94-005968RP Florida Perfusion Society And Florida Hospital Association vs. Board Of Clinical Laboratory Personnel Status: Closed DOAH Final Order on Wednesday, March 8, 1995.

Summary: Board exceeded rulemaking authority in adopting amendments, and rules were abitrary and capricious.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA PERFUSION SOCIETY and )

FLORIDA HOSPITAL ASSOCIATION, )

)

Petitioners, )

)

vs. ) CASE NO. 94-5968RP

)

BOARD OF CLINICAL LABORATORY )

PERSONNEL, )

)

Respondent, )

and )

)

FLORIDA COALITION OF PROFESSIONAL )

LABORATORY ORGANIZATIONS, INC., )

)

Intervenor. )

__________________________________)

FLORIDA SOCIETY OF PATHOLOGISTS )

and LOUIS S. McCANN, JR., M.D., )

)

Petitioners, )

)

vs. ) CASE NO. 94-5969RP

)

BOARD OF CLINICAL LABORATORY )

PERSONNEL, )

)

Respondent. )

__________________________________)

FLORIDA LEAGUE OF HOSPITALS, )

INC., )

)

Petitioner, )

)

vs. ) CASE NO. 94-5970RP

)

BOARD OF CLINICAL LABORATORY )

PERSONNEL, )

)

Respondent, )

and )

)

FLORIDA COALITION OF PROFESSIONAL )

LABORATORY ORGANIZATIONS,INC, )

)

Intervenor. )

__________________________________)

FINAL ORDER

Pursuant to notice, the above matters were heard before the Division of

Administrative Hearings by its assigned Hearing Officer, Donald R. Alexander, on

November 23, 1994, in Tallahassee, Florida.

APPEARANCES

For Petitioners: Carol A. Forthman, Esquire

(Case No. 94-5968RP) 131 North Gadsden Street

Tallahassee, Florida 32301-1507

For Petitioners: Harold F. X. Purnell, Esquire

(Case No. 94-5969RP) Thomas W. Konrad, Esquire

Post Office Box 551

Tallahassee, Florida 32302-0551

For Petitioner: John H. French, Jr., Esquire

(Case No. 94-5970RP) Post Office Box 10095

Tallahassee, Florida 32302-2095

For Respondent: Claire D. Dryfuss, Esquire

Department of Legal Affairs

The Capitol, PL-01

Tallahassee, Florida 32399-1050

For Intervenor: Sandra E. Allen, Esquire

314 West Jefferson Street

Tallahassee, Florida 32301

STATEMENT OF THE ISSUE

The issue is whether proposed rules 590-2.002, 590-3.003, 590-5.001, 590-

5.002, 590-5.006, 590-9.002, 590-9.004, 590-10.004 and 590-13.006 are an invalid

exercise of delegated legislative authority.

PRELIMINARY STATEMENT

These cases began on October 21, 1994, when three petitions were filed

challenging the validity of certain proposed rules in Chapters 590-2, 59O-3,

59O-5, 59O-6, 59O-9, 59O-10 and 59O-13, Florida Administrative Code. The first

petition was filed on behalf of the Florida Perfusion Society, Florida Hospital

Association, Mallinckrodt Sensor Systems, Inc., i-Stat Corporation and

Boehringer Mannheim Diagnostics and was assigned Case No. 94-5968RP. The second

petition was filed by the Florida Society of Pathologists, Dr. Louis S. McCann,

Jr, and Dr. Timothy M. Kilpatrik and was assigned Case No. 94-5969RP. The last

petition was filed on behalf of the Florida League of Hospitals, Inc. and was

assigned Case No. 94-5970RP. The rules being challenged were proposed for

adoption by respondent, Board of Clinical Laboratory Personnel. After being

reviewed for legal sufficiency, the petitions were assigned to the undersigned

Hearing Officer on October 31, 1994.

By notice of hearing dated October 31, 1994, the final hearing was

scheduled on November 23, 1994, in Tallahassee, Florida. The same notice

consolidated the three cases on the hearing officer's own motion.

Prior to hearing, and based upon a motion filed by respondent, Mallinckrodt

Sensor Systems, Inc., i-Stat Corporation, and Boehringer Mannheim Corporation

were dismissed as parties in Case No. 94-5968RP on the ground they lacked

standing to file a petition. In addition, Dr. Timothy M. Kilpatrik voluntarily

withdrew as a petitioner in Case No. 94-5969RP. Finally, the Florida Coalition

of Professional Laboratory Organizations, Inc. was authorized to intervene in

Case Nos. 94-5968RP and 94-5970RP.

As in relevant here, on November 10, 1994, respondent published a notice of

change in the Florida Administrative Weekly wherein it proposed to change the

first sentence of proposed rule 59O-3.003(3)(e) and to add a sentence after the

first sentence in the first paragraph of proposed rule 59O-5.006. Those changes

have been considered by the undersigned in resolving this dispute.

At final hearing, petitioners in Case No. 94-5968RP presented the testimony

of Mark Orangio, a clinical perfusionist and accepted as an expert in that area;

Karen Brzys, a consultant and accepted as an expert in alternate site testing

regulations; Dr. Michael Groves, a manager for i-Stat Corporation; and Barbara

Foley, director of government affairs for the Florida Hospital Association.

Also, it offered FPS exhibits 1-10. All exhibits were received in evidence. In

addition, a request for official recognition of five documents has been granted.

Petitioners in Case No. 94-5969RP presented the testimony of Dr. Louis S.

McCann, Jr. and Dr. Richard Essman, both pathologists and accepted as experts in

pathology and the directorship of clinical laboratories. Petitioner in Case No.

94-5970RP offered FLH exhibit 1 which was received in evidence. That exhibit is

the deposition of its vice-president, Belita Moreton. Respondent presented the

testimony of George Mavros, a clinical laboratory supervisor and chairman of the

Board of Clinical Laboratory Personnel. Also, it offered respondent's exhibits

1-3. All exhibits were received in evidence. Intervenor adopted the evidence

submitted by respondent.

The transcript of hearing (three volumes) was filed on January 31, 1995.

Proposed findings of fact and conclusions of law were filed by the parties on

February 15, 1995. A ruling on each proposed finding has been made in the

Appendix attached to this Final Order.

FINDINGS OF FACT

Based upon all of the evidence, the following findings of fact are

determined:

A. Background

1. These cases arose after respondent, Board of Clinical Laboratory

Personnel (Board), published in the Florida Administrative Weekly its notice of

intent to adopt certain revisions in Chapters 59O-2, 59O-3, 59O-5, 59O-6, 59O-9,

59O-10 and 59O-13, Florida Administrative Code. The proposed rules deal with

the subject of alternate site testing within the state.

