Findings Of Fact The Department of Health and Rehabilitative Services (Department or HRS) drafted and published an Invitation to Bid (ITB) DCPHU-93-02, inviting bids for laboratory services for the ten medical clinics located in Duval County, Florida. ITB DCPHU-93-02 provided that prospective bidders could submit written questions prior to the bidders' conference and make verbal inquiries at the bidders' conference regarding the terms of the ITB. The ITB provided that "no change, modifications or additions to the bids submitted will be accepted by the Department after the deadline for submitting bids has passed." The ITB provided that any prospective bidder could file a written protest of the provisions of the ITB as outlined in the Item 5 of the General Conditions. See Joint Exhibit 1, Page 13. The ITB provided that the vendor was responsible to develop the bid as clearly and succinctly as possible to avoid misinterpretations of the information presented, and that the bids would be reviewed and evaluated solely on the basis of the information contained therein. The ITB provided that the contract would be awarded to the bidder who satisfied the requirements of the evaluation criteria in Section E and who provided the lowest overall valued bid. The ITB specifically invited the attention of the prospective bidders to Section E of the ITB which contained fatal criteria, i.e., requirements which if the prospective bidders failed to meet would result in the rejection of their bid. Contained in Section E among the various fatal criteria was the specific requirement that bids were to include proof of registration with the Department of State to do business in the State of Florida. Section E, "Bid Evaluation Criteria," provided, "listed below are the minimum requirements (Fatal Criteria) that all bids must satisfy," and that "a bid given a 'no' response to one or more of these requirements will be removed automatically from further consideration." See Joint Exhibit Page 14. The Petitioner did not challenge bid specifications or designation of "proof of registration with the Department of State to do within business in the State of Florida" within 72 hours of receiving the ITB. No bidders provided written questions concerning the meaning of "proof of registration with the Department of State to do business within the State of Florida." Representatives of the Petitioner attended the bidders' conference on August 11, 1993. Although representatives of the Petitioner asked certain questions at the bidders' conference, they did not question the meaning of the term, "proof of registration with the Department of State to do business within the State of Florida." Shortly before the bid opening on August 18, 1993, a representative of the Department emphasized to a representative of the Petitioner the need to fully comply with the Fatal Criteria contained in the ITB. The Petitioner submitted its bid to the Department ten minutes prior to the bid opening scheduled for 10:00 a.m. on August 18, 1993. The bid opening was conducted in public with representatives of the various prospective bidders in attendance. Among those attending were three representatives of the Petitioner. The Department's representative opened four responses which appeared to be, and were, "no bids." The representative then opened SmithKline's bid and reviewed the Intervenor's submittal to determine if it complied with the Fatal Criteria. Upon review, it was determined that SmithKline complied with the Fatal Criteria. SmithKline's bid contained a certification from the Department of State of the State of Florida certifying that SmithKline Beecham Clinical Laboratories, Inc., was authorized to transact business in the State of Florida and that it had paid all fees and penalties due the State of Florida through December 31, 1993, filing its most recent annual report on May 1, 1993, and that its status was active. This certificate was dated the 13th day of August 1993 under the seal of the Secretary of State of the State of Florida. The Department's representative next opened the proposal of the Petitioner and evaluated it to determine whether it complied with the Fatal Criteria. This review of the Petitioner's proposal revealed that the Petitioner had not included in its submittal any specific document or paper showing that the Petitioner was registered with the Department of State to do business in the State of Florida. The Petitioner had not filed a certificate of the Secretary of State or a copy of its annual report required to be filed with the Department of State. The Department rejected the Petitioner's bid for failure to comply with the Fatal Criteria concerning proof of registration with the Department of State to do business in the