The Issue Whether Respondent is unable to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, in violation of section 464.018(1)(j), Florida Statutes (2020); and, if so, the appropriate penalty.
Findings Of Fact Based upon the credibility of witnesses and evidence presented at the final hearing and stipulated facts, the following Findings of Fact are found: 1 Respondent objected to Petitioner’s admission of Exhibit 7, which was a close-captioned television video recording of Respondent and others on July 2, 2020. Respondent argued that Petitioner only offered a portion of the recordings from that day, and, thus, Petitioner should offer the complete video. To address Respondent’s objection, Petitioner was instructed to contact Mr. Anderson to verify whether additional recordings were available for July 2, 2020. However, Mr. Anderson was not available. Given the location of the camera and the area of treatment, the video camera may have captured Respondent leaving the emergency room. After considering the record, however, additional recordings would not have changed the outcome of the undersigned’s findings in this matter. 2 Respondent indicated at hearing that he was offering the reference letter as his sole exhibit. He was permitted to file the exhibit with DOAH after the hearing. Instead, Respondent filed a copy of a certificate of completion for nursing continuing education courses. The reference letter was not filed and, thus, is not a part of the record. Stipulated Facts At all times material to this complaint, Respondent was licensed as a registered nurse within the State of Florida, having been issued license number RN 3349322. Respondent’s address of record is 805 Sunday Road, Chipley, Florida 32428. At all times material to this complaint, Respondent was employed by Doctors Memorial Hospital (DMH), located in Bonifay, Florida. Respondent submitted to a blood alcohol test, which returned positive at a level of 0.2637 g/dl. Facts Related to the Events on July 2, 2020 On July 2, 2020, several colleagues of Respondent observed Respondent’s behavior at work, which raised questions regarding whether Respondent was impaired. Janet Smith, a registered nurse, worked at DMH. She had worked with Respondent for approximately 10 years before July 2, 2020. Ms. Smith arrived to work at 8:00 a.m. She observed Respondent at the emergency room desk from a distance of 10 feet for approximately 10 to 15 minutes. She testified that Respondent’s speech was “different, it was drawn out, and he was talkative, more friendly than usual.” Ms. Smith had more than 30 years of experience working in the emergency room and was familiar with the behavior of persons under the influence of alcohol. Based on her experience, she believed that “[Respondent] appeared drunk.” Concerned about Respondent’s behavior, Ms. Smith shared her concerns with other staff members, including Ashley Hall, Debra Smitty, Rohan Anderson, and Dr. Contini. Dr. Contini and Ms. Smitty were not offered as witnesses at the final hearing. Although Ms. Smith had concerns about Respondent’s behavior on July 2, 2020, she otherwise believed he was a strong nurse. Rohan Anderson also observed Respondent on July 2, 2020, after Debra Smitty shared her concerns about Respondent’s behavior. Mr. Anderson works at DMH as the Chief Operating Officer and Director of Information Technology. Mr. Anderson had also worked with Respondent at another hospital and did not recall any prior impairment issues. Similar to Ms. Smith, Mr. Anderson observed Respondent from a distance of 10 to 15 feet near the emergency room desk. He also noticed that Respondent’s speech was different than usual. Mr. Anderson testified that Respondent was “slurring his words … the way he was controlling the pitch of his voice. And I knew something was going on based on that.” Mr. Anderson then shared his concerns about Respondent’s behavior with Dr. Ulhaq, the emergency room director. Mr. Anderson unequivocally testified that Respondent was known for being a good nurse and was used as an example for training purposes. Loyd Simmons, an advanced registered nurse practitioner, was working in the emergency room on July 2, 2020. At Dr. Ulhaq’s request, Mr. Simmons evaluated Respondent based on the reports of suspected alcohol use. Mr. Simmons noted that Respondent was not acting like his “normal” self and he appeared to be unsteady on his feet. Respondent experienced difficulty with upward gaze. However, he was alert, oriented, with clear speech. Mr. Simmons performed a physical examination of Respondent, where he did not find any bruises or signs of a recent fall. He also conducted a neurological examination with Dr. Ulhaq, which revealed a positive Babinski. A positive Babinski result may be an indicator of a problem in the central nervous system. It may, however, also be related to alcohol use. Mr. Simmons interpreted findings of Respondent’s EKG and CT scan as within normal limits. Mr. Simmons found Respondent’s EKG and CT scan results did not indicate a condition that would affect his blood alcohol level. The hematology results returned normal results. The blood alcohol level test returned a result of 263.7 mg/dc, meaning .263 g/dcl.3 The chemical analyzer machine used to perform the blood alcohol test was working properly, calibrated properly, and the machine properly reported correct blood alcohol test results for Respondent. Based on his findings, Mr. Simmons diagnosed Respondent with alcohol intoxication. There was no evidence deduced from the tests performed that Respondent suffered from liver complications or COVID-19 that would cause his significantly high alcohol level results. Mr. Simmons testified that he had no prior personal knowledge of Respondent being impaired at work. Ms. Hall worked with Respondent on July 2, 2020. She observed Respondent for approximately 30 minutes while working together. She testified that he was more “jolly” than usual on that day and his mannerisms were exaggerated. She then shared her belief with the Director of Nursing that Respondent appeared to be impaired. Ms. Hall was present during Respondent’s evaluation in the emergency room. She assisted with placing an IV catheter to withdraw a blood sample from Respondent. She followed the standard process by cleaning the insertion site with isopropyl alcohol, and allowing the area to dry before inserting the catheter. She withdrew the blood sample and then delivered the sample to the lab drop-off window for testing. She had no further contact with the blood sample. Although Ms. Hall primarily worked a different shift than Respondent, she had never witnessed Respondent exhibiting similar behavior as he exhibited on July 2, 2020. Overall, each witness who worked with Respondent on July 2, 2020, reported that he was not behaving like normal and his behavior was consistent with alcohol impairment. Evaluation on January 14, 2021 Respondent was placed on administrative leave and ultimately, terminated for “being at work while under the influence of alcohol.” He was 3 The legal limit in Florida for intoxication is considered a blood alcohol level of .08 or above. presented with the option to voluntarily report to Intervention Project for Nurses (IPN) in lieu of a complaint filed with the Department, and he agreed to contact IPN. Respondent subsequently elected not to voluntarily participate in IPN because he could not “afford it.” The Department then issued an Order requiring Respondent to undergo an evaluation with Dr. Reeves. Dr. Reeves, a licensed medical doctor in the State of Florida since 1994, has specialized in addiction medicine since 2010. Dr. Reeves is board certified in addiction medicine and a member of several professional organizations for addiction treatment providers. Dr. Reeves serves as the Medical Director for two treatment facilities, South Walton Medical Group and Sacred Heart Hospital of the Emerald Coast. Prior to practicing addiction medicine, he worked as a vascular surgeon. Dr. Reeves has written articles and delivered presentations on the topic of addiction medicine. Dr. Reeves has testified in other legal proceedings within the past 10 years and has never been disqualified as an expert. Dr. Reeves was accepted as an expert on addiction medicine in this matter. Dr. Reeves performed an independent medical examination (IME) of Respondent on January 14, 2021. Dr. Reeves routinely conducts IMEs of health care professionals to determine whether an individual has an issue with addiction or addictive substances, including alcohol. Dr. Reeves follows a process for conducting an IME. He reviews the available records, any medical history, and witness statements. Dr. Reeves then meets with the individual to conduct an in-person evaluation, which includes assessment tests and screening exams. Dr. Reeves testified that he understood that Respondent was referred to him for alleged alcohol intoxication while at work. Dr. Reeves was concerned as alcohol is a depressant and directly affects the judgement and decision-making functions in the brain. Dr. Reeves discussed the events that gave rise to the Department’s complaint and subsequent referral for evaluation. Respondent explained to Dr. Reeves that he began drinking more often while he was quarantined with COVID-19. Respondent told Dr. Reeves that he had increased his drinking from two to three beers a night to three to four beers per night, four to five times per week. Respondent stated that he drank several drinks the night before he returned to work to help him sleep. He did not believe that he drank a lot and was surprised that his test results reflected a significantly elevated alcohol level. He denied being intoxicated at work on July 2, 2020. Respondent completed a questionnaire after he arrived for his evaluation, which Dr. Reeves reviewed with him during the evaluation. Respondent suggested in his questionnaire that perhaps the alcohol level was because he had taken Nyquil4 while driving to work. Respondent later retracted that statement. Regarding assessments, the evaluation included an ethyl glucuronide (ETG) test, which was performed upon Respondent’s arrival to Dr. Reeves office. An ETG test is a urine test that measures the level of ethyl glucuronide in the body. An ETG test would generally yield positive results within two to five days after alcohol is ingested. Respondent’s test was negative. Dr. Reeves testified that the negative test results suggest Respondent had not drank alcohol within the prior three to five days. Dr. Reeves also asked Respondent to undergo a phosphatidylethanol (PEth) test, which tests a blood sample to measure intake of alcohol. The PEth test has a longer timeframe for measurement than the ETG test, as it measures alcohol in the system for up to 14 days after ingestion. To maintain the validity of the test, it must be completed within 48 hours of the request. 4 Dr. Reeves testified that a dose of Nyquil contains approximately the same amount of alcohol as a glass of wine. He estimated that a person would need to consume 10 to 15 doses of Nyquil to achieve a result of .2637 gm/dcl (Respondent’s test results). Respondent did not complete the test within that timeframe. Thus, there were no PEth test results for Dr. Reeves to consider. Dr. Reeves testified that the PEth test was not a necessary factor for diagnosing an alcohol-use disorder, as he had sufficient objective data from his evaluation to make a diagnosis. Expert Opinion Based upon his evaluation, Dr. Reeves diagnosed Respondent with moderate alcohol disorder. Dr. Reeves relied upon the criteria established in the Diagnostic Statistic Manual-5 (DSM-5), which sets out the standard of care for diagnosis of psychiatric disorders. The DSM-5 includes alcohol-use disorder as a psychiatric diagnosis. Dr. Reeves testified that if you meet two or more of 11 alcohol-use disorder criteria used in the DSM-5, the individual meets the criteria for that level of the disorder. Applying objective factors identified during his evaluation of Respondent, Dr. Reeves determined that Respondent met four of the 11 criteria for moderate alcohol-use disorder. Specifically, Dr. Reeves identified the following criteria in making his assessment: Alcohol is often taken in larger amounts or over a longer period than was intended; * * * 5. Recurrent alcohol use resulting in a failure to fulfill major role obligations at work, school, or home; * * * 8. Recurring alcohol use in situations in which it is physically hazardous; and * * * 10. Tolerance is defined by (a) a need for markedly increased amounts of alcohol to achieve intoxication or desired effect, or (b) a markedly diminished effect with continued use of the same amount of alcohol. Dr. Reeves testified that a nursing professional is considered a safety sensitive occupation, which requires good decision-making ability. Since alcohol significantly impairs judgement and decision-making ability, an individual who is impaired by alcohol is not safe to practice as a nurse. Dr. Reeves credibly opined that Respondent is not safe to practice as a nurse due to his diagnosis of moderate alcohol-use disorder. Dr. Reeves’ opinion is accepted. Dr. Reeves recommended a course of intensive outpatient treatment for a specified period of time. Even if Respondent indicated he stopped drinking, without treatment, Dr. Reeves maintains that Respondent is not safe to practice nursing. Based on his review of the records obtained from DMH, Dr. Reeves concluded that Respondent’s records reflected no symptoms to demonstrate that he suffered from a transient ischemic attack (TIA)5 as Respondent suggested. There was no evidence offered at hearing that Respondent harmed patients while he was impaired. Other than his behavior exhibiting impairment, the testimony overwhelmingly supported that he was considered a good nurse. Ultimate Findings of Fact Petitioner presented clear and convincing evidence to demonstrate that Respondent was impaired while at work on July 2, 2020. 5 A TIA is a temporary period of symptoms similar to a stroke. Petitioner presented clear and convincing evidence to demonstrate that Respondent is unable to practice nursing with reasonable skill and safety to patients due to his moderate alcohol-use disorder and alcohol use.
