96-004336RP Florida Coalition Of Professional Laboratory Organizations, Inc., Et Al. vs. Department Of Health, Clinical Laboratory Personnel Status: Closed DOAH Final Order on Friday, October 17, 1997.

Summary: Respondent agency has burden of proof to show proposed rules valid. Did not show, under circumstances that rules supplemented by adequate rationale and attended by logic and reason.

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

(11) 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-3.0 01(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 c hanges 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 13 th , 14 th , and 15 th 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.

1 st 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 affec ting 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. 1 st 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:

a. The Agency has materially failed to

follow the applicable Rule making procedures

or requirements set forth in this chapter;

b. The Agency has exceeded its grant of Rule

making authority, citation to which is required

by Section 120.54(3)(a) 1, Florida Statutes;

c. 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;

d. The Rule is va gue, it fails to establish

adequate standards for agency decisions, or

vests unbridled discretion in the agency;

e. The Rule is arbitrary or capricious;

f. The Rule is not supported by competent,

substantial evidence; or

g. 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);

(c) issue a license authorizing the performance of procedures of

one or more categories (Section 483.15, Florida Statutes);

(d) 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

[phone] SUNCOM 278-9675

Fax Filing [phone]

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.