State of Florida. Because of its rejection, the Department did not consider whether the Petitioner's bid complied with any of the remaining Fatal Criteria and did not consider any amount of the Petitioner's bid in considering which of the proposals was the lowest bid. At 4:30 p.m. on August 18, 1993, the Petitioner provided the Department a 1975 certificate from the Secretary of State indicating that the Petitioner was authorized to do business in the State of Florida and a copy of an annual report the Petitioner had submitted to the Secretary of State on March 10, 1993. These were filed too late to cure the fatal defect. The Department also determined that three other bidders, including Consolidated/St. Vincent's failed to comply with Fatal Criteria. Subsequent to its disqualification of Consolidated/St. Vincent's bid, said bidder brought to the Department's attention of the that its proposal included a copy of a corporate report filed with the Secretary of State and dated August 3, 1993. The Department determined that this was sufficient proof that the bidder was registered to do business in the State of Florida with the Secretary of State. On August 25, 1993, the Department awarded to the contract to SmithKline Beecham, Intervenor. On August 28, 1993, the Petitioner formally protested this award. The Petitioner did include in its proposal the following: a sworn statement of public entity crimes; a clinical laboratory certificate of licensure from the Department of Health and Rehabilitative Services of the State of Florida; a Federal Health Care and Finance Administration number issued pursuant to Federal law; and a College of American Pathology number.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer RECOMMENDS: that the Department dismiss the Petition of National Health Laboratories, Inc., and award the contract to the Intervenor, SmithKline Beecham Clinical Laboratories. DONE and ENTERED this 17th day of November, 1993, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of November, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-5552BID The Petitioner filed proposed findings which were read and considered. The Intervenor filed proposed findings which were read and considered. The Respondent adopted the findings of the Intervenor. The following states which of the proposed findings were adopted, and which were rejected and why. Intervenor's Recommended Order Proposed Findings Paragraph 1 Adopted in paragraph 1. Paragraph 2 Adopted in paragraphs 2 - 9. Paragraph 3 Adopted in paragraph 10. Paragraph 4 Adopted in paragraph 11. Paragraph 5 Adopted in paragraph 12. Paragraph 6 Rejected, argument. Paragraph 7 Adopted in paragraph 13. Paragraph 8 Adopted in paragraph 14. Paragraph 9 Adopted in paragraphs 15, 16 and 20. Paragraph 10 Adopted in paragraph 19. Paragraph 11 Adopted in paragraph 20 and 21. Paragraph 12 Adopted in paragraph 22. Paragraph 13 Adopted in paragraph 23. Paragraph 14-25 Arguments and ultimate findings contained in conclusions of law. Petitioner's Recommended Order Proposed Findings Paragraph 1 Adopted in paragraph 1. Paragraph 2, 3 Rejected, irrelevant. Paragraph 4 Adopted in paragraph 4. Paragraph 5 Adopted in paragraph 8. Paragraphs 6-13 Rejected, irrelevant. All argument based upon attack on criteria. Paragraph 14 Adopted in paragraph 13. Paragraph 15, 16 Rejected, irrelevant. Paragraph 17, 18 Adopted in paragraph 13. Paragraphs 19-31 Rejected. See comments to paragraph 6, et seq. above. Also see paragraphs 15, 16, 17 and 18. Paragraph 32 Adopted in paragraph 23 Paragraph 33-45 See comments to paragraph 19 above. COPIES FURNISHED: Thomas F. Panza, Esquire 3081 East Commercial Boulevard, Suite 200 Fort Lauderdale, Florida 33308 Scott D. Leemis, Esquire Department of Health and Rehabilitative Services Post Office Box 2417 Jacksonville, Florida 32231-0083 SmithKline Beecham Clinical Laboratories Donald E. Hemke, Esquire Carlton, Fields, Ward, Emmanuel, Smith & Cutler Post Office Box 3239 Tampa, Florida 33601 Robert L. Powell, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Kim Tucker, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
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
