistic substances including "de-tox drops", prescribed a tranquillizer, and recommended that the patient return in three weeks to be re-checked. Respondent used the Interro machine as a diagnostic instrument. His medical records contain no notation that the patient gave informed consent for the use of the Interro machine for that purpose, and no written informed consent is contained in Respondent's records. The Interro machine is a device with certain dials and switches on it and an electrode 3-4 inches long and approximately 1/2 inch in diameter, cylinder-shaped, which is held in the patient's hand. The other cord attached to the machine has two electrodes that go around the patient's index and ring fingers of the left hand, much like a polygraph machine. The third component is a wand which is held by the tester. When the patient is hooked up to the Interro machine with the two electrodes on the left hand and holding the other electrode in the right hand, the wand is pressed into certain "acu-pressure points" by the tester. A needle on the machine indicates the patient's sensitivity to whatever substance the tester has the machine "tuned to". The Interro machine is a device purported by its manufacturer to be a computerized question and answer device which measures changes in the patient's skin conductivity in response to computer-generated questions. The Interro's training manual specifically represents that it is not a medical device; rather, it is a communication device. The Interro machine is not approved by the federal Food and Drug Administration as a medical diagnostic device. Rather than returning to Respondent or Unity Health Center, the patient went to Dr. Tillinghast Lybass, a specialist in allergies and immunology, for a second opinion on January 9, 1990. She complained of allergies and chemical toxicity and advised Lybass of Respondent's diagnosis. She advised Lybass of the inspection of her home by the health department and of the repairs done on her roof. She discussed her previous exterminating service. D.W.'s complaints to Lybass were headaches, itching, body jerking, blurred vision, redness of her eyes, and insomnia. Lybass took a complete history of her symptoms, the course of her illness, her past medical history, her family medical history, and her environmental history. He did an allergy work-up on D. W. and tested her for sensitivity to mold and mildew, to a natural pesticide found in a plant, to formaldehyde, and to some of the materials that were listed in the safety information sheets the patient obtained from the contractor that had done the repair work in her home. He obtained a copy of Respondent's medical records on the patient. Dr. Lybass was unable to document any significant degree of allergy antibodies in the patient's blood. Although he performed specific skin tests for the major molds, the patient did not demonstrate any sensitivity. Further, the patient's blood chemistries were normal except for an elevated cholesterol level. Lybass did not do any specific tests for heavy metals since there was no reason to indicate or expect that the patient had any kind of heavy metal poisoning from the patient's history. He had the patient expose a culture plate at her home and learned there was no significant amount of mold there. Dr. Lybass diagnosed the patient's condition, based on her history and his physical examination and the tests he performed, as stress, anxiety, and fear or phobia of her environment. Respondent was engaged in the practice of medicine when he diagnosed and treated patient D. W. His diagnosis was a medical diagnosis. He undertook to treat her complaints, recommending certain holistic or homeopathic remedies and even prescribing a tranquillizer which is a prescription drug. Respondent failed to keep an adequate medical record of his examination and treatment of the patient. He took only a minimal history and documented no physical examination, not even vital signs. His medical record includes no plan for any recognized medical tests to support his diagnosis, and his records contain no justification for the use of the Interro machine on that patient. Although the patient presented with complaints that could have serious medical implications, Respondent did not perform or document any recognized medical tests to rule out any potential causes for the patient's symptoms. The Interro device is not an accepted medical device in the medical community. The Interro device cannot be used to make a diagnosis of chemical toxicity since it does not test the patient's bloodstream. The Interro report contained in Respondent's medical record for patient D. W. does not purport to measure the chemicals in a patient's body; rather, it simply lists body systems in a graph. Since the Interro device is not a diagnostic medical device, the use of that device to make a medical diagnosis, without first obtaining the full and informed consent of the patient, constitutes experimentation on a human subject. Respondent made deceptive or untrue representations