STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA COALITION OF PROFESSIONAL ) LABORATORY ORGANIZATIONS, INC.; ) AMERICAN ASSOCIATION FOR CLINICAL ) CHEMISTRY-FLORIDA SECTION; )

AMERICAN SOCIETY OF CLINICAL )

PATHOLOGISTS-ASSOCIATE MEMBER )

SECTION; CLINICAL LABORATORY )

MANAGEMENT ASSOCIATION-GREATER )

FLORIDA CHAPTERS; FLORIDA ) ASSOCIATION OF MEDICAL TECHNOLOGY; ) FLORIDA SOCIETY OF HISTOTECHNOLOGY; ) FLORIDA SOCIETY FOR MEDICAL ) TECHNOLOGY; FLORIDA STATE SOCIETY ) OF AMERICAN MEDICAL TECHNOLOGISTS; ) FLORIDA STATE SOCIETY OF CYTOLOGY; ) NORTHWEST FLORIDA LABORATORY )

ASSOCIATION; and PROFESSIONAL ) ASSOCIATION OF LABORATORY MEDICINE, )

)

Petitioners, )

)

vs. ) Case No. 96-4336RP

)

STATE OF FLORIDA, AGENCY FOR ) HEALTH CARE ADMINISTRATION, BOARD ) OF CLINICAL LABORATORY PERSONNEL, )

)

Respondent. )

)

and )

) FLORIDA ASSOCIATION OF BLOOD BANKS, )

)

Intervenor. )

)

FINAL ORDER

Pursuant to notice this cause was heard by P. Michael Ruff, duly designated Administrative Law Judge of the Division of Administrative Hearings, on March 21, 1997, in Tallahassee, Florida. The appearances were as follows:

APPEARANCES

For Petitioners:

Sandra E. Allen, Esquire

314 West Jefferson Street, Tallahassee, Florida 32301

For Department of Legal Affairs:

Ed Bayo, Esquire

The Capitol, Plaza Level 01 Tallahassee, Florida 32302

For Intervenor:

Thomas J. Guilday, Esquire Rex Ware, Esquire

Huey, Guilday and Tucker, P. A.

106 East College Avenue Highpoint Center, Suite 900 Tallahassee, Florida 32302

STATEMENT OF THE ISSUES

The issues to be resolved in this proceeding concern whether proposed rules 59O-2, 59O-3, 59O-5, 59O-7, 59O-9 and 59O-10, Florida Administrative Code, which revise and replace existing provisions of the same rules, are invalid exercises of delegated legislative authority to the above-named agency, in light of the standards set forth in Section 120.52(8), Florida Statutes.

PRELIMINARY STATEMENT

This proceeding arose upon the filing of a Petition for Administrative Determination of Invalidity of Proposed Rules in accordance with Section 120.54(4), Florida Statutes, filed on September 13, 1996. The petition challenged the validity of proposed amendments to Rules 59O-2.002; 59O-5.004; 59O-7.001;

59O-3.001; 59O-3.002; 59O-3.003; 59O-5.002; and 59O-10.005,

Florida Administrative Code. The rules concern the licensure of clinical laboratory personnel. On November 15, 1996, the Intervenor, FLORIDA ASSOCIATION OF BLOOD BANKS (FABB), filed a

petition to intervene which was unopposed and was granted. The Intervenor contends that the agency departed from rule-making requirements by failing to disclose or provide notice that it was considering deletion of rules pertaining to the blood banking specialty until the August 23, 1996 notice appearing in the Florida Administrative Weekly. The Intervenor adopted the proposed findings of fact and conclusions of law contained in the proposed Final Order of the Petitioners herein and offered its own proposed Final Order focused on the limited issue concerning disclosure and notice of rule-making proceedings which was the subject of the testimony of Jeanne E. Dariotis, MT(ASCP) SBB, its witness.

The Final Hearing was held as noticed and concluded on March 21, 1997. The Petitioners offered the testimony of Cynthia S. Johns and George Mavros, and offered twelve (12) exhibits, eleven

1. of which were admitted into evidence. The other exhibit was withdrawn. In addition to the testimony of Jeanne E. Dariotis, the Intervenor offered pages 111 through 131 of the transcript of the rule challenge case filed by the Florida Association of Blood Banks in Division of Administrative Hearings Case Number 96- 4335RP, which had already been concluded by Final Order. The

   Respondent presented the testimony of Patricia Johns in support of the validity of the proposed rules, and offered four (4) composite exhibits which were admitted into evidence.

   Upon the conclusion of the hearing, the parties elected to obtain a transcription thereof and elected to file proposed Final Orders. Subsequent to the hearing, extensions were granted by agreement of the parties and proposed Final Orders were timely filed by the parties pursuant thereto.

   FINDINGS OF FACT

   
   

   1. This case arose when the Respondent, BOARD OF CLINICAL LABORATORY PERSONNEL (BOARD), published notice of its intent to adopt certain amendments to the rules described above. Publication was on August 23, 1996. The general effect of the proposed rules is to change definitions related to the practice of clinical laboratory technology and technicianry; to change certain provisions dealing with the qualifications; testing, and licensure of technicians and to provide certain national examinations for licensure for directors of clinical laboratories.

   2. The Board was created by the legislature in 1992, to regulate clinical laboratory personnel. These authorities and duties are set forth in Part IV of Chapter 483, Florida Statutes. The Board’s purpose is to protect the safety and welfare of the public from the hazards of improper performance by clinical

      laboratory personnel. To this end the Board is required by law to prescribe minimal qualifications for clinical laboratory personnel.

   3. Clinical laboratory personnel are persons who perform clinical laboratory examinations on specimens taken from the human body for the purpose of diagnoses, management or treatment of a medical condition. The field of clinical laboratory science is divided into two (2) areas: anatomical, which includes the disciplines of histology (tissues), cytology (cells); and clinical. The largest group of licensees fall under the clinical area and are licensed under five (5) specialties: Microbiology, Serolgy/Immunology, Chemistry, Hematology, and Immunohematology. The five (5) disciplines are collectively known as general laboratory practice. Florida licenses four (4) categories of clinical laboratory personnel: Director, Supervisor, Technologist, and Technician.