2. The Board was created by the legislature in 1992 to regulate clinical

laboratory personnel. Its authority and duties are set forth in Part IV of

Chapter 483, Florida Statutes. The Board's purpose is to ensure the protection

of public health, safety, and welfare through the regulation of clinical

laboratory personnel. To this end, the Board is required by law to prescribe

minimal qualifications for clinical laboratory personnel.

3. Alternate site testing is any "laboratory testing done under the

administrative control of a hospital, but performed out of the physical or

administrative confines of the central laboratory." It can only exist in a

hospital under the direct supervision of the central clinical laboratory and its

clinical laboratory director. The alternate site laboratory does the same type

of testing as does the central laboratory but it uses different equipment.

Alternate site testing is performed using ten to twelve instruments specifically

designed for that purpose, and which specifically incorporate safeguards to

prevent misuse or misinterpretation.

4. Clinical laboratory personnel are persons who perform clinical

laboratory examinations on specimans derived from the human body for the purpose

of delineating information for the diagnosis, management and treatment of

patients. There are four classes of clinical laboratory personnel, namely,

technician, technologist, supervisor and director. Within the category of

technician are various specialty categories including clinical chemistry,

hematology, immunohematology, histology, radioassay, serology, microbiology,

exclusive use and alternate site.

5. In general terms, the proposed rules define an alternate site

technician, set forth the curriculum requirements for training programs for

alternate site technicians, state the minimum standards for licensure as an

alternate site technician, prescribe the initial licensure and renewal fees for

alternate site technicians, set forth the scope of practice for all clinical

laboratory personnel, and enumerate the responsibilities of alternate site

technicians including limits on tests that can be performed with this type of

licensure. These rules were adopted after various workshops, public meetings

and member conference calls were conducted by the Board in 1993 and 1994.

6. As clarified by a more definite statement, petitioners in Case No. 94-

5968RP, Florida Perfusion Society (FPS) and Florida Hospital Association (FHA),

contend that all or parts of proposed rules 590-2.002, 590-3.003, 590-5.006,

590-9.002, 590-9.004, 590-10.004 and 590-13.006 are invalid on the grounds (a)

the Board exceeded its rulemaking authority, (b) the rules are arbitrary and

capricious, and (c) the rules contravene the law being implemented.

7. Petitioners in Case No. 94-5969RP, Florida Society of Pathologists

(FSP) and Dr. Louis S. McCann, Jr., have challenged proposed rules 590-5.001 and

590-5.002 on the grounds the two rules contravene the statutes being implemented

and are arbitrary and capricious.

8. Petitioner in Case No. 94-5970RP, Florida League of Hospitals (FLH),

has challenged the validity of all the proposed rules on the ground the Board

has exceeded its rulemaking authority. In addition, it has challenged Rules

590-2.002(7), 590-5.006(2), 590-9.002(4), 590-9.004(7) and 590-13.006 on the

ground they contravene the statutes being implemented.

9. Intervenor, Florida Coalition of Professional Laboratory Organizations,

Inc., is a nonprofit corporation representing twelve organizations who represent

the interests of laboratory professionals licensed under Part IV of Chapter 483,

Florida Statutes. It supports the challenged rules and is aligned with the

Board in these proceedings.

B. Standing

10. Respondent has stipulated to the standing of the FSP, a professional

association of pathologists, and Dr. McCann, its president-elect, and thus there

is no dispute that those petitioners are substantially affected by the proposed

rules.

11. FPS is a statewide professional medical society representing

professional cardiovascular perfusionists in Florida. Perfusionists are

principally known for the safe operation and maintenance of the heart-lung

machine in open heart surgery. The FPS currently has more than one hundred

members, most of whom are actively engaged in the practice of perfusion.

12. The purpose of the FPS is to promote perfusion education and clinical

expertise and to address the professional interests of perfusionists on issues

affecting the profession, including representation before governmental bodies.

13. Perfusionists are regularly required to perform the type of tests that

are performed at alternate sites as part of their profession. The proposed

rules would directly regulate their practice. In addition, a substantial number

of FPS members would be affected by the proposed rules because they would be

required to obtain a license as a laboratory professional in order to continue

practicing using alternate test sites, or to use alternate test sites in the

future. As such, they are substantially affected by the proposed rules.

14. The FHA is a statewide, nonprofit trade association representing all

types of hospitals in the state. As of August 1994, or three months before the

hearing, it had 233 institutional members (licensed hospitals), plus various

organizational and individual members. Its purpose is to serve its members by

developing and promoting programs and services that will enhance their ability

to provide comprehensive, efficient, high quality health care to the people of

Florida. The association also represents its members at the state and national

levels in providing an effective health care system.

15. Only hospitals with clinical laboratories can have alternate site

laboratories where alternate site technicians would be employed. The number of

institutional members having clinical laboratories is not of record nor is the

number of hospitals who plan to operate alternate site laboratories. Even so,

it may be reasonably inferred that at least some of the hospitals provide

clinical laboratory services in their facilities and, in the future, they intend

to provide alternate site testing. Because the proposed rules require medical

professionals already licensed or certified to obtain an additional license,

limit the professionals who can provide these services, and impose regulatory

and financial requirements on the provision of those services, the institutional

members of the FHA are substantially affected by these proceedings. Moreover,

because the proposed rules impose new training requirements on medical

personnel, the hospitals who employ such individuals would be required to absorb

the cost of training these employees and providing coverage for their duties

while they are being trained. In these respects, they are further impacted by

the rules.

16. The FLH is a trade association comprised of seventy-six for-profit

hospitals. Of its seventy-six members, seventy-three have clinical

laboratories. Because the proposed rules limit the categories of hospital

personnel who could be licensed as alternate site testing technicians and

restrict the tests that these licensees can perform, the FLH is substantially

affected by the proposed rules.

C. Legislative History of Alternate Site Testing

17. In 1993, the Florida Legislature adopted Chapter 93-178, Laws of

Florida. That act specifically provided for the implementation of alternate

site testing in Florida. The section relating to alternate site testing, which

has been codified as Subsection 483.051(9), Florida Statutes, provides as

follows:

(9) Alternate Site Testing.- The agency,

in consultation with the Board of Clinical

Laboratory Personnel, shall adopt, by rule,

the criteria for alternate-site testing to be

performed under the supervision of a clinical

laboratory director. The elements to be addressed

in the rule include, but are not limited to: a

hospital internal needs assessment; a protocol

of implementation including tests to be performed

and who will perform the tests; criteria to be

used in selecting the method of testing to be

used for alternate-site testing; minimum training

and education requirements for those who will

perform alternate-site testing, such as documented

training, licensure, certification, or other

medical professional background not limited to

laboratory professionals; documented inservice

training as well as initial and ongoing competency

validation; an appropriate internal and external

quality control protocol; an internal mechanism

for identifying and tracking alternate-site testing

by the central laboratory; and recordkeeping

requirements. Alternate-site testing locations

must register when the clinical laboratory applies

to renew its license. For purposes of this

subsection, the term "alternate-site testing"

means any laboratory testing done under the

administrative control of a hospital, but

performed out of the physical or administrative

confines of the central laboratory.

