STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA SOCIETY OF NUCLEAR ) MEDICINE TECHNOLOGISTS, INC., )

)

Petitioner, )

)

vs. ) CASE NO. 76-1963RX

)

DEPARTMENT OF HEALTH AND )

REHABILITATIVE SERVICES, )

)

Respondent. )

)

FINAL ORDER

THIS CAUSE came on to be heard upon the filing of a petition by the Florida Society of Nuclear Medicine Technologists, Inc. ("Petitioner" hereafter). The Petitioner was originally challenging the validity of certain proposed rules of the Florida Department of Health and Rehabilitative Services ("Respondent" hereafter) respecting the regulation of medical laboratories. The proposed rules have now been codified as a part of Chapter 10D-41, Florida Administrative Code.

APPEARANCES

For Petitioner: James R. Lavigne, Winter Park, Florida Florida Society of Nuclear Medicine Technologists, Inc.

For Respondent: Barbara Dell McPherson, Jacksonville Department of Health and Rehabilitative Services.

For Intervenor: John Michael Huey, Tallahassee, Florida Florida Society of Pathologists.

Julie Pogue, St. Petersburg, Florida Unity Council for Medical Technology in Florida.

The petition was originally filed in the form of telegrams from the Petitioner and several other individuals and groups directed to the Director of the Division of Administrative Hearings. The telegrams did not remotely comport with the requirements of the Model Rules of Procedure respecting the content of petitions for formal proceedings. Rule 28-5.15, Florida Administrative Code.

The Respondent did not, however, object to the sufficiency of the telegrams.

The parties proceeded as if adequate petitions had been filed, and sought a negotiated settlement of the issues. On at least two occasions they appeared to have reached a consensus, but no agreement was consummated. By notice dated January 25, 1977, the final hearing was scheduled to be conducted on February 24, 1977, in Tampa, Florida. In the meantime, the proposed rules became effective. The parties agreed to treat the original petitions as if they had been filed in accordance with Florida Statutes Section 120.56, and to treat the

proceeding as a proceeding for administrative determination of the validity of the rules.

At the hearing only the Florida Society of Nuclear Medicine Technologists, Inc., among the individuals and groups who had submitted petitions in the form of telegrams, appeared through counsel or otherwise. All other petitioners were dismissed on account of their failure to appear, and on account of the insufficiency of their petitions. The Unity Council for Medical Technology in Florida filed a Petition for Leave to Intervene which was granted at the hearing. The Florida Society of Pathologists appeared at the hearing, moved to intervene, and leave to intervene was granted.

Petitioner called the following witnesses: Donald G. Ward, the Administrative Director of Radiological Services at Tampa General Hospital; William Caudle, the Technical Director of Pathology at Tampa General Hospital;

W. Martin Miller, Jr., the Supervisor of in vitro testing at the Nuclear Medicine Department at Tampa General Hospital; Douglas James Anderson, the Petitioner's Chairman, and Chief of the Department of Nuclear Medicine at Doctor's Hospital in Lake Worth, Florida; Doctor James Huwitt, a physician employed with Radiology Associates in Tampa, Florida; and Huey Barnett, the Coordinator of the Nuclear Medicine Technology Training Program at Hillsborough Community College.

The Respondent called the following witnesses: Doctor Frank C. Coleman, the Director of the Patterson Coleman Laboratories in Tampa, Florida; Doctor Carl Blank, the Chief of the Examination and Documentation Branch of the Laboratory Testing Division of the Center for Disease Control; Doctor David K. Davis, a physician who practices pathology and nuclear medicine; Doctor Lowell

1. Foster, the Technical Director of the Patterson Coleman Laboratory in Tampa, Florida; Doctor Jerome Benson, a physician who practices pathology, the vice president of a national accrediting agency for the clinical laboratory sciences, and a member of a review committee for the American Medical Association Council on Medical Education; John Lanham, a Health Physicist employed by the Respondent in its State Radiological Health Program; and Doctor Nathan J. Schneider, the Director of the Respondent's Office of Laboratory Services.

   
   

   The Intervenors called no additional witnesses, but participated in cross examination of the witnesses called by the Petitioner and the Respondent.

   Hearing Officer's Exhibit 1, Petitioner's Exhibits 1 and 4, and Respondent's Exhibit 1 were offered into evidence at the hearing and were received.