to patient D. W. Based on the results of the Interro testing, Respondent diagnosed the patient's symptoms as chemical sensitivity and mold sensitivity and recommended treatments and remedies. Respondent's representation of the Interro machine as a medical diagnostic device was untrue as was Respondent's representation that the patient was suffering from chemical and mold sensitivity. Those misrepresentations constituted a trick or scheme in the practice of medicine. D. W. was tricked into believing that Respondent had made an accurate diagnosis with the Interro device when the device in fact had no medical value. Respondent practiced medicine below the acceptable standard of care of a reasonably prudent physician under similar conditions and circumstances in his diagnosis and treatment of patient D. W. On the basis of just a few questions and without a physical examination or the use of any medically recognized tests, Respondent made the diagnosis of chemical toxicity and prescribed various holistic medicine drops. He then used the Interro machine as a medical testing instrument and relied on the results of that testing in prescribing various holistic or homeopathic substances and diets.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered: Finding Respondent guilty of the allegations contained in Counts One, Two, Three, Five and Six of the Administrative Complaint filed in this cause; Finding Respondent not guilty of the allegations contained in Count Four; Dismissing Counts Seven and Eight of the Administrative Complaint filed in this cause; and Suspending Respondent's license to practice medicine in the State of Florida until such time as Respondent can demonstrate to the Board of Medicine that Respondent can practice with skill and safety. DONE and ENTERED this 5th day of February, 1996, at Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 1996. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 94-3214 Petitioner's proposed findings of fact numbered 2, 4-24, 26 and 27 have been adopted either verbatim or in substance. Petitioner's proposed finding of fact numbered 1 has been rejected as not constituting a finding of fact. Petitioner's proposed finding of fact numbered 3 has been rejected as being irrelevant to the issues involved herein. Petitioner's proposed finding of fact numbered 25 has been rejected as not being supported by competent evidence. COPIES FURNISHED: Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Joseph S. Garwood, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Richard Plagenhoef, M.D. Post Office Box 12131 Dallas, Texas 75225 Richard Plagenhoef, M.D. Post Office Box 2129 Cherokee, North Carolina 28789
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: The petitioner, Michael Selinsky, was a candidate for the chiropractic examination given in November of 1987. The practical examination is composed of three portions, X-ray interpretation, technique and physical diagnosis, and a score of 75% must be achieved on all three subject areas in order to pass. The petitioner received a score of 77.1 on the X-ray interpretation area, a score of 77.5 on the technique area and a score of 72.5 on the physical diagnosis area. In this proceeding, petitioner challenges two of the scores he received on the examination in the area of physical diagnosis. The physical diagnosis portion of the examination consists of oral questions posed to the candidate by two examiners. The answers are graded on a scale of 1 to 4, with 4 being the highest grade. Petitioner challenges the grade of 3 one of the examiners gave him for the "neurological" portion of the exam and the grade of 2 another examiner gave him for the "X-ray technique & diagnosis" portion of the examination. On these two areas of the examination, Examiner number 14 awarded petitioner a grade of 3 on both areas. Examiner number 23 awarded petitioner a grade of 4 on the "neurological" portion anal a grade of 2 on the "x-ray technique & diagnosis" portion. During the neurological section of the oral examination, petitioner was requested to demonstrate upon a live model how he would test the extensor hallicus longus muscle for the L-5 mytome. In response, he extended the great toe in the wrong direction. In responding to a question concerning an upper motor neuron lesion and a lower motor lesion, petitioner's answers were very incomplete. During the X-ray technique portion of the oral examination, petitioner was requested to demonstrate with a live model how he would position a patient for a lateral shoulder x-ray. The petitioner responded that he had never heard of such a position, but then attempted to position the patient. In fact, there is no way to take an x-ray of the lateral shoulder view because two bones would be superimposed. While this might be viewed as a "trick" question, petitioner should have been aware that no such x-ray could be taken. During another x-ray positioning question, petitioner failed to turn the patient's head. Also, during the X-ray technique portion of the oral