Findings Of Fact The Respondent is a licensed medical doctor holding license number 0013446 issued by the Florida Board of Medical Examiners. He specializes in internal medicine, geriatrics, endocrinology and nuclear medicine with an extensive educational and professional background in those fields. He is currently in private practice in Dade County, Florida. The Petitioner is an agency of the State of Florida charged by Chapter 458, Florida Statutes (1981), with administering, regulating, and enforcing the licensure and medical practice standards as delineated by that chapter and related rules. Maurice Blanchar was examined at the Miami Heart Institute in 1976. At that time it was suggested by his attending physician that Mr. Blanchar have a "nuclear scan" because of a suspected abnormality described as "Gallin Syndrome." Mr. Blanchar was also examined at the Cooper Clinic in Dallas, Texas, in 1979, at which time it was also suggested that he have a nuclear scan (apparently related to cardiac complaints at that time of an unspecified nature). A coronary angiogram was performed at the Cooper Clinic, which was within normal limits. Sometime in 1979, Mr. Blanchar, with a prior history of undiagnosed cardiac complaints, read an advertisement in a local newspaper which offered nuclear scans to be performed by the Respondent, Dr. Sternberg. Mr. Blanchar kept this advertisement in his possession for approximately one year and ultimately called the Respondent's office for an appointment in July of 1980. Upon obtaining his appointment, Mr. Blanchar was advised to bring $95 as a initial fee, together with proof of medical insurance coverage. Upon arriving for his scheduled appointment at the Respondent's office, Mr. Blanchar executed a questionnaire designed to disclose his medical history. His specific presenting complaint was that he was suffering chest pains. He was a regular "jogger" and had no pain or discomfort attendant to this exercise, but suffered chest pains only while resting in bed at night. He met with the Respondent and informed the Respondent that he was responding to the advertisement regarding "nuclear scans" and informed the Respondent of his complaint, a somewhat unusual occurrence. Based upon Mr. Blanchar's complaints, together with information discerned from Mr. Blanchar's previous records from the Cooper Clinic and the Miami Heart Institute, Dr. Sternberg discussed the procedures he intended to perform with Mr. Blanchar. Dr. Sternberg informed him of the tests he would perform before and as he was performing them. Dr. Sternberg explained, and Mr. Blanchar admitted in his testimony, that the $95 fee was not for the entire nuclear scan series of tests performed, but was rather for a consultation and initial examination performed by the Respondent. The record does not clearly reflect whether specific fees for tests or procedures to be performed were discussed between the Respondent and Mr. Blanchar at this time, other than the Respondent informing Mr. Blanchar that his insurance company would pay for the cost of the nuclear scans involved. Prior to beginning the testing, the Respondent had no presupposition that Mr. Blanchar had cardiac arterial disease, based upon a previous normal coronary angiogram, and the symptoms of lack of pain while jogging, but pain while at rest in bed at night. Dr. Sternberg was aware that Mr. Blanchar was a jogger, which indicated to the Respondent that in terms of likelihood, his chances of having coronary artery disease were extremely small in terms of percentages. However, the fact that he developed chest pains while at rest in bed, led Dr. Sternberg to believe that this symptom could possibly be related to coronary artery disease. Because of the possibility of a hiatal hernia, arthritis, or possibly a congenital heart lesion, the Respondent performed three tests, the so-called "first pass," "MUGA at rest" and "MUGA at stress." All tests were designed to give complementary information, which information is not necessarily achievable by any one procedure in and of itself. The first procedure performed was the cardiac imaging blood pool test, commonly referred to as a "first pass study." It is the function of this test to assess the pattern of blood flow through the heart to determine right and left ventricular performance which is measured by cardiac wall motion and "ejection fraction." The first pass test is also utilized if there is a suspicion of vascular misformation, obstruction or shunting in a patient's heart. The first pass test was found to yield results within normal limits. The next procedure performed by the Respondent was the cardiac imaging, gated, static test, designed to show cardiac wall motion and ejection fraction, which last term is related to the volume of blood pumped by the heart upon ventricular contraction. This procedure is commonly termed the "MUGA at rest" study. The main concern of this test is a measurement of cardiac function as observed by wall motion of the heart and measured by the ejection fraction while the patient is at rest. This procedure is most commonly done as a baseline study for obtaining information concerning cardiac function while the patient is at rest for purposes of comparison with the cardiac imaging, gated, wall motion, ejection fraction test done with the patient at stress. This latter test is referred to as "MUGA at stress" and is performed in the case of patient Blanchar by using the so-called "Cold Presser Method," which involves stressing the heart to the required degree for the test by fastening an ice bag on the arm of the patient until he has reached the level of stress desirable for performing the MUGA at stress test. The MUGA at stress performed by the Cold Presser Method, although somewhat experimental, is an accepted means of inducing cardiac stress in the patient for purposes of obtaining meaningful MUGA at stress results. The MUGA at stress test, when used in conjunction with the MUGA at rest study, gives the physician a comparison of relevant data concerning cardiac function. Dr. Sternberg was the primary treating physician for Mr. Blanchar. He did not see him on a referral basis from any other physician with any attendant request to do a specific or narrow diagnostic service. Rather, Mr. Blanchar presented himself with a complaint of chest pains at night while at rest, therefore Dr. Sternberg had a broader range of potential problems to consider in determining which diagnostic test to perform on Mr. Blanchar. When Dr. Sternberg performed the first pass test, which was performed first of the three tests performed on patient Blanchar, the ejection fraction was normal, but on the lower side of a normal range for this patient. Dr. Sternberg and the Respondent's expert witness, Dr. Epstein, as well as Dr. Gottlieb testifying for the Petitioner, established that the first pass test is medically indicated to rule out problems such as "shunting," obstructions or regurgitation. Dr. Sternberg had no prior medical history of Mr. Blanchar which would automatically rule out any such problems and, in the exercise of sound medical judgment, felt that the first pass test should he performed. The decision to perform this test was medically appropriate given the patient's symptoms and the doctor's responsibility as the only primary care physician involved. Dr. Sternberg then performed the MUGA studies at rest and at stress and found that the wall motion of the heart looked normal in the left anterior oblique view. The ejection fraction was normal with the MUGA study "at rest" test, but was higher in the normal range than had been the case with the first pass study, which led him to believe that the previous first pass study had an anxiety factor in the patient as a contributing factor to its results. Thus, the MUGA at stress test was able to confirm the efficacy of the performance of and results of the first pass study and Dr. Sternberg was, as well, able to rule out any problems related to shunting, regurgitation, or obstruction in the patient. He was able to confirm that the first pass study, with the patient's anxiety as a factor, had resulted in a slightly altered ejection fraction result. In any event, after these two tests were performed, he also felt the need to look at the wall motion of the heart, under stress conditions in the other areas of the heart, because he had not yet found any area of abnormality. Ultimately, no substantial abnormality was found in the patient's heart, except a suggestion that stress altered his ejection fraction. He also found that the wall motion of Mr. Blanchar's heart in the region of the left circumflex branch, the posterior laterial wall, towards the apex, showed sluggish motion, in fact, almost a paradoxical type of motion during stress, as compared with the baseline study which indicated that there was evidence of probable coronary artery disease at that point. Dr. David Allen Epstein practices diagnostic radiology and nuclear medicine. He was accepted as an expert witness on behalf of the Respondent and largely corroborated the Respondent's testimony, finding the procedures performed by Dr. Sternberg for patient Blanchar to be medically legitimate and to constitute matters of clinical judgment. Dr. Epstein established that the Respondent had available to him other justifiable tests beyond those he performed for Mr. Blanchar and established that the first pass, MUGA at rest and MUGA at stress studies performed, were for medically justifiable reasons and, in a patient with the presenting symptoms of Mr. Blanchar, were each designed to elicit information not directly available from the other tests. The use of color for cardiac computer studies is a useful diagnostic procedure. Neither Dr. Stuart Gottlieb nor Dr. Stolzenberg (Petitioner's expert witnesses) found any fault with the management or care provided these patients, nor the choice of tests performed by Dr. Sternberg with the exception of the first pass test and the separately billed stress test. Both Drs. Gottlieb and Stolzenberg felt the first pass test was redundant. However, their testimony in this regard is rejected and Dr. Epstein's and the Respondent's is accepted, inasmuch as the Respondent was the primary care physician and the only physician concerned with these proceedings who saw the patients in a clinical setting, charged with evaluating the patient's own complaints and arriving at a diagnosis. Patient Blanchar was not presented to the Respondent by another referring physician upon a narrow area of specific inquiry, rather Dr. Sternberg had to perform the added first pass study in order to rule out possible shunting, obstruction, regurgitation and other problems and his testimony regarding the necessity for this is corroborated by that of his expert, Dr. Epstein. It was established that all three cardiac studies were efficacious with regard to patient Blanchar and the Respondent's testimony and Dr. Epstein's testimony is accepted to the exclusion of other testimony in this regard. The Respondent's bill presented to patient Blanchar (and presumably his insurance carrier) is set forth in Petitioner's Exhibit "A" and reflects the following charges: Comprehensive office visit, new patient $ 95.00 Stress testing 150.00 Provision of Radionuclide 20.00 Cardiac Imaging gated (wall Motion, ejection fraction) w/stress 500.00 Cardiac Imaging gated (wall Motion, ejection fraction) static 500.00 Cardiac Imaging blood pool (1st pass) and or vascular flow 500.00 Dr. Sternberg charged patient Blanchar an additional $150 for "stress testing" which is represented on his bill to be a separate and different test from the cardiac imaging, gated, wall motion study with stress or "MUGA at stress," for which the doctor charged Blanchar $500. Although the Respondent represented that this "stress testing" was a separate service performed, there is no evidence whatever in the record which would establish that such a stress test was performed separate and apart from the MUGA at stress, performed for the $500 charge. A separate stress test would have been redundant and unnecessary in any event. It is obvious therefore that the patient Blanchar was billed for a separate item called "stress testing" in the amount of $150 which was not actually performed and which was not necessary. Dehlia Teramo suffered an automobile accident on March 12, 1980. She was initially seen by Dr. Carlos B. Fernandez, who saw her on the day of the accident. He ultimately referred Ms. Teramo to the Respondent with a history of trauma sustained in the accident with subsequent pain throughout her head, ears, eyes, neck, nose, and left shoulder. On April 10, 1980, Ms. Teramo initially saw the Respondent complaining of frequent headaches, neck pain, eye pain, high blood pressure, back and shoulder pains and pain in her nose, having sustained trauma and unconsciousness after being thrown about in the interior of her car during the auto accident. She additionally suffered pain in the left upper and lower parts of her mouth and suffered a recurrence of her menstrual period. Dr. Fernandez sent her to the Respondent for evaluation and diagnosis with reference to all these physical complaints, including the possibility of a fracture in the head or left shoulder area, but not solely for determination of the presence of a fracture of the sphenoid bone of the head. The Respondent performed three diagnostic tests or studies on different dates to attempt to determine the basis of Ms. Teramo's injuries. The first study was conducted on April 10, a blood circulation study. This study, when confined to the cerebral area is known also as a brain flow study. The study was conducted by the Respondent in area of the head as well as the spine and shoulder. The test is performed by injecting the patient with a radionuclide and then following the "bolus" throughout the areas in the which the physician is interested in gathering data with an x-ray camera assisted by a computer. In effect, this test images the blood flow in the blood vessels involved in the head, spine and shoulder areas and is used to detect subdural or epidural hematomas, abnormal vascular changes in the brain and in the other areas tested. It is designed to show any breaks or "leaks" in the blood/brain barrier, that is, any passage of blood from the vascular system of the brain into surrounding brain tissue. In itself, it is not the primary test for determining a fracture, but it is useful and all expert witnesses agreed and established that it was within sound medical judgment and patient management to perform such a test to aid and ascertain the basis for the complaints Ms. Teramo had regarding her head, neck and shoulder areas. A sphenoid bone fracture would be difficult to diagnose with this one test alone, but that was not the sole basis for the referral of Ms. Teramo to the Respondent. The radionuclide which is injected travels throughout the patient's body and the physician can do a number of limited scans or a total body scan utilizing the one injection of radionuclide. In performing the blood circulation or blood flow study, the Respondent charged patient Teramo for each component of the study, in effect, each view taken was charged for as a separate procedure as was the injection of the radionuclide. The computer processing and color image analysis was also disclosed to patient Teramo to be a separate procedure and was billed for separately, as shown on Petitioner's Exhibit "K," the bill set forth below. The blood circulation study and the quantitative cerebral blood flow study were represented to the patient Teramo on the bill as being separate studies and a separate $200 charge was assessed against the patient for the quantitative cerebral flow study. These studies are performed during the same patient visit and utilizing the same injection of radionuclide. The cerebral blood flow study is dynamic, with imaging done as the radioactive "bolus" moves through the vascular area in question. The blood circulation study, also called blood pool study, is the static form phase of the procedure performed after the vascular system in the area in question has already been completely infused with radionuclide. The testimony of Dr. Stolzenberg, coupled with that of the Respondent himself, establishes that the quantitative cerebral blood flow study is indeed tested with the same injection of radionuclide at the same patient visit. It is a different test or procedure, however, although many practitioners do not use it and it is unusual to see it used. However, it was not demonstrated, because it is not a standard type of procedure, that a practitioner should not charge a separate fee for it, not that the brain flow study always necessarily includes a quantitative, cerebral blood flow study. Thus it was not shown that the quantitative, cerebral blood flow study with the separate charge of $200 on Ms. Teramo's bill was not a separately identifiable test performed on her. The Petitioner also was unable to establish that this particular test was not medically indicated for a patient with Ms. Teramo's presenting symptoms. On April 14, 1980, the Respondent performed another nuclear scan on patient Teramo, known as a bone scan. This is accomplished by again injecting the patient with a radionuclide substance which adheres to the bones and joints after passage of a period of time while the patient waits in the examining facility. This scan was utilized for the same areas as the previous scan or blood flow study, that is the head and left shoulder areas and cervical spine area. The bone scan is used to aid in the physician's determination of the presence of fractures. The Respondent separated his charges for this procedure into a separate charge for each view obtained, as well as a separate charge for the injection of the radionuclide, and a separate charge for computer processing and clinical color imaging analysis done by the Respondent himself. On April 18, 1980, the Respondent performed an echoencephalogram upon patient Teramo. This procedure is designed to determine the presence of subdural or epidural hematomas, fractures and tumors. It is commonly utilized in cases of patients who sustain traumatic injury. Having reviewed the results of all these procedures, the Respondent arrived at a diagnosis of patient Teramo as having a fracture of the sphenoid bone of the head. No apparent diagnosis was made with reference to the shoulder area. The Respondent presented a bill to patient Teramo, admitted as Petitioner's Exhibit "K," reflecting the following pertinent charges: 4/10/80 Initial consultation $ 95.00 Injection of Radio- nuclide for scans 20.00 Scans: (Blood circulation study) Head LL 75.00 Head PA 75.00 Head Vertex 75.00 Cervical Spine PA 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head AP 75.00 Head RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis 350.00 Quantitative Cerebral Blood Flow Study 200.00 4/14/80 Office visit 25.00 Injection of Radio- nuclide for scans 20.00 Scans: (Bone and Joint Study) Head AP 75.00 Head RL 75.00 Head LL 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head PA 75.00 Cervical Spine PA 75.00 Cervical Spine LL 75.00 Cervical Spine RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis. 350.00 4/18/80 Office visit 25.00 Echoencephalogram, A-Mode 150.00 The blood and bone scan studies done with regard to Ms. Teramo's complaints, as well as the echoencephalogram, are medically appropriate and a proper exercise of sound medical judgment by a clinical physician and primary treating physician in the position of Dr. Sternberg with regard to this patient. It must be remembered that Ms. Teramo was not merely presented for determining the presence of a sphenoid fracture, rather she was presented to Dr. Sternberg by Dr. Fernandez, for investigation of various types of suspected pathologies. Dr. Sternberg's testimony, as corroborated by that of Dr. Epstein, establishes that certain fractures not always detectable by specific types of radiographic techniques may be detected by the device of blood pool scans. The Respondent showed (corroborated to some extent by Drs. Gottlieb and Stolzenberg) that the tests performed on Ms. Teramo constituted matters of clinical judgment and that Dr. Sternberg had available to him other tests which he could have performed on Ms. Teramo or Mr. Blanchar and did not. Some physicians use color imaging in computer processing and that is a legitimate type of evaluation and diagnostic technique. Further, Dr. Stolzenberg recognizes that there are some physicians who do cerebral blood flow studies of the brain and charge fees there for and acknowledges that there is no prohibition against such a procedure and that some physicians use the aid of a computer during performance and evaluation of brain scans as a routine matter. Neither of the Petitioner's expert witnesses are primary care physicians and Dr. Stolzenberg admitted that he does not practice internal medicine; neither have examined either of Dr. Sternberg's patients concerned in this proceeding. Only Dr. Sternberg, of the three doctors involved, is a primary care physician. It has thus been shown that the first pass study, the MUGA at rest and the MUGA at stress studies, as well as the blood circulation study, quantitative cerebral blood flow study and bone scans performed on these two patients were medically legitimate and all were within an appropriate choice of tests and were selected and performed in a manner within acceptable medical standards. The fact that the Respondent charged a $75 fee for each of the various scans or views of the head, shoulders, and cervical spine of Ms. Teramo for purposes of the blood circulation study and the bone scans performed appears exorbitant, however there is no evidence that it was not a charge directly related to the Respondent's time and skill as a highly trained specialist, coupled with a component in each of those charges for the use of highly sophisticated, color, computer processing equipment and camera which he owned and operated himself in his own office. Since the specific rates charged by physicians for this and any other type of service, are not regulated, these charges cannot be delved into further for purposes of this proceeding once the diagnostic procedures to which they relate have been established, to be medically acceptable, which they have, with the exception of the $150 charged patient Blanchar for the unperformed stress test.
