06-000832RX Kanithahalli Satya-Prakash, Ph.D. vs. Department Of Health, Board Of Clinical Laboratory Personnel Status: Closed DOAH Final Order on Tuesday, June 6, 2006.

Summary: The challenged rule does not exceed the Respondent`s grant of rulemaking authority and does not enlarge, modify, or contravene the specific provisions of the law implemented.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

KANITHAHALLI SATYA - PRAKASH, )

)

Petitioner, )

)

vs. ) Case No. 06 - 08 32RX

)

DEPARTMENT OF HEALTH, BOARD )

OF CLINICAL LABORATORY )

PERSONNEL, )

)

Respondent. )

_ )

FINAL ORDER

Pursuant to notice, a formal hearing was held on

April 13, 2006, in Tallahassee, Florida, before the Division

of Administrative Hearings, by its designated Administrative

Law Judge, Barbara J. Staros.

APPEARANCES

For Petitioner: Lisa Hurley, Esquire

J. Bruce Culpepper, Esquire

Akerman Senterfitt

106 East College Avenue, Suite 1200

Tallahassee, Florida 32301

For Respondent: Michael T. Flury, Esquire

Reginald Dixon, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

STATEMENT OF THE ISSUE

Whether Florida Administrative Code Rule 64B3 - 5.007 is an

invalid exercise of de legated legislative authority pursuant

to Subsection 120.52(8), Florida Statutes (2005).

PRELIMINARY STATEMENT

Petitioner, Kanithahalli Satya - Prakash, filed a Petition

to Determine Invalidity of Existing Rule with the Division

of Administrative Hearings (Division) on March 8, 2006, which

was assigned to the undersigned on March 9, 2006. The

Petition challenged the validity of Florida Administrative

Code Rule 64B3 - 5.007.

A Notice of Hearing was issued on March 10, 2006,

scheduling a formal hearing for Ap ril 6, 2006. On March 21,

2006, Respondent filed an unopposed Motion for Continuance,

which was granted. The hearing was rescheduled for April 13,

2006. The parties filed a Joint Pre - Hearing Stipulation on

April 11, 2006.

At hearing, neither pa rty presented any witnesses.

Petitioner's Exhibits numbered 1 through 3 were admitted into

evidence. Respondent's Exhibit numbered 1 was admitted into

evidence. Official Recognition was taken of the

interpretative guidelines of the Centers for Medicare and

Medicaid Services of the Department of Health and Human

Services, found at Title 42 Code of Federal Regulations

Section 493.

A Transcript consisting of one - volume was filed on May 2,

2006. On Friday, May 12, 2006, Respondent made an unopposed

ore ten us motion for a brief extension of time to file

proposed final orders. The motion was granted. The parties

timely filed Proposed Final Orders, which have been considered

in the preparation of this Final Order. 1/

FINDINGS OF FACT

Stipulated Facts

1. Pe titioner, Kanithahalli Satya - Prakash, is seeking

licensure in Florida as a clinical laboratory director

pursuant to Section 483.824, Florida Statutes, and Florida

Administrative Code Rule 64B3 - 5.007.

2. Petitioner is a cytogeneticist who has served as th e

Director of the Cancer Cytogenetics laboratory at the Medical

College of Georgia since 1986. Petitioner holds an earned

doctoral degree in chemical, physical, or biological science

from a regionally accredited institution. Petitioner received

his docto ral degree in India in 1976. Petitioner trained at

the M.D. Anderson Cancer Center in Houston, Texas.

3. The Florida Department of Health, Board of Clinical

Laboratory Personnel (the Board), has been delegated by the

Florida Legislature to serve as the r egulatory board for

clinical laboratory directors in the state of Florida.

4. After submitting his application for licensure as a

clinical laboratory director, the Board instructed Petitioner

that he lacked the requisite board certification requirement

ne cessary for licensure under Florida Administrative Code Rule

64B3 - 5.007. Petitioner is not board certified and does not

maintain certification by a board approved by the United

States Department of Health and Human Services.