examination, petitioner was asked to identify three factors that affected his exposure to radiation as an operator. The petitioner's answer included such things as lead- lined booths, lead-lined walls in the x-ray room and proper film developing to decrease the number of retakes. Several times, the examiners asked him questions regarding his answers, and the petitioner responded that he was not sure. When considering an operator's safety with regard to radiation exposure, there are three fundamental and established factors to take into account: time of exposure, distance and shielding. The petitioner's answers had relevance to patient safety, but not to the safety of the operator. In spite of prodding and grilling by the examiners with regard to operator safety, petitioner was unable to elucidate the three fundamental factors of radiation safety.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that the petition be DISMISSED. Respectfully submitted and entered this 17th day of October, 1988, in Tallahassee, Florida. DIANE D. TREMOR 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 17th day of October, 1988. COPIES FURNISHED: Copies furnished: William A. Leffler, III, Esquire Bruce D. Lamb, General Counsel Department of Professional Department of Professional Regulation Regulation 130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32399-0750 Tallahassee, Florida 32399-0750 Michael Selinsky Pat Guilford, Executive 5259 Wayside Court Director Spring Hill, Florida 34606 Board of Chiropractic Examiners Lawrence A. Gonzalez, Secretary Department of Professional Department of Professional Regulation Regulation 130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32399-0750 Tallahassee, Florida 32399-0750
Findings Of Fact Respondent, Stella Mae Browning Brumley, has been a registered nurse in Florida since 1954 and worked at the Sunland Development Center in Ft. Myers for approximately 10 years before she was dismissed in June, 1975 by the hospital authorities. During the period March-May, 1975 Mrs. Brumley entered on the clinic log that she had administered tannic acid, 20 percent solution, to approximately 14 "clients of the center who had suffered minor cuts, abrasions etc. At the time this medication was administered the standing orders did not provide for use of this medication and there was no doctor's order for this treatment to be given to any of the "clients" so treated. Tannic acid was supplied to the medicine cabinets in each of the cottages where the clients reside and was available for use by the "parents" although all of the Petitioner's witnesses testified that a doctor's order was required before thee use of tannic acid was authorized. Dr. Murray, present Medical Director at Sunland, introduced the use of tannic acid at Sunland but never put it on the standing orders. He considers tannic acid to be an effective medication for minor abrasions. There are standing orders for treating minor skin irritations and rash but there is nothing in the standing orders providing specifically for treatment of abrasions (TR p 44, 47). Webster's New Collegiate Dictionary shows another sense of the word, abrasion, to be irritation. Cottage parents generally considered that medications made available in the medicine cabinets and not kept locked, such as tannic acid, were there for use in first aid treatment, and frequently used same assuming it was authorized by standing orders. On or about February 27, 1975, Manuel Horton, a client at Sunland received ant bites which resulted in his being taken to the clinic. The doctor ordered treatment with furacil and entered same on clinic chart. No copy of the orders or the medication was sent to the cottage. Later that evening Respondent was called to the cottage to administer to Horton. He had scratched himself in several places deeply enough to draw blood. After ascertaining that no record of treatment ordered was in the cottage Mrs. Brumley called the nurse'supervisor on duty in the clinic to discuss treatment but she did not go across the road to the clinic to look at the clinic chart. Mrs. Miller, the supervisor on duty in the clinic, was partially supervisor of the cottage nurses and Mrs. Brumley testified she considered Mrs. Miller to be so because she was a grade higher. Mrs. Miller advised that she had caladryl available if someone could come for it. Mrs. Brumley testified that calomine was received and Horton was treated with calomine. She entered on his chart that he was treated with caladryl. Furasin, which was ordered by the doctor, is an antibiotic while caladryl, a combination of benedryl and calamine, is an antihistimatic. During a period when pin worms were prevalent Povan was ordered administered to all employees as well as the clients. In the initial planning stages Mrs. Brumley was asked to administer the treatment in the cottages in the evening but she demurred. Later it was decided that the treatment would be given only during the day hours. Mrs. Brumley understood the time limitation on treatment during day hours