Conclusions For Petitioner: Ellen LeGendre Carlos, Esquire Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 For Respondent: Benjamin Dallas Stoe, pro se 805 Sunday Road Chipley, Florida 32428
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Nursing enter a final order finding: Respondent violated section 464.018(1)(j), Florida Statutes (2020); and suspending Respondent’s registered nursing license, until such time that Respondent enters into IPN and complies with any and all terms and conditions imposed by IPN. DONE AND ENTERED this 26th day of August, 2021, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 2021. COPIES FURNISHED: Ellen LeGendre Carlos, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399 Benjamin Dallas Stoe 805 Sunday Road Chipley, Florida 32428 Joe Baker, Jr., Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399 Deborah McKeen, BS, CD-LPN Board of Nursing Department of Health 4052 Bald Cypress Way, Bin D02 Tallahassee, Florida 32399
The Issue The issue for determination is whether the nursing license of Alice M. Thomas Lofton should be disciplined for violations of Section 464.018(1)(f) and (h), F.S., by reporting to duty under the influence of alcohol.
Findings Of Fact Alice M. Thomas Lofton is now, and was at all times relevant in this proceeding, licensed as a registered nurse in Florida under license number 59769-2. In September 1985, Ms. Lofton was employed as a staff nurse at Tampa General Hospital. On September 15, 1985, she reported for duty smelling of alcohol and unsteady on her feet. Her speech was slow, deliberate and slurred and she was observed to have difficulty in taking a patient's blood pressure. She appeared to be intoxicated. When confronted by her supervisor, Ms. Lofton voluntarily submitted to a blood and urine test. The blood-alcohol test was returned with the result of .14 percent (.141 gm/dl). Ms. Lofton was sent home. She was subsequently given an opportunity to keep her job if she would participate in and follow the recommendations of the employee assistance program at Tampa General Hospital. She agreed to participate but did not comply with the counselor's recommendations, so she was terminated. It is both unprofessional and unsafe for a nurse to practice while under the influence of alcohol. Alice Lofton was a longtime employee of Tampa General Hospital. She had been an assistant head nurse for four and a half years. She admitted that at one time she thought she had a drinking problem and was once admitted to the emergency room under the influence of alcohol. No evidence was presented of other disciplinary actions regarding Ms. Lofton's license or regarding her employment as a registered nurse. No evidence was presented that a patient was harmed or that Ms. Lofton, except for her intoxicated appearance at work, ever failed to conform to minimal standards of acceptable prevailing nursing practice. Ms. Lofton claimed that the incident was the result of a conspiracy against her because she had asked for a transfer when her supervisors really needed her and wanted her to stay. The claim was inherently contradictory and was unsubstantiated.
Recommendation Based on the foregoing, it is hereby, RECOMMENDED that a final order be entered finding Alice M. Thomas Lofton guilty of a violation of Subsections 464.018(1)(f) and (h), F.S., and suspending her license for a period of 30 days and thereafter until she can demonstrate her ability to practice nursing safely. The demonstration should include a physical or psychological examination to determine whether she has an alcoholism problem requiring treatment, and, if so, continued probation is recommended to insure that such treatment is obtained. DONE and RECOMMENDED this 17th day of December 1986, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 17th day of December 1986. COPIES FURNISHED: William M. Furlow, Esquire Senior Attorney Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Alice T. Lofton 2703 Spruce Street Tampa, Florida 38687 Judie Ritter Executive Director Board of Nursing Room 504, 111 East Coastline Drive Jacksonville, Florida 32201 Fred Roche Secretary Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301
The Issue Whether, in evaluating the responses to an Invitation to Bid and in making a preliminary decision to award the subject contract for drug screening services, Respondent acted contrary to a governing statute, rule, policy, or project specification; and, if so, whether such misstep(s) was/were clearly erroneous, arbitrary or capricious, or contrary to competition.
Findings Of Fact At all times relevant to these proceedings, Respondent has been the duly-constituted school board for Miami-Dade County, Florida. Respondent issued the subject ITB to obtain the services of an organization to screen applicants for employment and existing employees for drug use. Screening of employees subject to the Omnibus Transportation Employee Testing Act (OTETA) was included in the subject ITB. The purpose of the subject ITB was stated as follows in paragraph 1 of the section styled “Special Conditions”: The purpose of this bid is to obtain the services of an organization to conduct applicant and employee specimen collection and drug screening services, both to meet the general requirements for collection and drug screening services and the Omnibus Transportation Employee Testing Act (OTETA) requirements for collection and drug screening services. These professional services are described in the Miami-Dade County Public Schools (M-DCPS) Drug-Free Workplace Technical Guide. [1] Petitioner and Mercy timely filed responses to the ITB. Following the bid opening on May 23, 2006, Respondent determined that the bid award should go to Mercy, which was the low bidder. After Mercy, Petitioner was the next low bidder.2 Petitioner thereafter timely filed its notice of intent to file a bid protest, which was followed by a timely filed bid protest. Paragraph 4 of the Special Conditions Section of the ITB (paragraph 4) pertained to technical requirements and provided, in part, as follows: TECHNICAL REQUIREMENTS: The following items, which shall constitute proof of technical competency, are requested to be submitted with the bid, or within three (3) days of request: * * * Copies of the certifications/licenses of all collection site staff and laboratory staff who will be handling specimens in the chain of custody as indicated in Attachment B. A copy of the quality assurance program of the testing laboratories, which must encompass all aspects of the testing process as indicated in Attachment B and Attachment E. List all collection sites, which must include the site address and copy of the certification of each site to be considered for this bid. Number of mobile sites available and proof of compliance and/or certification of mobile sites, if applicable. When it submitted its initial response to the ITB, Mercy did not specifically respond to the items listed in subparagraphs b., c., d., and e. of paragraph 4. On May 24, 2006, Respondent wrote to Mr. Rey, Mercy’s, laboratory director and the person responsible for Mercy’s response to the ITB, requesting copies of documents responsive to subparagraphs b., c., d., and e. of paragraph 4. Mercy thereafter timely supplied the requested information. CERTIFICATION Attachment B to the ITB contained the following pertaining to certification: A laboratory must be certified by the United States Department of Health and Human Services (DHHS). DHHS has established comprehensive standards for laboratory policies, procedures, and personnel, which provide quality assurance and performance testing specific to urine testing. To be certified, a laboratory must be capable of testing for, at a minimum, the following classes of drugs: Alcohol, Marijuana, Cocaine, Opiates, Amphetamines, Barbiturates, Benodiazepines, Methaqualone, and Phencyclidines, as listed in Attachment E. There was a dispute between the parties as to whether Mercy demonstrated it had the requisite certification. That dispute is resolved by finding that Mercy demonstrated that it had the requisite certification to perform all testing other than the OTETA testing.3 Mr. Rey testified, credibly, that Mercy intended to subcontract out the OTETA testing to a laboratory certified to perform such testing. Mercy did not identify the entity that would conduct the OTETA testing, however, there is nothing in the ITB to prohibit such subcontracting and there is nothing in the ITB that would require a bidder to have such a subcontract in place at the time it submitted its response to the ITB. Further, there is no requirement in the ITB that the bidder identify the entity that would serve as the subcontractor for the OTETA testing.4 There was also a dispute as to whether the certifications provided by Mercy would suffice as certification for the contemplated collection sites. The greater weight of the credible evidence resolved that dispute in the affirmative. Mr. Rey testified, credibly, that the collection sites could be operated by Mercy pursuant to its existing certifications. MEDICAL REVIEW OFFICER Attachment B contained the following in paragraph 17 under the heading of “Compliance”: 17. Reporting and Review of Results. (The service of a Medical Review Officer (MRO) is required to review ALL [sic] test results. The MRO may NOT [sic] be an employee of the laboratory. Mercy did not identify the person or organization that would serve as the MRO in the event it was awarded the contract. That omission did not make Mercy’s response to the ITB non- responsive because Paragraph 17 is merely a statement of industry practice. The ITB did not require bidders to identify the person or organization that would serve as the MRO for the winning bidder. THIRD PARTY ADMINISTRATOR A laboratory performing the type screening contemplated by the ITB must have a third party administrator (TPA) to administer the drug testing program. As with the MRO, a TPA must be independent of the laboratory to avoid conflicts of interest. Mercy’s response did not identify the person or organization that would serve as the TPA in the event it was awarded the contract. That omission did not make Mercy’s response to the ITB non-responsive because the ITB did not require bidders to identify the person or organization that would serve as the TPA for the winning bidder. IDENTIFICATION OF COLLECTION SITES Under the heading of Collection and Screening Site Parameters in Attachment B, Technical Requirements, the ITB provides, in part, as follows: Collection and screening sites shall be accessible Monday through Friday from 8:00 to 4:30 p.m., at a minimum, and shall meet the following parameters: The following locations [sic] parameters are examples of locations, which shall comprise the areas for collection and drug screening to insure convenience for applicants and employees: Area 1. East of 27th Ave. from Flagler St. North to 215th St. Area 2. West of 27th Ave. from Flagler St. North to 215th St. Area 3. East of State Road 836, south to intersection of US 1, then south to 392nd St. Area 4. West of State Road 836, south to intersection of US 1, then south to 394th St. * * * 4. At least one site in the North end of Miami-Dade County and one site in the South end of Miami-Dade County must be available to perform reasonable suspicion testing of employees. The hours of operation of these facilities must be from 8:00 a.m. to 12:00 midnight. Mercy’s response to the foregoing was to provide specific addresses to two locations that were presently available as collection sites, to advise that it had a mobile collection site, and to provide three approximate locations where it would establish collection sites if awarded the bid. There was a dispute between the parties as to whether Mercy was responsive to the foregoing item pertaining to collection sites. The greater weight of the credible evidence resolved that dispute in the affirmative. The ITB did not require bidders to provide specific addresses for collection sites, nor did it require bidders to specify the hours of operation of each proposed collection site. The testimony of Ms. Fahmy and Ms. Jones established that Mercy adequately responded to this item of the ITB. BREATH ALCOHOL TESTING Mercy’s response to the ITB did not separately address breath alcohol testing or certification for such testing. Mercy’s response did include bid prices on specified breath alcohol testing procedures as required by the ITB. There was no requirement that Mercy provide a separate certification for breath alcohol testing. Petitioner is a TPA, not a laboratory, and is the existing provider for the drug screening services contemplated by the ITB. Petitioner intended to subcontract all laboratory work required by the ITB. Petitioner’s response to the ITB was responsive. Mercy’s response to the ITB was also responsive. Mercy committed to comply with all requirements of the ITB and it established by its responses that it had the wherewithal to meet that commitment. Mercy was the low, responsive, responsible bidder on the ITB.
Conclusions For Petitioner: Holiday Hunt Russell, Esquire The Law Offices of Holiday Hunt Russell, Chartered 1930 Harrison Street, Suite 309 Hollywood, Florida 33020 For Respondent: Stephen L. Shochet, Esquire Miami-Dade County School Board 1450 Northeast 2nd Avenue, Suite 400 Miami, Florida 33132
Recommendation Based on the foregoing findings of fact and conclusions of Law, it is RECOMMENDED that Respondent enter a final order dismissing Petitioner’s bid protest and awarding the ITB to Mercy. RESERVATION OF JURISDICTION Jurisdiction is reserved to rule on Petitioner’s Motion for Attorney’s Fees and Costs following Respondent’s entry of a Final Order in this matter. DONE AND ORDERED this 18th day of December, 2006, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 18th day of December, 2006.
