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.


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

1STATE OF FLORIDA

4DIVISION OF ADMINISTRATIVE HEARINGS

8FLORIDA PERFUSION SOCIETY and )

13FLORIDA HOSPITAL ASSOCIATION, )

17)

18Petitioners, )

20)

21vs. ) CASE NO. 94-5968RP

26)

27BOARD OF CLINICAL LABORATORY )

32PERSONNEL, )

34)

35Respondent, )

37and )

39)

40FLORIDA COALITION OF PROFESSIONAL )

45LABORATORY ORGANIZATIONS, INC., )

49)

50Intervenor. )

52__________________________________)

53FLORIDA SOCIETY OF PATHOLOGISTS )

58and LOUIS S. McCANN, JR., M.D., )

65)

66Petitioners, )

68)

69vs. ) CASE NO. 94-5969RP

74)

75BOARD OF CLINICAL LABORATORY )

80PERSONNEL, )

82)

83Respondent. )

85__________________________________)

86FLORIDA LEAGUE OF HOSPITALS, )

91INC., )

93)

94Petitioner, )

96)

97vs. ) CASE NO. 94-5970RP

102)

103BOARD OF CLINICAL LABORATORY )

108PERSONNEL, )

110)

111Respondent, )

113and )

115)

116FLORIDA COALITION OF PROFESSIONAL )

121LABORATORY ORGANIZATIONS,INC, )

125)

126Intervenor. )

128__________________________________)

129FINAL ORDER

131Pursuant to notice, the above matters were heard before the Division of

143Administrative Hearings by its assigned Hearing Officer, Donald R. Alexander, on

154November 23, 1994, in Tallahassee, Florida.

160APPEARANCES

161For Petitioners: Carol A. Forthman, Esquire

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

174Tallahassee, Florida 32301-1507

177For Petitioners: Harold F. X. Purnell, Esquire

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

191Post Office Box 551

195Tallahassee, Florida 32302-0551

198For Petitioner: John H. French, Jr., Esquire

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

212Tallahassee, Florida 32302-2095

215For Respondent: Claire D. Dryfuss, Esquire

221Department of Legal Affairs

225The Capitol, PL-01

228Tallahassee, Florida 32399-1050

231For Intervenor: Sandra E. Allen, Esquire

237314 West Jefferson Street

241Tallahassee, Florida 32301

244STATEMENT OF THE ISSUE

248The issue is whether proposed rules 590-2.002, 590-3.003, 590-5.001, 590-

2585.002, 590-5.006, 590-9.002, 590-9.004, 590-10.004 and 590-13.006 are an invalid

268exercise of delegated legislative authority.

273PRELIMINARY STATEMENT

275These cases began on October 21, 1994, when three petitions were filed

287challenging the validity of certain proposed rules in Chapters 590-2, 59O-3,

29859O-5, 59O-6, 59O-9, 59O-10 and 59O-13, Florida Administrative Code. The first

309petition was filed on behalf of the Florida Perfusion Society, Florida Hospital

321Association, Mallinckrodt Sensor Systems, Inc., i-Stat Corporation and

329Boehringer Mannheim Diagnostics and was assigned Case No. 94-5968RP. The second

340petition was filed by the Florida Society of Pathologists, Dr. Louis S. McCann,

353Jr, and Dr. Timothy M. Kilpatrik and was assigned Case No. 94-5969RP. The last

367petition was filed on behalf of the Florida League of Hospitals, Inc. and was

381assigned Case No. 94-5970RP. The rules being challenged were proposed for

392adoption by respondent, Board of Clinical Laboratory Personnel. After being

402reviewed for legal sufficiency, the petitions were assigned to the undersigned

413Hearing Officer on October 31, 1994.

419By notice of hearing dated October 31, 1994, the final hearing was

431scheduled on November 23, 1994, in Tallahassee, Florida. The same notice

442consolidated the three cases on the hearing officer's own motion.

452Prior to hearing, and based upon a motion filed by respondent, Mallinckrodt

464Sensor Systems, Inc., i-Stat Corporation, and Boehringer Mannheim Corporation

473were dismissed as parties in Case No. 94-5968RP on the ground they lacked

486standing to file a petition. In addition, Dr. Timothy M. Kilpatrik voluntarily

498withdrew as a petitioner in Case No. 94-5969RP. Finally, the Florida Coalition

510of Professional Laboratory Organizations, Inc. was authorized to intervene in

520Case Nos. 94-5968RP and 94-5970RP.

525As in relevant here, on November 10, 1994, respondent published a notice of

538change in the Florida Administrative Weekly wherein it proposed to change the

550first sentence of proposed rule 59O-3.003(3)(e) and to add a sentence after the

563first sentence in the first paragraph of proposed rule 59O-5.006. Those changes

575have been considered by the undersigned in resolving this dispute.

585At final hearing, petitioners in Case No. 94-5968RP presented the testimony

596of Mark Orangio, a clinical perfusionist and accepted as an expert in that area;

610Karen Brzys, a consultant and accepted as an expert in alternate site testing

623regulations; Dr. Michael Groves, a manager for i-Stat Corporation; and Barbara

634Foley, director of government affairs for the Florida Hospital Association.

644Also, it offered FPS exhibits 1-10. All exhibits were received in evidence. In

657addition, a request for official recognition of five documents has been granted.

669Petitioners in Case No. 94-5969RP presented the testimony of Dr. Louis S.

681McCann, Jr. and Dr. Richard Essman, both pathologists and accepted as experts in

694pathology and the directorship of clinical laboratories. Petitioner in Case No.

70594-5970RP offered FLH exhibit 1 which was received in evidence. That exhibit is

718the deposition of its vice-president, Belita Moreton. Respondent presented the

728testimony of George Mavros, a clinical laboratory supervisor and chairman of the

740Board of Clinical Laboratory Personnel. Also, it offered respondent's exhibits

7501-3. All exhibits were received in evidence. Intervenor adopted the evidence

761submitted by respondent.

764The transcript of hearing (three volumes) was filed on January 31, 1995.

776Proposed findings of fact and conclusions of law were filed by the parties on

790February 15, 1995. A ruling on each proposed finding has been made in the

804Appendix attached to this Final Order.

810FINDINGS OF FACT

813Based upon all of the evidence, the following findings of fact are

825determined:

826A. Background

8281. These cases arose after respondent, Board of Clinical Laboratory

838Personnel (Board), published in the Florida Administrative Weekly its notice of

849intent to adopt certain revisions in Chapters 59O-2, 59O-3, 59O-5, 59O-6, 59O-9,

86159O-10 and 59O-13, Florida Administrative Code. The proposed rules deal with

872the subject of alternate site testing within the state.

8812. The Board was created by the legislature in 1992 to regulate clinical

894laboratory personnel. Its authority and duties are set forth in Part IV of

907Chapter 483, Florida Statutes. The Board's purpose is to ensure the protection

919of public health, safety, and welfare through the regulation of clinical

930laboratory personnel. To this end, the Board is required by law to prescribe

943minimal qualifications for clinical laboratory personnel.

9493. Alternate site testing is any "laboratory testing done under the

960administrative control of a hospital, but performed out of the physical or

972administrative confines of the central laboratory." It can only exist in a

984hospital under the direct supervision of the central clinical laboratory and its

996clinical laboratory director. The alternate site laboratory does the same type

1007of testing as does the central laboratory but it uses different equipment.

1019Alternate site testing is performed using ten to twelve instruments specifically

1030designed for that purpose, and which specifically incorporate safeguards to

1040prevent misuse or misinterpretation.

10444. Clinical laboratory personnel are persons who perform clinical

1053laboratory examinations on specimans derived from the human body for the purpose

1065of delineating information for the diagnosis, management and treatment of

1075patients. There are four classes of clinical laboratory personnel, namely,

1085technician, technologist, supervisor and director. Within the category of

1094technician are various specialty categories including clinical chemistry,

1102hematology, immunohematology, histology, radioassay, serology, microbiology,

1108exclusive use and alternate site.

11135. In general terms, the proposed rules define an alternate site

1124technician, set forth the curriculum requirements for training programs for

1134alternate site technicians, state the minimum standards for licensure as an

1145alternate site technician, prescribe the initial licensure and renewal fees for

1156alternate site technicians, set forth the scope of practice for all clinical

1168laboratory personnel, and enumerate the responsibilities of alternate site

1177technicians including limits on tests that can be performed with this type of

1190licensure. These rules were adopted after various workshops, public meetings

1200and member conference calls were conducted by the Board in 1993 and 1994.