5. On or about June 15, 2005 , Petitioner filed a

Petition for Variance from or Waiver of Florida Administrative

Code Rule 64B3 - 5.007, with the Board. The Board informed

Petitioner that he had to pass the specialty examination in

clinical cytogenetics prepared by the American Board o f

Medical Genetics in order to become licensed in Florida as a

clinical laboratory director.

6. On August 18, 2005, the Board issued an Order Denying

the Petition for Variance/Waiver. The Board ruled that

Petitioner failed to meet "the board certificatio n

requirements set forth in Rule 64B3 - 5.007(4) for licensure as

a laboratory director."

7. Petitioner has over four years of clinical laboratory

experience with two years of experience in the specialty to be

directed. 2/

8. The federal Health Care Financi ng Administration is

now known as Centers for Medicare and Medicaid Services (CMS).

9. Petitioner is substantially affected by the

challenged Rule and has standing to bring this action.

CONCLUSIONS OF LAW

10. The Division of Administrative Hearings h as

jurisdiction over the parties and subject matter of this

proceeding pursuant to Subsections 120.56(1) and (3), Florida

Statutes.

11. Petitioner has standing to challenge the Rule which

is the subject of this dispute.

12. The Board is the agency respon sible for licensing

clinical laboratory personnel in the state. § 483.809, Fla.

Stat.

13. The challenged rule, Florida Administrative Code

Rule 64B3 - 5.007, reads in pertinent part as follows:

(4) Qualifications - Non - Physician

Directors. . . . In order to be licensed

as a director, an applicant . . . shall

meet the following requirements: holds an

earned doctoral degree with a chemical,

biological or clinical laboratory science

as a major and is certified in one of the

laboratory specialties by an agen cy

recognized by the U.S. Department of

Education or the U.S. Department of Health

and Human Services which includes the

American Board of Medical Microbiology, the

American Board of Clinical Chemistry, the

American Board of Medical Genetics, the

American Board of Bioanalysts, the American

Board of Medical Laboratory Immunology, and

the American Board of Histocompatibility

and Immunogentics. (emphasis supplied)

14. The party attacking an existing agency rule has the

burden to prove by a preponderance of the evidence that the

rule constitutes an invalid exercise of delegated legislative

authority as to the objections raised. § 120.56(3)(a), Fla.

Stat. Cortes v. State Board of Regents , 655 So. 2d 132 (Fla.

1st DCA 1995). The challenger's burden is a stringent one.

Id. ; Charity v. Florida State University , 680 So. 2d 463 (Fla.

1st DCA 1996). Petitioner has not met this burden.

15. The Petition to Determine Invalidity of Existing

Rule, which challenges the validity of Florida Administrative

Code Rule 64B3 - 5.007, alleges that the Rule is an invalid

exercise of delegated legislative authority within the context

of paragraphs 120.52(8)(b) and (c), Florida Statutes, in that

the Rule exceeds the rule - making authority given to the Board

and that the Rule en larges, modifies, or contravenes the

specific provisions of law implemented.

16. Subsection 120.52(8), Florida Statutes, reads, in

pertinent part, as follows:

(8) 'Invalid exercise of delegated

legislative authority' means action which

goes beyond the p owers, functions, and

duties delegated by the Legislature. A

proposed or existing rule is an invalid

exercise of delegated legislative authority

if any one of the following applies:

* * *

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(3)(a)1.;

(c) The rule enlarges, modifies, or

contravenes the specific provisions of law

implemented, citation to which is required

by s. 120.54(3)(a)1.

* * *

A grant of rulemaking auth ority is

necessary but not sufficient to allow an

agency to adopt a rule; a specific law to

be implemented is also required. An agency

may adopt only rules that implement or

interpret the specific powers and duties

granted by the enabling statute. No age ncy

shall have the authority to adopt a rule

only because it is reasonably related to

the purpose of the enabling legislation and

is not arbitrary and capricious or is

within the agency's class of powers and

duties, nor shall an agency have the

authority t o implement statutory provisions

setting forth general legislative intent or

policy. Statutory language granting

rulemaking authority or generally

describing the powers and functions of an

agency shall be construed to extend no

further than implementing o r interpreting

the specific powers and duties conferred by

the same statute.