applied only to the children and on the evening of April 15, 16, and 17 she administered Povan to employees in the cottages. On February 14, 1975 Kenneth Skogland and Linda Sallak, clients at Sunland, were administered Visteril by Respondent Brumley. At the time Thorozine was the authorized sedative when a child became unruly. No doctor's orders for substitution of Visteril for Thorozine was entered. Respondent contends that during a conversation with Dr. Murray he suggested the substitution of Visteril for Thorozine and she considered that to be authorization for the substitution. Visteril is both an antihistamine and a sedative. Dr. Miller denied he ever said that Visteril could be substituted for Thorozine. In March, 1972 Respondent entered on the medical records that bread, butter, and cotton was administered to a patient who had swallowed pins. At the hearing Mrs. Brumley acknowledged that she had administered the cotton sandwich but its use had been authorized by a doctor at Sunland who is now deceased. No record of such an order was found. Mrs. Brumley's testimony that she and the prescribing doctor had discussed the cotton sandwich with the Medical Director at the time gas disputed by the Medical Director at the hearing. He had no recollection of such conversation although he recalled the incident where the patient was so treated. No adverse effects resulted from this treatment and the pins were eliminated by the patient without surgery being required.
The Issue The issue in this case is whether the Respondent should be disciplined for allegedly practicing medicine below the generally accepted standard of care when he performed a laminectomy and discectomy at the incorrect level of a patient's lumbar spine.
Findings Of Fact Respondent, William O. DeWeese, is a Florida licensed physician, having been issued license number ME 0025687. Respondent is Board-certified in Neurological Surgery and is a Fellow of the American College of Surgeons. He has practiced medicine since graduating from medical school in 1968. He received his Florida license in 1975 and established his practice in Tampa where he has continuously practiced medicine ever since. In twenty-four years of practice, the Florida Board of Medicine has never disciplined Respondent. Respondent's Standard Practice Respondent conducts his practice primarily through two local hospitals, St. Joseph’s Hospital and University Community Hospital. He has a typical practice common to neurological surgery. On average, Respondent performs three to four laminectomy-discectomy procedures each week. Before performing surgery on the spine, Respondent’s protocol is to review available medical records and films (CT, MRI, X-ray), obtain an EKG, obtain chest X-rays, and blood work. During surgery, he routinely obtains "real time" radiological confirmation of the level of the spine where he intends to operate based on his initial pre-surgical work-up. Respondent does this by marking the level where surgery is to take place with radio-opaque material (usually a cottonoid sponge), and has an X-ray film of the patient's spine and the marker exposed and developed in the operatory (OR). Respondent reviews the X-ray in the OR before having the X-ray technician take it to the radiology department for review by a radiologist. The radiologist on duty reviews the X-ray and usually writes on the X-ray to label the location of the marker and has the technician bring the labeled X-ray back to the OR; he then calls the OR, usually on a speaker telephone, to inform the surgeon as to the radiologist's interpretation of the film. Any question as to the level of surgery is resolved at that time. If Respondent is not at the intended level of the spine, he makes the appropriate adjustment in the surgical procedure and completes the surgery at the correct level. The First Surgery S.D. first presented to Respondent in November 1989 with complaints and symptoms of intractable back and left leg pain. She had been seen previously by other physicians but had not experienced any relief. At the time she presented to Respondent, S.D. was 5 feet 5 inches tall and obese (at 175 pounds). Unbeknownst to Respondent at the time, the patient also had an anatomical anomaly of six lumbar vertebrae instead of the more common five. As a result of the patient's anatomical anomaly, physicians could easily be misled, fooled, or misunderstood in reporting the level of spine being evaluated or treated. Depending upon awareness of the patient's specific anomaly and terminology used, the same location on the spine could be referred to as L4-L5, as L5-S1, or as L5-L6. Usually, neurosurgeons can predict the location of nerve root pathology fairly accurately based solely on a patient's complaints, objective examination, and symptoms. Specific nerves innervate specific areas of the body, and a deficit in one area of the body can reasonably lead a physician to suspect nerve root pathology at a particular level of the spine. Because Respondent was unable to determine from initial review