12136. As clarified by a more definite statement, petitioners in Case No. 94-

12265968RP, Florida Perfusion Society (FPS) and Florida Hospital Association (FHA),

1236contend that all or parts of proposed rules 590-2.002, 590-3.003, 590-5.006,

1247590-9.002, 590-9.004, 590-10.004 and 590-13.006 are invalid on the grounds (a)

1258the Board exceeded its rulemaking authority, (b) the rules are arbitrary and

1270capricious, and (c) the rules contravene the law being implemented.

12807. Petitioners in Case No. 94-5969RP, Florida Society of Pathologists

1290(FSP) and Dr. Louis S. McCann, Jr., have challenged proposed rules 590-5.001 and

1303590-5.002 on the grounds the two rules contravene the statutes being implemented

1315and are arbitrary and capricious.

13208. Petitioner in Case No. 94-5970RP, Florida League of Hospitals (FLH),

1331has challenged the validity of all the proposed rules on the ground the Board

1345has exceeded its rulemaking authority. In addition, it has challenged Rules

1356590-2.002(7), 590-5.006(2), 590-9.002(4), 590-9.004(7) and 590-13.006 on the

1364ground they contravene the statutes being implemented.

13719. Intervenor, Florida Coalition of Professional Laboratory Organizations,

1379Inc., is a nonprofit corporation representing twelve organizations who represent

1389the interests of laboratory professionals licensed under Part IV of Chapter 483,

1401Florida Statutes. It supports the challenged rules and is aligned with the

1413Board in these proceedings.

1417B. Standing

141910. Respondent has stipulated to the standing of the FSP, a professional

1431association of pathologists, and Dr. McCann, its president-elect, and thus there

1442is no dispute that those petitioners are substantially affected by the proposed

1454rules.

145511. FPS is a statewide professional medical society representing

1464professional cardiovascular perfusionists in Florida. Perfusionists are

1471principally known for the safe operation and maintenance of the heart-lung

1482machine in open heart surgery. The FPS currently has more than one hundred

1495members, most of whom are actively engaged in the practice of perfusion.

150712. The purpose of the FPS is to promote perfusion education and clinical

1520expertise and to address the professional interests of perfusionists on issues

1531affecting the profession, including representation before governmental bodies.

153913. Perfusionists are regularly required to perform the type of tests that

1551are performed at alternate sites as part of their profession. The proposed

1563rules would directly regulate their practice. In addition, a substantial number

1574of FPS members would be affected by the proposed rules because they would be

1588required to obtain a license as a laboratory professional in order to continue

1601practicing using alternate test sites, or to use alternate test sites in the

1614future. As such, they are substantially affected by the proposed rules.

162514. The FHA is a statewide, nonprofit trade association representing all

1636types of hospitals in the state. As of August 1994, or three months before the

1651hearing, it had 233 institutional members (licensed hospitals), plus various

1661organizational and individual members. Its purpose is to serve its members by

1673developing and promoting programs and services that will enhance their ability

1684to provide comprehensive, efficient, high quality health care to the people of

1696Florida. The association also represents its members at the state and national

1708levels in providing an effective health care system.

171615. Only hospitals with clinical laboratories can have alternate site

1726laboratories where alternate site technicians would be employed. The number of

1737institutional members having clinical laboratories is not of record nor is the

1749number of hospitals who plan to operate alternate site laboratories. Even so,

1761it may be reasonably inferred that at least some of the hospitals provide

1774clinical laboratory services in their facilities and, in the future, they intend

1786to provide alternate site testing. Because the proposed rules require medical

1797professionals already licensed or certified to obtain an additional license,

1807limit the professionals who can provide these services, and impose regulatory

1818and financial requirements on the provision of those services, the institutional

1829members of the FHA are substantially affected by these proceedings. Moreover,

1840because the proposed rules impose new training requirements on medical

1850personnel, the hospitals who employ such individuals would be required to absorb

1862the cost of training these employees and providing coverage for their duties

1874while they are being trained. In these respects, they are further impacted by

1887the rules.

188916. The FLH is a trade association comprised of seventy-six for-profit

1900hospitals. Of its seventy-six members, seventy-three have clinical

1908laboratories. Because the proposed rules limit the categories of hospital

1918personnel who could be licensed as alternate site testing technicians and

1929restrict the tests that these licensees can perform, the FLH is substantially

1941affected by the proposed rules.

1946C. Legislative History of Alternate Site Testing

195317. In 1993, the Florida Legislature adopted Chapter 93-178, Laws of

1964Florida. That act specifically provided for the implementation of alternate

1974site testing in Florida. The section relating to alternate site testing, which

1986has been codified as Subsection 483.051(9), Florida Statutes, provides as

1996follows:

1997(9) Alternate Site Testing.- The agency,

2003in consultation with the Board of Clinical

2010Laboratory Personnel, shall adopt, by rule,

2016the criteria for alternate-site testing to be

2023performed under the supervision of a clinical

2030laboratory director. The elements to be addressed

2037in the rule include, but are not limited to: a

2047hospital internal needs assessment; a protocol

2053of implementation including tests to be performed

2060and who will perform the tests; criteria to be

2069used in selecting the method of testing to be

2078used for alternate-site testing; minimum training

2084and education requirements for those who will

2091perform alternate-site testing, such as documented

2097training, licensure, certification, or other

2102medical professional background not limited to

2108laboratory professionals; documented inservice

2112training as well as initial and ongoing competency

2120validation; an appropriate internal and external

2126quality control protocol; an internal mechanism

2132for identifying and tracking alternate-site testing

2138by the central laboratory; and recordkeeping

2144requirements. Alternate-site testing locations

2148must register when the clinical laboratory applies

2155to renew its license. For purposes of this

2163subsection, the term "alternate-site testing"

2168means any laboratory testing done under the

2175administrative control of a hospital, but

2181performed out of the physical or administrative

2188confines of the central laboratory.

2193(emphasis added)

219518. The bill which became Chapter 93-178, Laws of Florida, originated as

2207PCB 93-01 of the House Committee on Health Care. It was later filed as House

2222Bill 2071 (HB 2071), Medical Tests and Procedures/Sunset. The overall purpose

2233of the bill was to review provisions of Part I of Chapter 483 related to

2248clinical laboratories, which was scheduled for sunset review under Section

225811.61, Florida Statutes. The original version of PCB 93-01, dated January 28,

22701993, had no provisions relating to alternate site testing.

227919. During consideration of the bill on February 3, 1993, the House

2291Committee on Health Care amended PCB 93-01 to provide for rulemaking by the

2304Board. Specifically, the amendment stated that "(t)he board shall adopt rules

2315for alternate site testing to be performed under the supervision of clinical

2327laboratory director." However, the authority for the Board to adopt rules was

2339subsequently removed from the bill by amendment on the House floor on March 23,

23531993.

235420. The House bill was then considered by the Senate, which amended the

2367House bill on March 31, 1993. The amendment was a "strike everything after the

2381enacting clause" amendment. In effect, the amendment substituted all new bill

2392language in place of the House bill, while retaining the bill number of HB 2071.

2407The alternate site testing language substituted was identical to the bill that

2419had been considered in the Senate as SB 156, which, among other things, added

2433subsection 483.051(9), relating to alternate site testing. This provision gave

2443rulemaking authority to the Agency for Health Care Administration (ACHA) "in

2454consultation with the Board of Clinical Laboratory Personnel."

246221. The Senate passed the amended bill and this version was returned to

2475the House. The House then passed HB 2071 as it had been amended and passed in

2491the Senate (with two amendments not related to alternate site testing). The

2503Senate then concurred in the final House version. The amendment relating to

2515subsection 483.051(9) (on alternate site testing) remained intact and eventually

2525became the current Subsection 483.051(9), Florida Statutes.

253222. Subsection 483.051(9), as adopted, specifically delegates the

2540rulemaking authority for alternate site testing to AHCA. That provision calls

2551for "consultation" with the Board, but does not give the Board any rulemaking

2564authority.

256523. The Board had a designated member, George Mavros, who represented the

2577Board during the legislative session. Initially, the Board recognized ACHA's

2587exclusive rulemaking authority in a report from its legislative liason and in

2599discussions with affected public at its regularly scheduled meetings. That

2609position was reiterated in an official letter to a representative of an affected

2622organization from the Board's chairman. The chairman was specifically

2631authorized to speak for the Board, and the letter reflected the official

2643position of the Board at that time.

265024. In its discussions and letters, the Board specifically stated that the

2662newly adopted statute did not give the Board rulemaking authority. Such public

2674statements and letters are evidence of the Board's contemporaneous construction

2684of the statute that it had no authority to adopt rules governing alternate site

2698testing. Since that time, however, the Board has taken an opposing position,

2710that is, that it has authority to adopt rules pertaining to alternate site

2723testing requirements, and the rules under challenge are the end product of this

2736changed position.

