Findings Of Fact Based upon the stipulations of the parties, the testimony of the witness, and the documentary evidence received at the hearing, the following findings of fact are made: The Department is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. The Respondent is, and has been at all times material to this case, a licensed physician in the State of Florida, license no. ME 0045691. The Respondent was born in the U.S.S.R. in 1926 and graduated with honors from the Moscow Medical Institute in 1951. She also received a PhD degree in medical science and obtained the equivalent of board certification as a surgeon oncologist in that country. While employed in the U.S.S.R., Respondent worked for the state. In 1976, Respondent, who is Jewish, immigrated to Israel where she received that country's board certification in surgery. During her residence in Israel, the Respondent was employed as a surgeon in a state-sponsored clinic. From Israel, the Respondent came to the United States in 1983. Respondent passed the ECFMG and the FLEX examinations in 1984. Subsequently, she became licensed in Florida. Currently, Respondent is neither board certified nor board eligible. Respondent attributes her foreign education and age as the primary reasons she has not achieved certification in this country. Because she is not board certified or eligible for certification, Respondent has sought employment where those criteria are not mandatory. Consequently, since becoming licensed in Florida, she has worked almost exclusively at clinics practicing general medicine. In November, 1987, Respondent began employment with Doctor's Diagnostic and Medical Centers (DDMC). Respondent was one of several doctors employed by DDMC. At all times material to this case, DDMC operated walk-in clinics in New Port Richey and Clearwater, Florida. At the outset of her employment with DDMC, Respondent worked only part-time for approximately 16 to 18 hours per week. Her hours increased over time, and, in July or August of 1988, Respondent went to a full-time schedule. Her initial agreement with DDMC provided that Respondent would be paid based upon the rate of $30.00 per hour worked. At that time, DDMC was involved in a program of providing free Doppler examinations for persons requesting that evaluation. Respondent was aware that DDMC engaged in advertisements to solicit patients. All management or administrative decisions such as advertising, billing, or scheduling employees at DDMC were made by a Dr. Neese, the owner of the facilities, or his designee. Respondent did not participate in management decisions. At some early point in her employment at DDMC, Respondent agreed to provide additional services for the company which had formerly been performed by a technician. More specifically, Respondent agreed to interpret Doppler test results. DDMC provided Doppler testing as part of its preventative medicine program. The purpose of the program was to screen patients for potential further treatment or testing. Doppler, cholesterol, and triglyceride testing are all appropriate preventative medicine approaches to determine a patient's potential need for services. According to Respondent, preventative medicine assists in early detection of potentially harmful illnesses. Doppler tests measure or indicate circulation and cardiac function. In the event a Doppler test evidences some abnormality, further testing such as ultrasound or echocardiogram may be suggested as appropriate follow up. While assigned to the New Port Richey clinic, Respondent provided many Doppler interpretations. For each Doppler test interpreted where the patient returned to DDMC for additional testing, Respondent was to receive $60.00. After reviewing the Doppler, some patients would be examined by Respondent. Respondent would perform a limited examination and take a medical history. If the testing and examination suggested some abnormality, Respondent would advise the patient as to the options available. In the event the Doppler showed no problem, Respondent would not recommend additional testing. Where the patient's Doppler results and additional information suggested a medical basis for additional testing, Respondent advised patients that they could confer with their regular physician, have the testing elsewhere if they would like, or could have the testing done at DDMC. At Dr. Neese's direction Respondent kept a list of the patients for whom she had interpreted the Doppler results and for whom additional testing was to be performed at DDMC. Respondent did not confer with all of the patients on the list. According to Respondent some patients on her list did receive additional testing at DDMC. She had presumed she would be compensated in accordance with her agreement; however, Respondent did not receive compensation for that work. For the period November 11, 1987 to December 31, 1987, Respondent received $5,685.00 in compensation from DDMC.
Recommendation Based on the foregoing, it is RECOMMENDED: That the Department of Professional Regulation, Board of Medicine, enter a final order finding the Respondent guilty of violating Section 458.331(1)(i), Florida Statutes, placing the Respondent on probation for a period of two years, and imposing an administrative fine in the amount of $2500.00. DONE and ENTERED this 24th day of May, 1991, in Tallahassee, Leon County, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of May, 1991. APPENDIX TO CASE NO. 90-6331 RULINGS ON THE PROPOSED FINDINGS OF FACT SUBMITTED BY THE DEPARTMENT: Paragraphs 1 through 4 are accepted. With regard to paragraph 5, it is accepted that an individual known to Respondent as Dr. Neese hired her for work at the DDMC and controlled the administration or management of that facility. Otherwise, rejected as irrelevant. Paragraph 6 is accepted as to clinics at New Port Richey and Clearwater which would be the only locations material to this case. With regard to paragraph 7, with the deletion of the words "independent contractor" which are rejected as a conclusion of law, it is accepted. Paragraphs 8 and 9 are accepted. With the deletion of the word "scheme" which is rejected as argumentative, paragraph 10 is accepted. Paragraph 11 is rejected as contrary to the weight of the evidence. With the deletion of the word "scheme" (see comment above), paragraph 12 is accepted. Paragraphs 13 and 14 are rejected as contrary to the weight of the credible evidence. Paragraph 15 is accepted. Paragraphs 16 and 17 are rejected as argumentative or contrary to the weight of credible evidence. Paragraph 18 is accepted. Paragraphs 19 through 21 are rejected as irrelevant or contrary to the weight of the credible evidence. Paragraphs 22 and 23 are accepted. Paragraphs 24 through 30 are rejected as irrelevant, speculative, or contrary to the weight of credible evidence. Paragraph 31 is accepted. Paragraphs 32 and 33 are rejected as argumentative or contrary to the weight of the credible evidence. RULINGS ON THE PROPOSED FINDINGS OF FACT SUBMITTED BY THE RESPONDENT: Paragraphs 1 through 5 are accepted. With regard to paragraphs 6 and 7, it is accepted that those paragraphs state Respondent's perception of her situation. This record does not establish, in fact, the basis for her failure to obtain certification, eligibility or hospital privileges. Paragraphs 8 through 10 are accepted. The first sentence of paragraph 11 is rejected as a conclusion of law or irrelevant. The balance of the paragraph is accepted. Paragraphs 12 through 15 are accepted. With the deletion of the last sentence which is rejected as contrary to the weight of the evidence, paragraph 16 is accepted. Respondent was, in fact, aware that some of the patients for whom she had interpreted the Doppler did return to the clinic for additional testing. The first sentence of paragraph 17 is accepted. The remainder of the paragraph is rejected as comment, argument, or contrary to the weight of the evidence. It is accepted that no patient records were admitted into evidence. COPIES TO: Richard A. Grumberg Sr. Medical Atty. DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Grover C. Freeman 4600 West Cypress, Ste. 500 Tampa, FL 33607 Dorothy Faircloth Executive Director DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Jack McRay General Counsel DPR 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792
The Issue The issue is whether Respondent violated paragraph 2(G) of the December 14, 2010, Final Order of the Education Practices Commission ("EPC"), and, if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner, Commissioner of Education, is the head of the Florida Department of Education, the state agency charged with the ultimate responsibility to investigate and take disciplinary actions against persons who hold a Florida Educator's Certificate and are alleged to have violated specified statutes. The EPC is charged with imposing discipline for violations of sections 1012.795 and 1012.796, Florida Statutes. Respondent holds Florida Educator's Certificate Number 519374 issued by the Department. Respondent's Employment History and Disciplinary History Respondent has been employed in the State of Florida public education system for thirty-one years, twenty-seven of which she has served as a full-time teacher. During the four years in which she was not a teacher, she served as an occupational specialist and career counselor, involved in helping at-risk students find employment and providing guidance regarding academic training for specific careers. She also served as a counselor for Project Hope, a drug rehabilitation program, and as a substitute teacher. She currently is employed as a classroom teacher by Broward County Public Schools. She has received positive job performance evaluations throughout her career. On or about May 14, 2010, Petitioner filed an Administrative Complaint against Respondent, alleging violations of specified Florida Statutes and agency rules, and seeking to impose disciplinary sanctions against Respondent's Certificate. Following an informal hearing on the Administrative Complaint conducted pursuant to sections 120.569 and 120.57(2), the EPC entered a Final Order dated December 14, 2010, placing Respondent on two employment years of probation, subject to specified conditions. The Final Order provides in pertinent part: "2. Upon employment in any public or private position requiring a Florida educator's certificate, Respondent shall be placed on 2 employment years of probation with the conditions that during that period, she shall: . . . G. [n]ot consume, inject or ingest any controlled substance unless prescribed or administered for legitimate medical purposes." To ensure compliance with paragraph 2(G)1 of the Final Order, Respondent is required to submit to random substance abuse testing, as directed by the Recovery Network Program for Educators ("RNP") or her employer.2 Pursuant to the Final Order, Respondent submitted to random substance abuse testing on January 28, 2011. Respondent was notified by letter from the RNP dated February 7, 2011, that she was in violation of the Final Order. The letter stated in pertinent part: "you failed to comply with Paragraph 2(G) of the Final Order, to wit: You consumed, ingested, or injected a controlled substance that was not prescribed by a doctor as evidenced by your drug test on January 28, 2011, that was positive for Cocaine Metabolite." On February 17, 2011, the EPC issued a Notice to Show Cause, requiring Respondent to show cause why a penalty for violating the Final Order should not be imposed. A hearing on the Notice to Show Cause was convened before the EPC on April 8, 2011. At the hearing, Respondent claimed that she had not consumed, injected, or ingested a controlled substance not prescribed or administered for legitimate medical purposes. Respondent's Random Drug Test of January 28, 2011 On January 28, 2011, Respondent reported to Occupational Medicine Centers of America ("OMC"), in Miramar, Florida, to submit to a random drug test as required under the Final Order, paragraph 2(H). Because she had to work that day, Respondent reported to OMC in late afternoon, before 5:00 p.m. Respondent brought a chain of custody form, formally known as a Forensic Drug Testing Chain of Custody Form ("Form"), with her to OMC.3 The Form for Respondent's testing was provided by the RNP or Respondent's employer.4 The Form is multi-layered, with the pages (or "layers") designated for specific recipients ——i.e., the collection laboratory, the testing laboratory, the employer, the medical review officer ("MRO"),5 and the donor. The Form lists "8543245" as the "Specimen ID No." for Respondent's random drug test conducted on January 28, 2011. Because Respondent's employer or the RNP provided the Form for her drug testing, OMC could not, and did not, generate a chain of custody form that could be used in collecting Respondent's specimen. The Form is to be filled out by the person collecting the specimen in accordance with the specific steps set forth on the Form. Step 1 lists the employer's name, address, and identification number, and the MRO's name, address, phone number, and facsimile number. Step 1 requires the specimen collector to fill in the donor's name and social security number or employee identification number; verify the donor's identity; identify the reason for the drug test; identify the type of test to be performed; and provide the collection site name, address, phone number, facsimile number, and collection side code. Step 2 is completed by the collector once the donor has provided the specimen. The collector identifies the type of specimen provided (i.e., split, single, or none provided) on the Form, reads the temperature of the specimen within four minutes of collection, and verifies on the Form whether the temperature is between 90 and 100º Fahrenheit. Step 3 requires the collector to pour the specimen into a bottle, seal the bottle with a tamper-evident label or seal, have the donor initial the seal, and place the specimen bottle in a laboratory bag along with the testing laboratory's copy of the Form. Step 4 requires the collector to certify that "the specimen given to me by the donor identified in the certification section on Copy 2 of this form was collected, labeled, sealed, and released to the Delivery System noted in accordance with applicable requirements." To complete Step 4, the collector must sign and date the form, fill in the time that the specimen was collected, and identify the courier service to which the specimen bottle is released. After the collector completes Steps 1 through 4 of the Form, the donor completes Step 5. Step 5 requires the donor to certify that he or she provided the specimen to the collector and did not adulterate the specimen, that the specimen bottle was sealed with a tamper- evident seal in his or her presence, and that the information and numbers provided on the Form and label affixed to the bottle were correct. Upon arriving at OMC, Respondent was called into the portion of the facility where drug testing is conducted. She provided the Form to OMC's medical