The Issue The amended Administrative complaint, forwarded to the Division of Administrative Hearings on January 20, 1987, alleges that Respondent is unable to practice medicine with reasonable skill and safety to patients by reason of alcohol and substance abuse; that Respondent attempted to treat patients while under the influence of alcohol, constituting gross or repeated malpractice or failure to practice medicine with the level of care recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances; and that Respondent failed to fulfill a statutory or legal obligation placed upon a licensed physician. After lengthy discovery and negotiations and Respondent's submittal to an inpatient mental and physical examination, the parties filed a stipulation substantially limiting the issue to the conditions under which Respondent should be allowed to return to the practice of medicine and appropriate monitoring once he returns to practice. At the final hearing, DPR presented the testimony of two witnesses: Lynn Hankes, M. D., qualified as expert in addictionology without objection, treated Dr. Pigg for alcoholism in 1985 and examined him as an inpatient in January, 1988. Robert A. Goetz, M. D., qualified without objection as an expert in the field of impaired physicians, has been the director of Florida's Physicians' Recovery Network since February 1988, and has known Dr. Pigg since shortly after that time. Respondent's sole witness was Milton R. Burglass, M.D., qualified without objection as an expert in psychiatry and in addiction treatment. Dr. Burglass reviewed Dr. Pigg's records and files and interviewed him on April 7, 1988, in anticipation of this hearing. After the hearing the transcript was filed and both parties submitted proposed recommended orders. Specific rulings on the proposed findings of fact are found in the attached appendix.
Findings Of Fact William Larry Pigg is, and has been at all time material, a licensed physician in the State of Florida, having been issued license number ME 0040625. The parties in their prehearing stipulation filed on February 15, 1988, agree to the following: Peitioner, the Department of Professional Regulation, is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes; Chapter 455, Florida Statutes; and Chapter 458, Florida Statutes. Since at least the summer of 1984, Respondent has had a problem with alcohol abuse. On or about June 13, 1985, Respondent entered the Impaired Physician's Program. Respondent completed an alcohol treatment program in Miami, Florida. Thereafter, Respondent also completed an extended program in Mississippi. On or about December 17, 1985, Respondent was granted staff privileges at Holmes Regional Medical Center in Melbourne, Florida. In order to obtain staff privileges, Respondent signed a statement agreeing to do the following: to abide by the Aftercare Con- tract of the Mississippi State Medical Association Impaired Physician's Program; and to submit to blood alcohol levels [sic] at any time at the request of any physician on the staff of Holmes Regional Medical Center. In or about April 1986, Respondent began to abuse alcohol again. On or about April 12, 1986, Respondent was attempting to perform a right hip reduction on a patient at Holmes Regional Medical Center. The patient in question was legally intoxicated and a large muscular man. Respondent, in attempting to relax the patient, ordered a large dose of narcotics, including Demerol and Nubain, as well as Phenergan and Valium. On or about the evening of April 12, 1986 or the morning of April 13, 1986, Respondent left the emergency room, took a Phenergan tablet and went home. Phenergan is the brand name for prometnazine Hydrochloride. Phenergan can cause drowsiness or impair the mental and/or physical abilities of the individual taking the drug. Later on the same evening, the Emergency Department Physician, Dr. Wagner, spoke with Dr. Pigg by telephone in reference to two patients with fractures that required orthopedic intervention. Respondent agreed to come and resume care for the patients. However, Respondent never came to the medical center and could not be located by police. On or about April 16, 1986, Respondent's wife contacted the Melbourne Police Department because her husband had come home intoxicated. On or about June 7, 1986, Respondent was arrested for driving while under the influence of alcohol and reckless driving. On or about June 30, 1986, the Director of the Florida Medical Foundation Committee on Impaired Physicians, Roger A. Goetz, M.D., advised the Petitioner, by letter, that Respondent was not progressing satisfactorily with the program and had not complied with all aspects of his aftercare contract. Respondent is and has been at all times alleged in the above stipulated facts, unable to practice medicine with reasonable skill and safety to patients by reason of alcohol abuse. No evidence was presented as to substance abuse, other than alcohol. Nor was there evidence that Dr. Pigg suffers from a mental condition. Although his records reflect some prior diagnosis of a passive/aggressive personality disorder, the prevailing thought in the addictionology community is that psychiatric diagnoses are invalid until an individual has been sober long enough to assure that the problem is not solely the alcohol's effect on the individual. There is no evidence that Dr. Pigg has had this requisite period of sobriety since 1984, and particularly the time that he was examined by Dr. Burglass, the only psychiatrist to testify in this proceeding. Of the experts who testified, Dr. Hankes is most familiar with Dr. Pigg, having been his primary treating physician in the past, and having examined him recently over several days as an inpatient. Dr. Hankes found that Dr. Pigg progressed from the mid stage of alcoholism to the early late stage of this disease between 1985 and 1988. In addition to Dr. Hankes' program at South Miami Hospital, Dr. Pigg has undergone primary treatment at a series of facilities in Georgia, Mississippi and Florida, all of which have an excellent reputation. At this point, in Dr. Hankes' opinion, he is a treatment failure. He has, at various times in his treatment experience also undergone detoxification at a Myers Act facility, attempted Antabuse therapy, and tried and rejected Alcoholics Anonymous. In spite of the past failures, the experts concurred that Dr. Pigg, like other alcoholics, is capable of recovery and that once recovered, Dr. Pigg would be capable of practicing medicine safely. All concurred that the recovery must be verified prior to Dr. Pigg's return to practice, and that thereafter the recovery must be monitored for an unforeseeable period of time. Dr. Hankes' advice, based on his concern as Dr. Pigg's treatment provider and primary therapist, is a six-part program: that addiction therapy continue on an outpatient basis, at least weekly, by a certified alcohol or addiction professional; that Dr. Pigg engage in psychotherapy with a qualified psychiatrist knowledgeable about addictive disease, the frequency to be determined by the psychiatrist; that a primary internist or family general practitioner monitor his physical well-being, especially his liver dysfunction; that Dr. Pigg participate in Alcoholics Anonymous, with a lay individual sponsor, as well as engage in International Doctors in Alcoholics Anonymous with a recovering physician sponsor; that Dr. Pigg be assigned a monitoring physician, knowledgeable in addictive disease, who has the authority to require random, unannounced surprise testing of blood or urine and that personal contact be made every two weeks and telephone contact in the alternate weeks; that the treating and monitoring individuals report on a quarterly basis to Dr. Roger Goetz, the Recovery Network director and that at the end of a two-year period Dr. Pigg be examined again by Dr. Hankes who would make his recommendation to Dr. Goetz. Dr. Pigg would also have the right to go to another AMA approved treatment provider for a second opinion. Dr. Hankes distinguishes between the state of being "dry" or free from alcohol use for a period, and recovery from alcoholism which requires a personal transformation with some undefined indicators. Dr. Hankes is convinced that the latter state is essential for real recovery and that Alcoholics Anonymous is the most effective, though not exclusive, route to that state. Although Dr. Hankes recommends a two year period during which Dr. Pigg would not be permitted to practice, he concedes that recovery could be effective in less time and that he would readily endorse his return to practice if the recovery were completed sooner. He describes Dr. Pigg as a "very competent physician", a "very bright guy", a "multi-talented individual, who flies airplanes and does wonderful things in his life." None can predict the time required for recovery, but each of the three experts recommends a period of one to two years of verified sobriety prior to the return to practice. Dr. Burglass recommends neither Alcoholics Anonymous participation nor the multi-part program outlined by Dr. Hankes. Since Alcoholics Anonymous and the other treatment/recovery models have been unsuccessful, Dr. Burglass suggests that Dr. Pigg be allowed to devise his own method of achieving recovery; he emphasizes that the goal, and not the route to that goal, is the concern here. He recommends that sobriety be verified for a period of one year and thereafter Dr. Pigg be allowed to return to practice with monitoring for approximately three years. The evidence, weighed and considered as a whole, fails to establish that an absolute two-year suspension from medical practice is necessary or that involvement in Alcoholics Anonymous is essential.
