The Issue Whether Respondent medical physician violated Subsection 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; Subsection 458.331(1)(m), Florida Statutes, by failing to keep medical records to justify the course of treatment of a patient; and/or Subsection 458.33(1)(p), Florida Statutes, by performing surgery at the spinal level of C6-7 without patient consent and without statutory exception.
Findings Of Fact Petitioner, through the Board of Medicine, is the state agency which licenses and has regulatory jurisdiction of medical physicians. At all times material, Respondent has been a licensed medical physician in the state of Florida, having been issued license No. ME 0017399. He is board-certified in orthopedic surgery, is a member of many spine-specialized medical societies, and is highly published in the field of spinal surgery. He has devoted 100 percent of his practice to spinal surgery since 1989. On or about August 16, 1991, Patient R.L., then a thirty-two-year-old woman, was referred to Respondent with complaints of neck and shoulder pain due to a work-related accident. On August 16, 1991, Respondent diagnosed R.L. as having cervical spondylosis with radiculopathy, and thoracolumbar scoliosis. He recommended she undergo magnetic resonance imaging (MRI) of her cervical spine at North Florida Regional Medical Center (NFRMC). R.L. underwent MRI of her cervical spine at NFRMC on September 20, 1991. The radiologist's report of R.L.'s September 20, 1991, MRI indicated no disc herniation, central stenosis, or foraminal impingement at the C3-4 and C4-5 disc levels or at the C6-7 and C7-T1 levels. The radiologist's report did indicate that at the C5-6 level there was a small abnormal posterior protrusion of disc material, centrally and slightly eccentric towards the right side and that axial images demonstrated a small, right-sided central/right paracentral herniation. The report added that a very mild and early uncontrovertral spurring was noted at this level but was not resulting in impingement for exiting nerve roots. R.L. next saw Respondent on September 24, 1991. On that date, Respondent reviewed R.L.'s cervical spine MRI with her and diagnosed a probable small central and right paracentral herniation at the C5-6 level. Respondent was then of the opinion that the cervical spine MRI did not clearly delineate a disc herniation at R.L.'s C5-6 level. Respondent accordingly recommended that R.L. undergo a myelogram-CT scan. Respondent did not indicate to R.L. that he detected any pathology at C6-7. On October 29, 1991, R.L. underwent a cervical myelogram and CT scan at NFRMC. The radiologist's report indicated an extradural defect at C5-6, which was moderate in size and touched the cord but which did not cause any cord compression. The report also stated that the nerve sleeved well and that there was a very slight posterior subluxaton of C5 on C6 associated with this. The report did not indicate any pathology at C6-7. R.L. next saw Respondent on November 14, 1991. On that date, Respondent reviewed R.L.'s cervical myelogram and CT scan with her, diagnosed a herniated nucleus pulposus at C5-6, and recommended C5-6 anterior cervical fusion with plates. Respondent did not, on that date, indicate to R.L. that he had identified any pathology at C6-7. R.L. testified that before surgery, Respondent did not tell her that he would be removing any disc other than the one at C5-6; that he did not indicate he thought R.L. would need more surgery than the surgery planned at C5-6; or that he might discover something during the planned surgery which would require the removal of any disc different than C5-6. Respondent testified that he did not recall whether he did or did not tell R.L. that C6-7 might some day require an operation or that C6-7 might need work while he was operating on C5-6. His office notes for January 21, 1992, only state She returns today for her preoperative visit. The nature and extent of her surgery has been explained to her and she voices understanding. R.L.'s and Respondent's testimony agree that before surgery, Respondent intended to remove and fuse only at C5-6; that R.L. understood and agreed that Respondent would remove only the disc at level C5-6 and fuse it; and that before surgery, neither of them expected Respondent to operate at a level of R.L.'s cervical spine different than C5-6. Experts for Petitioner and Respondent, (Drs. Gonzalez- Perez and Smith respectively), concurred that if Respondent discussed the proposed procedure, most common and potential risks and complications, and the potential course of rehabilitation with R.L., and if Respondent and R.L. then reached a mutual decision to operate, full disclosure and informed consent had occurred, regardless of whether a written consent form had been filled out and signed. On January 29, 1992, R.L. signed an NFRMC "Authorization for Surgical Treatment and/or Special Procedure" which provided: I, the undersigned, a patient in the below named hospital, hereby authorize Dr. Lowery (and whomever he may designate as his assistants) to administer such treatment as is necessary, and to perform the following operation: anterior cervical fusion and instruments with autolugus and/or bone bank bone and such additional operations or procedures as are considered therapeutic on the basis of findings during the course of said operation. I also consent to the administration of such anesthetics as are necessary with the exception of none. Any tissues or parts surgically removed may be disposed of by the hospital in accordance with accustomed practice. I hereby certify that I have read and fully understand the above AUTHORIZATION FOR SURGICAL TREATMENT, the reasons why the above-named surgery is considered necessary, its advantage and the possible complications, if any, as well as possible alternative modes of treatment, which were explained to me by Dr. Lowery. I also certify that no guarantee or assurance has been made as to the results that may be obtained (Underlined portions were written in; the remainder was pre-printed). The foregoing hospital authorization did not identify the level of the cervical spine where the procedure would be performed. It merely indicated that an anterior cervical fusion would be performed, without stating which of the seven vertebrae were intended to be fused. Dr. Gonzalez-Perez, Petitioner's expert witness, testified that this is not the type of release a reasonable and prudent physician would use for informed consent. Petitioner contends that Respondent's use of the authorization form deviated from the level of care, skill, and treatment recognized by a reasonable and prudent physician as being acceptable under similar facts and circumstances, but even Petitioner's expert, Dr. Gonzalez-Perez, testified that such a form is usually filled-out by a nurse employed by the hospital, and that if Respondent and R.L. went through an informed consent conversation prior to surgery, that would be sufficient, without a written acknowledgement or authorization, for Respondent to have met the standard of care for informed consent and patient pre-authorization