Recommendation Having considered the foregoing Finding of Fact, Conclusions of Law, the candor and demeanor of the witnesses and the pleading and arguments of the parties, it is, therefore RECOMMENDED: That the Board of Medical Examiners enter a Final Order finding the Respondent, Joshua L. Sternberg, M.D., guilty of a violation of Sections 458.331 (1)(1) and (o) Florida Statutes (1981), to the extent delineated above, and that he be fined the sum of $1,000 for each of the above two violations. DONE and ENTERED this 30th day of November, 1983, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 30th day of November, 1983. COPIES FURNISHED: Harold M. Braxton, Esquire 45 S.W. 36th Court Miami, Florida 33135 Steven M. Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues to be resolved in this case concern whether Proposed Rules 590-3.002, 590-5.003, 590-3.003, 590-5.004, and 0094 Sf =e 590-7.001, Florida Administrative Code, which substantially revise and replace existing provisions of the same rules are invalid on the basis that they are allegedly an invalid exercise of delegated legislative authority for reasons set forth more ‘fully in Section 120.52(8), Florida Statutes.
Findings Of Fact 1. The Respondent, Agency for Health Care Administration, is an agency of the State of Florida charged with administering licensing of clinical laboratory personnel in pertinent part. This responsibility was formerly that of the Department of Health and Rehabilitative Services. 2. The Florida Association of Blood Banks, the Petitioner, is a non-profit organization made up of community blood banks throughout the state of Florida. The organization represents the interest of individual member physicians, technicians, technologists and other health care workers who work in blood banks, hospitals, community blood banks, and blood centers throughout the state as well as institutional blood banks and transfusion services. 3. The association is organized to assure good blood banking practices in the state of Florida in order to improve safety of the blood supply in the state for the public. Both the individual and institutional memberships of the association are affected by the proposed rule in terms of both institutional community blood centers and individual technicians and technologists working in blood centers because changes to licensure provisions will make employment more difficult and otherwise make qualified staff prospectively ineligible for employment and thus make it more difficult for blood banking entities in hiring qualified personnel. ° 0096 _€ we ae 4. Hospital-based blood banks which perform transfusion services will also be impacted because changes in the proposed rules may disqualify certain technologists and technicians from -working in blood banks, may increase costs and make it more. -.-. difficult for these blood banks to replace qualified staff. It has not been shown that the changes will improve the safety or quality of health care provided. 5. The proposed rules will impose education and training programs which are not adequate for the specialized procedures performed by the blood banks, thus making licensure more difficult. They will provide less qualified applicants. 6. The Petitioner has demonstrated that it represents the interests of its institutional and individual members and that a substantial number of those members will be affected by the proposed rules. The rules are within the scope of interest which the Petitioner/association was organized and is operated to protect. 7. Clinical laboratory personnel are defined to include technologists and technicians who perform or are responsible for performing laboratory test procedures. This definition includes personnel in blood banks performing laboratory test procedures but does not include trainees, persons who perform screening for blood banks or plasmapheresis centers, phlebotomists or persons employed by the clinical laboratory to perform manual pre-testing duties, clerical personnel or those with other administrative responsibilities. 8. Clinical laboratory personnel and blood banks currently C C perform test procedures in the field of immunohematology and the current specialization of blood banking. 9. All laboratories must comply with the conditions imposed under the Federal Clinical Laboratory Improvement Amendments of 1988 ("CLIA"). Those regulations appear at 42 Code of Federal Regulation Section 493.1, et. seq. The CLIA regulations, however, do not relate to licensure of laboratory personnel themselves. CLIA imposes specific qualifications and requirements for individuals who perform "high complexity testing." Compliance with these regulations requires that each individual performing such testing "possess a current license issued by the state in which the laboratory is located as well as certain other requirements which are discussed herein." The CLIA rules provide detailed and specific regulations concerning performance of laboratory test procedures. 10. The proposed rules at issue substantially modify the existing laboratory personnel rules and eliminate the specialty designation in blood banking. The following proposed rules delete the specialty designation in blood banking: A. The specialty designation of blood banking is deleted from the provision pertaining to general requirements of clinical laboratory personnel training programs (Fla. Admin. Code R. 59)-3.001); B. The specialty designation in blood banking is deleted from clinical laboratory personnel training programs (Fla. Admin. Code R. 590-3.003); c. The licensing procedure for technologists with a specialty in blood banking is deleted (Fla. Admin. Code R. 590- 5.004); and 0098 11. = ¢ ~e D. The licensing psocedure for technicians with a specialty in blood banking is deleted (Fla. Admin. Code R. 590-5.004); and E. Provisions providing for licensure examinations for the specialty in blood banking are deleted (Fla. Admin. Code R. 590- 7.001). Substantial changes are made in technician and technologist training and experience requirements. These changes include: 12. A. Education and training requirements for licensure as a technician are changed from 400 hours of instruction in a designated specialty under the existing rules toa minimum of one year of integrated instruction covering all categories, including categories of clinical chemistry, hematology, immunohematology, microbiology and serology immunology. (Fla. Admin. Code R. 590- 3.001(6) (1)). B. Experience requirements for licensure as a technologist are changed from 400 hours of training and experience in a designated specialty (no longer including blood banking) to five years of pertinent clinical laboratory experience with one year of experience in each category for which licensure is sought (Fla. Admin. Code R. 590- 5.003(1)(g)). Alternatively, three years of pertinent clinical laboratory experience of which one year shall be in the category for which licensure is sought for an applicant with a baccalaureate degree. The laboratory personnel licensure rules have been in existence for a substantial period of time but until recently did not provide for a specialty designation in blood banking. Because of new laboratory tests for specific diseases which were imposed on blood banks pursuant to federal regulation issued by the Federal Food and Drug Administration and the need for specially trained personnel in order to perform these tests, a 0099 C C task force was formed in 1988 and 1989 to work with the Department of Health and Rehabilitative Services to develop a blood banking specialty under the laboratory personnel rules. This specialty was created by rules adopted in May of 1995. The specialization was intended to focus training in specific areas of work in blood banks in order to ensure that laboratory personnel working in blood banks complied with controlling federal regulations. 13. A comprehensive examination for this blood banking specialty was developed and adopted by rule in December of 1995. See Rule 590-7.001, Florida Administrative Code. The examination was administered for the first time in September of 1996. 14. The proposed rules were published in the August 23, 1996, Florida Administrative Weekly. The agency offered no testimony or evidence that any change in circumstances that occurred with respect to licensure of laboratory personnel in the specialization of blood banking. Further no evidence was offered that any difficulty had been created in maintaining the blood banking specialization. There was no evidence of the existence of any problem with respect to specialized training and educational requirements for licensed technologists and technicians. To the contrary, the evidence indicates that failure to provide specialized education for training in blood banks would create significant problems for blood banks and their personnel. 15. The agency offered several reasons for the proposed changes at the hearing. These included the agency's desire to 0700 _C€ CC minimize proliferation of specialties; a desire to make licensure dependent upon the discipline related to the particular laboratory test procedures performed and a desire to make the state regulatory scheme consistent with CLIA. 16. The proposed rules limit the categories in which training and education are provided for licensure to certain limited categories. These are the categories of Chemistry, Hematology, Immunchematology, Microbiology, and Serology/Immunology. The department contends that these categories of tests are "disciplines" while blood banking is not. It maintains that the categories of Histology, Radioassay and Blood Gas Analysis are also disciplines. (See Proposed Rules 590-3.003(2) (a) (b) (c) and (d), Florida Administrative Code). However, each of these areas involves performance of one or more test procedures from a specialty category. Thus these categories are no more discrete "disciplines" than is blood banking. 17. The agency contends that while immunohematology is synonymous with blood banking, the "donor processing" aspect of blood banking is not a disciplined-based specialty and should therefore be deleted. 18. The disciplines which the department intends to reccgnize in its proposed rules are Chemistry, Hematology, Immunohematology, Microbiology, and Serology/Immunology, as well as Histology, Radioassay, and Blood Gas Analysis. Except for Radioassay and Blood Bas Analysis these categories are based upon laboratory tests proficiency standards described in the federal regulatory scheme known as CLIA. CLIA regulations contains 8 0101 CC C_ specific proficiency standards for tests performed in these general categories. A blood bank performs a limited number of tests in each category, to wit, Immunology (42 CFR Section 493.027), Routine Chemistry (42 CFR Section 493.931), Syphilis Serology (42 CFR Section 493.923), Hemotology (42 CFR Section 493.941), and Immunohematology (42 CFR Section 493.959). Each CLIA category includes numerous tests within the category. While CLIA does not provide for personnel standards, the proficiency tests' standards are the basis upon which personnel are licensed in the various specialty categories. 19. While clinical laboratory procedures are utilized to assist in the diagnosis and treatment of disease, blood is considered a product. Thus standards for performing clinical laboratory test procedures and testing blood are different. For this reason CLIA provides specific standards respecting the activities of blood banks. These provisions includes standards concerning the operation of a transfusion service and blood bank pursuant to standards of immunohematology (42 CFR Section 493.1271), standards governing immunohematological collection, processing dating periods, labeling and distribution of blood and blood products (42 CFR Section 493.1273), standards for blood and blood products storage (42 CFR Section 493.1275), standards for the provision of testing (42 CFR Section 493.1279), standards for the retention of samples of transfused blood (42 CFR Section 493.1283), and standards for the investigation of transfusion reactions (42 CFR Section 493.1285). 9 0102 ~C€ = 20. The CLIA standards incorporate provisions of 21 CFR Section 640 and 21 CFR Part 606, pertaining to blood and blood product collection, processing and distribution. Pertinent regulations adopted by the Food and Drug Administration Act provide comprehensive regulatory requirements controlling the manner, method and procedures of a blood bank in collecting, testing, processing, and storing blood. See generally 21 CFR Section 640.1 through Section 640.56. Additionally, other provisions of the Act provide extensive regulation pursuant to provision of good manufacturing practices for blood and blood components. See 21 CFR Section 606.3 through Section 606.17. Thus, these regulations provide the primary regulation of the performance of laboratory procedures by blood bank personnel. They are the focus of a blood bank training and education program. The blood bank specialty examination provided for by the existing rules which the department proposes to delete, incorporates applicable provisions of the above-described federal regulations. The preponderant evidence does not demonstrate that the agency considered the import of the CLIA and Food and Drug Administration provisions in proposing to delete the blood bank specialization. 21. A blood bank performs a limited number of test procedures in a number of different categories. These include a single Serology test (Syphilis), two Immunology tests (HIV and hepatitis), a single Chemistry test (ALT), several Hemotology procedures and several Immunohematology test procedures. Although CLIA provides proficiency standards for many laboratory (on) 103 - C test procedures in each category, a blood bank performs only the specific procedures identified by FDA regulations. The FDA regulations, previously referred to, specify the methodology and manner of performing these specific tests. 22. Performance of these test procedures in a blood bank is fundamentally different than that which occurs in a general laboratory. In a general laboratory, personnel are trained to perform a multiple of tests and to interpret the results for purposes of diagnosis. It is essential that personnel be able to interpret tests and determine if additional tests are required. No FDA regulations control the performance of these test procedures. Rather, CLIA describes general proficiency standards for performance of each specialty and sub-specialty tests procedures. (See 42 CFR Section 493.812 through Section 493.865 42 CFR Section 493.909 through Section 493.959). These performance standards provide the basis for education and training in the licensure of personnel. However, blood banks provide specific training in the performance of test procedures required by CLIA and the FDA. This type of training is not available in a general medical technologist program nor ina training program which was not provided by a blood bank. 23. In proposing rules deleting the blood bank specialty, the agency has admitted that it did not consider the import of any of the federal regulations, described above, pertaining to blood banks, nor did it consider the provisions of CLIA pertaining to unique standards and procedures applied to blood banks in adopting personnel training and licensure provisions. cD aed ; (om) Further, although the agency acknowledges that the training and educational programs necessary for training laboratory personnel licensed and employed in blood banks would require inclusion of the relevant federal regulations, the deletion of the blood banking specialty would effectively delete education and training under these provisions. . 24. Part of the agency's justification for the proposed rules was to assure consistency between the provisions of CLIA and the clinical laboratory personnel rules. However, representatives of the department admitted that the proposed rules regarding training programs for licensure were not consistent with CLIA and in fact, would exceed the CLIA requirements. The specific provision of CLIA pertaining to experience and training at issue provides as follows: Section 493.1489 Standard: Testing Personnel. Qualifications Each individual performing high complexity testing must: A. Possess a current license issued by the state in which the laboratory is located, if such licensing is required; and B. Meet one of the following requirements: k* ke * (2) (B) have laboratory training that includes either of the following: kek ek (2) At least three months documented laboratory training in each specialty in which the individual performs high complexity testing. C C 2S. This provision is consistent with existing rule provisions which require 400 clock hours of pertinent clinical laboratory experience in each specialty for which licensure is sought. (See Rules 59)-5.003(2) (a)1, Florida Administrative Code). Additionally, this provision in CLIA is consistent with clinical laboratory training programs for the technicians which require a minimum of 400 clock hours of instruction in each specialty (See Rule 590-3.003(3), Florida Administrative Code, Rule 59)-5.004(2) (b), Florida Administrative Code). The proposed rules, however, delete these provisions and instead require participation in a one year educational program for each specialty in which licensure is sought or one year of experience in each category for which licensure is sought. (See Proposed Rule 590-3.001(6) (1) and 590-5.003(1) (g), Florida Administrative Code). 26. Change of the experience and training requirement of 400 hours (approximately three months) to one year represents a substantial departure from the CLIA requirements. The agency offered no preponderant evidence explaining the reason for the departure. Moreover, such an inconsistency contradicts one of the stated goals expressed by the agency - to make the personnel standards consistent with CLIA. 27. Change of the experience and training requirements from 400 hours to one year would impose unnecessary and unreasonable requirements in training blood bank personnel. A blood bank performs only a limited number of tests in several categories. Training for each procedure is based upon federal regulatory 13 0106 _C _C oe requirements imposed by CLIA and the FDA. Thus, training of laboratory personnel to perform a wide array of tests in each category as proposed is unnecessary, costly and counterproductive. 28. For personnel employed with broad-based designations, the blood bank is forced to provide additional specialized education and training because of the unique nature of the test procedures performed. Thus, 400 hours of training in each specialty in which tests are to be performed in a blood bank setting (rather than one year) appears to be a reasonable allocation of time. 29. Training programs have been established which provide training in each specialty consistent with these requirements and which have been approved by the state as recently as in the last year. Adoption of the longer training and experience requirements in the proposed rules would result in more difficult recruitment of qualified personnel, will increase personnel costs and will not produce more qualified, competent personnel. 30. The agency offered as justification for the change the fact that under the existing regulatory scheme, a high school graduate who obtained 400 hours of education and/or training could qualify as a technician. Although the agency appears to imply that something is wrong with this standard, it offered no evidence or testimony that such individuals would be ill-equipped or ill-trained to perform laboratory test procedures for which they had been thus trained. 0107 ~ CL 31. The effect of the proposed change as it would apply to personnel employed by a blood bank would be, in many instances, to change the education and experience requirements from 400 hours in the specialty licensure obtained to one year in each specialty. Thus, in a blood bank in which personnel were employed to perform limited testing in each of four different areas, a minimum of four years of experience and/or training would be required. These are significant and substantial changes from the requirements of the present rules. 32. The agency has suggested that there is no interest in the blood banking designation because no one is currently designated in that specialty. However, it is apparent that the examination for this specialty has only recently been developed and the first examination was only given in September of 1996, approximately one month after the agency proposed the rules at issue which would delete that specialty. Even though it was not well-advertised, sixty-two people took the blood bank examination, including ten who took only the blood bank specialty. There was evidence that there are many individuals who are interested in taking the examination and making application for the blood bank licensure designation.