Recommendation Based on the foregoing, it is, hereby RECOMMENDED: That William Larry Pigg, M.D. be suspended from the practice of medicine for an indefinite period, provided that he be given an opportunity to appear before the Board at twelve month intervals to demonstrate that he can resume the competent practice of medicine with reasonable skill and safety to patients. That demonstration should include, as a minimum: a ) That he has totally abstained from the use of alcohol for a period of twelve months, as evidenced by frequent unannounced random collection of blood samples by an agent designated by the Board. That he has been under the continuous care and supervision of a physician qualified to provide addiction therapy and that, if recommended by that individual after a necessary period of sobriety, he has also undergone a psychiatric evaluation to determine the existence of mental disease or disorder. If detected, the disease or disorder must be treated. That he has been evaluated successfully participated in Alcoholics Anonymous or other similar peer support group program. Successful participation means frequent regular attendance at meetings and the association with a qualified sponsor from the program. That he has been evaluated and recommended for return to practice by Dr. Hankes or other treatment professional designated by the Board. However, if the recommendation is negative, Dr. Pigg should be permitted to obtain a second opinion independent of the Board's designated evaluator, from an individual other than that described in b), above, who is also qualified in the field of addictionology. The length and type of monitoring necessary once Dr. Pigg returns to practice should be determined at that time, based on recommendations of the professionals responsible for assisting in his recovery. DONE and RECOMMENDED this 4th day of August, 1988, in Tallahassee, Florida. MARY CLARK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of August, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-0225 The following constitute specific rulings on the findings of fact proposed by the parties. Petitioner's Proposed Findings Adopted in paragraph 2. Adopted in paragraph 1. 3-13. Adopted in paragraph 2, incorporating the parties pre-hearing stipulation. 14. Adopted in paragraph 7. Respondent's Proposed Findings 1-4. Incorporated in Issues and Background statement. 5. Adopted in paragraph 2, incorporating the parties' prehearing stipulation. 6-8. Included in Background Statement. 9-12. Rejected as unnecessary restatement of the witnesses' testimony. Adopted in substance in paragraph 3. Included in Background Statement. 15-16. Adopted in substance in paragraph 4. Adopted in paragraph 6. Adopted in paragraph 9. 19-20. Adopted in paragraph 7. Adopted in paragraph 8. Adopted in paragraph 9. 23-24. Incorporated in substance in the Background statement. 25-28. Adopted in substance in paragraph 11, otherwise rejected as cumulative and unnecessary. 29. Adopted by implication in paragraph 12. 30-31. Rejected as cumulative and unnecessary. Adopted in paragraph 12. Rejected as a conclusion of law. Rejected as contrary to the evidence. Abstinence alone is insufficient. Adopted in substance in paragraphs 3, 11, and 12. Rejected as unnecessary. COPIES FURNISHED: John Namey, Esquire 22 East Pine Street Orlando, Florida 32801 Deborah J. Miller, Esquire One Biscayne Tower, Suite 2400 Two South Biscayne Boulevard Miami, Florida 33131 Dorothy Faircloth Executive Director Board of Medicine Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact Respondent is now and at all relevant times has been a licensed registered nurse in Florida under license number 1074052. She is currently on active status. Her latest license renewal expires on March 31, 1989. Respondent was hired in April, 1986, as a charge nurse at John Knox Village Medical Center in Tampa. John Knox Village Medical Center is a long- term care facility divided into two wings. The wing to which Respondent was assigned houses between 24 and 32 patients requiring skilled nursing care. For the first three weeks on the job, Respondent performed her duties quite well. She learned the names of all of the long-term patients. She was a good manager and motivator of her employees. She was not absent from work. After about three weeks on the job, Respondent began to exhibit minor lapses of memory. Her hands began shaking. Her face became puffy and pale. She often became withdrawn and subject to mood swings. Occasionally, she could not be located for short periods of time by her nurse's aides, who required her supervision. A coworker smelled what was clearly alcohol on Respondent's breath one evening while Respondent was on duty. Shortly thereafter, on or about May 21, 1987, Respondent admitted to the Director of Nursing, Cary Boylan, that Respondent was an alcoholic. Respondent agreed, at Ms. Boylan's urging, to enter an alcohol treatment program sponsored by Alcohol Community Treatment Services, Inc. ("ACTS"). Respondent had been working at John Knox Village Medical Center for about six weeks at the time of her departure to enter the ACTS Program. Respondent underwent extensive residential treatment in the ACTS program from June 9, 1986 through July 7, 1986. She received counseling seven days a week. On July 14, 1986, Respondent successfully completed the intensive phase of the ACTS program and returned to work. She was rehired on that date, but was no longer the charge nurse. For the first few weeks after her return, Respondent was compliant, exhibited no signs of alcohol consumption, and generally performed her duties quite well. Respondent subsequently began a pattern of absenteeism starting at the end of August, 1986. At first, Respondent would notify her supervisors in advance of her absence. By September, it was "no call, no show." At one point, she missed six working days during a two-week period. About ten absences were unexplained. Others were accompanied by a doctor's excuse. By this time, the hand tremors had returned. Respondent's failure to show up for work or even alert her supervisor in advance of her absence left the floor short-handed. Other nurses were suddenly required to work overtime or report to work early. Sometimes a temporary nurse had to be called in. Respondent evaded Ms. Boylan's attempts to discuss Respondent's behavior. Generally, she avoided Ms. Boylan's telephone calls. When Ms. Boylan terminated Respondent from employment, Respondent's face had the pale and puffy look that it had prior to her entering the ACTS program. There were no charting or care problems with Respondent while she was employed at John Knox Village Medical Center. Ms. Barbara Burhop, a nurse responsible for the orientation of new employees at John Knox Village Medical Center, testified affirmatively to this fact. Also, Respondent was preoccupied at the time with the hospitalization of her father who was suffering from an illness that later claimed his life on November 14, 1986. However, Ms. Boylan and Rosemary Myers, a licensed practical nurse who worked with Respondent at John Knox Village Medical Center, both opined that Respondent could not practice nursing safely while at John Knox Village Medical Center, before and after the ACTS treatment, due to alcohol use. After leaving John Knox Village Medical Center, Respondent worked for six or seven months for a temporary nurse pool. On November 2, 1987, Respondent was hired to work as a staff curse at Centro Espanol Memorial Hospital in Tampa. She was assigned to the med-surg unit, but was first required to undertake two weeks of orientation and employee training. Respondent never completed the orientation training program. On the first day, she fell asleep while another nurse was training Respondent in a one- on-one session. Other times, Respondent appeared to be nodding off while on duty; often, she appeared to be trying hard to stay awake. Other nurses detected the odor of alcohol on Respondent's breath. Respondent frequently left her nurse's station for short periods of time for no apparent reason and during which she could not be found. There was no competent evidence of any charting or care problems during Respondent's short term of employment at Centro Espanol Memorial Hospital. In one instance, Respondent failed to release an in-going catheter, but Respondent's unrebutted testimony was that she told the nurse who followed her on the next shift about the unreleased catheter. Her chart entries were difficult to read, but "made sense" and were not illegible in the strict sense of the word. However, Ms. Gloria Carper, who is Assistant Director of Nursing at Centro Espanol Memorial Hospital, opined that Respondent was impaired due to alcoholism. Respondent admits that she is an alcoholic and has been for 2 1/2 to 3 years. She admits that she does not abstain from alcohol consumption. She testified that she did not drink while on duty. On days that she felt that she could not adequately care for a patient, Respondent stated that she would not report to work. She has attended various alcoholic treatment groups, including Alcoholics Anonymous, but has not successfully completed her recent treatment programs. On February 19, 1987, the Impaired Nurses Program ("INP") found Respondent noncompliant in her treatment program. On March 17, 1987, her noncompliance necessitated an extension of her INP two-year monitoring to February 4, 1989. Respondent was again found noncompliant by INP by letter dated May 11, 1987. Respondent was dismissed for noncompliance from Petitioner's Intervention Project by letter dated May 22, 1987. By letter dated June 25, 1987, Respondent was also unfavorably terminated from the post- residential, out-patient counseling phase of the ACTS program. Her ACTS counselor noted Respondent's sporadic attendance, closed attitude, and insistence upon her alcohol and drug-free status, which insistence was belied upon her uncooperative behavior. Although there is no direct, clear and convincing evidence of alcohol intoxication or even consumption while on duty, the evidence is clear and convincing that Respondent consumed alcohol during the terms of her employment at John Knox Village Medical Center and Centro Espanol Memorial Hospital. The most reasonable inference is that she consumed alcohol excessively the night before work. As a result, Respondent was either so tired and sick the next morning that she was unable to work or, if not quite so tired and sick, she would report to work and doze off.
The Issue The issues are whether Respondent committed the acts alleged in the Administrative Complaint, and, if so, what penalty, if any, should Petitioner impose on Respondent's teaching certificate.
Findings Of Fact Respondent is authorized to teach English, the mentally handicapped, and psychology in Florida pursuant to Florida Educator's Certificate No. 435635. The certificate is valid through June 30, 2008. Respondent was an outstanding teacher for the Manatee County School District (the District) for approximately 21 years. The District employed Respondent as a language arts teacher at Manatee High School (Manatee) in 2000. On November 4, 2000, Respondent drove a white Dodge van approximately 30 miles an hour on the wrong side of U.S. Highway 41 (Highway 41) toward a deputy sheriff who was directing traffic during an annual festival. The deputy was off duty, but was in uniform and wore an orange vest. Highway 41 contains six lanes where the deputy was directing traffic. Three northbound and three southbound lanes are divided by a landscaped median with a turning ramp. Oncoming vehicles pulled off the road to avoid the van. The left front tire of the van was flat. The deputy attempted to stop Respondent by waiving his arms, jumping up and down, and yelling and screaming for Respondent to stop. Respondent drove past the deputy, and the deputy pushed off the front window of the vehicle. The deputy's vehicle was approximately 15 feet away with blue lights and strobe lights already operating. The deputy drove his vehicle after Respondent with the siren on. Respondent stopped the van approximately 1.4 miles from the location where she drove past the deputy. Respondent pulled into a parking lot of a chain restaurant. The deputy arrested Respondent for aggravated assault on a police officer and fleeing to elude a police officer. Respondent subsequently pled guilty to both charges. The court withheld adjudication and sentenced Respondent to six months of community control, 25 hours of community service, imposed fines and costs, and placed Respondent on probation for one year. Respondent satisfactorily completed her sentence, paid her fines, and completed her probation. On November 10, 2000, Respondent was under the influence of alcohol at Manatee as students were arriving for school. Administrators at Manatee gave Respondent a Breathalyzer test. The test disclosed a positive reading of .23. The legal limit is .07. The District suspended Respondent without pay on November 10, 2000. Respondent resigned from her teaching position with the District on November 16, 2000. The acts committed by Respondent on November 4 and 10, 2000, constitute neither gross immorality nor moral turpitude within the meaning of Section 1012.795(1)(c), Florida Statutes (2003). The acts were not base, depraved, dishonest, or unprincipled. They were related to alcohol addiction and a long-term illness of Respondent's mother. Respondent did not violate Section 1012.795(1)(e), Florida Statutes (2003). Respondent was not convicted of a criminal charge. The court withheld adjudication. Petitioner acknowledges in its PRO that Petitioner could find no authority to support a conclusion that the withholding of adjudication is a conviction for the purpose of this alleged violation. Respondent did not violate Section 1012.795(1)(f), Florida Statutes (2003). The evidence is less than clear and convincing that the acts committed by Respondent seriously reduced her effectiveness as a teacher. The traffic incident occurred away from school. The second incident occurred before school began and did not harm students or their parents. Respondent was an outstanding teacher prior to her resignation. She resigned her position before her condition had any effect in the classroom. Respondent violated Section 1012.795(1)(i), Florida Statutes (2003), by committing acts prohibited by Principles of Professional Conduct for the Education Profession. Respondent violated Section 1012.795(2), Florida Statutes (2003), by pleading guilty to the criminal charges against her. Three aggravating factors support a significant penalty against Respondent's teaching certificate. First, the offenses on November 4 and 10, 2000, were severe within the meaning of Florida Administrative Code Rule 6B-11.007(3)(a). (References to rules are to rules promulgated in the Florida Administrative Code on February 27, 1994.) Second, both offenses created a danger to the public within the meaning of Florida Administrative Code Rule 6B-11.007(3)(b). Third, the offense on November 10, 2000, was a repetition of an alcohol- related problem. The District had previously transferred Respondent from another school to Manatee in an effort to help Respondent with problems associated with alcohol addiction. Numerous mitigating factors listed in Florida Administrative Code Rule 6B-11.007(3) justify a penalty less severe than the three-year revocation and probation that Petitioner proposes. The last offense occurred more than three years ago. Respondent practiced as an educator for over 21 years before the last incident, made significant contributions to students and the educational system in which she worked, and has no other disciplinary history. Fla. Admin. Code R. 6B-11.007(3)(d)-(f). Respondent caused no actual damage to any person or property. A penalty in this case has little, if any, deterrent effect and will have a significant adverse impact on Respondent's livelihood. Respondent voluntarily resigned her position and successfully rehabilitated herself from alcohol addiction. Respondent candidly admitted actual knowledge of her offenses and their severity. Respondent pled guilty to the charges against her and voluntarily resigned her teaching position. No pecuniary gain inured to Respondent, and Respondent did not harm any student or child. Respondent is rehabilitated from her previous alcohol addiction. Fla. Admin. Code R. 6B-11.007(3)(g)-(k), (m), and (q)-(s). The evidence does not support a period of probation. Respondent's alcohol addiction was related to external circumstances involving Respondent's mother who was ill and in need of constant attention in 2000. Those external circumstances no longer exist. Respondent is rehabilitated.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent not guilty of violating Subsections 1012.795(1)(c), (e), and (f), Florida Statutes (2003); guilty of violating Subsections 1012.795(1)(i) and (2), Florida Statutes; suspending Respondent's teaching certificate for one year beginning on November 10, 2000; and thereafter activating the certificate forthwith. DONE AND ENTERED this 7th day of July, 2004, in Tallahassee, Leon County, Florida. S DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of July, 2004. COPIES FURNISHED: Kathleen M. Richards, Executive Director Education Practices Commission Department of Education 325 West Gaines Street, Room 224 Tallahassee, Florida 32399-0400 Nina Ashenafi, Esquire FEA/United 118 North Monroe Street Tallahassee, Florida 32301 Bruce P. Taylor, Esquire Post Office Box 131 St. Petersburg, Florida 33731-0131 Daniel J. Woodring, General Counsel Department of Education 325 West Gaines Street 1244 Turlington Building Tallahassee, Florida 32399-0400 Marian Lambeth, Program Specialist Bureau of Educator Standards Department of Education 325 West Gaines Street, Suite 224-E Tallahassee, Florida 32399-0400
