Findings Of Fact The Petitioner Theresa Didick is a licensed laboratory technologist holding licenses in the specialties of hematology and chemistry. She has a substantial amount of experience as a laboratory technologist with the major emphasis of her work involving performance of all sorts of blood tests and blood chemistry analyses as well as urinalysis tests. She has approximately 15 hours of higher education courses in such fields as biology, psychology and English. She has extensive experience in the operation and maintenance of laboratory equipment. From September, 1968 to September, 1968 the Petitioner worked as a medical technician et Pondville State Hospital in Norfolk, Massachusetts, performing duties involving routine hematology, chemistry and bacteriology in a laboratory. From September, 1969 to July, 1970 she worked as a medical technician at Beth Israel Hospital in Boston, Massachusetts again performing routine hematology and urinalysis testing. Her experience in the medical laboratory field then lapsed until January, 1973 when from that date until September, 1973 she worked at Milford Hospital, Milford, Massachusetts, performing STAT blood and urine tests. Then from September, 1973 to February of 1976, Petitioner worked as a medical-technologist at Massachusetts Hospital School at Canton, Massachusetts. Her duties there consisted of running a small "one-person" lab conducting routine blood tests which included manual blood chemistries, hematology and bacteriology, as well as being responsible for maintaining inventory and ordering lab supplies. From December, 1976 to February, 1977 she worked as a part-time consultant medical-technologist for that same entity, providing technical assistance in updating and preparing the laboratory and the current lab technician for accreditation inspection. From March, 1976 to February, 1984 she worked as a medical technologist at Norwood Hospital and Southwood Community Hospital in Norwood, Massachusetts. Her responsibilities there as a technologist were for all aspects of hematology and chemistry, including maintaining quality control, maintaining instruments and equipment, as well as training students and new employees. Her experience at Massachusetts Hospital School for almost four years did involve delivery of blood to operating rooms, but did not specifically involve "blood banking" such. The Petitioner's experience in immunohematology or "blood banking," which involves the sub-specialty of blood grouping, typing and cross matching of blood, RH typing, the withdrawal of blood from donors and the storage and dispensation of blood and blood derivatives, consists of her duties from January, 1973 to September, 1973 at Milford Hospital in Milford, Massachusetts, and her approximate four years tenure at Massachusetts Hospital School. That last experience is only partially pertinent in that she was responsible insofar as blood banking is concerned, for only dispensing and delivery of blood to operating rooms. Such experience, however, even if all pertinent under the sub- specialty of immunohematology or blood banking does not amount to six years of pertinent experience. Unfortunately neither does the other experience of the Petitioner, involving work in laboratories performing routine blood tests involving blood chemistry, hematology and bacteriology, as well as urinalysis, constitute the practice or performance of blood banking or immunohematology. In short, the Petitioner did not establish that she has six years or more experience in performing all of the different types of tests and other duties involved in blood banking, as opposed to the mere delivery of blood to operating rooms or the mere routine chemistry and hematological blood tests performed in the normal operation of a clinical laboratory. The pertinent experience at Milford Hospital which involved more of the duties of blood banking only amounts to less than a year of such experience. George S. Taylor, Jr. is a biological scientist in the Lab Personnel Licensing Agency of the Department of Health and Rehabilitative Services. He established that it is consistent department policy to require six years experience in the field of immunohematology or blood banking consisting of performance for those six years of the various procedures and processes involving blood banking delineated above. The performance of routine blood chemistry and hematological tests and urinalyses normally performed in clinical laboratories does not constitute experience in the field of immunohematology blood banking for purposes of licensure as a technologist in that sub-specialty by the department.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED: That the petition of Theresa M. Didick for licensure as a laboratory technologist in the sub-specialty of immunohematology be DENIED. DONE and ORDERED this 10th day of May, 1985 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 10th day of May, 1985. COPIES FURNISHED: Ms. Theresa M. Didick 1675 Strasburg Drive Port Charlotte, Florida 33952 Anthony N. DeLuccia, Jr., Esquire David Pingree, Secretary Department of Health and Department of Health and Rehabilitative Services Rehabilitative Services 8800 Cleveland Avenue, S. 1323 Winewood Boulevard Fort Myers, Florida 33907 Tallahassee, Florida 32301