Conclusions For Petitioner: Thomas J. Guilday, Esquire Rex D. Ware, Esquire Huey, Guilday and Tucker, P.A. Post Office Box 1794 Tallahassee, Florida 32302 For Respondent: Edwin A. Bayo, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050
Appeal For This Case A party who is adversely affected by this final order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of the notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.
Findings Of Fact At all times material hereto, Respondent has been licensed to practice medicine in the State of Florida, having been issued license number ME 0034265. In the course of his medical practice, Respondent examined and/or treated the following patients during the following time periods: Marisella Conde January 25, 1980 through March 31, 1980 Pedro B. Conde February 23, 1980 through April 14, 1980 Michelle Conde February 26, 1980 through February 27, 1980 Ana Franjul January 20, 1981 Alfonso deLaTorre September 11, 1980 through November 3, 1980 Zoraida Estrada March 5, 1980 through January 7, 1981 Maria Estrada June 1, 1981 Dulce Febles June 30, 1980 through June 9, 1981 Maria Febles August 5, 1980 through October 17, 1980 At all times material here to, Respondent had in his office a Dow Spectophotometer, a table-sized colorimeter manufactured by Dow Chemical Company and used to diagnose the chemical content of blood. The machine compares the color of a particular reagent with the color of a patient's plasma sample and gives a reading which is interpreted by the physician to achieve a diagnosis. A different, specific reagent is used to achieve each specific component analysis of a plasma sample. The plasma must first be separated from the blood sample by centrifuge, which separates the whole blood from the plasma. The plasma sample must be manually, individually prepared for each specific blood analysis desired and must pass through seven different steps in the Dow machine before completion. A separate vial of plasma and reagent must be manually prepared for each specific blood component test, such as cholesterol or bilirubin, and must be individually loaded into the Dow machine. The machine processes one vial at a time. Each analysis test is prepared separately and manually only the ultimate reading is performed automatically by the machine. The reading is then interpreted by the physician. In September or October 1981, Respondent replaced his Dow machine with an ACA II, a room-sized computer/clinical analyzer manufactured by the Dupont Company and used to analyze blood samples. Respondent is the only private Florida physician known to own and operate an ACA II in his office. The ACA II is in use by several hospitals in the Miami area. The SMAC machine is manufactured by the Technicon Company and is one of the first automated blood analysis machines available. The machine takes one blood sample and is capable of performing up to 26 different analyses from the one blood sample loaded into the machine. It does not require separate, manual preparation of a blood sample for each analysis, as do the Dow and the ACA II machines. The SMAC machine inserts the same needle device into the blood sample for each analysis performed and inserts the same needle device into the blood samples of different patients loaded into the machine. The Technicon SMAC machine is not as accurate as the ACA II machine. Although the Technicon SMAC machine is as accurate as the Dow machine, tests run on the Dow colorimeter have more quality control, since blood samples are individually analyzed and not mixed. The word "SMAC" has come to be generically used by physicians to mean blood tests performed on any type of machine. Thus, the term "SMAC" is generic for blood tests as the word "Frigidaire" is generic for refrigerators. Physicians refer to blood tests as "SMAC 22" or "SMAC 26" to denote a blood test involving 22 or 26, or any other number of analyses, without meaning a blood test performed on Technicon's SMAC machine. Respondent follows the practice of-most other physicians in indicating on his billings that a "SMAC 26" test has been performed, for example, which simply means that a blood test of 26 analyses has been performed. When Respondent billed for "SMAC" tests with each of the nine patients named in the Administrative Complaint, his billing used the word "SMAC" followed by the number of analyses, such as "SMAC 22" or "SMAC 26," and then specifically referred the reader to the attached page. The attached sheet of paper itemized each test included within the battery of analyses and the specific fee being charged by Respondent for each individual analysis. Accordingly, Respondent's use of the generic heading next to the total cost for the blood testing, followed by an itemized listing of each individual analysis together with its specific fee, reflects the chemical analyses as being actually performed as separate blood tests individually processed rather than blood testing run by a Technicon SMAC machine. Respondent's method of billing is an appropriate way to bill a patient for individual tests performed, since Respondent was not using a machine which produces multiple readings from one blood sample loaded into the machine. Occasionally, Respondent used an independent laboratory to perform the blood test as a double check to the test performed in his office by him. In those instances, he did not bill for the independent laboratory test. Respondent himself performed the blood tests for which he billed in the manner in which he billed, each test being performed separately and individually as billed. Respondent advised each of the patients named in the Administrative Complaint as to the use and costs of the tests he intended to perform before performing them, thus obtaining his patient's consent to both the testing and the charges therefor. There are no standards in the practice of medicine prohibiting the use of a Dow machine. There is no maximum fee which can be charged by a physician for laboratory tests, throat cultures or hospital visitations. Petitioner based its entire case on two discovery depositions taken by the Respondent: the deposition of a physician serving as a consultant to Petitioner on this case, and the deposition of a physician employed by an insurance company to whom Respondent sent billings for several of the patients named in the Administrative Complaint filed herein. Both doctors based their opinions on the assumptions that Respondent did not have the equipment in his office capable of testing as was reflected in Respondent's billing, that Respondent did not perform the blood tests but rather had them performed by an independent lab, and that the equipment which Respondent allegedly used could not be purchased. Neither doctor has ever discussed Respondent's billing practices with Respondent or with the patients in question, neither has ever seen Respondent's office or equipment, and neither has examined any of the patients in question nor caused any of the patients in question to be examined. Although each doctor believed that Respondent's charges for testing and examination were excessive, that many of the procedures utilized by Respondent were unnecessary, that Respondent inadequately explained his billing, and that the frequency with which Respondent repeated chemistry profiles on his patients was not medically justified, both doctors admitted that they had inadequate information upon which to support their medical opinions for the reason that both doctors based their entire testimony on only the billings that Respondent rendered to each of the patients; and neither doctor had ever seen any of the patient's medical records, which records include Respondent's office notes which contain the results of his examination of the patients, his impressions, his reasoning for each diagnosis, and his intended course of treatment. Long before the filing of the Administrative Complaint in this cause, the insurance company which referred this matter to Petitioner for investigation sent its own investigator to Respondent's office to ascertain if Respondent had the equipment necessary to perform individual blood testing. The insurance company investigator reported Respondent had much equipment, including the Dow Spectophotometer. Yet that insurance company requested an investigation by Petitioner. Petitioner then sent its investigator to Respondent's office to ascertain if Respondent owned any testing equipment. Respondent showed his machinery, specifically the Dow Spectophotometer, to Petitioner's investigator and demonstrated the equipment by taking a blood sample from the investigator and performing the individualized testing on that sample on the Dow machine. As a result of that demonstration, Petitioner's investigator became a patient of the Respondent.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty of the charges contained in the Administrative Complaint filed herein and dismissing the Administrative Complaint filed against him. DONE and RECOMMENDED this day of April, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of April, 1983. COPIES FURNISHED: Spiro T. Kypreos, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire Stephen Marc Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Directors 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Respondent raced an animal with a drug in violation of section 550.2415(1)(a), Florida Statutes (2012),1/ as alleged in the Administrative Complaints, and, if so, what sanction is appropriate.
Findings Of Fact The Division is the state agency charged with regulating pari-mutuel wagering in the state of Florida, pursuant to chapter 550, Florida Statutes (2015). At all times material, Mr. Ziadie held a pari-mutuel wagering occupational license, number 701515-0121, issued by the Division. At all times material, Mr. Ziadie was subject to chapter 550 and the implementing rules in Florida Administrative Code Chapter 61D-6.2/ Under section 550.2415(1)(a), an animal may not be raced with any drug. It is a violation for any person to administer a drug to an animal which results in a positive test in samples taken from the animal after the race. Under section 550.2415(1)(c), "[t]he finding of a prohibited substance in a race-day specimen constitutes prima facie evidence that the substance was administered and was carried in the body of the animal while participating in the race." Under rule 61D-6.002(1), "[t]he trainer of record shall be responsible for and be the absolute insurer of the condition of the . . . horses he/she enters to race." As reflected in Division records kept in accordance with the 2010 Equine Detention Barn Procedures Manual ("the Manual"), which was in effect at all relevant times, Mr. Ziadie was the trainer of record of the thoroughbred horses from which samples were obtained in Ziadie I and Ziadie II. Mr. Ziadie is substantially affected by the Division's intended action. The equine detention barn is the site at each licensed racetrack in Florida where employees of the Division collect urine and blood samples from racehorses. It includes a fenced- in and secured area that generally has at least six stalls, as well as an area for walking the horses after a race. After a horse has been selected for sample collection (usually the top two or three finishers and sometimes a "special" that has been added at the request of the stewards), a Division employee tags the horse and accompanies it back to the detention barn. Along the way, a Division veterinary assistant assigned to the horse assumes custody and escorts the horse. At the barn, the horse is positively identified by means of a tattoo on the underside of its lip. The horse is walked to cool it down and sometimes bathed, and then taken into a stall for sample collection. Following their respective races, Mr. Ziadie's horses were immediately taken in this fashion to the detention barn for the taking of urine and blood samples. The Division publishes the Manual under the direction of Ms. Blackman as the chief of operations. The Manual is used at all horse racing facilities in the state of Florida and was last updated on June 25, 2010. The Manual provides that veterinary assistants, chief veterinary assistants, detention barn security guards, and detention barn supervisors "study, become completely familiar with, and put into practice" the procedures outlined in the Manual. It describes seven steps in chain-of-custody procedures, three of which are "collecting the specimen, sealing the specimen, and completing the required forms," and describes detailed procedures in this "strict sequence of events that must be followed." As the Manual makes clear, Division employees at the detention barns in the state of Florida are all required to follow the procedures outlined in the Manual "each and every time" they work with samples. They do not have discretion not to follow its requirements. Mr. Stirling credibly testified that in his capacity as executive director of the Florida Horseman's Benevolent and Protective Association, a position he has held for 20 years, he was an advocate for the horsemen. He attended all of the workshops for rules relating to medication overages as one of his primary duties. The centrifuging process, extraction of the serum, and sealing of the serum specimen as described in detail in the Manual were never discussed at a rulemaking hearing. These procedures are not a part of rule 61D-6.005, adopted in 2001. As he testified, Mr. Stirling was not even aware of these procedures until a month or two before the final hearing in these cases. The Manual has not been adopted under the procedures of section 120.54. At the time of these races, rule 61D-6.005, effective November 19, 2001,3/ governed the procedures for the taking of urine and blood samples from the horses. Subsection (3) provided in part: The specimen shall be sealed in its container, assigned an official sample number which is affixed to the specimen container, and the correspondingly numbered information portion of the sample tag shall be detached and signed by the owner, trainer, groom, or the authorized person as a witness to the taking and sealing of the specimen. Subsection 4.5 of the Manual describes the sample tag in greater detail: RL 172-03 is a self-adhesive sequentially numbered bar-coded, three part form (blood label, urine label and card) provided by the University of Florida Racing Laboratory that is used to catalog specimens by assigning them "Specimen Numbers." As specimens are collected, information regarding the animal from which the sample was collected is written on the bottom of this form. The top two portions of the form (Blood, Urine) are completed with the Track Number and Collection Date. The applicable top portions of the form are then separated and applied to the urine specimen cup and/or evergreen blood tube. The bottom portion, or Specimen Card, is completed and appropriately signed and is sent to the Tallahassee Office of Operations to be filed. The sample tag thus consists of three portions: the numbered portion designated for the blood specimen ("blood label"), the numbered portion designated for the urine specimen ("urine label"), and the numbered portion containing additional information about the animal and trainer that is to be signed by the witness ("card"). In the sampling procedures followed in these cases, the blood label was not affixed to the collection tube. The blood label, from which the card portion was "detached," was affixed to the evergreen blood tube. This was consistent with the governing rule, as well as the Manual. The evergreen tube is the specimen container for the serum. The sampling procedures followed with respect to the serum and urine samples taken in Ziadie I and Ziadie II were in compliance with the procedures set forth in the Manual. As stated in subsection 4.4 of the Manual, "[s]ealing the sample ensures the specimen does not spill during shipment to the laboratory and assures all parties that the sample has not been tampered with." The same purposes are served by sealing the serum specimen. After the blood samples were taken by the veterinarian, they were not "sealed" in the collection tubes. The fact that the collection tubes are air tight prior to and after the taking of the blood and initially contain a partial vacuum to facilitate collection, does not constitute "sealing" of the specimen in its container for purposes of the rule. As Dr. Watson testified: Q: Okay. Are these 15 milliliter tubes sealed? A: Well, they're sealed in that there's a vacuum in there and in order to draw the blood efficiently, that vacuum has to be there. If that seal is broken then it would not work. But, as far as sealing for legal purposes, they're not sealed at that time. There's a process that it has to go through in order to extract the serum. The three collection tubes are not the specimen container, but the last three digits of the number from the blood label affixed to the specimen container were written on each blood collection tube with a black "Sharpie" type marking pen to ensure control of the sample. The Manual prescribes detailed procedures for spinning the blood collected from the race horses in a centrifuge to extract the serum. After the blood was centrifuged, and the serum was poured into the evergreen tube, the serum was sealed with evidence tape, as described in the Manual, and the chief veterinary assistant put his initials over the seal. This constituted "sealing" of the specimen in its container. Subsection 4.6 of the Manual provides: Serum is poured into applicable (numbered) "evergreen" tubes. Each "evergreen" tube is immediately properly sealed with evidence tape. Rule 61D-6.005 does not make any reference to spinning the blood in the centrifuge to extract serum, the pouring of serum into an evergreen tube, the sealing of the evergreen tube with evidence tape, or the freezing of the specimen. The Manual establishes additional policies and procedures not contained in the rule. The serum must be separated from the blood because whole blood cannot be frozen without damage that would affect its usefulness in laboratory testing. Centrifuging facilitates the separation of the serum from the whole blood. The transfer of the separated serum from the glass collection tubes to the plastic evergreen tube is then done for two reasons. First, the plug that helps separate the serum can allow the blood cells to seep around and return to the serum, where they can release hemoglobin and iron, which can distort laboratory analysis. Second, using the plastic evergreen tube saves shipping weight and reduces the incidence of breakage during shipping. The centrifuged collection tubes are stored in a locked refrigerator. The opening of the centrifuged collection tubes and the pouring of the serum into correspondingly numbered evergreen specimen containers is carefully performed by Division employees with the intent to avoid contamination. The sealed evergreen specimen containers then remain in a locked freezer until they are shipped to the laboratory. The evidence was clear and convincing that the serum specimens in these consolidated cases were derived from the blood sample tubes bearing the same last three numbers as the tag which was prepared when the blood was taken. The serum specimens came from Mr. Ziadie's horses. Dr. Barker testified that the "free pour" of the serum was the point at which the specimen was most vulnerable, and that contamination or tampering was possible. He stated he would have preferred more supervision, witnessing, and documentation as to who was doing what, at what time. Dr. Cole concurred that there is always a possibility of contamination when a sample is transferred from one container to another. However, the free pour method used to transfer the serum from the collection tubes into the evergreen specimen container is one of the better approaches, as opposed to using a pipette or other method that