The Issue Whether Petitioner, Jupiter Outpatient Surgery Center ("Petitioner"), is entitled to additional reimbursement from the carrier in the amount of $4,210.50 for Rotation Medical surgical implants pursuant to section 440.13, Florida Statutes (2017).
Findings Of Fact Petitioner is a Florida ambulatory surgical center ("ASC") with its principal office located at 2055 North Military Trail, Suite 100, Jupiter, Florida 33458. Lucia Alcira is Petitioner's business office manager. Petitioner is a health care provider as defined in section 440.13(1). Sedgwick Claims Management Services and Ace American Insurance Company are carriers as defined in section 440.13(1). On May 25, 2017, a representative of Rotation Medical, Inc. ("Rotation Medical"), arrived at Petitioner's surgical facility and delivered to Petitioner the Rotation Medical implants that are the subject of this dispute. The implants are described on a Rotation Medical acquisition form (inventory slip) (Dep't Composite Ex. 1, p. 13), provided by the manufacturer representative to Petitioner on the date of surgery. The form describes the Rotation Medical implants in pertinent part, as follows: Rotation Medical Implant Set REF 2516-1, $1,000.00 Rotation Medical Reconstituted Collagan Scaffold-Arthroscopic, Medium, REF 2169-2, $2,600[.] The acquisition form, which is not an invoice, identifies Dr. Ryan Simovitch as the physician, and a service date of May 25, 2017.1/ On May 25, 2017, a patient presented to Dr. Simovitch at Petitioner's facility for a right shoulder rotator cuff arthroscopic surgical repair. Dr. Simovitch performed the surgical repair of the patient's right shoulder on May 25, 2017. Dr. Simovitch's operative report reflects the insertion of "a single 5-5 Cayenne anchor double loaded" into the patient. In addition, an "additional 4.5 mm titanium tipped cayeene knot-less anchor" was utilized. The report further reflects that Dr. Simovitch subsequently "assembled the guide and nitinol wire for the Rotation Medical graft insert." (Emphasis added). According to Dr. Simovitch, "[w]e did this in order to augment the tendon because of the tendinopathy." Dr. Simovitch's report goes on to state, in pertinent part: We inserted the pin. We then inserted the gun device in order to deploy the graft. Passing through a 10x3 passport cannula, we deployed the graft. Once we held it, we it with soft tissue staples and accessory superior portal. Multiple soft tissues samples were placed stapling the graft back down to the supraspinatus tendon. Once that was completed, the lateral edge of the graft tensioned over the greater tuberosity and was secured with two PEEK anchors one anterior and one posterior into the bone. The graft showed good tension. We then debrided all soft tissue and bony debris in the subacromial space. We then closed the arthroscopic portals with 3-0 Monocryl inverted subcutaneous followed by Mastisol and Steri-Strips. A sterile compressive dressing was applied. The patient was awakened from anesthesia and transferred to PACU in stable condition. On June 9, 2017, Petitioner submitted its bill charges to the carrier for reimbursement for the Rotation Medical implants, Cayenne implants, disposable items, and services provided to the patient. However, Rotation Medical did not invoice Petitioner for the Rotation Medical implants until June 24, 2017. (Dep't Composite Ex. 1, p. 10). The invoice identifies the Rotation Medical implants by the same item numbers and prices as those in the acquisition form. The invoice required payment by Petitioner within 30 days. On July 5, 2017, the carrier initially denied payment to Petitioner for all of the items requested. On July 14, 2017, Petitioner filed the petition disputing the carrier's denial for reimbursement of the implants. Petitioner timely provided the Rotation Medical invoice and Cayenne implants invoices to the Department in response to a Notice of Deficiency, which the Department considered in making its Reimbursement Dispute Determination. The Department issued its Reimbursement Dispute Determination on August 1, 2017. Out of the total of $6,589.00 that was requested by Petitioner for reimbursement, the Department awarded Petitioner an additional $2,379.00 for the Cayenne implants. The Department awarded Petitioner this amount because it determined Petitioner had provided invoices showing it purchased the Cayenne implants and the operative report specifically referenced them. At hearing, Petitioner acknowledged it is not seeking reimbursement for the disposable items in the amount of $266.76. These disposable items are not reimbursable under the reimbursement manual because they were not on the same invoice as the implants. Consequently, the total amount Petitioner seeks to recover as reimbursement in this proceeding is $4,210.50, for the Rotation Medical implants.2/ The Department contends that reimbursement should be disallowed for the Rotation Medical implants because "there was no substantiation that documented the Rotation Medical implants were, in fact, used" during the surgery of the patient on May 25, 2017. In support of its position, the Department contends the operative report does not specifically note the use of bioinductive implants or an implant set. Although the operative report makes no specific mention of the phrases "bioinductive implants" or "implant set," no specific language in the operative report is required to allow for reimbursement. Page two of the report specifically notes the use of the "the Rotation Medical graft insert" during the surgery. On page one, the graft is specifically described as a "rotational medical allograft." Moreover, Petitioner's Implant Charge Sheet, prepared by a nurse in the operating room at the time of the patient's surgery, specifically identifies the use of the Rotation Medical Implant Set, Ref 2516-1, and Rotation Medical/Reconstituted Collagan Scaffold-Arthroscopic, Medium, Ref 2169-2, during the patient's surgery. (Dep't Composite Ex. 1, p. 6). The persuasive and credible evidence adduced at hearing demonstrates that the Rotation Medical implants were inserted into the patient's body during the May 25, 2017, surgery, with the intent to remain in the patient's body.3/ The Department also contends that reimbursement for the Rotation Medical implants should not be allowed because the billing was not done in accordance with the reimbursement manual. Specifically, the Department argues that the implants were not "purchased" before they were billed to the carrier because Petitioner did not pay for them before the items were billed to the carrier. Petitioner purchased the Rotation Medical implants prior to billing the carrier. In sum, the persuasive and credible evidence adduced at hearing demonstrates that Petitioner is entitled to additional reimbursement in the amount of $4,210.50 for the Rotation Medical surgical implants.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Financial Services, Division of Workers' Compensation, enter a final order granting Petitioner's request for additional reimbursement from the carrier in the amount of $4,210.50 for the Rotation Medical surgical implants pursuant to section 440.13, Florida Statutes. DONE AND ENTERED this 2nd day of March, 2018, in Tallahassee, Leon County, Florida. S DARREN A. SCHWARTZ Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of March, 2018.
Findings Of Fact Petitioner passed all parts of the acupuncture examination except sections one and two of Part Four, which was the clinical-practical segment of the examination. That portion required the demonstration of various needling techniques and was independently graded by two observer-examiners. Respondent then averaged the two grades to arrive at a single score for each technique Petitioner was required to demonstrate. Respondent administered its first acupuncture examination in December, 1981, and its second in August, 1982 (at issue here). The examinations were developed and administered in consultation with California examiners, since that state had the greatest experience in testing and licensing acupuncturists. Petitioner raised no factual dispute with respect to examiner credentials, qualifications tested, or the scoring system. Rather, Petitioner pointed to alleged errors by the examiners in administering and grading certain questions. Additionally, Petitioner contends the reading list given for the written portion of the examination was misleading in that it was not intended to apply to the practical portion. Petitioner points to several questions where she received full credit from one examiner and a much lower grade from the other. Rather than averaging the two grades, Petitioner believes the lower grades should be thrown out as errors. However, Respondent instructed its examiners to give full credit where they failed to observe a specific technique or were otherwise uncertain of the performance. Thus, there was no showing that these diverse grades were other than a result of an examiner's failure to observe (for which Petitioner was not penalized). Petitioner further challenges the instructions given, contending the examiner erred in administering certain questions. Again, however, it is at least as likely that Petitioner misinterpreted instructions which were properly given. Petitioner also claims one grade was transferred in error from the examination sheet to the score box. However, it does not appear that the letter written by the examiner, as part of a note, was intended to be a letter grade. Rather, the grade as written in the box provided for that purpose must be accepted as the score assigned by the examiner. Petitioner failed the sanitation portion of the examination by breaking the sterile field. She denies she touched the needle to her shoe strap as stated by the examiner and claims she could not have performed the assignment with her shoe on. This contention was demonstrated to be incorrect by Respondent, and it is probable that Petitioner simply failed to notice her error during the examination. Petitioner contends she was misled by the reading list provided in advance of the examination. It was not clear, as Respondent argues, that the reading list was intended only for the written portions of the examination. However, Petitioner did not show that this misunderstanding prevented her from performing satisfactorily on the practical portion of the examination.
Recommendation Based on the foregoing, it is RECOMMENDED that Respondent enter a Final Order denying the petition. DONE and ENTERED this 14th day of July, 1983, in Tallahassee, Florida. R. T. CARPENTER 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 July, 1983. COPIES FURNISHED: Clarine Smissman, Esquire 217 North Eola Orlando, Florida 32801 Drucilla E. Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ann Mayne, Executive Director Board of Acupuncture Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether the Petitioner is qualified for licensure as a medical doctor in Florida by examination.