for surgery at the mutually understood level of C5-6. On February 3, 1992, Respondent performed an anterior cervical fusion with plates on R.L. at NFRMC, with the intention of operating at the C5-6 level of R.L.'s cervical spine. In doing so, he utilized a portable fluoroscopy unit, intraoperatively, to ascertain the correct level of R.L.'s cervical spine for the anterior cervical fusion with plates. The success of such a procedure depends upon properly identifying the pathological discs. It is critical to correctly ascertain the site where the surgery is to be performed. Failure to correctly identify the location for surgery can result in a failure to perform the intended surgery, a failure to resolve the problem which required the surgery, and/or performing surgery in a location not requiring surgery. The method Respondent used was to palpate the boney structures, make an incision to the vertebral bodies, insert a single needle, take an X-ray, and see if the needle had correctly located where surgery should take place. Respondent's expert, Dr. Smith, and Respondent testified that they prefer the one-needle method utilized by Respondent. Dr. Gonzalez-Perez admitted that use of X-rays, including fluoroscopy in the operating room in order to locate the level of the operation is the "gold standard" of care in this type of orthopedic surgery. He would have used a two- needle technique for locating and checking the location of the surgical site, but even he considered the one-needle method to constitute acceptable medical practice. In R.L.'s case, Respondent placed the single needle at the C7-T1 level, and the fluoroscopic lateral spot films of R.L.'s cervical spine obtained in the operating room showed the needle at the C7-T1 level. Respondent, however, concluded incorrectly that the fluoroscopic lateral spot films showed a needle at the C6-7 level. Respondent miscounted from the vertebra landmark of what he thought was C-2, and removed and fused the wrong disc. On February 3, 1992, after drawing the conclusion that the intraoperative fluoroscopic lateral spot films showed a needle at the C6-7 level of R.L.'s cervical spine, Respondent proceeded with an anterior cervical fusion with plates at what he assumed was the C5-6 level of R.L.'s cervical spine, which, in fact, was the C6-7 level. Respondent, in fact, performed an anterior cervical fusion with plates at the C6-7 level of R.L.'s cervical spine. Respondent surmised in his testimony that he had been confused because on R.L., the C-2 and C-3 structures were very similar. Dr. Gonzalez-Perez maintained that Respondent should have been able to locate the correct level based on the jaw bone and part of the skull being visible in the first and pre-removal X-ray (lower image of P-7). Respondent disagreed that skull and jaw are the best landmarks. Dr. Smith testified that C-2 and C-3 look similar due to their scalloped edges, but either would be an appropriate point from which to begin counting. He, personally, would normally begin counting with C-2, which is a very distinctive- looking vertebra. He opined that even reasonable and prudent physicians can make mistakes in counting and removing the wrong disc. Dr. Gonzalez-Perez felt that Respondent could have and should have involved others in the operating room in counting vertebrae and selecting the surgical location. Respondent disagreed, maintaining that only the surgeon should make such a decision. Dr. Smith testified that he, personally, asks someone else in the operating room to check him after he has counted. Petitioner contends that by failing to correctly identify the level of the spine and to make certain of the operative level before proceeding, Respondent failed to practice with the level of care, skill and treatment which is recognized by a reasonable and prudent medical physician under similar facts and circumstances as being acceptable and that Respondent had the information and should have been able to properly and correctly count the levels of the cervical spine and find the appropriate disc. However, even Petitioner's expert, Dr. Gonzalez-Perez, testified that Respondent met the standard of care up to the point at which Respondent performed the actual operation, and that operating at an unintended level is a known complication of such surgery, as stated in the textbooks. Respondent testified that during the surgery, he found a disc fragment and a tear in the posterior longitudinal ligament (PLL) at the wrong level (C6-7) where he removed the wrong disc, and that during the surgery, he relied upon this discovery as indicative that he was operating at the correct location/level (C5-6). Respondent testified that he removed the piece of disc at C6-7 in one piece, found a rent in the PLL behind it, and believed the pathology he had found corresponded to what he had expected to find at the C5-6 level, based on his preoperative evaluation. Dr. Gonzalez-Perez testified that a rent in the PLL cannot be seen until the disc is removed, so viewing it does not verify the location at which a discectomy should occur. He also stated that although a surgeon tries not to push down, occasionally s/he must dig in and push tissue to the back so as to remove the desired tissue and that portions of the disc may remain in the disc space until they are scooped out. Therefore, the procedure itself can result in a tear of the PLL. In light of the pre-operative tests not showing disc material or a PLL tear, Petitioner urges that the conclusion be drawn that Respondent's surgery itself caused the tear and protrusion at R.L.'s C6-7 level, but Dr. Gonzalez-Perez did not clearly state such a conclusion. Dr. Smith testified that finding such pathology after beginning the disc removal would have been a comforting (re- enforcing) sign to any surgeon that s/he had operated at the correct level, but Dr. Smith acknowledged that such a sign would not identify the correct disc for removal before removal actually began. Due to the superiority of Respondent's and Dr. Smith's cervical spine surgical experience over that of Dr. Gonzalez- Perez, who does only an average of two cervical spine operations per year, and due to Respondent's explanation of how the PLL/annulus structures differ in the cervical spine from the lumbar spine, it is found that even if the Respondent did not see the disc fragment and PLL rent until after he began removal of the C6-7 disc, the pathology at C6-7 reasonably reinforced Respondent's belief that he was operating in the correct location of C5-6 for the duration of the operation. No one clearly testified that the C6-7 removal and fusion was necessary on February 3, 1992, or that it would become necessary at some later date. Likewise, no one clearly testified that the removal and fusion at C6-7 was not necessary on February 3, 1992, or would not have become necessary later. Dr. Smith testified that in his pre-operative discussions with his own patients, they usually tell him to fix any additional unexpected pathology he finds once he begins an operation. The evidence falls short of being clear and convincing that the wrong disc