Findings Of Fact The Respondent, Joseph A. Buttacavoli, is a licensed chiropractor, having been issued license number 00335. The Respondent practices chiropractic at 7162 Beneva Road, Sarasota, Florida 33583. (See Prehearing Stipulation.) On July 6, 1981, Jeffrey Goldman responded to the Respondent's newspaper advertisement offering a free examination. (See Prehearing Stipulation; Tr. 15.) On July 6, 1981, Goldman was complaining of pain in the neck radiating into the left shoulder. The pain was recent in origin, having started a few weeks prior to July 6, 1981. Goldman had suffered similar problems during the past 10 or 12 years on an intermittent basis, but this instance was more intense than previously experienced. (Tr. 12, 13.) The Respondent performed a free examination consisting of certain orthopedic and neurological tests. (Tr. 73, 77.) The Respondent did not record in writing the results of this examination. (Tr. 117.) Two of the tests were positive on Goldman's left side. (Tr. 73-77.) After completion of the examination, the Respondent tentatively diagnosed a pinched nerve in the neck and recommended to Goldman that x-rays be taken. (Tr. 78.) Goldman consented to the x-rays and was charged $80 for four x-rays which were taken. (See Prehearing Stipulation.) After the x-ray examination, the Respondent concluded that Goldman had a straightening of the normal cervical spine, some arthritic spurring and disc degeneration at the C4/C5 and C5/C6 level, and several vertebral misalignments. (See Prehearing Stipulation; Tr. 87.) The Respondent advised Goldman that his condition was serious and recommended treatment for 90 days. (See Prehearing Stipulation.) The Respondent told Goldman what the 90 days' treatment would cost and advised Goldman that the cost would be less if paid in advance. The Respondent practices a chiropractic technique known as Grostic or orthospinology. (Tr. 53, 55.) A diagnosis cannot be reached without x-rays using the Grostic technique, and the Respondent takes x-rays in every case except those in which the problem is muscular or x-rays are refused by the patient. (Tr. 115, 116.) The preliminary or free examination is the basis for the Respondent's recommending that x-rays be taken. (Tr. 117.) In the Grostic technique, a complex analysis of x-rays is the basis for a final diagnosis. This requires that x-rays be taken of the patient to apply the technique. (Tr. 59-63, 117-118.) In addition to the x-rays, which were kept by the Respondent as part of the record, Goldman's history/interview form was also maintained. (Tr. 48.) The x-rays on file and the medical history form constitute sufficient justification for the recommendation made by the Respondent to Goldman. The diagnosis of Goldman's problem was based upon his history, a physical examination and x-ray findings. These findings were reviewed by Dr. George Stanford Pierce, who verified the Respondent's suggested course of treatment based upon the records the Respondent maintained. (Tr. 150.) Goldman refused further treatment by the Respondent. (Tr. 26.) No evidence was received that the Respondent practiced chiropractic with less than the required level of care, skill and treatment recognized by reasonably prudent chiropractic physicians as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Administrative Complaint filed by the Petitioner against the Respondent, Joseph A. Buttacavoli, be dismissed. DONE and RECOMMENDED this 12th day of July, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1983. COPIES FURNISHED: Diane K. Kiesling, Esquire 517 East College Avenue Tallahassee, Florida 32301 Michael R. N. McDonnell, Esquire 600 Fifth Avenue, South, Suite 301 Post Office Box 8659 Naples, Florida 33941 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Jane Raker, Executive Director Board of Chiropractic 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER =================================================================
Findings Of Fact Rubin Klein, M.D., dispenses radiation therapy treatments at his office in Hollywood, Broward County, Florida, just north of the Dade County line. He uses two cobalt machines for this purpose. Cobalt's radioactivity fades at an approximate rate of one percent per month, and at least one of Dr. Klein's machines has deteriorated to the point that it cannot be used much longer. Dr. Klein would like to see the failing machine replaced by a linear accelerator, but he does not want to bear the expense of acquiring a linear accelerator, particularly since his practice fell off sharply two or three years ago with the opening of a radiation therapy department at Hollywood Memorial Hospital. Dr. Klein has offered to donate his equipment to petitioner, and petitioner proposes to accept Dr. Klein's donation of his better cobalt unit, to bear the expense of moving the cobalt unit, to acquire a linear accelerator, to construct an appropriate facility, and to install the equipment. Petitioner estimates that it would cost approximately eight hundred twenty-three thousand dollars ($823,000.00) to accomplish this. On the other hand, Dr. Klein estimates that it would cost approximately two hundred five thousand dollars ($205,000.00) to acquire a linear accelerator and to install it in his office. Once the physical changes which it proposes have been