(emphasis added)

18. The bill which became Chapter 93-178, Laws of Florida, originated as

PCB 93-01 of the House Committee on Health Care. It was later filed as House

Bill 2071 (HB 2071), Medical Tests and Procedures/Sunset. The overall purpose

of the bill was to review provisions of Part I of Chapter 483 related to

clinical laboratories, which was scheduled for sunset review under Section

11.61, Florida Statutes. The original version of PCB 93-01, dated January 28,

1993, had no provisions relating to alternate site testing.

19. During consideration of the bill on February 3, 1993, the House

Committee on Health Care amended PCB 93-01 to provide for rulemaking by the

Board. Specifically, the amendment stated that "(t)he board shall adopt rules

for alternate site testing to be performed under the supervision of clinical

laboratory director." However, the authority for the Board to adopt rules was

subsequently removed from the bill by amendment on the House floor on March 23,

1993.

20. The House bill was then considered by the Senate, which amended the

House bill on March 31, 1993. The amendment was a "strike everything after the

enacting clause" amendment. In effect, the amendment substituted all new bill

language in place of the House bill, while retaining the bill number of HB 2071.

The alternate site testing language substituted was identical to the bill that

had been considered in the Senate as SB 156, which, among other things, added

subsection 483.051(9), relating to alternate site testing. This provision gave

rulemaking authority to the Agency for Health Care Administration (ACHA) "in

consultation with the Board of Clinical Laboratory Personnel."

21. The Senate passed the amended bill and this version was returned to

the House. The House then passed HB 2071 as it had been amended and passed in

the Senate (with two amendments not related to alternate site testing). The

Senate then concurred in the final House version. The amendment relating to

subsection 483.051(9) (on alternate site testing) remained intact and eventually

became the current Subsection 483.051(9), Florida Statutes.

22. Subsection 483.051(9), as adopted, specifically delegates the

rulemaking authority for alternate site testing to AHCA. That provision calls

for "consultation" with the Board, but does not give the Board any rulemaking

authority.

23. The Board had a designated member, George Mavros, who represented the

Board during the legislative session. Initially, the Board recognized ACHA's

exclusive rulemaking authority in a report from its legislative liason and in

discussions with affected public at its regularly scheduled meetings. That

position was reiterated in an official letter to a representative of an affected

organization from the Board's chairman. The chairman was specifically

authorized to speak for the Board, and the letter reflected the official

position of the Board at that time.

24. In its discussions and letters, the Board specifically stated that the

newly adopted statute did not give the Board rulemaking authority. Such public

statements and letters are evidence of the Board's contemporaneous construction

of the statute that it had no authority to adopt rules governing alternate site

testing. Since that time, however, the Board has taken an opposing position,

that is, that it has authority to adopt rules pertaining to alternate site

testing requirements, and the rules under challenge are the end product of this

changed position.

25. The statute authorizing AHCA to adopt rules is clear on its face and

unambiguous. Moreover, the legislative history reveals that during the 1993

session the legislature specifically considered the delegation of rulemaking

authority to the Board in an early version of the bill. The provision giving

specific rulemaking authority to the Board was deleted by later action of the

same legislature. The final version of the bill contains a delegation of

rulemaking authority to AHCA and omits any delegation to the Board. This is

clear evidence that the legislature considered giving rulemaking authority to

the Board, and instead evinced a clear intent to give exclusive rulemaking

authority to AHCA.

26. The legislature cannot be said to have simply forgotton the authority

of the Board. Subsection 483.051(9) specifically sets forth the Board's role as

a consultant. If the legislature had intended to "split" the rulemaking

authority for alternate site testing between the Board and AHCA, it would not

have specifically set out a different role in the statute. The legislative

staff analyses of the bill support these findings. The staff analyses of

subsection 483.051(9) refer solely to AHCA when referencing rulemaking authority

for alternate site testing. Therefore, the Board did not have statutory

authority to adopt the rules. For the reasons given in the conclusions of law

portion of this order, the statutes which the Board relies upon for its

rulemaking authority are not deemed to be controlling or relevant.

D. Are the Challenged Rules Invalid for Other Reasons?

27. Nothwithstanding the above findings, and solely for the sake of

judicial economy in the event an appeal is taken by any party, additional

findings are made relative to each of the challenged rules. In making these

findings, it is noted that where new grounds for invalidating a rule have been

raised for the first time in a party's proposed order, they have been

disregarded as being untimely. Further, where a party has not addressed a

previously raised ground in its proposed order, the undersigned has assumed that

ground has been abandoned. Where a party speaks to a rule in general terms, and

not a specific part thereof, and the undersigned is unable to discern which part

of the rule is being attacked, that contention has been disregarded.

a. Rule 59O-2.002(7)

28. The first challenged rule is 59O-2.002(7), which defines the term

"technician in the specialty of Alternate Site Testing" as follows:

(7) Technician in the specialty of Alternate

Site Testing means a person qualified to be

a technician in the specialty of alternate

site testing pursuant to the rules of the

Board who under the general supervision of a

laboratory director, supervisor or technologist

may perform specific testing authorized by the

Agency pursuant to rule chapter 59A-7 and the

Board pursuant to rule chapter 59O-13 in a

hospital based alternate site testing environ-

ment approved by the Agency pursuant to section

483.051(9), F. S. and whose practice is limited

to an alternate site testing environment.

The Board had cited Subsections 483.805(4) and 483.811(3) and (4), Florida

Statutes, as the specific authority for adopting the rule while Subsections

483.803 and 483.811(3) and (4), Florida Statutes, are cited as the laws being

implemented.

29. Besides leveling the broad charge that the Board lacks statutory

authority to adopt the rule, a contention already decided in their favor,

petitioners FPS and FHA contend that the rule is arbitrary and capricious

because it sets up an impossible condition for qualifying as an alternate site

technician since necessary related rules in Chapter 59A-7 have never been

adopted by AHCA.

30. In order for the proposed rule to become operable, AHCA must first

adopt amendments to its Chapter 59A-7, which pertain to alternate site testing

laboratories. Also, AHCA must approve a "hospital based alternative site

testing environment" in which such tests can take place. At the time of

hearing, a draft of new proposed rules 59A-7.034 and 59A-7.035 was being

circulated by AHCA, but had not yet been adopted. Even so, the fact that the

Board's rule is contingent on further rules being adopted by another agency does

not render the rule arbitrary or capricious. The contention is accordingly

rejected.

