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SHEILA JOY SUTTLE vs DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 90-001880 (1990)
Division of Administrative Hearings, Florida Filed:Sarasota, Florida Mar. 27, 1990 Number: 90-001880 Latest Update: Jul. 25, 1990

The Issue Should Petitioner be considered eligible for licensure and licensed as a clinical laboratory supervisor in the specialties sought.

Findings Of Fact At all times pertinent to the matters in issue here, Petitioner was licensed as a clinical laboratory supervisor in the State of Florida in the areas of hematology, serology and microbiology, under the provision of Chapter 483, Part I, Florida Statutes. This licensure is based upon her passing an examination in those subjects and her certification as qualified pursuant to Section 241, Public Law 92-603 by the Bureau of Quality Assurance, Public Health Service of the United States Department of Health, Education and Welfare. She is not certified in the areas in which certification is herein sought. The Department is the state agency responsible for the licensure and regulation of clinical laboratory personnel, including supervisors, in Florida. Petitioner has been licensed as a clinical laboratory supervisor in the disciplines set out above for approximately 12 years, the last six of which, she has spent at the laboratory at Doctor's Hospital in Sarasota, a laboratory approved by the State of Florida. In November, 1989, she applied for supplemental licensure as a clinical laboratory supervisor in the fields of chemistry and immunohematology, but was denied the requested licensure because she does not have either a bachelor's degree with a major in science, or 90 semester hours study in that field at an accredited college or university. Her educational and experience background are, however, impressive. Between June, 1965 and December, 1966, she was in training in the areas of hematology, serology, chemistry, microbiology and immunohematology. In January, 1967, she went to work in a doctor's office and set up his laboratory in which she worked in hematology testing, chemistry and urinalysis. In September, 1967, she went back to a hospital as a technologist in all phases of laboratory work. In July, 1973, she moved to Sarasota and went to work in the laboratory at Doctors Hospital, working with all five subspecialties. She held the job of technician and supervisor in all fields in which she was licensed. Petitioner asserts, and the Department agrees, that she was licensed in Florida as a supervisor in hematology in 1978, and in the areas of microbiology and serology in 1979. In April, 1980, Petitioner went to work for several doctors in Bradenton as a laboratory technician/technologist, remaining there through December, 1980, when she went back to Doctors Hospital, again working in all five specialty areas, and remained there as a technologist and supervisor in those areas in which she was licensed, until October, 1989. Since that time, she has worked in a Sarasota oncology laboratory, in hematology and clinical chemistry. She does no on-site chemical testing, however, since all is sent out. Through cross examination of the Petitioner, Respondent established that in 19878, and again in 1979, Petitioner took and failed to pass the Florida examination for supervisor in clinical chemistry and hematology. In the instant case, however, her protest is not about the grade she received on those examinations, but of the refusal to grant her licensure without examination on the basis of her experience. Petitioner is well thought of by the physician's for whom she works. Dr. Barbara J. Harty-Golder, a pathologist and her current supervisor, has known her since 1983 and has indirectly supervised her work since that time. She feels that Petitioner's performance in laboratory technology in the areas in which she seeks certification, is quite good. She has rarely worked with anyone as proficient and competent. Petitioner has exceptionally good people skills. She keeps up with current advances, and based on the witness' experience, which comes from supervision of several laboratories, she feels the Petitioner is fully qualified to be a supervisor in the areas in which she seeks certification. In late November, 1989, after Petitioner had submitted her request for licensure without examination, Ms. Nancy Chapman, assistant administrator of the Department's laboratory licensure division, and the individual responsible for evaluating Petitioner's application, wrote to her requesting information which was not on file in the Department's records. This information related to Petitioner's holding a bachelor's degree with a major in science. Petitioner did not respond to that request, and Petitioner stipulates that she does not possess the technical formal education specified in the Department's rules.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that the Secretary enter a Final Order denying Petitioner's application to add the specialty areas of clinical chemistry and immunohematology to her clinical laboratory supervisor's license. RECOMMENDED this 25th day of July, 1990, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of July, 1990. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 90-1880 The following constitutes my specific rulings pursuant to S 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. Accepted that Petitioner is a duly certified laboratory technologist, but not proven as to the subject matters in which so certified. & 4. Accepted and incorporated herein. 5. Accepted and incorporated herein. FOR THE RESPONDENT: 1. & 2. Accepted and incorporated herein. COPIES FURNISHED: Edward A. Haman, Esquire DHRS 7827 North Dale Mabry Highway Tampa, Florida 33614 Lawrence J. Robinson, Esquire Robinson, Robinson & Fogleman, P.A. P.O. Box 2720 Sarasota, Florida 34230-2720 John Miller General Counsel DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700 Sam Power Agency Clerk DHRS 1323 Winewood Blvd. Tallahassee, Florida 32399-0700

Florida Laws (2) 120.57483.051
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ANGELO P. RIVERS vs DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES, 93-001557 (1993)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Mar. 22, 1993 Number: 93-001557 Latest Update: Jun. 15, 1995

The Issue The issue for determination is whether Respondent is guilty of discrimination in employment on the basis of race in connection with the terms and conditions of employment of Petitioner.