assistant, Jackie Scialabba, who was on duty at that time. Scialabba completed Step 1 of the Form, and instructed Respondent to place her belongings in a locker, wash her hands, and provide a urine specimen in the collection cup. While Respondent was in the restroom providing the specimen, Scialabba completed Step 4 of the Form. Specifically, she signed and dated the form, filled in the portion of the Form stating the "Time of Collection" as 4:25 p.m., and checked the box identifying the delivery service courier. Respondent emerged from the restroom and handed Scialabba the specimen to pour into a specimen bottle for sealing and delivery to the testing laboratory. At that time, Scialabba discovered that Respondent had not provided a specimen of sufficient quantity to be tested. Scialabba provided water to Respondent so that she would be able to produce a specimen of sufficient quantity for testing. Respondent waited in the lobby of the facility until she was able to provide another specimen. Scialabba's shift ended at 5:00 p.m. and she left for the day. By the time Respondent was able to provide another specimen, Scialabba was gone. Before she left, Scialabba informed Christin Visbal, also a medical assistant at OMC,6 that Respondent's drug test was incomplete and that Visbal needed to complete the test. Scialabba left the partially completed Form with Visbal. Scialabba testified that Respondent did not complete Step 5 of the Form in her presence. Once Respondent indicated she was able to provide another specimen, Visbal called Respondent back into the testing facility. Both Visbal and Respondent stated that they were the only people present in the testing facility at that time.7 Visbal had Respondent her wash her hands, gave her the specimen collection cup, and instructed her regarding providing the specimen. At that time, Respondent provided a urine specimen of sufficient quantity to meet the testing requirements. Visbal checked the temperature of the specimen as required on Step 2 of the Form, and completed the portion of Step 2 requiring verification that the specimen temperature was between 90 and 100º Fahrenheit.8 Visbal poured the urine into a specimen bottle, sealed the bottle with a tamper-evident seal, and had Respondent initial the seal. Respondent then completed Step 5 of the Form, which constituted her certification that the specimen bottle was sealed with a tamper-evident seal in her presence.9 Visbal placed the sealed urine specimen and the testing laboratory's copy of the Form in a bag, and sealed the bag. Visbal provided Respondent with the donor copy of the Form. Respondent collected her belongings from the locker and left the facility. Because Scialabba had prematurely completed Step 4 of the Form while attempting to collect Respondent's specimen before she left work for the day, Visbal was unable to complete Step 4. However, Visbal provided a sworn statement and testified at hearing regarding the substance of the certification in Step 4——specifically, that the urine specimen given to her by Respondent was collected, labeled, sealed, and released to the delivery service10 in accordance with applicable requirements. The evidence establishes, and the undersigned determines, that Visbal correctly followed the established protocol in collecting, labeling, sealing, and releasing the specimen to the courier in accordance with the applicable chain of custody requirements. Accordingly, the chain of custody for Respondent's urine specimen was maintained. Scialabba's paperwork error did not compromise the chain of custody for Respondent's urine specimen. On February 7, 2011, FirstLab provided a document titled "Participant Call Test Edit" to the RNP, showing a positive test result for cocaine metabolite. The document bears "Specimen ID No. 8543245"——the same specimen identification number as was listed on the Form that Respondent brought to OMC on January 28, 2011, for use in her drug test that day. Respondent does not dispute that the tested specimen yielded a positive test result for cocaine metabolite. She maintains that she did not produce the tested specimen. Respondent's Subsequent Random Drug Test Results Since January 28, 2011, Respondent has been randomly tested for drug use each month. Respondent's drug test results have been negative every time that she has been tested since the January 28, 2011 test——nine times as of the hearing date. Respondent served a subpoena duces tecum on FirstLab in August 2011, seeking to obtain all documents related to Respondent's random drug test results, including the negative test results. The subpoena provided the correct spelling of Respondent's full name but did not list her social security number, employee identification number, date of birth, address, or school system by which she is employed. Instead of producing Respondent's test results, FirstLab produced test results for another teacher having a similar name who is employed by Miami- Dade County Public Schools.11 Ultimate Facts Regarding Alleged Violation and Penalty For the reasons set forth above, the undersigned determines that the chain of custody for Respondent's urine specimen was maintained. The evidence does not support an inference that Respondent's specimen was tampered with, tainted, or otherwise compromised in the collection, sealing, labeling, or delivery process. Therefore, either Respondent had cocaine metabolite in her system when she donated the urine specimen on January 28, 2011, or the testing laboratory or MRO made a mistake in testing or reporting the test results of her urine specimen. Respondent maintains it is the latter, but did not present any persuasive evidence to support her position. To that point, FirstLab's error in producing the wrong person's records in response to Respondent's subpoena does not provide a sufficient basis to infer that in this case, FirstLab reported another person's drug test result instead of Respondent's. It shows only that FirstLab makes mistakes when not provided sufficiently specific information about the person whose records are being subpoenaed. Accordingly, the undersigned finds that Petitioner has demonstrated, by clear and convincing evidence, that Respondent, in violation of paragraph 2(G) of the Final Order, consumed, injected, or ingested a controlled substance not prescribed or administered for a legitimate medical purpose, as revealed by the random drug test to which Respondent submitted on January 28, 2011. However, there is no evidence in the record showing that Respondent's violation of the Final Order presented any danger, or caused physical or mental harm to any students or to the public. Nor is there any evidence that the violation caused any actual damage, physical or otherwise, or that Respondent benefited from the violation. To the contrary, the sole evidence shows that Respondent is a good teacher who has performed well as a public school employee for thirty-one years. There is no evidence that the violation has in any way impaired her performance of her duties as a classroom teacher. Moreover, the sole evidence regarding Respondent's subsequent random drug test results shows that Respondent is now complying with the Final Order, and apparently has complied ever since her January 28, 2011, test. This evidences Respondent's contrition and her recognition of the seriousness of this matter. At hearing, Petitioner elicited testimony from Respondent regarding her criminal history, and an excerpt of the transcript of the EPC hearing, during which her criminal history was discussed, was admitted into evidence.12 However, her criminal history and alleged failure to report that history were the basis for the EPC's Final Order imposing penalties against Respondent, including the probation that she now is charged with violating. Respondent already has been penalized by the EPC on these bases, and they are not relevant to this proceeding. As justification for the penalty it seeks, Petitioner asserts that Respondent "never accepts responsibility for her own behavior, but blames others for her miscreant deeds." However, the evidence does not support this position. With respect to the hearing before the EPC that resulted in issuance of the Final Order, Respondent offered a plausible explanation for not having previously reported her criminal history on her Florida Educator's Certificate applications——specifically, that when she filled out the previous certification application forms, she did not realize that the form required the reporting of all prior criminal history, including offenses for which adjudication had been withheld. Indeed, when she filled out an updated version of the application form that apparently was clearer regarding criminal history disclosure requirements, she reported all prior offenses.13 Respondent acknowledged responsibility for her actions more than once during the EPC hearing. Moreover, the undersigned finds credible Respondent's testimony that she understood she was to be drug tested on a monthly basis as a condition of her probation.14 To the extent Respondent may have been incorrect regarding this detail, that mistake is more likely attributable to confusion (which is understandable under the circumstances) rather than lack of truthfulness on her part.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Education Practices Commission enter a Final Order determining that Respondent violated the December 14, 2011, Final Order of the Education Practices Commission, and suspending Respondent's Florida Educator's Certificate for a period of six consecutive calendar months, followed by two years of probation. DONE AND ENTERED this 17th day of November, 2011, in Tallahassee, Leon County, Florida. S CATHY M. SELLERS 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 17th day of November, 2011.
The Issue The issue for consideration in this case is whether Respondent's license as a medical technologist in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the issues herein, the Board of Clinical Laboratory Personnel was the state agency in Florida responsible for the regulation of the medical technology profession in this state, and for the licensing of medical technologists in Florida. Respondent, James A. Beyer, was licensed as a medical technologist under license number JC0033961, originally issued on November 27, 1995, and current until June 30, 2000. On February 23, 1996, B.A., a 21-year-old female, was admitted to Naples Community Hospital complaining of increasing abdominal pain. Laboratory tests run on the patient indicated she was undergoing an ectopic pregnancy. A diagnostic laporoscopy was performed, as were subsequent laporotomy and left salpingectomy with lysis of adhesions. It was also determined she had severe pelvic inflammatory disease with bilateral tubo-ovarian complexes. As a result, she was placed on drug and antibiotic therapy which improved her condition. The pathology report based on the surgery performed on the patient revealed no evidence of intrauterine pregnancy in the fallopian tube specimen. She was discharged from the hospital on February 29, 1996. Final diagnosis, as indicated on the discharge summary, was "left ectopic pregnancy" with secondary diagnoses of chronic pelvic inflammatory disease and extensive pelvic adhesions. Notwithstanding the final diagnosis, as noted on the discharge summary, the Agency contends a second pregnancy test done on the patient revealed she was not pregnant. The laboratory tests giving rise to the allegedly erroneous initial diagnosis were processed in the hospital's lab by one of two technologists. Respondent was one of the two. It appears the test results for patient B.A. were confused in the lab with those of another patient. No evidence was presented to show who actually handled and processed B.A.'s specimen, nor was any evidence introduced by Petitioner to show what the laboratory's appropriate procedures were. However, Respondent's initials were entered into the computer as having done the allegedly erroneous test. Respondent labeled the incident regrettable, as indeed it was. He admits that human error caused the mix-up in specimens, but notes that the incident took place in the primary care chemistry section of the laboratory which was staffed by several different individuals. He claims it is impossible to determine who was responsible for the error. Respondent has no memory of doing the procedure and does not believe he did it. His belief is based on several factors. The first of these is that for the error to have occurred, there would have to have been at least two specimens present: that of B.A. and that of another patient. The demographic information relating to B.A. would have to have been placed on the analyzer with the specimen from the other patient. When Respondent does this test, it is his procedure to hold the specimen in his hand while he reads the label and enters the patient identification information into the analyzer computer. Then he labels the serum cup to be used with the same patient identification information as is on the specimen container he is holding. Before running the test, he verifies the identification number on the test sample cup against the identification number in the computer, and it is inconceivable to him that he would have picked up another patient's sample and placed a portion of it on the instrument instead of the sample on which he was working. Another reason he believes he did not commit the error is that the incident was thoroughly and promptly investigated by laboratory and hospital personnel, and the human error cause was treated without placing blame on anyone. No disciplinary action was taken against him by the hospital, and he is still employed by Naples Community Hospital in the laboratory in the same position as before the incident occurred. His annual ratings before and after the incident have been "meets" or "exceeds" standards. Respondent is of the opinion that the Department of Health's investigation into the incident was superficial at best and lacks concrete evidence to support the claims of misconduct made. Petitioner presented no information to indicate what are the appropriate procedures to be followed in the laboratory for the procedure in issue.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Clinical Laboratory Personnel enter a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 8th day of September, 1999, in Tallahassee, Leon County, Florida. ARNOLD H. POLLOCK 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) 921-6947 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of September, 1999. COPIES FURNISHED: Howard M. Bernstein, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 James A. Beyer 2501 8th Street West Lehigh Acres, Florida 33971 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Eric G. Walker, Executive Director Board of Clinical Laboratory Personnel Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issue in this case is whether Petitioner, Frank W. Fender, should have received a passing grade on the March 1997 Clinical Chemistry Technologist examination.