removal and fusion on February 3, 1992, resulted in any subsequent damage to R.L.'s spine. While still in the operating room, Respondent checked his work with a second fluoroscopic image (upper image of P-7). Respondent and both experts agreed that this second image would cause a surgeon who thought he had counted correctly to assume he had removed the correct disc and created a good fusion at the correct level. However, the two experts concurred that there were no clear landmarks whatsoever on this view to show that the operation had occurred at either the correct or the incorrect level. Respondent's operative report for the February 3, 1992, procedure incorrectly described removal of the C5-6 disc space. On February 4, 1992, postoperative X-rays taken at NFRMC showed that the anterior cervical fusion with plates had, in fact, been performed at the wrong level, C6-7, of R.L.'s cervical spine. Copies of the report concerning the X-rays were supplied to Respondent at about that time. About a week later, the radiologist's narrative to the same effect was provided to Respondent. Nonetheless, Respondent did not discover his error for nearly six months. After the surgery, R.L. continued to experience pain, presumably because she still had the same uncorrected, pre- operative problem at C5-6. R.L. returned to Respondent on an outpatient basis on February 11, 1992. On that date, Respondent performed a radiographic examination of R.L.'s cervical spine but made no mention to her that the anterior cervical fusion with plates had been performed at the wrong level. He made no such notation in her chart. Respondent told R.L. that he had looked at the X- rays and everything had gone well and everything looked good. R.L. next saw Respondent on March 12, 1992, when he again performed a radiographic examination of R.L.'s cervical spine. At that time, Respondent made no mention of the C6-7 level of the anterior cervical fusion with plates in her chart and again did not tell R.L. that he had removed the wrong disc and fused the wrong location. R.L. next saw Respondent on April 23, 1992, and again Respondent did not reveal his error to R.L., but he did make a narrative note to her chart which stated that R.L. "is now approximately eleven weeks from having an ACF, C6-7." Even so, Respondent did not discover he had operated on the incorrect level until R.L.'s July 23, 1992 visit, at which time, he informed R.L. what had occurred. Respondent's July 23, 1992, narrative note for R.L.'s chart makes the statement that I have explained that there is a discrepancy in her clinical exam and also the intraoperative findings and postoperative x- rays, both to the patient and her rehabilitation counselor, Ms. Terry L. Smith, R.N. Respondent clearly remembered the presence of the nurse on July 23, 1992.1 Dr. Gonzalez-Perez opined that Respondent's performance was acceptable up to the operation itself, but was not up to the acceptable level of care thereafter, because from the first (lower image P-7) fluoroscopy image, Respondent should have been able to tell the needle was on the wrong level by counting vertebrae; because Respondent should have involved others in the operating room in analyzing the X-ray; because Respondent should not have removed the C6-7 disc, based on his own preoperative work-up; and because Respondent should not have relied on the rent and fragmentation at C6-7 to confirm his conclusion that he was operating at the correct level/location. Dr. Gonzalez-Perez faulted Respondent's record-keeping for failing to write in a recommendation; because his records did not justify the removal and fusion at C6-7; and because Respondent did not follow his own initial surgical plan. Ultimately, however, Dr. Gonzalez-Perez testified that it is not "malpractice" to operate at the wrong level, provided the error is discovered at the end of the operation, because one may decide to re-operate correctly. Dr. Smith's opinion was that an acceptable level of care had been met if Respondent informed the patient of his error once he discovered it. There is no dispute that at the July 1992 office visit, Respondent offered to do the C5-6 surgery for R.L. immediately. Respondent has had no prior or subsequent disciplinary actions against him. This event occurred three years after he began to devote himself exclusively to spinal surgery. Eight years have passed since this event. There is no evidence of any other level of practice problem of any kind.
Recommendation Based upon the Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medicine enter a final order finding Respondent guilty of violating Subsections 458.331(1)(m),(p), and (t), Florida Statutes, with mitigating circumstances, reprimanding him for same, and imposing a $750.00 fine. DONE AND ENTERED this 28th day of December, 2000, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of December, 2000.
The Issue The issue for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. ERROL H. POWELL 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 2nd day of December 1994.
Findings Of Fact The Department hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order directly Children's Medical Services for District VII to authorize coverage for the reconstructive surgery recommended and proposed by J. Barry Boyd, M.D. DONE and ORDERED this 6th day of November, 1985, in Tallahassee, Florida. DIANE K. KIESLING 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 6th day of November, 1985. COPIES FURNISHED: Gerry L. Clark, Esquire HRS District Seven Assistant Legal Counsel 400 West Robinson Street Orlando, Florida 32801 Ms. Cynthia Thibeault 1415 Overdale Street Orlando, Florida 32817 David Pingree Secretary 1323 Winewood Boulevard Tallahassee, Florida 32301 ================================================================ =
Findings Of Fact The Respondent is a state agency which initiated a proceeding with the filing of an Administrative Complaint against Marc Richman, D.O. The said complaint was assigned to the Division of Administrative Hearings pursuant to a request for Administrative Hearing pursuant to Chapter 120 and was assigned Division of Administrative Hearing Case Number 88-5258. On June 24, 1989, the Department of Professional Regulations issued a notice of voluntary dismissal in the above captioned proceeding and dismissed all charges against Marc Richman, D.O., in that case. Marc Richman, D.O. is a prevailing small business party within the meaning of Section 57.111(3)(c) and (d). The amount of attorney's fees and cost sought by the Petitioner in the Petition for Attorney's Fees is reasonable for the Representation of Marc Richman, D.O., in the defense of the Administrative Complaint through the date of issuance of the Notice of Dismissal. The Department of Professional Regulation maintains that the proceeds (sic) above-captioned were substantially justified at the time the Administrative Complaint was initiated by the state agency in that it maintains that there existed a reasonable basis in law and fact at the time of the filing of the Administrative Complaint. This position is disputed by the Petitioner, Marc