   4. Clinical laboratories are subject to Federal and State Regulation. Part I of Chapter 483, Florida Statutes, is the “Florida Clinical Laboratory Law”. It provides for the qualification and licensing of clinical laboratories. Regulations adopted pursuant to the Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), established the standards that all laboratories must meet to be certified to perform testing on human specimens. The regulations under CLIA provide

      for the certification and registration of laboratories, but not of the personnel employed therein.

   5. Persons working in clinical laboratories are subject to the requirements and regulations imposed under Part IV of Chapter 483, Florida Statutes. In addition, the qualifications of personnel working in clinical laboratories are also regulated indirectly through federal law. Although testing personnel are not licensed pursuant to CLIA, one of the standards which must be met by laboratories licensed under CLIA is the employment of testing personnel qualified pursuant to specifically enumerated training and educational requirements.

   6. In addition to setting laboratory standards by discipline, CLIA also sets standards by three (3) types of testing complexity: Waived, Moderate and High Complexity.

      Waived Tests are those for which there are no personnel standards or laboratory regulations, other than the requirement of a “Certificate of Waiver.” High Complexity Tests, as indicated by their name, are more difficult to perform and require more intervention on the part of the analysts.

   7. The FLORIDA COALITION OF PROFESSIONAL LABORATORY ORGANIZATIONS, INC., is a not-for-profit corporation which has twelve (12) member organizations, eleven (11) of which are joined in this proceeding. The coalition and its member organizations are independent organizations which represent the licensed laboratory personnel who are licensed by the Board. The

      coalition was created in 1992, about the same time that the Board was created by the Florida Legislature. The coalition was organized for three (3) main reasons: to educate the members of the profession, monitor legislative activity that would affect the members and their ability to practice their profession, and to unify the “laboratory voice” within the state. The coalition has regularly monitored all activities of the Board and has intervened in support of Board rules under challenge in the past.

   8. The coalition, its individual organizations, and the licensed laboratory personnel who are members of these organizations are affected by the proposed rules because the changes to the rules in the training, licensure qualifications, licensure examination, licensure by specialty and scope of practice of medical technicians will affect not only the currently licensed medical technicians, but also the medical technologists and the laboratory supervisors and directors who work with and supervise the medical technicians. It has been shown that these proposed changes will allow medical technicians to be licensed under different and lower standards than is required in the current rules and will allow a broadening of the scope of practice of the licensed medical technicians, thus directly and adversely affecting the practice of the profession and the currently licensed professionals. The other proposed and challenged changes to the rules similarly affect the members of the coalition and Petitioner organizations. The Petitioners have

      demonstrated that the coalition and its member organizations represent the interests of its individual members, the licensed laboratory personnel and that a substantial number of its members will be affected by the proposed rules. The rules are thus within the scope of interests for which the Petitioner coalition and its member organizations were organized.

   9. The Board was newly created in late 1992 and inherited a set of rules for licensure and discipline of laboratory personnel from the Department of Health and Rehabilitative Services. The Board undertook a systematic review of these rules in order to make them current with the changed and modern practice of clinical laboratory science. The Board also considered the changes to federal law and regulations regarding the practice of clinical laboratory science, especially the law and regulations known as CLIA. All laboratories in the country must comply with conditions imposed under CLIA and the CLIA amendment provides detailed and specific conditions under which all laboratories must operate in order to perform laboratory testing. CLIA does not require laboratory personnel to be licensed but state regulations require licensure, as in Florida, and CLIA requires that individuals performing moderate and highly complex tests “possess a current license issued by the state in which the laboratory is located.” (See 42 CFR, Sections 493, Subpart M).

   10. Although the Agency for Health Care Administration, which licenses and inspects laboratories, is statutorily mandated to assure that the laboratories meet the CLIA requirements (See Sections 483.821, 483.035, 483.051(a), 483.172(4), Florida Statutes), the Board of Clinical Laboratory Personnel is not similarly mandated by the legislature. The CLIA provisions are not to be exceeded by the Board when it adopts rules for the licensure, education and training of personnel in “exclusive use” laboratories. These personnel and laboratories are not at issue in the present case. The Board’s representative testified that compliance with the CLIA regulations was an overall goal for the state of Florida because if the state regulation of laboratories meets or exceeds the CLIA requirements, then the state can obtain an exemption from the federal requirements, thus eliminating a dual set of regulations. It is clear, however, that the legislature has not mandated that the Respondent Board incorporate the CLIA regulations into the Board’s rules.

   11. The proposed rules at issue substantially modify the existing laboratory personnel rules, the essential change being the elimination of licensure of medical technicians by specialty, with the end result of the proposed changes being the licensure of laboratory technicians as “generalists”. The following proposed rules effect these changes: Rule 59O-5.004, Qualifications for licensure as a technician, is substantially rewritten so that an individual must successfully complete a

       Board-approved technician level training program of one year of integrated study in order to become licensed as a general laboratory technician.(Proposed rule 59O-3.001(l)) The current rule, 59O-5004(2)(b), allows an individual to complete a training program which consists of 400 clock hours per specialty, and a course in general laboratory practice. The specialties are: microbiology, serology/Immunology, clinical chemistry, hematology, blood banking, immunohematology, cytology, and histology. Proposed Rule 59O-5004(3)(a), creates a general licensure category for technicians encompassing the five specialties. The proposed rules further would effect a change from a specialty licensure of technicians to a general technician licensure by changing the examination requirements of Rule 59O- 7.001(12), so that a generalist examination covering microbiology, serology/immunology, clinical chemistry, hematology, and immunohematology is given, rather than the current two-part examination: Part A, consisting of one technician level specialty examination in each of the five

       above-cited areas, and Part B, consisting of an exam in general laboratory practice. (Current rule 59O-77.001(4), F.A.C.).

   12. The proposed rule changes also create a route for qualification to sit for the generalist technician exam by allowing various periods of practical experience, depending on an individual’s education level, rather than requiring any formal training in laboratory procedures. (Proposed rule 59O-5.0904(d))

       The Proposed rules add a definition of “general clinical laboratory experience” in proposed rule 59O-2.003(18), which has no counterpart provision in the current rules.