273825. The statute authorizing AHCA to adopt rules is clear on its face and

2752unambiguous. Moreover, the legislative history reveals that during the 1993

2762session the legislature specifically considered the delegation of rulemaking

2771authority to the Board in an early version of the bill. The provision giving

2785specific rulemaking authority to the Board was deleted by later action of the

2798same legislature. The final version of the bill contains a delegation of

2810rulemaking authority to AHCA and omits any delegation to the Board. This is

2823clear evidence that the legislature considered giving rulemaking authority to

2833the Board, and instead evinced a clear intent to give exclusive rulemaking

2845authority to AHCA.

284826. The legislature cannot be said to have simply forgotton the authority

2860of the Board. Subsection 483.051(9) specifically sets forth the Board's role as

2872a consultant. If the legislature had intended to "split" the rulemaking

2883authority for alternate site testing between the Board and AHCA, it would not

2896have specifically set out a different role in the statute. The legislative

2908staff analyses of the bill support these findings. The staff analyses of

2920subsection 483.051(9) refer solely to AHCA when referencing rulemaking authority

2930for alternate site testing. Therefore, the Board did not have statutory

2941authority to adopt the rules. For the reasons given in the conclusions of law

2955portion of this order, the statutes which the Board relies upon for its

2968rulemaking authority are not deemed to be controlling or relevant.

2978D. Are the Challenged Rules Invalid for Other Reasons?

298727. Nothwithstanding the above findings, and solely for the sake of

2998judicial economy in the event an appeal is taken by any party, additional

3011findings are made relative to each of the challenged rules. In making these

3024findings, it is noted that where new grounds for invalidating a rule have been

3038raised for the first time in a party's proposed order, they have been

3051disregarded as being untimely. Further, where a party has not addressed a

3063previously raised ground in its proposed order, the undersigned has assumed that

3075ground has been abandoned. Where a party speaks to a rule in general terms, and

3090not a specific part thereof, and the undersigned is unable to discern which part

3104of the rule is being attacked, that contention has been disregarded.

3115a. Rule 59O-2.002(7)

311828. The first challenged rule is 59O-2.002(7), which defines the term

"3129technician in the specialty of Alternate Site Testing" as follows:

3139(7) Technician in the specialty of Alternate

3146Site Testing means a person qualified to be

3154a technician in the specialty of alternate

3161site testing pursuant to the rules of the

3169Board who under the general supervision of a

3177laboratory director, supervisor or technologist

3182may perform specific testing authorized by the

3189Agency pursuant to rule chapter 59A-7 and the

3197Board pursuant to rule chapter 59O-13 in a

3205hospital based alternate site testing environ-

3211ment approved by the Agency pursuant to section

3219483.051(9), F. S. and whose practice is limited

3227to an alternate site testing environment.

3233The Board had cited Subsections 483.805(4) and 483.811(3) and (4), Florida

3244Statutes, as the specific authority for adopting the rule while Subsections

3255483.803 and 483.811(3) and (4), Florida Statutes, are cited as the laws being

3268implemented.

326929. Besides leveling the broad charge that the Board lacks statutory

3280authority to adopt the rule, a contention already decided in their favor,

3292petitioners FPS and FHA contend that the rule is arbitrary and capricious

3304because it sets up an impossible condition for qualifying as an alternate site

3317technician since necessary related rules in Chapter 59A-7 have never been

3328adopted by AHCA.

333130. In order for the proposed rule to become operable, AHCA must first

3344adopt amendments to its Chapter 59A-7, which pertain to alternate site testing

3356laboratories. Also, AHCA must approve a "hospital based alternative site

3366testing environment" in which such tests can take place. At the time of

3379hearing, a draft of new proposed rules 59A-7.034 and 59A-7.035 was being

3391circulated by AHCA, but had not yet been adopted. Even so, the fact that the

3406Board's rule is contingent on further rules being adopted by another agency does

3419not render the rule arbitrary or capricious. The contention is accordingly

3430rejected.

3431(b) Rule 59O-3.003(3)(e)

343431. This rule sets out the proposed requirements for training for

3445individuals performing specific alternate site tests. As modified by the notice

3456of change published in the Florida Administrative Weekly on November 10, 1994,

3468the challenged portion of the rule now provides the following training

3479requirements:

3480(e) Notwithstanding all other provisions

3485of rule chapter 59O-3.003, the only require-

3492ments for training in the specialty of Alternate

3500Site Testing shall be 4 contact hours of

3508instruction per test system with an additional

35150.5 contact hour of instruction for each analyte

3523above 8 analytes performed on the same test

3531system. The contact hours of instruction shall

3538be by a Board approved continuing education

3545provider approved pursuant to rule chapter 59O-11

3552which shall include as a minimum instruction in

3560the tasks defined as follows:

3565* * *

3568The terms "analyte" and "test system," which are

3576the guages on which training is measured, are not

3585defined anywhere in the Board's rules.

359132. Besides the argument that the Board lacks statutory authority to adopt

3603the rule, petitioners FPS and FHA contend the proposed rule is arbitrary and

3616capricious in that the requirements are excessive and inflexible. They also

3627contend that the rule contravenes the provisions of Subsection 455.201(4),

3637Florida Statutes, which prohibits a regulatory board from adopting "unreasonably

3647restrictive and extraordinary standards" for a given profession.

365533. In proposing the number of hours of training for alternate site

3667testing, the Board relied mainly upon its own members' expertise and judgment.

3679It also relied on public comment given at a Board meeting on August 7, 1993,

3694including testimony from a manufacturer's representative. Finally, it relied

3703upon a training and certification program manual by i-Stat Corporation, a

3714manufacturer of equipment used in clinical laboratories, and on other

3724unspecified "documents and manuals." It did not conduct any surveys of

3735professional literature or other outside services, nor did its staff conduct any

3747research on the subject.

375134. Initially, it is noted that the proposed rule gives no consideration

3763to the relative levels of medical training and education in the various

3775professions regulated by the rules, even though that can affect how much

3787training time is needed. For some professionals, such as an ICU nurse or

3800emergency physician nurse, four hours of training is excessive, based on

3811approved manufacturer's training protocol. By providing uniform instruction for

3820all professionals, regardless of their prior training, and without any factual

3831basis for doing so, the Board acted in an arbitrary manner.

384235. In arriving at the number of hours of instruction required for each

3855test system, the Board relied in part on the testimony of a manufacturer's

3868representative (Mallinckrodt) given at the August 7, 1993 meeting. A review of

3880his comments, however, reveals that the representative recommended far fewer

3890hours of instruction than is provided for in the rule. Moreover, in prescribing

3903four hours training per test system, the Board relied primarily on its own

3916judgment rather than on technical material submitted by other affected persons.

3927Likewise, the basis for the additional 0.5 hours per analyte over eight analytes

3940was not grounded on empirical data. Indeed, analytes and test systems are not

3953even defined in the rule. Given these shortcomings, it cannot be said that the

3967requirements of the rule are based on facts or logic. The rule is accordingly

3981deemed to be arbitrary and capricious. Given this finding, it is unnecessary to

3994reach the issue of whether the rule contravenes Subsection 455.201(4), Florida

4005Statutes, by providing unreasonable and restrictive standards.

4012(c) Rule 59O-5.001(1)(b), (2)(a), and (2)(b)

401836. This rule prescribes the educational requirements for the director of

4029a clinical laboratory. Under current standards (rule 10D-41.067), a director

4039must be a physician or a doctoral scientist. By its rule, the Board proposes to

4054allow a person with a master's degree to become licensed as a clinical

4067laboratory director. The challenged portions of the rule read as follows:

4078(1) Education. An applicant shall meet one

4085of the following education requirements:

4090* * *

4093(b) Have a master's degree in clinical laboratory

4101science, one of the specialty areas, or one of

4110the chemical or biological sciences.

4115(2) Experience. An applicant who qualifies

4121pursuant to rule 59O-5.001(1) shall meet one of

4129the following requirements:

4132(a) Have full time pertinent clinical laboratory

4139experience in an approved laboratory subsequent

4145to receipt of the relevant degree as follows:

4153* * *

41562. If qualifying under rule 59O-5.001(b), 8 years

4164of experience.

4166* * *

416937. Petitioners FSP and Dr. McCann generally contend the foregoing rule

4180contravenes Section 483.800, Florida Statutes, and is arbitrary and capricious

4190in that it allows untrained persons to become laboratory directors.

420038. All state clinical laboratories and their personnel are subject to

4211federal regulation under the federal Clinical Laboratory Improvement Act (CLIA).