The Issue Whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2000), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes (2003), and Chapters 456 and 458, Florida Statutes (2003). Dr. Dunn was issued license number ME 37819 in 1981 and is board certified in internal medicine and oncology. At all material times to this proceeding, Dr. Dunn was a licensed medical physician in the State of Florida. Prior to this case, Dr. Dunn has never been the subject of disciplinary action regarding his license to practice medicine in Florida. B.P. became Dr. Dunn's patient in 1984, when she was diagnosed with a tumor at the base of her tongue. The tumor was a malignant, large cell lymphoma. Dr. Dunn treated her with radiation and chemotherapy, and the lymphoma disappeared. Dr. Dunn monitored her for seven years, and B.P. did well until 1991, when nodules were discovered on the sides of her neck, underneath her arm, and in her groin area. She was diagnosed with diffuse mixed lymphoma. At the time she was diagnosed with lymphoma, she had asthmatic bronchitis and was under the care of pulmonary physicians. B.P. again received chemotherapy, but the results were not as positive as they were with her earlier bout of lymphoma. She was switched to an oral chemotherapy, which she took until 1993 when she began a remission. Her remission lasted until 1998, when she was diagnosed with lymphoma in her blood and bone marrow. Another course of chemotherapy was begun. However, the chemotherapy did not completely cure the lymphoma, and B.P. had problems with low blood counts and intermittent reappearances of the lymphoma cells in her blood. From 1998 to 2000, B.P. also suffered chronic respiratory problems with asthmatic bronchitis and fibrosis in the lungs. In July 2000, B.P. was diagnosed with proptosis, which meant that her eye was bulging out of the eye socket. The lymphoma had reoccurred, and a mass of lymphoma cells were behind the eye pushing the eyeball forward. Dr. Dunn attempted to treat B.P. with radiation therapy, but B.P. could not complete the radiation therapy because her blood counts were too low, and her bone marrow was malfunctioning. B.P.'s white blood count steadily decreased, and she was not producing red blood cells. On August 17, 2000, Dr. Dunn saw B.P. in his office and ordered a blood transfusion to increase her blood counts. On August 25, 2000, B.P. was hospitalized in Orlando Regional Medical Center (ORMC) for a fever and a low white blood count. She was given antibiotics and blood transfusions. After she was released from the hospital, Dr. Dunn continued to see her in his office to monitor her blood counts. On October 3, 2000, B.P. came to Dr. Dunn's office. She appeared very ill and frail and was confined to a wheelchair. B.P.'s prognosis was very poor. Her breathing was problematic; her bone marrow was overrun with lymphoma; the mass behind her eye was causing the eye to bulge; and she was unable to tolerate either radiation therapy or chemotherapy. There was very little that could be done for B.P.'s condition other than to try measures to keep her comfortable. At the time of the October 3 office visit, B.P.'s blood counts were low. Dr. Dunn ordered a transfusion for B.P. in an attempt to raise her hemoglobin count above ten so that her oxygen-carrying capacity would be optimal. There was little that could be done for the low platelet and white cell counts. The transfusion was to be performed at ORMC, where B.P. had most of her care done. ORMC did not have any beds available so B.P. was sent to Sand Lake Hospital to have the transfusion done on an outpatient basis. When B.P. went to Sand Lake Hospital, an Interdisciplinary Patient Care Flowsheet was completed, indicating that B.P. could communicate pain and that she was not having any pain. Originally it was not anticipated that the transfusion would require an overnight stay. However, because of the hour when the transfusion would be completed, the nurses requested that B.P. be allowed to stay overnight. The transfusion was completed around 1:20 a.m. on October 4, 2000. At approximately 5 a.m., B.P. attempted to go to the bathroom alone and fell. She sustained a bruise to the head approximately five-by-four centimeters in size. There was a reddened area on her left temple and a laceration to the left internal cheek. There were no other external injuries. Ice was applied to B.P.'s head, and her mouth was rinsed with water. At 5:45 a.m., a nurse called Dr. Dunn's answering service to advise of B.P.'s condition and that B.P. had fallen. The evidence does not establish that the answering service called Dr. Dunn at his home. At 8:00 a.m., a nurse called Dr. Dunn's office concerning B.P. Dr. Zehngebot, Dr. Dunn's partner, returned the telephone call. The nurse advised Dr. Zehngebot that B.P. had been found on the floor where she had fallen around 5 a.m. and that B.P. had sustained a quarter-sized bruise to her left forehead. Dr. Zehngebot was told that the patient was not in distress and that she was alert and oriented times three. Dr. Zehngebot ordered