   13. The proposed changes to the current rules also have the net effect of changing and broadening the scope of practice of medical technicians by changing the definition of “direct supervision,” removing the current language of “reviews results prior to being made available for patient care,” and adding the language “is responsible for the oversight of testing and reporting of results” (Proposed rule 59O-2.002(8)), and making changes in rule 59O-2.002(4) (the definition of technician). These changes, together with proposed changes to rule 59O- 10.005(2)(a), allow technicians to practice in their category of licensure under the proposed new definition of “direct supervision”. These changes remove the requirement that the work of technicians be reviewed by a technologist, supervisor, or director before or after the results are released to the public. The Board has testified that the proposed revisions in the technician rules (qualifications [59O-5], training [59O-3] and scope of practice [59O-10]) were made in order to align the Board’s rules with federal regulations (CLIA 88), yet federal regulations mandate review of results and specifically require that certain results be reviewed by supervisory personnel within twenty-four (24) hours. The existing rules provide for similar requirements, consistent with these federal standards, whereas

       the proposed rules eliminate these requirements, in contradiction to the stated reason for proposing the changes in the rules (i.e., to meet federal standards).

   14. Proposed changes to rule 59O-5.004(3)(6), set up qualifications for two (2) types of technicians, “general” and those who perform “highly complex” tests. The current rule provides for the licensure of one type of technician only.

   15. Proposed rule 59O-3.001(1) provides a requirement for a technician training program of one (1) year of integrated study, including the five (5) specialty areas making up the “generalist” category of technician. The current rule requires 400 clock hours in each of the five (5) specialty areas that make up the generalist technician program. An individual can no longer take training in only one (1) or more (up to five (5)) of the individual specialty areas. (Rule 59O-3.003(3), Florida Administrative Code).

   16. Proposed rule changes to 59O-3.002(2) are also made to allow non-licensed personnel to teach clinical laboratory science, whereas the current rule requires a person to be licensed as supervisor or technologist and provides that the instructor may teach only in a specialty area in which he or she is currently licensed. (Rule 59O-3.002(2), Florida Administrative Code).

   17. Proposed changes to rule 59O-3.003 allow the Board to generally adopt without review, and by reference, curriculum

       standards of the Department of Education for clinical laboratory training programs for laboratory technicians. The current rule requires the Board to actually review and approve the Department of Education standards in relationship to the requirements in the current Board rule. (Rule 59O-3.003(2), Florida Administrative Code).

   18. Challenge is also made to proposed changes to rule 59O- 3.003(4)(e)i., which removes the current requirement that a licensed technologist must have received the training required of a technician. (Rule 59O-3.003(3)).

   19. Proposed rule changes regarding the examinations for laboratory directors would require candidates for the director license, to take and pass nationally certified examinations (Proposed rule 59O-7.001(1)), rather than the Board and

       agency-created examinations, as allowed in current rule 59O- 7.001(1), Florida Administrative Code.

   20. The proposed rules were published in the August 23, 1996, Florida Administrative Weekly. The Board offered no testimony or evidence that any change in circumstances had occurred with respect to the examination and licensure of medical technicians in effect nor reasons why there should be a general examination and licensure, rather than specialty examination and licensure. Neither did the agency offer any change in circumstances that had occurred with respect to the other challenged proposed changes in the current rules. The overriding

       argument of the Board was that the new Board had considered the recently promulgated rules and had decided to make changes based on a change in the philosophy of the new Board. No articulation was made of this change in philosophy or the basis for it.

   21. The Board offered, at hearing, several reasons for the proposed changes to the examination and licensure of medical technicians. First the Board argued that the changes were philosophical, that new Board members had been appointed to the Board, and that this Board could not be bound by a prior Board. The Board also offered that the long-standing practice had been to examine and license technicians as generalists, and that the fairly recent changes had been “controversial.” Further, this recent change had been challenged by the Agency for Health Care Administration (AHCA) because of the increased costs to applicants of taking each of the specialty exams and concern over the implementation date of the new exams. It was shown that in October 1995, as a result of a challenge, the Board had agreed to re-visit this issue in the future. However, it was also shown that the agency had withdrawn its challenge and that the current rule had been promulgated and published in the Florida Administrative Weekly in December 1995.

   22. The challengers presented several reasons why the proposed technician exams and licensure changes, as well as the other proposed changes are invalid. First, the process under which these rules were proposed and adopted did not comply with

       the applicable rule-making procedures of the Administrative Procedures Act, especially in contrast to the past procedures which had been used by the previous Board. The previous Board had established a pattern of rule-making procedures which gave notice to the public, accepted public input and provided open, full debate and consideration before rules were adopted. Second, the current rules, including those regarding licensure and examination of medical technicians, had only recently been adopted after full consideration of the industry practices and needs and the pros and cons of general versus specialty exams and licensure and after a systematic review of the state of the profession. The challengers presented evidence that the prior Board, in establishing the specialty exam for technicians, had evidence before it from examination specialists that the former 100-question, generalist technician exam was a poor test of the candidates’ knowledge of the practice. A candidate could fail three (3) of the five (5) specialty areas which were tested on the general exam and still pass the exam and become licensed as a technician and could therefore practice in all five (5) areas.

       Further, the chair of the prior Board testified to the detailed information the various considerations and debate that the prior Board had undertaken in order to reach the decision to change to a specialty exam and licensure by specialty for technicians.

   23. The evidence shows that these rule changes began when the Board met in March 1996. At that time a long-term member of

       the Board became the new chair of the Board and two (2) new Board members were present at their first full Board meeting at that time. The Board received a report from the recently created and appointed credentials committee. That committee recommended that the examination for medical technicians be changed from the two- part specialty exam, (one portion testing general laboratory principles and the other testing individuals in up to six (6) specialties) to a general exam covering all of the specialty areas. The evidence shows that with very little discussion and no other information before them, the Board voted to change the exam rule and instructed their attorney to prepare the necessary rule language for them. For the next full meeting of the Board in June 1996, the Board received, reviewed and voted on a wholesale package of proposed rule changes covering many rules, including the changes to the examination and licensure qualifications and scope of practice for technicians here under challenge. The Board did not complete consideration of these rule changes and continued their discussions and voting at a July conference-call meeting.