of the patient's prior MRI that she had a sixth vertebra, he expected to find nerve root pathology at the L5-S1 level of the spine based on S.D.'s complaints, objective examination, and symptoms. But on X-ray and re-review of the MRI with benefit of the radiologist’s report, Respondent noted the sixth vertebra. Following a complete examination of S.D., including review of a recent CT scan, her prior MRI study, and X-ray films, Respondent believed that S.D. had a "large disc protrusion" at the L5-L6 level of the spine and a "small disc bulge" at the L4- L5 level. The patient's extra lumbar vertebra helped explain the location of the patient's nerve root pathology in relation to her complaints, objective examination, and symptoms. Respondent recommended that S.D. undergo lumbar surgery to explore the disc spaces, remove extruded disc material, and free any entrapped nerves. He expected to have to remove disc material only at the L5-L6 level. His pre-operative diagnosis was: degenerative lumbar disc with lateral angle stenosis (narrowing) at L5-L6; and possible disc protrusion at the L4-L5 level on the left. Respondent performed surgery on S.D. on December 4, 1989. The operation consisted of: a left laminectomy, exploration and inspection of the L4-L5 disc; and a laminotomy, foraminotomy, and partial discectomy at L5-L6. To accomplish the surgery, Respondent dissected away the soft tissues above L4, L5, L6, and S1. He then followed his protocol by placing radio-opaque cotton underneath the ligament at the level he believed was L4-L5 for radiological confirmation. After "real time" radiological confirmation that he was at L4-L5, Respondent removed enough lamina at L4-L5 to inspect the disc and nerve root. He did not observe any entrapment of the nerve and did nothing further at L4-L5. He next proceeded to L5- L6, where he repeated the same procedure but noted entrapment at the posterior aspect of the nerve root. The majority of the pressure on the nerve came from the neural foramen, and this was removed with osteotomy. Some disc material also was removed to free the nerve root. While inspecting the disc space at L5-L6, Respondent observed that the disc space was so narrow that a spinal needle was the thickest instrument that the disc space would receive; a straight pituitary curet could not be placed into the disc space. Respondent recorded these observations in his surgical notes. Similarly, the radiologist's report noted "considerable narrowing of the interspace at the L5-L6 level." Respondent completed the operation by performing a foraminotomy (removal of bone surrounding the point of exit of the nerve from the vertebras of the spinal column). The operation in December 1989 was uneventful; S.D. did well post-operatively and was discharged from the hospital after a normal stay. The Second Surgery S.D. returned to Respondent in March 1993 because of recurrent severe back pain and left leg pain. Following appropriate diagnostic tests and examination of S.D., which revealed what was thought to be a herniated disc on the left side at L5-L6, Respondent planned to "re-do" a laminectomy and discectomy at L5-L6. By the time of the patient's second surgery on May 10, 1993, she had gained about 40 pounds (up to 215 pounds.) The planned surgery was made more difficult by S.D.'s weight gain, as well as by her previous surgery. Additional fatty tissue decreased the operative field of view, as well as the quality of the intra- operative X-ray. S.D.'s anatomical landmarks had been altered as a result of the December 1989 surgery, and there was considerable scaring in the area to be explored during surgery, which obscured the remaining landmarks. Without the presence of normal landmarks and with heavy scaring and weight gain, Respondent had fewer tools to locate the correct level, making the second surgery more difficult. One landmark still available to Respondent to aid in the second surgery was the very narrow interspace at the L5-L6 level. However, Respondent did not the read surgical notes from the first surgery carefully enough to recall the landmark; or, if he read them and recalled the landmark, he attached little significance to the notes and landmark, as compared with other factors influencing his decisions during surgery. One of the reasons Respondent and his expert gave for not attaching more significance to the December 1989 findings as to the remarkably narrow L5-L6 interspace was that a patient's position on the Wilson laminectomy holder and the operation of the holder can alter the apparent width of lumbar interspaces. The holder is a special, adjustable operating table that can be made to "bridge up" in a continuous arc to force the patient (lying on the stomach) to stretch over the "bridge" and make the vertebral interspaces widen for easier access during surgery. While theoretically position on and operation of the holder can affect the width of the interspaces, in practice the surgeon always positions the patient and operates the holder so as to maximize the interspaces. One