a complete blood count (CBC) to determine B.P.'s blood count level. The nurse was told to call Dr. Dunn if the results of the CBC were abnormal. According to Dr. Zehngebot's telephone order, B.P. was to be discharged on that day and was to follow-up with Dr. Dunn in one week. At 8 a.m., another Interdisciplinary Patient Care Flowsheet was completed for B.P. It was noted on the form that B.P. had a purple, quarter-sized bruise on her left forehead and a bruise on her right upper chest area. It was noted that the doctor was aware of these bruises. Based on the timing of the telephone conversation between the nurse and Dr. Zehngebot, the completion of the Interdisciplinary Patient Care Flowsheet and the nurse's notes, it can be inferred that the doctor referenced on the 8 a.m. Interdisciplinary Patient Care Flowsheet as having been advised of the bruises on B.P. was Dr. Zehngebot and not Dr. Dunn. It was also noted on the Interdisciplinary Patient Care Flowsheet completed at 8 a.m. that B.P. was having intermittent headaches. Nothing in the record indicates that either Dr. Zehngebot or Dr. Dunn was ever advised that B.P. was having headaches after her fall. The CBC was done, and the results were abnormal. The white count was 1100 and the platelet count was 6000. The normal platelet count range is from 145,000 to 355,000. A nurse telephoned the results to Dr. Zehngebot at 9:50 a.m. At 10:30 a.m., another call was placed to Dr. Zehngebot to get a response to the lab work which had been performed. A message was left with the doctor's nurse. By 12:30 p.m., the nurse at Sand Lake Hospital had not received a response from either Dr. Zehngebot or Dr. Dunn; thus, another call was placed to Dr. Dunn's office. A message was left with a nurse in Dr. Dunn's office that B.P.'s husband was at the hospital to pick up his wife and that they were still waiting for an answer from the doctor's office. At 2 p.m., Dr. Dunn returned the telephone 12:30 p.m. call from the hospital. He was aware of the laboratory results. Although, the white cell count and the platelet count were similar to what they had been in his office on October 3, the hemoglobin count was up to 10.9; thus, Dr. Dunn felt that the transfusion had accomplished its purpose by raising the hemoglobin count above ten. The nurse gave him a patient status update and advised him that B.P. was alert and oriented times three and that her vital signs were stable. Dr. Dunn was aware at the time of his two o'clock telephone call that B.P. had fallen; however, the record does not clearly establish that Dr. Dunn knew that B.P. had sustained bruises to her head as a result of the fall or that B.P. had headaches after her fall. He did not order a neurological consult nor did he go to the hospital to examine B.P. before he gave the order to discharge B.P. at 2:00 p.m. Normally a physician may not come to the hospital to examine a patient while the patient is at the hospital to receive a transfusion on an out-patient basis. Dr. Dunn did not see B.P. from the time she went to Sand Lake Hospital on October 3, 2000, and the time he discharged her on October 4, 2000. On October 6, 2000, Dr. Dunn received a telephone call from B.P.'s husband, who told Dr. Dunn that B.P. had slipped and fallen on the way to the bathroom and was now having headaches and nausea. Dr. Dunn told the husband to take B.P. to the emergency room at ORMC, called the hospital, and ordered a stat CT scan to be done as soon as B.P. arrived at the hospital. Dr. Dunn went to the hospital to see B.P. B.P. was diagnosed with Traumatic Subdural Hematoma, admitted to ORMC, and referred to a neurosurgeon who, on October 16, 2000, performed an evacuation of the hematoma. B.P. died on October 22, 2000. The Department called Dr. Howard R. Abel as its expert witness. Dr. Abel opined that Dr. Dunn fell below the standard of care because he did not go to the hospital and evaluate B.P., or if Dr. Dunn could not go to the hospital, he did not request a neurological consultation. Dr. Abel's opinion is premised on the assumption that Dr. Dunn was aware that B.P. had sustained head trauma when she fell. Dr. Abel further opined that if Dr. Dunn were not aware that B.P. had suffered a head trauma, Dr. Dunn did not fall below the standard of care by not going to the hospital or ordering a neurological consultation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Philip Herbert Dunn, M.D., did not violate Subsection 458.331(1)(t), Florida Statutes (2000), and dismissing the Administrative Complaint. DONE AND ENTERED this 20th day of April, 2004, in Tallahassee, Leon County, Florida. S 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 20th day of April, 2004. COPIES FURNISHED: Irving Levine, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Post Office Box 2753 Orlando, Florida 32802-2753 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether Respondent raced a horse that was impermissibly medicated in violation of section 550.2415(1)(a), Florida Statutes (2015), and implementing administrative rules1/ as alleged in the Amended Administrative Complaint; 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. At all times material, Ms. Pompay