   24. The Petitioners maintain that the vote taken to change the technician exam rule at the March 1996 Board meeting was not properly noticed, because the agenda that was published for the Board meeting did not contain any notice that a rule change was being proposed and no indication that action, a vote, would be taken to change a rule. Promulgation of such a notice was the

       standard operating procedure for agendas of the previous Board meetings. The Board representatives who testified alleged that the agenda for the March meeting was submitted in a timely fashion to comply with Board rule 59O-1.008(4), Florida Administrative Code, as well as Section 120.53(1)(b), Florida Statutes. The coalition’s witness testifying about this matter, however, never received the amended agenda; and she had been on the mailing list to receive such agendas, based upon previous activity with regard to the Board’s official business, including rule-making. The amended agenda added language to the effect that the credentials committee was scheduled to make a recommendation for the technician exam rule change (See item No.6, agenda of March 1996 Board Meeting, Respondent’s composite Exhibit No.1). The coalition chair testified that she had received and read the original agenda, but did not receive any notice that the rule change recommendation was to be made, or that a vote would be taken to change the rule. Previous to this time notice of possible rule changes had been provided to the public via the Board’s agendas. The coalition had regularly monitored proposed rule changes by obtaining and reviewing the agendas and, after considering the proposed changes, gave input to the Board about the proposed rule changes. Section 120.53(1)(d), Florida Statutes, requires that agency rules concerning scheduling of meetings and workshops shall provide:

       An agenda shall be prepared by the agency in time to insure that a copy of the agenda

       be received at least seven (7) days before the event by any person in the state who requests a copy and pays a reasonable cost of the copy. The agenda shall contain items to be considered in the order of presentation. After the agenda has been made available, change shall be only for good cause, as determined by the person designated to preside, and state it in the record. Notification of such change shall be at the earliest practicable time.

       One of the organizational rules of the Board-Rule 59O-1.008(4), Florida Administrative Code, contains essentially the same language as Section 120.53(1). It appears that the immediate agenda was not made available to the public seven (7) days prior to the March 1996 Board meeting. Further, no announcement of good cause for the change to the agenda was made by the chair of the Board “at the earliest practicable time,” or at any other time.

   25. The order of items on the March agenda was also re- arranged without prior notice to the public, so that when a vote was taken to accept the recommendation of the credentials committee and to change the specialty exam for technicians to a general exam, one of the Board members was out of the room. Members of the public were not present and might have wanted to be there. The re-arrangement of the agenda placed the vote on the credentials committee recommendation to change the technician exam in between votes on discipline hearings and denial proceedings. Section 120.53(1)(d), Florida Statutes, requires that the agenda list items “in order of presentation.”

   26. Moreover, it had been announced that a public workshop on rules was to be held the second day of the scheduled meeting as part of the Board’s March meeting. The agenda indicates a rules workshop and lists each of the current rule chapters of the Board. There were no specific, proposed rule changes noticed or proposed new rule language available for the public to review. The purpose of the workshop was to obtain public comments on any of the current rules. Questions were raised by the public at the public workshop meeting, concerning the vote taken the previous day to change the technician exam, especially since the specialty exam was to be given for the first time in October 1996. The rule providing for it had only become effective in December 1995. Some persons spoke in favor of the change of the examination to a general one, while others spoke against that change.

   27. In June of 1996, the proposed re-write of the rules concerning technician exams, training and experience requirements for licensure, changes to the scope of practice for technicians, and changes to the director exam, among other changes, was proposed and voted on by the Board. The proposed rules were written by the new chair of the Board. The Board did not finish considering the changes at the June meeting and it was announced what the Board would continue its review and vote on the proposed changes at the July conference-call meeting.

   28. No new agenda was published for that July conference- call meeting and the Petitioners maintain that votes taken at

       that meeting, and at the March 1996 meeting, render the rules invalid for the failure of the Respondent Board to materially comply with applicable rule-making procedures provided for in Chapter 120.

   29. The Petitioners contend that the rule-making procedures followed by the Board through the March to August rule-making effort were flawed because no public input was sought or allowed during the rule-making process. No public workshops or notice of rule development were announced, scheduled or held until the rules were published in the August 23, 1996, Florida Administrative Weekly. No public comment was accepted at the three (3) Board meetings where the rules were re-written and voted on. Drafts of the proposed rule changes were not available to the public at the June or July meeting, either prior to or during the meeting.

   30. The new chair of the Board and the Board Administrator appear to have instigated this major revision. It represents a change from the philosophy and prescription contained in the current rules, even though there was objection to the proposed changes and despite serious doubts about the necessity; the lack of proper debate and deliberation; and the speed of adoption, which were expressed by a number of Board members and by the Board attorney. The motives for such a radical change in so short a time after the prior rules became effective in December 1995, after a number of years of rule-making effort, deliberation

       and consideration thereon are not clear. The chair did express concern about upcoming changes to the Administrative Procedure Act, to be effective October 1, 1996, and her resultant desire to have the rule changes accomplished before the new Administrative Procedure Act went into effect.

   31. The credentials committee of the Board was newly created in January 1996, approximately a month after the previously-enacted rules took effect in December 1995. It was created for the purpose of reviewing credentials of candidates for licensure. It was made up of two (2) new members of the Board, and one member who had been on the Board for only approximately six (6) months. It held one meeting to review credentials and then immediately thereafter proposed a change to the technician’s exam: from the specialty exam, only enacted in December 1995, to the “generalist” exam.

   32. Once the decision was made to return to the general exam for technicians, then related rule changes were made to the training criteria for technicians, required of candidates to be able to sit for the exam. No cogent reasons were offered by the Respondent as to why the training program requirements for medical technicians were changed in the proposed rules, except to assert that a requirement in the current rule (enacted in December 1995) providing for a four-hundred (400) clock hour training program was eliminated because there were only two (2) locations where the courses were offered. The Board apparently

       decided that once the decision was made to return to a general exam for technicians, then there was no need to allow an individual to take four-hundred (400) clock hours of training in each specialty of the general category.