Findings Of Fact Petitioner, Frank W. Fender, took the Clinical Chemistry Technologist examination in March 1997 (hereinafter referred to as the "Examination"). The Examination consists of fifty multiple choice questions. The instructions for the Examination specifically informed persons taking the examination that they were to "[a]lways choose the BEST answer." It was determined that Mr. Fender had answered twenty- seven of the Examination questions correctly. Mr. Fender was, therefore, awarded a score of 349. A score of 350 or more was required for a passing score. If Mr. Fender were determined to have answered one more question correctly, he would receive a passing score. Mr. Fender was informed that he had not passed the Examination. By letter dated July 25, 1997, Mr. Fender requested a formal administrative hearing to contest his failing score. In particular, Mr. Fender challenged the determination that he did not answer questions 3, 9, 16, and 21 correctly. Question 3: Question 3 involved obtaining "true serum triglyceride results." Mr. Fender selected answer "D" which was: "measure a blank in which the dye-coupling is omitted." The answer considered correct was "B." The evidence failed to prove that answer "D" was the best answer. While the use of blanks in triglyceride methodologies is correct, "dye-coupling" is not. Therefore, answer "D" is not a correct response. The evidence failed to prove that answer "D" was the best answer for question 3. Question 9: Question 9 asks which enzyme listed in the answers is found to be elevated in the majority of alcoholics. Mr. Fender selected "B," ALT, as the correct response. The evidence failed to prove that answer "B" was the best answer. While ALT may be raised in an alcoholic, it also may not be. GGT is the most sensitive indicator of alcoholism. Even if ALT is normal, GGT will be raised in an alcoholic. The best answer to question 9 was, therefore, "C," GGT. The evidence failed to prove that answer "B" was the best answer to question 9. Question 16: Question 16 asks why one must wait approximately 8 hours to draw a blood sample after administering an oral dose of digoxin. Mr. Fender selected "D" as the correct response. This answer indicates that the reason one must wait is because "all" of the digoxin "will be in the cellular fraction." Mr. Fender's response was not the best response because of the use of the work "all" in the answer he selected. The most digoxin that could be in the cellular fraction is approximately twenty-five percent, because approximately seventy-five percent is excreted through the kidneys. The evidence failed to prove that answer "D" was the best answer to question 16. Question 21: Question 21 asks the best way to test for suspected genetic abnormalities in an unborn fetus. Mr. Fender selected answer "B," "performing L/S ratios" as the best answer. While the evidence proved that L/S ratios will measure immature fetal lungs, this condition results in respiratory distress syndrome. Respiratory distress syndrome is an "acquired" disorder and not a "genetic" abnormality. While an L/S ratio can be used to test for acquired disorders, a "chromosome analysis," answer "C," is used to test for genetic abnormalities. The evidence failed to prove that answer "B" was the best answer to question 21. The evidence failed to prove that Mr. Fender should have received a score higher than 349 on the Examination.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Department of Health dismissing Frank W. Fender's challenge to the grade awarded to him on the March 1997 Clinical Chemistry Technologist examination. DONE AND ORDERED this 2nd day of March, 1998, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of March, 1998. COPIES FURNISHED: Frank W. Fender 7603 North Laura Street Jacksonville, Florida 32208 Anne Marie Williamson, Esquire Department of Health Office of the General Counsel 1317 Winewood Boulevard Building 6, Room 106 Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health 1317 Winewood Boulevard Building 6, Room 306 Tallahassee, Florida 32399-0700 Pete Peterson Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700
Findings Of Fact The Respondent, Joya L. Schoen, graduated from medical school in 1966. Dr. Schoen is board eligible in psychiatry. T. 195-96. She had three years residency in general psychiatry and a two year fellowship in child psychiatry. From 1967 to about 1979, she practiced in psychiatry. Dr. Schoen has been licensed by the State of Florida since 1973. The Respondent's father was a physician, and in 1979, she began to take over his practice in general medicine. The Respondent took about three years to discontinue her psychiatric practice and assume her father's general practice. T. 196. On June 14, 1985, a patient, who will identified by her initials, K. H., was referred to Dr. Schoen by another physician, Dr. Mengel. T. 197. Her symptoms were an inability to concentrate, "spaciness," pervasive fatigue, P.M.S. (premenstrual syndrome), and irregular-periods. Her symptoms were aggravated by certain foods, fumes, and perfumes. T. 217. K. H. had discovered that dairy foods and foods containing high- carbohydrates aggravated her condition, and she was then avoiding them in her diet. T. 218. K. H. had already been seen by a Dr. Mengel, and he had recommended that she receive allergy testing. T. 198. Dr. Schoen had K. H. take the RAST I.G.E. test. T. 217. The RAST I.G.E. test is a screening test to determine, in a general sense, whether a patient has allergies. T. 216; (Supplemental Transcript, ST) ST-14. The degree of allergy is related to the score. A score over a hundred is considered a positive indication of the presence of allergies. T. 217. K. H.'s score on the RAST I.G.E. test was 1,993, T. 85, which was an extraordinarily high level, T. 88-89, indicating a probability of a high degree of allergy. T. 217, ST-14. The RAST test, like the cytotoxic test, is performed on blood samples, and thus is not traumatic to the patient. T. 222. All witnesses viewed this test as an acceptable test. Dr. Schoen also did a general screening for allergies, and determined that environmental allergies were not very high. T. 218. That left food allergies to be investigated. Id. Cytotoxic testing tests for food allergies, or more precisely, for adverse reaction of white blood cells to foods. T. 218, 233. The cytotoxic test confronts samples of the patient's blood with certain foods. The reaction of the leukocytes in the patient's blood is observed. ST-12; T. 47. Foods which cause reactions are then selectively removed from the patient's diet, and the increase or decrease of the allergy is observed. In this way, by trial and error, it is hoped that the particularly food to which the patient is allergic will be identified. Cytotoxic testing was available in 1985, and had been available since at least 1979. Approximately ten thousand cytotoxic tests were conducted from 1979 to 1986 by the laboratory that performed the cytotoxic test for Dr. Schoen for K. H. T. 158. Hundreds of physicians ordered cytotoxic testing from this laboratory; some physicians ordered it repetitively. T. 171. See also T. 101. The users of the cytotoxic test were primarily medical doctors, but were also doctors of osteopathy, chiropractors, and dentists. T. 172-73. The laboratory ceased performing the test in 1986 due to increasing questions concerning the efficacy and reliability of the test and the advent of better tests. T. 165-67. A large number of physicians have used the cytotoxic test at one time or another. ST-12; T. 172-73. Dr. Schoen traveled to Washington, D. C., to learn more about cytotoxic testing. T. 234. She also discussed the utility of the test with another physician. T. 233. Dr. Schoen has used the cytotoxic test about forty or fifty times; in some cases the test has led to marked improvement in the patient's condition, and in other cases, the test has not been helpful. T. 219. She was not aware of any patient having been harmed by use of the test. T. 221. Cytotoxic testing for food allergies ordinarily was less expensive than skin testing. T. 190-92. In August, 1983, the Health Care Financing Administration, United States Department of Health and Human Services, issued in the Federal Register a notice that cytotoxic testing would not be reimbursed by that agency under Medicare coverage. P. Ex. 3. The notice in the Federal Register noted that "there was a wide range of conflicting views regarding the efficacy of cytotoxic food testing ..." P. Ex. 3, p. 37717. The article discusses a number of evaluations of the test, some favorable to the test, and many unfavorable. Cytotoxic testing is a subjective test, T. 47, and is considered by some physicians to be experimental and useful only in research. T. 50. Nonetheless, as discussed above, a large number of physicians disagreed, and used the test in their practice from 1979 through 1985. Since 1985, other tests have come along that are more reliable than the cytotoxic test, and the cytotoxic test is no longer given. T. 220-21. Currently, Dr. Schoen does not use the cytotoxic test, but uses tests like the RAST test in part because it is covered by insurance, and cytotoxic testing is not. (The other reason is that the laboratory that performed cytotoxic testing for Dr. Schoen has discontinued the test.) T. 222. When she arrived at Dr. Schoen's office, K. H. had read The Yeast Connection by William G. Crook, M.D. (R. Ex. 1), and asked Dr. Schoen to give her a cytotoxic test. T. 197-98. K. H. had concluded that she preferred the cytotoxic test because she thought it would be less stressful than other allergy tests. T. 198. She also wanted to be given treatment with the drug Nystatin in hopes that she could avoid shots, desensitization, and a long and expensive process of allergy treatments. T. 199. It is inferred that K. H. was fully aware that the diagnosis of systemic candidiasis and treatment by Nystatin as described by Dr. Crook was a new theory. This inference is based upon the fact that she had been to several physicians, none of whom turned to Dr. Crook's theory, and that she was familiar with Dr. Crook's book. T. 198-99. It is evident from Dr. Crook's book, which is entitled in part "A Medical Breakthrough," and in the first few pages communicates an awareness that the theory is quite new and still not' accepted by mainstream medicine. R. Ex. 1. This finding of fact is further corroborated by the affidavit of K. H. R. Ex. 8. Dr. Schoen gave K. H. reading material about cytotoxic testing and discussed with K. H. the nature of the cytotoxic test and the alternative procedures that were available, that is, to be referred to a physician who specialized in allergies, and to undergo allergy testing by skin testing using needles and shots. See T. 25, 199. This finding is corroborated by the affidavit of K. H., wherein K. H. states that Dr. Schoen explained to K. H. that cytotoxic testing was accepted by only a minority of physicians. R. Ex. 8. K. H. said that she was terrified of needles, and was so allergic to so many things that such testing might make her worse. K. H. wanted to try cytotoxic testing and treatment with Nystatin before trying testing by an allergist. T. 202, 236. K. H. understood that the cytotoxic test was an out-of-the-mainstream test and was perhaps not proven. T. 199; R. Ex. 8. Dr. Schoen's written records of treatment of K. H. do not show consent of K. H. to take the cytotoxic test, or advice to K. H. by Dr. Schoen that the test was experimental and that other alternatives existed. T. 54. Dr. Schoen did not make a written record of her advice to K. H. concerning the cytotoxic test, or of K. H.'s understanding of the nature of the test. The affidavit of K. H., R. Ex. 8, constitutes after-the-fact written evidence of such explanation by Dr. Schoen and consent and understanding by K. H. Failure to obtain written consent from K. H. prior to cytotoxic testing had no adverse effect or potential adverse effect to the health of K. H. T. 68. Dr. Schoen directed that K. H. be given a cytotoxic test. T. 218. Dr. Schoen diagnosed K. H.'s condition as allergies and systemic candidiasis. T. 218. Dr. Schoen prescribed treatment with Nystatin and a diet that avoided yeasty foods, such as dairy foods and foods containing high carbohydrates. T. 218. K. H. took Nystatin as prescribed by Dr. Schoen from June, 1985, to November, 1985. This is the course of treatment recommended by William. G. Crook, M.D., for systemic candidiasis. Id. Dr. Schoen told K. H. that Nystatin is usually given to treat candidiasis, and that the drug is virtually nontoxic and safe. She also told K. H. that Nystatin was not something a regular physician would prescribe for her condition, but that it was widely used among physicians that she knew with safe results. T. 201. This finding is corroborated by