accomplished, petitioner proposes to hire Dr. Klein's office staff, including a full-time radiation physicist and two radiation therapy technicians. In August of 1977, petitioner submitted its application for certificate of need, joint exhibit No. 1, receipt of which was acknowledged by Mr. Robert E. Straughn on behalf of the Office of Community Medical Facilities, on August 29, 1977. Joint exhibit No. 2. The staff of the Health Systems Agency of South Florida, Inc. prepared an analysis of petitioner's application, which concluded with a recommendation against approval of the application. Joint exhibit No. 4, p. 31. Because of petitioner's proximity to Broward County, the Health Systems Agency of South Florida, Inc. solicited the views of the Health Planning and Development Council for Broward County on petitioner's application, but these views were never made known. A review committee of the Health Systems Agency of South Florida, Inc. voted against granting petitioner's application. In a memorandum from the review committee's chairperson to the Health Systems Agency's Board of Directors, the committee's reasons were stated as follows: Although this is a transfer and upgrade of existing equipment, it still represents excess capacity for the total community. The project does not foster cost containment since construction costs represent the expense of building a new unit. (The committee felt that such expense would be asking the community to absorb unnecessary costs.) Joint exhibit No. 7. On October 18, 1977, the Board of Directors of the Health Systems Agency of South Florida, Inc. adopted the staff's analysis and voted to recommend denial of petitioner's application because, inter alia, "[i]t is less costly to maintain the facility in its present location." Joint exhibit No. 8. On November 16, 1977, Mr. Art Forehand wrote petitioner that the Office of Community Medical Facilities had also reviewed the application and had also concluded that it should be denied. Joint exhibit No. 9. Petitioner's hospital is located in Dade County on Biscayne Boulevard one fifth of a mile south of the Broward County line. Petitioner has six or seven oncologists on its medical staff and 20 percent of its beds are filled by cancer victims, half of whom receive radiation therapy. The demographic data suggest that cancer patients will continue to occupy petitioner's beds in like or greater numbers. Seventy-eight percent of petitioner's patients are 65 years old or older, an age group three or four times more vulnerable to cancer than the general population. As things now stand, petitioner's patients must leave the hospital in order to receive radiation therapy. This ordinarily necessitates transportation by ambulance. The cost for such transportation to Dr. Klein's office and back is sixty-five dollars ($65.00). Dr. Klein's office is four and one half miles from petitioner's hospital. Approximately three percent of Dr. Klein's patients are hospitalized at Biscayne Medical Center, Inc., and travel to and from his office by ambulance. The practice of radiation medicine occurs more and more in hospitals rather than in radiologists' offices, and this trend is generally believed to be desirable. Tumors may be treated surgically or chemically instead of or in addition to being treated with radiation. Physicians sometimes disagree among themselves as to whether surgery, medicine or radiation is indicated in a given case. Petitioner's cancer patients would benefit from examination by a radiation oncologist as well as by other medical specialists. A cancer victim who presents himself at a radiologist's office may not have been examined beforehand by a medical oncologist or by a surgical oncologist; a cancer patient who has been admitted to a hospital is perhaps more likely to be examined by these specialists before a course of treatment is settled on. Chemotherapy and various heat treatments, which are more readily administered in a hospital setting, may enhance the beneficent effects of radiation in some cases. Hospitalization facilitates observation of patients and detection of untoward side effects. In practice, however, nine outpatients for every one inpatient "tends to be the normal spread for a radiation therapy department." (R326) Radiation emitted from a linear accelerator can be focussed more sharply than radiation emitted from a cobalt unit. For Hodgkin's disease, certain pituitary and other disorders, a linear accelerator is a much better means of treatment than a cobalt unit is. Since radiation tends to destroy human tissue, whether diseased or healthy, the linear accelerator's relative precision can be a significant advantage in a wide range of cases. Treatment takes more time with a cobalt unit, especially