Findings Of Fact Petitioner Angelo Rivers, a black male, was employed in the formulation/confirmation unit of Respondent's pesticide laboratory located in Tallahassee, Florida from May 25, 1990, through August 20, 1992. Marshall Gentry, a white male, provided overall supervision of the pesticide laboratory during Petitioner's employment. Petitioner's direct supervisor when he began work in the laboratory, however, was Wendy King, a female of oriental extraction. Subsequently, King was promoted and direct supervision of Petitioner was accomplished by Patty Lucas, a white female, who in turn was supervised by Wendy King. In the course of his employment with Respondent's pesticide laboratory, Petitioner exhibited a good attitude and received good performance ratings from Respondent. Included among these ratings was a special evaluation related to the conclusion of Petitioner's probationary period following his promotion from laboratory technician I to laboratory technician II. Two other laboratory technicians were employed in the pesticide laboratory. William Reeves, a black male, was employed as a laboratory technician IV in the formulation/confirmation unit of the laboratory. Elliott Healy, a white male, was employed as a laboratory technician III in the pesticide use monitoring unit of the laboratory. Both of these individuals were required to perform all the functions of a laboratory technician. The formulation/confirmation unit is the consumer protection component of the pesticide laboratory. The unit's field staff surveys the marketplace and collects samples of pesticides that are in channels of trade for distribution and sale. Those samples are then analyzed by the unit to assure that the contents of the package match the label guarantee, thereby providing reasonable assurances to consumers that the products which are sampled contain the represented contents. The pesticide use monitoring unit of the pesticide laboratory performs analyses associated with either groundwater sampling used to determine trace levels of pesticides or samples collected in association with determining misuse, property damage or human health damage connected with exposure to pesticides. Personnel in this unit are usually analyzing within the range of parts per billion, sometimes parts per million, and to prevent contamination the unit is separated from the formulation unit. The pesticide laboratory contains three permanent types of employees: Chemists (including supervisors), clerical and laboratory technicians. Each of these have their own duties and responsibilities. With regard to educational requirements, a chemist is required to have at least one college degree in the subject area of chemistry. Requirements for laboratory technicians are fairly minimal although a scientific education may play a part in initial assignment. In accordance with normal practices, training was provided to Petitioner commensurate with his position as a laboratory technician II, inclusive of some formal training but generally on the job training. William Reeves, the black laboratory technician IV, is presently in his junior year of undergraduate study in Entomology; Elliot Healy, the white laboratory technician III, received his degree in Entomology in 1979. Petitioner offered no evidence at final hearing regarding his education, except to state that he does not have a college degree. There is no laboratory technician position above the laboratory technician IV position. Neither Petitioner, Reaves or Healy meet requirements for promotion to the position of chemist since they do not possess the required chemistry degree. With regard to promotion within the laboratory technician family, no specific time periods are required to elapse before employees are granted a promotion. Such action depends upon other factors such as promotional opportunities. Duties within the laboratory are assigned on the basis of the position (e.g., chemist II, laboratory technician III, etc.) and the area where the individual is assigned. Race is not a consideration in making duty assignments. Twelve of Respondent's twenty-six laboratory technicians are white and fourteen are black. Laboratory technicians perform the duties required for their specific level without regard to the individual technician's race. The same is true of chemists in the laboratory. James Fort, a black chemist, performs the functions of a chemist. There are occasions or special events that occur from time to time when news media or officials tour the facility and all personnel are expected to help with cleaning the pesticide laboratory. The laboratory technicians, however, are responsible for the laboratory at large. This responsibility does not include the normal maintenance chores such as changing light bulbs, fixing water fountains and leaking sinks or similar functions since these duties are normally performed by a maintenance and grounds crew who also take care of the exterior grounds of the facility. The end product of the laboratory is the analytical result for which laboratory technicians and clerical staff provide support. Chemists or their supervisors perform the analytical chemistry work, quantitative analytical work and detailed analyses of samples, resulting in a laboratory report. Such work could require the use of nitrogen analyzers, gas chromatographs, high performance liquid chromatographs and other similar analytical instrumentation. Laboratory technicians perform the less technical tasks in the laboratory while clerical and support staff handle paperwork, correspondence and similar functions. Non-black employees, whether laboratory technicians or not, performed physical and other tasks of which Petitioner has complained. Such non-black employees include Marshall Gentry, Wendy King, Patty Lucas, David Bevis, Michael Bentley, Elliot Healy and David Goldston. Healy and Goldston are laboratory technicians in the pesticide laboratory. On January 22, 1992, Petitioner suffered a back injury in the course of assisting with the moving of a freezer at the laboratory. Numerous whites assisted in the moving the freezer, including Marshall Gentry, David Goldston, David Bevis, Michael Bentley, and three or four other unnamed white persons. None of the persons involved in moving the freezer had lifting belts. Laboratory services, a section within Respondent's Feed, Seed and Fertilizer Laboratory Bureau, functions as the receiver for all feed, seed and fertilizer samples for Respondent's laboratories. Marshall Gentry eventually discovered that assistance of laboratory services personnel would be required to move the freezer. After obtaining that assistance, Gentry withdrew from the effort of moving the freezer and went about other tasks. Gentry mistakenly thought that Petitioner had also returned to other duties. Petitioner did not report his injury to anyone on January 22, 1992, until after the movement of the freezer had been completed and disposal of packing materials accomplished. He was immediately taken to see a physician and an accident report was filed. Following his injury, supervisory staff made periodic inquires regarding Petitioner's physical condition and made good faith efforts to comply with the limited information flowing to them which placed physical restrictions on Petitioner. Petitioner received doctor's orders dictating that he not lift more than a certain amount of weight. Over the course of ensuing months, these orders varied the amount of weight that Petitioner could be expected to lift with weight limits ranging from as low as 10 pounds to as much as 20 or 40 pounds upon occasion. Eventually, Petitioner was given doctor's orders that prescribed "light work" for Petitioner. Petitioner did not elaborate on the doctor's orders to his superiors. Petitioner's supervisors determined that his disability would be accommodated through a practice whereby Petitioner would simply tell his supervisor if Petitioner felt unable to perform a particular task. There is no evidence that Petitioner's race was considered by his supervisors in the assignment of tasks to him. John Stupka, an Other Personal Services (OPS) employee with Respondent was assigned to the pesticide laboratory in April or May of 1991. He was not used, however, as a substitute for permanent laboratory technician employees although he did on occasion perform certain work that they would have performed if he had not been employed. He was never assigned to a position in any permanent employee class, including the laboratory technician class. Stupka was a white male premed student who was attending college in addition to his sporadic work with Respondent. He had no formal description of duties and was utilized as a temporary addition to the overall laboratory operation. Stupka's strong background in and interest in various chemical procedures permitted his utilization to a significant degree in this area, although he did not perform sophisticated chemical procedures. Generally, since his daily work schedule varied and lacked predictability as to when he would be present, the OPS employee was assigned long term duration projects such as cataloging information for a library of pesticide standards. On or about June 30, 1992, Petitioner felt concerned about what he perceived to be discriminatory treatment in the assignment of job tasks received by him and, unknown to any of his supervisors, filed a complaint with the Florida Human Relations Commission. The evidence of record fails to indicate the disposition of this complaint. 1/ At any rate, supervisory personnel were unaware of the complaint when Gentry, King and Lucas met with Petitioner on July 10, 1992, to discuss what activities could be undertaken by Petitioner. The meeting was precipitated by Petitioner's note to Patty Lucas on July 8, 1992, stating he could not comply with an assignment given to him by Lucas. Lucas excused him from the assignment. In the course of the meeting, his supervisors reiterated to Petitioner that he should perform only those tasks that he could perform and inform his supervisors of tasks that he could not perform. His supervisors anticipated that Petitioner would eventually recover and return to full duties. A functional capacity examination was not taken by Petitioner until August 25, 1992, due to cancellation of an earlier appointment. On August 20, 1992, Petitioner submitted his voluntary resignation stating that he was unable to perform the duties of the laboratory technician II position. When Marshall Gentry learned of the resignation letter on that date, he approached Petitioner to give him the opportunity to rescind the resignation. Petitioner responded that he recognized that the laboratory had a "big job to do" and that they "need somebody else to do it."

Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered dismissing the Petition for Relief. DONE AND ENTERED this 14th day of July, 1994, in Tallahassee, Leon County, Florida. DON W. DAVIS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of July, 1994.

Florida Laws (2) 120.57760.10
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AGENCY FOR HEALTH CARE ADMINISTRATION vs USA REHAB AND CHIROPRACTIC CENTER, INC., 14-003118 (2014)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Jul. 08, 2014 Number: 14-003118 Latest Update: Jun. 02, 2015

The Issue Whether Respondent, USA Rehab and Chiropractic Center, Inc., should have a penalty and fine imposed against its license for alleged statutory and rule violations.