held a pari-mutuel wagering professional individual occupational license, number 1001817-1021, issued by the Division. At all times material, Ms. Pompay was subject to chapter 550 and the implementing rules in Florida Administrative Code Chapter 61D. Under section 550.2415(1)(a), an animal that has been impermissibly medicated or determined to have a prohibited substance present may not be raced. It is a violation of the statute for a person to impermissibly medicate a horse which results in a positive test for such medications based on samples taken immediately after the race. Rule 61D-6.002(1) provides: "[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." Ms. Pompay was the trainer of record for the horse named R Bling Shines who raced at Gulfstream Park on February 20, 2016. R Bling Shines won her race and was then sent to the Division-operated equine detention barn for the taking of urine, blood or other such samples pursuant to rule 61D-6.005. The equine detention barn is the site at each licensed racetrack in Florida where employees of the Division obtain urine and blood samples from racehorses. Ms. Pompay was the trainer of record for the horse named Run Saichi who raced at Gulfstream Park on May 13, 2016. Run Saichi finished second in his race and was then sent to the Division-operated equine detention barn for the taking of urine, blood or other such samples pursuant to rule 61D-6.005. Rule 61D-6.005, entitled "Procedures for Collecting Samples from Racing Animals" was in effect when R Bling Shines and Run Saichi were sent to the equine detention barn for the collection of "urine, blood or other such samples" as authorized by the rule. The term "other such samples," as used in the rule, means hair and saliva. The rule does not refer to the "processing" of whole blood samples into blood serum. The University of Florida Laboratory determined that the post-race blood sample taken from R Bling Shines tested positive for a blood serum overage of the permitted medication "betamethasone." The University of Florida Laboratory determined that the post-race blood sample taken from Run Saichi tested positive for a blood serum overage of the permitted medication "mepivicaine." On February 20, 2016, the Equine Detention Barn Procedures Manual (2010 Manual) was in effect for all equine detention barn facilities. The 2010 Manual was in effect between June 2010 and April 7, 2016. At the time the 2010 Manual became effective, rule 61D-6.005 (2001) was in effect. On November 25, 2015, the Recommended Order issued in Case No. 15-5037 concluded that subsection 4.6 of the 2010 Manual was an unadopted rule of the Division and that pursuant to section 120.57(1)(e)1., Florida Statutes, the Division could not base agency action on blood serum samples obtained pursuant to it. On January 11, 2016, the director of the Division issued a Final Order finding that subsection 4.6 of the 2010 Manual was an unadopted rule of the Division. On December 15, 2015, the Recommended Order issued in consolidated Case Nos. 14-4716 and 15-2326 concluded that subsection 4.6 of the 2010 Manual was an unadopted rule of the Division and that pursuant to section 120.57(1)(e)1. the Division could not base agency action on blood serum samples obtained pursuant to the unadopted rule. On January 11, 2016, the director of the Division issued a Final Order finding that subsection 4.6 of the 2010 Manual was an unadopted rule of the Division. On April 7, 2016, the 2016 Guidelines were distributed to all equine detention barn facilities to become effective as of that date. The 2016 Guidelines superseded and replaced the 2010 Manual. At the time the 2016 Guidelines became effective, rule 61D-6.005 (2015) was in effect. The 2016 Guidelines were in effect on May 13, 2016, when Run Saichi raced at Gulfstream Park. The 2010 Manual prescribed detailed procedures for collecting blood samples from race horses, spinning the blood in the centrifuge to extract the serum, pouring of the serum into the evergreen tube, sealing of the evergreen tube with evidence tape, and mailing of the specimen to the laboratory for testing. The 2010 Manual was applicable to every horse racing facility within the State of Florida. It had been in effect in its then- current form between 2010 and April 2016 and, by its own terms, was mandatory. It provided 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 2010 Manual. It described seven steps in chain-of-custody procedures, three of which are "collecting the specimen, sealing the specimen, and completing the required forms," and described detailed procedures in this "strict sequence of events that must be followed." The 2016 Guidelines do not prescribe the detailed procedures for collecting blood samples from racehorses, spinning the blood in the centrifuge to extract the serum, pouring of the serum into the evergreen tube, sealing of the evergreen tube with evidence tape, freezing the sample and mailing of the specimen to the laboratory for testing. However, since the date the 2016 Guidelines were put into effect, the procedures followed by Division employees in the testing barn for the processing of the whole blood into blood