(b) Rule 59O-3.003(3)(e)

31. This rule sets out the proposed requirements for training for

individuals performing specific alternate site tests. As modified by the notice

of change published in the Florida Administrative Weekly on November 10, 1994,

the challenged portion of the rule now provides the following training

requirements:

(e) Notwithstanding all other provisions

of rule chapter 59O-3.003, the only require-

ments for training in the specialty of Alternate

Site Testing shall be 4 contact hours of

instruction per test system with an additional

0.5 contact hour of instruction for each analyte

above 8 analytes performed on the same test

system. The contact hours of instruction shall

be by a Board approved continuing education

provider approved pursuant to rule chapter 59O-11

which shall include as a minimum instruction in

the tasks defined as follows:

* * *

The terms "analyte" and "test system," which are

the guages on which training is measured, are not

defined anywhere in the Board's rules.

32. Besides the argument that the Board lacks statutory authority to adopt

the rule, petitioners FPS and FHA contend the proposed rule is arbitrary and

capricious in that the requirements are excessive and inflexible. They also

contend that the rule contravenes the provisions of Subsection 455.201(4),

Florida Statutes, which prohibits a regulatory board from adopting "unreasonably

restrictive and extraordinary standards" for a given profession.

33. In proposing the number of hours of training for alternate site

testing, the Board relied mainly upon its own members' expertise and judgment.

It also relied on public comment given at a Board meeting on August 7, 1993,

including testimony from a manufacturer's representative. Finally, it relied

upon a training and certification program manual by i-Stat Corporation, a

manufacturer of equipment used in clinical laboratories, and on other

unspecified "documents and manuals." It did not conduct any surveys of

professional literature or other outside services, nor did its staff conduct any

research on the subject.

34. Initially, it is noted that the proposed rule gives no consideration

to the relative levels of medical training and education in the various

professions regulated by the rules, even though that can affect how much

training time is needed. For some professionals, such as an ICU nurse or

emergency physician nurse, four hours of training is excessive, based on

approved manufacturer's training protocol. By providing uniform instruction for

all professionals, regardless of their prior training, and without any factual

basis for doing so, the Board acted in an arbitrary manner.

35. In arriving at the number of hours of instruction required for each

test system, the Board relied in part on the testimony of a manufacturer's

representative (Mallinckrodt) given at the August 7, 1993 meeting. A review of

his comments, however, reveals that the representative recommended far fewer

hours of instruction than is provided for in the rule. Moreover, in prescribing

four hours training per test system, the Board relied primarily on its own

judgment rather than on technical material submitted by other affected persons.

Likewise, the basis for the additional 0.5 hours per analyte over eight analytes

was not grounded on empirical data. Indeed, analytes and test systems are not

even defined in the rule. Given these shortcomings, it cannot be said that the

requirements of the rule are based on facts or logic. The rule is accordingly

deemed to be arbitrary and capricious. Given this finding, it is unnecessary to

reach the issue of whether the rule contravenes Subsection 455.201(4), Florida

Statutes, by providing unreasonable and restrictive standards.

(c) Rule 59O-5.001(1)(b), (2)(a), and (2)(b)

36. This rule prescribes the educational requirements for the director of

a clinical laboratory. Under current standards (rule 10D-41.067), a director

must be a physician or a doctoral scientist. By its rule, the Board proposes to

allow a person with a master's degree to become licensed as a clinical

laboratory director. The challenged portions of the rule read as follows:

(1) Education. An applicant shall meet one

of the following education requirements:

* * *

(b) Have a master's degree in clinical laboratory

science, one of the specialty areas, or one of

the chemical or biological sciences.

(2) Experience. An applicant who qualifies

pursuant to rule 59O-5.001(1) shall meet one of

the following requirements:

(a) Have full time pertinent clinical laboratory

experience in an approved laboratory subsequent

to receipt of the relevant degree as follows:

* * *

2. If qualifying under rule 59O-5.001(b), 8 years

of experience.

* * *

37. Petitioners FSP and Dr. McCann generally contend the foregoing rule

contravenes Section 483.800, Florida Statutes, and is arbitrary and capricious

in that it allows untrained persons to become laboratory directors.

38. All state clinical laboratories and their personnel are subject to

federal regulation under the federal Clinical Laboratory Improvement Act (CLIA).

Regulations promulgated thereunder classify clinical laboratories based on the

complexity of the tests performed. The three category of tests are waived,

moderately complex and highly complex. Laboratories performing waived tests, or

those that are simple and pose no risk to the public, are not regulated by CLIA

while those performing moderate to highly complex testing must meet CLIA's

minimum requirements for quality control, quality assurance and personnel.

39. CLIA regulations link personnel requirements with the complexity of

testing. The requirements for moderate and highly complex testing personnel are

defined separately and are significantly different. Those facilities providing

only moderately complex testing may use directors having both master's level and

bachelor's level degrees. In recognition of both the sophistication of highly

complex tests and the broad scope of a laboratory director's duties and

responsibilities, however, CLIA regulations require directors of clinical

laboratories performing any highly complex testing whatsoever to be either

physicians or doctoral scientists. It is noted that hospital laboratories and

independent laboratories perform highly complex testing, and that any hospital

laboratory, including rural hospitals, providing full service functions will

perform highly complex testing.

40. Under CLIA regulations, laboratories which perform highly complex

testing allow the director to reapportion performance of responsibilities to

persons having less qualifications. The overall responsibility, however, rests

with the director, and the regulations do not allow a master's level individual

to direct the clinical laboratory performing highly complex testing, or to

delegate responsibilities to a more qualified individual.

41. The proposed rule would allow master's degree scientists to direct

laboratories performing highly complex testing so long as that individual hired

a "co-director" who was a physician or a doctoral scientist. Under this

arrangement, the co-director would be left with only those responsibilities that

the lesser qualified master's level director called upon him or her to perform.

In this respect, the proposed rule is at variance with federal regulations.

While the Board justifies this change on the ground a study shows a shortage of

various professionals in the rural hospital setting, the study itself was not

introduced into evidence. Moreover, the rule would apply to all hospitals,

whether rural or not.

42. Even though the proposed rule is inconsistent with CLIA, in its filing

with the Joint Administrative Procedures Committee, the Board represented that

"(t)here is no ascertainable parallel federal rule or standard with which to

make a comparison." It is reasonable to infer that this response was given so

that the Board would not have to give an explanation of the rule's inconsistency

with CLIA.

43. Although the Board had a wide range of input regarding this rule, it

failed to address a number of valid concerns raised by the opponents. Because

of the nature of the testing involved in laboratories performing highly complex

testing, severe injury or even death can result from an incorrect test result

being reported by one of the clinical laboratory personnel. It is esential,

therefore, that clinical laboratories performing highly complex testing be

directed by the most competent and trained personnel. This goal is not attained

in the proposed rule. The appointment of a lesser qualified person would also

mean that a director would not be able to perform all work functions in the

laboratory, something current directors can now perform. Further, the proposed

allocation of responsibilities would place virtually all of the professional

liability on the "co-director" (physician or doctoral scientist) even though the

co-director does not "direct" the laboratory. Finally, even though a laboratory

can be licensed by specialty, this does not eliminate the above concerns since a

specialty is not limited to moderately complex testing.