Richman, D.O. The request for attorney's fees in the amount of $8,572.00 and costs of $563.96 for a total of $9,225.96 is reasonable for the representation of Petitioner throughout the instant proceeding. These proceedings were initiated by the filing of a complaint on September 16, 1986 with the Department of Professional Regulation (DPR), Petitioner in Case 88-5258, by the parents of G.H. who died October 18, 1984. G.H. was a long time patient of Dr. Jaffee, D.O. who called in Dr. Richman, an orthopedic surgeon to consult and perform an arthodesis on the left ankle of G.H. to relieve constant pain. G.H. was a 34 year old male accountant who had suffered from juvenile rheumatoid arthritis since the age of 4. Although badly crippled he was able to lead a relatively independent life. As a result of his malady G.H. had for years taken steroid and corticosteroid medications. These medications depress the body's immune system and the ability to fight off infections. Accordingly, G.H. was at more than normal risk anytime he was exposed to infectious diseases. After Petitioner explained the procedure and the risks to G.H., the latter elected to have Petitioner perform the arthodesis. This operation consists of grafting bone into the ankle to stabilize that joint. The donor site chosen for the bone to graft to the ankle was the crest of the left ilium of the patient. This operation was successfully performed on August 2, 1984 at Metropolitan General Hospital, Pinellas Park, Florida. In the hospital on August 9, 1984, while G.H. was being adjusted in his bed, he felt a pop in his left hip and a large hematoma developed over the wound at the donor site. It is not unusual for hematomas to develop over surgical wounds but it is important that such conditions be closely watched because hematomas are a fertile field for an infection. The hematoma on G.H.'s hip showed no evidence of infection and G.H. was discharged from the hospital August 12, 1984 and sent home. Arrangements were made by Petitioner for Robert's Home Health Services, Inc. of Pinellas Park to send a nurse 3 times per week to check on G.H., take his vital signs, dress his wounds and attend to any other medical needs he may have. Verbal reports were made by the nurse to Richman reporting the condition of G.H. While being helped from his wheel chair into bed by his parents on or about August 15, 1984, G.H. apparently fell and caused additional bleeding of the wound on the left hip. On August 16, 1984 the nurse reported to Richman the additional bleeding and she was directed to have G.H. taken to the hospital to be seen by Richman. On August 16, 1984, Petitioner examined the wound, noted the reports that the hematoma was neither inflamed nor more tender, and that G.H.'s temperature had remained normal since the hematoma developed. He sent G.H. back home without further tests. The classic signs and symptoms of infection are redness, swelling, heat and pain. Redness of the skin due to intense hyperemia, is seen only in infections of the skin itself. Swelling accompanies infection unless the infection is confined to the bone which cannot swell. Heat results from hyperemia and may be detected even in the absence of redness. Pain is the most universal sign of infection. Along with pain goes tenderness, or pain to the touch, which is greatest over the area of maximal involvement. (Exhibit 12, Principals of Surgery, Fourth Edition). The hematoma on G.H.'s left hip between its inception and September 13, 1984 never exhibited any sign of infection. On September 6, 1984, G.H. reported to the visiting nurse that he had a pain in his stomach and didn't feel well. The nurse described this as having flu-like symptoms. This was reported to Petitioner and the nurse received no additional orders. On the nurse's next visit on September 10, 1984, G.H. reported his abdomen was still hurting and he didn't feel good. At this time his temperature was elevated at 101. The nurse called Dr. Jaffee's office and was told to have the patient admitted to Metropolitan Hospital. Upon admission to the hospital on September 10, 1984, G.H. was nauseous, vomiting, and had a high fever (103). He had no complaints regarding his ankle or iliac crest and the hematoma had decreased greatly. On September 13, 1984, while G.H. continued showing signs of infection (high fever) Petitioner operated on G.H. to remove the hematoma. At this time aerobic and anaerobic cultures were obtained. Forty-eight and seventy-two hours later these cultures had grown no infectious substance. Further studies and tests revealed that G.H. had bleeding ulcers and surgery was required to patch the ulcers. At this time the spleen was also removed. Following this surgery G.H. was more debilitated and with the precarious condition of his immune system he continued to go down hill until he expired on September 18, 1984. Cause of death was cardiac pulmonary arrest caused by candida septicemia. During the initial stage of the investigation, which was initiated some two years after the death of G.H., the investigator interviewed the parents of G.H., who had filed the complaint, and assembled the medical records including those kept by the home health agency. The parents contended that when the hematoma was removed by Dr. Richman he told the parents that he had found infection at that site. Dr. Richman denies making any such statement to the parents of G.H. and the medical records support the conclusion that there was no infection in the hematoma on September 13, when the hematoma was excised. The parents complained of the treatment that G.H. received from Drs. Jaffee and Richman as well as Roberts Home Health Services. Accordingly the investigation started with both Jaffee and Richman charged with malpractice by the parents of G.H. The investigator selected an orthopedic surgeon, Dr. Richard M. Couch, D.O., from DPR's consulting list and forwarded to him on January 7, 1987, the patient records of G.H. and requested he review those records and give his opinion on whether Drs. Jaffee and Richman diagnoses and treatment of G.H. was appropriate. In this letter (Exhibit 1) the investigator advised Dr. Couch that following surgery a hematoma developed, that after G.H.'s discharge from the hospital the hematoma ruptured and that G.H. was taken back to the emergency room where Dr. Richman saw the patient but found nothing significant about the hematoma. He also told Dr. Couch that when Richman cleaned out the hematoma he advised the family (of G.H.) that infection was found, and that, after this G.H. started internal bleeding which ultimately resulted in the patient's death. Dr. Couch responded to this request with two letters, the first of February 16, 1987 and a second on March 6, 1987. In his first letter Dr. Couch concluded that the iliac wound began draining on or about August 14, 1984 and cultures of this wound were not secured until after G.H.'s hospitalization on September 10, 1984. Since the hematoma was a post-operative complication he opined that Richman failed to adhere to certain tenets regarding wound care in this situation. However, Dr. Couch suggested