would not expect the positioning and operation of the holder in two operations at the same level of the lumbar spine to significantly widen an interspace as narrow as the one described in the December 1989 surgical notes. But it might reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. Through answers to his attorney's questions on direct, Respondent also initially attempted to take the position that the patient's weight gain between the two surgeries was enough to warrant ignoring the December 1989 surgical note as to the narrow L5-L6 interspace. But the Department's expert opined that the added weight would not make a significant difference, and on cross- examination Respondent admitted that he actually did not have the patient's weight gain in mind as a reason to gloss over the December 1989 surgical note as to the narrow L5-L6 interspace. Indeed, consistent with Respondent's admission on cross- examination, both Respondent and his expert, Dr. Maniscalco, opined that, if anything, the added weight probably would tend to reduce the maximum flexion obtainable through use of the Wilson laminectomy holder and make the interspaces at the surgical site appear narrower, not wider. Nonetheless, depending on its distribution on the patient, weight gain could possibly alter the apparent width of the interspace during surgery on a Wilson laminectomy holder, and this could also reduce the relative importance of the landmark, compared to other information available to the surgeon, such as radiological confirmation and visual examination of the site. While conceding that he really did not pay much attention to the December 1989 findings as to the remarkable narrowing of the L5-L6 interspace, Respondent also attempted to take the position in testimony that the L4-L5 interspace was fairly narrow itself, as compared for example to the L3-4 interspace. But the L5-L6 interspace clearly was much narrower than L4-L5 and could have been used as a landmark. See Findings 25 and 29, infra. Nonetheless, as previously mentioned, the relatively narrow interspace at L-5-L6 was just one factor to be considered, along with radiological confirmation and visual examination. As Respondent wrote in his notes on May 10, 1993, he thought: "The previous laminectomy site was easily identified and confirmed with a lateral X-ray." The Department's expert took the use of the singular "previous laminectomy site" as evidence that Respondent was unaware of the previous laminectomy at L4-L5. But Respondent testified convincingly that he had reviewed the patient's medical records and was fully aware of both previous laminectomies--at both L5-L6 and L4-L5. (Respondent also testified that his use of the singular, "previous laminectomy site" was intended to mean the general site of both previous laminectomies. But it was the L5-L6 laminectomy site that he thought was "confirmed with a lateral X-ray," so it seems that the language used probably actually referred to the site of the intended surgery. In that respect, the wording of Respondent's surgical notes was ambiguous, if not erroneous.) As usual, an X-ray technician took the lateral X-ray, developed the film, and showed it to Respondent in the OR. Respondent testified that he then had the X-ray technician take the film to the radiology department, along with the pre-operative MRI, and that a radiologist on duty confirmed for him that he was at the "correct level" before he proceeded with the surgery. When Respondent proceeded with the surgery, he widened the laminectomy site and found a disc fragment (which he presumed to be recurrent) underneath and entrapping the nerve root. The nerve root was retracted medially, and the disc space was entered. A large fragment of disc was found in the subligamentous position. Respondent removed the large fragment; then more disc material was removed from the interspace, freeing the nerve. Respondent then performed a foraminotomy and completed the surgery. The pathology found during the second surgery was not inconsistent with the general kind of pathology Respondent expected to find at the L5-L6 level. Relying on visual examination and radiological confirmation, Respondent believed that he was operating at L5-L6. He did not notice, or attached no significance to, the ease of access to the disc space in May 1993, as compared to the narrow interspace encountered at L5-L6 in the first surgery. The Third Surgery After normal recuperation in the hospital, the patient noticed apparent improvement and began regular walking. However, approximately six to eight weeks after surgery, back and leg pain recurred, and the patient returned to Respondent for consultation. Respondent ordered another MRI and scheduled the patient for an appointment in August 1993. When Respondent reviewed the post- operative MRI with the patient, he realized that he had operated at L4-L5 instead of L5-L6. He asked the patient to go to the hospital and get the intra-operative X-ray to help him understand what had happened. It was his belief that the X-ray would