serum, the pouring of the serum into the evergreen tube, the sealing of the tube with evidence tape, the freezing of the sample and the mailing of the specimen to the laboratory have been the same as those prescribed by the 2010 Manual. At the time of the implementation of the 2016 Guidelines, there were no "established procedures pursuant to applicable law and administrative rule" to process whole blood into blood serum other than the procedures set forth in subsection 4.6 of the 2010 Manual. In addition, at the time of the implementation of the 2016 Guidelines, there were no "testing laboratory SOPs" or "protocols" in place for detention barn personnel to follow. According to the laboratory director, the laboratory’s SOPs and protocols do not begin to operate until the moment the samples arrive at the laboratory in Gainesville. The Division published the 2010 Manual under the direction of its deputy director and distributed it to every employee who worked at a detention barn, including the state veterinarian, the chief veterinary assistant, other veterinary assistants, detention barn security guards, and detention barn supervisors. The 2010 Manual was not made available to the general public unless a copy was requested as a public record. The 2010 Manual was an official publication of the Division used at all horse racing facilities in the State of Florida and was last updated on June 25, 2010. During the approximate six-year period that the 2010 Manual was in effect, not one owner’s witness went to the detention barn at the end of the racing day to observe the pouring of blood serum from the blood tubes into the evergreen tube. The Division published the 2016 Guidelines under the direction of its deputy director and distributed it to every employee that worked at a detention barn, including the state veterinarian, the chief veterinary assistant, other veterinary assistants, detention barn security guards, and detention barn supervisors. The 2016 Guidelines were not made available to the general public unless a copy was requested as a public record. Since the 2016 Guidelines took effect, not one owner’s witness has gone to the detention barn at the end of the racing day to observe the pouring of blood serum from the blood tubes into the evergreen tube. The Division uses various forms in connection with blood and urine sampling. The forms catalog the specimens and, if the procedures set forth in the 2010 Manual and the 2016 Guidelines are followed, demonstrate that the horse was in the testing barn at the time the blood and urine samples were taken. The Division’s Form RL 173-3 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 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, appropriately signed, and 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 information about the animal and trainer that was required to be signed by the witness (card) under rule 61D-6.005 (2001) and "may" be signed by the witness under rule 61D-6.005 (2015). In the sampling procedures followed in this case, the blood labels were not affixed to the collection tubes. The blood labels, from which the card portion was "detached," were affixed to the evergreen blood tubes. This was consistent with the governing rule, as well as the 2010 Manual. The evergreen tube is the specimen container for the serum. The sampling procedures followed on February 20, 2016, were in compliance with the procedures set forth in the 2010 Manual. The sampling procedures followed on May 13, 2016, were the same as those followed on February 20, 2016. As stated in subsection 4.4 of the 2010 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" between the time the sample is sealed at the detention barn and the time the sample is received by the University of Florida Laboratory. The same purposes are served by sealing the serum specimen. The procedures prescribed in the 2010 Manual for the collection of whole blood and the processing of the whole blood into serum were followed when the blood samples from the horses trained by Ms. Pompay were taken on February 20, 2016, and May 13, 2016. After the blood was centrifuged, and the serum was poured into the evergreen tube, the serum was sealed with evidence tape, as described in subsection 4.6 of the 2010 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 2010 Manual provided: Serum is poured into applicable (numbered) "evergreen" tubes. Each "evergreen" tube is immediately properly sealed with evidence tape. The opening of the blood tubes, the pouring of the serum from the blood tubes into the evergreen tube, and the sealing of the evergreen tube was witnessed by two Division employees: a chief veterinary assistant or detention barn supervisor who pours the serum from the blood tubes to the evergreen tubes and another employee who observes the process. In the proposed recommended orders referred to in paragraphs 14 and 15 above, a specific finding of fact was made that the 2001 version of rule 61D-6.005 did not make 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 state veterinarian who took the blood sample from R Bling Shines and Run Saichi signed PMW Form 504, a Daily Record of Sample Collection, indicating