   33. The Petitioners maintain that the reason the four- hundred (400) clock hour training requirement in each specialty and in general laboratory practices was developed was that they provide specific, quantifiable training requirements, so that all potential candidates are certain of the requirements for licensure. The proposed rule, however, provides only a vague standard for one to employ in determining how much training is provided in each specialty area in the “one year of integrated study” the new rule would require. Thus there are no uniform standards and the Board will have to proceed on a case-by-case basis (making incipient policy) in determining whether a particular candidate has been properly trained. The proposed rule is vague in comparison to the current rule. The proposed rule could tend to lower the standards for training of technicians and would not, therefore, meet the legislative mandate concerning protection of public health.

   34. Various changes to the current rules will change the scope of practice for technicians in that they may perform laboratory tests and immediately release their tests results to the public without review by licensed technologists, supervisors or directors. The Board offered no clear reasons why these

       proposed changes were made. Instead, it traced the history of the review of the work of technicians and contended that the proposed rules would simply clarify conflicts in the current rule. It also considered that the previous Board had heard conflicting views about the proper review of technician test results. The Board offered no new or different studies or considerations that it had learned of since the adoption of the current rules in December 1995.

   35. The Petitioners traced the history of the difference between the scope of practice of technologists and technicians to support the maintenance of the distinction between the two in the current rules. Technologists, by training and tradition, are professionals who exercise independent judgment while performing the three (3) phases of the laboratory test — the pre-analytical, the analytical, and post-analytical phases. A technician is trained only to perform manual analytical tasks and thus does not possess the skills and training to properly assess and relate the wider body of knowledge to the current tests in order to determine if the test result is correct, needs to be re-run, whether the tests controls were proper or any of a number of other possible errors. The end result of the changes in the scope of practice rules for technicians will create a blending of the two (2) levels of licensure which will create confusion as to the extent and scope of permissible practice of technologists and technicians.

   36. The Board has proposed a new means whereby one can become licensed as a medical technician by experience. The Petitioners claim that allowing this means the Board is not requiring minimal standards for licensure to ensure safe practice of laboratory science, for a number of reasons. An individual is not required to have any formal training in laboratory science and the amount of experience required to sit for the exam is vague. If an individual has a high school diploma, five (5) years of “pertinent general laboratory experience” accrued within the last ten (10) years is necessary. If a candidate has an associates degree then four (4) years, or, if a bachelors degree, then three (3) years of pertinent general laboratory experience is required. The new definition of clinical laboratory experience is “a minimum of six months of full-time experience in at least four of the five categories: microbiology, serology/immunology, chemistry, hematology, and immunohematology.” This last definition is vague and indefinite, allowing the Board to decide on a case by case basis what “six

       (6) months” means and what “full-time” means. Moreover, the proposed rule does not require a minimum of six (6) months in each of the four (4) specialty areas.

   37. The current training requirement of four-hundred (400) clock hours in each specialty area, provides a clear standard to determine if the individual has been properly trained. In allowing an individual to sit for the exam without this defined

       training and with no clear experience route, the Board has arbitrarily lowered the standards for safe practice of laboratory science or has so vaguely stated the requirements that such lower standards can be effected in decisions made on a case-by-case basis. No rationale was offered in evidence for requiring an individual to have experience in four (4) out of the five (5) specialty areas that make up the general category. Thus an individual could qualify to take the general exam with no formal training, have an undefined amount of experience in only four (4) specialty areas, have no experience in one (1) of the five (5) areas and still become licensed. When this situation is combined with the evidence that an individual could pass the generalist exam by failing all of the questions in three (3) of the five (5) specialty areas, then the result is a failure by the Board to set adequate minimum standards for safe practice of laboratory science by the proposed rule.

   38. The Board provided no new evidence concerning why it had now decided to establish an experience route to examination and licensure, other than to simply contend that there had always been individuals who wanted to qualify by experience. The evidence shows that the prior Board had systematically and recently reviewed all of the medical technician qualification rules and had decided not to provide an experience means for qualification. No preponderant evidence was offered of a clear, logical rationale for such changes, only a few short months after

       the current rules took effect in December 1995 and before an opportunity was even afforded to administer the first scheduled examination under the new rules (in October 1996).

   39. The Board also seeks to change the “Director Examination Rule” to provide that only national certification examinations will be given, rather than the current state examinations. The qualification requirements that a candidate would have to meet to qualify to sit for the various national examinations exceed the current qualifications needed to sit for the state examinations. The evidence shows that the prior Board had received reports from the state examination services that the national certification examinations now proposed to be required do not meet the state examination services rules for national examinations. It was also shown that by changing the rule to require Director candidates to sit for certain specified national certification examinations that there would be some individuals who could qualify under the state requirements to sit for the Director examination, but who could not qualify to take any of the specified national examinations. Thus, under the current qualification rule for Director, which was not proposed to be changed, there would be no available examination for such individuals to take. No evidence was produced by the Board as to why it had proposed to change the Director examination rules or any evidence that it has received any different information from its examination services or other sources, compared to what the

       prior Board had heard and considered when it adopted the current Director examination rule, effective December 1995.

   40. The Petitioners also challenge the proposed changes that would apparently create two (2) types of technician licensure, “general” and “high complexity.” In light of the statutory definition found in Section 483.803, Florida Statutes, it would seem to create two (2) categories of technicians, those who perform general practice and those who do high complexity testing. The Board argued that it was re-arranging existing provisions found in several current rules into one rule regarding the qualifications needed by a medical technician in order to perform high complexity testing. Additionally, the Board maintains that it was aligning the Board’s rules with the training and education requirements in CLIA, that personnel must have if they are going to perform high complexity testing (only). The Respondent asserts that the proposed rule “mirrors” the CLIA requirements and that the current rule does not. The Petitioners maintain that there is no statutory authorization for the Board to place in its rules any qualification standards which would permit technicians to perform high complexity testing, merely for the purpose of meeting CLIA standards. The Board’s evidence indicated that this was desirable so that the state could qualify for an exemption from CLIA inspections.

   41. However, the Board did not present any evidence of any change in the CLIA regulations or any change in circumstances

       since the enactment of the current rules, that the current Board had heard, that would warrant making the proposed rules “mirror” the CLIA regulations. The Board presented no testimony in response to the Petitioners’ argument that two (2) types of licensure were being created, and especially in light of the testimony that the previous Board had accepted advice of its counsel not to create that type of provision.