Subsection 120.52(8)(b), Florida Statutes

17. The Board's general grant of rulemaking authority is

found in Section 483.805(4), Florida Statutes, which gives the

Board authority to adopt all rules necessary to implement the

provisions of Part III of Chapter 483, Florida Statutes,

entitled "Clinical Laboratory Personnel."

18. More specific rulemaking authority regarding

personnel licensure requirements is found in Subsection

483. 811(2), Florida Statutes, which reads in pertinent part as

follows:

(2) The board shall adopt rules for

training programs, including, but not

limited to, rules relating to . . .

personnel licensure requirements.

19. This statutory language contain s a specific grant of

authority to adopt rules relating to personnel licensure

requirements. See Florida Board of Medicine, et al., v.

Florida Academy of Cosmetic Surgery, Inc., et al. , 808 So. 2d

243 (Fla. 1st DCA 2002).

20. The statutory language a lso grants the Board broad

authority in adopting all rules necessary relating to clinical

laboratory personnel requirements. Accordingly, the Board has

not exceeded its grant of rulemaking authority as contemplated

by Subsection 120.52(8)(b), Florida Stat utes.

Subsection 120.52(8)(c), Florida Statutes

21. The challenged rule implements, among other

statutes, Section 483.824, Florida Statutes, which reads in

pertinent part as follows:

Qualifications of clinical laboratory

personnel.

A clinical laboratory director must have 4

years of clinical laboratory experience

with 2 years of experience in the specialty

to be directed or be nationally board

certified in the specialty to be directed,

and must meet one of the following

licensing requirements:

(1) Be a physician licensed under chapter

458 or chapter 459:

(2) Hold an earned doctoral degree in a

chemical, physical, or biological science

from a regionally accredited institution

and maintain national certification

requirements equal to those required by th e

federal Health Care Financing

Administration ; or

(3) For the subspecialty of oral

pathology, be a physician licensed under

chapter 458 or chapter 459 or a dentist

licensed under chapter 466. (emphasis

supplied)

22. In 1999, Section 483.824(2), Fl orida Statutes,

required that to qualify for licensure as a clinical

laboratory director in Florida, persons holding an earned

doctoral degree must also be "nationally certified."

23. Section 483.824(2), Florida Statutes, was amended by

s. 65, Ch. 2000 - 3 18, Laws of Florida. The term "nationally

certified" was replaced with the phrase "maintain national

certification requirements equal to those required by the

federal Health Care Financing Administration." This reflects

the current wording of the statute .

24. Petitioner argues that the 2000 amendment to Section

483.824, Florida Statutes, represents a material change to the

requirements of the statute and, since the challenged rule

requires persons to be "nationally certified," it constitutes

an invalid e xercise of delegated legislative authority.

25. Further, Petitioner argues that the statute was

changed to conform Florida's clinical laboratory director

qualifications for individuals with doctoral degrees, with the

federal standards. 3/

26. It is app ropriate at this juncture to look to the

federal regulations in relation to the statutory requirement

"national certification requirements equal to those required

by the Federal Health Care Administration" as used in Section

483.824, Florida Statutes.

27. Both parties cite 42 C.F.R. Section 493.1443, which

reads in pertinent part as follows:

Standard; Laboratory Director

Qualifications

* * *

(b) The laboratory director must --

(3) Hold an earned doctoral degree in a

chemical , physical, biological, or clinical

laboratory science from an accredited

institution and --

(i) Be certified and continue to be

certified by a board approved by HHS

(Department of Health and Human Services);

or

(ii) Before February 24, 2003, must have

s erved or be serving as a director of a

laboratory performing high complexity

testing and must have at least --

(A) Two years of laboratory training or

experience, or both; and

(B) Two years of laboratory experience

directing or supervising high complexi ty

testing. (emphasis supplied)

28. The interpretive guidelines of 42 C.F.R. Section

493.1443 contain a list of "currently approved boards." The

list includes, among others, all of the boards referenced in

the challenged rule.