Findings Of Fact On August 23, 2013, Respondent submitted to Petitioner a Health Care Licensing Application (Application) using AHCA Recommended Form 3110-0013, August 2013. The Application was submitted for the purpose of renewing Respondent’s license to operate as a health care clinic. Personnel File and Background Screening Results Section nine of the Application seeks a listing of Respondent’s “licensed health care practitioners and all personnel who provide personal care services to clients or with access to client funds.” Employees that fall within this classification are required to submit to, and successfully pass, a Level 2 background screening. Respondent identified on the Application four individuals that fell within the designated category. Florida Administrative Code Rule 59A-33.012(1) directs that a “survey” will be conducted for “[a]pplications for renewal licenses.” This rule also provides that the survey process “is an onsite inspection and review of the health care clinic facility or administrative office, by authorized Agency employees to determine the health care clinic’s compliance with the minimum standards established by the Act, its statutory references and rules regulating the operation and licensure of health care clinics.” Vanessia Bulger was assigned to conduct the survey related to Respondent’s Application. On November 25, 2013, Ms. Bulger visited Respondent’s facility for the purpose of conducting the required survey. Ms. Bulger met with the owner of the facility, Mr. Lavaud Fevry. While meeting with Ms. Bulger, Mr. Fevry disclosed that after submitting his Application to the Agency, the health care clinic hired two additional employees who provided personal care services to the clinic’s clients. Ms. Bulger wrote the names of the two new employees on her copy of section nine of the Application and further identified these employees with the letters “C” and “D.” Employee “C” is Eugene Grazette and employee “D” is Dexter K. John. For employee “C,” Ms. Bulger wrote “Eugene Grazette – 8- 31-15 – NO BG” and for employee “D” she wrote “Dexter K. John 10- 17-09 BG.” Ms. Bulger testified that “NO BG” stands for “no background screening results.” The Administrative Complaint does not allege that employee “C” had not passed a Level 2 background screening at the time of the survey conducted by Ms. Bulger. Count I of the Administrative Complaint does allege, however, that Respondent failed to maintain a copy of the Level 2 background screening results in the personnel file for employee “C.” It is undisputed that employee “C,” during all times relevant hereto, possessed a valid health provider license that authorized him to deliver personal care services to Respondent’s clients. Additionally, the evidence also establishes that on September 18, 2013, approximately two months before the survey, Respondent, via electronic submission, requested a Level 2 background screening for employee “C.” Ms. Bulger, as part of the survey process, completed a “Heath [sic] Care Clinic Surveyor Worksheet & Facility Questionnaire.” Item nine of the questionnaire asks, “[i]s there a log of all natural persons required to be screened and who have been screened under Level 2 criteria?” In response to this question, Ms. Bulger wrote “NO - New Chiropractor – massage therapist not listed.” The questionnaire does not ask on any of its 10 pages whether a copy of the Level 2 background screening results is maintained in the personnel files of the employees of the clinic. At the time of the survey, employee “C’s” personnel file did not contain a copy of the results from his Level 2 background screening. Attestation Regarding Background Screening Section 10 of the Application is labeled “Affidavit.” Mr. Fevry provided the following attestation in support of the Application: I, Lavaud Fevry, hereby swear or affirm that the statements in this application are true and correct. As administrator or authorized representative of the above named provider/facility, I hereby attest that all employees required by law to undergo Level 2 background screening have met the minimum standards of sections 435.04, and 408.809(5), Florida Statutes (F.S.) or are awaiting screening results. Count I of the Administrative Complaint also alleges that when Mr. Fevry met with Ms. Bulger during the survey he informed her that: he had no affidavit or documentation that the employees, including the Medical Director, had . . . attest[ed] to meeting the requirements for qualifying for employment pursuant to Florida law and agreeing to inform the employer immediately if arrested for any of the disqualifying offenses while employed by the employer per chapter 435, Florida Statutes. The evidence establishes that Respondent’s employees had not completed the required attestations until after the survey. In December 2013 Respondent submitted a plan of correction to address problems related to employee attestations. Exactly 21 months prior to the survey that provides the basis for the instant dispute, Petitioner, on February 23, 2012, conducted a survey of Respondent’s clinic. As a part of this earlier survey, Respondent was also cited for failing to ensure that required staff completed attestations, subject to penalty of perjury, wherein they acknowledged meeting the requirements for employment and agreeing to immediately inform Respondent if arrested for a disqualifying offense. Verifying Florida Licenses Emmanuel Nau, M.D. has served as Respondent’s medical/clinic director since August 2009. Dr. Nau, at all times relevant hereto, held Florida Department of Health medical license number ME48249. Dr. Nau, as medical director for Respondent’s clinic, acknowledges that he has legal responsibility for the clinic as specified in section 400.9935, Florida Statutes. On the day of the license renewal survey, Ms. Bulger inquired of Dr. Nau as to whether, in his capacity as medical director, he was verifying that all practitioners at the clinic who were providing health care services or supplies to clinic patients had active, unencumbered Florida licenses. Dr. Nau, in response to the inquiry, admitted to Ms. Bulger that he had not verified the license status of the clinic’s practitioners. There was, however, no evidence indicating that Respondent’s practitioners did not actually possess active, unencumbered Florida licenses during the period in question. Additionally, no evidence was offered that Respondent had previously been cited for committing violations of this nature. In December 2013 Respondent submitted a plan of correction that was designed to shore up its system of verifying that its employees have active, unencumbered Florida licenses. Failure to Document “When” and “What” Ms. Bulger testified that during the survey, Respondent failed to produce, upon request, confirmation that Dr. Nau documented, for the two years prior to the survey, compliance of when and what action was taken relative to several of the functions, duties and clinic responsibilities enumerated in section 400.9935(1)(a)-(g), Florida Statutes. When Ms. Bulger, on the day of the survey, questioned Dr. Nau about the omissions, he admitted that he failed to document and to maintain for the previous two years, records demonstrating “compliance, when and what action” he took in regards to the performance of his functions, duties, and responsibilities as medical director for the clinic. Dr. Nau also admitted during the final hearing that he had not been listing in his reports all information related to the performance of his duties as medical director of Respondent’s clinic. No evidence was offered that Respondent had previously been cited for committing violations of this nature. In December 2013 Respondent submitted a plan of correction designed to ensure that clinic reports adequately address those matters required by statute and rule.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order finding that USA Rehab and Chiropractic Center, Inc., violated sections 400.991, 400.9935, 408.809, and 435.05(2), Florida Statutes. It is also recommended that the Agency suspend Respondent’s health care clinic license for 10 business days and impose against Respondent a fine in the amount of $3,500. Finally, it is recommended that Count III of the Administrative Complaint be dismissed. DONE AND ENTERED this 22nd day of April, 2015, in Tallahassee, Leon County, Florida. S LINZIE F. BOGAN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of April, 2015.

Florida Laws (11) 120.569120.57400.9905400.991400.9935400.995408.809435.04435.05435.06435.07
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FLORIDA PERFUSION SOCIETY AND FLORIDA HOSPITAL ASSOCIATION vs BOARD OF CLINICAL LABORATORY PERSONNEL, 94-005968RP (1994)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Oct. 21, 1994 Number: 94-005968RP Latest Update: Feb. 14, 1997

The Issue The issue is whether proposed rules 590-2.002, 590-3.003, 590-5.001, 590- 5.002, 590-5.006, 590-9.002, 590-9.004, 590-10.004 and 590-13.006 are an invalid exercise of delegated legislative authority.

Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Background These cases arose after respondent, Board of Clinical Laboratory Personnel (Board), published in the Florida Administrative Weekly its notice of intent to adopt certain revisions in Chapters 59O-2, 59O-3, 59O-5, 59O-6, 59O-9, 59O-10 and 59O-13, Florida Administrative Code. The proposed rules deal with the subject of alternate site testing within the state. The Board was created by the legislature in 1992 to regulate clinical laboratory personnel. Its authority and duties are set forth in Part IV of Chapter 483, Florida Statutes. The Board's purpose is to ensure the protection of public health, safety, and welfare through the regulation of clinical laboratory personnel. To this end, the Board is required by law to prescribe minimal qualifications for clinical laboratory personnel. Alternate site testing is any "laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory." It can only exist in a hospital under the direct supervision of the central clinical laboratory and its clinical laboratory director. The alternate site laboratory does the same type of testing as does the central laboratory but it uses different equipment. Alternate site testing is performed using ten to twelve instruments specifically designed for that purpose, and which specifically incorporate safeguards to prevent misuse or misinterpretation. Clinical laboratory personnel are persons who perform clinical laboratory examinations on specimans derived from the human body for the purpose of delineating information for the diagnosis, management and treatment of patients. There are four classes of clinical laboratory personnel, namely, technician, technologist, supervisor and director. Within the category of technician are various specialty categories including clinical chemistry, hematology, immunohematology, histology, radioassay, serology, microbiology, exclusive use and alternate site. In general terms, the proposed rules define an alternate site technician, set forth the curriculum requirements for training programs for alternate site technicians, state the minimum standards for licensure as an alternate site technician, prescribe the initial licensure and renewal fees for alternate site technicians, set forth the scope of practice for all clinical laboratory personnel, and enumerate the responsibilities of alternate site technicians including limits on tests that can be performed with this type of licensure. These rules were adopted after various workshops, public meetings and member conference calls were conducted by the Board in 1993 and 1994. As clarified by a more definite statement, petitioners in Case No. 94- 5968RP, Florida Perfusion Society (FPS) and Florida Hospital Association (FHA), contend that all or parts of proposed rules 590-2.002, 590-3.003, 590-5.006, 590-9.002, 590-9.004, 590-10.004 and 590-13.006 are invalid on the grounds (a) the Board exceeded its rulemaking authority, (b) the rules are arbitrary and capricious, and (c) the rules contravene the law being implemented. Petitioners in Case No. 94-5969RP, Florida Society of Pathologists (FSP) and Dr. Louis S. McCann, Jr., have challenged proposed rules 590-5.001 and 590-5.002 on the grounds the two rules contravene the statutes being implemented and are arbitrary and capricious. Petitioner in Case No. 94-5970RP, Florida League of Hospitals (FLH), has challenged the validity of all the proposed rules on the ground the Board has exceeded its rulemaking authority. In addition, it has challenged Rules 590-2.002(7), 590-5.006(2), 590-9.002(4), 590-9.004(7) and 590-13.006 on the ground they contravene the statutes being implemented. Intervenor, Florida Coalition of Professional Laboratory Organizations, Inc., is a nonprofit corporation representing twelve organizations who represent the interests of laboratory professionals licensed under Part IV of Chapter 483, Florida Statutes. It supports the challenged rules and is aligned with the Board in these proceedings. Standing Respondent has stipulated to the standing of the FSP, a professional association of pathologists, and Dr. McCann, its president-elect, and thus there is no dispute that those petitioners are substantially affected by the proposed rules. FPS is a statewide professional medical society representing professional cardiovascular perfusionists in Florida. Perfusionists are principally known for the safe operation and maintenance of the heart-lung machine in open heart surgery. The FPS currently has more than one hundred members, most of whom are actively engaged in the practice of perfusion. The purpose of the FPS is to promote perfusion education and clinical expertise and to address the professional interests of perfusionists on issues affecting the profession, including representation before governmental bodies. Perfusionists are regularly required to perform the type of tests that are performed at alternate sites as part of their profession. The proposed rules would directly regulate their practice. In addition, a substantial number of FPS members would be affected by the proposed rules because they would be required to obtain a license as a laboratory professional in order to continue practicing using alternate test sites, or to use alternate test sites in the future. As such, they are substantially affected by the proposed rules. The FHA is a statewide, nonprofit trade association representing all types of hospitals in the state. As of August 1994, or three months before the hearing, it had 233 institutional members (licensed hospitals), plus various organizational and individual members. Its purpose is to serve its members by developing and promoting programs and services that will enhance their ability to provide comprehensive, efficient, high quality health care to the people of Florida. The association also represents its members at the state and national levels in providing an effective health care system. Only hospitals with clinical laboratories can have alternate site laboratories where alternate site technicians would be employed. The number of institutional members having clinical laboratories is not of record nor is the number of hospitals who plan to operate alternate site laboratories. Even so, it may be reasonably inferred that at least some of the hospitals provide clinical laboratory services in their facilities and, in the future, they intend to provide alternate site testing. Because the proposed rules require medical professionals already licensed or certified to obtain an additional license, limit the professionals who can provide these services, and impose regulatory and financial requirements on the provision of those services, the institutional members of the FHA are substantially affected by these proceedings. Moreover, because the proposed rules impose new training requirements on medical personnel, the hospitals who employ such individuals would be required to absorb the cost of training these employees and providing coverage for their duties while they are being trained. In these respects, they are further impacted by the rules. The FLH is a trade association comprised of seventy-six for-profit hospitals. Of its seventy-six members, seventy-three have clinical laboratories. Because the proposed rules limit the categories of hospital personnel who could be licensed as alternate site testing technicians and restrict the tests that these licensees can perform, the FLH is substantially affected by the proposed rules. Legislative History of Alternate Site Testing In 1993, the Florida Legislature adopted Chapter 93-178, Laws of Florida. That act specifically provided for the implementation of alternate site testing in Florida. The section relating to alternate site testing, which has been codified as Subsection 483.051(9), Florida Statutes, provides as follows: (9) Alternate Site Testing.- The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt, by rule, the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. The elements to be addressed in the rule include, but are not limited to: a hospital internal needs assessment; a protocol of implementation including tests to be performed and who will perform the tests; criteria to be used in selecting the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals; documented inservice training as well as initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for identifying and tracking alternate-site testing by the central laboratory; and recordkeeping requirements. Alternate-site testing locations must register when the clinical laboratory applies to renew its license. For purposes of this subsection, the term "alternate-site testing" means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory. (emphasis added) The bill which became Chapter 93-178, Laws of Florida, originated as PCB 93-01 of the House Committee on Health Care. It was later filed as House Bill 2071 (HB 2071), Medical Tests and Procedures/Sunset. The overall purpose of the bill was to review provisions of Part I of Chapter 483 related to clinical laboratories, which was scheduled for sunset review under Section 11.61, Florida Statutes. The original version of PCB 93-01, dated January 28, 1993, had no provisions relating to alternate site testing. During consideration of the bill on February 3, 1993, the House Committee on Health Care amended PCB 93-01 to provide for rulemaking by the Board. Specifically, the amendment stated that "(t)he board shall adopt rules for alternate site testing to be performed under the supervision of clinical laboratory director." However, the authority for the Board to adopt rules was subsequently removed from the bill by amendment on the House floor on March 23, 1993. The House bill was then considered by the Senate, which amended the House bill on March 31, 1993. The amendment was a "strike everything after the enacting clause" amendment. In effect, the amendment substituted all new bill language in place of the House bill, while retaining the bill number of HB 2071. The alternate site testing language substituted was identical to the bill that had been considered in the Senate as SB 156, which, among other things, added subsection 483.051(9), relating to alternate site testing. This provision gave rulemaking authority to the Agency for Health Care Administration (ACHA) "in consultation with the Board of Clinical Laboratory Personnel." The Senate passed the amended bill and this version was returned to the House. The House then passed HB 2071 as it had been amended and passed in the Senate (with two amendments not related to alternate site testing). The Senate then concurred in the final House version. The amendment relating to subsection 483.051(9) (on alternate site testing) remained intact and eventually became the current Subsection 483.051(9), Florida Statutes. Subsection 483.051(9), as adopted, specifically delegates the rulemaking authority for alternate site testing to AHCA. That provision calls for "consultation" with the Board, but does not give the Board any rulemaking authority. The Board had a designated member, George Mavros, who represented the Board during the legislative session. Initially, the Board recognized ACHA's exclusive rulemaking authority in a report from its legislative liason and in discussions with affected public at its regularly scheduled meetings. That position was reiterated in an official letter to a representative of an affected organization from the Board's chairman. The chairman was specifically authorized to speak for the Board, and the letter reflected the official position of the Board at that time. In its discussions and letters, the Board specifically stated that the newly adopted statute did not give the Board rulemaking authority. Such public statements and letters are evidence of the Board's contemporaneous construction of the statute that it had no authority to adopt rules governing alternate site testing. Since that time, however, the Board has taken an opposing position, that is, that it has authority to adopt rules pertaining to alternate site testing requirements, and the rules under challenge are the end product of this changed position. The statute authorizing AHCA to adopt rules is clear on its face and unambiguous. Moreover, the legislative history reveals that during the 1993 session the legislature specifically considered the delegation of rulemaking authority to the Board in an early version of the bill. The provision giving specific rulemaking authority to the Board was deleted by later action of the same legislature. The final version of