would put something into the sample. Contamination from the free pour of the serum is unlikely. There was no evidence introduced to suggest that misidentification, tampering, or contamination of the specimens was likely or probable. The state veterinarian who took the blood sample from each horse signed PMW Form 504, a Daily Record of Sample Collection, indicating that this had been done. After centrifuging the whole blood in the collection tubes, at the end of the day the state veterinarian usually leaves the collection tubes with the chief veterinary assistant, who pours the separated serum from each collection tube into the correspondingly numbered evergreen container and seals it. Sometimes, the state veterinarian stays to observe the transfer of the serum to the evergreen specimen container. No document is signed to note the time that the state veterinarian leaves the samples at the detention barn or the time that the chief veterinary assistant opens the collection tubes and transfers the serum. Custody of the samples remains with Division personnel throughout this process. No transfer of custody takes place until the specimen containers are shipped to the laboratory. In each instance of sampling in these cases, the owner's witness signed the card portion of the sample tag (Form RL 172-03) after the taking of the urine and blood samples. In each instance of sampling in these cases, the owner's witness signed the card portion of the sample tag after the sealing of the urine specimen in its container, but before the sealing of the serum specimen in its container, the evergreen tube. In each instance of sampling in these cases, the owner's witness did not observe the extraction of the serum or the sealing of the serum specimen in its container with the evidence tape. The witnesses could have remained to watch those procedures had they requested to do so. Subsection 4.6 of the Manual states, "the owner, trainer of record or designated authorized witness may leave with the released animal or may elect to witness the conclusion of the collected blood specimen processing and sealing cycle." According to Division policy, two signs are posted in the detention barns to advise owners' witnesses that they may remain to witness the centrifuge process and sealing of the sample. Specific testimony that a sign was in place at the exact times sample collection took place in each of these races, or the exact location that it was posted, was lacking. However, there was more general testimony from Dr. Watson that signs have been posted ever since he has been employed. Dr. Watson credibly testified that, during the five years he has been working at the tracks, no owner's representative has ever stayed to watch the centrifuging of the samples or the sealing of the serum specimen container. The pouring of the collection tubes into the specimen container takes place at the end of the racing day, after all of the horses have departed from the detention barn. It would be very inconvenient for an owner's witness to remain until the serum specimens were sealed. The procedures that were followed--set forth in the Manual--which allowed the owner's witness to sign the sample tag after witnessing the taking of the blood but before the sealing of the specimen, were not in compliance with rule 61D-6.005(3), quoted above, which required the owner's representative to sign as a witness to both the taking and sealing of the specimen. Even had it been clearly shown that signs advising the owners' representatives that they were allowed to stay and witness the sealing of the specimen container were prominently displayed on every occasion on which the samples were taken, this would not bring the procedure being followed into compliance with rule 61D-6.005(3). The requirement that the authorized representative must witness not only the taking, but also the sealing of specimens, is a provision directly related to maintaining integrity in the sample collection process. Such deliberate disregard of the plain language of the rule directly affects the fairness of the entire blood sampling procedure. The urine and serum samples in these cases were properly delivered to the University of Florida racing laboratory and the integrity of the samples was intact. The laboratory conducts an initial screening of each urine sample in a process of elimination to weed out negative samples that do not contain any suspected drugs. This screening looks at a large number of samples and screens them broadly. The suspicious samples are then subjected to confirmation testing, in either serum or urine, testing a fewer number of samples and targeting for detection of specific drugs. The Association of Racing Commissioners International create Uniform Classification Guidelines for Foreign Substances. Classes range from class I drugs, which have no therapeutic value and are most likely to affect the outcome of a race, to class V drugs, which have the most therapeutic value and the least potential to affect the outcome of a race. Class III, IV, and V drugs all have some therapeutic value. Clenbuterol is a bronchodilator, a drug which may be prescribed for horses for therapeutic purposes. If a horse had blood or sand in his lungs after a race, he might be placed on clenbuterol for five to eight days, twice a day, and the medication would clean the lungs out completely. Clenbuterol also has the capacity to be a repartitioning (conversion of fat into muscle) agent. It is not as effective as an anabolic steroid, but it does have the capacity for building muscle. Rule 61D-6.008 does not permit any clenbuterol in the body of a racing animal on race day. Clenbuterol is a Class III drug under the Uniform Classification Guidelines for Foreign Substances. Phenylbutazone is a nonsteroidal anti-inflammatory drug effective in treating fever, pain, and inflammation. It was credibly described as having effects similar to aspirin. Rule 61D-6.008(2)(a)2. provided in part that, "[p]henylbutzone may be administered to a horse providing . . . the post-race serum sample of such horse contains a concentration less than 2 micrograms (mcg) of Phenylbutazone or its metabolites per milliliter (ml) of serum." Phenylbutazone is a class IV drug under the Uniform Classification Guidelines for Foreign Substances. The laboratory routinely receives only the information on the urine and blood labels with the specimens and does not know the identity of the horse or trainer. Samples tested in the laboratory are assigned an "LIMS" number internal to the laboratory and do not contain any information that would identify the horse or trainer. The technicians who actually conduct the tests are not informed of the name of the horse or trainer involved. Once the Division is advised by a laboratory report that a sample has "tested positive" for a particular substance, the Division matches the laboratory report to the sample tag, which has been kept under lock and key, to determine the identity of the horse and trainer. The stewards and trainer are then notified. After the trainer is notified of positive results, he has the opportunity to request a split sample. In this procedure, a portion of the specimen is shipped from the University of Florida laboratory to an outside laboratory for independent analysis. There is a minimum amount of a drug that can be detected scientifically with a reliable concentration range. As the scientific capability to detect a drug improves, this testing level can be lowered by a laboratory. The instrumentation can almost always detect the presence of the drug below the reliable concentration range that establishes the testing level. As Ms. Wilding testified, a "withdrawal time" is the time interval prior to sample collection at which the last administration of a drug can take place to allow the drug to be cleared from the horse's system so that no "positive" would be reported in that sample based upon the test detection level or reporting point for that particular drug. Mr. Stirling testified that based upon informal conversations with Dr. Tebbet, Dr. Cole, and Dr. Sams, former directors of the laboratory, he had disseminated information to horsemen for years that a five-day withdrawal time would be appropriate for clenbuterol. From July 1, 2010, until June 30, 2011, there were four clenbuterol positives from horse race tracks in Florida. From July 1, 2011, until June 30, 2012, there were 13 clenbuterol positives from horse race tracks in Florida. During this same fiscal year, the laboratory also found the presence of clenbuterol in 193 additional samples, but did not deem them "positives." In these samples, the laboratory detected clenbuterol in a concentration of less than 25 picograms per milliliter. Dr. Barker credibly testified that the fact that 193 findings of clenbuterol at less than 25 picograms per milliliter were not called "positives" indicated that either the laboratory or the Division had some form of confirmation level established. As Ms. Wilding testified, changes to the protocol as to the amount of a drug that must be present in a sample before that sample will be called "positive" are made through revisions to the laboratory's standard operating procedures (SOPs). Ms. Blackman testified that she had conversations with Ms. Wilding at the laboratory "sometime in, maybe, the summer of 2012" about the ability of the laboratory to calibrate their instruments to detect clenbuterol at the lowest level, based upon Ms. Blackman's understanding that clenbuterol was being abused, in that it was being prescribed not just for its bronchodilator effect, but also for its anabolic effects. SOP DCN: R1.07.04.05.04-07, entitled "Extraction of Clenbuterol from Horse Serum or Plasma and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective April 27, 2012, established the low end of the calibration curve at 10 picograms per milliliter. The amount of the lower positive control was 25 picograms per milliliter. The SOP provided: "If the mean concentration of clenbuterol in the test sample is less than the lower end of the calibration curve, it will not be reported." From July 1 until December 31, 2012, there were nine clenbuterol positives from horse race tracks in Florida. The first Florida positive called by the laboratory for a thoroughbred race horse whose post-race serum sample contained a level of clenbuterol less than 25 picograms per milliliter of serum was for the first race in Ziadie I, on July 4, 2012, which was reported as a positive with a level of 18 picograms per milliliter. Testing also confirmed in serum the presence of phenylbutazone in that first sample, in the amount of 2.3 micrograms per milliliter, an amount in excess of the 2 micrograms per milliliter which is permitted. The laboratory results were sent to the Division by letter dated August 6, 2012. The initial confirmation of the phenylbutazone overage and clenbuterol positive from the race of July 4, 2012, was originally sent to the stewards to resolve but was later taken from the stewards and turned into an administrative complaint. On August 9, 2012, a long article appeared in the Miami New Times entitled "Cheaters Prosper at Calder Park." The article described a racing industry tainted by drug violations and criticized the Division for lax regulations and poor enforcement. The article identified Mr. Ziadie by name, giving a short biography and saying there were signs of "systematic rulebreaking" over his long racing career. Ms. Blackman saw the article. She also forwarded an e-mail attaching the article to Ms. Wilding at the laboratory. Clenbuterol was confirmed in serum taken after the other four races of the Ziadie I complaint, held on August 17, August 30, September 14, and September 27, 2012. The concentration of clenbuterol in those samples ranged from 10 to 21 picograms per milliliter. The results from the laboratory were provided to the Division on September 25, October 1 (two races), and October 16, 2012. At Mr. Ziadie's request, the samples were split, and an independent laboratory confirmed the presence of clenbuterol in each sample. In late December 2012, the Division gave the laboratory authority to begin conducting confirmation testing for clenbuterol in urine rather than in serum. In the beginning of 2013, the laboratory changed to a 140 picogram per milliliter confirmation level for clenbuterol in urine. The Division did not give notification to the horsemen or veterinarians of these changes. From January 1, 2013, until June 30, 2013, there were 154 clenbuterol positives from the horse race tracks in Florida. Dr. Barker testified: So you would be able to see clenbuterol in urine for a much longer period of time. And, of course, that's also why ARCI now has a urine threshold instead of a plasma threshold because the idea was to push it out as far as they could and still be able to call it. They couldn't do that sufficiently in blood, they felt, so they converted it to a urine threshold. So if you go from a plasma threshold to a urine threshold, particularly the-–if it's a threshold that ARCI has recommended, you know, ARCI threshold is 140 picograms per ml in urine, and that's based on using the lowest dose and a 14-day withdrawal. Well, if you had been using the lowest dose and had been following a five-day withdrawal, you would come up positive. If you had been using the lowest dose and had been following a ten-day withdrawal, you're going to come up positive. And so if people, trainers and veterinarians, were not being informed of a change in how the laboratory was testing and interpreting data, and basically was working from a position that required a longer withdrawal time and the horsemen didn't know that, well, you're going to-–you should get all kinds of positives. Dr. Barker's explanation of the consequences of changing from a serum confirmation to a urine confirmation for clenbuterol is credited. His testimony also at least partially explains why there is not a clear correlation between the concentrations of clenbuterol detected in serum with the concentrations detected in urine from samples taken at the same time. The amounts of clenbuterol and the times it was administered to the horse remain unknown variables, and clenbuterol is detectable for a longer period of time in urine. Differences might also be explained by the amount of water the horse drank, or other factors. On or about February 8, 2013, following the great increase in the number of positive calls for clenbuterol, Mr. Stirling posted a notice regarding withdrawal times at the tracks and published it in the "overnights" that went to trainers. The notice stated: According to the Department [sic] of Pari Mutuel Wagering the withdrawal time for clenbuterol is the same as it was previously (5 days) at the proper dosage. If you had a recent positive for clenbuterol and used the old/new withdrawal time there should be no administrative action taken against you. At either the end of February or the beginning of March of 2013, the Division requested the laboratory to return to clenbuterol confirmation screening in serum, rather than urine. SOP DCN: R1.07.04.05.04-09, entitled "Extraction of Clenbuterol from Horse Serum or Plasma and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective March 7, 2013, established the low end of the calibration curve at 5 picograms per milliliter. The low end of the calibration curve reflects the lower limit of detection at which the SOP can detect a drug with a reliable concentration range. The amount of the lower positive control was set at 15 picograms per milliliter. The SOP provided: "If the mean concentration of clenbuterol in the test sample is less than the lower end of the calibration curve, it will not be reported." Clenbuterol was confirmed in serum in confirmation testing of 13 of the Ziadie II samples, taken after races from March 13, 2013, through October 27, 2013, ranging in concentration from 5 to 14 picograms per milliliter. These samples were also split, and an independent laboratory confirmed the presence of clenbuterol in each sample. Testing also confirmed in serum the presence of phenylbutazone in the sample taken from the race on January 19, 2014, in Ziadie II, in the amount of 2.3 micrograms per milliliter, plus or minus .3 micrograms. The Division did not give notification to the horsemen of any changes in the testing level at which the laboratory would report that a sample had tested positive for clenbuterol. Ms. Blackman testified that clenbuterol is not permitted at any level on race day, and it is the trainers' responsibility, in conjunction with their veterinarians, to decide whether to administer a particular medication at all. She testified that she did not think it was in the best interest of the horses or the Division to make announcements every time they are able to detect a new drug or an existing drug at a lower level. In contrast, she noted, when the amount of phenylbutazone permitted in a horse on race day was lowered from mg to 2 mg, this was announced to the horsemen through the public rulemaking process. An advance notice of about six months allowed trainers to work out adjustments with veterinarians so there would not be a huge number of phenylbutazone positives when the new rule became effective. Since phenylbutazone is a "threshold" drug permitted on race day at no greater than prescribed amounts, Ms. Blackman testified that it was reasonable to give horsemen notice of this change. Dr. Cole testified that she had a different view about changes to testing levels of drugs such as clenbuterol that were completely prohibited on race day when she was the director of the lab, saying she believed it was "prudent and fair" to notify the horsemen of changes in advance: Often when we're changing levels or sensitivity for medication type—drugs that have legitimate use in a horse, we would try to have a conversation with the horsemen to let them know that change was coming so that they could comply. Generally it's going to be an increase in the withdrawal time that they're going to be needed. On March 20, 2013, Mr. Stirling sent an e-mail to Ms. Blackman stating that he was beginning to get low-level positives for clenbuterol again, giving an example of picograms per milliliter. He stated he thought the testing medium had been changed back to blood to return to a five-day withdrawal time and asked how the Division planned to handle the low-level clenbuterols from December. In e-mail correspondence continuing through April and May of 2013, Mr. Stirling continued to question the Division about the withdrawal time and to urge a 25 picogram per milliliter testing level. Ms. Blackman advised that the laboratory was re-confirming in serum the clenbuterol positives that had been confirmed in urine. She noted that a 10 picogram per milliliter reporting point for testing in serum had been established prior to the change in the medium for confirmation and noted there was no "threshold" for clenbuterol in Florida. On May 24, 2013, Ms. Blackman advised Mr. Stirling that clenbuterol positives confirmed in serum at 5 picograms per milliliter or a greater concentration would be prosecuted. On or about May 29, 2013, Mr. Stirling issued a memorandum to Florida horsemen advising that the Division was continuing to call clenbuterol positives at levels detected below 25 picograms per milliliter and suggesting that they should no longer rely on a five-day withdrawal time. The memorandum suggested that a 14-day withdrawal time "should be more than safe" for avoiding a clenbuterol positive. Mr. Ziadie admitted he did not change his practice of utilizing a five-day withdrawal time in response: I was still stuck on the five days, your honor. I was stubborn. I know I did wrong. I know that there was a rumor and I know there was a brochure going around 14 days. but I was trying to do the best for my horses. I thought that it was the medication that they needed at the time