44. Given the lack of a factual basis or logic to support the rule as

presently proposed, subsections (1)(b), (2)(a) and (2)(b) of rule 59O-5.001 are

deemed to be arbitrary and capricious and are thus invalid. These portions of

the rule also contravene Section 483.800, Florida Statutes, which requires,

among other things, the "licensure of clinical laboratory personnel who meet

minimum requirements for safe practice."

(d) Rule 590-5.006

45. This rule sets forth the educational requirements necessary for the

specific types of licensure and certification for clinical laboratory personnel.

As modified by the Board on November 10, 1994, the rule now reads as follows:

59O-5.006 Technician in the Specialty of

Alternate Site Testing.

Those persons licensed as a director, supervisor,

technologist or technician pursuant to part IV

of chapter 483, F.S., can work in the specialty

of alternate site testing without additional

licensure or certification. Persons only

performing waived tests as defined in section

483.041(9), F. S. in a laboratory holding a

certificate of exemption pursuant to section

483.106, F. S., are not required to be licensed

and need not meet these requirements. Persons

certified only under this rule shall not perform

testing beyond that defined in rule 590-13.006.

Persons who perform testing defined in rule

590-13.006 at alternate testing sites as defined

in section 483.051(9), F.S., shall meet the

requirements of rule 590-5.006(1), (2) and (3)

as follows:

(1) Education.

(a) Have a high school diploma or its

equivalent and

(b) Have completed 4 contact hours of

HIV/AIDS continuing education pursuant to

rule chapter 59O-11.

(2) Training. For purposes of this rule

the term "licensed" requires a full permanent

license not a temporary license. An applicant

who qualifies under the education requirements

of rule 59O-5.006(1) shall in addition meet one

of the following requirements:

(a) Is licensed as a registered nurse pursuant

to chapter 464, F. S.

(b) Is licensed as a radiologic technologist

pursuant to chapter 468, part IV, F. S.

(c) Is licensed as a respiratory therapist or

as a respiratory care practitioner certified to

perform critical care services pursuant to chapter

468, part V, F. S.

(d) Is a perfusionist certified by the American

Board of Cardiovascular Perfusion-ists.

(3) Additional Training. An applicant who

qualifies under the education requirements of

rule 590-5.066(1) and the training requirements

of rule 590.006(2) shall in addition meet one

of the following requirements:

(a) Have successfully completed a Board

approved Clinical Laboratory Personnel

Technician training program in general

laboratory practice principles pursuant to

rule 590-3.003(3)(d).

(b) Have successfully completed alternate

site testing training for each test the applicant

will be performing which provides instruction in

all subject matter areas of rule 590-3.003(3)(e).

After completing the training, the applicant shall

submit verification from the laboratory director

that the applicant has successfully completed

the alternate site testing training.

(c) Have received instruction in all subject

matter areas of rule 590-3.003(3)(d) or (e) while

enrolled in a program leading to licensure under

chapters 464, 468, part IV, or 468, part V,

F. S., or certification by the Board of

Cardiovascular Perfusionists and shall submit

verification from the program director of such

instruction.

46. Although a number of grounds for invalidating the rule were raised in

the initial petitions, in their joint proposed order, the FPS, FHA and FLH have

limited their grounds to four: (a) the Board was arbitrary and capricious in

limiting the application of the rule to five professions; (b) the Board did not

comply with Section 455.201, Florida Statutes; (c) the proposed rule contravenes

Section 468.351(2), Florida Statutes, by making the terms of the rule applicable

to respiratory therapists and respiratory care practitioners, and (d) the Board

was arbitrary and capricious by requiring training for waived tests. The

allegation regarding the validity of the requirement in subsection (1)(b) for

HIV/AIDS continuing education training has been disregarded as being untimely.

47. The rule applies to respiratory therapists and respiratory care

practitioners even though Subsection 468.351(2), Florida Statutes, which governs

the practice of those professions, clearly provides that "it is the intent of

the Legislature that personnel certified or registered pursuant to this part

shall be exempt from the licensure provisions of chapter 483." There is no

basis in the record for the Board's contention that the exemption in subsection

468.351(2) applies only to blood gas testing, and no others. Given this lack of

support for that limitation, the rule contravenes the provisions of the cited

statute, and paragraph (2)(c) is deemed to be invalid.

48. The contention is also made that the Board selected the remaining

three classes of professions (registered nurses, radiologic technologists and

perfusionists) without any justification. Although the Board contended it

studied the type of training and education received by these professions, there

is no evidence of such a discussion in the Board records, nor is there evidence

that rules regarding education and training of other professions were ever

presented to all of the Board members. Further, there is no evidence that the

Board ever considered other professionals of equal medical educational

background. While the Board did receive information from the American Board of

Cardiovascular Perfusionists regarding the certification requirements for that

organization, that by itself is an insufficient factual basis to justify the

limitation imposed by the rule. Under these circumstances, it cannot be said

that the remainder of the rule is supported by facts or logic.

49. Petitioners further contend that the rule contravenes the provisions

of Subsection 455.201(4), Florida Statutes, which makes it unlawful for the

Board to "create unreasonably restrictive and extraordinary standards that deter

qualified persons from entering the various professions." Since the Board acted

arbitrarily and capriciously in limiting the approved professions that are

subject to the rule, it is found that the proposed rule creates unreasonably

restrictive and extraordinary standards for the profession.

50. Finally, by modification to the rule on November 10, 1994, the Board

added the following sentence in the first paragraph: "Persons only performing

waived tests as defined in section 483.041(9), F. S., in a laboratory holding a

certificate of exemption pursuant to section 483.106, F. S., are not required to

be licensed and need not meet these requirements." In order to obtain a

certificate of exemption, a laboratory must be engaged only in waived tests.

These are tests that are relatively simple and pose little risk of harm to the

public. Petitioners complain that, while providing this exception to training

for waived tests at laboratories holding a certificate of exemption, the Board

did not remove the requirement for training for waived tests performed at

alternate site testing facilities, and thus the rule is arbitrary. Under the

proposed rule, any person performing waived tests, who later becomes certified

to perform a moderately complex test, must receive additional training in the

waived test as well. While the Board suggests that a hospital can avoid this

double training by setting up multiple laboratories in the same location, it

failed to provide any justification for this excessive testing. The challenged

sentence is accordingly deemed to be arbitrary.

(e) Rules 59O-9.002(4) 59O-9.004(7)

51. These two proposed rules levy a $20 fee for the initial and renewal

certification of alternate site testing technicians, respectively.