that this was 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 (under the observation of another detention barn employee). Sometimes, the state veterinarian stays to observe the transfer of the serum to the evergreen specimen container. There is no signature indicating the time the state veterinarian leaves the samples at the detention barn or the time the chief veterinary assistant opens the collection tubes and transfers the serum. In each instance of sampling in this case, 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 fact, since the change in rule 61D-6.005 in June 2015, no owner’s witness has refused to sign the sample tag. In each instance of sampling in this case, the owner's witness signed the card portion of the sample tag (Form RL 172- 03) after the sealing of the urine specimen in its container, but before the whole blood was processed into blood serum, the blood serum was poured into the serum container, and the serum container was sealed. The pouring of the collection tubes into specimen containers 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 authorized witness to remain until the serum specimens were sealed. The sampling procedures set forth in the 2010 Manual and the sampling procedures in use under the 2016 Guidelines are important to the Division, to the trainers, and to the public. These sampling procedures affect the substantive rights of the trainers as they are the "absolute insurer" of the horse’s condition when it races. The centrifuging process, extraction of the serum, and sealing of the serum specimen as described in detail in subsection 4.6 of the 2010 Manual were never discussed at a rule-making hearing. These procedures are not part of rule 61D- 6.005, adopted in 2001, nor are they part of rule 61D-6.005 as amended in 2015. Until it was superseded by the 2016 Guidelines, the 2010 Manual applied to every state-licensed horse racing facility in the State of Florida. It was a policy attributable to the Division. Amendments to rule 61D-6.005, effective June 15, 2015, to eliminate all references to the sealing of the blood serum specimen, left the 2010 Manual provisions establishing policy on extracting and sealing the serum specimen without support in statute or adopted rule. After the amendments to the rule, the provisions of the 2010 Manual requiring extraction and sealing of the serum specimen were generally applicable Division policy that created rights important to a trainer. These provisions constituted an unadopted rule. The established procedures pursuant to applicable law and administrative rule referenced by the 2016 Guidelines, which Division employees are required to follow, are the procedures that were set forth in the 2010 Manual. These procedures for the processing of the whole blood into blood serum, the pouring of the serum into the evergreen tube, the sealing of the tube with evidence tape, the freezing of the sample, and the mailing of the specimen to the laboratory survive as de facto policies of the Division notwithstanding the "repeal" of the 2010 Manual. The de facto Division policy regarding extraction and sealing of serum specimens affect rights important to trainers and has the direct and consistent effect of law. Division employees do not have the discretion not to follow the de facto Division policy regarding extraction and sealing of serum specimens. The de facto Division policy regarding extraction and sealing of serum specimens constitutes an unadopted rule.
Findings Of Fact Valaria Alsina has been licensed as a medical physician in Florida since 1976 and was so licensed at all times here relevant. On August 19, 1980, Elsa Trujillo and her daughter Nancy, age 12, visited the office of Respondent for treatment. This was the initial visit to Respondent by these patients. Patient histories in Exhibit 3 for Elsa show the first entry to be October 7, 1980; however, the language used in this history clearly shows this to be not Elsa's first visit. Respondent's testimony and reports submitted by Respondent to Petitioner, Exhibit 3, reveal initial complaints by this patient to be dizziness, urinary tract infection, vomiting, vaginal discharge, headache, depression, burning sensation while voiding, and dark urine. Respondent did a urinalysis, took blood for testing, did a PAP smear and vaginal irrigation. Other treatment rendered this patient was not disclosed. The skin and blood tests performed constitute the gravamen of the charges here involved. In Exhibit 1 Respondent billed the insurance carrier for Elsa $359.50 for this visit of August 19, 1980. Those blood tests, the necessity for some of which is questioned by Petitioner, are for glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including sodium, potassium, chlorides, and carbon dioxide) total protein, bilirubin, and albumin. The reason the need for these tests is questioned is because they were billed to Prudential Insurance Company as individual tests for each of which Respondent billed from $10.00 to $20.00. These tests are normally performed by medical laboratories in groups, automatically, in which testing machines are programmed to do certain tests on one blood sample