the records be referred to an internist who reviewed the treatment provided by Dr. Jaffee. In his second letter Dr. Couch opined that Richman was at fault for not incising, debriding and draining the hematoma when it developed and for not taking cultures when Richman saw G.H. in the emergency room on later dates. He also found Richman at fault for not referring G.H. to a consultant in infectious diseases. A letter similar to the letter sent to Dr. Couch was sent by the investigator to Neal B. Tytler, Jr., D.O., an internist. Although the investigator contends he submitted the records maintained by Roberts Home Health Services in this case to Dr. Tytler it is obvious that before he submitted his report on June 5, 1987, Dr. Tytler had not read those records and was concerned regarding the absence of medical records during the period between G.H.'s discharge from the hospital on August 12, 1984, and his readmission on September 10, 1984. In his report Dr. Tytler carefully noted G.H.'s long term medication for juvenile rheumatoid arthritis and the serious side effects, viz depression of the immune system, which results from long-term steroid therapy. Recognizing the risk to G.H. from any surgery Dr. Tytler questioned the wisdom of the arthodesis but recognized that this was more of an orthopedic problem than an internal medicine problem. From the records received, Dr. Tytler concluded that G.H. developed a hematoma after his departure from the hospital and before September 6, 1984. Significantly, Dr. Tytler reported "Of concern to me is the apparent lack of records to document the events which transpired between August 12, 1984 and September 10, 1984. In this one month period an abscess formed at the surgical site and led to disastrous consequences. Unfortunately it can only be inferred that the first recognition of any problem occurred on September 6, 1984, when the patient developed `flu-like symptoms'. He was not examined and no one perceived that his problems were serious." When the probable cause panel met on June 25, 1988 to consider the charges against Drs. Jaffee and Richman, no probable cause was found as to Jaffee. One of the two members of the probable cause panel disclosed at the opening of the panel meeting that he knew Dr. Richman socially and that Richman had been his treating physician for a finger injury. He was excused from further participation and the hearing was tabled regarding Dr. Richman. At a subsequent panel meeting by telephone conference call, after a substitute lay panel member was selected and had been furnished the medical records, a vote was taken to find probable cause. The excerpt from those proceedings (Exhibit 8) shows that the DPR attorney opened the conference call by stating that Richman was charged with medical conduct falling below acceptable minimal standards and "at the last probable cause panel meeting you voted to find probable cause, and asked that administrative complaint be issued. At this time the Department recommends that you do find probable cause to believe that this violation exists." Following receipt of this erroneous information regarding the previous probable cause panel meeting, the Chairman, Mr. Wheeler, stated that after reviewing the entire file he believes probable cause exists to file an Administrative Complaint. Dr. Barker concurred. The case against Dr. Richman began to unravel when the deposition of Dr. Tytler was taken on February 24, 1989. Prior to taking this deposition Dr. Tytler had been provided records from Metropolitan General Hospital, records from Roberts Home Health Services and a copy of the Administrative Complaint. In response to questions regarding the treatment of G.H. as afforded by Dr. Richman, Dr. Tytler stated that a review of all medical records clearly demonstrated that after the hematoma developed at the donor site for the transplant no indication of infection ever appeared; that considering the medical history of G.H. and his high susceptibility to infection it would be more dangerous to the patient to evacuate the hematoma and risk additional infection than it would to continue to observe the hematoma and let it cure itself; that the cultures taken on September 13, 1984, when the hematoma was evacuated clearly and unequivocally demonstrated that the hip wound was not the source of the infection that ultimately led to the demise of G.H.; and that the treatment rendered by Petitioner was in all respects in conformance with required medical standards and procedures. Dr. Tytler further opined that treating an immune compromised patient with antibiotics without a specific infection in mind "could lead to the very scenario that caused his (G.H.) death", namely secondary infection. Further, with respect to the contention of Dr. Couch regarding the failure of Petitioner to take cultures at the hematoma site before September 10, 1984, Dr. Tytler opined that indiscriminate taking of cultures when no evidence of infection is present could result in a positive culture unrelated to the wound but which the doctor would be called upon to treat. This could invite a major change in therapy and an inappropriate prescribing of an antibiotic. Following the deposition of Dr. Tytler, DPR referred the medical records to another orthopedic physician and this doctor concurred with the opinion of Dr. Tytler that Dr. Richman's treatment of G.H. was not below minimally acceptable standards, that no malpractice was involved and that the treatment was in accordance with acceptable medical standards. The Department then dismissed the Administrative Complaint. In his deposition the physician member of the probable cause panel, James H. Barker, D.O., emphasized that his conclusion that probable cause existed to go forward with the Administrative Complaint was significantly influenced by the fact that no culture was done at the hematoma site. From his subsequent testimony it is clear that Dr. Barker was unaware, when he voted to find probable cause, that the culture taken from the hematoma site on September 13, 1984 was negative. The record clearly shows this to be a fact. As stated by Dr. Tytler in his testimony "hematoma yes; infection no." Dr. Barker was also concerned, and perhaps rightly so, that any time that someone goes in for an elective procedure and he dies "that alone makes you think there may be probable cause here." However, there must be factual evidence to support a finding of probable cause and here there was no such evidence.
The Issue An Administrative Complaint dated May 22, 1990, alleges that Respondent violated Section 458.331(1)(t), F.S. by gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. More specifically, Petitioner alleges that Respondent undertook certain surgical procedures on patient, R.M., without conducting necessary pre-surgery work up and testing. At the hearing Petitioner voluntarily dismissed remaining allegations in the Complaint, related to a subsequent hospitalization of the same patient. (transcript, pp 13 & 14) The issue for determination is whether Respondent committed the alleged violation, and if so, what discipline is appropriate.