4221Regulations promulgated thereunder classify clinical laboratories based on the

4230complexity of the tests performed. The three category of tests are waived,

4242moderately complex and highly complex. Laboratories performing waived tests, or

4252those that are simple and pose no risk to the public, are not regulated by CLIA

4268while those performing moderate to highly complex testing must meet CLIA's

4279minimum requirements for quality control, quality assurance and personnel.

428839. CLIA regulations link personnel requirements with the complexity of

4298testing. The requirements for moderate and highly complex testing personnel are

4309defined separately and are significantly different. Those facilities providing

4318only moderately complex testing may use directors having both master's level and

4330bachelor's level degrees. In recognition of both the sophistication of highly

4341complex tests and the broad scope of a laboratory director's duties and

4353responsibilities, however, CLIA regulations require directors of clinical

4361laboratories performing any highly complex testing whatsoever to be either

4371physicians or doctoral scientists. It is noted that hospital laboratories and

4382independent laboratories perform highly complex testing, and that any hospital

4392laboratory, including rural hospitals, providing full service functions will

4401perform highly complex testing.

440540. Under CLIA regulations, laboratories which perform highly complex

4414testing allow the director to reapportion performance of responsibilities to

4424persons having less qualifications. The overall responsibility, however, rests

4433with the director, and the regulations do not allow a master's level individual

4446to direct the clinical laboratory performing highly complex testing, or to

4457delegate responsibilities to a more qualified individual.

446441. The proposed rule would allow master's degree scientists to direct

4475laboratories performing highly complex testing so long as that individual hired

4486a "co-director" who was a physician or a doctoral scientist. Under this

4498arrangement, the co-director would be left with only those responsibilities that

4509the lesser qualified master's level director called upon him or her to perform.

4522In this respect, the proposed rule is at variance with federal regulations.

4534While the Board justifies this change on the ground a study shows a shortage of

4549various professionals in the rural hospital setting, the study itself was not

4561introduced into evidence. Moreover, the rule would apply to all hospitals,

4572whether rural or not.

457642. Even though the proposed rule is inconsistent with CLIA, in its filing

4589with the Joint Administrative Procedures Committee, the Board represented that

"4599(t)here is no ascertainable parallel federal rule or standard with which to

4611make a comparison." It is reasonable to infer that this response was given so

4625that the Board would not have to give an explanation of the rule's inconsistency

4639with CLIA.

464143. Although the Board had a wide range of input regarding this rule, it

4655failed to address a number of valid concerns raised by the opponents. Because

4668of the nature of the testing involved in laboratories performing highly complex

4680testing, severe injury or even death can result from an incorrect test result

4693being reported by one of the clinical laboratory personnel. It is esential,

4705therefore, that clinical laboratories performing highly complex testing be

4714directed by the most competent and trained personnel. This goal is not attained

4727in the proposed rule. The appointment of a lesser qualified person would also

4740mean that a director would not be able to perform all work functions in the

4755laboratory, something current directors can now perform. Further, the proposed

4765allocation of responsibilities would place virtually all of the professional

4775liability on the "co-director" (physician or doctoral scientist) even though the

4786co-director does not "direct" the laboratory. Finally, even though a laboratory

4797can be licensed by specialty, this does not eliminate the above concerns since a

4811specialty is not limited to moderately complex testing.

481944. Given the lack of a factual basis or logic to support the rule as

4834presently proposed, subsections (1)(b), (2)(a) and (2)(b) of rule 59O-5.001 are

4845deemed to be arbitrary and capricious and are thus invalid. These portions of

4858the rule also contravene Section 483.800, Florida Statutes, which requires,

4868among other things, the "licensure of clinical laboratory personnel who meet

4879minimum requirements for safe practice."

4884(d) Rule 590-5.006

488745. This rule sets forth the educational requirements necessary for the

4898specific types of licensure and certification for clinical laboratory personnel.

4908As modified by the Board on November 10, 1994, the rule now reads as follows:

492359O-5.006 Technician in the Specialty of

4929Alternate Site Testing.

4932Those persons licensed as a director, supervisor,

4939technologist or technician pursuant to part IV

4946of chapter 483, F.S., can work in the specialty

4955of alternate site testing without additional

4961licensure or certification. Persons only

4966performing waived tests as defined in section

4973483.041(9), F. S. in a laboratory holding a

4981certificate of exemption pursuant to section

4987483.106, F. S., are not required to be licensed

4996and need not meet these requirements. Persons

5003certified only under this rule shall not perform

5011testing beyond that defined in rule 590-13.006.

5018Persons who perform testing defined in rule

5025590-13.006 at alternate testing sites as defined

5032in section 483.051(9), F.S., shall meet the

5039requirements of rule 590-5.006(1), (2) and (3)

5046as follows:

5048(1) Education.

5050(a) Have a high school diploma or its

5058equivalent and

5060(b) Have completed 4 contact hours of

5067HIV/AIDS continuing education pursuant to

5072rule chapter 59O-11.

5075(2) Training. For purposes of this rule

5082the term "licensed" requires a full permanent

5089license not a temporary license. An applicant

5096who qualifies under the education requirements

5102of rule 59O-5.006(1) shall in addition meet one

5110of the following requirements:

5114(a) Is licensed as a registered nurse pursuant

5122to chapter 464, F. S.

5127(b) Is licensed as a radiologic technologist

5134pursuant to chapter 468, part IV, F. S.

5142(c) Is licensed as a respiratory therapist or

5150as a respiratory care practitioner certified to

5157perform critical care services pursuant to chapter

5164468, part V, F. S.

5169(d) Is a perfusionist certified by the American

5177Board of Cardiovascular Perfusion-ists.

5181(3) Additional Training. An applicant who

5187qualifies under the education requirements of

5193rule 590-5.066(1) and the training requirements

5199of rule 590.006(2) shall in addition meet one

5207of the following requirements:

5211(a) Have successfully completed a Board

5217approved Clinical Laboratory Personnel

5221Technician training program in general

5226laboratory practice principles pursuant to

5231rule 590-3.003(3)(d).

5233(b) Have successfully completed alternate

5238site testing training for each test the applicant

5246will be performing which provides instruction in

5253all subject matter areas of rule 590-3.003(3)(e).

5260After completing the training, the applicant shall

5267submit verification from the laboratory director

5273that the applicant has successfully completed

5279the alternate site testing training.

5284(c) Have received instruction in all subject

5291matter areas of rule 590-3.003(3)(d) or (e) while

5299enrolled in a program leading to licensure under

5307chapters 464, 468, part IV, or 468, part V,

5316F. S., or certification by the Board of

5324Cardiovascular Perfusionists and shall submit

5329verification from the program director of such

5336instruction.

533746. Although a number of grounds for invalidating the rule were raised in

5350the initial petitions, in their joint proposed order, the FPS, FHA and FLH have

5364limited their grounds to four: (a) the Board was arbitrary and capricious in

5377limiting the application of the rule to five professions; (b) the Board did not

5391comply with Section 455.201, Florida Statutes; (c) the proposed rule contravenes

5402Section 468.351(2), Florida Statutes, by making the terms of the rule applicable

5414to respiratory therapists and respiratory care practitioners, and (d) the Board

5425was arbitrary and capricious by requiring training for waived tests. The

5436allegation regarding the validity of the requirement in subsection (1)(b) for

5447HIV/AIDS continuing education training has been disregarded as being untimely.

545747. The rule applies to respiratory therapists and respiratory care

5467practitioners even though Subsection 468.351(2), Florida Statutes, which governs

5476the practice of those professions, clearly provides that "it is the intent of

5489the Legislature that personnel certified or registered pursuant to this part

5500shall be exempt from the licensure provisions of chapter 483." There is no

5513basis in the record for the Board's contention that the exemption in subsection

5526468.351(2) applies only to blood gas testing, and no others. Given this lack of

5540support for that limitation, the rule contravenes the provisions of the cited

5552statute, and paragraph (2)(c) is deemed to be invalid.

556148. The contention is also made that the Board selected the remaining

5573three classes of professions (registered nurses, radiologic technologists and

5582perfusionists) without any justification. Although the Board contended it

5591studied the type of training and education received by these professions, there

5603is no evidence of such a discussion in the Board records, nor is there evidence

5618that rules regarding education and training of other professions were ever

5629presented to all of the Board members. Further, there is no evidence that the

5643Board ever considered other professionals of equal medical educational

5652background. While the Board did receive information from the American Board of

5664Cardiovascular Perfusionists regarding the certification requirements for that

5672organization, that by itself is an insufficient factual basis to justify the

5684limitation imposed by the rule. Under these circumstances, it cannot be said

5696that the remainder of the rule is supported by facts or logic.