the bill contains a delegation of rulemaking authority to AHCA and omits any delegation to the Board. This is clear evidence that the legislature considered giving rulemaking authority to the Board, and instead evinced a clear intent to give exclusive rulemaking authority to AHCA. The legislature cannot be said to have simply forgotton the authority of the Board. Subsection 483.051(9) specifically sets forth the Board's role as a consultant. If the legislature had intended to "split" the rulemaking authority for alternate site testing between the Board and AHCA, it would not have specifically set out a different role in the statute. The legislative staff analyses of the bill support these findings. The staff analyses of subsection 483.051(9) refer solely to AHCA when referencing rulemaking authority for alternate site testing. Therefore, the Board did not have statutory authority to adopt the rules. For the reasons given in the conclusions of law portion of this order, the statutes which the Board relies upon for its rulemaking authority are not deemed to be controlling or relevant. Are the Challenged Rules Invalid for Other Reasons? Nothwithstanding the above findings, and solely for the sake of judicial economy in the event an appeal is taken by any party, additional findings are made relative to each of the challenged rules. In making these findings, it is noted that where new grounds for invalidating a rule have been raised for the first time in a party's proposed order, they have been disregarded as being untimely. Further, where a party has not addressed a previously raised ground in its proposed order, the undersigned has assumed that ground has been abandoned. Where a party speaks to a rule in general terms, and not a specific part thereof, and the undersigned is unable to discern which part of the rule is being attacked, that contention has been disregarded. a. Rule 59O-2.002(7) The first challenged rule is 59O-2.002(7), which defines the term "technician in the specialty of Alternate Site Testing" as follows: (7) Technician in the specialty of Alternate Site Testing means a person qualified to be a technician in the specialty of alternate site testing pursuant to the rules of the Board who under the general supervision of a laboratory director, supervisor or technologist may perform specific testing authorized by the Agency pursuant to rule chapter 59A-7 and the Board pursuant to rule chapter 59O-13 in a hospital based alternate site testing environ- ment approved by the Agency pursuant to section 483.051(9), F. S. and whose practice is limited to an alternate site testing environment. The Board had cited Subsections 483.805(4) and 483.811(3) and (4), Florida Statutes, as the specific authority for adopting the rule while Subsections 483.803 and 483.811(3) and (4), Florida Statutes, are cited as the laws being implemented. Besides leveling the broad charge that the Board lacks statutory authority to adopt the rule, a contention already decided in their favor, petitioners FPS and FHA contend that the rule is arbitrary and capricious because it sets up an impossible condition for qualifying as an alternate site technician since necessary related rules in Chapter 59A-7 have never been adopted by AHCA. In order for the proposed rule to become operable, AHCA must first adopt amendments to its Chapter 59A-7, which pertain to alternate site testing laboratories. Also, AHCA must approve a "hospital based alternative site testing environment" in which such tests can take place. At the time of hearing, a draft of new proposed rules 59A-7.034 and 59A-7.035 was being circulated by AHCA, but had not yet been adopted. Even so, the fact that the Board's rule is contingent on further rules being adopted by another agency does not render the rule arbitrary or capricious. The contention is accordingly rejected. (b) Rule 59O-3.003(3)(e) This rule sets out the proposed requirements for training for individuals performing specific alternate site tests. As modified by the notice of change published in the Florida Administrative Weekly on November 10, 1994, the challenged portion of the rule now provides the following training requirements: (e) Notwithstanding all other provisions of rule chapter 59O-3.003, the only require- ments for training in the specialty of Alternate Site Testing shall be 4 contact hours of instruction per test system with an additional 0.5 contact hour of instruction for each analyte above 8 analytes performed on the same test system. The contact hours of instruction shall be by a Board approved continuing education provider approved pursuant to rule chapter 59O-11 which shall include as a minimum instruction in the tasks defined as follows: * * * The terms "analyte" and "test system," which are the guages on which training is measured, are not defined anywhere in the Board's rules. Besides the argument that the Board lacks statutory authority to adopt the rule, petitioners FPS and FHA contend the proposed rule is arbitrary and capricious in that the requirements are excessive and inflexible. They also contend that the rule contravenes the provisions of Subsection 455.201(4), Florida Statutes, which prohibits a regulatory board from adopting "unreasonably restrictive and extraordinary standards" for a given profession. In proposing the number of hours of training for alternate site testing, the Board relied mainly upon its own members' expertise and judgment. It also relied on public comment given at a Board meeting on August 7, 1993, including testimony from a manufacturer's representative. Finally, it relied upon a training and certification program manual by i-Stat Corporation, a manufacturer of equipment used in clinical laboratories, and on other unspecified "documents and manuals." It did not conduct any surveys of professional literature or other outside services, nor did its staff conduct any research on the subject. Initially, it is noted that the proposed rule gives no consideration to the relative levels of medical training and education in the various professions regulated by the rules, even though that can affect how much training time is needed. For some professionals, such as an ICU nurse or emergency physician nurse, four hours of training is excessive, based on approved manufacturer's training protocol. By providing uniform instruction for all professionals, regardless of their prior training, and without any factual basis for doing so, the Board acted in an arbitrary manner. In arriving at the number of hours of instruction required for each test system, the Board relied in part on the testimony of a manufacturer's representative (Mallinckrodt) given at the August 7, 1993 meeting. A review of his comments, however, reveals that the representative recommended far fewer hours of instruction than is provided for in the rule. Moreover, in prescribing four hours training per test system, the Board relied primarily on its own judgment rather than on technical material submitted by other affected persons. Likewise, the basis for the additional 0.5 hours per analyte over eight analytes was not grounded on empirical data. Indeed, analytes and test systems are not even defined in the rule. Given these shortcomings, it cannot be said that the requirements of the rule are based on facts or logic. The rule is accordingly deemed to be arbitrary and capricious. Given this finding, it is unnecessary to reach the issue of whether the rule contravenes Subsection 455.201(4), Florida Statutes, by providing unreasonable and restrictive standards. (c) Rule 59O-5.001(1)(b), (2)(a), and (2)(b) This rule prescribes the educational requirements for the director of a clinical laboratory. Under current standards (rule 10D-41.067), a director must be a physician or a doctoral scientist. By its rule, the Board proposes to allow a person with a master's degree to become licensed as a clinical laboratory director. The challenged portions of the rule read as follows: Education. An applicant shall meet one of the following education requirements: * * * (b) Have a master's degree in clinical laboratory science, one of the specialty areas, or one of the chemical or biological sciences. Experience. An applicant who qualifies pursuant to rule 59O-5.001(1) shall meet one of the following requirements: (a) Have full time pertinent clinical laboratory experience in an approved laboratory subsequent to receipt of the relevant degree as follows: * * * If qualifying under rule 59O-5.001(b), 8 years of experience. * * * Petitioners FSP and Dr. McCann generally contend the foregoing rule contravenes Section 483.800, Florida Statutes, and is arbitrary and capricious in that it allows untrained persons to become laboratory directors. All state clinical laboratories and their personnel are subject to federal regulation under the federal Clinical Laboratory Improvement Act (CLIA). Regulations promulgated thereunder classify clinical laboratories based on the complexity of the tests performed. The three category of tests are waived, moderately complex and highly complex. Laboratories performing waived tests, or those that are simple and pose no risk to the public, are not regulated by CLIA while those performing moderate to highly complex testing must meet CLIA's minimum requirements for quality control, quality assurance and personnel. CLIA regulations link personnel requirements with the complexity of testing. The requirements for moderate and highly complex testing personnel are defined separately and are significantly different. Those facilities providing only moderately complex testing may use directors having both master's level and bachelor's level degrees. In recognition of both the sophistication of highly complex tests and the broad scope of a laboratory director's duties and responsibilities, however, CLIA regulations require directors of clinical laboratories performing any highly complex testing whatsoever to be either physicians or doctoral scientists. It is noted that hospital laboratories and independent laboratories perform highly complex testing, and that any hospital laboratory, including rural hospitals, providing full service functions will perform highly complex testing. Under CLIA regulations, laboratories which perform highly complex testing allow the director to reapportion performance of responsibilities to persons having less qualifications. The overall responsibility, however, rests with the director, and the regulations do not allow a master's level individual to direct the clinical laboratory performing highly complex testing, or to delegate responsibilities to a more qualified individual. The proposed rule would allow master's degree scientists to direct laboratories performing highly complex testing so long as that individual hired a "co-director" who was a physician or a doctoral scientist. Under this arrangement, the co-director would be left with only those responsibilities that the lesser qualified master's level director called upon him or her to perform. In this respect, the proposed rule is at variance with federal regulations. While the Board justifies this change on the ground a study shows a shortage of various professionals in the rural hospital setting, the study itself was not introduced into evidence. Moreover, the rule would apply to all hospitals, whether rural or not. Even though the proposed rule is inconsistent with CLIA, in its filing with the Joint Administrative Procedures Committee, the Board represented that "(t)here is no ascertainable parallel federal rule or standard with which to make a comparison." It is reasonable to infer that this response was given so that the Board would not have to give an explanation of the rule's inconsistency with CLIA. Although the Board had a wide range of input regarding this rule, it failed to address a number of valid concerns raised by the opponents. Because of the nature of the testing involved in laboratories performing highly complex testing, severe injury or even death can result from an incorrect test result being reported by one of the clinical laboratory personnel. It is esential, therefore, that clinical laboratories performing highly complex testing be directed by the most competent and trained personnel. This goal is not attained in the proposed rule. The appointment of a lesser qualified person would also mean that a director would not be able to perform all work functions in the laboratory, something current directors can now perform. Further, the proposed allocation of responsibilities would place virtually all of the professional liability