52. In its petition, the FLH contended that the Board lacked statutory

authority to adopt both rules, a contention already resolved in petitioner's

favor. In its posthearing filing, however, it argues for the first time that

the rules are arbitrary and capricious. This contention has accordingly been

rejected as not being timely.

53. The FPS and FHA have similarly contended that rule 59O-9.004(7) is

invalid on the ground the agency lacks statutory authority to adopt the rule.

They also contend for the first time that the rule is arbitrary. This untimely

allegation has been disregarded.

(f) Rule 59O-10.004

54. This proposed rule sets forth minimum standards that all laboratory

professionals must meet. At issue here are the requirements that all clinical

laboratory personnel provide the following services:

(14) Process aliquots or components of

specimens for analysis according to the type

of specimen and procedure to be performed.

* * *

(18) Recognize output signals and observations

and convert them to prescribed units for recording

and reporting.

* * *

55. In their initial petition, as clarified by a more definite statement,

FPS and FHA contended the Board exceeded its rulemaking authority by including

professionals engaged in alternate site testing as clinical laboratory personnel

subject to Board regulations, a ground already discussed. In their proposed

order, petitioners have added the contention that the rule is vague because it

contradicts the terms of another rule. Because this newly raised ground is

untimely, it has been disregarded.

(g) Rule 59O-13.006

56. The final rule being challenged describes the responsibilities of

alternate site testing technicians. Among other things, the rule prescribes the

tests that the technicians can perform. The specific portions of the rule which

are being challenged read as follows:

(1) Alternate Site Testing Technican shall:

* * *

(b) Perform only tests from the following

list provided the requirements of Rule

59O-13.006 have been met:

1. Tests designated as waived pursuant to

42 CFR 493.15, incorporated by reference.

* * *

3. Tests designated as moderately complex

pursuant to 42 CFR 493.10 and 42 CFR 493.17

which employ whole blood and require no pre-

analytical, analytical or post-analytical

specimen or reagent manipulation, treatment,

extraction, separation or other processing

of any kind and must employ an automated

single, closed, dry or electrochemical sensor

reagent system. The instrumentation shall

provide for instrument calibration without

any operator adjustment. Post analytical

instrument output signals must be directly

reportable in the correct units of measure-

measure without need for data conversion or

other manipulation. Electronic instrumen-

tation must have a mechanism whereby the

operator is alerted when patient results

exceed reportable limits and when internal

or external quality control or calibration

is not acceptable. Such results shall not

be used for the diagnosis, treatment,

management or monitoring of patients and

shall be validated through the central

laboratory. Validation shall be documented

at the alternate test site.

* * *

(j) When affixing the name or signature

to any laboratory record or patient report,

indicate the professional status by adding

the designation "ASTT" to designate Alternate

Site Testing Technician immediately following

the name or signature if holding a current

Florida certificate. The holder of temporary

certification must use the designation "GASTT"

to designate Graduate Alternate Site Testing

Technician until such time as certification is

granted by the Board.

* * *

The specific authority for adopting the rule

is Subsection 483.805(4), Florida Statutes,

while the laws being implemented are Sections

483.800, 483.813 and 483.825, Florida Statutes.

57. Although a number of grounds for invalidating the rule were raised in

the petitions filed by the FLH, FPS and FHA, these grounds have been narrowed in

their joint proposed order. As to the newly raised contention that certain

parts of the rule, including subparagraph (1)(b)3., are vague, this contention

has been disregarded as not being timely. Similarly, the argument that

subparagraph (1)(b)3. contravenes the provisions of Subsection 455.201(4),

Florida Statutes, was not specifically pled by any party. Likewise, the

assertion that paragraph (1)(a) is invalid because its effectiveness is

dependent on other rules being enacted has been rejected as being untimely.

Since no other viable claim has been raised, the rule is deemed to be invalid on

the single ground that the agency has exceeded its rulemaking authority.

CONCLUSIONS OF LAW

58. The Division of Administrative Hearings has jurisdiction of the

subject matter and the parties hereto pursuant to Subsections 120.54(4) and

120.57(1), Florida Statutes.

59. As the parties challenging the proposed rules, petitioners have the

burden of proving by a preponderance of the evidence that the challenged rules

are an invalid exercise of delegated legislative authority. Agrico Chemical

Company v. Department of Environmental Regulation, 365 So.2d 759, 763 (Fla. 1st

DCA 1978).

60. Subsection 120.52(9), Florida Statutes, defines an invalid exercise of

authority as follows:

"Invalid exercise of delegated legislative

authority" means action which goes beyond

the powers, functions, and duties delegated

by the legislature.

The same statute goes on to provide that a

proposed rule is invalid if:

(a) The agency has materially failed to

follow the applicable rulemaking procedures

set forth in s. 120.54;

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(7);

(c) The rule enlarges, modifies, or contravenes

the specific provisions of law implemented,

citation to which is required by s. 120.54(7);

(d) The rule is vague, fails to establish

adequate standards for agency decisions, or

vests unbridled discretion in the agency; or

(e) The rule is arbitrary or capricious.

61. Respondent contends that FPS, FHA and FLH have failed to prove

standing to bring these actionsade and professional associations are, of

course, accorded standing to represent the interests of their injured members.

Florida Home Builders Ass'n v. Department of Labor and Employment Security, 412

So.2d 351, 352-53 (Fla. 1982). To do so, the association must demonstrate that

a substantial number of its members, although not necessarily a majority, are

substantially affected by the challenged rule, that the subject matter of the

rule is within the association's general scope of interest and activity, and

that the relief requested is of the type appropriate for an association to

receive on behalf of its members. Florida League of Cities, Inc. v. Department

of Environmental Regulation, 603 So.2d 1363, 1366 (Fla. 1st DCA 1992).

Importantly, a failure by the association to allege a specific number of members

affected by the proposed action is not fatal. Federation of Mobile Home Owners

of Florida, Inc. v. Department of Business Regulation, 479 So.2d 252, 254 (Fla.

2d DCA 1985). Further, "(i)t is not necessary to elaborate how each member

would be personally affected by the proposed rule" so long as a substantial

portion of the association's members will be regulated by the rule. Fla. League

of Cities at 1367; Coalition of Mental Health Professionals v. Department of

Professional Regulation, 546 So.2d 27, 28 (Fla. 1st DCA 1989).

62. The previously established facts show that FPS, FHA and FLH are

statewide professional associations representing perfusionists who work in, and

hospitals that operate, clinical laboratories, that the proposed rules will

regulate the staffing of the laboratories in licensed clinical laboratories,

that the three organizations are charged with the responsibility of representing

their respective members on such issues, and the relief requested is the type of

relief appropriate for an association to receive on behalf of its members. This

being so, it is concluded that the FPS, FHA and FLH have standing to bring this

action. The standing of petitioners FSP and Dr. McCann has not been questioned.