570849. Petitioners further contend that the rule contravenes the provisions

5718of Subsection 455.201(4), Florida Statutes, which makes it unlawful for the

5729Board to "create unreasonably restrictive and extraordinary standards that deter

5739qualified persons from entering the various professions." Since the Board acted

5750arbitrarily and capriciously in limiting the approved professions that are

5760subject to the rule, it is found that the proposed rule creates unreasonably

5773restrictive and extraordinary standards for the profession.

578050. Finally, by modification to the rule on November 10, 1994, the Board

5793added the following sentence in the first paragraph: "Persons only performing

5804waived tests as defined in section 483.041(9), F. S., in a laboratory holding a

5818certificate of exemption pursuant to section 483.106, F. S., are not required to

5831be licensed and need not meet these requirements." In order to obtain a

5844certificate of exemption, a laboratory must be engaged only in waived tests.

5856These are tests that are relatively simple and pose little risk of harm to the

5871public. Petitioners complain that, while providing this exception to training

5881for waived tests at laboratories holding a certificate of exemption, the Board

5893did not remove the requirement for training for waived tests performed at

5905alternate site testing facilities, and thus the rule is arbitrary. Under the

5917proposed rule, any person performing waived tests, who later becomes certified

5928to perform a moderately complex test, must receive additional training in the

5940waived test as well. While the Board suggests that a hospital can avoid this

5954double training by setting up multiple laboratories in the same location, it

5966failed to provide any justification for this excessive testing. The challenged

5977sentence is accordingly deemed to be arbitrary.

5984(e) Rules 59O-9.002(4) 59O-9.004(7)

598851. These two proposed rules levy a $20 fee for the initial and renewal

6002certification of alternate site testing technicians, respectively.

600952. In its petition, the FLH contended that the Board lacked statutory

6021authority to adopt both rules, a contention already resolved in petitioner's

6032favor. In its posthearing filing, however, it argues for the first time that

6045the rules are arbitrary and capricious. This contention has accordingly been

6056rejected as not being timely.

606153. The FPS and FHA have similarly contended that rule 59O-9.004(7) is

6073invalid on the ground the agency lacks statutory authority to adopt the rule.

6086They also contend for the first time that the rule is arbitrary. This untimely

6100allegation has been disregarded.

6104(f) Rule 59O-10.004

610754. This proposed rule sets forth minimum standards that all laboratory

6118professionals must meet. At issue here are the requirements that all clinical

6130laboratory personnel provide the following services:

6136(14) Process aliquots or components of

6142specimens for analysis according to the type

6149of specimen and procedure to be performed.

6156* * *

6159(18) Recognize output signals and observations

6165and convert them to prescribed units for recording

6173and reporting.

6175* * *

617855. In their initial petition, as clarified by a more definite statement,

6190FPS and FHA contended the Board exceeded its rulemaking authority by including

6202professionals engaged in alternate site testing as clinical laboratory personnel

6212subject to Board regulations, a ground already discussed. In their proposed

6223order, petitioners have added the contention that the rule is vague because it

6236contradicts the terms of another rule. Because this newly raised ground is

6248untimely, it has been disregarded.

6253(g) Rule 59O-13.006

625656. The final rule being challenged describes the responsibilities of

6266alternate site testing technicians. Among other things, the rule prescribes the

6277tests that the technicians can perform. The specific portions of the rule which

6290are being challenged read as follows:

6296(1) Alternate Site Testing Technican shall:

6302* * *

6305(b) Perform only tests from the following

6312list provided the requirements of Rule

631859O-13.006 have been met:

63221. Tests designated as waived pursuant to

632942 CFR 493.15, incorporated by reference.

6335* * *

63383. Tests designated as moderately complex

6344pursuant to 42 CFR 493.10 and 42 CFR 493.17

6353which employ whole blood and require no pre-

6361analytical, analytical or post-analytical

6365specimen or reagent manipulation, treatment,

6370extraction, separation or other processing

6375of any kind and must employ an automated

6383single, closed, dry or electrochemical sensor

6389reagent system. The instrumentation shall

6394provide for instrument calibration without

6399any operator adjustment. Post analytical

6404instrument output signals must be directly

6410reportable in the correct units of measure-

6417measure without need for data conversion or

6424other manipulation. Electronic instrumen-

6428tation must have a mechanism whereby the

6435operator is alerted when patient results

6441exceed reportable limits and when internal

6447or external quality control or calibration

6453is not acceptable. Such results shall not

6460be used for the diagnosis, treatment,

6466management or monitoring of patients and

6472shall be validated through the central

6478laboratory. Validation shall be documented

6483at the alternate test site.

6488* * *

6491(j) When affixing the name or signature

6498to any laboratory record or patient report,

6505indicate the professional status by adding

6511the designation "ASTT" to designate Alternate

6517Site Testing Technician immediately following

6522the name or signature if holding a current

6530Florida certificate. The holder of temporary

6536certification must use the designation "GASTT"

6542to designate Graduate Alternate Site Testing

6548Technician until such time as certification is

6555granted by the Board.

6559* * *

6562The specific authority for adopting the rule

6569is Subsection 483.805(4), Florida Statutes,

6574while the laws being implemented are Sections

6581483.800, 483.813 and 483.825, Florida Statutes.

658757. Although a number of grounds for invalidating the rule were raised in

6600the petitions filed by the FLH, FPS and FHA, these grounds have been narrowed in

6615their joint proposed order. As to the newly raised contention that certain

6627parts of the rule, including subparagraph (1)(b)3., are vague, this contention

6638has been disregarded as not being timely. Similarly, the argument that

6649subparagraph (1)(b)3. contravenes the provisions of Subsection 455.201(4),

6657Florida Statutes, was not specifically pled by any party. Likewise, the

6668assertion that paragraph (1)(a) is invalid because its effectiveness is

6678dependent on other rules being enacted has been rejected as being untimely.

6690Since no other viable claim has been raised, the rule is deemed to be invalid on

6706the single ground that the agency has exceeded its rulemaking authority.

6717CONCLUSIONS OF LAW

672058. The Division of Administrative Hearings has jurisdiction of the

6730subject matter and the parties hereto pursuant to Subsections 120.54(4) and

6741120.57(1), Florida Statutes.

674459. As the parties challenging the proposed rules, petitioners have the

6755burden of proving by a preponderance of the evidence that the challenged rules

6768are an invalid exercise of delegated legislative authority. Agrico Chemical

6778Company v. Department of Environmental Regulation, 365 So.2d 759, 763 (Fla. 1st

6790DCA 1978).

679260. Subsection 120.52(9), Florida Statutes, defines an invalid exercise of

6802authority as follows:

"6805Invalid exercise of delegated legislative

6810authority" means action which goes beyond

6816the powers, functions, and duties delegated

6822by the legislature.

6825The same statute goes on to provide that a

6834proposed rule is invalid if:

6839(a) The agency has materially failed to

6846follow the applicable rulemaking procedures

6851set forth in s. 120.54;

6856(b) The agency has exceeded its grant of

6864rulemaking authority, citation to which is

6870required by s. 120.54(7);

6874(c) The rule enlarges, modifies, or contravenes

6881the specific provisions of law implemented,

6887citation to which is required by s. 120.54(7);

6895(d) The rule is vague, fails to establish

6903adequate standards for agency decisions, or

6909vests unbridled discretion in the agency; or

6916(e) The rule is arbitrary or capricious.

692361. Respondent contends that FPS, FHA and FLH have failed to prove

6935standing to bring these actionsade and professional associations are, of

6945course, accorded standing to represent the interests of their injured members.

6956Florida Home Builders Ass'n v. Department of Labor and Employment Security, 412

6968So.2d 351, 352-53 (Fla. 1982). To do so, the association must demonstrate that

6981a substantial number of its members, although not necessarily a majority, are

6993substantially affected by the challenged rule, that the subject matter of the

7005rule is within the association's general scope of interest and activity, and

7017that the relief requested is of the type appropriate for an association to

7030receive on behalf of its members. Florida League of Cities, Inc. v. Department

7043of Environmental Regulation, 603 So.2d 1363, 1366 (Fla. 1st DCA 1992).

7054Importantly, a failure by the association to allege a specific number of members

7067affected by the proposed action is not fatal. Federation of Mobile Home Owners

7080of Florida, Inc. v. Department of Business Regulation, 479 So.2d 252, 254 (Fla.