introduced into the testing machine. These automatic testing procedures are generically designated "SMA" and are known as SMAC-6, SMAC-16, SMAC-26, etc., with the number denoting the number of tests performed. Those blood tests performed on the Trujillos are all included in the SMAC-22 program for which a laboratory normally charges the doctor $10-$12. Had these tests been charged as SMAC-22, the fact that several were unnecessary would have been accepted because, as a SMAC-22 neither physical nor financial harm resulted to the patient from the unnecessary blood tests conducted. The SMAC-22 could have been performed as cheaply as or cheaper than two manual and individual tests. Since Petitioner's expert witnesses both agreed that some of the tests conducted on this patient were indicated from the symptoms presented, the only fault they found was in Respondent's performing, and charging the patient for, individual and manual blood tests for which there was no medical justification. Nancy Trujillo was seen by Respondent on August 19, 1980. For this visit Respondent billed Prudential Insurance Company $262.50. Clinical data prepared by Respondent for Nancy shows usual childhood diseases, tonsillectomy, adenoid-ectomy, fever, sore throat accompanied by ear pains and swelling, patient complaining of weakness, history of anemia, poor appetite, burning sensation when voiding, dark urine, and a skin rash on right leg. Patient's weight was recorded as 70 pounds, but neither height nor temperature was recorded. In addition to a complete physical examination, a urinalysis, skin culture, and sensitivity test were done, and blood chemistry tests included complete blood count, calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. These blood tests, all of which (except the cbc) are included in a SMAC-22, were billed as having been performed as individual tests at costs ranging from $10.00 to $17.50 each. Treatment prescribed for Nancy consisted of aspirin suppositories. Respondent testified that Nancy was under weight, although her height was not measured, and that she took Nancy's temperature but failed to record it. Jose Trujillo was seen by Respondent on February 4, 1981, as a patient. Clinical data recorded by Respondent on this visit (Exhibit 3) include ". . . history of diverticulitis of colon, states that have diet but feels like some abdominal discomfort accompanied by diarrhea and feels weak. Patient with history of admission in the hospital, admission Palmetto General Hospital. Some lower discomfort abdomen and dark urine." For this visit prudential Insurance Company was billed $340 for complete physical examination (genital exam omitted) complete blood count; urinalysis; blood tests including glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including calcium, potassium, chlorides, and carbon dioxide) total protein, cholesterol, triglycerides, SGOT, SGPT, and alkaline phosphates; urine culture; sensitivity test; and collection and handling. The blood tests were all included in a SMAC- 22 but were billed as individual and manually performed tests with costs ranging from $10.00 to $20.00 each. Petitioner's expert witnesses both testified that some of the tests performed on these three patients were indicated by the symptoms and complaints described. Other tests conducted were not appropriate for the symptoms given. They also agreed that had these tests been conducted and billed as a SMAC-22 they would not consider that that could be a violation of the Medical Practices Act because, even though some of these tests were not medically indicated, they "come with the package" and would not increase the cost to the patient. However, when conducted manually and individually and so billed, the practice of conducting blood tests for which there is no medical justification does not conform to the generally prevailing standards in the medical community. Because of the findings below, it is unnecessary to denote those tests performed on each of the Trujillos for which there was no medical justification. Although billed to Prudential Insurance Company as manually and individually performed, the blood tests on the three patients above-named were conducted as a SMAC-22 and were not performed manually and individually as testified to by Respondent. This determination is based on the following facts, circumstances, and rationalizations: Respondent sent the blood samples from these three patients to Central Medical Laboratory, Inc., for a SMAC-22 test. Respondent testified that she performed each of the series of 10 to 15 tests on the blood samples of these patients in 20 to 30 minutes; however, other medical witnesses testified it took a trained technician 20 minutes to perform one of these blood tests manually. The latter testimony is deemed more credible. Many of these tests have subjective characteristics, such as color comparisons, and identical results from the same blood sample tested by two technicians or run through the same automated process would be rare. The odds against a technician performing individual and manual tests on 16 blood samples and obtaining the identical result on all tests that is obtained from a