when we were racing and I take blame for being stubborn and making a mistake, but I did keep it at 5 days. SOP DCN: R1.07.04.05.11-06, entitled "Extraction of Clenbuterol from Horse or Dog Urine and Identification by Liquid Chromatography-Tandem Mass Spectrometry," effective October 9, 2014, established the low end of the calibration curve at 50 picograms per milliliter and the high end of the calibration curve at 2000 picograms per milliliter. The amount set for both positive controls was 140 picograms per milliliter. The SOP provided: Report the calculated concentration of clenbuterol in the suspect sample as the average of its duplicates if its calculated value lies within the range of the calibration curve. If the calculated concentration of clenbuterol in the test sample is outside the range of the calibration curve, it will be reported as either greater than, or less than the limits of the calibration curve. Based on the serum test results, the Second Amended Complaint in Ziadie I was served on Mr. Ziadie on or about September 8, 2014. The First Amended Complaint in Ziadie II was served on Mr. Ziadie on or about March 16, 2015. Other trainers whose horses tested positive for clenbuterol did not have administrative complaints filed against them. The Division, instead, settled their cases with fines. Almost all of these trainers had few prior violations, however. There was credible testimony that the Division had offered to settle charges against one other trainer who had numerous prior violations with the imposition of fines and a short suspension, but there was no evidence that a settlement had been reached. It was also noted at hearing that this trainer's recent violations were in close proximity, which suggested that he might not have been informed of the violations in one case before the samples were taken in the next. The Division noted that this could be a mitigating factor, because a trainer would not reasonably have had an opportunity to adjust his medication levels in response to the earlier violations. Ms. Wilding testified that, in early 2015, she was asked by the Division to re-confirm the 2012 positive serum confirmations from Ziadie I using the urine samples taken immediately after those races. The urine samples had been used for initial screening in 2012, but had not been used for confirmation at that time. The urine samples had been stored in a minus 30-degree freezer since the initial screening in 2012 had determined them suspicious for clenbuterol. On March 18, 2015, Ms. Wilding sent an e-mail to her immediate subordinates, the supervisors of the laboratory's four main divisions, advising that "PMW Legal is asking us to analyze the five urine samples in the first Ziadie case for clenbuterol." Her e-mail listed the sample numbers for the five urine samples and directed that they be rescreened for clenbuterol and then tested for confirmation. The 2012 urine samples were rescreened for clenbuterol in 2015, and, as Ms. Wilding testified, the results were in "good agreement" with the screening results from 2012. This indicated that the presence of clenbuterol remained relatively stable over that period of time. Although the laboratory supervisors knew the trainer associated with the samples, as Ms. Wilding and Mr. Russell testified, samples tested in the laboratory do not contain identification of the horse or trainer and are only marked with a "LIMS" number internal to the lab. The technicians who actually performed these tests were not informed of the name of the horse or trainer involved. Clenbuterol was confirmed in the urine in the 2015 tests in each of the five samples from Ziadie I, ranging in concentration from 1.8 nanograms per milliliter to 1.3 nanograms per milliliter. The samples were also split, and an independent laboratory confirmed the presence of clenbuterol in each urine sample. There was no significant degradation of the urine samples over the three-year period. The results were scientifically sound. In early May 2015, again at the Division's request, the laboratory began confirmation testing for clenbuterol in urine samples from the Ziadie II races. These urine samples were not rescreened because, as Ms. Wilding had earlier determined from the Ziadie I urine samples, the stability of clenbuterol in urine stored in a minus 30-degree freezer for several years was "excellent." The senior staff members were again likely told about the identity of the trainer. Again, samples tested in the laboratory do not contain identification of the horse or trainer and are only marked with a "LIMS" number internal to the lab. The technicians who actually performed the confirmation testing were not informed of the name of the horse or trainer involved. The samples confirmed positive for clenbuterol at concentrations, in picograms per milliliter, of 973, 551, 390, 212, 718, 450, 236, 740, 698, 225, 435, 197, and 435, all amounts with a measurement of uncertainty at plus or minus 30 picograms. Again, these results were scientifically sound. The serum specimens were routinely collected without the owners' representatives witnessing the sealing of the specimens and were not collected pursuant to the requirements of chapter 61D-6. The systematic and regular violation of this important requirement constituted a significant procedural error that affected the fairness of the blood sampling procedure. Subsection 4.6 of the Manual is an unadopted rule. The only evidence of the presence of phenylbutazone in any of Mr. Ziadie's horses was from serum obtained pursuant to the unadopted procedures of subsection 4.6 of the Manual and in a manner contrary to the Division's own rule. The Division failed to prove that Mr. Ziadie's horses carried a prohibited level of phenylbutazone in their bodies on race day. The urine test results proved that Mr. Ziadie's horses in these consolidated cases had clenbuterol in their bodies on race day. Mr. Lawson testified that as a licensed horse owner in the United States, South Africa, and Jamaica, he has had an opportunity to observe the different ways that trainers care for their thoroughbred horses. He testified that Mr. Ziadie's stalls were always clean, the handling of the feed was always done in a very systemized and structured way, and the best feed available was used, even though it had to be imported and was much more expensive. He testified that Mr. Ziadie's horses were always well groomed, they always looked very healthy, their coats were very shiny, their feet were carefully inspected, and they were happy horses. He testified that Mr. Ziadie looked after the specific needs of each horse, rather than treating them all the same, and spent a lot of time personally inspecting them. He noted that Mr. Ziadie didn't race his horses as often as other trainers. Mr. Lawson's testimony was bolstered by the stipulated testimony of Dr. Al Smollen, a veterinarian for the tracks, and the testimony about the excellent condition of Mr. Ziadie's horses, the cleanliness of their surroundings, the quality of the feed, and the care given to the horses is credited. The Division presented clear evidence that Mr. Ziadie has had 14 prior violations of section 550.2415, Florida Statutes. The Division case number, date of offense, name of restricted drug, classification, and disposition are as follows: CASE NUMBER DATE DRUGS CLASS
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Department of Business and Professional Regulation, Division of Pari-Mutuel Wagering, enter a final order finding Mr. Kirk M. Ziadie guilty of 18 counts of violating section 550.2415(1)(a), Florida Statutes, and Florida Administrative Code Rule 61D-6.002(1); imposing an administrative fine of $18,000; and suspending his license for six years. DONE AND ENTERED this 15th day of December, 2015, in Tallahassee, Leon County, Florida. S F. SCOTT BOYD 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 15th day of December, 2015.
The Issue The issue presented in this case is whether Respondent should be subjected to discipline for the violations of Chapter 458, Florida Statutes, alleged in the Administrative Complaint issued by Petitioner on August 17, 1999.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Section 20.43, Florida Statutes, Chapter 455, Florida Statutes, and Chapter 458, Florida Statutes. Pursuant to the provisions of Section 20.43, Florida Statutes, Petitioner has contracted with the Agency for Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards. Respondent is a licensed physician in the State of Florida, having been issued license number ME 0063067. Respondent is board-certified in internal medicine. On March 10, 1995, Patient C.C., a 68-year-old woman with a history of cigarette smoking first presented to Respondent as a new patient with a complaint of nocturia (frequent urination at night). Patient C.C. completed a medical history form for Respondent indicating her past medical history and any medical complaints that she had at that time. Patient C.C.'s history was negative, with the exception of treatment for a skin disorder and arthritis of the fingers. Patient C.C. reported no history of cardiorespiratory problems and had no complaints of cardiorespiratory problems. Patient C.C. had undergone laboratory testing on March 8, 1995, that revealed an elevated glucose level of 167. While the blood glucose level was elevated, Patient C.C. did not meet the specific diagnosis criteria, as it existed in 1995, to be diagnosed as a diabetic. Respondent conducted a physical examination of Patient C.C., noting his findings in Patient C.C.'s chart. Due to the elevated glucose level, Respondent directed Patient C.C. to begin a 1500 calorie diet and follow an exercise regimen. Respondent advised Patient C.C. of his evaluation, assessment, and proposed plan of treatment. While in his care, Respondent regularly ordered laboratory testing to monitor Patient C.C.'s glucose levels. A report dated May 13, 1995, revealed that Patient C.C.'s glucose level had decreased to 136. A report dated September 7, 1995, revealed Patient C.C.'s glucose level to be 128. Laboratory testing performed at Community Hospital of New Port Richey on October 17 and 18, 1995, revealed glucose levels of 135 and 133, respectively. Upon receipt of the laboratory findings and pertinent diagnostic testing, Respondent advised Patient C.C. of the results, discussed his recommended course of treatment, and noted the discussion in her medical record. On October 16, 1995, Patient C.C. presented to Respondent suffering from uncontrolled hypertension, anxiety, stress, and non-specific chest discomfort. Respondent immediately admitted Patient C.C. into Community Hospital of New Port Richey. Patient C.C. underwent a chest X-ray during her hospitalization. The X-ray revealed a right upper lobe consolidation and the radiologist's report urged follow-up. Respondent received the radiologist's report and discussed the findings with Patient C.C. On October 24, 1995, Respondent advised Patient C.C. by certified letter that he would no longer provide medical care for Patient C.C., that her condition required medical attention, and that she should seek the care of another physician without delay. Patient C.C. received the certified letter on October 27, 1995. Respondent never had the opportunity to provide follow-up or additional care to Patent C.C. as related to the abnormal chest X-ray or elevated glucose level. The evidence at the hearing established that the care provided to Patient C.C. by Respondent was within the standard of care. The evidence at hearing also established that the Respondent's medical records for Patient C.C. documented and justified the course and scope of his treatment of Patient C.C. Respondent's expert testified that the standard of care did not require Respondent to obtain a chest X-ray when he initially saw Patient C.C. in March 1995. Petitioner's expert offered no testimony and presented no evidence on this issue. Practice guidelines did not require and, in fact, recommended against obtaining routine chest X-rays to screen for lung cancer, even for patients at risk, such as smokers. Respondent and the Respondent's expert, Dr. Corral, both testified that Patient C.C. was not a diabetic, and therefore, did not require treatment for a condition from which she did not suffer. Petitioner's expert, Dr. Benson, testified that Patient C.C. was a diabetic and required definitive treatment for that specific condition. Dr. Benson's testimony is less credible on this issue, and the testimony of Respondent and Dr. Corral is found to be more persuasive and credible. Patient C.C. did not meet the 1995 criteria to be diagnosed as a diabetic. The clear and unambiguous criteria required elevation of plasma glucose greater than 200 mg/dl, or a feasting plasma glucose greater than 140 mg/dl on two consecutive occasions. Patient C.C. never met the criteria. Respondent adhered to the standard of care in diagnosing, evaluating, monitoring, and treating Patient C.C.'s elevated glucose levels. In summary, Petitioner failed to establish by clear and convincing evidence that Respondent failed to meet the standard of care with regard to his alleged failure to (1) perform a complete history and physical examination on a new patient with significant risk factors for cardiopulmonary disease; (2) to order a chest X-ray as part of a work-up on a new elderly patient with a long history of smoking; (3) follow up on the patient's abnormal chest X-ray; and (4) follow up with the patient's test results that revealed an elevated glucose level. Additionally, Petitioner failed to establish by clear and convincing evidence that Respondent did not keep written medical records justifying the course of treatment of the patient by failing to document a plan or evaluation for the course of treatment of Patient C.C.'s abnormal chest X-ray and elevated plasma glucose level.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Health, Board of Medicine, enter a final order dismissing the August 17, 1999, Administrative Complaint against Respondent, Rajesh Bhagvatipras Dave, M.D. DONE AND ENTERED this 6th day of March, 2001, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 6th day of March, 2001. COPIES FURNISHED: Christopher J. Schulte, Esquire Burton, Schulte, Weekley, Hoeler, Poe & Robbins, P.A. 100 West Kennedy Boulevard Suite 800 Tampa, Florida 33602 Eric Scott, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Tanya Williams, Executive Director Board of Medicine 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 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether Respondent, Catherine Marie Lynch, M.D., should be disciplined on charges alleged in the Amended Administrative Complaint filed by Petitioner, the Department of Health (DOH), in DOH Case No. 98-14411. Essentially, the charges are that Respondent practiced obstetrical medicine below acceptable standards on November 9, 1997, by not decreasing or discontinuing a patient's Pitocin and by delaying performance of a Cesarean section notwithstanding fetal heart rate (FHR) decelerations requiring contrary action.
Findings Of Fact Respondent, Catherine Marie Lynch, is and was at all times material to the allegations in the Amended Administrative Complaint, a licensed physician in the State of Florida, having been issued License No. ME 0061336. Respondent received a Bachelor of Science degree in science and biology from Georgetown University in Washington, D.C., in 1986. She received her Doctor of Medicine degree from the University of South Florida (USF) College of Medicine in Tampa, Florida, in 1990. She completed a standard residency program in obstetrics and gynecology through the USF College of Medicine in 1994. Dr. Lynch currently holds hospital appointments at Tampa General Hospital (Tampa General), H. Lee Moffitt Cancer Center, Bay Pines Veterans Administration Hospital, and Town 'N' Country Hospital, all in Tampa, Florida. After her formal education, Dr. Lynch joined the faculty of the USF College of Medicine in July of 1994 as an instructor. She was promoted to Assistant Professor of Medicine in July of 1995 and was appointed Director of the Division of General Obstetrics and Gynecology of the USF College of Medicine in 1997. Since 1994, Dr. Lynch has been involved in the education of medical students and resident physicians, teaching both general obstetrics and gynecology, as well as urogynecology, incontinence, and pelvic reconstruction. She is responsible for oversight of the attending physicians within the Division of General Obstetrics and Gynecology, for operating room assignments and labor and delivery assignments, and coverage for these physicians. She also is responsible for the development of the schedule for resident physicians. These attending physicians and resident physicians provide care and treatment to patients at Tampa General Hospital, other hospitals, and obstetrics clinics. Respondent is Board-certified in obstetrics and gynecology by the American Board of Obstetrics and Gynecology, having first become Board-certified in November 1996. She is a Fellow of the American College of Obstetrics and Gynecology. Staffing at Tampa General During November of 1997, there were approximately 24 residents in the obstetrics and gynecology (OB/GYN) residency program at the USF College of Medicine. There were six residents per year of matriculation. During a regular work week in November of 1997, 21 of the 24 residents would cover a variety of services on the labor and delivery floor and throughout Tampa General. The other three would be at other locations, such as Genesis, a clinic, or the Moffitt Cancer Center. But November 9, 1997, the date in question in this case, was a Sunday. On weekends (and nights), "full services" were consolidated under the "on-call team." This team consisted of a first-year resident, a second-year resident, a third-year resident, a fourth-year resident, and one attending physician. The "on-call" team would cover all of the services provided at Tampa General, including not only labor and delivery but also antepartum, admissions to regular hospital floor, the postpartum ward, the gynecology ward, the gynecology-oncology ward, the emergency room, and emergency surgeries (such as ectopic pregnancy surgeries.) The "on-call" team's first-year resident is primarily responsible for the triage (initial evaluation) of patients who presented to labor and delivery for evaluation as to whether such patients needed to be admitted to the hospital or could return to their residence. In addition, the first-year resident is primarily responsible for the "laboring" patients on labor and delivery under the supervision of the third-year resident. The "on-call" team's second-year resident responds to calls or questions on any of the wards for obstetrical or gynecological problems or complaints other than labor and delivery. The second-year resident also consults with other physicians in the area of obstetrics and gynecology and sees patients in the emergency room. The second-year resident also is responsible for operative interventions, whether gynecological or obstetrical in nature, under the supervision of the fourth-year resident. The "on-call" team's third-year resident is responsible for supervision of the first-year resident in labor and delivery. Its fourth-year resident is responsible for oversight of the other residents. The fourth-year resident also is responsible for any sort of operative intervention, whether it be gynecological or obstetrical in nature. The "on-call" team's attending physician oversees all of the residents. Residents practice as unlicensed doctors-in-training under Section 458.345, Florida Statutes. Florida Administrative Code Rule 64B8-6.005 provides: Resident Physician and Assistant Resident Physician; Duties of. An assistant resident or resident physician participates in an organized graduate education program in which he has daily