70932d DCA 1985). Further, "(i)t is not necessary to elaborate how each member

7106would be personally affected by the proposed rule" so long as a substantial

7119portion of the association's members will be regulated by the rule. Fla. League

7132of Cities at 1367; Coalition of Mental Health Professionals v. Department of

7144Professional Regulation, 546 So.2d 27, 28 (Fla. 1st DCA 1989).

715462. The previously established facts show that FPS, FHA and FLH are

7166statewide professional associations representing perfusionists who work in, and

7175hospitals that operate, clinical laboratories, that the proposed rules will

7185regulate the staffing of the laboratories in licensed clinical laboratories,

7195that the three organizations are charged with the responsibility of representing

7206their respective members on such issues, and the relief requested is the type of

7220relief appropriate for an association to receive on behalf of its members. This

7233being so, it is concluded that the FPS, FHA and FLH have standing to bring this

7249action. The standing of petitioners FSP and Dr. McCann has not been questioned.

726263. Even if the argument could be made that petitioners FHA and FLH are

7276not directly regulated by the rules, the hospitals cannot operate their

7287respective licensed clinical laboratories in the absence of clinical laboratory

7297personnel who are licensed by the Board. In this further respect, they are

7310substantially affected by the proposed rules.

731664. To resolve the issue of whether the Board lacks statutory authority to

7329adopt the rules, a review of several provisions within Chapter 483, Florida

7341Statutes, is required. Initially, it is noted that Subsection 483.051(9),

7351Florida Statutes, provides in relevant part that

7358(t)he agency (AHCA), in consultation with

7364the Board of Clinical Laboratory Personnel,

7370shall adopt, by rule, the criteria for alternate

7378site testing to be performed under the supervision

7386of a clinical laboratory director. The elements

7393to be addressed in the rule include, but are

7402not limited to: . . . a protocol of implementation

7412including tests to be performed and who will

7420perform the tests; criteria to be used in selecting

7429the method of testing to be used for alternate

7438site testing; minimum training and education

7444requirements for those who will perform alternate

7451site testing, such as documented training,

7457licensure, certification, or other medical

7462professional background not limited to laboratory

7468professionals; documented inservice training as

7473well as initial and ongoing competency validation;

7480. . . and recordkeeping requirements. (emphasis added)

7488Here, the statute unambiguously gives the rulemaking authority relating to

7498alternate site testing to the Agency for Health Care Administration. This

7509conclusion is supported by the fact that the law is specific to alternate site

7523testing, and it was adopted more recently than the statutory authority relied

7535upon by the Board for its rulemaking authority.

754365. Although the clear statement by the legislature should be sufficient

7554to determine that the Board lacks authority to adopt the rules, the Board's

7567interpretation to the contrary raises ambiguities that require analysis of the

7578legislative history to discern legislative intent. Reference to legislative

7587history confirms that the legislature considered and rejected rulemaking

7596authority by the Board on the subject and that the intent of the legislature was

7611that AHCA would have exclusive rulemaking authority.

761866. Notwithstanding the clear mandate of the legislature, the Board

7628nonetheless contends that authority to adopt the rules is found in various parts

7641of Part IV of Chapter 483, Florida Statutes. More specifically, it argues that

7654authority to adopt rules 59O-2.002, 59O-10.004 and 59O-13.006 derives from

7664Subsection 483.805(4), Florida Statutes, which authorizes the Board "to adopt

7674such rules not inconsistent with law as may be necessary to carry out the duties

7689and authority conferred upon the board by this part." It is well settled,

7702however, that a general grant of rulemaking authority does not authorize an

7714agency to adopt rules outside of that specifically given to that agency. State

7727Dept. of Insurance v. Insurance Services Office, 434 So.2d 908 (Fla. 1st DCA

77401983). In fact, the limitation of this authority [in s. 483.805(4)] to Part IV

7754of Chapter 483 can be seen as more limiting than a general grant of rulemaking

7769authority.

777067. The Board also cites Subsection 483.811(2), Florida Statutes, as

7780authority to adopt rule 59O-3.003. That subsection authorizes the Board to

7791adopt "rules relating to curriculum" for laboratory personnel. However,

7800Subsection 483.051(9), Florida Statutes, specifically states that alternate site

7809testing is "not limited to laboratory professionals."

781668. The Board next relies upon Subsection 483.807(1), Florida Statutes, as

7827authority for adopting rules 59O-9.002 and 59-9.004. That subsection authorizes

7837the Board to establish fees for application, examinations and licensure under

7848Part IV of Chapter 483. If the Board is authorized to establish a licensure

7862category, it would also have the authority to impose fees. However, the

7874authority for a new licensure category must exist before this provision can be

7887effected. Here, there are no authorizing statutes referred to by the Board as

7900authority for it to regulate alternate site testing.

790869. The Board has also cited Subsection 483.811(3), Florida Statutes, as

7919authority for adopting rules 59O-2.002, 59O-3.003 and 59O-5.006. That section,

7929however, applies to the adoption of rules relating to exclusive use (physician's

7941office) laboratories and is not applicable to alternate site testing which by

7953definition is limited to the administrative supervision of a hospital.

796370. Finally, the Board relies upon Subsection 483.811(4), Florida

7972Statutes, as authority for adopting rule 59O-2.002. That subsection authorizes

7982the Board to "approve training programs for laboratory techicians in a hospital

7994or clinical laboratory." It also requires that "any person who completes a

8006training program must pass, before licensure, an examination by the department."

8017The statute does not, however, contain authorization for the Board to adopt

8029rules establishing a new licensure category.

803571. In summary, the elements that the Board attempts to regulate in its

8048rules include: "tests to be performed" (59O-13.006); "who will perform the

8059tests" [59O-5.006(2)]; "minimum training and education requirements for those

8068who will perform alternate site testing" (59O-3.003, 59O-5.006); "such as

8078documented training, licensure, certification or other medical professional

8086background not limited to laboratory professionals" (59O-5.006); "documented

8094inservice training as well as initial and ongoing competency validation" (59O-

81053.003(a), 59O-9.004); and "recordkeeping requirements" (59O-13.006). Because

8112the Board's rules essentially track the elements that the legislature directed

8123AHCA to adopt, it must be concluded that the Board exceeded its rulemaking

8136authority in proposing to adopt the rules. For this reason, the challenged

8148rules are an invalid exercise of delegated legislative authority.

815772. If petitioners had simply filed a motion for summary final order on

8170this dispositive legal issue, considerable resources expended in prosecuting

8179these cases could have been saved. However, the cases proceeded to final

8191hearing, and evidence was presented on the numerous other grounds raised by the

8204parties. Although this presents an unnecessary laborious task, for the sake of

8216judicial economy in the event an appeal is taken, further conclusions are made

8229with respect to the individual rules being challenged.

823773. The remaining contentions are that the rules are either arbitrary or

8249capricious, or that in some respect they contravene the law being implemented.

8261Case law instructs us that a proposed rule is arbitrary only if it is not

8276supported by facts and logic. On the other hand, a proposed rule is capricious

8290if it is taken without thought and reason. Agrico at 763. Also relevant here

8304is the proposition that in making a factual record to support a rule, an agency

8319cannot rely on "literature" or other unspecified documents that are not made a

8332part of the record. Ameraquatic, Inc. et al v. State, Dept. of Natural

8345Resources, 20 F. L. W. D366, D369 (Fla. 1st DCA, February 7, 1995). At the same

8361time, an agency cannot enlarge, modify or contravene the provisions of a

8373statute, and a rule which purports to do so constitutes an invalid exercise of

8387delegated legislative authority. See, e. g., Cataract Surgery Center v. Health

8398Care Cost Containment Board, 581 So.2d 1359 (Fla. 1st DCA 1991). Finally, a

8411hearing officer cannot adjudicate claims on matters not timely raised by the

8423parties. Compare Agency for Health Care Administration v. Principal Nursing

8433Services, Inc., 20 F. L. W. D492 (Fla. 1st DCA, February 24, 1995)(improper for

8447hearing officer to determine the validity of a rule not specifically alleged to

8460be invalid in the initial petition).

846674. Assuming for the sake of argument only that the Board has authority to

8480promulgate the rules, the undersigned rejects the contention that proposed rule

849159O-2.002(7) is invalid because it is arbitrary and capricious. Simply because

8502a rule's operation is contingent on the adoption of other rules is not a ground

8517to invalidate a rule. A second contention that the rule is vague and fails to

8532establish adequate standards for agency discretion has been rejected as being

8543untimely raised.

854575. Because rule 59O-3.003(3) lacks an adequate factual basis, as more

8556specifically described in findings of fact 33-35, it is concluded that the rule

8569is arbitrary, and it is therefore an invalid exercise of delegated legislative

8581authority.