Findings Of Fact Respondent, Irving L. Colvin, M.D., is and has been at all times material hereto, a licensed physician, having been issued license number ME0008095 by the State of Florida. He has practiced in the Central Florida area since 1958, and is a Board-certified surgeon. R.M., a 35 year old male, became a patient of Dr. Colvin in 1985, when he complained of right upper quadrant pain. Gallbladder x-rays were obtained at that time, and several months later when the complaints persisted. In August 1985, Dr. Colvin obtained a sonogram (echo test) of the gallbladder and an upper gastrointestinal series. Blood tests were also taken. The results of these tests did not, in Dr. Colvin's opinion, indicate a need for surgery, and the patient was treated symptomatically. R.M. continued to complain of pain in 1986 and was treated symptomatically. He was seen by another internist and a gastroenterologist and was placed on several medications. None of the medications appeared to relieve his pain, and he visited Dr. Colvin again in June 1988, with the same complaints: recurring episodes of right upper quadrant pain radiating to the back. Laboratory tests were done and some jaundice was found. His serum bilirubin was elevated and was treated symptomatically for a couple of weeks, until the patient was admitted to AMI Medical Center in Orlando for exploratory surgery in July 1988. None of the tests conducted prior to the surgery revealed the existence of gallstones. Three gallbladder x-rays were performed between 1985 and 1988. At least one sonogram was conducted, as well as blood tests and upper gastrointestinal series. Dr. Colvin considered that the tests ruled out other bases for the recurring complaints and clinically concluded that the patient had chronic cholecystitis (gallbladder disease) with bile duct obstruction and possibly intermittent stones. By the time of the surgery, the patient indicated he was tired of putting up with the pain and wanted something done other than the medications. At Dr. Colvin's request, the morning of surgery, Dr. Talal Hilal, a gastroenterologist, conducted an endoscopy to rule out other causes of the intermittent jaundice. This consisted in the insertion of a tube through the mouth and esophagus, down to the stomach and to the small intestine where the gallbladder is found in the duodenum. Dr. Hilal's findings were essentially normal, and he recommended that Dr. Colvin proceed to surgically explore the common bile duct. The surgery conducted by Dr. Colvin included exploration of the duct with a choledoscope and removal of the gallbladder. The surgery was appropriate as the gallbladder was diseased. Post operative diagnoses were: chronic acalculus cholecystitis, chronic pancreatitus and stenosis (constriction) of the distal common bile duct and sphincter of odi. None of the experts claims that the surgery should not have been performed. Rather, the agency's two experts, who reviewed the medical files only, claim that insufficient work-up was completed prior to the surgery. The original function of the gallbladder was to store bile in lower animals, which has carried over into a gallbladder in human beings and which may or may not have very much function. Still, invasive procedures should be avoided unless they are necessary, as they can be life-threatening. The agency's experts claim that less invasive procedures should have been tried prior to surgery. More specifically, they suggest that an operative cholangiogram should have been done. That is a procedure wherein a small tube is inserted through a small nick in the part of the gallbladder that joins the common bile duct. Dye is injected, and x-rays of the duct are taken. They also suggest other procedures, including sonography or ultrasound, hiatiscan, CAT scan, a study of the bilirubin, and ERCP (endoscopic retrograde cholangiopancreatogram). At least two of these procedures, sonography and bilirubin tests, were obtained by Dr. Colvin prior to surgery. By the time that he performed surgery on R.M., Dr. Colvin surmised through his clinical observations that the patient's gallbladder disease was not likely caused by stones. Chronic acalculus cholecystitis is a specific disease characterized by the absence of stones but still caused by an inflammatory reaction. From five to ten percent of gallbladder cholecystitis exists without the presence of stones. Diagnosis of the disease is made clinically, through the elimination of possibilities of other diseases, by skillfully feeling the patient and by listening to his complaints. Typically, the symptoms of chronic acalculus cholecystitis are upper abdominal pain, sometimes radiating to the back, digestive disturbances and low grade fever. The disease recurs chronically, with subsidence of the symptoms from time to time. There is substantial difference of opinion on the utility of the multiple tests suggested by the agency's experts. A cholangiogram is helpful when stones are strongly suspected, as it indicates how many stones exist, so that surgery will remove them all. While not as life-threatening as the exploratory surgery, this procedure also has risks, including inflamation of the pancreas, and it still involves opening the abdomen. Dr. Colvin already had the advantage of several sonagrams and X-rays indicating that stones did not exist. He had the laboratory tests revealing fluctuating bilirubin levels and strongly indicating the need for bile duct exploration. The hiatiscan, involving a nuclear radiation determination of obstructions, is most commonly used in cases of acute, rather than chronic cholecystitis. If the ERCP needed to have been done, Dr. Hilal would have performed it at the time that he did the pre-surgery endoscopy. He did not feel it was necessary and recommended that Dr. Colvin follow his plan for the surgery. A CAT scan would have been very costly and is an inaccurate means of detecting gallstones, detecting less than ten or fifteen percent of existing stones. From his review of the records, Dr. Corwin, an expert witness for the agency, conceded that R.M. probably had chronic cholecystitis. He has never treated a patient with chronic acalculus cholecystytis and stated that he does not consider it an acceptable diagnosis. Dr. Corwin admitted that some people might consider the laboratory tests and endoscopy ordered by Dr. Colvin to be an adequate work-up, and he stated that he would "hedge a little bit" on his own opinion. All of the remaining witnesses, including Dr. Goggin, the agency's other expert, have heard of the disease and consider it a valid diagnosis. This is a case of reasonably prudent physicians disagreeing as to appropriate pre-surgery work-up of a patient. Other than Dr. Colvin, only one witness was personally familiar with the patient. That witness, Dr. Hilal, the gastroenterologist, unequivocally supported Dr. Colvin's handling of the case. Once Dr. Colvin determined clinically that surgical exploration was necessary through his treatment of the patient and through the process of elimination of alternative diagnoses, the other available tests suggested by Drs. Goggin and Corwin were redundant. Petitioner failed to prove that the means by which Respondent reached his clinical diagnosis violates the applicable standard of care.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED: That the Board of Medicine enter its final order dismissing the Administrative Complaint against Irving L. Colvin, M.D. DONE AND RECOMMENDED this 28th day of February, 1991, in Tallahassee, Leon County, Florida. MARY CLARK 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 Divisionof Administrative Hearings this 28th day of February, 1991. APPENDIX The following constitute specific rulings on the findings of fact proposed by the parties. Petitioner's Proposed Findings Adopted in paragraph 1. Adopted in paragraph 7. Adopted in substance in paragraph 5. Adopted in relevant part in paragraph 4. Rejected as irrelevant. Rejected as contrary to the weight of evidence. Rejected as contrary to the weight of evidence. What comprises a "complete history and physical" is not explained, nor is this failure alleged as a violation of Section 458.331, F.S., in the Administrative Complaint. Rejected as immaterial. Rejected as contrary to the weight of evidence. Rejected as cumulative, immaterial (as to elevated alkaline phosphatase level) and contrary to the weight of evidence (as to no evidence of need for exploration). Adopted in substance in paragraph 9. Rejected as immaterial, and contrary to the weight of evidence. Rejected as contrary to the weight of evidence. and Adopted in relevant part in paragraph 5. Adopted in paragraphs 3 and 4. 17.and 18. Rejected, as to the persuasiveness of the two experts' opinion. Respondent's Findings of Fact The Respondent's proposed findings consist of 2 numbered paragraphs. The first is adopted in Recommended finding #1; the second is argument and commentary on the testimony, rather than proposed findings. COPIES FURNISHED: Francesca Small, Esquire Larry G. McPherson, Esquire DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Gary Siegel, Esquire 6500 S. Highway 17-92 Fern Park, FL 32730 Jack McRay, General Counsel DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director DPR-Board of Medicine 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792
The Issue Whether the Respondent committed the violations alleged in the administrative complaints; and, if so, what penalty should be imposed.