the affidavit of K. H. R. Ex. 8. Nystatin is one of the safest drugs available to physicians today, having no serious side effects. ST-9. It is well-tolerated by patients. T. 45. Nystatin is an antifungal medicine that is frequently used to treat localized candidiasis. The alternative course of testing and treatment by an allergist would perhaps take one to three years, and would ultimately be quite a bit more expensive than the testing and treatment selected by Dr. Schoen, due to the need in such alternative treatment for numerous physician visits and shots. T. 203- 04. This finding of fact is corroborated by the medical report of Elmer M. Cranton, M.D. R. Ex. 7, p. 2. Some maladies are difficult to diagnose, but may be diagnosed through trial therapy. Trial therapy is a course of nontoxic therapy without a specific diagnosis. If health improves during such therapy, it is concluded that the patient had the disease treatable by such therapy. T. 200, 205. It is not uncommon in medicine for a physician to prescribe a course of treatment that in fact works to either cure the malady or relieve the symptoms, but no one understands scientifically why it works. T. 205-06. This finding of fact is corroborated by R. Ex. 6, attachment: "`Think Yeast'--The Expanding Spectrum of Candidiasis," reprinted by "The Journal of the South Carolina Medical Association," and by R. Ex. 1, "A Special Message for the Physician," p. 2. The diagnosis of systemic candidiasis cannot be tested by conventional scientific tests. This finding of fact is corroborated by R. Ex. 4, p. 10. It may take many months, or a year or two years, for a patient to respond to Nystatin treatment. Dr. Schoen saw no significant improvement in K. H. from June, 1985, to November, 1985, when she was her patient. T. 236. K. H. had psychological problems when she visited Dr. Schoen. Dr. Schoen was aware that K. H. had psychological problems, but determined that she deserved a chance to receive the treatment Dr. Schoen selected because it was not harmful, and might be of help to her in her case. T. 201. Dr. Schoen assessed K. H.'s circumstances and determined that medical treatment should be attempted first, and that psychological treatment was then not appropriate. Her conclusion was based upon her observation that due to K. H.'s symptoms (irregular memory, spaciness, and fatigue), K. H. would not be capable of participating in psychological therapy. She also noted the dysfunctional condition of her parents as an additional reason that psychological treatment was not appropriate at that time. T. 202-04. Finally, K. H. was a newly converted fundamentalist Christian, and had turned to religion for emotional help. She had psychological counseling suggested to her, but apparently did not follow up on the suggestion. Under these circumstances, Dr. Schoen concluded that psychological counseling was not possible at that-time. T. 238. Dr. Schoen did not discuss these conclusions with K. H. There is no evidence that she should have discussed these conclusions with K. H. Dr. Robert M. Stroud graduated from medical school in 1956, and is licensed to practice in Florida, Alabama, and North Carolina, and is board certified in internal medicine, allergy, immunology, and rheumatology. His board certification in immunology was in 1974. Dr. Stroud practices in Ormond Beach, Florida, and specializes in allergy and rheumatology, ST-4,6. Allergy is a subspecialty of internal medicine. ST-15. He was a professor of medicine at the University of Alabama for 14 years, teaching medicine, microbiology, and immunology. ST-3. He has been a clinical professor at the University of Florida since 1982. ST-4, 6. Dr. Stroud was accepted as an expert in medicine, allergy, and immunology. ST-7. Dr. Stroud uses the diagnosis "yeast allergy" or candida allergy" in his practice, and by that diagnosis, means the same thing as systemic candidiasis. ST-7. He views the condition as an allergic reaction to yeast on the surface of membranes. Id. When Dr. Stroud makes the diagnosis of yeast allergy, or if he strongly suspects that diagnosis, the treatment he prescribes is a yeast elimination diet and Nystatin administered orally. ST-9. Dr. Schoen discussed K. H.'s case with Dr. Crook, and Dr. Crook told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 206- 11; R. Ex. 6. Dr. Schoen also discussed K. H.'s case with Elmer Cranton, M.D., and Dr. Cranton told Dr. Schoen that he agreed with her diagnosis and course of treatment. T. 211-15; R. Ex. 7. (Both of these findings of fact find that Dr. Schoen was in fact told this by both physicians. To the extent that the opinions of these two physicians are offered for the truth of the opinions, the evidence is hearsay, but is corroborative of the finding of fact which follows.) The diagnosis of systemic candidiasis, or yeast allergy, as used by Dr. Stroud, is used by a thousand or more physicians in this country who practice internal medicine, osteopathy, and allergy medicine, and the number has been growing rather than diminishing. ST-10, 16-17. Serious research continues in this field, and a large number of physicians in the country have seriously investigated the possible link between candida and the immune system. ST-11. A substantial minority of physicians in Florida and in other states agree with the theories of diagnosis and treatment of Dr. Crook in The Yeast Connection, and believe that systemic candidiasis is a medically proper diagnosis. T. 225, 228- 30, and the testimony of Dr. Stroud. This finding of fact is corroborated by R. Exs. 2, 6 (attachments), and 7, and T. 206-15. The American Academy of Allergy has issued position papers disapproving the diagnosis of systemic candidiasis and cytotoxic testing, and calling them experimental. P. Ex. 2. 45. Dr. James E. Quinn is a medical doctor and has practiced family medicine in Sanford, Florida, for 11 years. He has been board certified in family practice for the last 8 years. T. 10. On about November 26, 1985, K. H. came to Dr. Quinn for treatment. Her sister and brother-in-law were concerned about the treatment she was receiving from Dr. Schoen, and told Dr. Quinn that the family felt that K. H. actually had an emotional problem. T. 10. K. H. complained that she was being poisoned by the environment around her, by chemicals, by perfumes, and by foods. T. 11. She could not tolerate certain foods, would become confused when near perfume, and her period was irregular. T. 12. She was chronically fatigued. T. 12. K. H. was examined by Dr. Quinn. Dr. Quinn diagnosed the existence of a severe emotional problem, but found no evidence of a typical amount of allergic disease. T. 11. In Dr. Quinn's opinion, systemic candidiasis occurs only in association with severe illnesses in a general hospital setting, such as certain carcinoma, leukemia, AIDS, after chemotherapy, or after sustained use of antibiotics. T. 12-13, 22. This form of candidiasis occurs in identifiable areas, such as the esophagus, the bladder, or other systems. T. 22. Dr. Quinn was of the opinion that it would be proper to treat this form of systemic candidiasis with an infectious disease medication and with an antifungal agent such as Nystatin. T. 23-24. Dr. Quinn had no familiarity with the concept of systemic candidiasis as set forth by Dr. Crook. T. 26. Dr. Quinn had no personal experience with cytotoxic testing. T. 25. Dr. Quinn saw K. H. only once, T. 19, and did not review Dr. Schoen's records for K. H. T. 26. Dr. Quinn referred K. H. to a psychiatrist, Dr. Moises, for mental health evaluation, and referred K. H. to an allergist, Dr. Alidena, for an allergy evaluation. T. 13-14. Dr. Alidena felt that K. H. possibly had mild food allergies. T. 18. She recommended a food elimination diet and wait for the psychiatric report. Id. Dr. Eugene F. Schwartz is a medical doctor who has been in private practice specializing in adult and pediatric allergy and immunology since August, 1983, in Altamonte Springs, Florida. T. 28, 30. He is board certified in pediatrics and allergy and immunology. T. 29. He is a member of the American Academy of Allergy and Immunology, an organization composed of the largest number of board certified allergists and immunologists in the country. T. 41, 104. Dr. Schwartz agreed with Dr. Quinn that systemic candidiasis occurred in certain severely debilitated patients, such as those with cancer, or having immune suppression problems. T. 37. Dr. Schwartz was of the opinion that systemic candidiasis as described by Dr. Crook was not an appropriate diagnosis, and thus that prescription of Nystatin for such a diagnosis was inappropriate because the diagnosis "did not exist." T. 39-40. Dr. Schwartz had two methods of diagnosing patients who thought that they had systemic candidiasis after reading Dr. Crook's book: to either find another cause of the problems or to advise the patient that he (Dr. Schwartz) did not know what the cause of the problem was. T. 40, 44. If a patient came in complaining of adverse reactions after eating certain foods, Dr. Schwartz would have prescribed a skin test for food allergies. T. 48. Dr. Schwartz was of the opinion that the cytotoxic test was spurious and "quite experimental," and should be limited to research projects. T. 50. Dr. Schwartz was of the opinion that Dr. Schoen's practice with respect to diagnosis of K. H. as having systemic candidiasis was "outside the mainstream of medicine, that other prudent, physicians would not have done so." T. 65. He was also of the opinion that prescription of Nystatin was not proper, that use of cytotoxic testing was not proper, and that lack of written informed consent to the cytotoxic test was not proper. T. 66-67. Dr. Schwartz believed that a minority of physicians thought that the diagnosis of systemic candidiasis is a proper diagnosis. T. 109. Dr. Schwartz stated that Dr. Crook is one of the leading authorities with respect to the diagnosis of systemic candidiasis and treatment by use of Nystatin, T. 70, and agreed that there have been other articles supportive of Dr. Crook's Views. Id. Dr. Schwartz testified that the symptoms that K. H. presented to Dr. Schoen met the criteria for Dr. Crook's diagnosis of systemic candidiasis. T. Dr. Schwartz also agreed that if the diagnosis of systemic candidiasis was proper, Dr. Schoen did prescribe the proper treatment as recommended by Dr. Crook, and that her prescription of Nystatin was proper as recommended by Dr. Crook. T. 42, 81. Dr. Schwartz also conceded that a minority of physicians used cytotoxic testing to determine the presence of allergies to various given substances. T. 110. Dr. Joseph Akerman has been in the general practice of medicine since 1952 in Apopka, Florida. He is board eligible in family practice medicine. T. 120. He was accepted as an expert witness in the practice of medicine, including the standard of care for general medical practitioners and family practitioners in the Orlando area. T. 122. Dr. Akerman had never seen a case of systemic candidiasis. T. 124. Dr. Akerman would not use that diagnosis in his own practice, nor would he use the course of treatment prescribed by Dr. Crook. T. 124, 130. He was not familiar with any physicians who subscribed to Dr. Crook's theories. T. 131. Dr. Akerman personally disagreed with Dr. Crook's theories. T. 130. If Dr. Crook's theory of systemic candidiasis were correct, Dr. Schoen's diagnosis of systemic candidiasis in the case of K. H. was correct, in Dr. Akerman's opinion. T. 130. On December 31, 1987, the Respondent filed a motion to dismiss the administrative complaint. The motion raised two issues: whether the probable cause panel considered some evidence that the violations alleged occurred, and whether the probable cause panel was composed of three members as required by law. Attached to the motion was a transcript from that portion of the meeting of the probable cause panel that considered the charges against the Respondent. That transcript was admitted into evidence as R. Ex. 4. The probable cause panel met in Palm Beach, Florida, on August 21, 1987. Two members were present. The members present had been furnished the investigative report and a recommendation. R. Ex. 4, p. 3-5. The transcript shows who attended the meeting, but does not show the composition of the panel. The two members agreed with the administrative complaint. R. Ex. 4, p. 10-11, with one exception which apparently was deleted from the complaint. Id. at p. 10. The Petitioner submitted an affidavit concerning the composition of the probable cause panel. P. Ex. 7. The affidavit is hearsay, and cannot be relied upon to make a finding of fact as to the composition of the probable cause panel. There is no competent evidence in the record from which a finding of fact can be made that the probable cause panel in this case was composed of less than three members.