contact with patients and assumes increasing responsibility for their care under the supervision of the attending staff of the hospital. The assumption of responsibility is a most important aspect of residency training. As each assistant resident or resident physician demonstrates increasing knowledge and ability, an increasing amount of reliance should be placed in his judgment in the diagnosis and in treatment of patients. He may also participate in the teaching of interns and medical students to an increasing extent. In surgery and surgical specialties, the assistant resident and resident physician should be given ample opportunity to perform major surgical procedures under direct supervision of qualified members of the professional staff of the hospital, particularly in the later stages of his training, in order that he may acquire surgical skill and judgment. This rule was in effect in November 1997, and remained in effect at the time of the final hearing. In 1997, the USF OB/GYN residency program utilized both didactic lectures and clinical training to educate medical students and residents. Such training included the assessment of patients in labor, including the interpretation of fetal heart rate (FHR) monitoring strips. Chronology of Events at Tampa General On Sunday, November 9, 1997, Respondent was the "on- call" team's attending physician at Tampa General. The team's first-year resident was Sheila Devanesan, M.D. The second-year resident was Cathy Johnson, M.D. The third-year resident was Scott E. Musinski, M.D. The fourth-year (chief) resident was Kimberly Huffman, M.D. On November 9, 1997, the patient, S.N., then age 40, was two days past her estimated due date of delivery. The gestational age of the fetus was 40 weeks. S.N. had received her prenatal care at the Genesis outpatient clinic of Tampa General and was classified as a low-risk patient. She had delivered vaginally after normal pregnancies in 1978 and 1983. She had no infections or any other medical condition during her pregnancy in 1997 that would have impaired the health of the fetus. S.N. experienced a spontaneous rupture of the membranes of the amniotic sac at approximately 8:00 a.m. on November 9, 1997. She and her husband, Frank Britt, came to Tampa General and arrived at approximately 9:35 a.m. Nursing staff initiated electronic fetal heart monitoring for S.N. by way of the maternal abdomen, along with electronic monitoring of the patient's uterine contractions. At Tampa General, the electronic fetal heart monitor and uterine contraction sensors are attached to several display monitors. One is in the patient's labor and delivery room; others are located in the doctors' lounge, at the nursing station, and in the "well" on the labor and delivery floor. The display monitors only depict current events. The history of the FHR and the patient's contractions while on labor and delivery are recorded on a paper strip located only in the patient's room. The first "on-call" team member to examine and assess S.N. on November 9, 1997, was Sheila Devanesan, M.D., who saw the patient at approximately 9:45 a.m. Dr. Devanesan performed a cervical examination, which indicated that S.N.'s cervix was dilated to five centimeters. Dr. Devanesan also noted the presence of light meconium (fetal fecal matter) in the amniotic fluid. The volume of meconium was not felt to present a problem for the fetus. In the course of her initial examination and assessment, Dr. Devanesan also noted the presence of variable fetal heart decelerations but characterized the fetal heart rate (FHR) as "reassuring" at that time. Fetal heart decelerations denote a decline in fetal heart beats-per-minute (bpm) to a rate below the FHR "baseline." The baseline is an average of the beat-to-beat variations in the FHR when the FHR is neither accelerating nor decelerating. The baseline can vary from fetus to fetus and also can vary during the course of any one patient's labor. Generally, the baseline heart rate of a fetus will be between 120 and 160 bpm. Fetal heart decelerations are not uncommon during labor and delivery, and are not necessarily indicative of fetal distress. However, certain categories of fetal heart decelerations are of more concern to the clinician than others. In this case, "variable" fetal heart decelerations were found virtually from the time electronic fetal heart monitoring was initiated at 9:35 a.m. Variable decelerations can indicate a compressed umbilical cord, which in turn can require intervention by the obstetrician, or even a change in the plan of delivery (from a vaginal delivery to delivery by Cesarean section). Repeated variable decelerations can deplete fetal oxygen reserves and lead to complications, including metabolic acidosis. At approximately 10:00 a.m. on November 9, 1997, Dr. Musinski performed a sonogram in an attempt to determine the cause of the variable decelerations. Based on the sonogram, he diagnosed oligohydramnios, or deficient amniotic fluid. Compression of the umbilical cord is a complication of oligohydramnios. With help from Dr. Musinski, Dr. Devanesan placed a fetal scalp electrode to more precisely monitor fetal heart rate at approximately 10:12 a.m. Dr. Devanesan also ordered amnioinfusion (infusion of fluid into the amniotic sac) in the amount of 500 cubic centimeters (cc's), at approximately 10:19 a.m. Amnioinfusion is an appropriate intervention to treat possible cord compression from oligohydramnios. Respondent came to S.N.'s bedside at 10:34 a.m. and reviewed the FHR tracing strip recorded by electronic fetal heart monitoring. Generally, it was Respondent's practice to review the strip retroactively 30-45 minutes whenever she was at bedside in labor and delivery. Appropriately, Respondent did nothing to change the care being provided to the patient by the residents at that point. At 11:00 a.m., it was decided to give the patient an epidural for pain. An epidural is the infusion of pain medication through a catheter into a location in the patient's spine; it relieves pain without affecting the patient's level of consciousness. To place an epidural catheter, the patient must be repositioned to a sitting position. This repositioning can cause FHR decelerations. The patient's labor record confirms that she was in a sitting position for placement of the epidural at 11:00 a.m. The patient's record indicates that a test dose was administered through the epidural at 11:10 a.m. Dr. Devanesan performed another cervical examination at 11:36 a.m., and found S.N.'s cervix still dilated to five centimeters. The patient's record indicates that a bolus of Fentanyl was given to the patient by epidural at 11:37 a.m. The administration of Fentanyl through an epidural catheter can cause FHR decelerations. After conferring with Dr. Musinski, Dr. Devanesan gave an order for a second amnioinfusion at 11:40 a.m. due to continued variable decelerations. The second order was for 250 cc's; according to the patient's hospital record, it was the last amnioinfusion ordered for or administered to the patient. Due to S.N.'s lack of progress in labor, Dr. Devanesan gave an order for Pitocin at 11:52 a.m., after conferring with Dr. Musinski, to augment labor by stimulating uterine contractions. Dr. Devanesan's order was for 1 milli- International Unit (mIU), to be increased by 1 mIU every 30 minutes up to 20 mIU's of Pitocin or until adequate contractions began. There is no evidence that Respondent participated in the decision to start Pitocin. Pitocin is a brand name; the generic name for the drug is oxytocin. Pitocin is not used to manage fetal heart decelerations. To the contrary, Pitocin is generally contraindicated where FHR is considered non-reassuring. But one mIU is a miniscule amount, and the progression of 1 mIU every 30 minutes was very conservative. Dr. Devanesan noted on S.N.'s chart that FHR was "overall reassuring" at 11:40 a.m. Respondent reasonably believed that Dr. Devanesan had the education and training to identify nonreassuring, as well as reassuring, FHR patterns. But Dr. Devanesan testified at final hearing that she did not have the competence as a first-year resident to judge when FHR patterns were nonreassuring overall. At approximately 12:03 p.m., after successive, milder fetal heart decelerations that morning, the fetus experienced an abrupt deceleration, from its baseline of approximately 120 bpm to just under 50 bpm. The heart rate did not return to baseline for approximately four minutes. At approximately 12:07 p.m., the notation "U/S" appears on the heart monitor strip. That notation may refer to a second ultrasound examination; however, neither Dr. Devanesan nor Dr. Musinski could recall performing a second ultrasound. At approximately 12:10 p.m., Dr. Devanesan was at S.N.'s bedside. The heart monitor strip bears a nurse's notation at 12:10 p.m., reading "Off by Dr. Devanesan to stop flash light." The monitor in the labor room flashed automatically to call attention to significant FHR decelerations. The screen had activated in response to the 12:03 p.m. deceleration. Dr. Devanesan instructed nursing staff to turn off a flashing screen at that time, since the medical professionals were aware of the patient's recurrent decelerations. Following the 12:03 p.m. deceleration, the FHR decelerated to approximately 50 bpm again at 12:10 p.m., 12:14 p.m., and 12:20 p.m., in tandem with uterine contractions. The 12:10 p.m. deceleration is notable in itself due to its onset, which is less abrupt than the 12:03 p.m., deceleration. The gradual nature of the deceleration is suspicious for possible hypoxia, or lack of oxygen, in the fetus. Fetal heart rate decelerated to 60 bpm at approximately 12:27 p.m., remained at 60 bpm for approximately thirty seconds, and did not return to baseline for approximately three minutes. Fetal heart rate decelerated to 50 bpm at approximately 12:36 p.m., again during a uterine contraction. Also at that time, Pitocin was increased from one mIU to two mIU's. Dr. Devanesan returned to S.N.'s bedside at approximately 12:45 p.m. due to her concern with continued fetal heart decelerations. At the same time, the FHR became irregular, with multiple decelerations over the course of the next eight minutes. Nurses' notes for 12:45 p.m. indicate fetal heart decelerations to "60's-90's for approx. 3-4 [minutes with] slow return to 100's". Dr. Musinski came to S.N.'s bedside at approximately 12:55 p.m., likewise due to concern with fetal heart decelerations. He performed a vaginal (cervical) examination at that time, and found S.N. to be dilated to seven-to-eight centimeters. At 12:58 p.m., Respondent joined Dr. Musinski at S.N.'s bedside, along with Catherine Johnson, M.D., a second-year resident in obstetrics and gynecology. Dr. Musinski did not recall why Respondent came to the labor room. Respondent testified that she observed the fetal heart tracing on one of the remote monitors and made an independent determination to come to S.N.'s bedside. Respondent testified further that she spent approximately ten minutes at S.N.'s bedside; she also testified that she was there until 1:15 or 1:20 p.m. She testified that she instructed Dr. Musinski to perform a cervical examination. Respondent also performed a cervical examination. The cervical examination indicated that S.N.'s cervix remained dilated to seven-to-eight centimeters. Respondent also testified that, while Respondent was at bedside on this occasion, she instructed Dr. Musinski to perform a fetal scalp stimulation. A fetal scalp stimulation (also known as Clark's test) is a simple assessment measure used to learn whether the fetus is acidotic. Essentially, the doctor stimulates the fetal scalp and looks for a FHR acceleration in response. If so, the doctor has some reassurance that the fetus is not acidotic at that time. There is no notation in Dr. Musinski's progress note of 1:03 p.m. to indicate that the fetal scalp stimulation was performed, or what results were obtained if it was performed. There is a notation in Dr. Musinski's 1:03 p.m. note indicating significant variable fetal heart decelerations, with "prolonged recovery" and good beat-to-beat variability. However, Respondent testified that there was a reassuring response to the fetal scalp stimulation performed by Dr. Musinski. During her time at bedside on this occasion, Respondent became aware of the administration of Pitocin. The heart monitor strip in fact indicates that the dosage of Pitocin was increased to three mIU's at 1:01 p.m. Respondent did not think it was necessary to decrease or discontinue Pitocin at that time. While at bedside on this occasion, Respondent reviewed the fetal heart monitor strip. Respondent conceded that there were nonreassuring FHR tracings prior to her arrival at 12:58 p.m. At approximately 1:07 p.m., fetal heart rate decelerated from 150 to 90 bpm, recovered momentarily to 120, and then decelerated to 60, returning to baseline approximately two minutes later. But while Respondent was still at bedside, she saw some improvement and drew the conclusion that FHR still was reassuring overall, notwithstanding the variable decelerations. She left with the instruction that she be notified if FHR patterns deteriorated so that the team could decide what to do next. At approximately 1:25 p.m., the FHR accelerated momentarily to 150 bpm and then declined abruptly to 60, in tandem with a uterine contraction. Robert Yelverton, M.D., Respondent's own expert witness, conceded that fetal heart rate did not return to baseline until almost 1:30 p.m. At approximately 1:38 p.m., fetal heart rate decelerated to approximately 65 bpm, in tandem with a uterine contraction, and did not return to baseline for approximately two minutes. At approximately 1:48 p.m., Dr. Musinski performed another cervical examination; he found S.N.'s cervix dilated to seven centimeters and 70% effaced. The fetus was in minus 1 station (not yet to mid-pelvis). The results of that examination are noted on both the fetal heart monitor strip itself and in Tampa General's nurses' notes. The strip itself indicates that the fetus experienced a heart deceleration to 60 bpm at 1:48 p.m., in tandem with a uterine contraction. At approximately 1:55 p.m., fetal heart rate accelerated momentarily to 150 bpm, then abruptly decelerated to 60, and did not return to baseline until over two minutes later, and then decelerated twice more over the next four minutes. At approximately 2:00 p.m., the dosage of Pitocin was increased to five mIU's. Also at 2:00 p.m., Dr. Musinski came to the patient's bedside and reviewed the fetal heart tracing. Beginning at approximately 2:01 p.m., the fetal heart tracing took on a markedly different appearance. The tracing at that point becomes notably flat in nature, whether at, above, or below baseline. There was no more beat-to-beat variability. A marked lack or absence of beat-to-beat variability can indicate metabolic acidosis, which is of great concern to the clinician, and can dictate an intervention or change in the plan of delivery, and on an emergency basis depending upon circumstances. In instances of metabolic acidosis, the fetus begins to break down fats as well as sugars in order to create energy supply, due to lack of normal intake of oxygen. In the process, lactic and other acids accumulate, resulting in acidosis. Dr. Musinski again reviewed the tracing on the heart monitor strip and examined S.N. at 2:18 p.m. Again, he found S.N.'s cervix dilated to seven centimeters. There was a conflict in the evidence as to what happened next. Dr. Musinski recalled discussing a Cesarean with Respondent at approximately 2:18 p.m. Other evidence tends to support Dr. Musinski's version of events. A written consent form for a Cesarean was signed by Dr. Musinski and the patient's husband and bore the handwritten time of 2:18 p.m. Respondent denied that Respondent discussed a Cesarean with her at 2:18 p.m. She also testified that she never was notified of the loss of baseline variability but saw the tracing on one of the other three monitors at approximately 2:35 p.m., just after finishing a Cesarean on another patient with Drs. Huffman and Devanesan. Respondent testified that, at that point, she sent Dr. Huffman to the patient's labor room and instructed the nursing staff to set up for a fetal scalp pH test sample. Respondent believed that the consent form must have been signed later when circumstances became even more urgent. See Findings 66-67, infra. Otherwise, Respondent would have expected the patient to sign, not just her husband. But Respondent had no cogent explanation as to why the time 2:18 p.m. would have been written on the form. The patient's husband also recalled talking to Respondent about a Cesarean at some point during the afternoon, presumably at or after the time the consent form was signed, and being told that the delivery would be vaginal. But the evidence is not clear as to exactly when the husband spoke to Respondent. Considering all of the evidence on this point, although it may be suspected that Dr. Musinski spoke to Respondent about a Cesarean around 2:18 p.m., the evidence on this point was not clear and convincing, and the Respondent's version of the circumstances leading to her coming to bedside must be accepted. Multiple fetal heart decelerations followed from 2:18 p.m. to 2:37 p.m., bearing an uncertain relationship to uterine contractions during that span of time. In accordance with Dr. Devanesan's order, Pitocin was increased to six mIU's at 2:30 p.m. Dr. Huffman arrived at S.N.'s bedside at 2:37 p.m. She viewed the tracing on the heart monitor strip and performed a cervical examination. Dr. Huffman's examination indicated that S.N.'s cervix was still dilated to seven centimeters. Respondent herself entered S.N.'s room at 2:40 p.m. She intended to proceed with a fetal scalp pH at that point and ordered nursing staff to place S.N. in the lithotomy position for the procedure. The term pH refers to potential of hydrogen, and the value assigned upon clinical laboratory examination determines the extent to which blood is normal, or has excessive alkaline content, or excessive acid. The values given are logarithmic in nature: e.g., a blood pH of 6 is ten times more acidic than a blood pH of 7; and a blood pH of 5 is one hundred times more acidic than a blood pH of 7. Normal blood pH in the fetus is 7.25 to 7.35. A fetal scalp pH test is a means of assessing the health of the fetus in labor. A mixture of arterial and venous blood is taken from the fetal scalp. While somewhat useful, the test only tells the clinician the fetal pH at the point in time when the sample is drawn. The test lacks predictive value concerning the onset of metabolic acidosis. After reviewing the tracing strip, and seeing that baseline had increased to 150 bpm, but with no beat-to-beat variability, Respondent abandoned the fetal scalp pH test, deciding instead to try to complete a vaginal delivery. (This may have been what the patient's husband was recalling when he testified that Respondent told him it would not be a Cesarean but a vaginal delivery.) Respondent performed a cervical examination of S.N. and found S.N.'s cervix to be dilated to nine centimeters. However, she also found that the fetus was in an occiput transverse position, with the fetal head unfavorably situated for a spontaneous vaginal delivery. At hearing, Respondent described her actions at that point as follows: . . . And I hoped that if I could bring it down just a little further, get rid of that last bit of cervix, I could get forceps in and pull the baby out in under five minutes. Q. You demonstrated that the fetal head was turned sideways; is that correct? A. Yes. Q. And that's not the ideal position for use of forceps; is that correct? A. Correct. Q. So what did you decide to do at that point? A. Well, since the baby had come down just with repositioning the mother, obviously her, you know, increasing intra-abdominal