   42. Proposed Rule 59O-3.002(2), would allow non-licensed personnel to teach clinical laboratory courses. The only evidence offered by the Board was that it had received comments about the advantages and disadvantages of the two (2) possible options—licensed versus non-licensed instructors and that it had decided to change the rule. The Board did not specify when these comments were received and did not present any evidence to show that any different data, studies or information had been received by the current Board when it decided to change the current rule. Further, Section 483.811(2), Florida Statutes, provides a statutory requirement for licensure of personnel engaged in training of students of laboratory science. Thus the proposed rule conflicts with the statute.

   43. The Petitioners also maintain that the Board has abdicated its oversight of development and establishment of laboratory testing, training standards and programs by incorporating by reference the requirements of the Department of Education in this area, when Section 483.811, Florida Statutes,

       requires it to perform oversight of the development of such standards. This is with reference to the proposed change to current Rule 59O-3.003. The Board presented no evidence for the reason for this change or if any circumstances had changed or new information had come to the attention of the current Board, since the current rule was adopted in December 1995.

   44. The proposed rule which changes current Rule 59O-3.003, would fail to require those trained at the technologist level to meet the training requirements of the technician level, as shown by proposed Rule 59O-3.004. The result will be that the technologists who supervise the technicians will not be required to meet the training requirements of the technician personnel they are supervising. This can lead to a general lowering of the standards designed to protect the public health in violation of the legislative mandate, referenced above. No evidence was offered by the Board concerning why these requirements found in existing Rule 59O-3.003(4)(e)i., were eliminated by the proposed Rule 59O-3.004.

       Findings of Fact as to Intervenor

       
       

   45. Paragraphs two (2) through five (5) of the Intervenor’s Proposed Findings of Fact are adopted by reference. They concern establishment of the Intervenor’s standing and the agency has stipulated that the Intervenor FABB has standing to challenge the procedural notice and the manner in which the agency implemented rule-making proceedings.

   46. A proposal to terminate the blood banking specialty, enacted by the rules which took effect in December 1995, as it pertained to the subject proposed rules, was never agendaed nor discussed at any meeting of the Board. Based upon

       un-contradicted testimony, it was apparent that a course of communication, cooperation and assistance had occurred between representatives of the agency and its predecessors and representatives of the Florida Association of Blood Banks (FABB) regarding the development and implementation of the rule pertaining to the blood banking specialty designation. This included communications from representatives of the FABB to the agency and its predecessors to set up a committee to resolve various licensure issues pertaining to unique needs of blood bank personnel. The agency and the FABB worked closely together for a number of years to address the problem and develop a rule providing for a blood bank specialty and examination. That rule was adopted in December 1995, and the first examination under that new rule was scheduled to be administered in October of 1996.

   47. At no point during the period that the Board was presumably considering repeal of the rule providing for the blood bank specialty and related changes to rules pertaining to technologists and technicians, did it communicate or otherwise notify the FABB of its intended action, until the filing of a

       Notice of Proposed Rules in the Florida Administrative Weekly on August 23, 1996.

   48. The agenda for the meeting held in connection with the workshop and Board meeting on March 7-8, 1996, made no specific notice that a decision to delete the blood banking specialty would be considered. Rather, it noted only that a workshop would occur in which the Board would receive input from the public. Drafts of the proposed rule changes were not available for review by the public at the June 13th, 14th, and 15th meeting of the Board. The Board did not receive any public policy input regarding termination of the blood bank specialty rule, from the time it was adopted in December of 1995 through the Board’s decision to repeal it in June 1996.

   49. On August 23, 1996, the agency filed a Notice of Rule Making. The Notice of Rule Making provided that if requested, a hearing would be scheduled within twenty-one (21) days of the notice. There was no evidence presented by the agency that at any time prior to publication of the notice of August 23, 1996, it had held workshops or otherwise explicated its decision to terminate the rules pertaining to the blood banking specialty. While the agency referred to several workshops which were held in March and June of 1996, there was no testimony that repeal of the blood banking specialty was agendaed or discussed.

       CONCLUSIONS OF LAW

   50. The Division of Administrative Hearings has jurisdiction of the subject matter of and the parties to this proceeding. Section 120.56(1), Florida Statutes.

   51. The Petitioners have established they have standing to challenge the proposed rules. The changes to the present rules regarding the licensure requirements and scope of practice of medical technicians which were proposed to be made to the existing rules would have a direct adverse impact upon the coalition’s member organizations, and individual members of those organizations, because less qualified technicians would be licensed to perform laboratory testing. The coalition represents those adversely impacted members and established that the subject matter of the proposed rules comes within the scope of interests the coalition and its members were organized to protect. Thus, the Petitioners have standing. See Florida Home Builders v. Dept of Labor, 412 So. 2d 351 (Fla 1982); Dept of Professional Regulation v. Fla Dental Hygienists Assn., 612 So 2d 646 (Fla. 1st DCA 1993).

   52. The Agency for Health Care Administration licenses clinical laboratories pursuant to Section 483.057, Florida Statutes, et. seq., and clinical laboratory personnel who work in those laboratories are licensed by the Respondent Board of Clinical Laboratory Personnel, pursuant to Section 483.800, et. seq., Florida Statutes. The clinical laboratories are defined as laboratories:

       Where examinations are performed

       on material or specimens taken from the human body to provide information or materials for use in the diagnosis, prevention or treatment of a disease

       or the assessment of a medical condition.

       
       

       Section 483.041(2), Florida Statutes.

       
       

   53. In order to protect the public health, safety and welfare, the Board has been delegated authority to license clinical laboratory personnel and is authorized to license personnel who meet the minimum requirements for safe practice. Section 483.800, et. seq., Florida Statutes. The performance of clinical laboratory examinations or reports requires licensure. Section 483.813, Florida Statutes. The Board of Clinical Laboratory Personnel is authorized to establish for licensure “minimal qualifications for clinical laboratory personnel.” Section 483.823, Florida Statutes.