Recommendation For these reasons, it is recommended that the Department of Professional Regulation, Board of Medicine, enter its final order dismissing the administrative complaint against the Respondent. DONE and ENTERED this 26th day of September, 1988, in Tallahassee, Florida. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of September, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-4351 The following are rulings upon proposed findings of fact which have either been rejected or which have been adopted by reference. The numbers used are the numbers used by the parties. Numbers have been sequentially attributed to the unnumbered paragraphs filed by the Respondent. Statements of fact contained in this appendix or adopted herein by reference are intended to be additional findings of fact. Findings of fact proposed by the Petitioner: 5. A categorical finding that the cytotoxic test was considered to be purely experimental by allergists and immunologists cannot be made in view of the fact that many physicians used the test in the years in question. The record cited does not contain evidence that Nystatin is a legend drug. Findings have been made that K. H. received this drug through prescription by Dr. Schoen. The first sentence is not supported by the record cited. The second sentence is thus not relevant. Since a substantial minority of physicians accept the diagnosis of systemic candidiasis as described by Dr. Crook, the word "only" in the first sentence is rejected. The second sentence is a true statement of the opinion of the majority of such physicians, but a substantial minority of physicians disagree. All physicians who testified agreed that K. H.'s symptoms were consistent with the diagnosis of systemic candidiasis as described by Dr. Crook. It is true that K. H. did not suffer from a severe illness of the type with which systemic candidiasis is also a potential associated diagnosis. Since systemic candidiasis as described by Dr. Crook cannot be detected by testing, the lack of the tests set forth in this proposed finding of fact is irrelevant. Diagnosis by trial therapy is a medically accepted way to proceed where testing is ineffective for diagnosis. Rejected for the reasons stated in findings of fact 11-14. Rejected for the reasons stated in findings of fact 18-25. Rejected for the reasons stated in findings of fact 30-36, 39-43, 62- 64, and 69. Findings of fact proposed by the Respondent: 1. The first sentence of this proposed finding of fact is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 3. Mr. Zavik was accepted only a- an expert in cytotoxic testing procedures. T. 164, 166, 169-70. He did not have expertise to express an opinion as to the jurisdiction of the Food and Drug Administration. The second sentence is cumulative and unnecessary. 9. The fourth sentence is cumulative and unnecessary. The sixth sentence is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 14. These proposed findings of fact are not supported by the record cited. The summary of what Dr. Godorov said is confused and ambiguous. 17. The sixth sentence is cumulative and unnecessary. The second sentence is irrelevant. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 25 and 28. These proposed findings of fact are subordinate to findings of fact that have been adopted. They are true, however, and are adopted by reference. 29. The second is subordinate to findings of fact that have been adopted. It is true, however, and is adopted by reference. 31. These proposed findings of fact are irrelevant since the summary of what Dr. Godorov said is too confused and ambiguous to be a basis for a finding of fact. COPIES FURNISHED: Robert D. Newell, Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 Salvatore A. Carpino, Esquire One Urban Centre, Suite 750 4830 West Kennedy Boulevard Tampa, Florida 33609 Bruce D. Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Ms. Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue Should discipline be imposed against Respondent's license to practice medicine for violation of Section 458.331(1)(t), Florida Statutes (2003)?
Findings Of Fact Stipulated Facts Petitioner is the state department charged with the regulation of the practice of medicine pursuant to Chapter 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. Respondent is Michael D. Fox, M.D. Respondent is board certified in obstetrics and gynecology. Respondent is a licensed medical doctor in the State of Florida having been issued license ME 66312. Respondent's address is 3627 University Boulevard, South, Suite 200, Jacksonville, Florida 32216-4211. At all times material to this complaint, Respondent provided professional services as an employee of North Florida Gynecologic Specialists in Jacksonville, Florida. On or about September 26, 2003, Patient T.D. presented to Respondent with a history of worsening pelvic pain and abnormal menstrual bleeding. On or about October 6, 2003, Respondent and Patient T.D. agreed that Patient T.D. would undergo a hysterectomy. On or about October 22, 2003, during a pre-operative examination, Respondent ordered pre-operative lab studies, including a urine pregnancy test, for Patient T.D. On or about October 27, 2003, Respondent performed a total abdominal hysterectomy on Patient T.D. During Patient T.D.'s hysterectomy, Respondent took a specimen from Patient T.D., which was sent to pathology for evaluation. On or about October 29, 2003, a microscopic examination of the surgical specimen was performed that revealed Patient T.D. was pregnant at the time Respondent performed the hysterectomy on Patient T.D. Respondent did not ascertain the correct results of Patient T.D.'s pre-operative pregnancy test prior to performing the October 27, 2003, hysterectomy on Patient T.D. Respondent's Care of Patient T.D. Respondent attended medical school at the University of Alabama, Birmingham, Alabama. He did a four-year residency in obstetrics and gynecology (ob/gyn) in Jackson, Mississippi, and a two-year sub-specialty fellowship in reproductive endochrinology in Lexington, Kentucky. He is board-certified in reproductive endochrinology and ob/gyn. At present his specialty is reproductive endochrinology. Respondent has experience in performing hysterectomies and the pre-operative evaluations associated with those surgeries. Respondent does 30 to 40 hysterectomies a year. That number represented his experience in 2003. The principal reason for performing hysterectomies in his practice, is associated with sub-specialty interests, surgery for endometriosis and adenomyosis, a co-disease with endometriosis. Respondent has privileges to practice in hospitals in the Jacksonville, Florida area. In particular, he has privileges at St. Vincent's, St. Luke's, Baptist, Baptist Beaches, Memorial and Shands hospitals. He performs surgeries in all those hospitals. The hospitals where Respondent practices have computer systems that allow access to laboratory records and other forms of information associated with patient care. Although he has access to the computer systems in the facilities, his routine is to obtain laboratory information in the hospital setting from other persons involved in the patient care. He asks those persons to find out the information for him and report the finding(s). Respondent would have access to the patient hospital record, as well as a source for obtaining laboratory information. Respondent routinely looks at the patient hospital record in preparing for surgery. Concerning Patient T.D., the subject of this proceeding, when seen by Respondent she was described as a young female, of child-bearing age who presented with chronic pain. She had pain with periods which Respondent found to be characteristic of adenomyosis. She had pre-cycle pain approximately a week prior to her menses, another characteristic of adenomyosis. The patient had irregular bleeding that is an indication of adenomyosis. The patient was found to have an enlarged uterus, the primary source of her pain on the examination. This visit with Respondent, that formed the basis for his impression, took place on September 26, 2003. On the initial visit Respondent also obtained a history consistent with endochrine disorder causing irregular cycles. In the patient's case, the cycles extended as much as 60 days in relation to her periods. Based upon his initial impression, Respondent did not find evidence that Patient T.D. was pregnant. The patient told Respondent that she had no desire for fertility. At that time, she did not report having a partner, nor did she indicate that she was sexually active. To further evaluate the Patient T.D.'s condition and complaints, Respondent ordered an ultrasound test. That study was performed on October 2, 2003, and a gynecological ultrasound report rendered. Based upon the report, Respondent held to the view that the report showed evidence of adenomyosis. There was a mild and moderate enlargement of the uterus, which Respondent found to be consistent with adenomyosis. The patient had had a prior pregnancy and delivery and Respondent found the depiction on the ultrasound of a mild enlargement of the uterus consistent with the prior pregnancy and delivery. On their next visit, Respondent discussed the choice of a hysterectomy or some other form of surgery that did not involve a hysterectomy, to treat the endometriosis and relieve her symptoms. That visit took place on October 6, 2003. On October 22, 2003, Respondent met the patient again. He reviewed the details of what he believed was the underlying disease and potential treatments in discussion with the patient. The patient indicated that she wanted to proceed with the hysterectomy. That choice having been made, the surgery was discussed between the patient and Respondent and the necessary paperwork was started to arrange for the surgery in the hospital. When preparing for surgery Respondent ordered a pregnancy test to verify whether the patient was pregnant or not. The nature of the test was a urine pregnancy test under Respondent's preoperative orders given October 22, 2003. The specimen was collected on October 22, 2003, and received by Memorial Hospital (Memorial), Jacksonville, Florida, where the hysterectomy was to be performed. The test result was positive for pregnancy. The point in time that the result was revealed to Respondent will be discussed beyond this reference to the result. On October 27, 2003, Respondent began his surgery cases at Memorial at 7:30 a.m. On that date there was no indication in the patient record or chart maintained in his office practice that reflected information concerning the pregnancy test result, nor was that information found in the hospital chart related to Patient T.D. Absent the information, Respondent testified that he asked the circulating nurse at Memorial about the result of the pregnancy test. That was Tracy Lloyd, R.N. According to Respondent, the nurse went away to check the result and as Respondent describes "subsequently told me it was negative." No further effort was made by Respondent to confirm the oral report that Respondent says was made by the nurse. Respondent did not document the results of Patient T.D.'s pre-operative pregnancy test in the medical record. It was not his habit to write that type of a pre-operative note. Respondent testified that Ms. Lloyd told him about the pregnancy test results while in the holding area in the presence of the patient. Respondent commented that his question to the nurse would have been "What are the results of the pregnancy test?"1/ Aside from the results of the pregnancy test, nothing in the patient's condition, known to Respondent, led him to believe that the patient was pregnant. When the laparoscopic surgery commenced, Respondent did not perform an examination of the patient under anesthesia, given his recent examination of the patient in his office and the results of the ultrasound. Moreover, Respondent does not believe that such an examination under anesthesia would reveal anything other than the adenomyosis and the endometriosis which conformed to his preoperative diagnosis. On that subject, the later examination of the specimen on October 29, 2003, revealed that Patient T.D. had an early pregnancy, estimated as 4 to 5 weeks. In Respondent's opinion, in a 4-to 5-week pregnancy, the uterus would not normally achieve the size of a uterus that was reported on the ultrasound as mildly enlarged, not pregnant. Mildly enlarged refers to a 6 to 8 weeks' pregnancy. Respondent expected to see an enlarged uterus because of the adenomyosis which could be anticipated to cause an inflammatory response in the wall of the uterus, softening the uterus and giving it an appearance that would be similar to an early pregnancy. The rounded globular description of the findings during surgery were consistent with the expectations in addressing cases involving adenomyosis, according to Respondent. Returning to the surgical specimen obtained in Patient T.D.'s case, it was examined through surgical pathology conducted by Robert E. Barnes, M.D. A report was rendered. The report explains that in the examination of the specimen, the endometrium, "gestational endometrium with products of conception" were present. This was the finding related to Patient T.D.'s pregnancy. Dr. Barnes, is a board-certified pathologist in anatomic and clinical pathology. He describes his findings pertaining to Patient T.D., the gestational endometrium with products of conception, as referring to an early embryo, the endometrium showing changes associated with pregnancy. In his opinion the pregnancy was between 10 and 16 days following conception. When Dr. Barnes contacted Respondent on October 29, 2003, to advise of his findings in the pathology. It was a brief conversation and he does not recall the details. After the revelation concerning the pathology, Respondent's office staff found the information concerning the results of the urine pregnancy test in the hospital chart retained in the computer at Memorial. This finding was made around November 4, 2003. In a section within the report on the pregnancy test it refers to the "Result" and underneath that, the word "POSITIVE" is entered referring to pregnancy. When it was discovered that the hysterectomy had been performed while the Patient T.D. was pregnant, at her post- surgery scheduled office visit, a discussion was held with the patient concerning the "checks and balances" in place to avoid the problem. That refers to the surgery at a time the patient was pregnant. Respondent talked to the patient about counseling, or something similar, given the outcome in the case. As a result of the error, steps were taken within Memorial to address this circumstance. The Respondent