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2019 Florida Statutes

Title XXXII REGULATION OF PROFESSIONS AND OCCUPATIONS
Chapter 483
HEALTH TESTING SERVICES
CHAPTER 483
CHAPTER 483
HEALTH TESTING SERVICES
PART I
MULTIPHASIC HEALTH TESTING CENTERS
(ss. 483.28-483.325)
PART II
CLINICAL LABORATORY PERSONNEL
(ss. 483.800-483.828)
PART III
MEDICAL PHYSICISTS
(s. 483.901)
PART I
MULTIPHASIC HEALTH TESTING
CENTERS
483.28 Short title.
483.282 Declaration of policy and statement of purpose.
483.285 Application of part; exemptions.
483.288 Definitions.
483.291 Powers and duties of the agency; rules.
483.294 Inspection of centers.
483.30 Licensing of centers.
483.302 Application for license.
483.305 Requirements for advertisement.
483.308 Medical director of center.
483.312 Notice of fees charged.
483.314 Collection and transmittal of specimens.
483.317 Grounds for disciplinary action against centers.
483.32 Administrative fines.
483.322 Offenses.
483.325 Criminal penalties.
483.28 Short title.—This part may be cited as “The Florida Multiphasic Health Testing Center Law.”
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 1, 19, ch. 93-40; s. 25, ch. 93-178.
483.282 Declaration of policy and statement of purpose.—The purpose of this part is to protect the health, safety, and welfare of the people of this state from the hazards of improper performance by multiphasic health testing centers. Multiphasic health testing centers provide to people certain health testing services that are either performed at the center or involve the sending of specimens to a clinical laboratory. Unreliable or inaccurate reports and findings may cause unnecessary anxiety, suffering, and financial expense for individuals or may create a false and injudicious sense of security with respect to the state of an individual’s health, and may even contribute directly to an individual’s death. Therefore, the Legislature finds and declares that the protection of the public health requires the licensing of such centers, the establishment of certain minimum standards, and other necessary safeguards as authorized by this part.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 2, 19, ch. 93-40; s. 25, ch. 93-178.
483.285 Application of part; exemptions.—This part applies to all multiphasic health testing centers within the state, but does not apply to:
(1) An entity operated by the United States Government or by the state or any political subdivision of the state.
(2) An entity that limits screening to tests intended to identify specific physical disorders or conditions and that provides health services to the public free of charge or for a donation to be used for charitable purposes.
(3) A hospital licensed under chapter 395.
(4) An ambulatory surgical center licensed under chapter 395.
(5) A home health agency licensed under part III of chapter 400.
(6) A health maintenance organization certified under part I of chapter 641.
(7) An office of a duly licensed practitioner of the healing arts for the diagnosis and treatment of her or his patients.
(8) Screening conducted by a county medical society.
History.—s. 1, ch. 77-48; s. 207, ch. 79-400; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 3, 19, ch. 93-40; s. 25, ch. 93-178; s. 41, ch. 95-144; s. 439, ch. 97-103; s. 116, ch. 2007-5; s. 86, ch. 2019-3.
483.288 Definitions.—As used in this part:
(1) “Agency” means the Agency for Health Care Administration.
(2) “Multiphasic health testing center” or “center” means any fixed or mobile facility where specimens are taken from the human body for delivery to registered clinical laboratories for analysis and where certain measurements such as height and weight determinations, blood pressure determinations, limited audio and visual tests, and electrocardiograms are made.
(3) “Center personnel” includes persons employed by a center, except persons employed to perform clerical or other administrative responsibilities.
(4) “Consumer multiphasic health testing center” is a multiphasic health testing center that is open to the general public.
(5) “Contract multiphasic health testing center” is a multiphasic health testing center that tests employees under the authorization of the medical director of a contracting employer or the medical director of the contract multiphasic health testing center.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 24, 29, 30, ch. 83-276; ss. 4, 19, ch. 93-40; s. 25, ch. 93-178.
483.291 Powers and duties of the agency; rules.—The agency shall adopt rules to implement this part and part II of chapter 408, which rules must include the following:
(1) LICENSING STANDARDS.—The agency shall prescribe standards necessary for licensure.
(2) FEES.—In accordance with s. 408.805, an applicant or a licensee shall pay a fee for each license application submitted under this part, part II of chapter 408, and applicable rules. The licensure fee must be not less than $600 or more than $2,000.
(3) STANDARDS OF PERFORMANCE.—The agency shall prescribe standards for the performance of health testing procedures.
(4) CONSTRUCTION OF CENTERS.—The agency may adopt rules to ensure that centers comply with all local, county, state, and federal standards for the construction, renovation, maintenance, or repair of centers, which standards must ensure the conduct and operation of the centers in a manner that will protect the public health.