   54. The primary effect of the proposed rule changes is to change the licensure requirements in terms of training, experience and examination requirements for medical technicians. All levels of licensed laboratory personnel will be affected by the proposed changes. Likewise, the proposed changes to the scope of practice of medical technicians will affect the functioning of the laboratories and the practice of laboratory testing for all licensed personnel working in laboratories.

   55. A substantially affected person may seek an administrative determination of the invalidity of a proposed Rule. Section 120.56(2)(a), Florida Statutes. The Petition

       filed by the Florida Coalition of Professional Laboratory Organizations, Inc., described with particularity the objections to the proposed rules and the reasons that the proposed rules are an invalid exercise of delegated legislative authority.

       Additionally, the Petitioners provided substantial evidence that the proposed rules are, under the circumstances, unreasonable and not attended by logic and reason. Therefore, under Section 120.56(2)(a), Florida Statutes (1996), the agency has the burden of establishing that the proposed rules are not an invalid exercise of delegated legislative authority as to the objections raised. The specific provision of Section 120.56(2)(a), Florida Statutes, provides as follows:

       The agency then has the burden to prove that the proposed Rule is not an invalid exercise of delegated legislative authority

       as to the objections raised. The Administrative Law Judge may declare the proposed Rule wholly or partially invalid. Section 120.56(2)(a), Florida Statutes.

       
       

   56. The above-cited provisions of Section 120.56(2), Florida Statutes, became effective October 1, 1996. Thus the effective date of the statute is after the date that the agency proposed these rules. The proposed rules were published in the Florida Administrative Weekly, on August 23, 1996. The Petition was filed on September 13, 1996. The hearings were conducted on February 27 and March 21, 1997. As issue thus exists as to whether the newly adopted provisions regarding the placement of the burden of proof apply to the instant proceedings.

   57. A statute affecting the burden of proof is generally deemed to be procedural in nature. 49 Fla. Jur. 2d Section 108. Even in the absence of clear legislative intent, a procedural rule may be applied retroactively under the general provision that no one has a vested right to a given mode of procedure. Moreover, the First District Court of Appeal has recently considered this issue in an analogous situation involving other October 1996 amendments to Chapter 120. In Life Care Centers of America v. Sawgrass Care Center, 603 So. 2d 609 (Fla. 1st DCA 1996), Judge Benton applied amendments to Section 120.59(2), Florida Statutes, retroactively. In addressing the issue of retroactive application of statutory changes, the court cited general principles stating:

       The general rule (of statutory construction) is that a substantive statute will not operate retrospectively absent clear legislative intent to the contrary, but that a procedural or remedial statute is to operate retrospectively. (Citations Omitted).

       Additionally, statutes that relate only to procedure or remedy generally apply to all pending cases. at 613.

   58. The court noted that “procedure within an administrative agency is subject to statutory regulation.” Thus, the court applied the amended statute. The same result applies here. Newly enacted Section 120.56(2), Florida Statutes, shifts the burden of proof to the agency.

   59. Having concluded that the agency carries the burden of proof in establishing that the proposed rules are not an invalid

       exercise of delegated legislative authority, it must be determined what showing the Board was required to make.

   60. Section 120.52(8), Florida Statutes, defines an invalid exercise of delegated legislative authority as action which goes beyond the powers, function and duties delegated by the Legislature. In accordance with this provisions, a proposed or existing rule is an invalid exercise of delegated legislative authority if any one of the following bases for invalidity, raised generally or specifically in the Petition exists:

       1. The Agency has materially failed to follow the applicable Rule making procedures or requirements set forth in this chapter;

          
          

       2. The Agency has exceeded its grant of Rule making authority, citation to which is required by Section 120.54(3)(a) 1, Florida Statutes;

          
          

       3. The Rule enlarges, modifies or contravenes the specific provisions of law implemented, citation to which is required by Section 120.54(3)(a) 1, Florida Statutes;

          
          

       4. The Rule is vague, it fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;

          
          

       5. The Rule is arbitrary or capricious;

          
          

       6. The Rule is not supported by competent, substantial evidence; or

          
          

       7. The Rule imposes regulatory costs on a regulated person, county or city which can be reduced by adoption of less costly alternatives that substantially accomplish the statutory objectives.

       
       

   61. Application of the burden of proof requirements of Section 120.56(2), Florida Statutes, to this definition logically

       requires the agency to show by a preponderance of the evidence that the proposed rules satisfy the above elements. Moreover, the rule-making authority of the Board is additionally circumscribed by the general principle stated in Section 120.52(8), Florida Statutes, to the effect that the agency’s powers extend no further than the particular powers and duties conferred by statute. The agency has no authority to adopt rules only because they are “reasonably related to the purpose of enabling legislation and (are) not arbitrary or capricious.” The proposed rules are invalid in a number of respects.

   62. In Part IV, Chapter 483, Sections 483.800-827, Florida Statutes, the Board is given broad statutory authority to (a) set minimal standards for the safe practice of laboratory testing (Sections 483.800 & 483.823); (b) license clinical laboratory personnel in four areas-director, supervisor, technologist and technicians (Sections 483.083(3); 483.815, Florida Statutes);

       1. issue a license authorizing the performance of procedures of one or more categories (Section 483.15, Florida Statutes);

       2. require examinations to be conducted by the Department (Section 483.809(2), Florida Statutes); (e) approve curriculum in schools and colleges offering education and training for licensure (Section 483.809(4), Florida Statutes); (f) approve training programs, in laboratories or schools, including approving curriculum, evaluation procedures, pre-entry requirements (Section 483.811(1),(2),(3), and (4)); and (g)

       require licensure before an individual can conduct a clinical laboratory examination (Section 483.813, Florida Statutes).

   63. Given this broad statutory framework, in order to determine whether a challenged rule is arbitrary or capricious, it must still be determined whether the proposed rule is supported by fact or logic or is undertaken without thought or reason. Dravo Basic Materials Company, Inc. v. State Department of Transportation, 602 So. 2d 632 (Fla. 2d DCA 1992). This is especially so in light of the fact that the agency had enacted the existing rules, effective December of 1995. These rules were presumably enacted with logical thought and reason as a result of fact-gathering and consideration of related federal regulations and the mode of practice of the profession.