on the "co-director" (physician or doctoral scientist) even though the co-director does not "direct" the laboratory. Finally, even though a laboratory can be licensed by specialty, this does not eliminate the above concerns since a specialty is not limited to moderately complex testing. Given the lack of a factual basis or logic to support the rule as presently proposed, subsections (1)(b), (2)(a) and (2)(b) of rule 59O-5.001 are deemed to be arbitrary and capricious and are thus invalid. These portions of the rule also contravene Section 483.800, Florida Statutes, which requires, among other things, the "licensure of clinical laboratory personnel who meet minimum requirements for safe practice." (d) Rule 590-5.006 This rule sets forth the educational requirements necessary for the specific types of licensure and certification for clinical laboratory personnel. As modified by the Board on November 10, 1994, the rule now reads as follows: 59O-5.006 Technician in the Specialty of Alternate Site Testing. Those persons licensed as a director, supervisor, technologist or technician pursuant to part IV of chapter 483, F.S., can work in the specialty of alternate site testing without additional licensure or certification. Persons only performing waived tests as defined in section 483.041(9), F. S. in a laboratory holding a certificate of exemption pursuant to section 483.106, F. S., are not required to be licensed and need not meet these requirements. Persons certified only under this rule shall not perform testing beyond that defined in rule 590-13.006. Persons who perform testing defined in rule 590-13.006 at alternate testing sites as defined in section 483.051(9), F.S., shall meet the requirements of rule 590-5.006(1), (2) and (3) as follows: Education. Have a high school diploma or its equivalent and Have completed 4 contact hours of HIV/AIDS continuing education pursuant to rule chapter 59O-11. Training. For purposes of this rule the term "licensed" requires a full permanent license not a temporary license. An applicant who qualifies under the education requirements of rule 59O-5.006(1) shall in addition meet one of the following requirements: Is licensed as a registered nurse pursuant to chapter 464, F. S. Is licensed as a radiologic technologist pursuant to chapter 468, part IV, F. S. Is licensed as a respiratory therapist or as a respiratory care practitioner certified to perform critical care services pursuant to chapter 468, part V, F. S. Is a perfusionist certified by the American Board of Cardiovascular Perfusion-ists. Additional Training. An applicant who qualifies under the education requirements of rule 590-5.066(1) and the training requirements of rule 590.006(2) shall in addition meet one of the following requirements: Have successfully completed a Board approved Clinical Laboratory Personnel Technician training program in general laboratory practice principles pursuant to rule 590-3.003(3)(d). Have successfully completed alternate site testing training for each test the applicant will be performing which provides instruction in all subject matter areas of rule 590-3.003(3)(e). After completing the training, the applicant shall submit verification from the laboratory director that the applicant has successfully completed the alternate site testing training. Have received instruction in all subject matter areas of rule 590-3.003(3)(d) or (e) while enrolled in a program leading to licensure under chapters 464, 468, part IV, or 468, part V, F. S., or certification by the Board of Cardiovascular Perfusionists and shall submit verification from the program director of such instruction. Although a number of grounds for invalidating the rule were raised in the initial petitions, in their joint proposed order, the FPS, FHA and FLH have limited their grounds to four: (a) the Board was arbitrary and capricious in limiting the application of the rule to five professions; (b) the Board did not comply with Section 455.201, Florida Statutes; (c) the proposed rule contravenes Section 468.351(2), Florida Statutes, by making the terms of the rule applicable to respiratory therapists and respiratory care practitioners, and (d) the Board was arbitrary and capricious by requiring training for waived tests. The allegation regarding the validity of the requirement in subsection (1)(b) for HIV/AIDS continuing education training has been disregarded as being untimely. The rule applies to respiratory therapists and respiratory care practitioners even though Subsection 468.351(2), Florida Statutes, which governs the practice of those professions, clearly provides that "it is the intent of the Legislature that personnel certified or registered pursuant to this part shall be exempt from the licensure provisions of chapter 483." There is no basis in the record for the Board's contention that the exemption in subsection 468.351(2) applies only to blood gas testing, and no others. Given this lack of support for that limitation, the rule contravenes the provisions of the cited statute, and paragraph (2)(c) is deemed to be invalid. The contention is also made that the Board selected the remaining three classes of professions (registered nurses, radiologic technologists and perfusionists) without any justification. Although the Board contended it studied the type of training and education received by these professions, there is no evidence of such a discussion in the Board records, nor is there evidence that rules regarding education and training of other professions were ever presented to all of the Board members. Further, there is no evidence that the Board ever considered other professionals of equal medical educational background. While the Board did receive information from the American Board of Cardiovascular Perfusionists regarding the certification requirements for that organization, that by itself is an insufficient factual basis to justify the limitation imposed by the rule. Under these circumstances, it cannot be said that the remainder of the rule is supported by facts or logic. Petitioners further contend that the rule contravenes the provisions of Subsection 455.201(4), Florida Statutes, which makes it unlawful for the Board to "create unreasonably restrictive and extraordinary standards that deter qualified persons from entering the various professions." Since the Board acted arbitrarily and capriciously in limiting the approved professions that are subject to the rule, it is found that the proposed rule creates unreasonably restrictive and extraordinary standards for the profession. Finally, by modification to the rule on November 10, 1994, the Board added the following sentence in the first paragraph: "Persons only performing waived tests as defined in section 483.041(9), F. S., in a laboratory holding a certificate of exemption pursuant to section 483.106, F. S., are not required to be licensed and need not meet these requirements." In order to obtain a certificate of exemption, a laboratory must be engaged only in waived tests. These are tests that are relatively simple and pose little risk of harm to the public. Petitioners complain that, while providing this exception to training for waived tests at laboratories holding a certificate of exemption, the Board did not remove the requirement for training for waived tests performed at alternate site testing facilities, and thus the rule is arbitrary. Under the proposed rule, any person performing waived tests, who later becomes certified to perform a moderately complex test, must receive additional training in the waived test as well. While the Board suggests that a hospital can avoid this double training by setting up multiple laboratories in the same location, it failed to provide any justification for this excessive testing. The challenged sentence is accordingly deemed to be arbitrary. (e) Rules 59O-9.002(4) 59O-9.004(7) These two proposed rules levy a $20 fee for the initial and renewal certification of alternate site testing technicians, respectively. In its petition, the FLH contended that the Board lacked statutory authority to adopt both rules, a contention already resolved in petitioner's favor. In its posthearing filing, however, it argues for the first time that the rules are arbitrary and capricious. This contention has accordingly been rejected as not being timely. The FPS and FHA have similarly contended that rule 59O-9.004(7) is invalid on the ground the agency lacks statutory authority to adopt the rule. They also contend for the first time that the rule is arbitrary. This untimely allegation has been disregarded. (f) Rule 59O-10.004 This proposed rule sets forth minimum standards that all laboratory professionals must meet. At issue here are the requirements that all clinical laboratory personnel provide the following services: (14) Process aliquots or components of specimens for analysis according to the type of specimen and procedure to be performed. * * * (18) Recognize output signals and observations and convert them to prescribed units for recording and reporting. * * * In their initial petition, as clarified by a more definite statement, FPS and FHA contended the Board exceeded its rulemaking authority by including professionals engaged in alternate site testing as clinical laboratory personnel subject to Board regulations, a ground already discussed. In their proposed order, petitioners have added the contention that the rule is vague because it contradicts the terms of another rule. Because this newly raised ground is untimely, it has been disregarded. (g) Rule 59O-13.006 The final rule being challenged describes the responsibilities of alternate site testing technicians. Among other things, the rule prescribes the tests that the technicians can perform. The specific portions of the rule which are being challenged read as follows: Alternate Site Testing Technican shall: * * * (b) Perform only tests from the following list provided the requirements of Rule 59O-13.006 have been met: 1. Tests designated as waived pursuant to 42 CFR 493.15, incorporated by reference. * * * 3. Tests designated as moderately complex pursuant to 42 CFR 493.10 and 42 CFR 493.17 which employ whole blood and require no pre- analytical, analytical or post-analytical specimen or reagent manipulation, treatment, extraction, separation or other processing of any kind and must employ an automated single, closed, dry or electrochemical sensor reagent system. The instrumentation shall provide for instrument calibration without any operator adjustment. Post analytical instrument output signals must be directly reportable in the correct units of measure- measure without need for data conversion or other manipulation. Electronic instrumen- tation must have a mechanism whereby the operator is alerted when patient results exceed reportable limits and when internal or external quality control or calibration is not acceptable. Such results shall not be used for the diagnosis, treatment, management or monitoring of patients and shall be validated through the central laboratory. Validation shall be documented at the alternate test site. * * * (j) When affixing the name or signature to any laboratory record or patient report, indicate the professional status by adding the designation "ASTT" to designate Alternate Site Testing Technician immediately following the name or signature if holding a current Florida certificate. The holder of temporary certification must use the designation "GASTT" to designate Graduate Alternate Site Testing Technician until such time as certification is granted by the Board. * * * The specific authority for adopting the rule is Subsection 483.805(4), Florida Statutes, while the laws being implemented are Sections 483.800, 483.813 and 483.825, Florida Statutes. Although a number of grounds for invalidating the rule were raised in the petitions filed by the FLH, FPS and FHA, these grounds have been narrowed in their joint proposed order. As to the newly raised contention that certain parts of the rule, including subparagraph (1)(b)3., are vague, this contention has been disregarded as not being timely. Similarly, the argument that subparagraph (1)(b)3. contravenes the provisions of Subsection 455.201(4), Florida Statutes, was not specifically pled by any party. Likewise, the assertion that paragraph (1)(a) is invalid because its effectiveness is dependent on other rules being enacted has been rejected as being untimely. Since no other viable claim has been raised, the rule is deemed to be invalid on the single ground that the agency has exceeded its rulemaking authority.