commercial laboratory SMA test is astronomical. Yet, the one report obtained from Central Medical Laboratory for the SMAC-22 conducted on the blood sample from Jose Trujillo (Exhibit 7) is identical to the "manual and individual" test report maintained by Respondent for the same blood sample in Exhibit 3--with one exception. The laboratory found the triglyceride test to be 254 MG/DL, well outside the 30-175 range for this test. On Exhibit 3 Respondent recorded 175 for this test. She testified she sent blood samples from the three Trujillos to the laboratory to have a check on her tests but did not ask the laboratory to do a recheck on the triglycerides test on Jose or recheck her test for triglycerides after receiving the laboratory report. Only a small amount of blood (5 or 10 cc) is required for an automated procedure for up to 40 different tests, whereas at least three times this amount of serum would be required for 10 tests conducted manually or individually. Accordingly, manual testing would require the drawing of a lot more blood than would be required for automated testing in a commercial lab. Respondent testified that she sent one-half of the blood sample taken on each Trujillo to the laboratory and kept the other one-half to test in her office. Commercial medical laboratories are licensed by the state; are checked for compliance with proper procedures; equipment used is checked for proper calibration at frequent intervals; reagents used in the testing is frequently replaced; and, when compared to the equipment, procedures, calibration, and reagents used in a physician's office which are subject to no regulation, the former should provide the more reliable test in a much shorter time. The equipment in Respondent's office is capable of being used to conduct all of the tests on these three patients for which Respondent billed Prudential Insurance Company. No rational explanation was provided to justify having a SMAC-22 performed and duplicating these tests manually. Respondent's testimony that the SMAC-22 was ordered to check the results of the manual tests she performed is not credible. If a check on the manual tests conducted on blood samples of Nancy and Elsa Trujillo for the August 17, 1980, visit was desired, it would appear appropriate to check the office procedures by doing a SMAC-22 on only one of those blood samples, rather than have both of these samples checked as was done here. Repeating this "check" on the sample taken from Jose Trujillo on February 4, 1981, does not make sense. Either the laboratory test is trusted or it is not. The same applies to the individual tests conducted manually in the office. If confident of the procedures, there would be no reason for Respondent to check the manual tests conducted in the office by sending one-half of the serum to a commercial laboratory. Respondent testified that Central Medical Laboratory picks up blood samples at her office daily. This suggests that some tests are routinely ordered by Respondent and conducted by the laboratory, and no evidence was presented to rebut such a conclusion. On the other hand, Petitioner presented no evidence of the volume of tests conducted by Central Medical Laboratory for Respondent which would solidify this conclusion. Nor did Petitioner submit the SMAC-22 results obtained by Central Medical Laboratory for the blood test conducted on the serum taken from Elsa and Nancy Trujillo on August 17, 1980, to see if they too were identical to the results shown in Exhibit 3. The only rational explanation for having SMAC-22 tests performed in a commercial laboratory and reporting these tests as done individually and manually in Respondent's office is the amount the insurance company will pay for the latter is nearly ten times what they will pay for the former. Laboratory tests billed for Jose Trujillo for the February 4, 1981, visit amount to nearly $250. Charges submitted for these tests reported on the SMAC-22 (Exhibit 7) amount to $187. Respondent testified she paid for the SMAC-22 tests she ordered and did not bill the insurance company for these tests because "they won't pay for both" SMAC and manual tests performed on the same sample. Since the lab charged Respondent only $10-$12 for the SMAC-22 tests conducted, the insurance company would not pay $187 if these tests were charged as automated tests. Considerable evidence was submitted that there was no medical justification for certain of the tests performed on Nancy, Elsa, and Jose Trujillo. For Nancy, these unnecessary tests included tests for calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. For Elsa, these unnecessary tests were calcium, phosphorus, uric acid, total protein, bilirubin, with either BUN or creatinine justified, but not both. For Jose, no medical justification was shown for manually performed tests for glucose, calcium, phosphorus, electrolytes, SGDT and SGNT. In view of the finding above, that these tests were not manually done but were performed as a SMAC-22, the fact that they are not medically justified if done manually becomes immaterial.
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 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.