and the Memorial Department of OB/GYN made changes, by requiring a pre- operative pregnancy test as protocol, that established a urine pregnancy test within 72 hours of surgery. That test would be performed by the nurses in the holding area. Respondent now orders a blood pregnancy test which is a more sensitive test to determine pregnancy. Expert Opinion Jose Cortes, M.D., is board-certified in ob/gyn, licensed to practice in Florida. He was recognized as a expert in ob/gyn for purposes of expressing his opinion about the care Respondent provided Patient T.D. Dr. Cortes has done hysterectomies in his practice, as recent as June 2006. He was called upon to render an opinion concerning the care Respondent provided Patient T.D. involving her hysterectomy. He had access to material concerning her care involved with this case. Dr. Cortes' impression of Respondent's medical treatment of the patient in the beginning, was that it was adequate and correct, with the proper evaluation performed and an appropriate decision made for surgery. Dr. Cortes expressed the opinion that in performing a hysterectomy on a woman who is of child-bearing age, which Patient T.D. was, a physician should order a pre-operative pregnancy test. In reviewing Patient T.D.'s records Dr. Cortes did not find a record documenting that the pregnancy test was ascertained by Respondent, referring to the test results. In his experience the results of the preoperative tests would be reflected in the patient's medical records as a matter of custom. Respondent, according to Dr. Cortes, could have obtained the results of the pre-operative pregnancy test for Patient T.D. by a fax to his office, a copy obtained through a computer, laboratory printouts sent to Respondent's office, and a copy of the pre-operative laboratory results obtained by the hospital placed in its medical record. Dr. Cortes stated the position that an experienced ob/gyn, and Respondent fits that category, could reasonably be expected to rely upon an oral report from a nurse as to the results of the pregnancy test, before entering the operating room, in the area of the pre-operative alcove as the patient is being interviewed by the physician. Dr. Cortes goes on to explain that if the conversation with the nurse in the presence of the patient was in the operating room holding area, then the pregnancy test results would have to have been documented in the patient chart to find the oral report acceptable. Those test results as reported would have had to be entered by the physician in the patient chart to meet the standard of care upon the oral report.2/ Later on, Dr. Cortes in his testimony seems to subscribe to the view that an oral report by the nurse as to the pregnancy test results would meet the standard of care, assuming that the Respondent in this case was provided an oral report. In the testimony at hearing, Dr. Cortes also said that obtaining an oral report or verbal report on test results, in an emergency situation, would meet the standard of care. By contrast, in elective surgery, such as that being performed on Patient T.D., it would be such that there was ample time to review a chart and laboratory studies before the patient was brought into the surgical suite. Generally stated, Dr. Cortes accepts that physicians frequently rely upon oral information imparted by nurses in performing surgeries, be they elective or emergent, but without an oral report this concession is not important. Regardless of the pre-conditions for Respondent to receive and rely on an oral report of the results of the pregnancy test, without an oral report, there being no other basis for Respondent's knowledge of the pregnancy test results, it was below standards to proceed with the hysterectomy. This view is taken from Dr. Cortes' testimony. Dr. Cortes expressed the opinion that it was below the standard of care to not ascertain the results of the patient's pre-operative pregnancy test prior to performing a non-emergent hysterectomy, that is an elective hysterectomy. Dr. Cortes expressed the opinion that it was below the standard of care for Respondent to perform a hysterectomy on Patient T.D. while she was pregnant in an elective setting. In addition to the results of the pregnancy test, Dr. Cortes believes that Respondent had other opportunities to detect the pregnancy, including an examination of the patient while she was under anesthesia during the surgery, and would have allowed a comparison of the results at the time of surgery against previous examinations that Respondent had performed on the patient. In referring to the previous examinations compared to an examination under anesthesia, this included the results of the ultrasound performed on October 2, 2003. Dr. Cortes does agree that the underlying condition visualized under anesthesia could be associated with prior pregnancy or the pre-operative diagnosis of adenomyosis. Dr. Cortes believes that Respondent's medical records, in the context of what could have been found upon an examination under anesthesia during the surgery, could be consistent with a possible pregnancy. A change seen in the pelvic examination at surgery would create an opportunity to evaluate and raise in the Respondent's mind any doubt concerning pregnancy. A slight increase in the size of the uterus between September 26, 2003, and October 27, 2003, is what is being referred to, promoting clinical judgment about possible pregnancy. Bryan Cowen, M.D. specializes in ob/gyn and reproductive endochrinology. He practices at the University of Mississippi in Jackson, Mississippi. He is a professor and chair in the Department of OB/GYN and has been for five years. He has been affiliated with the University of Mississippi for 24 years. He did his undergraduate work at the University of Colorado in Boulder, Colorado, and attended medical school in Denver, Colorado. Dr. Cowen is licensed to practice medicine in Mississippi and is board-certified. Dr. Cowen has performed a number of hysterectomies during his career. Dr. Cowen is familiar with the standard of care applicable for physicians such as Respondent, in the evaluation of patients suspected of endometriosis and adenomyosis and the considerations for treatment by hysterectomy. He is also familiar with the standard of care in relation to pre-operative testing and the associated duties of physicians when ordering such tests. In preparing to testify in this case, Dr. Cowen examined the Memorial medical records, Respondent's office records, and the depositions of Respondent, Dr. Freeman, Dr. Widrich, Dr. Barnes, and Dr. Cortes. With this information in mind, Dr. Cowen was able to provide an opinion concerning the standard of care in relation to the treatment provided by Respondent to Patient T.D. That opinion was that Respondent did not breach the standard of care in that he met due diligence in the process by the pre-operative laboratory-ordered, and pre- operative evaluation and assessment. Speaking to the September 26, 2003, office visit, Dr. Cowen saw nothing on the physical examination to indicate to him that Patient T.D. was pregnant. Concerning the ultrasound that was conducted on October 2, 2003, Dr. Cowen's opinion is that Respondent's assessment that Patient T.D. had adenomyosis based upon presentation, was confirmed by the ultrasound, the overall impression being that the Patient T.D. was not pregnant at that time. The further visit by the patient prior to the hysterectomy did not reveal anything in the history or physical examination that would suggest that Patient T.D. was pregnant, according to Dr. Cowen. On October 22, 2003, the pregnancy test was ordered by Respondent. The arrangement of ordering the test, sending the patient for pre-operative evaluation and laboratory tests is a common practice in Dr. Cowen's experience. In the instance where Respondent did not get a call from the pre-admission testing as to any abnormal results in the pregnancy test, and no report reflecting in the patient chart that the results were normal, Dr. Cowen commented on the need to check the laboratory results before taking the patient into the operating room. Based on Dr. Cowen's experience, there was no necessity to personally lay eyes on the test results to ascertain those results. He recognizes that his hospital may be different from Memorial in its expectations but he believes that Respondent followed Memorial's policy in accepting the report of a nurse as to the results of the pregnancy test. Dr. Cowen's opinion relies upon the factual predicate that Respondent was told by a nurse that the pregnancy test was negative, to the extent that is not true, and it has not been found as a fact, his opinion is without foundation. Further, Dr. Cowen believes that in the setting where surgery is being performed in other than an emergency, it is a sufficient practice to rely upon an oral report of a nurse concerning laboratory results, such as the outcome in the pregnancy test for Patient T.D. In his experience he has relied upon nurses to report both in an emergent and non-emergent settings. He goes on to describe how those reports come back to the medical records and the physician signs off, which did not occur in this case. Dr. Cowen was asked to express his opinion about the value of an examination under anesthesia as an assist to understanding the underlying condition of the Patient T.D. Dr. Cowen does not believe that this would provide additional information. In his experience most physicians have abandoned examinations under anesthesia. If a better insight is needed an ultrasound is the best choice. To Dr. Cowen, an examination under anesthesia does not relate to standard of care, it is in relation to an individual practitioner's protocol. An ultrasound used in this case, a transvaginal ultrasound, may have shown the gestational sack at the time of the hysterectomy but proceeding on the basis that a negative pregnancy test had been established and other findings during the course of the operation, as well as the preoperative record, would not indicate the necessity for an ultrasound in this case, at that time, the place in time where the hysterectomy was being performed. Dr. Cowen did not find anything in the intra-operative findings that would suggest to Respondent that the Patient T.D. was pregnant. Overall Dr. Cowen believes that Respondent met the standard of care in addressing the case of Patient T.D., who probably had polycystic ovarian disease, irregular cycles, was without a sexual partner by history, used condoms for contraception, had an ultrasound that confirmed a slightly enlarged uterus and had symptoms compatible with adenomyosis or endometriosis. Respondent discussed the treatment options, made an appropriate pre-operative evaluation, learned that the lab results for pregnancy were negative (an erroneous assumption), and therefore, he met the standard of care, according to Dr. Cowen. Ultimately, Dr. Cowen believes that it is essential to determine whether a patient is pregnant prior to performing a non-emergent/elective hysterectomy, which was not done here. Wyatt McNeill, M.D., testified. He is an ob/gyn practicing in Jacksonville, Florida, who in the past has had privileges at Memorial. He has performed hysterectomies at that facility. Dr. McNeill graduated from Florida State University. He graduated from the University of Miami Medical School. He is licensed in the state of Florida and is board-certified in ob/gyn. Dr. McNeill is familiar with the standard of care in relation to preoperative laboratory work done before a hysterectomy. Dr. McNeill is familiar with the standard of care applicable to Respondent in the evaluation of Patient T.D. for hysterectomy, knowing after the fact that the patient was found to be pregnant. To familiarize himself with the facts of this case, Dr. McNeill examined the hospital records of Memorial, Respondent's office records, various depositions, to include that of Dr. Cortes and the anesthesiologist and pathologist, before providing testimony. He also examined the testimony of the nurses involved in the care before offering his opinions. Concerning the patient history, objective and subjective evidence available, Dr. McNeill did not believe that there was anything to suggest that Patient T.D. was pregnant. In particular, Dr. McNeill comments on the history and physical done by Respondent, counseling, laboratory evaluation, and the decision beyond that to proceed with the surgery. Dr. McNeill found the ultrasound results consistent with a patient, who by history had a previous child and had the complaints expressed in the report concerning the September 26, 2003, visit with Respondent. Nothing in the ultrasound results compared to the findings in the operative report indicated to Dr. McNeill that the patient needed to be examined under anesthesia. The use of the examination under anesthesia is a training regimne for residents and students, in his experience. It has no utility beyond that application, in Dr. McNeill's opinion. Dr. McNeill believes that an oral report of the results of the pregnancy test meets the standard of care. As with others, Dr. McNeill assumes that Respondent was told the test results, which is not found. There was no further duty by Respondent to investigate those results having been told. In Dr. McNeill's opinion, the test results are either positive or negative, they are highly accurate. A negative test result means that the patient is not pregnant. No further duty is established beyond that realization, according to Dr. McNeill. In summary, there is no disagreement among the experts that Respondent is expected to ascertain the results of the preoperative pregnancy test before performing the hysterectomy and it would be inappropriate to perform the hysterectomy without those results. Respondent does not disagree with that perception. Conceptually, having considered the testimony of Respondent and the experts, it would be acceptable to proceed on an oral report, if one had been made, a report that the pregnancy test was negative.3/ Otherwise, the physical examination of the patient prior to surgery, the results of the ultrasound, and the observations intra-operatively made by Respondent did not indicate that the patient was pregnant. There was no necessity to make an examination under anesthesia. Even if made, it would not necessarily lead to the conclusion that the patient was pregnant, taking into account other information known by Respondent. Mitigation/Aggravation The outcome here was that the patient underwent a hysterectomy when she was pregnant, an adverse result. There is no indication that Respondent has ever been disciplined in Florida or other jurisdictions while practicing medicine.