63. Even if the argument could be made that petitioners FHA and FLH are

not directly regulated by the rules, the hospitals cannot operate their

respective licensed clinical laboratories in the absence of clinical laboratory

personnel who are licensed by the Board. In this further respect, they are

substantially affected by the proposed rules.

64. To resolve the issue of whether the Board lacks statutory authority to

adopt the rules, a review of several provisions within Chapter 483, Florida

Statutes, is required. Initially, it is noted that Subsection 483.051(9),

Florida Statutes, provides in relevant part that

(t)he agency (AHCA), in consultation with

the Board of Clinical Laboratory Personnel,

shall adopt, by rule, the criteria for alternate

site testing to be performed under the supervision

of a clinical laboratory director. The elements

to be addressed in the rule include, but are

not limited to: . . . a protocol of implementation

including tests to be performed and who will

perform the tests; criteria to be used in selecting

the method of testing to be used for alternate

site testing; minimum training and education

requirements for those who will perform alternate

site testing, such as documented training,

licensure, certification, or other medical

professional background not limited to laboratory

professionals; documented inservice training as

well as initial and ongoing competency validation;

. . . and recordkeeping requirements. (emphasis added)

Here, the statute unambiguously gives the rulemaking authority relating to

alternate site testing to the Agency for Health Care Administration. This

conclusion is supported by the fact that the law is specific to alternate site

testing, and it was adopted more recently than the statutory authority relied

upon by the Board for its rulemaking authority.

65. Although the clear statement by the legislature should be sufficient

to determine that the Board lacks authority to adopt the rules, the Board's

interpretation to the contrary raises ambiguities that require analysis of the

legislative history to discern legislative intent. Reference to legislative

history confirms that the legislature considered and rejected rulemaking

authority by the Board on the subject and that the intent of the legislature was

that AHCA would have exclusive rulemaking authority.

66. Notwithstanding the clear mandate of the legislature, the Board

nonetheless contends that authority to adopt the rules is found in various parts

of Part IV of Chapter 483, Florida Statutes. More specifically, it argues that

authority to adopt rules 59O-2.002, 59O-10.004 and 59O-13.006 derives from

Subsection 483.805(4), Florida Statutes, which authorizes the Board "to adopt

such rules not inconsistent with law as may be necessary to carry out the duties

and authority conferred upon the board by this part." It is well settled,

however, that a general grant of rulemaking authority does not authorize an

agency to adopt rules outside of that specifically given to that agency. State

Dept. of Insurance v. Insurance Services Office, 434 So.2d 908 (Fla. 1st DCA

1983). In fact, the limitation of this authority [in s. 483.805(4)] to Part IV

of Chapter 483 can be seen as more limiting than a general grant of rulemaking

authority.

67. The Board also cites Subsection 483.811(2), Florida Statutes, as

authority to adopt rule 59O-3.003. That subsection authorizes the Board to

adopt "rules relating to curriculum" for laboratory personnel. However,

Subsection 483.051(9), Florida Statutes, specifically states that alternate site

testing is "not limited to laboratory professionals."

68. The Board next relies upon Subsection 483.807(1), Florida Statutes, as

authority for adopting rules 59O-9.002 and 59-9.004. That subsection authorizes

the Board to establish fees for application, examinations and licensure under

Part IV of Chapter 483. If the Board is authorized to establish a licensure

category, it would also have the authority to impose fees. However, the

authority for a new licensure category must exist before this provision can be

effected. Here, there are no authorizing statutes referred to by the Board as

authority for it to regulate alternate site testing.

69. The Board has also cited Subsection 483.811(3), Florida Statutes, as

authority for adopting rules 59O-2.002, 59O-3.003 and 59O-5.006. That section,

however, applies to the adoption of rules relating to exclusive use (physician's

office) laboratories and is not applicable to alternate site testing which by

definition is limited to the administrative supervision of a hospital.

70. Finally, the Board relies upon Subsection 483.811(4), Florida

Statutes, as authority for adopting rule 59O-2.002. That subsection authorizes

the Board to "approve training programs for laboratory techicians in a hospital

or clinical laboratory." It also requires that "any person who completes a

training program must pass, before licensure, an examination by the department."

The statute does not, however, contain authorization for the Board to adopt

rules establishing a new licensure category.

71. In summary, the elements that the Board attempts to regulate in its

rules include: "tests to be performed" (59O-13.006); "who will perform the

tests" [59O-5.006(2)]; "minimum training and education requirements for those

who will perform alternate site testing" (59O-3.003, 59O-5.006); "such as

documented training, licensure, certification or other medical professional

background not limited to laboratory professionals" (59O-5.006); "documented

inservice training as well as initial and ongoing competency validation" (59O-

3.003(a), 59O-9.004); and "recordkeeping requirements" (59O-13.006). Because

the Board's rules essentially track the elements that the legislature directed

AHCA to adopt, it must be concluded that the Board exceeded its rulemaking

authority in proposing to adopt the rules. For this reason, the challenged

rules are an invalid exercise of delegated legislative authority.

72. If petitioners had simply filed a motion for summary final order on

this dispositive legal issue, considerable resources expended in prosecuting

these cases could have been saved. However, the cases proceeded to final

hearing, and evidence was presented on the numerous other grounds raised by the

parties. Although this presents an unnecessary laborious task, for the sake of

judicial economy in the event an appeal is taken, further conclusions are made

with respect to the individual rules being challenged.

73. The remaining contentions are that the rules are either arbitrary or

capricious, or that in some respect they contravene the law being implemented.

Case law instructs us that a proposed rule is arbitrary only if it is not

supported by facts and logic. On the other hand, a proposed rule is capricious

if it is taken without thought and reason. Agrico at 763. Also relevant here

is the proposition that in making a factual record to support a rule, an agency

cannot rely on "literature" or other unspecified documents that are not made a

part of the record. Ameraquatic, Inc. et al v. State, Dept. of Natural

Resources, 20 F. L. W. D366, D369 (Fla. 1st DCA, February 7, 1995). At the same

time, an agency cannot enlarge, modify or contravene the provisions of a

statute, and a rule which purports to do so constitutes an invalid exercise of

delegated legislative authority. See, e. g., Cataract Surgery Center v. Health

Care Cost Containment Board, 581 So.2d 1359 (Fla. 1st DCA 1991). Finally, a

hearing officer cannot adjudicate claims on matters not timely raised by the

parties. Compare Agency for Health Care Administration v. Principal Nursing

Services, Inc., 20 F. L. W. D492 (Fla. 1st DCA, February 24, 1995)(improper for

hearing officer to determine the validity of a rule not specifically alleged to

be invalid in the initial petition).