The Issue Whether Florida Administrative Code Rules 11D-8.011, 1D-8.012, 11D-8.013, and 11D-8.014 constitute an invalid exercise of delegated legislative authority.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing and the entire record in this proceeding, the following findings of fact are made: FDLE is the state agency responsible for the regulation of blood analysts who conduct blood testing for purposes of the driving and boating under the influence and related provisions of Chapters 316, 322, and 327, Florida Statutes. § 316.1932(1)(a)2., Fla. Stat. Among FDLE's enumerated powers under the Alcohol Testing Program (the "program") are the authority to approve the "type" of blood test utilized and the authority to "specify techniques and methods" for blood testing utilized under the driving and boating under the influence and related provisions of Chapters 316, 322, and 327, Florida Statutes. § 316.1932(1)(a)2.n., and o., Fla. Stat. Petitioner, William Lane, has been charged with DUI manslaughter and is awaiting trial on that charge in the 18th Judicial Circuit, in and for Brevard County, Florida. Petitioner was subjected to a blood alcohol test that purported to be conducted in compliance with Sections 316.1932, 316.1933, and 316.1934, Florida Statutes. FDLE has not contested the standing of Petitioner to initiate this proceeding. Petitioner has challenged Florida Administrative Code Rules 11D-8.011, 11D-8.012, 11D-8.013, and 11D-8.014 as invalid exercises of delegated legislative authority.1 Florida Administrative Code Rule 11D-8.011 provides: 11D-8.011 Approval of Blood Alcohol Test Methods. The Department approves the following test methods for determining blood alcohol level: Alcohol Dehydrogenase (Enzymatic). Gas Chromatography. Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.353(2), 327.354(3) FS. History–New 10-31-93. Florida Administrative Code Rule 11D-8.012 provides: 11D-8.012 Blood Samples - Labeling and Collection. Before collecting a sample of blood, the skin puncture area must be cleansed with an antiseptic that does not contain alcohol. Blood samples must be collected in a glass evacuation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethylenediaminetetraacetic acid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence. Immediately after collection, the tube must be inverted several times to mix the blood with the preservative and anticoagulant. Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample. Blood samples need not be refrigerated if submitted for analysis within seven (7) days of collection, or during transportation, examination or analysis. Blood samples must be otherwise refrigerated, except that refrigeration is not required subsequent to the initial analysis. Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hand-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service. Notwithstanding any requirements in Chapter 11D-8, F.A.C., any blood analysis results obtained, if proved to be reliable, shall be acceptable as a valid blood alcohol level. Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3., (d) FS. Law Implemented 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.353(2), 327.354(3) FS. History–New 10-31-93, Amended 7-29-01. Florida Administrative Code Rule 11D-8.013 provides: 11D-8.013 Blood Alcohol Permit - Analyst. The application for a permit to determine the alcohol level of a blood sample shall be made on a form provided by the Department and shall include the following information: Name and address of applicant; A copy of state license if licensed, or college transcript; Name and address of employer and laboratory facility where applicant performs analyses; Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and, A complete description of proposed analytical procedure(s) to be used in determining blood alcohol level. Qualifications for blood analyst permit - To qualify, the applicant must meet all of the following requirements: Department approval of analytical procedure(s). All proposed analytical procedures will be reviewed and a determination of approval will be made by the Department; Satisfactory determination of blood alcohol level in five proficiency samples provided by the Department using the proposed analytical procedure. Satisfactory determination shall be made by reporting results for blood alcohol proficiency samples within the acceptable range for the samples. For blood alcohol testing, acceptable ranges shall mean the calculated proficiency sample mean + or - 3 standard deviations iterated twice. The mean and standard deviations will be calculated using the results reported by the analysts and reference laboratories; Identify at least one Agency for which blood analyses are to be performed pursuant to Chapters 316, 322, and 327, F.S.; and, Meet one of the following: Possess a clinical laboratory license in clinical chemistry as a technologist, supervisor or director, under Chapter 483, F.S.; or Be a licensed physician pursuant to Chapter 458, F.S.; or Complete a minimum of 60 semester credit hours or equivalent of college, at least 15 semester hours of which must be in college chemistry. The department shall approve gas chromatographic analytical procedures and enzymatic analytical procedures based on alcohol dehydrogenase which meet the following requirements: Includes the approved method used and a description of the method, and the equipment, reagents, standards, and controls used; Uses commercially-prepared standards and controls certified by the manufacturer, or laboratory-prepared standards and controls verified using gas chromatography against certified standards. For commercially-prepared standards and controls, the manufacturer, lot number and expiration date must be documented for each sample or group of samples being analyzed. For laboratory-prepared standards and controls, date, person preparing the solution, method of preparation and verification must be documented; A statement of the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range; Uses a new or existing calibration curve. The new calibration curve must be generated using at least three (3) standards: one at 0.05 g/100mL or less, one between 0.05 and 0.20 g/100mL (inclusive) and one at 0.20 g/100mL or higher, and must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher. The existing calibration curve must be verified using a minimum of two (2) controls, one at 0.05 g/100mL or less and one at 0.20g/100mL or higher; Includes the analysis of an alcohol- free control, and the analysis of a whole blood or serum control. The whole blood or serum control may be used to satisfy the control requirement(s) in paragraph (d); A gas chromatographic analytical procedure must discriminate between methanol, ethanol, acetone and isopropanol and employ an internal standard technique; An enzymatic analytical procedure based on alcohol dehydrogenase must use the procedure recommended by the instrument manufacturer/test kit vendor for whole blood alcohol analysis, and the enzyme used must have sufficient selectivity to provide negligible cross-reactivity towards methanol, acetone and isopropanol. The permit shall be issued by the Department for a specific method and procedure. Any substantial change to the method, analytical procedure, or laboratory facility must receive prior approval by the Department before being used to determine the blood alcohol level of a sample submitted by an agency. The Department shall determine what constitutes a substantial change. An analyst shall only use a Department- approved procedure to determine the blood alcohol level of samples submitted by an agency. Approval of blood alcohol analysis methods and procedures shall be based on rule requirements in effect at the time they were submitted for approval. Specific Authority 316.1932(1)(a)2., (f)1., 316.1933(2)(b), 316.1934(3) 322.63(3)(b), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b), 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(b), (e), 327.353(2), 327.354(3) FS. History–New 10- 31-93, Amended 4-1-94, 2-1-95, 1-1-97, 11-5- 02, 12-9-04. Florida Administrative Code Rule 11D-8.014 provides: 11D-8.014 Blood Alcohol Permit - Analyst: Renewal. Permits to conduct blood alcohol analyses shall remain valid until otherwise suspended or revoked by the Department. In order to remain qualified for such permit, an analyst must satisfactorily determine the blood alcohol level of at least two (2) proficiency samples provided by the Department each annual quarter. Satisfactory determination shall be made by reporting results for blood alcohol proficiency samples within the acceptable range for the samples. For blood alcohol testing acceptable ranges shall mean the calculated proficiency sample mean + or - 3 standard deviations iterated twice. The mean and standard deviations will be calculated using the results reported by the analysts and reference laboratories. An analyst, who is in good standing, may elect to not participate in one proficiency test cycle each calendar year. The analyst must notify the Department in writing, of his/her election prior to the date the proficiency test results must be reported to the Department. Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on any set of proficiency samples, the analyst shall be required to satisfactorily determine the blood alcohol level of a second set of five proficiency samples provided by the Department. Upon notification by the Department that an analyst has failed to satisfactorily determine the blood alcohol level on a second set of proficiency samples, the analyst shall not perform any duties authorized by the analyst’s permit until the analyst satisfactorily determines the blood alcohol level of a subsequent set of proficiency samples provided by the Department. This section shall not preclude the Department from taking further action in accordance with Rule 11D-8.015, F.A.C. Failure to satisfactorily determine the blood alcohol level of any six (6) sets of proficiency samples provided by the Department within a twelve (12) month period shall result in revocation of the blood analyst permit. Specific Authority 316.1932(1)(a)2., (f)1., 322.63(3)(a), 327.352(1)(b)3. FS. Law Implemented 316.1932(1)(b), 316.1933(2)(b), 316.1934(3), 322.63(3)(b), 327.352(1)(e), 327.353(2), 327.354(3) FS. History–New 10- 31-93, Amended 1-1-97, 11-5-02. Subsections 316.1932(1)(a)2. and (f)1., Florida Statutes, cited as specific authority for all four rules, provide: (2) The Alcohol Testing Program within the Department of Law Enforcement is responsible for the regulation of the operation, inspection, and registration of breath test instruments utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program is responsible for the regulation of the individuals who operate, inspect, and instruct on the breath test instruments utilized in the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program is further responsible for the regulation of blood analysts who conduct blood testing to be utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. The program shall: Establish uniform criteria for the issuance of permits to breath test operators, agency inspectors, instructors, blood analysts, and instruments. Have the authority to permit breath test operators, agency inspectors, instructors, blood analysts, and instruments. Have the authority to discipline and suspend, revoke, or renew the permits of breath test operators, agency inspectors, instructors, blood analysts, and instruments. Establish uniform requirements for instruction and curricula for the operation and inspection of approved instruments. Have the authority to specify one approved curriculum for the operation and inspection of approved instruments. Establish a procedure for the approval of breath test operator and agency inspector classes. Have the authority to approve or disapprove breath test instruments and accompanying paraphernalia for use pursuant to the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. With the approval of the executive director of the Department of Law Enforcement, make and enter into contracts and agreements with other agencies, organizations, associations, corporations, individuals, or federal agencies as are necessary, expedient, or incidental to the performance of duties. Issue final orders which include findings of fact and conclusions of law and which constitute final agency action for the purpose of chapter 120. Enforce compliance with the provisions of this section through civil or administrative proceedings. Make recommendations concerning any matter within the purview of this section, this chapter, chapter 322, or chapter 327. Promulgate rules for the administration and implementation of this section, including definitions of terms. Consult and cooperate with other entities for the purpose of implementing the mandates of this section. Have the authority to approve the type of blood test utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. Have the authority to specify techniques and methods for breath alcohol testing and blood testing utilized under the driving and boating under the influence provisions and related provisions located in this chapter and chapters 322 and 327. Have the authority to approve repair facilities for the approved breath test instruments, including the authority to set criteria for approval. Nothing in this section shall be construed to supersede provisions in this chapter and chapters 322 and 327. The specifications in this section are derived from the power and authority previously and currently possessed by the Department of Law Enforcement and are enumerated to conform with the mandates of chapter 99-379, Laws of Florida.