USC (3) 42 CFR 4242 CFR 493.1042 CFR 493.15 Florida Laws (14) 120.52120.54120.57120.68455.201468.351483.041483.051483.800483.803483.805483.807483.811483.825 Florida Administrative Code (2) 59A-7.03459A-7.035
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ELLEN MOLDOFF vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 79-000648 (1979)
Division of Administrative Hearings, Florida Number: 79-000648 Latest Update: Sep. 07, 1979

The Issue At issue herein is whether Petitioner, Ellen Moldoff, is qualified for a supervisor's license in microbiology under Section 10D-41.24(10), Florida Administrative Code.

Findings Of Fact Based on the testimony of the witnesses and their demeanor while testifying, the following relevant facts are found. On February 27, 1979, George S. Tylor, Jr., B.A., Clinical Laboratory program, advised Ellen Moldoff, petitioner, that her application for licensure as a supervisor was being denied under the provisions of the Florida Clinical Laboratory Law, Chapter 483, Florida Statutes, in that, "You do not have the 60 semester hours and the 10 years experience required under Section 10D-41.24 (10), of the Florida Administrative Code." Petitioner timely appealed the Department's denial of her application for a supervisor's license in microbiology. During the course of the hearing, Petitioner acknowledged the fact that she failed to satisfy either the sixty-semester-hour requirement or its equivalent in quarter or semester hours (two years of academic study) in an accredited college or university or that she possessed the ten years pertinent experience requirement as set forth in Chapter 10D-41.24 (10), Florida Administrative Code. However, Petitioner introduced four letters of recommendation written by employees and other supervisors who were familiar with the Petitioner's skills and abilities. It suffices to say that they all spoke highly of Petitioner's qualifications and highly recommended her to take the supervisor examination in microbiology. Petitioner, during the hearing, alluded to numerous persons whom she considered less qualified than she who were permitted to take the supervisory examination based on an overstatement of qualifications in their applications for licensure as a supervisor. Finally, Petitioner felt that her honesty alone prevented her from being permitted to take the supervisory examination Petitioner expressed her opinion that based on her observation of the clinical supervisors and the duties to which she is assigned, she considered herself as qualified, if not more qualified than those she observed. Respondent does not question Petitioner's ability to fulfill supervisory functions; however, it hastens to add that it has no authority to waive the qualifications for supervisory laboratory personnel as set forth in Chapter 10D-41.24(10), Florida Administrative Code.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby, RECOMMENDED: That the Petitioner's appeal of the Respondent's determination that she is ineligible to take the supervisory examination be DENIED. DONE and ENTERED this 6th day of August, 1979, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Ms. Ellen Moldoff 3690 Inverrary Drive Lauderhill, Florida 33319 Harold Braynon, Esquire District X Legal Counsel Department of Health and Rehabilitative Services 800 West Oakland Park Boulevard Fort Lauderdale, Florida 33311

Florida Laws (1) 120.57
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MARILYN L. EDWARDS vs. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES, 87-000852 (1987)
Division of Administrative Hearings, Florida Number: 87-000852 Latest Update: Jul. 23, 1987