   Petitioner's Exhibits 2 and 3 were offered into evidence but were rejected. The parties have submitted Post-Hearing Memoranda of Law.

   
   

   The Respondent contends that rules 10D-41.22(1), (2), (12); 10D-41.24(13); 10D-41.25(12); and 10D-41.30(3)(h) are an invalid exercise by the Respondent of delegated legislative authority. Petitioner contends that the matters sought to be regulated through these rules are not included within the definition of "clinical laboratory" set out in Florida Statutes, Section 483.041(3), and that the Respondent does not otherwise have delegated authority to regulate those matters. This contention will be discussed below under the following heading: "I. WHETHER THE RESPONDENT HAS THE AUTHORITY TO REGULATE THE SUBJECT MATTER OF

   THE RULES." Petitioner alternatively contends that Rules 10D-41.24(13)(n), 10- D41.25(12)(n), and 10D-41.30(3)(h) are not reasonably calculated to effectuate the purposes of Florida Statutes Chapter 483, and that said rules are unreasonable and unsafe. This contention will be considered under the discussion below headed "II. WHETHER THE RULES ARE REASONABLY CALCULATED TO EFFECT THE PURPOSES OF THE STATUTES."

   1. WHETHER THE RESPONDENT HAS THE AUTHORITY TO REGULATE THE SUBJECT MATTER OF THE RULES

      
      

      The Florida Clinical Laboratory Law, Florida Statutes Chapter 483, provides framework for the regulation of clinical laboratories in order to insure that clinical laboratories meet certain minimum standards and follow necessary safeguards. The Chapter provides for the licensure of clinical laboratories and certain of their employees. The Chapter applies to all clinical laboratories and clinical laboratory personnel within the State of Florida, with certain exceptions not relevant to this matter. Florida Statutes, Section 483.031. A clinical laboratory is defined in Section 483.041(3) as follows:

      
      

      "'Clinical laboratory' means a laboratory where microbiological, serological, chemical, hematological, immunohematological, biophysical, cytological, or histopathological examinations are performed on materials or specimens taken from the human body to provide information or materials for use in the diagnosis, prevention or treatment of a disease or assessment of a medical condition."

      
      

      The Respondent is required and authorized to adopt rules to effectuate the purposes of the Chapter. Florida Statutes Section 483.051.

      
      

      The Respondent's rules set out in Chapter 10D-41, Florida Administrative Code, provide, inter alia, for the registration of laboratories, and the licensure of personnel performing in vitro procedures (examinations conducted in a laboratory on materials taken from the human body) utilizing radioactive materials. These procedures would include tests known as radiobioassay, radioimmunoassay, competitive binding assay, and similar procedures. The Respondent rests its authority to regulate laboratories and personnel who conduct these tests on the language from Section 483.041(3) quoted above which defines a clinical laboratory as a laboratory where biophysical examinations are performed on materials or specimens taken from the human body.

      
      

      Petitioner contends that "biophysical examinations" do not include in vitro procedures in which materials or specimens collected from patients are subsequently treated with radioactive materials as part of the test procedure.

      The Respondent's rules (Rule 10D-41.22(2)) purport to include these testing procedures within the definition of biophysical examinations. The Respondent has defined a clinical laboratory as including radioisotope, radiological, and nuclear medicine facilities. Rule 10D-41.22(1). An "approved laboratory" is defined to include a radiological or nuclear medicine laboratory. Rule 10D- 41.22(12). Having thus defined clinical laboratories, the Respondent's rules set requirements for a supervisor in the specialty of biophysics (Rule 10D-41.24 (13)); set the requirements for a technologist in the specialty of biophysics (Rule 10D-4125(12)), and establish qualifications for laboratories performing the tests (Rule 10D-41.30(3)(h)).

      
      

      The Petitioner presented several witnesses who testified that the term "biophysical" is not used to describe in vitro procedures utilizing radioactive materials. As defined in the dictionary, as commonly used in the medical profession, and as used in rules and regulations which predated the Florida

      Clinical Laboratory Law, the term biophysical would, however, include these tests.

      
      

      "Biophysics" is defined in Webster's New World Dictionary, 2nd College Edition (World Publishing Company, 1974) as follows:

      
      

      "The study of biological phenomena using the principles and techniques of physics."