858276. In a similar vein, given the lack of a factual basis for rules 59O-

85975.001(1)(b), (2)(a), and (2)(b), as further explained in findings of fact 38-43,

8609these portions of the rule are deemed to be arbitrary and are thus an invalid

8624exercise of delegated legislative authority.

862977. By making respiratory therapists and respiratory care practitioners

8638subject to the requirements of rule 59O-5.006, in contravention of Subsection

8649468.351(2), Florida Statutes, rule 59O-5.006(2)(c) is deemed to be an invalid

8660exercise of delegated legislative authority. Further, there is a lack of facts

8672or logic to support the Board's decision to include only three classes of

8685professions within the terms of the rule. Accordingly, the remainder of the

8697rule is deemed to be arbitrary and thus invalid. It is also concluded that the

8712same rule is invalid on the ground it contravenes the provisions of Subsection

8725455.201(4), Florida Statutes, by creating unreasonable restrictions and

8733standards on qualified professions. Finally, the second sentence in the first

8744paragraph of the rule is deemed to be arbitrary and thus an invalid exercise of

8759delegated legislative authority.

876278. Finally, the contention that proposed rules 59O-9.002(4), 59O-

87719.004(7), 59O-10.004 and 59-13.006 are invalid for other reasons has been

8782rejected since the grounds were not timely raised.

8790Based on the foregoing findings of fact and conclusions of law, it is

8803ORDERED that proposed rules 59-2.002(7), 59-3.003, 59O-5.001(1)(b), (2)(a)

8811and (2)(b), 59O-5.006, 59O-9.002(4), 59O-9.004(7), 59O-10.004 and 59O-13.006 are

8820declared to be an invalid exercise of delegated legislative authority on the

8832ground the agency exceeded its rulemaking authority.

8839DONE AND ORDERED this 8th day of March, 1995, in Tallahassee, Florida.

8851___________________________________

8852DONALD R. ALEXANDER

8855Hearing Officer

8857Division of Administrative Hearings

8861The DeSoto Building

88641230 Apalachee Parkway

8867Tallahassee, Florida 32399-1550

8870(904) 488-9675

8872Filed with the Clerk of the

8878Division of Administrative Hearings

8882this 8th day of March, 1995.

8888APPENDIX TO FINAL ORDER

8892Petitioners FPS, FHA, and FLH:

88971-2. Partially accepted in finding of fact 3.

89053. Rejected as being irrelevant.

89104. Rejected as being unnecessary.

89155-21. Partially accepted in findings of fact 10-16.

892322-36. Partially accepted in findings of fact 17-26.

893137-39. Partially accepted in findings of fact 28-30.

893940-47. Partially accepted in findings of fact 31-35.

894748-55. Partially accepted in findings of fact 45-50.

895556-58. Partially accepted in findings of fact 51-53.

896359. Partially accepted in findings of fact 54 and 55.

897360-71. Partially accepted in findings of fact 56 and 57.

8983Petitioners FSP and McCann:

89871-37. Partially accepted in findings of fact 36-44.

8995Respondent:

89961. Partially accepted in finding of fact 14.

90042. Partially accepted in findings of fact 11 and 12.

90143. Partially accepted in finding of fact 16.

90224. Partially accepted in finding of fact 10.

90305. Partially accepted in findings of fact 2 and 9.

90406-13. Partially accepted in findings of fact 10-16.

904814. Partially accepted in finding of fact 2.

905615. Partially accepted in finding of fact 4.

906416. Partially accepted in finding of fact 3.

907217-18. Partially accepted in findings of fact 5, 33 and 35.

908319. Covered in preliminary statement.

908820-24. Rejected as being unnecessary.

909325. Partially accepted in finding of fact 43.

910126. Partially accepted in finding of fact 35.

910927. Partially accepted in finding of fact 36.

911728-31. Partially accepted in findings of fact 38-44.

912532. Partially accepted in findings of fact 28-30.

913333-34. Partially accepted in findings of fact 31-35.

914135-36. Partially accepted in findings of fact 45-50.

914937. Partially accepted in findings of fact 51-53.

915738. Partially accepted in finding of fact 54.

916539. Partially accepted in finding of fact 56-57.

9173Note - Where a proposed finding has been partially accepted, the remainder has

9186been rejected as being unnecessary for a resolution of the issues, irrelvant,

9198cumulative, subordinate, not supported by the evidence, or a conclusion of law.

9210COPIES FURNISHED:

9212Carol A. Forthman, Esquire

9216131 North Gadsden Street

9220Tallahassee, Florida 32301-1507

9223Harold F. X. Purnell, Esquire

9228Thomas W. Konrad, Esquire

9232Post Office Box 551

9236Tallahassee, Florida 32302-0551

9239John H. French, Jr., Esquire

9244Post Office Box 10095

9248Tallahassee, Florida 32302-2095

9251Claire D. Dryfuss, Esquire

9255Department of Legal Affairs

9259The Capitol, PL-01

9262Tallahassee, Florida 32399-1050

9265Sandra E. Allen, Esquire

9269314 West Jefferson Street

9273Tallahassee, Florida 32301

9276V. Carroll Webb, Director

9280Joint Administrative Procedures Committee

9284Holland Building, Room 120

9288Tallahassee, Florida 32399-1300

9291Liz Cloud, Chief

9294Bureau of Laws and Administrative Code

9300The Capitol, Room 1802

9304Tallahassee, Florida 32399-0250

9307NOTICE OF RIGHT TO JUDICIAL REVIEW

9313A party who is adversely affected by this Final Order is entitled to judicial

9327review pursuant to Section 120.68, Florida Statutes. Review proceedings are

9337governed by the Florida Rules of Appellate procedure. Such proceedings are

9348commenced by filing one copy of a notice of appeal with the agency clerk of the

9364Division of Administrative Hearings and a second copy, accompanied by filing

9375fees prescribed by law, with the District Court of Appeal, First District, or

9388with the district court of appeal in the appellate district where the party

9401resides. The notice of appeal must be filed within 30 days of rendition of the

9416order to be reviewed.

9420=================================================================

9421DISTRICT COURT OPINION

9424=================================================================

9425IN THE DISTRICT COURT OF APPEAL

9431FIRST DISTRICT, STATE OF FLORIDA

9436BOARD OF CLINICAL LABORATORY NOT FINAL UNTIL TIME EXPIRES TO

9446PERSONNEL, FILE MOTION FOR REHEARING AND

9452DISPOSITION THEREOF IF FILED.

9456Appellant,

9457CASE NO. 95-1196

9460vs. DOAH CASE NO. 94-5968RP

9465FLORIDA PERFUSION SOCIETY,

9468et al.,

9470Appellee.

9471______________________________/

9472Opinion filed January 28, 1997.

9477An appeal from an order of the Division of Administrative Hearings.

9488Robert A. Butterworth, Attorney General, and Claire D. Dryfuss, Assistant

9498Attorney General, Tallahassee, for Appellant.

9503Carol A. Forthman of Cobb, Cole & Bell, Tallahassee, for Appellees Florida

9515Hospital Association and Florida Perfusion Society; Harold F.X. Purnell of

9525Rutledge, Ecenia, Underwood, Purnell & Hoffman, P.A., Tallahassee, for Appellees

9535Florida Society of Pathologists and Louis S. McCann, Jr.

9544PER CURIAM.

9546AFFIRMED.