one with a failing source of radiation. Dr. Klein estimates he could treat a fifth again as many people in the same time, with a linear accelerator. What constitutes optimum utilization of radiotherapy equipment is a matter of debate. Dr. Richard Johnson testified that six to seven thousand patients annually constitute "the maximum you can give good treatment," (R153) apparently on the basis of a 35 hour work week. (Rl54) On the other hand, the staff of the Health Systems Agency of South Florida, Inc. used a 48 hour work week in its calculations and concluded that both Dade and Broward County have substantial excess capacity in radiotherapy equipment. Both Dade and Broward Counties do, in fact, have excess capacity in radiotherapy equipment. On the assumption that Dr. Klein's practice would grow, if removed to petitioner's hospital, and on the assumption that Dr. Klein would charge (in addition to the hospital's charges) twenty dollars per procedure (which he indicated was the very minimum he might charge), Mr. Donald Dahlfues testified that the federal government might be billed less for the same number of treatments if Dr. Klein performed them in petitioner's hospital than if he performed them in his present office. The foregoing findings of fact should be read in conjunction with the statement required by Stuckey's of Eastman, Georgia v. Department of Transportation, 340 So.2d 119 (Fla. 1st DCA 1976), which is attached as an appendix to the recommended order.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That respondent deny petitioner's application for certificate of need. DONE and ENTERED this 17th day of April, 1978, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of April, 1978. APPENDIX Paragraphs one, two, three, four, five, six, seven, eight, nine, ten, eleven, fourteen, fifteen, and nineteen of petitioner's proposed findings of fact are generally supported by the evidence and have largely been adopted, in substance, insofar as relevant. Paragraph thirteen of petitioner's proposed findings of fact recites an "optimum accepted utilization rate" which was not established by the evidence. Paragraph sixteen of petitioner's proposed findings of fact is not supported by the evidence and has not been adopted for that reason. One of petitioner's witnesses indicated that 90 percent of the anticipated use of the equipment would be on an outpatient basis. While another of petitioner's witnesses claimed that hospital bed time would be reduced in some cases, petitioner's administrator is looking to "increased inpatient days as a result of having the equipment" (R43) to help defray the cost of the equipment. Paragraph seventeen of petitioner's proposed findings of fact states a debatable policy conclusion rather than a fact established by the evidence at the hearing. Paragraphs eighteen, twenty and twenty-one of petitioner's proposed findings of fact are not supported by the evidence as a whole and have not been adopted for that reason. Paragraphs one, three, four, five, six, seven, eight, nine, ten, thirteen, fourteen, sixteen, seventeen, eighteen, nineteen and twenty-one of respondent's proposed findings of fact are generally supported by the evidence and have largely been adopted, in substance. COPIES FURNISHED: Edward R. Rumin, Esquire Adams and Adams 2870 East Oakland Park Boulevard Fort Lauderdale, Florida 33306 Milton E. McRay, Esquire 6502 Powers Ferry Road, N. W. Atlanta, Georgia 30339 Steven W. Boss, Esquire 1323 Winewood Boulevard Room 309 Tallahassee, Florida 32301
Findings Of Fact The Respondent, Wayne A. Bryan, is a chiropractic physician holding license number 0001861 issued by the Board of Chiropractic Examiners. At all times pertinent to the allegations contained in the Administrative Complaint, the Respondent engaged in the practice of chiropractic at the Bryan Chiropractic Clinic, 155 Ridgeway Drive, Sebring, Florida. On April 24, 1981, Jeanne Speight went to the Respondent's office for treatment of low back pain, which she attributed to work in her garden. Upon her arrival at the Respondent's office, Mrs. Speight was advised by an unknown female office employee that she would have to be "X-rayed before she was seen by the Respondent. A total of ten x-rays were taken of Mrs. Speight by an unknown employee before she was seen by the Respondent. After a physical examination, the Respondent told Mrs. Speight to return the next day with her husband because she had a serious, life-threatening problem. On the following day, Mrs. Speight returned to the Respondent's office with her husband. The Respondent spoke with the Speights and advised them that Mrs. Speight required an intensive treatment program consisting of four treatments per week over a three-month period