      
      

      In its commonly accepted medical sense, a biophysical test is a test in which a biological phenomenon is subjected to a physical measurement. The term biophysical has historically been used in regulatory provisions to include in vitro test procedures utilizing radioactive materials. The term was utilized in that manner in 1966 in administrative standards for coverage of medical laboratories adopted under the Federal Medicare Law. The Federal Clinical Laboratory Act, which was adopted in 1967, utilized the word, apparently following the Medicare standards precedent. The Florida Clinical Laboratory Act was also enacted in 1967, and it is logical to assume that the same definition of biophysical as was in the Medicare regulations and in the Federal Act was intended.

      
      

      Although the term "biophysical" may not be used generally by persons who perform in vitro tests utilizing radioactive materials to describe their tests, it is apparent that the term covers the tests under its dictionary definition, its commonly accepted medical definition, and under regulatory frameworks adopted prior to the Florida Clinical Laboratory Act. It is therefore concluded that the Florida Clinical Laboratory Law applies to clinical laboratories where in vitro tests utilizing radioactive materials are performed. Regulation of these laboratories is not beyond the delegation of authority provided in Section 483.051.

      
      

   2. WHETHER THE RULES ARE REASONABLY CALCULATED TO EFFECTUATE THE PURPOSES OF THE STATUTE

      
      

      A. Rules 10D-41.24(13)(n) and 10D-41.25(n)

      
      

      Rule 10D-41.24(13) sets out the requirements for a supervisor in the specialty of biophysics. Sub-paragraphs (a) through (n) set out alternative educational and experiential backgrounds that would qualify an individual to be a supervisor in the specialty of biophysics. Sub-paragraph (n) specifies the following requirements: graduation from high school and at least nine years of experience in nuclear medicine technology.

      
      

      Rule 10D-41.25(12) sets out the requirements for a technologist in the area of biophysics. Sub-paragraphs (a) through (n) set forth alternative qualifications. Sub-paragraph (n) provides the following requirements: graduation from high school and at least five years of experience in nuclear medicine technology.

      
      

      The Petitioner contends that the licensing of persons who meet only these requirements would present a distinct possibility of seriously endangering health, safety, and welfare of patients. The evidence presented at the hearing does not support this contention. It is apparent from the evidence presented that persons with five years or nine years of experience would be competent to perform in vitro test procedures utilizing radioactive materials.

      Petitioner presented no evidence from which it could be determined that persons with the nine years and five years of experience would not be competent to perform the functions of a supervisor and a technologist respectively in the specialty of biophysics.

      
      

      B. Rule 10D-41.30(3)(h).

      Rule 10D-41.30 provides in pertinent part as follows: "The laboratory shall be under the direction

      of a licensed director and shall have a sufficient number of other qualified personnel commensurate with the volume and types of tests performed.

      1. The laboratory performs only those laboratory procedures and tests that are within the specialties or sub-specialties in which the laboratory, supervisors, or other persons engaged to perform the tests are qualified.

      2. The laboratory may perform laboratory procedures and tests in all specialties provided that the director or supervisor is a pathologist certified or eligible for certification in both anatomical and clinical pathology of the American Board of Pathology or American Osteopathic Board of Pathology.

      3. In circumstances where subsection 10D- 41.30(2) is not met, the following criteria shall be used to establish qualification of laboratory to perform in each specialty.

* * *

(h) Biophysics - The Laboratory engages the service of a licensed practitioner of the healing arts except when a laboratory performs radioimmunoassay, competitive binding assay, or other procedures performed on materials or specimens collected from patients who have not been given or exposed to radioactive materials, but in which the materials or specimens are subsequently treated with radioactive materials as part of the test procedure only, it engages the services of a licensed director, supervisor or technologist qualified in the applicable specialty or sub-specialty, i.e., biophysics microbiology, serology, chemistry, hematology or immunohematology. Laboratories registered and personnel licensed in other applicable specialties of microbiology, serology, chemistry, hematology or immunohematology under other provisions of Chapter 483, F.S. may perform radioimmunoassay, competitive binding assay, or other procedures performed on specimens collected from patients who have been given radioactive materials in tracer (sic) doses, or in which the specimens are

subsequently treated with radioactive materials as part of the test procedure, without being required to obtain additional registration or licensure in the specialty of biophysics."