29. The challen ged rule appears to substantially track

the language of 42 C.F.R. Section 1443(3)(i), in requiring a

director to be certified by an approved board. Subsection

483.824(2), Florida Statutes, requires a laboratory director

to hold the requisite doctoral degr ee and maintain national

certification requirements equal to those required by the

Federal Health Care Administration, now known as the Center

for Medicaid and Medicare Services (CMS). The undersigned is

not persuaded that the language of the challenged r ule, which

requires certification by an agency recognized by Health and

Human Services, is inconsistent with the statutory language of

Section 483.824(2), which requires the applicant to "maintain

national certification equal to those required by the Healt h

Care Financing Administration," now CMS.

30. Petitioner further argues that the above - quoted

federal regulation does not require board certification, but

requires either board certification or a certain amount of

experience prior to February 24 , 2003. 42 C.F.R. §

493.1442(b)(3)(ii). This "grandfather clause" provides an

alternative to board certification for applicants with

doctoral degrees who have the requisite experience.

Petitioner argues that Florida must recognize this

alternative. The re is no competent evidence in the record to

support this argument.

31. While the introductory language of Section 483.824,

Florida Statutes, references being "nationally board certified

in the specialty to be directed" as an alternative requirement

for licensure, the introductory language concludes with, "and

must meet one of the following licensing requirements."

Subsection (2) clearly requires that a clinical laboratory

director, who is not a physician licensed under Chapters 458

or 459, hold an e arned doctoral degree in a specified field

and maintain national certification equal to those required by

CMS. Thus, the requirement to maintain national certification

is in addition to holding the appropriate degree for non -

physicians seeking licensure.

32. Accordingly, Florida Administrative Code Rule 64B3 -

5.007 does not constitute an invalid exercise of delegated

legislative authority in that it does not enlarge, modify, or

contravene the specific provisions of law implemented.

ORDER

Based upon th e foregoing Findings of Fact and Conclusions

of Law, it is

ORDERED:

The Petition for the Administrative Determination of the

Invalidity of Florida Administrative Code Rule 64B3 - 5.007 is

dismissed.

DONE AND ORDERED this 6th day of June, 2006, in

Tallahassee , Leon County, Florida.

S

___________________________________

BARBARA J. STAROS

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Fi ling (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 6th day of June, 2006.

ENDNOTES

1/ All references to the Florida Statutes will be to Florida

Statutes 2005, unless otherwise indicated.

2/ Paragraphs 7, 8, and 9 were included in the Pre - Hearing

Stipulation as issues of law on which there is agreement.

3/ There is no competent evidence in the record to support the

conclusion that the 2000 amendment was for the purpose of

conforming to feder al standards.

COPIES FURNISHED :

Lisa Hurley, Esquire

J. Bruce Culpepper, Esquire

Akerman Senterfitt

106 East College Avenue, Suite 1200

Tallahassee, Florida 32301

Michael T. Flury, Esquire

Reginald Dixon, Esquire

Office of the Attorney General

The Ca pitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

Scott Boyd, Executive Director

and General Counsel

Joint Administrative Procedures Committee

120 Holland Building

Tallahassee, Florida 32399 - 1300

Liz Cloud, Program Administrator

Bureau of Adminis trative Code

Department of State

R. A. Gray Building, Suite 101

Tallahassee, Florida 32399 - 0250

Timothy M. Cerio, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Joe B aker, Jr., Executive Director

Board of Clinical Laboratory Personnel

Department of Health

4052 Bald Cypress Way, Bin C07

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who i s 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 the original notic e of appeal with the

Clerk of the Division of Administrative Hearings and a 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 part y

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

rendition of the order to be reviewed.