Recommendation Based upon the findings of facts found and the conclusions, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2003), and imposing an administrative fine of $10,000.00, requiring Respondent to take a course on Risk Management for physicians, and issuing a letter of reprimand. DONE AND ENTERED this 22nd day of June, 2007, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS 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 22nd day of June, 2007.
The Issue Whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43, and Chapters 456 and 458, Florida Statutes. Respondent is at all times material to this case a licensed physician in the state of Florida. As such, he is subject to disciplinary action for failure 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. Iribar has been disciplined on two prior occasions. Both cases involved standard of care violations. In Case No. 113487, the Board of Medicine entered a Final Order on April 20, 1992, disciplining Respondent for multiple violations of Section 458.331(1)(t) related to, among other things, prescribing errors. In Case No. 1991-03407, the Board of Medicine entered a Final Order on July 17, 1995, disciplining Respondent for additional prescribing violations. On August 25, 1997, C. H. required medical attention for pain and swelling in his left knee. By the time he was "worked in" at the office of his primary care physician, C. H. was unable to get around without the aid of crutches. In seeking relief for his knee problem, C. H. set in motion a chain of events which would cost him his life. C. H. had been for years a patient at the clinic where Iribar practiced medicine in partnership with Dr. Raul Alvarez (Alvarez). C. H. had a complex medical history, and had long been under the care of Alvarez. Iribar had never seen C. H., but was covering his partner's emergencies on August 25, 1997. C. H.'s knee swelling, which was visible from across a medical examining room, plainly qualified as a matter which needed prompt attention. The clinic had an extensive chart on C. H. It contained records of many office visits, tests, and information concerning care received at other locations which occurred over a period of years in which Alvarez served as C. H.'s primary care doctor. As a partner in the practice, Iribar would of course have been authorized to read every word on the chart before, during or after C. H.'s visit. Numerous references in the chart address real or perceived allergies. At many places in C. H.'s chart, an allergy to aspirin in indicated. In many other places, C. H. is said to be allergic to penicillin as well as aspirin. Iribar's focus in his lone encounter with C. H. was totally upon the need for emergency attention to the swollen and sore knee. On August 25, 1997, it was the routine in the Iribar/Alvarez practice to maintain a form detailing the patient's history, including allergies, on the inside left cover of the file. C.H.'s chart had such a document and it reflected an allergy to penicillin. Iribar freely admits that he never looked at C. H.'s chart prior to prescribing penicillin for his injured knee. Instead, Iribar testified that he conversed with C. H. while examining him and felt that he could obtain from C. H. an accurate answer to the question of whether he was allergic to any medications. During the examination and treatment process, C. H. was articulate regarding his complex medical history. He enumerated at least six medications which he was currently taking. Iribar testified that he asked C. H. if he was allergic to any medications and C. H. responded "aspirin." Iribar states that he informed C. H. that he was going to place him on oral penicillin, which might later be discontinued depending upon the outcome of lab results. According to Iribar, C. H. failed to inform him of a penicillin allergy. For reasons more fully set forth below, the undersigned does not credit Iribar's recollection that he in fact asked C. H. if he had allergies. Neither does the undersigned credit Iribar's testimony to the effect that he informed C. H. of his intent to administer penicillin. Apart from that dispositive fact, the undersigned does credit Iribar's account of his encounter with C. H. Based upon that testimony and the corroborating opinion of the experts for both sides, the evidence established that Iribar entered the examining room and noted that C. H. had a large left knee effusion with pain, redness, and increased temperature to touch. Iribar properly performed an arthrocentesis (a puncture through a joint capsule to relieve an effusion), removing 20cc of yellow pus-like material to relieve the pain. He then prescribed ibuprofen for pain and Pen VK, which is in fact penicillin, to prevent infection. Penicillin is, for most patients, safe and effective for the prevention of infection following a procedure such as the one performed on C. H. Alternative antibiotics exist and would have been prescribed for C. H. had Iribar been aware of the existence of a possible allergy. For an allergic patient such as C. H., the result of taking penicillin can be, and in this case was, swift cardiac arrest followed by a coma from which the patient never emerged. He died five months later. Expert witnesses for both sides agree, and the undersigned finds, that it would have been a gross violation of the standard of care to prescribe penicillin to a person known to be allergic. There is no contention that Iribar actually knew of the allergy, and Iribar did not intend any harm to C. H. Instead, the evidence established that Iribar was covering his partner's emergency and trying to help the patient. Thus, the issue is whether Iribar fell below the standard of care of failing to take reasonable steps to determine whether C. H. had a penicillin allergy. In this case, the totality of the record compels the conclusion that Iribar did not take even a first step. He did not inquire of C. H. as to whether he had any allergies, nor did he look at the patient's chart, which would have placed him on inquiry notice regarding the existence of a penicillin allergy. In failing to take either precaution, he fell below the standard of care. Iribar's disciplinary history reveals prior failures in adhering to the standard of care with respect to the professional obligation to ask the questions a doctor needs to ask to determine if a drug should or should not be prescribed. Additionally, his careless response to the Board of Medicine's inquiry regarding his treatment of C. H. is telling. In an undated letter to Board investigator, Lidice Muniz, Iribar stated, ". . . I asked the patient in front of two medical assistants aiding me [Ana Dickinson and Barbara Olesco] if he was allergic to any medication, he replied 'Aspirin' and he denied all other drug allergies." Common sense suggests that Iribar would have been scrupulously accurate in communicating in writing to state investigators about a matter of such importance. Thus, the undersigned takes seriously Iribar's statement that two assistants witnessed the exchange referenced in the letter. Yet, at the final hearing, neither Iribar nor Olesco claimed that this exchange was witnessed by one, let alone two medical assistants. The undersigned carefully observed Iribar's demeanor while under oath. His recollection that he engaged C. H. on the question of allergies is determined to be untrustworthy. Specifically, the undersigned does not credit Iribar's assertion that he asked his patient about allergies. In light of this finding, it is not necessary to address whether Iribar would have been bound to review the chart had C. H. in fact been asked about allergies. With respect to C. H., Respondent failed 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 in that he failed to take any step to afford himself the opportunity to know what if any allergies C. H. had prior to prescribing the medication which caused the patient's death.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and having reviewed the Recommended Range of Penalty under the Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty and imposing the following penalty: A fine of $10,000; continuing medical education classes specified by the Board of Medicine; a six- month suspension; two years of probation, with terms set by the Board of Medicine; a letter of reprimand; and requiring Respondent to report to the Board of Medicine regarding procedures he has or will implement to assure appropriate inquiry of patients regarding their allergies in accordance with the standard of care currently prevailing. It is also RECOMMENDED that the Board impose costs associated with the investigation and prosecution of this case in compliance with Section 456.072(4), Florida Statutes. DONE AND ENTERED this 14th day of January, 2003, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 14th day of January, 2003. COPIES FURNISHED: Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violations set forth in the Administrative Complaint.
Findings Of Fact Petitioner, Department of Health, Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Respondent, Santo S. Bifulco, M.D. (Respondent), is, and has been at all times material hereto, a licensed physician in the State of Florida, having been issued License Number ME 0056868 on February 13, 1990. He has been continuously licensed since February 1990 and has never been disciplined by the Board of Medicine. Respondent, a physiatrist, specializes in physical medicine and rehabilitation. He entered private practice immediately after completing a four-year residency program in physical medicine and rehabilitation. During his residency, Respondent learned and performed electrodiagnostic and neurodiagnostic tests. He was trained in the use of videofluoroscopy, electroencephalogram, needle and surface electromyography, nerve conduction studies, and other electrodiagnostic tests. Respondent performed far above the minimum 200 required for successful completion of the residency program. As a part of his residency, Respondent also had the opportunity to observe and work with chiropractic physicians from the local chiropractic medical school, thereby allowing him to understand the role of chiropractic care and allopathic medicine in the treatment of a patient. Respondent first saw E. C. on December 9, 1991. At the time, he had been practicing physical medicine and rehabilitation for a little more than a year since completion of his residency program. Prior to coming under the care of Respondent, E. C. had been involved in a motor vehicle accident on August 9, 1991. The patient had been treated by both her family physician, Dr. George Harris, and her chiropractic physician, Dr. Richard Thomas, D.C., for the injuries which resulted from the accident. Dr. Harris prescribed medications for E. C. and Dr. Thomas provided and was continuing to provide several modalities for E. C.'s injuries resulting from her motor vehicle accident. Despite ongoing treatment by Dr. Thomas, E. C. was not significantly improving. Because E. C. was not improving under his care, Dr. Thomas referred her to Respondent. The purpose of the referral was for consultation and a second opinion. Respondent was also asked to determine what, if any, medications should be given to the patient and to provide them to the patient if it were appropriate. Respondent was not asked to nor did he assume direct primary care for the patient. Rather, Respondent's role was to provide Dr. Thomas with guidance as to the diagnosis and treatment direction for E. C. In his written report dated November 25, 1991, Dr. Thomas indicated that he was referring the patient to Respondent for further evaluation and for medication that might assist in the improvement of her symptoms. He noted that he would continue to provide palliative care to E. C. until such time as Respondent evaluated her and he had received Respondent's report and recommendation. When E. C. first came under Respondent's care, it was four months after the accident. However, her overall condition had not significantly improved. She had constant headaches, which were extreme and associated with dizziness, a history of high blood pressure, constant cervical pain radiating into her arms, thoracic pain or pain between the shoulder blades, numbness and tingling, and was limited in her physical activities. The pain was interfering with all aspects of her life, including her ability to work and sleep. Respondent performed a physical examination of E. C. on December 9, 1991. On physical examination, Respondent found that E. C.'s neck range of motion was markedly limited and associated with pain; that her lower back range of motion was markedly limited and associated with pain; and that she had positive findings on orthopedic examination, as well as, on neurologic examination. From Respondent’s examination, it appeared that E. C. had suffered injuries from the motor vehicle accident. Moreover, Respondent determined that E. C. was in need of continuing care and because she had not improved, was also in need of further diagnostic studies to evaluate the extent and nature of her injuries and her complaints. E. C. presented as a complicated case due to the length of time that had passed since the motor vehicle accident and the lingering and persistent complaints experienced by E. C. associated with that accident. Respondent’s impression was that E. C. had post- traumatic headaches and injuries to the soft tissues of the neck with radiating pain. Respondent believed that E. C. was involved in what is commonly known as a medical/legal case. Consistent with this belief, Respondent reasonably concluded that his role was to thoroughly evaluate E. C.'s condition by addressing and objectively documenting answers to the questions relative to the cause, extent, and nature of her injuries. Respondent obtained Dr. Thomas’ records to evaluate the care E. C. had been receiving and reviewed E. C.'s X-rays with her on her first visit. Based on his review of the records and his examination of E. C., Respondent believed that the care provided by Dr. Thomas was appropriate for E. C.'s condition and that she would benefit from continued conservative care. However, Respondent felt that for E. C. to reach her maximum potential, additional diagnostic tests could reasonably assist him in arriving at a diagnosis and recommendation