[2] * * * (f)1. The tests determining the weight of alcohol in the defendant's blood or breath shall be administered at the request of a law enforcement officer substantially in accordance with rules of the Department of Law Enforcement. Such rules must specify precisely the test or tests that are approved by the Department of Law Enforcement for reliability of result and ease of administration, and must provide an approved method of administration which must be followed in all such tests given under this section. However, the failure of a law enforcement officer to request the withdrawal of blood does not affect the admissibility of a test of blood withdrawn for medical purposes. Subsection 316.1933(2)(b), Florida Statutes, cited as specific authority for Rule 11D-8.0133, provides: (b) A chemical analysis of the person's blood to determine the alcoholic content thereof must have been performed substantially in accordance with methods approved by the Department of Law Enforcement and by an individual possessing a valid permit issued by the department for this purpose. The Department of Law Enforcement may approve satisfactory techniques or methods, ascertain the qualifications and competence of individuals to conduct such analyses, and issue permits that are subject to termination or revocation at the discretion of the department. Any insubstantial differences between approved methods or techniques and actual testing procedures, or any insubstantial defects concerning the permit issued by the department, in any individual case, shall not render the test or test results invalid. Subsection 316.1934(3), Florida Statutes, is cited as specific authority for Rule 11D-8.013.4 Section 316.1934, Florida Statutes, provides, in relevant part: 316.1934 Presumption of impairment; testing methods.— It is unlawful and punishable as provided in chapter 322 and in s. 316.193 for any person who is under the influence of alcoholic beverages or controlled substances, when affected to the extent that the person's normal faculties are impaired or to the extent that the person is deprived of full possession of normal faculties, to drive or be in actual physical control of any motor vehicle within this state. Such normal faculties include, but are not limited to, the ability to see, hear, walk, talk, judge distances, drive an automobile, make judgments, act in emergencies, and, in general, normally perform the many mental and physical acts of daily life. At the trial of any civil or criminal action or proceeding arising out of acts alleged to have been committed by any person while driving, or in actual physical control of, a vehicle while under the influence of alcoholic beverages or controlled substances, when affected to the extent that the person's normal faculties were impaired or to the extent that he or she was deprived of full possession of his or her normal faculties, the results of any test administered in accordance with s. 316.1932 or s. 316.1933 and this section are admissible into evidence when otherwise admissible, and the amount of alcohol in the person's blood or breath at the time alleged, as shown by chemical analysis of the person's blood, or by chemical or physical test of the person's breath, gives rise to the following presumptions: If there was at that time a blood- alcohol level or breath-alcohol level of 0.05 or less, it is presumed that the person was not under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. If there was at that time a blood- alcohol level or breath-alcohol level in excess of 0.05 but less than 0.08, that fact does not give rise to any presumption that the person was or was not under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired but may be considered with other competent evidence in determining whether the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. If there was at that time a blood- alcohol level or breath-alcohol level of 0.08 or higher, that fact is prima facie evidence that the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. Moreover, such person who has a blood-alcohol level or breath-alcohol level of 0.08 or higher is guilty of driving, or being in actual physical control of, a motor vehicle, with an unlawful blood-alcohol level or breath-alcohol level. The presumptions provided in this subsection do not limit the introduction of any other competent evidence bearing upon the question of whether the person was under the influence of alcoholic beverages to the extent that his or her normal faculties were impaired. A chemical analysis of a person's blood to determine alcoholic content or a chemical or physical test of a person's breath, in order to be considered valid under this section, must have been performed substantially in accordance with methods approved by the Department of Law Enforcement and by an individual possessing a valid permit issued by the department for this purpose. Any insubstantial differences between approved techniques and actual testing procedures or any insubstantial defects concerning the permit issued by the department, in any individual case do not render the test or test results invalid. The Department of Law Enforcement may approve satisfactory techniques or methods, ascertain the qualifications and competence of individuals to conduct such analyses, and issue permits that are subject to termination or revocation in accordance with rules adopted by the department. . . . For purposes of this proceeding, the remaining provisions cited as specific authority for or as laws implemented by the challenged rules are redundant to the provisions set forth above.5 11. Sections 316.1932, 316.1933, and 316.1934, Florida Statutes, are collectively referred to as the implied consent law. See Robertson v. State, 604 So. 2d 783, 789 n.4 (Fla. 1992). In Robertson, the Court, citing its earlier analysis in State v. Bender, 382 So. 2d 697 (Fla. 1980), discussed the implied consent law and its relation to earlier common law evidentiary principles as to the admissibility of expert testimony in a DUI prosecution. The implied consent law "includes an exclusionary rule prohibiting the use of blood-test results taken contrary to its core policies." Robertson, 604 So. 2d at 789. However, "this exclusionary rule does not prohibit the use of all evidence obtained contrary to the implied consent law, but only such evidence obtained in a manner that is contrary to the core policies of the statute: ensuring scientific reliability of the tests, and protecting the health of test subjects." Id. at 789 n.5. Prior to the adoption of the implied consent law, scientific tests for intoxication were admissible if a proper predicate established that (1) the test was reliable, (2) the test was performed by a qualified operator with the proper equipment, and (3) expert testimony was presented to explain the meaning of the test. Robertson, 604 So. 2d at 789. The Court explained the implications of this common law rule: This predicate had to be established in each and every case. If the state failed to do so, the evidence was not admissible. Moreover, when the state attempted to establish the necessary predicate, the defense enjoyed an opportunity to rebut all of this evidence. If the defense introduced sufficient evidence to rebut any one of the elements of the predicate, then once again the expert evidence was not admissible. Perhaps most significantly of all, the former procedure required the trial court to be the arbiter of what often was a dispute over arcane scientific principles. Id. (citation omitted). The implied consent law altered this practice by creating a presumption that the evidence is admissible, provided the state shows that the person conducting the test was properly licensed and has substantially complied with the governing regulations. "In other words, the state's burden of establishing a predicate is simplified in the sense that the state no longer has to guess what factors a particular trial judge will require the state to prove before admitting the test results; nor is the trial court required to wade into a morass of arcane scientific challenges and counterchallenges. If the state follows the HRS[6] 'checklist,' then the trial court's determination that the predicate has been established is clothed in a presumption of correctness." Robertson, 604 So. 2d at 789. In the instant case, Petitioner contends that the challenged rules do not provide a "checklist" in the area of blood alcohol testing sufficient to entitle the state to the presumption of correctness under the implied consent law. According to Petitioner, Robertson dictates that blood alcohol tests conducted under the challenged rules are not entitled to any presumption of correctness, and must be subjected to the three-step common law test for admissibility. Petitioner complains that the rules do not provide a checklist at all. Florida Administrative Code Rule 11D-8.011 simply approves alcohol dehydrogenase and gas chromatography as test methods for determining blood alcohol level, without setting forth a procedural checklist by which a judge could verify that the testing has been conducted in a scientifically reliable manner. In fact, the challenged rules do not prescribe a specific step-by-step procedure for the conduct of blood alcohol testing. Rather, blood alcohol permit applicants are required to propose analytical procedures that comport with the requirements set forth in Florida Administrative Code Rule 11D-8.013(3). If the application is approved by FDLE, then a permit is issued that allows the analyst to conduct testing only for the specific method and procedure described in the application, and only in the specific laboratory facility named in the application. Any substantial changes in the test method, analytical procedure, or in the laboratory facility itself must be approved by FDLE. Fla. Admin. Code R. 11D-8.013(4). Petitioner takes the position that in order to be consistent with the statutes as interpreted by Robertson, FDLE's rules must impose a uniform, step-by-step procedure for the administration of alcohol dehydrogenase and gas chromatography blood alcohol testing. FDLE takes the position that imposing such a procedure on every laboratory in the state would be absurdly expensive, scientifically unnecessary, and is not required by the governing statutes. Gas chromatography is the only test method currently used in Florida laboratories. "Headspace analysis" is the general procedure employed.7 Laura Barfield, the manager of the Alcohol Testing Program, explained that gas chromatography is a separation technique used to analyze blood samples for their alcohol (specifically, ethanol) content. Gas chromatography separates a compound into its individual components, using gas as the mode for separation. Petitioner's toxicology expert was Lawrence W. Masten, a former professor of toxicology at the University of Mississippi and currently a toxicology consultant. Dr. Masten explained the method in layman's terms. A small sample of blood is diluted with an internal standard, which is a chemical (usually a molecule similar to ethyl alcohol) of a known concentration. The diluted sample is placed into a vial, sealed, then heated to a constant temperature. The air sample in the head space above the heated liquid is analyzed in the gas chromatograph to derive findings as to the level of alcohol in the blood sample. Dr. Masten explained that the internal standard is included so that a ratio may be established between the molecules of alcohol in the blood sample and those in the standard. The inclusion of an internal standard also makes it less important to precisely measure the volume of the blood sample. Bruce Goldberger is a forensic toxicologist and is the director of toxicology at the University of Florida College of Medicine. In 1999-2000, Dr. Goldberger chaired a committee of scientific and legal experts who made recommendations to FDLE resulting in the current form of the challenged rules. Dr. Goldberger testified that the committee discussed the procedures needed to produce a reliable and accurate result from a gas chromatograph. He believed that the most important aspect of the rules is the requirement that the procedure be able to differentiate between ethanol and other volatiles in the specimen. Dr. Goldberger also cited the specific criteria for the calibration and control of the method as important factors in ensuring the reliability of tests performed pursuant to FDLE permits. Dr. Goldberger explained that, because there is the possibility of other alcohols in the blood specimen, the testing method must be able to differentiate between ethanol, which humans consume in alcoholic beverages, and acetone, isopropanol, methanol, and any other possible interferent. Dr. Goldberger agreed with Dr. Mastin on the importance of requiring the use of an internal standard. Dr. Goldberger testified that the use of an internal standard is always necessary in modern day quantitative analysis. While acknowledging the difficulties that these concepts pose to laymen, Dr. Goldberger stated that anyone trained in the area of quantitative analysis would understand the role of an internal standard. He explained that Florida Administrative Code Rule 11D-8.013(3)(f) does not prescribe one specific internal standard because there are two such standards that are commonly used throughout the world, and that either one, n-propanol or butanol, is accepted by scientists in the field of forensic toxicology. Dr. Goldberger testified that different laboratories may use different standards without affecting the accuracy and reliability of their tests, provided their testing methods are validated and provided the lab where the chemist is performing the test employs the calibrators and controls that are noted in Florida Administrative Code Rule 11D-8.013. Dr. Goldberger believes that it would be poor science to write rules that "get down to the nitty-gritty of a method." The rules should not prescribe the precise chemical composition of the internal standard, the temperature used to heat samples, or the column8 used. Different laboratories have different equipment, and the rules should provide some leeway to allow the analysts to perform their work in their own setting. As an example, Dr. Goldberger cited Florida Administrative Code Rule 11D-8.013(3)(c), which addresses the concentration range over which the procedure is calibrated. The calibration curve must be linear over the stated range. Dr. Goldberger noted that the range varies between laboratories, and even from day to day within a single lab. In Dr. Goldberger's lab, the range may be linear from 0.01 to 0.5 one day, and from 0.01 to 0.4 the next day. This variability is why the lab runs calibrators to verify the range, and includes the current range on the worksheet along with the testing data. Dr. Goldberger concluded that the variations make it impossible for FDLE to require a specific number for the range. As another example, Dr. Goldberger cited Florida Administrative Code Rule 11D-8.013(3)(d), which discusses the constitution and use of a calibration curve. Calibration curves also vary from lab to lab, and the rule allows for that variation. Dr. Goldberger stated that it would be possible to specify an exact concentration, but it would not be good practice and could not be done without retooling the labs. Dr. Goldberger conceded that it would be possible to develop a detailed checklist in a rule, but asserted that to do so would not be good science. If the rules dictated every aspect of the equipment and procedures to be used in the lab, then nearly every lab in the state would have to retool and purchase new gas chromatographs. The expense would be prohibitive and unnecessary in scientific terms. Dr. Goldberger asserted that there is no need for a detailed checklist in the rules because the labs performing blood alcohol testing in Florida all use validated methods and are adequately calibrated and controlled. The data verifying the labs' methods, calibrations and controls is available for expert review. Florida Administrative Code Rule 11D-8.014 establishes a proficiency testing program, requiring every analyst to undergo quarterly testing to make sure their work is satisfactory. Dr. Goldberger testified that he has worked in several labs during his 25-year career. The methods employed in each lab were essentially the same. The instruments vary from lab to lab, but the technique is the same. Some technological improvements have been made in newer gas chromatographs, but have not altered the essential techniques of gas chromatography, which have not changed in 30 to 40 years. Dr. Goldberger stated that, while a layman might not be able to look at the rules and know all the steps necessary to perform a valid blood alcohol analysis, an analyst would. Further, persons reviewing the analyst's work in the lab would know the steps because each analyst is required to file with FDLE a "standard operating procedures" ("SOP") document that is several