STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

KANITHAHALLI SATYA-PRAKASH, )

)

Petitioner, )

)

vs. )

) DEPARTMENT OF HEALTH, BOARD ) OF CLINICAL LABORATORY )

PERSONNEL, )

)

Respondent. )

_ )

Case No. 06-0832RX

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 delegated 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 April 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 party 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 tenus 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. Petitioner, 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 the 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 doctoral 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 regulatory 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 necessary 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 of 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 certification 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 Financing 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 has 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 responsible 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 agency 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 enlarges, 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 powers, 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:

    
    

    * * *

    
    

    1. The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;

       
       

    2. 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 authority 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 agency 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 to 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 or 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 contains 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 also 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 Statutes.

    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 the 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), Florida 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. 2000-318, 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 exercise 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 appropriate 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--

    
    

    1. Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and--

       
       

       1. Be certified and continue to be certified by a board approved by HHS (Department of Health and Human Services); or

       2. Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least--

    
    

    1. Two years of laboratory training or experience, or both; and

       
       

    2. Two years of laboratory experience directing or supervising high complexity 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 challenged 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 degree 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 rule, 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 Health 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. There 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 earned 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 the 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 Filing (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 federal 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 Capitol, 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 Administrative 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 Baker, 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 is adversely affected by this Final Order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice 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 party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.

Docket for Case No: 06-000832RX

Orders for Case No: 06-000832RX