Findings Of Fact The Department is the state agency charged with the responsibility of regulating the practice of medicine pursuant to Florida law. The Respondent is a licensed physician in the State of Florida having been issued license number ME 0043628. In September, 1987, J.B., a patient at Hialeah Hospital, underwent exploratory surgery and was diagnosed with terminal pancreatic cancer. At the time of the surgery, it was estimated that J.B. had six months to live. Dr. Roberto Cruz, J.B.'s doctor at Hialeah Hospital, recommended that the patient undergo chemotherapy; however, J.B.'s wife rejected that proposal. She did not want J.B. to know of the diagnosis. J.B. had told his family that if he had cancer, he would commit suicide. J.B.'s father and brother had had cancer, and the latter had committed suicide. J.B.'s wife and sister believed his threat to be sincere. Based upon the foregoing, J.B.'s wife implored J.B.'s doctors not to disclose his true condition. The families of J.B. and Respondent had been friends for many years going back to their common home in Central America. Respondent knew of J.B.'s diagnosis, and agreed to become his treating physician in November, 1987. Respondent did not tell J.B. of his true medical condition. Instead, Respondent let J.B. presume discomfort and other symptoms were the result of years of heavy drinking. In November, 1987, Respondent had been in private practice only a short time and was unfamiliar with office practices and billing procedures. Respondent did nothing to become familiar with billing practices, and relied on an employee who he mistakenly believed was competent to complete billing from the patient charts. When J.B. first presented at Respondent's office, he complained of abdominal pain. Further J.B. had discovered lumps which concerned him. To pacify J.B., Respondent suggested that a lymph node be removed and biopsied. J.B. and his wife discussed the removal of the lump and agreed that such removal would be appropriate. J.B. wanted to know that the lump was not cancer, and his wife wanted to know that the cancer had not spread or metastasized beyond the original sites. Respondent performed the lump removal in November, 1987, and billed J.B.'s medical insurance for same. At the time of this surgery Respondent was fully aware of J.B.'s medical condition, and knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. The only medical result of the procedure was the uplifting of J.B.'s mental attitude since the lump was not cancer. In March, 1988, Respondent performed a colonoscopy with biopsy on J.B. This procedure was suggested as Respondent had presented with rectal bleeding, a symptom common in terminal cancer patients, and was desirous of some diagnosis as to the medical origin of the bleeding. Instead of advising J.B. that the bleeding could be consistent with the known medical condition, Respondent went ahead with the colonoscopy after less intrusive examinations did not establish the origin of the blood. At the time of the colonoscopy, Respondent knew that the procedure would not affect the medical condition, treatment, or life expectancy of the patient. Again, the only beneficial effect from the colonoscopy was an uplifting of J.B.'s mental attitude since the colonoscopy results, which were medically inconclusive, did not disclose cancer to J.B. Even if the colonoscopy had revealed some medical condition which could be treated, it would not have been medically necessary given J.B.'s other, overriding, condition. Anemia, a condition resulting from the loss of blood which is common in terminal cancer patients, could be treated without the colonoscopy procedure. Respondent did not refer J.B. to a psychiatrist for mental evaluation or confirmation as to the suicidal ideation but accepted J.B.'s wife's representations regarding his mental state. Respondent did not allege J.B. had expressed suicidal thoughts to him and did not report same in his medical notes. At all times material to the treatment of J.B., Respondent performed medical services through a company owned by his wife. This company, Sigma Medical Center, submitted bills for the services afforded J.B. on the standard billing forms known as "HCFA 1500." Respondent, as the treating physician, was required to sign all HCFA 1500 forms submitted regarding services for J.B. By executing the HCFA 1500 form Respondent certified that the information was correct and the procedures billed for were medically necessary and appropriate. In this case, Respondent has admitted that numerous billing errors occurred, that the HCFA 1500 forms were incorrect, and that an over-billing regarding services provided to J.B. resulted. For example, consultation visits are billed at a higher rate than regular office visits. Respondent routinely billed J.B.'s visits at the consultation rate even though there was no consultation to be given. Second, Respondent billed post-operative visits which should have been included in the surgical charges separately. Third, J.B. returned for office visits more frequently than would be expected because of the pain management Respondent employed. Because J.B.'s wife would not allow Respondent to prescribe any pain medications which J.B. might associate with cancer, he ended up taking quantities of other prescriptions to manage the pain and to return to Respondent frequently due to the unexplained (to him) reoccurrence of pain. Despite an admission that he reviewed the HCFA 1500 forms before signing them, Respondent maintains he did not, at the time, know that the billing was inaccurate. This assertion has not been deemed credible As to various tests ordered by Respondent for J.B., it is concluded that the following tests were medically unnecessary: the RPR test designed to detect syphilis infection (a STD was the least of this patient's worries), the FTA (a follow-up test to the RPR), and thyroid studies. Given the totality of the circumstances, Respondent's care and treatment of the patient, J.B., fell below the standard of care and skill which a reasonably prudent physician under similar circumstances and conditions would recognize as acceptable. As to DOAH case no. 94-0778 L.G. was an employee in Respondent's office. Unbeknown to Respondent, L.G. took samples of aerobid and proventil without a prescription for the drugs. An aerobid inhaler is used to control the symptoms of bronchial asthma. Proventil is also used to control bronchospasm which may be associated with asthma. L.G. took the samples with the intent that she would forward them to a relative in Cuba who suffers from asthma. L.G. had access to the samples. Respondent had never treated L.G. and there would have been no medical justification to dispense the samples to her. Although somewhat incredulous, Respondent's admission that he had dispensed the samples to L.G. was given, to his understanding, to end the investigation of the matter. He mistakenly believed that if he made the admission the matter would be closed. L.G.'s account as to the events of her removing the samples without Respondent's knowledge has been accepted. Nevertheless, the statement Respondent gave to the Department in connection with this incident was false.