pages long and minutely details the procedures used by the analyst. Dr. Goldberger testified that "SOP" is a term of art in the industry. He acknowledged that the challenged rules do not employ that term, but testified that the language in Florida Administrative Code Rule 11D-8.013(2)(a) requiring FDLE approval of "analytical procedure(s)" is understood to mean that applicants must file their SOPs. The SOP is the "analytical procedure" to be approved by FDLE. The SOP contains all the analytical parameters necessary to perform gas chromatography, including the temperature, column, and column length. The SOP sets forth the steps employed by the analyst. Dr. Goldberger gave examples of the initial steps in a typical SOP: step one would call for removing the batch of specimens from the refrigerator, step two would be a review of the specimen identification information on the tubes, and step three would call for preparation of the dilution standard for that day's work. As the analysis goes forward, the analyst prepares a worksheet documenting each step in the process. The worksheet is used as part of the validation process for that batch and also for the calibration and control of that batch. An expert reviewing the analyst's work can combine the SOP, the worksheet and the raw data of the analysis to reconstruct exactly what occurred in the lab. Thus, Dr. Goldberger concluded that a "checklist" of sorts is provided under the challenged rules by way of each analyst's analytical procedure, which FDLE initially approves and periodically reviews. Dr. Goldberger concluded that the current standard of practice in forensic toxicology labs is to use head space gas chromatography for the analysis of blood alcohols. The standard of practice allows for differences in methodology from one lab to another, assuming the methodology is performed correctly. These variations do not prevent a qualified analyst from knowing what is required to conduct a gas chromatograph blood alcohol analysis. Ms. Barfield, the manager of the Alcohol Testing Program, testified as to the program's duties. The program grants permits only to the analysts, not to laboratories. Approximately 66 analysts are currently permitted in Florida, and 11 Florida labs are used for this work. Some analysts hold two permits, because they use two different analytical procedures and a separate permit is required for each procedure. A potential applicant may obtain an application from the program's office or download it from the program's web page. The application requires the applicant to identify her employer, the lab facility to be used, and at least one agency for which the analyst will perform blood alcohol analysis. The applicant must identify the method to be used and must include a copy of her SOP. Once filed, the SOPs are maintained by the Alcohol Testing Program as a public record. The program releases permitting and proficiency test information upon request. Ms. Barfield stated that the "method" referenced by the rules is the type of test, i.e., gas chromatography or alcohol dehydrogenase. The "procedure" contemplated by the rule is the SOP, the actual set of steps that the blood sample will go through when that analyst performs a blood alcohol analysis. Ms. Barfield testified that this "procedure" equates to the statutory term "method of administration" found at Subsection 316.1932(1)(f)1., Florida Statutes. The "method of administration" is spelled out at Florida Administrative Code Rule 11D-8.013(3)(a)-(g). Ms. Barfield personally reviews the applications for blood alcohol analyst permits. When reviewing an application and its accompanying analytical procedures, Ms. Barfield uses Florida Administrative Code Rule 11D-8.013 as a checklist to ensure that all requirements have been met. She checks off each requirement of the rule that the application meets. If the proposed procedure discriminates between methanol, ethanol, acetone and isopropanol, she gives it a check. If it uses an internal standard, it gets a check. If it employs appropriate levels of standards and controls, it gets a check. The steps described in the analytical procedure become requirements of that analyst's permit and must be performed each time the analyst conducts a blood alcohol analysis. Ms. Barfield also gives proficiency tests pursuant to Florida Administrative Code Rule 11D-8.013(2)(b). In a proficiency test, the applicant must use the proposed procedure to correctly determine the blood alcohol level in five proficiency samples provided by the Alcohol Testing Program. Ms. Barfield testified that the rules do not prescribe the specific steps to be used in the analytical procedure because there are many different laboratories and many different ways to achieve an accurate and reliable blood alcohol result. As an example, she described her own procedure in comparison to that of the lab at the University of Miami: I'm in the FDLE laboratory and I'm using a PerkinElmer gas chromatograph . . . and I'm going to prep my samples, meaning taking the blood vial that I receive, and I'm going to aliquot for a sample 50 microliters of that blood and put it in the correct container to be able, to be analyzing it. The head space gas chromatography has a special little container. You do not stick the blood vial on the autosampler. Anyway, you're aliquoting 50 microliters, and I'm going to do that twice because my procedure says I have to do it twice and the rule says I have to do it twice, and . . . I'm going to dilute it with n-propanol internal standard and I'm going to dilute it with a thousand milliliters of internal standard, and my n-propanol internal standard is at a .02 concentration. I put it on the gas chromatograph, and it's a head space autosampler, and I'm going to heat that bottle up to 60 degrees [Celsius] in order for equilibriation to occur between the alcohol in the blood and the alcohol in the head space above it, and I'm going to inject my needle into that. I'm going to leave the needle in there .02 seconds. I'm going to withdraw for .05 seconds. I'm going to put it on a transfer line that's 90 degrees C, and I'm going to run it through a gas chromatograph whose column on the inside is heated up to 55 C, and I'm going to detect it with a flame ionization detector. That's all great. That's the steps. That's the FDLE laboratory. We get a good result, a valid, reliable result. . . . The University of Miami, they use a Hewlett- Packard gas chromatograph. It has an autosampler on it, too, and to prep their samples, they don't have an automatic sampler to get the blood out where they can automatically sample 50 microliters and dilute it with 1,000 milliliters of internal standard. They're going to use pipettes. They're going to manually do it. Their sample size is 500 milliliters of blood. They automatically pipette their 500 milliliters of blood, put it in the special container for the autosampler. They're only diluting with 500 milliliters of internal standard, and their internal standard concentration is a .04. They seal off their bottle. They put it on the autosampler. They decide to equilibrate for 22 minutes at 50 C. The other lab was at 60. Their transfer line is-— they're going to inject for .05 seconds and withdraw for .05 seconds, and they're going to use their transfer line heated to 85 Celsius, and their gas chromatograph was heated to 50 Celsius, and they use a flame ionization detector, because most everybody does. Those are all little different parameters, right, but I just described two procedures, and the end result is they get the same answer. All the little minute things are laboratory-specific for the equipment that they have, everything from how they pipette the sample out of [the] blood tube to how they analyze it and the temperatures and the pressures and the operating parameters, transfer line temperatures, things like that, those are all individualized to a laboratory, and just because they're different doesn't make it wrong. To further go along with the description of their method and the overall requirements of the procedure that we're looking at, I proficiency test the analysts from the University of Miami. They're using different temperatures. They're doing things a little bit differently. Granted, everything's about-— generally, it's the same, but the temperatures are different and things like that. I proficiency test them before I even give them a permit, and both of their procedures provide accurate and reliable results, and that's why it's not detailed down to the minutia in that particular section [of the rule], because there are differences that can occur in the grand scheme that don't affect the overall end result. Ms. Barfield agreed that it would be possible to write a rule to encompass every detail for each of the labs, but stated that it is not scientifically necessary to enact such a rule. She further stated that such a rule would not be feasible because it would require every lab to have the same equipment and procedures, from pipetting the blood sample to the gas chromatograph to the autosampler to the same gases, operating at the same temperatures. Ms. Barfield testified that it would not be feasible to impose the same criteria for every procedural step in every lab without incurring an enormous outlay of money. She noted that a gas chromatograph alone costs around $50,000. Ms. Barfield acknowledged that Florida Administrative Code Rule 11D-8.003(2) specifically approves two, and only two, instruments for the conduct of breath tests: the Intoxilyzer 8000 and the Intoxilyzer 5000. FDLE rules also call for the Alcohol Testing Program to register and conduct validation inspections of particular breath testing machines. Fla. Admin. Code R. 11D-8.004. When questioned as to why FDLE did not regulate gas chromatographs in the same manner, Ms. Barfield replied that any comparison between breath and blood testing is "apples to oranges." There is no need for the rules to identify "approved" gas chromatographs because all of the commercially available machines do the job for which they are designed. Breath testing is complicated by the fact that law enforcement personnel are operating scientific equipment; having a multitude of different testing instruments could jeopardize accuracy. It is preferable to train all breath test operators on the same equipment. In contrast, the gas chromatographs used in blood testing are being operated by professional analysts who have their own standards of practice. Thus, there is no need to standardize the equipment used in blood testing. Ms. Barfield failed to note that Subsection 316.1932(1)(a)2., Florida Statutes, states: "The Alcohol Testing Program within the Department of Law Enforcement is responsible for the regulation of the operation, inspection, and registration of breath test instruments." (Emphasis added.) The statute charges the program with responsibility for the regulation of persons who operate, inspect and instruct on the breath test instruments, and for analysts who conduct blood testing, but nowhere does it specifically authorize the Alcohol Testing Program to regulate blood testing instruments. The apparent lack of statutory authority to regulate the gas chromatographs used by blood testing labs convincingly supplements Ms. Barfield's more practical reasons for the lack of a rule on this subject. Dr. Masten testified for Petitioner that it is possible to create a checklist for performing a gas chromatographic analysis of blood alcohol content. He also stated that a checklist such as those used by quality assurance auditors might be a desirable way to standardize operations and lessen the potential for error. However, Dr. Masten also conceded that alternate methods can achieve reliable, accurate results, and that proficiency testing can assure such results. Two analysts in different labs may use variations on the gas chromatography method, such as different temperatures and pressures during the testing. Dr. Masten knew of differences in instrumentation between FDLE's labs in Tallahassee and Orlando. However, if each analyst passes proficiency testing, then each analyst's processes are validated. Dr. Masten testified that there are a number of different manufacturers of gas chromatograph instruments, which vary in terms of their capacity but otherwise achieve reliable results in blood testing. Different gas chromatographs use different materials in their columns. There are also several internal standards that are acceptable. Dr. Masten defined a methodology as a set of specific conditions, some of which are columns, temperature, pressure of the gas flow or rate of the gas flow, and the type of machine. These are all different parameters that are normally addressed in the SOP. Reasonable scientists can disagree as to certain parameters, such as the amount of dilution. Dr. Masten stated that the prime criterion for any set of conditions is to prove they work. Because gas chromatography has so many variables, there is a large matrix of different conditions that potentially achieve correct results. These conditions vary from lab to lab, and to a lesser degree from analyst to analyst within a lab. If an analyst's method is validated, it can be used to reach an accurate and reliable test result. The greater weight of the expert testimony at the instant hearing established that a perfectly uniform manner of performing either gas chromatography or the alcohol dehydrogenase analysis would not be scientifically sound nor economically feasible. Dr. Goldberger reasonably opined that a defendant is provided with the equivalent of the "checklist" desired by Petitioner: the SOP, the analyst's worksheet, and the raw data of the analysis provide a reviewing expert with all the necessary information to contest the analyst's work. The fact that all SOPs are not perfectly uniform in accordance with the idealized rules envisioned by Petitioner is less important than the fact that all SOPs and analysts' test results are available as public records and may be reviewed for their accuracy and reliability. The evidence at hearing established that blood alcohol testing is dissimilar to breath testing. Specific instruments must be approved for breath testing because law enforcement personnel operate the instruments. Uniformity of equipment helps to simplify the permitting process and helps to ensure accuracy in testing. Also, Ms. Barfield at least suggested that there may be breath instruments on the market that are themselves unreliable. In contrast, the expert testimony at hearing established that all commercially available gas chromatographs perform their intended functions, and that blood alcohol analysts are trained professionals able to operate according to their labs' SOPs, without detailed, step-by-step instruction imposed by FDLE rules. The evidence established that Florida Administrative Code Rules 11D-8.011 and 8.013 substantially comply with their statutory authorities. Test methods are established by Rule 11D-8.011. Methods of administration are found in the uniform permitting criteria set forth in Rule 11D-8.013(3)(a)-(g). Dr. Goldberger testified at length regarding the development of the rules, and Ms. Barfield described the application of the rules during the permitting process and in the laboratory. Both of these experts agreed that it would be poor science to require every analyst in the state to perform testing according to the standards of a single laboratory. The science of gas chromatography in blood alcohol testing simply does not require such rigidity.9 The challenged rules reasonably set forth permitting criteria and proficiency testing that insure the scientific reliability of the blood alcohol testing carried out by analysts operating under permits issued by the Alcohol Testing Program of FDLE. No evidence was offered by either party regarding the necessity to specify the types or amounts of preservatives and anticoagulants that must be contained in the glass evacuation tubes used to collect blood samples. No evidence was offered by either party as to the necessity to specify a range of temperatures for the refrigeration of blood samples collected pursuant to the implied consent law.