for treatment of the patient’s condition. Respondent initially recommended that E. C. undergo diagnostic testing or studies including: nerve conduction studies; a Dermatomal Somatosensory Evoked Potential (DSEP); an electroencephalogram (EEG); a cervical Magnetic Resonance Imaging (MRI); and cinefluoroscopy or videofluoroscopy studies of the cervical spine. These tests were ordered and/or recommended because Respondent reasonably believed that they could assist him in determining the nature and extent of E. C.'s injuries and complaints and arriving at a recommendation for treatment. E. C. subsequently underwent the recommended testing. To assess the discs and other cervical soft tissues, Respondent recommended that E. C. receive imaging studies. Respondent recommended an MRI study of the cervical spine. This study was conducted on December 19, 1991, at the Access Imaging Center. The purpose of the MRI was to evaluate whether E. C. was suffering from a condition that could be treated by surgery. An MRI is a static exam and is the "gold standard" in looking for a herniated disc. E. C.'s MRI was normal, thus, ruling out the possibility of the need for surgical treatment of her condition. To assess ligamentous structures and capsular stability, Respondent also recommended that E. C. receive a videofluoroscopy of the cervical spine or dynamic motion studies. The videofluoroscopy was obtained on December 11, 1991, and was performed at the Tampa Bay Dynamic Imaging Center. The videofluoroscopy was the only test available to observe the movement of the cervical spine through a full range of motion versus the limited views obtained in extension and flexion X-rays, where the patient's neck is seen in a fully extended position, neutral position, and fully flexed position. In E. C.'s case, videofluoroscopy served to confirm the presence of a soft tissue injury. The videofluoroscopy exam revealed hypomobility of the cervical spine at the level of C5-6 and C6-7. This result was consistent with the extension and flexion X-rays of E. C. that had been taken while she was under Dr. Thomas' care. However, Respondent felt the videofluoroscopy was an appropriate diagnostic tool to determine if E. C. had deteriorated since her last exam or had greater instability than was thought to be present from review of the static flexion/extension films. The videofluoroscopy and the MRI allowed Respondent to determine the extent and nature of the patient’s injuries and make recommendations for continuing treatment to her primary physician, Dr. Thomas. Both imaging tests provided useful information in the diagnosis and treatment of the patient’s condition. E. C., who worked as a florist, was experiencing problems working, lifting, and performing many routine activities in her daily life. Because E. C. was not progressing in treatment, Respondent wanted an objective assessment of her strength and ability to lift. Respondent believed that this information would help guide E. C. and Dr. Thomas in advising the patient concerning what she should or should not be lifting. To accomplish this objective, Respondent ordered a N.I.O.S.H. lift test and a Range of Motion test. These tests were performed on December 19, 1991, in Respondent's office. The N.I.O.S.H. lift and Range of Motion tests are components of a battery of tests that make up what is commonly known as a functional capacity evaluation. A functional capacity evaluation is an extensive series of tests to determine a patient’s ability to return to work. By itself, a N.I.O.S.H. lift test is not a functional capacity evaluation and was never intended to be used in that manner by Respondent. Though E. C. had not significantly improved under Dr. Thomas' care, it appeared to Respondent that she had reached a plateau in that her condition was not improving. The N.I.O.S.H. test is appropriate when a patient like E. C. has reached a plateau in her care and is not progressing. It gives the physician information from which to base recommendations on the scope and nature of the activities in which the patient may participate. Furthermore, it helps the physician in designing a strengthening program appropriate to the patient’s physical limitations. It can also provide a baseline for future tests and serial evaluations of the patient’s progress. Respondent was unable to make use of the results from the N.I.O.S.H. test or obtain comparison tests because E. C. failed to return to his office after February 1992. To assess the presence or absence and the extent of any neurologic dysfunction in the upper extremities, Respondent recommended that the patient undergo nerve conduction studies. E. C. underwent those studies on December 30, 1991, in Respondent's office. The purpose of nerve conduction studies is to objectively evaluate peripheral nerve function. It is an average measure of the time it takes an electrical nerve impulse to travel down a segment of the nerve from the spinal column to a particular muscle group. It also includes a measure of the time it takes an electrical nerve impulse to travel from the point of stimulation up to the brain and back. Respondent’s use of nerve conduction studies to objectively look for pathology of the spine or peripheral nerves was warranted given her continued complaints and failure to improve after four months of conservative care. The nerve conduction studies were interpreted by Respondent as abnormal. However, many physicians would have interpreted the studies as normal because, in part, the latency was less than 30 and the difference was less than three milliseconds when compared to both sides. Nonetheless, it is also recognized that these interpretations are judgment calls by physicians based on several factors. To differentiate between problems with the peripheral nerves from those in the central nervous system, Respondent also recommended a DSEP of the upper extremities. This study was conducted on December 30, 1991, in Respondent's office. The DSEP was a companion exam to the nerve conduction studies and supplemented information learned from those studies. The combined exams assisted Respondent with localization of the source of the patient’s complaints and it was appropriate for the Respondent to have obtained both studies. In 1991, the use of the DSEP was relatively new, but it was a test that held out promise to physicians in helping them objectively quantify the functioning of nerves in all of their segments. Over time, it has been found that the DSEP does not provide any greater information than that gained by use of electromyography combined with imaging studies. However, in 1991, the thinking was different. In addition to the nerve conduction studies and the DSEP, Respondent recommended that E. C. undergo a standard awake or EEG. This test was performed on December 30, 1991, in Respondent's office. The purpose of the EEG was to evaluate the source of the patient’s continued complaints of headaches and of difficulty with sleeping. According to E. C., these problems had persisted for four months. The EEG was an inexpensive tool to evaluate whether E. C. was suffering from an intracranial bleed or from some other pathologic condition unrelated to her soft tissue injuries. Given the intensity and persistence of the headaches, Respondent felt that there was the possibility of trauma having gone undetected; he believed that such trauma could not be ruled out even though the patient had not related a history of having hit her head during the motor vehicle accident. The EEG came back as a normal study, thus, allowing Respondent to rule out more serious causes for the E. C.’s headaches. The results of the diagnostic tests allowed the Respondent to report to her primary treating physician his conclusions concerning the extent of the care to be provided, prescribe medications for E. C., identify the distribution of ligamentous instability, the etiology of her complaints, and her safe lifting capacities. It allowed him to rule out the possibilities of serious intracranial lesion and serious neurologic abnormalities. The data was suggestive of a problem in the thoracic outlet. In February 1992, E. C. returned to Respondent for re- evaluation and discussion concerning her medications. She was still experiencing headaches and was reporting that Dr. Thomas’ care was helping but she was unsure if her overall condition was improving. E. C. also reported a new problem with a burning sensation in the right foot at night, which Respondent had not assessed to be problematic. During this visit, Respondent altered her medications and scheduled her for surface electromyography exam (EMG) of the face and neck. The EMG was performed on February 28, 1992, in Respondent's office. The purpose of the surface EMG was to objectively evaluate whether E. C. had muscle spasms, and if so, the degree, interest and location of the spasms. The surface EMG also confirmed the clinical finding of muscle spasms. From the information gained from the study, Respondent could also objectively assess E. C.’s response to existing treatment and her need for further treatment including potential adjustments to be made to her medications in type and quantity. In 1991 and 1992, the results obtained from the surface EMG were thought to be important in providing care to patients or evaluating the treatment being provided. However, over time, it has been learned that muscle spasm can vary on a daily basis and, thus, the data obtained from the surface EMG may not be the best indicator as to how the patient is progressing in treatment. As physicians have learned more about the usefulness of surface EMG, they have come to rely upon it in biofeedback training. The exam provides the patient with an objective visual representation of muscle spasm, which then allows the clinician to teach the patient to relax the affected area. In E. C.’s case, the surface electromyography allowed Respondent to identify areas of muscle spasm for the purpose of planning her continued care. His use of the test in this manner, given the time period in which it was administered, was not inappropriate. E. C. left Respondent’s care after February 28, 1992, and subsequently came under the care of a neurologist, Dr. Alan Spiegel. Dr. Spiegel, who assisted in the treatment of the patient after she left Respondent’s care, did not have any criticisms of the care she had received from her prior treating physicians. As he formulated his treatment plan, Dr. Spiegel had the benefit of the records from E. C.'s prior physicians, including Respondent’s records. While receiving treatment from Dr. Spiegel, E. C. was still under the care of Dr. Thomas. Dr. Thomas’ role was to provide physical therapy while Dr. Spiegel provided medications to reduce inflammation and spasm. In fact, because she had received prior diagnostic exams, there was no need for Dr. Spiegel to perform any additional tests. Dr. Spiegel placed E. C. at maximum medical improvement on April 20, 1992, and found that there was a significant impairment of her physical condition. She experienced an exacerbation of her condition, received additional treatment, and was again placed at maximum medical improvement on October 9, 1992. At the time of the formal hearing, E. C. was still suffering from the injuries sustained in the motor vehicle accident of August 9, 1991. She continues to experience flare- ups of her condition and continues to receive treatment for her condition. Respondent's use of the diagnostic tests was not exploitative and was medically indicated at the time they were ordered. Respondent’s use of diagnostic tests was reasonably calculated to assist him in reaching a diagnosis and in making recommendations for continued treatment to her primary physician, Dr. Thomas. The tests were also used by her subsequent treating physicians in rendering care to the patient. This avoided the necessity of having the patient undergo further testing. As with many new practitioners, Respondent ordered more diagnostic tests than a more experienced practitioner might have thought necessary under the same circumstances. Moreover, since Respondent was fairly new in the practice, it was not unreasonable for him to have ordered more diagnostic exams than a more experienced practitioner might have ordered under similar conditions and circumstances. However, the fact that Respondent ordered more tests than a more experienced practitioner does not mean that the tests he obtained were not reasonably calculated to assist him in arriving at a diagnosis and recommendation for treatment of E. C.'s condition. Nor do more tests mean that they were not medically indicated. Several practitioners testified at the hearing and in their depositions that the tests were appropriate, particularly in 1991. Reasonable practitioners will differ as to the number and type of tests they will order to arrive at a diagnosis and treatment of a patient’s condition. At the formal hearing and in the written reports submitted into evidence, the opinions of seven physiatrists (Respondent, Dr. Gerber, Dr. Goodgold, Dr. Kelley, Dr. Krimshtein, Dr. Lichtblau, and Dr. Narula), a neurologist (Dr. Spiegel), a psychiatrist (Dr. Sprehe), and a neurosurgeon (Dr. Meriwether) were offered by the parties. Each of the physicians had a different belief as to the tests that he would order to evaluate E. C.'s condition. The Department provides appropriate and comprehensive training to members of the Board of Medicine as required by Section 458.307(4), Florida Statutes. At all times relevant to this proceeding, such training was provided to Board members when they were initially appointed as well as periodically throughout their tenure on the Board. Various methods utilized to implement and accomplish the required training included the following: viewing of appropriate videotapes; attendance at seminars and retreats; regular presentations at Board meetings; and dissemination of newsletters.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order in this case dismissing all charges against Respondent. DONE AND ENTERED this 7th day of July, 1999, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 7th day of July, 1999. COPIES FURNISHED: John E. Terrel, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Grover Freeman, Esquire Jon M. Pellett, Esquire 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