with complete x-ray work-up each month during the treatment. When Mr. Speight questioned the necessity of so many x-rays and suggested they obtain a second opinion, the Respondent became angry and predicted that Mrs. Speight would lose 99 percent of the use of her legs and be paralyzed if she did not take his treatment. After her visits with the Respondent, Mrs. Speight sought treatment from another chiropractic physician, Dr. O. A. Speigel. Dr. Speigel requested Mrs. Speight's x-rays from the Respondent; however, the Respondent did not provide the x-rays, but furnished Dr. Speigel with a full report of the Respondent's findings, which Dr. Speigel described as excellent. Mrs. Speight's records and x-rays were later examined by Dr. Richard Carr, a chiropractic physician. According to Drs. Speigel and Carr, Respondent's diagnosis concerning Mrs. Speight's condition was consistent with the x-rays and reports. Further, did Respondent's prognosis as stated to the Speights that Mrs. Speight would lose 99 percent of the use of her legs was inconsistent with his diagnosis. On January 6, 1981, J. C. Hickman sought chiropractic treatment from the Respondent for a muscle spasm in his leg. Upon Hickman's arrival at the Respondent's office, prior to being seen by him but after a medical history was taken, Hickman had a series of spinal x- rays taken by Barbara Bryan, the wife of the Respondent. Mrs. Bryan was not licensed as a radiologic technologist in the State of Florida until February 12, 1982. During Hickman's first visit, an unknown female employee of Respondent's demanded and obtained a sample of Hickman's hair without explaining the purpose for obtaining this sample. Hickman was examined by the Respondent, who advised him that he had serious problems and proposed a series of chiropractic treatments. The Respondent told Hickman that he did not use his hands directly on a patient in rendering treatment. According to Hickman, the Respondent had him lie on the examining table in a prone position, and while he was in this position he received a mechanized blow or thrust to his chest. This description by Hickman of his treatment is not rejected but given less weight than his testimony on other aspects of his treatment with which Hickman was more familiar than the nature of Respondent's manner and method of treatment. The Respondent advised Hickman to return the following day in order to receive the same treatment for his leg. At no time did the Respondent examine or touch Hickman's leg. On or about July 11, 1980, Don Payne sought chiropractic treatment from the Respondent. Prior to examination by the Respondent, his wife, Barbara Bryan, took a series of x-rays of Payne. As stated above, Mrs. Bryan was not licensed as a radiologic technologist in the State of Florida until February 12, 1982. Thereafter, without explaining the purpose of it, Mrs. Bryan demanded a sample of hair from Payne. The manner in which the sample of hair was demanded annoyed Payne, who, although he permitted her to take the sample, did not advise Mrs. Bryan that he wore a full hairpiece from which the sample was taken. The medical records of Mary Scofield were received into the record as Petitioner's Exhibit 4. The only other evidence presented concerning Ms. Scofield was the deposition of Dr. Richard Carr based upon his examination of her medical records. Dr. Carr could not conclude from the records that the Respondent's diagnosis and treatment of Ms. Scofield were improper. Based upon their medical records, Dr. Carr opined whether hair analysis was proper with regard to the Respondent's patients. Dr. Carr based his opinion of the appropriateness of using this technique upon whether heavy metal poisoning was indicated in these patients. Because the test is recognized but controversial with regard to testing for vitamin deficiency, Dr. Carr's opinion is appropriately qualified. Mrs. Speight did not testify to any hair analysis performed. Hickman and Payne stated, and it is found that Respondent performed hair analysis.
Recommendation Having found the Respondent, Wayne A. Bryan, guilty of the allegations contained in Count Three, Count Six, Count Seven, and Count Ten of the Administrative Complaint, it is recommended that the Board of Chiropractic Examiners revoke the license of Respondent. DONE and RECOMMENDED this day of December, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of December, 1983. COPIES FURNISHED: Diane F. Kiesling, Esquire Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 Wayne A. Bryan 12837 Township Road, 168-RR3 Findlay, Ohio 45840 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Jane Raker, Executive Director Board of Chiropractic Examiners 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