Under the newly adopted provisions of Chapter 10D-41, supervisors and technologists in the specialty of biophysics will be subject to testing and licensure as has previously been required under the rules of supervisors and technologists in other specialties. Under the provisions of newly adopted Rule 10D-41.30(3)(h), medical technologists who are licensed in the specialties of microbiology, serology, chemistry, hematology, or immunohematology will be able to perform biophysical testing procedures without the need for further licensure.

Petitioner contends that requiring the testing and licensure of nuclear medicine technologists while not requiring licensure of medical technologists in the specific specialty of biophysics is unreasonable on its face. Petitioner contends that medical technologists in the other specialties are not qualified by their education to perform these tests, and that permitting them to perform the tests subjects them to dangers from contact with radioactive materials, and subjects patients to dangers caused by inaccurate test results.

Medical technologists have been subject to testing and licensure in Florida since the adoption in 1967 of the Florida Clinical Laboratory Law. Educational programs for medical technologists are generally four-year programs leading to a Baccalaureate Degree. Medical technologists are required to establish their qualification to perform tests in each of the specialties set out in Rule 10D- 41.30(3) before they are permitted to perform tests in the specialty. A field of specialists known as nuclear medicine technologists has developed more recently. A standardized educational program generally of two years duration has been developed. Nuclear medicine technologists are not trained in any of the other specialties of medical laboratory work. Prior to the adoption of the instant rules nuclear medicine technologists were not licensed by the Respondent.

Medical technologists have been performing in vitro procedures utilizing radioactive materials since the tests came into general usage. Medical technologists by reason of their educational training are fully qualified and competent to perform the tests. The tests are sophisticated and do involve special problems due to the hazards of exposure to radioactive materials, but the hazards are similar to hazards involved in handling infectious disease specimens. Medical technologists who are qualified in the specialties of microbiology, serology, chemistry, hematology, or immunohematology are trained to conduct the tests, and to deal with the hazards involved in conducting the tests. The tests individually involve the use of extremely small quantities of radioactive substances. The quantities utilized in the tests are exempt from the regulatory provisions of Florida Statutes Section 290. If a laboratory stockpiles radioactive materials for the purpose of conducting many in vitro tests utilizing radioactive materials at a cheaper price, then the State would regulate the laboratory's safety procedures through the provision of Florida Statutes Section 290.

Nuclear medicine technologists are also capable and competent to perform in vitro tests utilizing radioactive materials. Nuclear medicine technologists are not, however, more qualified to perform the tests than are medical technologists. Nuclear medicine technologists are not licensed by the State

other than through the rules that are the subject of this matter. It is appropriate that Nuclear Medicine Technologists be licensed just as medical technologists are licensed. The fact that the new rules do not require separate testing and licensure for medical technologists in the specialty of biophysics is not unreasonable, and does not constitute an invalid exercise by the Respondent of the authority delegated by the Legislature through Florida Statutes Section 483-051

Based upon the foregoing Memorandum Opinion, it is, hereby, ORDERED:

1. The foregoing Memorandum Opinion shall constitute Findings of Fact, and Conclusions of Law.

2. Rules 10D-41.22(1)(2)(12); 10D-41.23(13); 10D-41.25(12); and 10D-

41.30(3)(h) of the Florida Department of Health and Rehabilitative Services constitute valid exercises by the Department of rule making authority delegated by the Legislature in accordance with Florida Statutes Section 483.051.

3. The petition filed by the Florida Society of Nuclear Medicine Technologists, Inc. is hereby dismissed.

DONE AND ORDERED this 29th day of March, 1977, in Tallahassee, Florida.

G. STEVEN PFEIFFER Hearing Officer

Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304

(904) 488-9675

COPIES FURNISHED:

James R. Lavigne, Esquire Suite 332, Lee World Center 1850 Lee Road

Winter Park, Florida 32789

Barbara Dell McPherson, Esquire

P. O. Box 2417F Jacksonville, Florida 32231

John Michael Huey, Esquire Suite 110

1020 E. Lafayette Street Tallahassee, Florida 32301

Ms. Julie Pogue

701 6th Street South

St. Petersburg, Florida 33701

Ms. Liz Cloud Department of State

403 E. Gaines Street Tallahassee, Florida 32302

Mr. Carroll Webb Executive Director

Administrative Procedure Committee Room 120, Holland Building Tallahassee, Florida 32304

Docket for Case No: 76-001963RX

Orders for Case No: 76-001963RX