pressure, just with the abdominal pressure, with the change, in position of the tubal lithotomy for the scalp pH, when I did the exam I hoped that since she already had two large babies, that if she could give me one good push she could bring the baby down to plus two and it would be a[n] easy-outlet delivery. Respondent asked S.N. to push at approximately 2:45 p.m., in an attempt to deliver the baby vaginally. The baby was not delivered at that point, however. Instead, the baby remained in utero, and prolonged fetal bradycardia (slowing of heart rate) ensued. Fetal heart rate decelerated to 60 bpm, and remained at 60 bpm for approximately three minutes. The heart monitor strip then shows a momentary return to baseline in tandem with a shift of S.N. to left lateral position, following which fetal heart rate decelerated back to 60 bpm, and then decelerated further to 40 bpm, over the next several minutes. Pitocin continued to be administered throughout Respondent's unsuccessful attempt to effect a vaginal delivery. It was not discontinued until 2:51 p.m., and then apparently only due to impending transport of S.N. to the operating room for an emergency Cesarean section. Respondent ordered an emergency Cesarean section at approximately that time, and the Cesarean section was performed at approximately 3:00 p.m. by Dr. Johnson, with Respondent assisting. The baby was delivered by Cesarean section at 3:01 p.m. In the course of the baby's delivery, Respondent found the umbilical cord over the baby's shoulder and down its back. The shoulder over which the cord coursed had been pressing against the maternal pubic bone, causing cord compression. One minute after birth, the baby's Apgar score was zero, equivalent to an absence of any signs of life. The baby was resuscitated following delivery, but there was a conflict in the evidence as to whether and how quickly the baby was initially intubated. Respondent's first iteration of the facts of this case, given in her attorney's correspondence dated August 26, 1998, indicates simply as follows: "Roberto Rivera, M.D., successfully intubated Baby Boy N. and provided ventilation. Jennifer Casetelli, M.D., monitored the heart rate, and the pediatric nurse provided cardiac compressions. At 5 minutes, the Apgar score was 3; 2 for heart rate, and 1 for skin color. At this point, Baby N. was receiving positive pressure ventilation via the endotracheal tube and was transported to the Neonatal Intensive Care Unit (NICU)." Respondent reviewed the August 26, 1998, correspondence before it was dispatched by her attorney, and she authorized its dispatch. At hearing, Respondent told a different story. According to her initial hearing testimony, she personally witnessed a first-year pediatric resident unsuccessfully attempt to intubate the baby, and it took over two minutes for the baby to be intubated. Respondent later answered another question about the intubation as follows: Q. Do you know how many attempts it took before the child was intubated? A. I know there was only one interval in which bagging occurred between attempts. What I observed, and in fact asked the anesthesia individual to go over and help, at which time--by the time the anesthesia resident got there the second-year had the tube in, the clock was reading about 2:10. I think it said 2:15. And it had been over a minute or more that they had been trying to get the tube down. (Vol. II transcript p. 228.) There are no notations in either the mother's chart or the baby's chart to indicate any difficulty of intubation. To the contrary, the notation in the baby's chart reads: "Apgar at 5 minutes was 3 with patient intubated." With the baby delivered at 3:01 p.m., an Apgar score of 3 at five minutes "with patient intubated" would mean that the baby was intubated at 3:06 p.m., if not sooner. Respiratory care notes in the baby's chart in fact indicate that the baby was intubated as of 3:03 p.m. Upon the baby's delivery at 3:01 p.m., the umbilical cord was clamped and cut, and a blood specimen taken from the cord for clinical laboratory analysis. The pertinent laboratory result was a cord blood pH of 7.15, which would signify acidosis. The baby was admitted to the neonatal intensive care unit (NICU) at 3:08 p.m. At 3:15 p.m., the baby suffered cardiorespiratory arrest. A "code" (emergency response) was called at that time in the NICU. The "Code 19 Flow Sheet" indicates that the code ended at 3:30 p.m., with the baby resuscitated at that time. NICU progress notes indicate that the baby's heart rate was steady at 148 bpm at 3:30 p.m. However, a blood sample drawn at 3:24 p.m. for arterial blood gas analysis resulted in a pH of 6.81, which is grossly acidotic. The baby was hospitalized at Tampa General for 25 days. He was treated with phenobarbital for seizures. He was diagnosed with metabolic acidosis on November 9 and 10, 1997. Reports of outpatient visits after discharge indicate developmental delays and a diagnosis of severe static encephalopathy, i.e., permanent brain damage. Medical Expert Evaluation The medical experts who testified in this case had differences of opinion as to the nomenclature as well as the significance of the variable decelerations evidenced by the FHR monitor tracings in this case. They also differed to when it was necessary to reduce or stop Pitocin and when it was necessary to initiate a Cesarean section. Respondent and her witness, Robert W. Yelverton, M.D., would be willing to wait longer than Petitioner's expert, Harold Schulman, M.D. Preliminary excerpts from authoritative literature will help put the subsequent discussion of these differences of opinion in context. The American College of Obstetricians and Gynecologists (ACOG) Technical Bulletin 207, published in July 1995, and still in effect on November 9, 1997, begins by stating: Intrapartum fetal heart rate (FHR) monitoring can help the physician identify and interpret changes in FHR patterns that may be associated with such fetal conditions as hypoxia, umbilical cord compression, tachycardia, and acidosis. The ability to interpret FHR patterns and understand their correlation with the fetus' condition allows the physician to institute management techniques, including maternal oxygenation, amnioinfusion, and tocolytic therapy. * * * Transient and repetitive episodes of hypomema and hypoxia, even at the level of the central nervous system (CNS), are extremely common during normal labor and are generally well tolerated by the fetus. Further, a progressive intrapartum decline in baseline fetal oxygenation and pH is virtually universal; levels of acidemia that would be ominous in an infant or adult are commonly seen in normal newborns. Only when hypoxia and resultant metabolic acidemia reach extreme levels is the fetus at risk for long- term neurologic impairment. For purposes of this bulletin, the following definitions will be used: Hypoxemia: Decreased oxygen content in blood Hypoxia: Decreased level of oxygen in tissue Acidemia: Increased concentration of hydrogen ions in the blood Acidosis: Increased concentration of hydrogen ions in tissue Asphyxia: Hypoxia with metabolic acidosis The bulletin later makes the following pertinent statements about interpretation of FHR patterns: Variable decelerations are the most common decelerations seen in labor and indicate umbilical cord compression; they are generally associated with a favorable outcome. Only when they become persistent, progressively deeper, and longer lasting are they considered nonreassuring. Although progression is more important than absolute parameters, persisting variable decelerations to less than 70 bpm lasting greater than 60 seconds are generally concerning. In addition to prolonged and deep variable decelerations, those with persistently slow return to baseline are also considered nonreassuring, as these reflect hypoxia persistent beyond the relaxation phase of the contraction. The response of the baseline FHR to the variable decelerations and the presence or absence of accelerations are important in formulating a management plan for the patient with significant variable decelerations. When nonreassuring variable decelerations are associated with the development of tachycardia and loss of variability, one begins to see substantial correlation with fetal acidosis. Late decelerations may be secondary to transient fetal hypoxia in response to the decreased placental perfusion associated with uterine contractions. Occasional or intermittent late decelerations are not uncommon during labor. When late decelerations become persistent (ie, present with most contractions), they are considered nonreassuring, regardless of the depth of the deceleration. Later decelerations caused by reflex--those mediated by the CNS [central nervous system]--generally become deeper as the degree of hypoxia becomes more severe. However, as metabolic acidosis develops from tissue hypoxia, late decelerations are believed to be the result of direct myocardial depression, and at this point, the depth of the late deceleration will not indicate the degree of hypoxia. A prolonged deceleration, often incorrectly referred to as bradycardia, is an isolated, abrupt decrease in the FHR to levels below the baseline that lasts at least 60-90 seconds. These changes are always of concern and may be caused by virtually any mechanism that can lead to fetal hypoxia. The severity of the event causing the deceleration is usually reflected in the depth and duration of the deceleration, as well as the degree to which variability is lost during the deceleration. When such a deceleration returns to the baseline, especially with more profound episodes, a transient fetal tachycardia and loss of variability may occur while the fetus is recovering from hypoxia. The degree to which such decelerations are nonreassuring depends on their depth and duration, loss of variability, response of the fetus during the recovery period, and, most importantly, the frequency and progression of recurrence. (Footnotes omitted.) The bulletin goes on to discuss evaluation and management of nonreassuring patterns: With a persistently nonreassuring FHR pattern in labor, the clinician should approach the evaluation and management in a four-step plan as follows: When possible, determine the etiology of the pattern. Attempt to correct the pattern by specifically correcting the primary problem or by instituting general measure aimed at improving fetal oxygenation and placental perfusion. If attempts to correct the pattern are not successful, fetal scalp blood pH assessment may be considered. Determine whether operative intervention is warranted and, if so, how urgently it is needed. The search for the cause of the nonreassuring FHR pattern should be directed by the clinician's interpretation of the pattern. . . . For severe variable or prolonged decelerations, a pelvic examination should be performed immediately to rule out umbilical cord prolapse or rapid descent of the fetal head. If no causes of such decelerations are found, one can usually conclude that umbilical cord compression is responsible. General measures that may improve fetal oxygenation and placental perfusion include administering maternal oxygen by a tight- fitting mask, ensuring that the woman is in the lateral recumbent position, discontinuing oxytocin, and, if maternal intravascular volume status is in question, beginning intravenous hydration. After discussing administration of oxygen to the mother, which was done in this case, the bulletin goes on to make the following pertinent observations about maternal position, epidural block, oxytocin, and amnioinfusion: Maternal Position Maternal position during labor can affect uterine blood flow and placental perfusion. In the supine position, there is an exaggeration of the lumbar lordotic curvature of the maternal spine facilitating compression of the vena cava and aortoiliac vessels by the gravid uterus. This results in decreased return of blood to the maternal heart leading directly to a fall in cardiac output, blood pressure, and uterine blood flow. In the supine position, aortic compression by the uterus may result in an increase in the incidence of late decelerations and a decrease in fetal scalp pH. The lateral recumbent position (either side) is best for maximizing cardiac output and uterine blood flow and is often associated with improvement in the FHR pattern. Other maternal positions may accomplish similar uterine displacement. Epidural Block Some degree of maternal hypotension is a relatively common complication of epidural block, occurring in 5-25% of procedures. . . . During the period of hypotension, uteroplacental perfusion may be compromised. This may be manifested by fetal tachycardia, prolonged decelerations, decreased beat-to- beat variability, late decelerations, or some combination of these. The frequency of prolonged decelerations after administration of epidural analgesia has been reported to be 7.9-12.5%. Uterine hypertonia with resultant prolonged decelerations has been observed in patients receiving epidural block during labor even in the absence of systemic hypotension. Management of epidural-associated decelerations should focus on treatment of the specific cause--either the increased uterine tone or maternal hypotension. Oxytocin Careful use of oxytocin is necessary to minimize uterine hyperstimulation and potential maternal and fetal morbidity. If nonreassuring FHR changes occur in patients receiving oxytocin, the infusion should be decreased or discontinued. Restarting the infusion at a lower rate or increasing it in smaller increments may be better tolerated. Amnioinfusion Variable decelerations are frequently encountered in both the first and second stages of labor. Those occurring prior to fetal descent at 8-9 cm of dilatation are most frequently seen in patients with oligohydramnios. In patients with decreased amniotic fluid volume in either preterm or term pregnancies, replacement of amniotic fluid with normal saline infused through a transcervical intrauterine pressure catheter has been reported to decrease both the frequency and severity of variable decelerations. Replacement of amniotic fluid may be elected therapeutically in patients with progressive variable decelerations. Although randomized, controlled trials are lacking, it is reasonable to replace amniotic fluid prophylactically at the onset of labor in patients with known oligohydramnios. Studies also have demonstrated that amnioinfusion results in reductions in rates of cesarean delivery for "fetal distress," primarily due to variable decelerations, and fewer low Apgar scores at birth. Acute saline amnioinfusion has been reported to be an effective therapy that relieves most repetitive variable or prolonged intrapartum decelerations and is without apparent maternal or fetal risk. Investigators have also reported a decrease in newborn respiratory complications from meconium in patients who receive amnioinfusion. This results presumably from the dilutional effect of amnioinfusion and possibly from prevention of in utero fetal gasping that may occur during episodes of hypoxia caused by umbilical cord compression. (Footnotes omitted.) Finally, the bulletin discusses management of persistent nonreassuring FHR patterns as follows: If the FHR pattern remains uncorrected, the decision to intervene depends on the clinician's assessment of the likelihood of severe hypoxia and the possibility of metabolic acidosis, as well as the estimated time to spontaneous delivery. For the fetus with persistent nonreassuring decelerations, normal FHR variability and the absence of tachycardia generally indicate the lack of acidosis. However, variability is difficult to quantify except in the extremes. Persistent late decelerations or severe variable decelerations associated with the absence of variability are always nonreassuring and generally require prompt intervention unless they spontaneously resolve or can be corrected rapidly with immediate conservative measures (i.e., oxygen, hydration, or maternal repositioning). The absence of variability or markedly decreased variability demonstrated on an external monitor is generally reliable. The presence of FHR variability is not confirmatory, however, and, in the presence of nonreassuring decelerations, a fetal electrode should be placed when possible. The presence of spontaneous accelerations of greater than 15 bpm lasting at least 15 seconds virtually always ensures the absence of fetal acidosis. Fetal scalp stimulation or vibroacoustic stimulation can be used to induce accelerations; these also indicate the absence of acidosis. Conversely, there is about a 50% chance of acidosis in the fetus who fails to respond to stimulation in the presence of an otherwise nonreassuring pattern. In these fetuses, assessment of scalp blood pH, if available, may be used to clarify the acid-base status. This technique, while occasionally helpful, is used uncommonly in current obstetric practice. If the FHR pattern remains worrisome, either induced accelerations or repeat assessment of scalp blood pH is required every 20-30 minutes for continued reassurance. In cases in which the FHR patterns are persistently nonreassuring and acidosis is present or cannot be ruled out, the fetus should be promptly delivered by the most expeditious route, whether abdominal or vaginal. (Footnotes omitted.) Another publication accepted by the experts as authoritative was an article by Drs. Low and Victory called "Predictive Value of Electronic Fetal Monitoring for Intrapartum Fetal Asphyxia with Metabolic Acidosis" published in Obstetrics and Gynecology, February 1999 (the Low article). The Low article reported the results of a matched case-control study of 71 births with and 71 births without asphyxia. The Low article's discussion of the results of the study stated in part: The unnecessary intervention reported in previous randomized clinical trials is understandable in view of the results of this study. Interpretation of FHR records is complicated by false-positive FHR patterns. Because predictive FHR patterns are not specific and fetal asphyxial exposure is an infrequent event, the positive predictive values of these findings were low, ranging from 18% for the most specific pattern to 2.6% when all predictive patterns were included. Because of the large number of false-positive patterns, the potential for unnecessary clinical intervention is great. This study demonstrates that the prediction of fetal asphyxial exposure by FHR patterns is possible, but difficult. There is a narrow window of 1 hour before diagnosis when FHR patterns will predict a pronounced metabolic acidosis. If the goal is to predict fetal asphyxial exposure before decompensation, one cannot wait for evidence of absent baseline variability. At this stage, the asphyxial exposure is moderate or severe, with substantial newborn morbidity. Asphyxial exposure must be considered if two or more cycles of minimal baseline variability and late or prolonged decelerations are observed in the record. Even these criteria will not identify all cases of asphyxial exposure. In the asphyxia group, ten infants had a single cycle of minimal baseline variability or late or prolonged decelerations, and four had no predictive FHR variables. The asphyxial exposure was mild in these latter cases. * * * During labor and delivery, fetal asphyxial exposure occurs in 2% and moderate and severe exposure in less than 0.3% of pregnancies. The goal of intrapartum fetal surveillance is to reduce the incidence of asphyxial exposure and to prevent moderate and severe asphyxial exposure. Electronic fetal monitoring with the identification of predictive FHR patterns can be a useful screening test in intrapartum surveillance for fetal asphyxia. The identification of predictive FHR patterns requires continuous scoring of FHR records because of the narrow 1-hour window of these patterns with developing