show that he had radiological confirmation. With the patient's help, Respondent obtained the X-ray the same day. See Finding 35, infra. Instead of showing radiological confirmation, the X-ray's labeling showed someone's interpretation that the radio-opaque marker on the X-ray was at L4- L5. (There was no evidence as to who labeled the interpretation. Id.) When Respondent saw the writing on the X-ray, he immediately conceded that he had operated at the wrong level and began the process of scheduling a third surgery (the second at L5-L6). Respondent performed the patient's third surgery free-of- charge on September 17, 1993. He had three X-rays taken during the third surgery. The first one apparently was taken before any incision was made. The second was made to confirm that the Respondent was at L5-L6 this time. Instead, the X-ray showed that he was at L6-S1. Respondent tried again, and a third X-ray confirmed L5-L6. Respondent continued with the operation as planned. Findings during the third surgery supported the reasonableness of using the narrow L5-L6 interspace as a landmark during the second surgery. Once again, Respondent found cause to note significant narrowing at L5-L6, stating: "A needle was placed exactly in the interspace, which was small and tight." (The patient weighed 217 pounds at the time of the third surgery--two pounds more than for the second surgery.) The third surgery was otherwise uneventful and apparently successful. The patient discharged after a short stay. The Questionable X-ray Confirmation Although it appears in hindsight that Respondent should have attached more significance to the notes from the first surgery as to the remarkably narrow disc space at L5-L6, even the Department's expert conceded that Respondent should not be found to have practiced below the generally accepted standard of care if he received "real time" radiological confirmation before proceeding with the second surgery. (The Department's expert assumed from the medical records that there was no radiological confirmation. See Finding 33, infra.) Excepting the possibility of an obvious and clear error by the radiologist, the generally accepted standard of care entitles a surgeon to rely on a radiologist's "real time" reading of an intra-operative X-ray. The radiologist's specialty is interpreting X-rays, and the viewing equipment and lighting in the radiology department is far superior to what is available to the surgeon in OR. The question becomes the truth of Respondent's claim of having had "real time" radiological confirmation in the context of the other evidence presented in the case. The radiologist normally would have conveyed the "real time" confirmation of the correct level to the surgeon over a speaker telephone in the OR. But no one else present at the time of the surgery testified. (The patient testified by deposition, but she was under general anesthesia during surgery and could not testify as to radiological confirmation.) Respondent could not remember the name of the radiologist he says confirmed the correct level, and he was unable to show through any other means who confirmed the correct level for Respondent. Meanwhile, the Department did not present any direct evidence to dispute Respondent's claim of "real time" radiological confirmation in the OR. But there was circumstantial evidence that raised questions as to the veracity of the claim. In a hospital radiology report on the intra-operative X- ray, a radiologist named Robert G. Isbell, M.D., stated: "Film was not available for interpretation in the radiology department. The film will be read upon its return." This report was dated May 17, 1993; it was not clear from the evidence whether the report was dictated on that date, released on that date, or both. This could indicate that the X-ray was not taken to the radiology department during the surgery on May 10, 1993, since standard procedure would be for the radiologist to dictate the report immediately after calling down to the OR to confirm the correct level for the surgeon. (The Department's expert assumed from this report that there was no radiological confirmation.) However, it also is possible that an unknown radiologist confirmed the correct level for Respondent and then failed to follow the normal procedure, and either he forgot to dictate the report, or the dictation got lost or for some other reason did not result in a transcribed report to go in the patient's file "jacket" in the radiology department. If there was radiological confirmation in the OR, the radiologist apparently did not label the film and have it sent back to the OR, as usual, because the X-ray apparently was not labeled until later. See Findings 35-36, infra. When the patient went to St. Joseph’s Hospital in August 1993 at the Respondent's request to ask for her X-ray, she was told that a doctor had just asked for it to be sent over to the hospital (apparently from where it ordinarily would have been kept.) S.D. was surprised and somewhat suspicious that the hospital was familiar with