Findings Of Fact At some time prior to August 14, 1986, the Petitioner herein, Marilyn L. Edwards, submitted an application for examination for licensure as a technologist in Florida under the provisions of the Florida Clinical Laboratory Law, Chapter 483, Florida Statutes. Petitioner's application was reviewed in the Office of Licensure and Certification of DHRS by Mr. George S. Taylor, Jr. Assistant Administrator of the Laboratory Personnel Licensure Section. The criteria for licensure as a technologist are outlined in Section 10D-41.69, Florida Administrative Code, which provides that the applicant must have one of the following: A bachelor's degree, from an accredited college or university in an approved Medical Technology Program, or 90 semester hours at an accredited college or university in addition to one year in an AMA approved school of medical technology, or A bachelor's degree from an accredited college or university in one of the chemical, physical, or biological sciences with one year laboratory experience at the technician level, or An associate degree or 60 semester hours at an accredited college or university in an approved Medical Laboratory Technician Program which includes 8 hours in chemistry and 8 hours in biological science, or 60 semester hours at an accredited college or university including 20 hours of science of which at least 8 hours is in chemistry and 8 in biological science plus 4 years experience as a chemical laboratory technician. Petitioner's application was filed under the provisions of Rule 10D- 41.69(4), Florida Administrative Code, above. However, Petitioner did not meet that criteria. The school at which she was trained a program administered by the Veteran's Administration, (VA), Hospital in Dublin, Georgia, was not an accredited college as required. Ms. Edwards attended a VA certified laboratory assistant program in Dublin, Georgia, approved by the American Society of Clinical Pathology during 1970 and 1971. After graduating from that program, she took and passed the technician's examination in Florida. The course work included in the VA program included 1388 of classroom hours of course work which have not, to this date, been converted to equivalent credit hours. The course work did, however include such subject matters as anatomy, organic and inorganic chemistry, hematology parasitology, microbiology, urinalysis coagulation, and aminohematology. Ms. Edwards contends that according to the current schedule of Miami-Dade Community College the above courses make up the course work for the Associate degree in technology and in addition to the above, Ms. Edwards did her practicals, which included phlebotomy training, at the VA Hospital in Dublin. Ms. Edwards has had fourteen years of training and experience in the medical technician field. Based on the course work taken and her fourteen years experience, she contends she meets the criteria for examination. It is her opinion that the agency, in denying her application for examination, has failed to consider the years of experience she has and it is her contention that some of the programs approved by the agency are not as thorough in the laboratory sciences as that which she took. Ms. Edwards feels she has the knowledge to be a technologist, but admits the rules currently existing prohibit her certification because of the fact that she does not have the required course work at an approved college or university. The American Medical Association approves various types of allied health education and three types of medical technology education which are referenced in the agency rule. These are: Medical technologist (a four year degree program from an accredited academic institution), A medical laboratory technician associate degree program offered by various community colleges (This is very similar to and generally geared to the technician levels but there is more academics involved than for the technician certification. This second pathway meets the academic requirements for certification.), and A one year medical laboratory technician course (not referenced for technologist licensure but for technician only). There is a difference between a technician and a technologist. The former can perform with supervision and undertake tasks requiring limited judgment. The latter may work independently without supervision. Petitioner is already designated as a medical technician. In her application, according to the agency, Petitioner submitted evidence of a course of training for a technician in order to be certified as such. She also submitted the same educational background with her application for licensure as a technologist. The Veteran's Administration Hospital's course is not accredited for college credit. Even though she applied under Section (4) of the rule, she could be considered under Subsection (5) which calls for 60 semester hours plus 20 hours of scientific courses in biology and chemistry, along with four years clinical laboratory experience. Petitioner has the clinical laboratory experience and has taken some courses, but she is not considered as meeting the academic requirement because the institution where her educational courses were taken is not an accredited academic institutions as outlined in the Education Directory published by the National Center for Education Statistics sponsored by the United States Department of Education. As a result, the courses she took do not qualify as college academic courses at the technologist level. DHRS does not establish equivalent course work. The 1388 hours of classroom work taken by the applicant are not semester hours. Though Mr. Taylor said that if she had an accredited junior college or other academic institution translate the equivalents within its degree program and give her academic credit for them and if it is determined by the institution that her course work is equivalent to the required 60 hours for licensure, Petitioner will be permitted to sit for the examination, this really cannot be done. The equivalents outlined in the rule refer to equivalent courses that is semester hours to quarter or trimester hours - not equivalent institutions.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Lawn it is, therefore: RECOMMENDED that Petitioner, Marilyn Edwards, be denied examination for 1icensure as a certified laboratory technologist in Florida based on her current educational background. RECOMMENDED this 23rd day of July, 1987, at Tallahassee Florida. ARNOLD H. POLLOCK, 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 23rd day of July, 1987. COPIES FURNISHED: Sam Powers, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee Florida 32399-0700 Marilyn L. Edwards 2300 Northwest 94th Street Miami, Florida 33147 Leonard T. Helfand Esquire Department of Health and Rehabilitative Services 401 Northwest 2nd venue, Suite 1040 Miami, Florida 33128

Florida Laws (1) 120.57
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BOARD OF NURSING vs. LAURA DRINKWATER, 78-001266 (1978)
Division of Administrative Hearings, Florida Number: 78-001266 Latest Update: Feb. 23, 1979

Findings Of Fact Laura Drinkwater, Respondent, was employed as a LPN by the Bond Clinic in Winter Haven, Florida in 1973 and has worked continuously at the Clinic since that time. At all times here relevant she assisted Dr. Erde, who specializes in obstetrics and gynecology. Respondent renewed her license annually from 1973 through 1976 but neglected to forward her renewal application to Petitioner in time for renewal prior to April 1, 1977. Respondent continued to be carried on the records of the Clinic as a LPN after 1 April 1977 and to perform the same duties she performed prior to 1 April 1977. On 18 October 1977 the Board of Nursing contacted the executive Director of Bond Clinic, learned that Respondent was still employed there, and advised the Executive Director (by phone) that Respondent could not continue to work as a LPN without a current license. Respondent submitted the application for renewal of her license bearing date of 6-2-77 which was received by the Board of Nursing on 31 October 1977 (Exhibit 2). By letter dated November 21, 1977 (Exhibit 1) to Respondent at an Alabama address, which had not been Respondent's address registered with the Board for several years, the Board advised Respondent that her reregistration was being denied because she had been working without a license and she could request a hearing on this denial of reregistration. This letter was never received by Respondent, nor was it returned to the Board. The Board instituted criminal proceedings, through the State's Attorney's office, against Respondent on charges stemming from her continuing to work as a LPN subsequent to the expiration of her license. This resulted in a trial at which Respondent was acquitted on 1 May 1978. On 11 May 1978 Respondent again requested reregistration as a LPN with the Board which was denied by Board's letter dated May 19, 1978 (Exhibit 3). Thereafter by letter dated May 26, 1978 Respondent requested an administrative hearing, the Administrative Complaint was filed and these proceedings followed. Upon receipt of information from the Board that Respondent was no longer licensed, the Executive Director of Bond Clinic contacted the Executive Director, Florida Board of Medical Examiners, who advised him that so long as Respondent was working under the supervision of a doctor at the Clinic she could, in his opinion, legally perform any medical task assigned by this doctor. Upon advice of counsel the Executive Director advised Respondent to remove indicia of LPN (cap, pin, etc.) and to cease giving injections to patients. Respondent gave no injections from 18 October 1977 until her acquittal in the criminal proceedings on 1 May 1978. Since Respondent had not worn the indicia of LPN before her license expired, no change in this regard was required. After 18 October 1977 Respondent's title was changed from LPN to Medical Assistant. Respondent was advised by her employer that she could continue her duties as an unlicensed assistant to the doctor, perform all duties previously performed except give injections, and after her acquittal on 1 May 1978 Respondent was authorized to resume giving injections. Several witnesses testified without objection regarding their interpretation of the Medical Practices Act, Chapter 458, Florida Statutes. Such "evidence" is disregarded as invading the province of this tribunal. All testimony of this nature purporting to show the practices of the profession is, of course, admitted. While Exhibit 5 purported to express the opinion of the Florida Board of Medical Examiners that "a licensed M.D. may employ any person to assist him in his office and in his medical practice and he may delegate to this employee any tasks which he feels are commensurate with that employee aptitude, proficiency and demonstrated abilities," the author of that opinion retracted the broad implications of the statement under cross-examination. Many unlicensed individuals are employed by medical doctors as their assistants and are given some training by these doctors. Some obviously receive more training than others and, regardless of the legality of the practice, many of these doctors assign tasks to these unlicensed employees that constitute the practice of nursing. The prevailing concept in this regard is expressed in th ultimate sentence of Exhibit 5 that "Otherwise, there is nothing in the laws pertaining to the practice of medicine which prevents any licensed physician from hiring anyone whom he chooses to perform any tasks in his office which he so designates or delegates to these employees." Unlicensed employees are normally paid lower wages than are licensed personnel and approximately one-third to one-half of the employees in doctors' offices and clinics are unlicensed.

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AGENCY FOR HEALTH CARE ADMINISTRATION vs MD PLUS CLINIC, LLC, 12-004023 (2012)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Dec. 17, 2012 Number: 12-004023 Latest Update: Jul. 05, 2024
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