74. Assuming for the sake of argument only that the Board has authority to

promulgate the rules, the undersigned rejects the contention that proposed rule

59O-2.002(7) is invalid because it is arbitrary and capricious. Simply because

a rule's operation is contingent on the adoption of other rules is not a ground

to invalidate a rule. A second contention that the rule is vague and fails to

establish adequate standards for agency discretion has been rejected as being

untimely raised.

75. Because rule 59O-3.003(3) lacks an adequate factual basis, as more

specifically described in findings of fact 33-35, it is concluded that the rule

is arbitrary, and it is therefore an invalid exercise of delegated legislative

authority.

76. In a similar vein, given the lack of a factual basis for rules 59O-

5.001(1)(b), (2)(a), and (2)(b), as further explained in findings of fact 38-43,

these portions of the rule are deemed to be arbitrary and are thus an invalid

exercise of delegated legislative authority.

77. By making respiratory therapists and respiratory care practitioners

subject to the requirements of rule 59O-5.006, in contravention of Subsection

468.351(2), Florida Statutes, rule 59O-5.006(2)(c) is deemed to be an invalid

exercise of delegated legislative authority. Further, there is a lack of facts

or logic to support the Board's decision to include only three classes of

professions within the terms of the rule. Accordingly, the remainder of the

rule is deemed to be arbitrary and thus invalid. It is also concluded that the

same rule is invalid on the ground it contravenes the provisions of Subsection

455.201(4), Florida Statutes, by creating unreasonable restrictions and

standards on qualified professions. Finally, the second sentence in the first

paragraph of the rule is deemed to be arbitrary and thus an invalid exercise of

delegated legislative authority.

78. Finally, the contention that proposed rules 59O-9.002(4), 59O-

9.004(7), 59O-10.004 and 59-13.006 are invalid for other reasons has been

rejected since the grounds were not timely raised.

Based on the foregoing findings of fact and conclusions of law, it is

ORDERED that proposed rules 59-2.002(7), 59-3.003, 59O-5.001(1)(b), (2)(a)

and (2)(b), 59O-5.006, 59O-9.002(4), 59O-9.004(7), 59O-10.004 and 59O-13.006 are

declared to be an invalid exercise of delegated legislative authority on the

ground the agency exceeded its rulemaking authority.

DONE AND ORDERED this 8th day of March, 1995, in Tallahassee, Florida.

___________________________________

DONALD R. ALEXANDER

Hearing Officer

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

[phone]

Filed with the Clerk of the

Division of Administrative Hearings

this 8th day of March, 1995.

APPENDIX TO FINAL ORDER

Petitioners FPS, FHA, and FLH:

1-2. Partially accepted in finding of fact 3.

3. Rejected as being irrelevant.

4. Rejected as being unnecessary.

5-21. Partially accepted in findings of fact 10-16.

22-36. Partially accepted in findings of fact 17-26.

37-39. Partially accepted in findings of fact 28-30.

40-47. Partially accepted in findings of fact 31-35.

48-55. Partially accepted in findings of fact 45-50.

56-58. Partially accepted in findings of fact 51-53.

59. Partially accepted in findings of fact 54 and 55.

60-71. Partially accepted in findings of fact 56 and 57.

Petitioners FSP and McCann:

1-37. Partially accepted in findings of fact 36-44.

Respondent:

1. Partially accepted in finding of fact 14.

2. Partially accepted in findings of fact 11 and 12.

3. Partially accepted in finding of fact 16.

4. Partially accepted in finding of fact 10.

5. Partially accepted in findings of fact 2 and 9.

6-13. Partially accepted in findings of fact 10-16.

14. Partially accepted in finding of fact 2.

15. Partially accepted in finding of fact 4.

16. Partially accepted in finding of fact 3.

17-18. Partially accepted in findings of fact 5, 33 and 35.

19. Covered in preliminary statement.

20-24. Rejected as being unnecessary.

25. Partially accepted in finding of fact 43.

26. Partially accepted in finding of fact 35.

27. Partially accepted in finding of fact 36.

28-31. Partially accepted in findings of fact 38-44.

32. Partially accepted in findings of fact 28-30.

33-34. Partially accepted in findings of fact 31-35.

35-36. Partially accepted in findings of fact 45-50.

37. Partially accepted in findings of fact 51-53.

38. Partially accepted in finding of fact 54.

39. Partially accepted in finding of fact 56-57.

Note - Where a proposed finding has been partially accepted, the remainder has

been rejected as being unnecessary for a resolution of the issues, irrelvant,

cumulative, subordinate, not supported by the evidence, or a conclusion of law.

COPIES FURNISHED:

Carol A. Forthman, Esquire

131 North Gadsden Street

Tallahassee, Florida 32301-1507

Harold F. X. Purnell, Esquire

Thomas W. Konrad, Esquire

Post Office Box 551

Tallahassee, Florida 32302-0551

John H. French, Jr., Esquire

Post Office Box 10095

Tallahassee, Florida 32302-2095

Claire D. Dryfuss, Esquire

Department of Legal Affairs

The Capitol, PL-01

Tallahassee, Florida 32399-1050

Sandra E. Allen, Esquire

314 West Jefferson Street

Tallahassee, Florida 32301

V. Carroll Webb, Director

Joint Administrative Procedures Committee

Holland Building, Room 120

Tallahassee, Florida 32399-1300

Liz Cloud, Chief

Bureau of Laws and Administrative Code

The Capitol, Room 1802

Tallahassee, Florida 32399-0250

NOTICE OF RIGHT TO JUDICIAL REVIEW

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 a 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.

=================================================================

DISTRICT COURT OPINION

=================================================================

IN THE DISTRICT COURT OF APPEAL

FIRST DISTRICT, STATE OF FLORIDA

BOARD OF CLINICAL LABORATORY NOT FINAL UNTIL TIME EXPIRES TO

PERSONNEL, FILE MOTION FOR REHEARING AND

DISPOSITION THEREOF IF FILED.

Appellant,

CASE NO. 95-1196

vs. DOAH CASE NO. 94-5968RP

FLORIDA PERFUSION SOCIETY,

et al.,

Appellee.

______________________________/

Opinion filed January 28, 1997.

An appeal from an order of the Division of Administrative Hearings.

Robert A. Butterworth, Attorney General, and Claire D. Dryfuss, Assistant

Attorney General, Tallahassee, for Appellant.

Carol A. Forthman of Cobb, Cole & Bell, Tallahassee, for Appellees Florida

Hospital Association and Florida Perfusion Society; Harold F.X. Purnell of

Rutledge, Ecenia, Underwood, Purnell & Hoffman, P.A., Tallahassee, for Appellees

Florida Society of Pathologists and Louis S. McCann, Jr.

PER CURIAM.

AFFIRMED.

BARFIELD, C. J., HAHN and DAVIS, JJ., CONCUR