metabolic acidosis. Predictive FHR patterns require supplementary tests such as fetal blood gas and acid-base assessment to confirm the diagnosis of fetal asphyxia and to identify the false-positive results to avoid unnecessary intervention. The Low article defined "prolonged" decelerations as decelerations lasting from 120 to 300 seconds. "Cycles" consisted of ten-minute increments of time during the last four hours of labor. Dr. Shulman defined a deceleration as a 15-bpm decline in FHR lasting at least 15 seconds. According to Dr. Shulman's definitions, a deceleration from 120 to 90 bpm would be called "mild-to-moderate" if it lasted 45 seconds. A deceleration below 70 bpm would be termed "severe" even if it lasted only 30 seconds, according to Dr. Shulman, as it could result in oxygen deprivation. Dr. Shulman defined a "prolonged" deceleration as one lasting more than 60-90 seconds, measured from onset to return to baseline. Initially, Dr. Yelverton defined a "prolonged" deceleration as a decline of 30 or more bpm lasting 120 or more seconds. Later, he accepted the ACOG Technical Bulletin 207 definition of 60-90 seconds used by Dr. Shulman. However, Dr. Yelverton measures the duration of a deceleration from beginning to end of the nadir plateau. If that measurement does not exceed 60 seconds, Dr. Yelverton would not call the deceleration "prolonged" even if it took considerably longer for the FHR to return to baseline. He would characterize such a deceleration as a "classic variable deceleration with a slow return to baseline." Respondent defined a "prolonged" variable deceleration as one that drops to 70 bpm or less and does not exceed 70 bpm for 90 seconds or more. Dr. Shulman reserved his most serious criticism of Respondent until her visit to bedside at 12:58 p.m. Regardless of differences of opinion as to nomenclature and the seriousness of the early variable decelerations, Dr. Yelverton conceded that, by that point in time, the FHR patterns were becoming nonreassuring. Dr. Schulman believed that it was necessary to stop Pitocin and begin preparations for a Cesarean at that time since repositioning, maternal oxygenation, and amnioinfusion had not stopped the variable decelerations. In his view, there already had been enough variable decelerations of sufficient amplitude and duration. Respondent and Dr. Yelverton disagreed. They thought caution was required but that labor toward a vaginal delivery still could proceed at that point. Respondent and Dr. Yelverton were critical of Dr. Shulman for not correlating the FHR monitoring strip with information other than the uterine contractions being recorded on the strip that could help explain some of the variable decelerations. For example, progress notes and other information in the record indicate various reasons why the patient was being repositioned from time-to-time, either causing or relieving cord compression. Similarly, the administration of epidural medication can affect FHR patterns. But regardless of the reason for variable decelerations, they can have an adverse effect on the fetus, especially if they are severe or prolonged or persistent. With good reason, Dr. Shulman was impressed with the amplitude, duration, and persistence of the variable decelerations regardless of their cause. Dr. Shulman's view of the case reflected an unwillingness to accept much risk of compromise of the fetus as a result of metabolic acidosis. Since metabolic acidosis is difficult to predict, short of loss of baseline variability, Dr. Shulman would be inclined to "bail out" and do a Cesarean after two or three of what he termed "prolonged" or "severe" variable decelerations. Although it could not be determined with certainty, he would be fearful that the FHR patterns signified hypoxia and that, by 12:58 p.m., the cumulative effects could result in metabolic acidosis without much additional warning. Respondent and Dr. Yelverton disagreed. They thought it was appropriate for Respondent to observe the patient until approximately 1:15 p.m., as she did. There was some improvement in the tracing by the time Respondent left the patient's bedside, and both Respondent and Dr. Yelverton thought it was acceptable to proceed further toward vaginal delivery at that point, with an admonition to the residents to watch the tracings closely and notify Respondent if they deteriorated. (It is noted that Dr. Yelverton, at least, also would not have criticized a doctor who opted for a Cesarean at 12:58 p.m.) Notwithstanding the testimony of Dr. Shulman, it is found that a Cesarean was not mandatory at 1:15 p.m. There was some improvement in the strip during Respondent's bedside visit, and the evidence was not sufficient to prove that no reasonably prudent physician would have allowed labor to continue. However, as Respondent acknowledged in her instructions to the residents, the team should have been very concerned about the tracings, should have monitored the tracings and the condition of the fetus closely, and should have been prepared to intervene promptly if not reassured as labor progressed. Dr. Shulman also believed that it was mandatory to cease Pitocin at 12:58 p.m. Respondent and Dr. Yelverton, on the other hand, emphasized the low dosage of Pitocin being administered at the time (3 mIU's). They also noted that the patient's contractions were not very strong, and there was no evidence of uterine hypertonis. They did not see a clear, direct connection between the Pitocin and the FHR. Under these circumstances, it is found that, notwithstanding Dr. Shulman's testimony, it was not mandatory to stop Pitocin by 1:15 p.m. even though Pitocin is relatively contraindicated if the FHR is nonreassuring. However, they should have been prepared to stop Pitocin if not reassured as labor progressed. Although the FHR tracings again became nonreassuring after Respondent left the patient's bedside, Respondent was not notified until sometime after baseline variability was lost at approximately 2 p.m. The reason for the delay is not clear from the evidence but probably was at least in part due to Respondent's being occupied with the care of another patient who required a Cesarean in this general time period. (Reference to the other patient was general; there was no evidence as to specifics at to the time or nature of the other Cesarean.) Respondent and her expert conceded that Pitocin should have been discontinued when the FHR lost baseline variability. Dr. Yelverton also conceded that a Cesarean should have been initiated no more than ten minutes later. However, Respondent's culpability for not discontinuing Pitocin and initiating a Cesarean at that time is complicated by questions as to when Respondent became aware of the loss of baseline variability. See Findings 56-58, supra. Respondent also testified that, when she arrived at bedside at 2:40 p.m., she assumed Pitocin already had been discontinued by the nursing staff in accordance with a hospital protocol for nurses. Respondent testified that she thought there was a protocol requiring the nurses to discontinue Pitocin when a doctor ordered a fetal scalp blood pH. In fact, the protocol cited by Respondent did not address sampling for a fetal scalp blood pH. It does, however, provide for discontinuance of oxytocin immediately "if significant nonreassuring FHR patterns occur, i.e., late or prolonged decelerations, bradycardia." Based on the FHR tracings, it would have been reasonable for Respondent to assume that the nursing staff had discontinued Pitocin by the time Respondent arrived at bedside at 2:40 p.m. Besides the hospital protocol for oxytocin, the dosage of Pitocin still was only 5 mIU's, and the patient's contractions still were not especially strong. At the same time, Respondent was occupied taking other actions on behalf of the patient. See Finding 88, supra. Under these circumstances, it is understandable and excusable that Respondent might not notice the Pitocin and discontinue it. It is not found that her failure to discontinue Pitocin immediately at 2:40 p.m. or during efforts to deliver vaginally constituted a "failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." Even assuming Respondent's version of the circumstances leading to her coming to the patient's bedside at 2:40 p.m., the evidence was clear and convincing that, at that time, she became aware of the tracing strip showing no baseline variability since approximately 2 p.m. Consistent with his belief that Respondent already should have proceeded to a Cesarean, Dr. Shulman believed that it was necessary to do so immediately at 2:40 p.m. Dr. Yelverton also testified that a Cesarean should have been initiated no later than 2:15 p.m. However, he excused Respondent's decisions and actions after her arrival at bedside. As reflected in Dr. Yelverton's testimony, it is difficult to second-guess a doctor's clinical judgment in such circumstances. Respondent examined the patient; judged the patient to be fully effaced and dilated to nine centimeters; and judged the fetus to be at "zero station," i.e., in mid-pelvis. Given the patient's two previous vaginal deliveries, it was Respondent's judgment that a relatively quick, assisted vaginal delivery was possible. If she was right, her decision would have been best for the baby (as well as the patient). However, the baby's head position was not favorable for the hoped-for outcome. Respondent's choice was risky, and failure would compound the distress of the fetus and delay the Cesarean. In hindsight, it is clear that Respondent made the wrong decision in trying for an assisted vaginal delivery instead of proceeding immediately to a Cesarean delivery. But under all of the circumstances, it is not found that Respondent's decision constituted a "failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." It also cannot be found that Respondent's decisions alone resulted in the negative outcome in this case. It appears from the evidence that events occurring after the Cesarean delivery caused further damage to the baby. See Findings 69-74, supra. It appears from the evidence that, absent the unfortunate subsequent events, permanent brain damage may not have resulted.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty. DONE AND ENTERED this 3rd day of July, 2000, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2000. COPIES FURNISHED: Richard Ellis, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Bruce D. Lamb, Esquire Ruden, McCloskey, Smith, Shuster & Russell, P.A. 401 East Jackson Street, Suite 2700 Tampa, Florida 33602-2378 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Respondent violated Subsections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Abdel- Aziz was a licensed physician within the State of Florida. He has been licensed to practice medicine in Florida since 1985. Dr. Abdel-Aziz is board-certified in obstetrics and gynecology. Since 1993, Dr. Abdel-Aziz has been patient D.D.'s obstetrician and gynecologist. In April 2000, when D.D. presented to Brandon Regional Hospital in labor, D.D. was 35 years old and had had three prior pregnancies. In 1993, D.D. has a missed abortion which was treated with suction D & C. D.D.'s second pregnancy in 1995 was at 41 weeks with spontaneous labor, and the baby was delivered with forceps. In 1997, D.D.'s third pregnancy went to term and was a spontaneous labor with spontaneous vaginal delivery. On admission to Brandon Regional Hospital on April 18, 2000, there were no known problems with D.D.'s fetus. D.D. was admitted to labor room 3 and placed on a fetal heart monitor at 15:04 hours. The fetal heart tones at that time were reported as 130 base line with good variability. D.D.'s contractions were reported as two every ten minutes. Dr. Abdel-Aziz ordered Pitocin to be administered to D.D. on April 18, 2000. Pitocin is the synthetic form of oxytocin, a hormone that is produced naturally in the body and is responsible for causing the uterus to contract during labor. At the time of D.D.'s admission, Brandon Regional Hospital had an established protocol for administering Pitocin during labor. Forty-five minutes later, at 15:45, the fetal heart tones were reported to show good variability and normal rate. There were accelerations and no decelerations were noted by D.D.'s nurse. D.D.'s contractions were reported to be irregular every two to six minutes and 30 to 60 seconds in duration. At 19:30 hours on April 18, 2000, D.D. was examined, her cervix was at 3-4 cm dilated, 80 percent effaced, and vertex was at -2/-3 station. Artificial rupture of the membranes was performed at 19:30 hours, and the amniotic fluid was noted in D.D.'s medical records to be clear. At 20:45 hours the Pitocin drip was switched off to allow for the administration of the epidural anesthetic. D.D. received the epidural anesthesia, and the Pitocin drip was restarted at 21:10 hours. D.D. was examined at 21:12 hours, and her cervix was found to be 5 cm dilated and 80 percent effaced with vertex at -2 station. At 22:20 hours, D.D. was again examined. Her cervix was 7 to 8 cm dilated, 100 percent effaced with vertex at 0 station. At 22:24 hours, Dr. Abdel-Aziz was notified about D.D.'s condition, and he gave instructions to the nurse on how to contact him. The hospital records for D.D. show that at 22:50 hours, the Pitocin drip was increased from 6 to 7 mu/min per protocol. The hospital records for D.D. show, according to the monitor clock, that at 22:50 hours there were adequate contractions and good fetal heart tones at baseline with variability. The fetal heart rate baseline was reported at around 150 beats per minute. D.D. was receiving Pitocin at 7 mu/min. Dr. Abdel-Aziz examined D.D. at 22:55 hours. There was no fetal distress evident. D.D.'s cervix was fully dilated, 100 percent effaced, vertex at +1 station. At that time, D.D. began pushing. Pitocin was being administered as ordered at 7 mu/min. At 22:55 hours Dr. Abdel-Aziz notified the nurse on how to contact him with any problems and informed the nurse that he would remain in the hospital. A non-reassuring fetal heart rate pattern is a pattern which gives one concern about the well-being of the baby. At 23:15 hours, Baby D. had a non-reassuring heart rate. The hospital records for D.D. do not show that the nurse notified Dr. Abdel-Aziz of the problems evident at 23:15 hours. At around midnight on April 18, 2000, D.D. was still pushing and was in the second stage of labor. The fetal heart rates were non-reassuring at this time. A review of the fetal heart monitor strip showed that Baby D. was experiencing late decelerations. A late deceleration is a slowing of the fetal heart rate which comes at the end of a contraction and is repetitive. At midnight D.D.'s contractions and progress were reported by the nurses as good. Although Baby D. was showing non-reassuring heart rate patterns, the fetal heart tones were erroneously reported as assuring. Dr. Abdel-Aziz was not notified of the non-reassuring heart rate which was present at midnight. D.D. was still receiving Pitocin at 7 mu/min at midnight. Shortly thereafter, at 00:15 hours on April 19, 2000, D.D.'s nurse increased D.D.'s Pitocin drip from 7 mu/min to 9 mu/min. Dr. Abdel-Aziz did not order the increased dosage of Pitocin. At 00:30 hours, the Pitocin was increased to 11 mu/min and then at 00:45 hours, increased once more to 13 mu/min. Dr. Abdel-Aziz did not order the increase of Pitocin either at 00:30 hours or 00:45 hours. The increased dosage of Pitocin was done by the nurse attending D.D., without the consulting Dr. Abdel-Aziz. The increases of Pitocin at 00:15, 00:30, and 00:45 hours were unnecessary as D.D. was making adequate progress on the 7 mu/min dosage. At 00:30 hours, Baby D.'s heart rate showed tachycardia, which means that the fetal heart rate exceeded 160 beats per minute. Tachycardia is a non-reassuring heart rate pattern. Tachycardia was evidenced again approximately at 00:35 hours and persisted for another 20 minutes intermittently with late decelerations. At 01:00 hours there was a pattern of late decelerations. At 01:15 and 01:24 hours there were episodes of tachycardia, followed by late decelerations. At 01:31 hours the fetal monitor shorted out for approximately eight minutes and did not pick up the fetal heart rate. Beginning around 01:39 hours, a new fetal heart pattern appeared without either tachycardia or late decelerations. At approximately 01:30 hours, D.D. was exhausted and wanted Dr. Abdel-Aziz to delivery the baby by using forceps. The nurse went to get Dr. Abdel-Aziz to examine D.D. Dr. Abdel- Aziz presented at the D.D.'s bedside at 01:30 hours and examined the patient. The baby's head was not low enough for a forceps delivery. D.D. strongly wanted to have a vaginal delivery and agreed to push for another 30 minutes. Dr. Abdel-Aziz did not review the fetal heart monitor recordings. At 01:55 hours, Dr. Abdel-Aziz again presented at D.D.'s bedside and examined D.D. At that point, Dr. Abdel-Aziz called for delivery by caesarean section. Dr. Abdel-Aziz did not review the fetal heart monitor recordings. D.D. was taken to the operating room. While D.D. was on the operating table, the fetal heart rate dropped from 120 to 80, and Dr. Abdel-Aziz was so advised. Dr. Abdel-Aziz performed a caesarean delivery. When Dr. Abdel-Aziz opened D.D.'s abdomen, he found meconium-stained fluid mixed with blood and suspected there was a uterine rupture. He delivered Baby D. and found the rupture, which he repaired. D.D. experienced a "silent" rupture. No symptoms of a rupture were present during D.D.'s labor. No complaints of abdominal pain were recorded by D.D.'s nurses and none were reported to Dr. Abdel-Aziz. No blood was seen oozing from the vagina at anytime during D.D.'s labor such that a uterine rupture could have been suspected any earlier than when it was noted by Dr. Abdel-Aziz when he performed a cesarean on D.D. No meconium was present at anytime during the labor. On delivery Baby D. had no pulse. After oropharyngeal and nasopharyngeal suctioning were performed, Baby D. was given to a neonatal service representative and was resuscitated. Baby D. was placed on life support. The life support was later discontinued, and Baby D. died. Between the hours of 23:00 on April 18, 2000, and 2:00 on April 19, 2000, no fetal scalp electrode was applied. It was not necessary to apply a fetal scalp electrode because the fetal heart monitor was recording non-reassuring fetal heart rate patterns, which were readily discernable from looking at the monitor's recordings. The standard of care requires that when a physician examines an obstetric patient in labor that the physician review at least the last 30 minutes of the fetal monitoring records. The standard of care of for a reasonably prudent physician who would have examined D.D. at 01:30 hours would have been to attempt intrauterine resuscitation by stopping the contractions, giving oxygen, giving more IV fluids to dilute the pitocin, and changing the position of the mother. If those efforts were unsuccessful, an emergency cesarean section would have been the appropriate course of action.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mohamed I. Abdel-Aziz did not violate Subsection 458.331(1)(m), Florida Statutes, finding that he did violate Subsection 458.331(1)(t), Florida Statutes, placing him on probation for six months, imposing an administrative fine of $7,500 to be paid within 90 days of the issuance of the Final Order, and requiring the completion of six hours of continuing medical education courses in obstetrics and four hours in risk management within one year. DONE AND ENTERED this 2nd day of June, 2003, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 2nd day of June, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Jon M. Pellett, Esquire Barr, Murman, Tonelli, Slother & Sleet, P.A. 201 East Kennedy Boulevard Suite 1700 Tampa, Florida 33602 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