   64. Indeed the rationale and fact-gathering process underlying the existing rules began in early 1993 when the newly created Board undertook to review all of the existing rules governing personnel, laboratory license and discipline, leading to their 1995 enactment. Only a few months later, in 1996, the agency embarked on the subject, rather singular course reversal, in proposing the rules at issue. These proposed rules significantly change the requirements for licensure and the examination for technician licensure; in effect eliminating specialty exams, before prospective licensees could even sit for the first examination administered under the rules which became effective in December of 1995. That first examination was

       administered in October of 1996. Some months previously the rule-making process of the proposed rules, deleting the examination for technicians by specialty was inaugurated and the proposed rules were noticed on August 23, 1996.

   65. The Board bears the burden of establishing by competent evidence the validity of the proposed rules. The Board must do more than contend that the members of the present Board who considered the proposed rules simply have a different philosophy about the profession as a basis for these rules changes. It is not sufficient that the Board merely received letters of concern or questions concerning the existing rules, which took effect in December of 1995, or received some comments about them at a public workshop. The Board must consider such public comments but the Board must have some proven rational basis for changing the rules. Even if it be assumed that the Board established some evidence in support of the rules it has not established a logical rationale for them by a preponderance of the evidence.

   66. However, the Petitioner has established by a preponderance of the evidence that the existing rule framework, which provided for the specialty examination and licensure of medical technicians, was developed by the previous Board, based upon a legitimate, lengthy review of the current state of laboratory personnel training and testing; and further was developed within a procedural process which involved full and prior public notice and opportunity for public input. It was

       also established that the current rules were developed by a Board that had systematically reviewed and debated the substance of each rule provision, had seriously considered the various possible positions to be taken on the rules, and had voted as a collegial body to adopt them. The Board is now seeking to delete those provisions without apparently considering the full impact of the changes, nor providing, by preponderant evidence, a cogent explanation for its abrupt, rapid change in philosophy in directing this area of regulation.

   67. The Board also failed to follow applicable rule-making procedures of Chapter 120.52(8)(a), Florida Statutes, and its own rules by failing to timely publish the amended March 1996 agenda, announcing no good cause for the amendment to the agenda, and by taking a vote based on the credentials committee meeting out of order. The Board also failed to follow applicable rule-making procedures when it failed to publish a new agenda for the July 1996 meeting (apparently a telephonic conference call meeting) after the June 1996 meeting had been adjourned. These failures form another reason as to why the rules are invalid.

   68. Section 483.11, states that the Board “shall” adopt rules for clinical laboratory training programs. The proposed rule change in Rule 59O-3 therefore unlawfully delegates the Board’s statutory authority in Section 483.11, to the Department of Education. In adopting national examinations for directors, the Board has failed to establish that such examinations meet the

       requirements of Section 455.2173(1)(c), Florida Statutes, and the rules adopted thereunder. Thus the rule has not been shown to be valid.

   69. All of the proposed rules contain vague criteria which grant undue discretion to the Board and incite creation of non- rule, incipient agency policy, contravening the requirements of Section 120.54(3)(d), Florida Statutes.

   70. It is presumed that the existing rules are valid. The Board offered no persuasive, preponderant evidence that the existing rules were arbitrary, capricious or based upon flawed rationale or differing circumstances, when they were adopted in December of 1995. In now proposing repeal of those same rules and adoption of new rules without any change in the organic statutory authority or other preponderantly proven changes in circumstances, the agency was required to provide some persuasive, preponderant rationale justifying elimination of the presumed valid existing provisions. The Board offered no evidence of studies, data, scientific papers or significant anecdotal evidence to support its changes. The Board failed to establish that the existing rules are arbitrary, capricious or without logic or reason. Moreover, it offered no credible explanation as to why the existing rules should be repealed or replaced with a new and contrary regulatory scheme.

   71. The proposed discarding of the existing rules only a few months after their enactment, when the enabling statutory

       basis for them, including the Board’s statutory charge to adopt minimal standards for licensure to assure public safety is unchanged, renders the proposed rule enactments to be arbitrary and in contravention of its rule-making authority and the specific provisions of law implemented. This is especially so since no insufficient time has elapsed to allow the December 1995 current rules to be carried out fully, especially with a view toward the first examination under the new rules, which only occurred in October of 1996. This was after the proposed rules had already been noticed by the agency.

   72. In summary, it has been established that, to the extent that the proposed rules change the type of examination given for medical technicians, change the licensure of technicians from specialty to general, change training and add experience requirements for technicians and change the scope of practice for technicians and make the other changes challenged and found herein, the Board has failed to establish that the proposed rules are not an invalid exercise of delegated legislative authority. Accordingly, in consideration of the foregoing, it is:

ORDERED that in light of the above-findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, the following proposed rules are invalid exercises of delegated legislative authority, to-wit: Proposed Rules

59O-2.002; 59O-5.004; 59O-7.001; 59O-3.001; 59O-3.002; 59O-3.003;

59O-5.002; and 59O-10.005, Florida Administrative Code. DONE AND ORDERED this 17th day of October, 1997, in

Tallahassee, Leon County, Florida.

P. MICHAEL RUFF Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(904) 488-9675 SUNCOM 278-9675

Fax Filing (904) 921-6847

Filed with the Clerk of the Division of Administrative Hearings this 17th day of October, 1997.

COPIES FURNISHED:

Sandra E. Allen, Esquire

314 West Jefferson Street Tallahassee, Florida 32301

Edwin A. Bayo, Esquire Department of Legal Affairs The Capitol, Plaza Level 01

Tallahassee, Florida 32399-1050

Thomas J. Guilday, Esquire Huey, Guilday, et al.

Post Office Box 1794 Tallahassee, Florida 32302

Carroll Webb, Executive Director Administrative Procedure Committee

120 Holland Building Tallahassee, Florida 32399-1300

Liz Cloud, Chief

Bureau of Administrative Code The Elliott Building Tallahassee, Florida 32399-0250

NOTICE OF RIGHT TO APPEAL

A party who is adversely affected by this final order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of the notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 96-004336RP

Orders for Case No: 96-004336RP