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Agency for Health Care Administration, Board of Medicine, enter a final order determining the Respondent violated Sections 458.331(1), (n) and (t), Florida Statutes, in the care provided to patient, J.B., suspending his license for a period of one year, placing him on probation for a period of two years thereafter, and imposing an administrative fine in the amount $10,000. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 24th day of December, 1996. JOYOUS D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of December, 1996. APPENDIX Rulings on the proposed findings of fact submitted by the Petitioner: Paragraphs 1 through 17, 19 through 39, 42 through 46, 48 through 52, 54 through 65, 69, 70, and 74 are accepted. Paragraph 18 would be rejected as contrary to the weight of the credible evidence IF J.B. had been sincerely suicidal; however, in this case Respondent did not refer J.B. to a psychiatrist, did not make an independent confirmation of J.B.'s mental state, and did nothing to which J.B.'s wife did not agree--therefore, it is impossible under the facts of this case to know whether or not J.B. should have been told. Under most circumstances, J.B. should have been told, and it is accepted that the care afforded to J.B. fell below the standard of care a reasonably prudent similar physician would have provided. Respondent's whole theory of this matter fails because Respondent never independently confirmed and had J.B. properly assessed, by a physician competent to make such assessment, as to whether this major hoax was appropriate. With all due respect to Dr. Blaustein, he merely relied on factual conclusions which are unsupported by medical records in this case. Paragraphs 40 and 41 are rejected as irrelevant because the examination was medically unnecessary regardless of how performed. Paragraph 47 is rejected as contrary to the weight of the credible evidence; this procedure, like others, was medically unnecessary and below the standard of care but its primary purpose was to pacify the patient and his wife regarding the rectal bleeding. Had Respondent been forthright this procedure would not have been performed. The overbilling for the procedure was for financial exploitation of the patient's insurance. Paragraph 53 is rejected as irrelevant because the studies were medically unnecessary anyway. Paragraphs 66 through 68 are rejected as irrelevant since the diagnosis would have always been subservient to the primary diagnosis and Respondent's services in this regard were medically unnecessary. Paragraph 71 is rejected as contrary to the weight of the evidence. L.G. was not Respondent's patient. L.G. stole the drugs and Respondent covered for her with the misguided idea that it would solve the problem and the investigation would be over. Paragraphs 72, 73, 75, 77, and 78 are all rejected since L.G. was not a patient they are irrelevant or contrary to the weight of the credible evidence. Rulings on the proposed findings of fact submitted by the Respondent: 1. Paragraphs 1 through 6, 8, 10, 11, 12, 18, 19, 22, 23, 24, 31, 32, 38 through 48, 51, 55 through 64, 68 through 74, 77, 81, 82, 84, 85, 86, 89 through 92, 100, 107 through 120, 122, and 123 are accepted. Paragraph 7 is rejected as speculation or irrelevant given the overriding issues of this case; further rejected as not credible. Paragraph 9 is rejected in part as contrary to the weight of the credible evidence as to the issue of money; otherwise, as to the families' long- standing friendship accepted. The credible evidence in this case supports the conclusion that Respondent was overpaid for unnecessary services until J.B.'s insurance ran out; that he did not require payment thereafter is irrelevant. It may also have been Respondent's motive for overcharging the insurance before it ran out. Paragraphs 13 through 17 are rejected as irrelevant or contrary to the weight of credible evidence. Respondent was not authorized to delegate the medical decisions regarding J.B.'s care to his wife or family. As the physician he was responsible, regardless of how difficult the situation, to either practice within the standard the care or refer the patient to a physician able to do so. Obviously, any physician would want to keep J.B. comfortable, that is why unpleasant procedures such as the colonoscopic examination were, in part, medically unnecessary. Respondent's highest obligation was to the patient not that person's family or their perceived (and uncorroborated by Respondent) notions as to the patient's mental state. Paragraph 20 is rejected as irrelevant. Paragraph 21 is rejected as contrary to the weight of credible evidence. Paragraphs 25 through 30 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraph 33 is rejected as contrary to the weight of credible evidence. Paragraphs 34 through 37 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 49, 50, 52, 53, and 54 are rejected as irrelevant or contrary to the weight of the credible evidence. The fact that J.B. was encouraged by the false or meaningless services performed by Respondent does not justify the performance or billing for same. Respondent could have listed a textbook full of conditions which J.B. did not have to encourage him but it would not have been based on medical reality any more than the colonoscopy was. Lying to a patient to make him fell better and for financial gain is not acceptable practice. Paragraphs 65, 66, and 67 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 75, 76, 78, 79, and 80 are rejected as irrelevant or contrary to the weight of the credible evidence. 13. Paragraphs 83, 87, 88, 93, 94, 95, 96, 97, 98, 99, 101, 102, 103, 104, and 105 are rejected as irrelevant or contrary to the weight of the credible evidence. Respondent was responsible for all insurance billing for Sigma Medical Center. Paragraph 106 is rejected as contrary to the weight of the evidence as to whether or not L.G. was a patient at the time of the incident complained of, or irrelevant if stating such relationship was at a prior time. Paragraph 121 is rejected as irrelevant. Paragraph 124 is rejected as contrary to the weight of credible evidence. COPIES FURNISHED: Hugh R. Brown Senior Attorney Agency for Health Care Administration Office of the General Counsel Post Office Box 14229 Tallahassee, Florida 32317-4229 Harold M. Braxton, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156-7815 Dr. Marm Harris Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792