9547BARFIELD, C. J., HAHN and DAVIS, JJ., CONCUR

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Date
Proceedings
Date: 02/14/1997
Proceedings: Mandate from the First DCA filed.
Date: 01/30/1997
Proceedings: First DCA Opinion (AFFIRMED) filed.
PDF:
Date: 01/28/1997
Proceedings: Opinion
Date: 09/27/1996
Proceedings: Index, Record, Certificate of Record sent out.
Date: 09/03/1996
Proceedings: First District Court of Appeal Case Number 1-95-1196 filed.
Date: 08/21/1996
Proceedings: Notice of Preparation of Record sent out. (Late Notice for payment)
Date: 11/13/1995
Proceedings: BY ORDER OF THE COURT (Court`s Order to show cause is discharged) filed.
Date: 08/04/1995
Proceedings: BY ORDER OF THE COURT (Motion for Extension of time is granted) filed.
Date: 07/27/1995
Proceedings: Index & Statement of Service sent out.
Date: 07/18/1995
Proceedings: Amended Index sent out.
Date: 07/12/1995
Proceedings: BY ORDER OF THE COURT (lower tribunal is directed to serve and amended index within 20 days) filed.
Date: 06/14/1995
Proceedings: Motion to Correct Record filed.
Date: 06/02/1995
Proceedings: Index & Statement of Service sent out.
Date: 04/12/1995
Proceedings: Letter to DOAH from DCA filed. DCA Case No. 95-1196.
Date: 04/10/1995
Proceedings: Certificate of Notice of Administrative Appeal sent out.
Date: 04/07/1995
Proceedings: Notice of Administrative Appeal filed.
PDF:
Date: 03/08/1995
Proceedings: DOAH Final Order
PDF:
Date: 03/08/1995
Proceedings: CASE CLOSED. Final Order sent out. Hearing held 11/23/94.
Date: 02/15/1995
Proceedings: (Respondent) Memorandum in Support of Request for Official Recognition; Notice of Filing Proposed Final Order; Proposed Final Order (for Hearing Officer Signature) filed.
Date: 02/15/1995
Proceedings: Proposed Final Order of the Florida Society of Pathologists and Louis S. McCann, Jr., M.D. filed.
Date: 02/15/1995
Proceedings: Intervenor`s Proposed Final Order filed.
Date: 02/15/1995
Proceedings: (Respondent) Board`s Proposed Final Order filed.
Date: 01/31/1995
Proceedings: Transcripts (Volumes I, II, III, tagged) filed.
Date: 12/05/1994
Proceedings: Board`s Response To Request for Official Recognition Of Documents In Case No. 94-5968RP filed.
Date: 12/01/1994
Proceedings: (Intervenor) Notice of Address Change filed.
Date: 11/23/1994
Proceedings: Prehearing Stipulation of Florida Society of Pathologists, Louis S. McCann, Jr., M.D. and The Board of Clinical Laboratory Personnel filed.
Date: 11/23/1994
Proceedings: CASE STATUS: Hearing Held.
Date: 11/22/1994
Proceedings: (Petitioner) Motion to Require Answer to Request for Admissions Or to Deem Request for Admission to Have Been Admitted, and to Compel Answer to Interrogatories filed.
Date: 11/21/1994
Proceedings: Board`s Response to Request for Production In Case No. 94-5969RP; Notice of Filing Answers to Interrogatories; Joint Stipulation On Expedited Discovery (case no. 94-5969RP); Board`s Response to Petitioner`s Second Request for Admissions In Case No. 94-5
Date: 11/21/1994
Proceedings: Florida Society of Pathologists Corrected Notice of Service of First Interrogatories to The Board of Clinical Laboratory Personnel; Cover Letter filed.
Date: 11/21/1994
Proceedings: (Petitioners) Response to Motion In Limine; Petitioner`s Notice of Service of Supplemental Answers to Board`s First Set of Interrogatories filed.
Date: 11/18/1994
Proceedings: Order sent out. (Intervention Granted for 94-5968RP & 94-5970RP)
Date: 11/18/1994
Proceedings: (Respondent) Notice of Taking Deposition filed.
Date: 11/18/1994
Proceedings: Letter to DRA from S. Allen (Re: Notice of change of address) filed.
Date: 11/17/1994
Proceedings: Board`s Motion In Limine; Board`s Response Petition to Intervene filed.
Date: 11/16/1994
Proceedings: Order sent out. (Petitioners` unopposed Motion for Leave to file amended Petition is granted; for case #94-5969RP)
Date: 11/16/1994
Proceedings: Petitioner`s Notice of Service of Answers to Board`s First Set of Interrogatories; Board`s First Set of Interrogatories to Petitioner; Response to Request for Admissions; Florida League of Hospitals Response to Request for Documents filed.
Date: 11/15/1994
Proceedings: (Respondent) 4/Notice of Taking Deposition Duces Tecum filed.
Date: 11/14/1994
Proceedings: Order sent out. (Motion to dismiss/more definite statement denied)
Date: 11/14/1994
Proceedings: (Timothy Kilpatrick) Notice of Voluntary Dismissal; Amended Petition for Administrative Determination of the Invalidity of a Proposed Rule (case no. 94-5969RP); Motion for Leave to File Amended Petition filed.
Date: 11/14/1994
Proceedings: (Florida Society of Pathologist) 2/Notice of Taking Deposition filed.
Date: 11/14/1994
Proceedings: (Petitioner) Petition to Intervene filed.
Date: 11/14/1994
Proceedings: Petitioner`s Notice of Service of Answers to Board`s First Set of Interrogatories filed.
Date: 11/14/1994
Proceedings: Petitioner`s Second Request for Admissions to Board of Clinical Laboratory Personnel; Petitioner`s Notice of Service of Second Set of Interrogatories to Board of Clinical Laboratory Personnel filed.
Date: 11/14/1994
Proceedings: Notice of Taking Deposition Duces Tecum (from C. Forthman) filed.
Date: 11/12/1994
Proceedings: Florida Society of Pathologists Notice of Service of First Interrogatories to The Board of Clinical Laboratory Personnel; Petitioner`s Notice of Service of Answers to Board`s First Set of Interrogatories filed.
Date: 11/12/1994
Proceedings: Florida Society of Pathologists First Request for Production of Documents to The Board of Clinical Laboratory Personnel; Petitioners Response to Board`s First Request for Admissions; Petitioner`s Response to Board`s First Request for Production of Docum
Date: 11/12/1994
Proceedings: (Petitioners) Response to Request for Production filed.
Date: 11/08/1994
Proceedings: (Respondent) Notice of Filing Answers to Interrogatories; Board`s Response to Request for Production of Documentation In Case No. 94-5968RP; Board`s Response to Petitioner`s Request for Admissions In Case No. 94-5968RP; board`s Response to Motion for Ex
Date: 11/08/1994
Proceedings: (Respondent) Notice of Taking Deposition Duces Tecum filed.
Date: 11/08/1994
Proceedings: Petitioner`s Response to Board`s First Request for Admissions; Response of Florida Perfusion Society, Florida Hospital Association Mallickrodt Sensor Systems, Inc., to i-Stat Corporation and Boehringer Mannheim Diagnostics, Inc., to Respondent`s Motion
Date: 11/08/1994
Proceedings: Board`s Filing of Supplement to Motion for Official Recognition filed.
Date: 11/04/1994
Proceedings: Board`s First Request for Production of Documents; Notice of Service of Interrogatories; Board`s First Request for Admission (case no. 94-5969RP) filed.
Date: 11/02/1994
Proceedings: Board`s First Request for Production of Documents; Board`s First Request for Admissions; Motion to Dismiss and/Or for More Definite Statement (case no. 94-5970RP) filed.
Date: 11/02/1994
Proceedings: (Respondent) Notice of Service of Interrogatories (case no. 94-5968RP) filed.
Date: 11/01/1994
Proceedings: Motion for official recognition (Respondent) filed.
Date: 11/01/1994
Proceedings: Board`s first request for Production of documents (Respondent) filed.
Date: 11/01/1994
Proceedings: Notice of service of interrogatories (Respondent) filed.
Date: 11/01/1994
Proceedings: Board`s first request for admissions (Respondent) filed.
Date: 10/31/1994
Proceedings: Notice of Hearing (set for 11/23/94; 9:00am; Tallahassee) sent out. (Cases Are Consolidated: 94-5968RP, 94-5969RP & 94-5970RP)
Date: 10/31/1994
Proceedings: Order of Assignment sent out.
Date: 10/28/1994
Proceedings: Petitioners` Motion to Establish Expedited Discovery Schedule filed.
Date: 10/27/1994
Proceedings: Petitioners` First Request for Production of Documents to Board of Clinical Laboratory Personnel filed.
Date: 10/27/1994
Proceedings: Petitioners` Notice of Service of First Set of Interrogatories to Board of Clinical Laboratory Personnel filed.
Date: 10/26/1994
Proceedings: (Respondent) Motion for Assignment of Case to Hearing Officer Charles Adams filed.
Date: 10/26/1994
Proceedings: (Respondent) Motion for Consolidation (with DOAH Case No/s. 94-5968RP& 94-5970RP) filed.
Date: 10/25/1994
Proceedings: Letter to Liz Cloud & Carroll Webb from Marguerite Lockard w/cc: Agency General Counsel sent out.
Date: 10/24/1994
Proceedings: Exhibits I & II (enclosures to Petition); & Cover Letter from C. Forthman filed.
Date: 10/21/1994
Proceedings: Petition for An Administrative Determination of the Invalidity of a Proposed Rule filed.

Case Information

Judge:
D. R. ALEXANDER
Date Filed:
10/21/1994
Date Assignment:
10/31/1994
Last Docket Entry:
02/14/1997
Location:
Tallahassee, Florida
District:
Northern
Agency:
Department of Health
Suffix:
RP
 

Related DOAH Cases(s) (4):

Related Florida Statute(s) (14):

Related Florida Rule(s) (2):