her X-ray by name and that it coincidentally had just been requested by a doctor. There was no evidence as to the identity of the doctor who requested the X-ray. S.D. insisted on receiving her X-ray immediately and waited until it was returned to her. When she got it, there appeared to be fresh "grease pen" writing on it. As previously mentioned, the grease pen writing labeled the X-ray and clearly indicated someone's interpretation that the radio-opaque marker on the X-ray was at L4-L5. Respondent has maintained that he had never seen the grease pen writing before the X-ray was brought to him by the patient in August 1993. This is consistent with the patient's testimony that the grease pen writing appeared to her to be fresh, and it seems clear from the evidence that the writing was placed on the X-ray shortly before S.D. retrieved it, contrary to normal procedures. This evidence also makes it possible that the X-ray never was sent to the radiology department during surgery, again contrary to normal procedures. It is not clear from the evidence where the X-ray had been between the time of the May 1993 surgery and the time S.D. picked it up with the fresh grease pen writing. There was no evidence as to who put the markings on the X-ray, or at whose request. There was no evidence of any hospital radiology report recording the mysterious August 1993 "reading" of the X-ray as reflected by the new grease pen writing. It also is not clear from the evidence exactly what was written on the X-ray in August 1993 when S.D. retrieved the film from the hospital, or what that particular X-ray looked like. While S.D. retained the X-ray until some time during her subsequent civil action against Respondent and the hospital, she then gave it to the hospital's risk manager, who was supposed to make her a copy. When S.D. went to retrieve the X-ray for her deposition in this administrative proceeding, she found several X-rays apparently given to her by her lawyer after disposition of the civil action, including one labeled "original" and bearing writing in addition to, or other than, the writing S.D. recalled from August 1993. The writing on the X-ray used in this administrative proceeding may have been placed on the "original" X- ray by experts in the civil action. The other X-rays in S.D.'s possession were not produced for use in this administrative proceeding, and it is not clear which, if any of them, is the X-ray labeled as when S.D. retrieved it in August 1993. The X-ray used in this administrative was of poor quality and actually did not show what was below the marked interspace. (As the Respondent described the lower part of the film, "It looks like a snowstorm.") As a result, it actually would not have been possible to confirm the correct level using that particular X-ray. But X-rays can deteriorate over time, and there is no way of knowing if the intra-operative X-ray as it existed on May 10, 1993, or when seen again by Respondent in August 1993, also was of such poor quality as to be virtually useless. If an unknown radiologist in fact called the OR to confirm the correct level for Respondent, it also is possible that there was a miscommunication. Respondent in his testimony made a point of explaining that he only used the terminology "correct level" in talking to the radiologist "to avoid confusion." But if Respondent just asked if he was at the "correct" level, and the radiologist just said, "yes, you're at the correct level," the radiologist actually either would be simply assuming that the level marked on the X-ray was the "correct" level, or he would be saying that pathology visible on the MRI matched the marked location on the X-ray. If the latter, the radiologist may have thought there was enough pathology showing on the MRI matching the marked interspace in this case (actually L4-L5) to justify surgery there. Taking all of this evidence into consideration, it cannot be found that the Department proved by clear and convincing evidence that Respondent did not receive "real time" radiological confirmation on which he was entitled to rely in proceeding with the second surgery. Without such proof, it cannot be found that Respondent practiced below the generally accepted standard of care, notwithstanding the little attention he paid to his December 1993 surgical notes as to the remarkably narrow interspace at L5-L6.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint in this case. DONE AND ENTERED this 27th day of September, 1999, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 27th day of September, 1999. COPIES FURNISHED: Britt Thomas, Esquire Agency for Health Care Administration 1580 Waldo Palmer Lane Tallahassee, Florida 32308 Jon M. Pellett, Esquire Grover C. Freeman, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Pete Peterson, General Counsel Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast, Bin A02 Tallahassee, Florida 32399-1703 Tayna Williams, Executive Director Board of Medicine Department of Health Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