Findings Of Fact Petitioner graduated from the School of Medicine at the University of Pennsylvania in 1955, following which he did a rotating internship at Abington Memorial Hospital before reporting for active duty in the U.S. Navy. Upon release from active duty in the Navy in 1959 he entered a residency program in general surgery at Hospital of University of Pennsylvania followed by thoracic surgery which he completed in 1965. Petitioner was certified by the American Board of Surgery in 1965 and by the Board of Thoracic Surgery in 1966. From 1965 to 1986 Petitioner was engaged in the practice of general, cardiac, thoracic and vascular surgery. In the latter part of this period, he headed a cardiothoracic surgery team at Lankenau Hospital, Philadelphia, which performed some 700-800 open-heart surgeries per year. It was during this period that most of the malpractice suits were filed against Petitioner, the hospital and other doctors on his team. As head of the surgical team Petitioner did the definitive surgery (bypass grafts) while other members of the team opened and closed the chest cavity. Petitioner is currently licensed to practice medicine in Pennsylvania, New York, New Jersey, Delaware and Arizona. At the time he first applied for licensure in Florida in 1988, he was licensed in Pennsylvania, New Jersey and Arizona. No licensing agency has brought any charges against Petitioner's license. Petitioner took and passed the FLEX examination in 1988 scoring 84 and 83 on the two parts of the exam. In the past twenty years, 19 malpractice suits have been filed against Petitioner. Of those suits 9, have been dismissed by Plaintiffs without any recovery from Petitioner, and two were settled on behalf of Petitioner, one in 1979 for $50,000 and one in 1989 for $25,000. Those settlements represented little more than nuisance value. The hospital defendant settled one case for $225,000 and another for $2,500. Of the remaining eight suits the complete medical records of those cases were reviewed by another cardiothoracic and vascular surgeon who opined that five are without merit. For the remaining three, additional evidence is needed to fairly appraise the merits of those suits. This additional information will not be available until discovery is completed. Petitioner's testimony, that these remaining three cases did not involve a failure on his part to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent similar physician as being acceptable under similar conditions and circumstances, corroborates the Affidavit of the risk manager (Exhibit 3) and letters in the file (Exhibit 1) stating those cases are deemed to be without merit and will be vigorously defended. All of these suits were brought in Pennsylvania where the backlog of civil cases is such that civil cases are not scheduled for trial until approximately seven years after the suit is filed. Furthermore, the complaints filed in these cases contain general allegations that the Respondent's negligence, inattention, failure to adequately apprise the plaintiff of possible complications of the surgery, along with the negligence of the hospital and others involved with the surgery, directly resulted in the plaintiff's death, injury, etc. These are catch- all allegations and the specific nature of the malpractice claim cannot be discerned from these pleadings. Cardiothoracic and vascular surgery is a high risk field of medicine in that the patients are frequently very sick and elderly. Accordingly, the success rate for this type surgery is lower than for most surgeries, and this leads to a higher incidence of suits alleging malpractice. Many of these earlier suits were brought before the doctors began paying attention to documenting that they fully explained the risks of the surgery to the patient and thereafter the patient gave informed consent to the operation. Petitioner has been more assiduous in this regard in recent years than he was several years ago. This practice will have the effect of reducing the incidence of malpractice suits against surgeons. It is noted that several of the suits alleged the plaintiffs were not adequately advised regarding the risks involved and, therefore, they did not give informed consent to the surgery.
Recommendation It is RECOMMENDED that Horace MacVaugh III be granted a license to practice medicine in Florida. DONE and ENTERED this 19th day of December, 1990, in Tallahassee, Leon County, Florida. K. N. AYERS 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 19th day of December, 1990. APPENDIX Petitioner's proposed findings are accepted, except: 8. Accepted only insofar as consistent with HO #5 and 6. 15. Rejected. No evidence was presented in this regard. Respondent's proposed findings are accepted except: 17. Second and third sentences rejected as not supported by any competent evidence. COPIES FURNISHED: Roger Lutz, Esquire Robin Uricchio, Esquire HOLLAND & KNIGHT Post Office Box 1526 Orlando, Florida 32802 Allan Grossman, Esquire The Capitol, Suite 1602 Tallahassee, Florida 32399-1050 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation Northwood Centre, Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether Respondent performed a wrong-site procedure in violation of section 456.072(1)(bb), Florida Statutes; if so, whether (and what) disciplinary measures should be taken against Respondent's license to practice medicine.
Findings Of Fact At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology. The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition." Dr. Akhtar's Examination On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer. Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words, Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix. Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows: Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX: NODULAR BASAL CELL CARCINOMA WITH SURFACE ULCERATION. TUMOR EXTENDS TO THE DEEP AND PERIPHERAL MARGINS OF BIOPSY. In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed." January 26, 2010 Consultation On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)." Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear. Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows: Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma? A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together. Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned. Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows: Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule. Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent. Plan: Therefore indicated for Mohs surgery. February 11, 2010 Mohs Surgery S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room, S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look." As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue. Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area. Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location. The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site. S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery. Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma. After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/ It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by Dr. Akhtar.3/ Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area. Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested. S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of performing a wrong-site procedure and, therefore, violating section 456.072(1)(bb); and imposing the following penalties: a $1,000.00 fine, a letter of concern, five hours of risk management education, and a one-hour lecture on wrong-site surgery. DONE AND ENTERED this 20th day of May, 2013, in Tallahassee, Leon County, Florida. S TODD P. RESAVAGE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of May, 2013.
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