The Issue Whether Respondent violated Subsection 466.028(1)(s), Florida Statutes (2000-2005), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of dentistry pursuant to Section 20.43 and Chapters 456 and 466, Florida Statutes (2006). Dr. Driggers is a licensed dentist in the State of Florida, having been issued license number 5473. The Professional Resource Network (PRN) is the impaired practitioner program for the Board of Dentistry, pursuant to Section 456.076, Florida Statutes (2006). PRN monitors the evaluation, care, and treatment of impaired healthcare professionals. Dr. Driggers has a long history of problems with alcohol. On January 15, 1987, he was arrested for driving under the influence (DUI). He was adjudicated guilty of that offense. In 1990, Dr. Ken Thompson did an intervention on Dr. Driggers based on Dr. Driggers' alcohol abuse. As a result, Dr. Driggers was admitted to Glenbeigh Hospital of Tampa for a three-day evaluation of alcoholism and chemical dependency. Dr. Driggers was diagnosed with alcohol abuse and benzodiazepine abuse. Dr. Martin Zfaz, who evaluated Dr. Driggers, recommended that Dr. Driggers attend an outpatient treatment program with Dr. Ken Thompson five days a week, attend 90 Alcoholic Anonymous (AA) and Narcotics Anonymous (NA) meetings in 90 days, and obtain a sponsor. On December 17, 1990, Dr. Driggers entered into an Impaired Practitioner Program of Florida Physicians Recovery Network Advocacy Contract. The contract required that he "abstain completely from the use of any medications, alcohol, and other mood altering substances." He agreed to attend a self-help group meeting such as AA or NA three times per week, to participate in continuing care group therapy one time per week, and to attend a 12-step program of recovering professionals every other week. The contract was for five years, with renewal subject to review by PRN. Dr. Driggers did complete an outpatient treatment program with Dr. Thompson by February 1991. He did attend some meetings of recovering professionals. In January 1992, PRN referred Dr. Driggers to Anton M. Krone, M.D., for an evaluation of Dr. Driggers' status. Dr. Driggers told Dr. Krone that he had not completely abstained from consuming alcohol, but that his consumption had not caused a problem. He was not attending AA meetings and did not have a sponsorship. Dr. Driggers did not consider himself to be an alcoholic and was opposed to attending AA meetings and abstaining completely from drinking. Dr. Krone opined that "it would be very difficult to engage [Dr. Driggers] in a recovery process at this time which is abstinence based." Dr. Krone suggested that "PRN follow him on an informal basis and watch to be sure that he is not getting into future trouble and to be ready to intervene with him promptly if such trouble begins to appear." The contract between Dr. Driggers and PRN dated December 17, 1990, was voided as of February 1992. On October 6, 2000, Dr. Driggers was again arrested for DUI. He drove his car into the back of a car stopped at a red light. He was given a breathalyzer test, which showed a blood alcohol level of .23, which is almost three times the limit for a presumption of DUI in Florida.1 Dr. Driggers did not feel like he was intoxicated and blamed the accident on his leaning over to prevent carry-out food from falling to the floor. He was adjudicated guilty of DUI in October 2001. Dr. Driggers reactivated with PRN and agreed to an inpatient evaluation. On November 13, 2000, he went to Shands at Vista for the evaluation. Dr. Thompson evaluated Dr. Driggers and concluded that he was concerned about Dr. Driggers' ability to practice with reasonable skill and safety. He made the following recommendation for the treatment of Dr. Driggers: "Return for inpatient detoxification with further assessment. I do not believe that in view of his denial, stress, shame, and anxiety level that he would likely be very successful in detoxing himself on an outpatient basis even with supervision." Dr. Driggers remained at Shands at Vista until he was discharged on March 9, 2001, with a diagnosis of alcohol dependence, sedative dependence, and anxiety disorder. On April 1, 2001, Dr. Driggers signed another five- year Impaired Practitioners Program of Florida Physician Recovery Network Advocacy Contract. As before, Dr. Driggers agreed to abstain completely from the use of any medications, alcohol, and other mood altering substances. He agreed to attend self-help meetings such as AA or NA three to four times per week. He agreed to attend a PRN monitored professional support group. Dr. Driggers agreed to participate in a random urine drug or blood screen program within 12 hours of notification. On June 23, 2004, Dr. Driggers tested positive for a metabolite of alcohol based on an ethyl glucuronide test, which detects metabolites of alcohol in urine. On July 12, 2004, Dr. Driggers again tested positive for a metabolite of alcohol based on an ethyl glucuronide test. His July score was higher than his June score. Dr. Driggers admits that he had not completely abstained from the use of alcohol and that he occasionally had a glass of wine with his new wife. Dr. Driggers rationalized his consumption of alcohol with the following comment: "I didn't think that the--that a glass of wine on a particular day would--would not only show in urine, but I didn't think that it was any major thing at the time. It was--it was something I did that I regret." On August 16, 2004, Dr. Driggers was referred by PRN to Martha E. Brown, M.D., for an evaluation. Dr. Driggers admitted to Dr. Brown that he had not abstained completely from alcohol. He told her that he went to PRN group meetings for a while, but quit going to the meetings. Dr. Brown concluded that she did "not feel Dr. Driggers can practice with reasonable skill and safety. He has been diagnosed with Alcohol Dependency in the past, yet has again resumed drinking. He appears to have much minimization of his alcohol use with rationalizations about it is okay that he has returned to drinking." Dr. Brown recommended that Dr. Driggers continue to participate in PRN, follow PRN recommendations, enter into a long-term residential treatment for chemical dependency, and abstain from all mood altering substances, including alcohol. In September 2004, Dr. Driggers sought a second opinion from Chowallur Dev Chacko, M.D., who is board-certified by the American Board of Psychiatry in general psychiatry, addiction psychiatry, and forensic psychiatry. Based on Dr. Driggers' long history of alcohol abuse and his continuing to drink while under a monitoring contract with PRN, Dr. Chacko opined that Dr. Driggers was not able to practice his profession with reasonable skill and safety and recommended that Dr. Driggers receive long-term residential treatment for his alcoholism. Dr. Driggers refused to follow the recommendations of either Dr. Brown or Dr. Chacko. On November 9, 2004, PRN sent notice to the Department advising that Dr. Driggers was not in compliance with his PRN monitoring contract. On June 17, 2005, Dr. Driggers returned to Dr. Brown for a new evaluation. Dr. Brown was still of the opinion that Dr. Driggers had a substance dependency problem and needed treatment. During her evaluation of Dr. Driggers, he told her that he would not be in PRN and would not follow PRN's recommendations. He was in severe denial concerning his chemical dependency. Dr. Brown recommended that Dr. Driggers should participate in PRN and follow the recommendations of PRN; that Dr. Driggers should minimally enter a partial hospitalization program with a step-down to an intensive out- patient program for his chemical dependency; that he should abstain from all mood altering substances, including alcohol; that he should attend 90 meetings of a self-help program in 90 days; and that he should turn in a signed list for attendance at 12-step meetings for six months to document his recovery. Dr. Driggers was evaluated by Jeffrey A. Danziger, M.D., on September 8, 2005, at the request of Dr. Driggers' attorney. Dr. Danziger opined that Dr. Driggers did not meet the criteria for alcohol dependence or active alcohol abuse at the time of the evaluation. Dr. Danziger diagnosed Dr. Driggers with posttraumatic stress disorder, in remission, and alcohol abuse, in sustained full remission. It was Dr. Danziger's "opinion that, from a psychiatric standpoint, Dr. Driggers did not have any substance abuse or psychiatric problems that would impair his ability to safely function as a dentist." Dr. Danziger explained that much of his evaluation was focused on whether Dr. Driggers posed an immediate danger that would justify an emergency suspension. Dr. Brown reviewed Dr. Danziger's evaluation report on Dr. Driggers and her prior evaluations of Dr. Driggers. On January 30, 2006, she opined as follows: I continue to believe that Dr. Driggers has a diagnosis of Alcohol Dependency as evidenced by having a BAL [blood alcohol level] of .2 at the time of one of his second DUI, indicating tolerance to the use of alcohol as "social" drinkers at a BAL of .2 would not have been able to get in their car to drive; he has been unsuccessful in his efforts to control his substance use while in PRN (he had continued to drink while in PRN) and again, if he was a social drinker, should have been able to completely abstain from substance use in PRN without any difficulty; and he has continued to use alcohol despite knowledge of having a persistent and recurrent problem with alcohol. Certainly of note is the fact that he has had not one but 2 DUIs in his past. He continues to have a great denial about the disease of chemical dependency and the need to abstain from all mood altering substances. This type of thinking poses an extreme risk to the public for him practicing without appropriate monitoring of his status by PRN. Alcohol Dependency is a permanent medical disease that does not go away once you develop it. A healthcare professional that has Alcohol Dependency must have long-term, appropriate treatment and monitoring to ensure they do well and can practice. In the most recent records you sent, numerous individuals gave affidavits that they have never seen him impaired while practicing. However, I would point out that simply not drinking at work, or not looking impaired, does not translate into whether one can practice their profession with reasonable skill and safety. Dr. Brown continued to recommend abstention from alcohol and mood altering substances, outpatient treatment, and participation in PRN monitoring. If those recommendations were followed, she felt that he could practice with reasonable safety and skill. However, Dr. Driggers has continued to refuse to participate in any PRN monitoring. On September 27, 2006, Dr. Danziger again evaluated Dr. Driggers. He was still of the opinion that Dr. Driggers had a diagnosis of alcohol abuse rather than alcohol dependence. Once you have a diagnosis of alcohol abuse, you will always have alcohol abuse, but it can be in remission. He agrees with Dr. Brown that Dr. Driggers is in need of outpatient treatment and monitoring. Whether Dr. Driggers' drinking problem is labeled alcohol abuse or alcohol dependence, the consensus of the experts in addiction psychiatry who evaluated Dr. Driggers is that Dr. Driggers must have some type of treatment and must be monitored in order for him to be able to practice dentistry with reasonable skill and safety. Dr. Driggers has been disciplined previously by the Board of Dentistry in 1989.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Driggers has violated Subsection 466.028(1)(s), Florida Statutes (2004); giving Dr. Driggers a written reprimand; requiring Dr. Driggers to undergo a new evaluation by a PRN- approved evaluator; requiring Dr. Driggers to comply with PRN recommendations; and suspending his license until he undergoes further evaluation and begins compliance with PRN recommendations. DONE AND ENTERED this 17th day of April, 2007, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 17th day of April, 2007.