(5) SAFETY AND SANITARY CONDITIONS WITHIN THE CENTER AND ITS SURROUNDINGS.—The agency shall establish standards relating to safety and sanitary conditions within the center and its surroundings, including water supply; sewage; the handling of specimens; identification, segregation, and separation of biohazardous waste as required by s. 381.0098; storage of chemicals; workspace; firesafety; and general measures, which standards must ensure the protection of the public health. The agency shall determine compliance by a multiphasic health testing center with the requirements of s. 381.0098 by verifying that the center has obtained all required permits.
(6) EQUIPMENT.—The agency shall establish minimum standards for center equipment essential to the proper conduct and operation of the center.
(7) PERSONNEL.—The agency shall prescribe minimum qualifications for center personnel. A center may employ as a medical assistant a person who has at least one of the following qualifications:
(a) Prior experience of not less than 6 months as a medical assistant in the office of a licensed medical doctor or osteopathic physician or in a hospital, an ambulatory surgical center, a home health agency, or a health maintenance organization.
(b) Certification and registration from a certification program accredited by the National Commission for Certifying Agencies and approved by the agency.
(c) Prior employment as a medical assistant in a licensed center for at least 6 consecutive months at some time during the preceding 2 years.
History.—s. 1, ch. 77-48; s. 208, ch. 79-400; s. 2, ch. 81-318; ss. 25, 29, 30, ch. 83-276; ss. 5, 19, ch. 93-40; s. 25, ch. 93-178; s. 55, ch. 97-264; s. 192, ch. 2007-230; s. 5, ch. 2017-50.
483.294 Inspection of centers.—In accordance with s. 408.811, the agency shall inspect the premises and operations of all centers subject to licensure under this part.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 6, 19, ch. 93-40; s. 25, ch. 93-178; s. 193, ch. 2007-230; s. 98, ch. 2018-24.
483.30 Licensing of centers.—The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to this part and part II of chapter 408 and to entities licensed by or applying for such licensure from the agency pursuant to this part. A license issued by the agency is required in order to operate a center. A license is not valid for any premises other than the center for which it is issued. However, a new license may be secured for the new location for a fixed center before the actual change, if the contemplated change is in compliance with this part and the rules adopted under this part.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 7, 19, ch. 93-40; s. 25, ch. 93-178; ss. 66, 71, ch. 98-171; s. 108, ch. 2000-349; s. 25, ch. 2001-53; s. 2, ch. 2001-67; s. 148, ch. 2001-277; s. 60, ch. 2004-267; s. 194, ch. 2007-230.
483.302 Application for license.—The application for a license must contain:
(1) A determination as to whether the facility will be fixed or mobile and the location for a fixed facility.
(2) The name of any person who owns at least a 10 percent interest in any professional service, firm, association, partnership, or corporation providing goods, leases, or services to the center for which the application is made, and the name and address of the professional service, firm, association, partnership, or corporation in which such interest is held.
(3) The name, address, and Florida physician’s license number of the medical director.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 8, 19, ch. 93-40; s. 25, ch. 93-178; s. 195, ch. 2007-230.
483.305 Requirements for advertisement.—
(1) Each center shall prominently display on its report of the tests, on all advertising and promotional materials, and in a place that is in clear and unobstructed public view within the center, a notice in block letters which reads: “Health screening tests may or may not alert you and your doctor to serious medical problems and are not intended to be a substitute for a physician’s examination.” The notice displayed within the center must be made up of block letters not less than 1 inch in height.
(2) A center may not use advertisements or promotional materials that tend to deceive prospective purchasers concerning the personnel, equipment, care, and services, or the quality thereof, provided by the center.
(3) Any violation of this section is subject to the Florida Deceptive and Unfair Trade Practices Act.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 9, 19, ch. 93-40; s. 25, ch. 93-178.
483.308 Medical director of center.—
(1) Each center licensed under this part shall employ a medical director who is either a physician licensed under chapter 458 or an osteopathic physician licensed under chapter 459 and who, as part of her or his usual medical practice, interprets electrocardiograms. In a contract multiphasic health testing center, electrocardiograms and X rays must be read and interpreted by the medical director of the contract center or respectively by a board-certified cardiologist or radiologist authorized by the medical director to read and interpret the electrocardiograms and X rays and report results to the medical director. Such secondary authorization by the medical director of the contract multiphasic health testing center does not operate to cede liability or responsibility for the test results to the board-certified cardiologist or radiologist. The medical director need not be present at the center while it is in operation. However, the medical director is responsible for assuring the proper clinical operation of the center.
(2) The medical director shall order all requests by the center for analyses to be conducted by clinical laboratories with respect to specimens collected at the center. The results of such analyses, together with the results of any measurements or other testing procedures performed at the center, including electrocardiographic interpretations, shall be released to the medical director. The medical director of a consumer multiphasic health testing center shall read, interpret, and sign the results before they are released by the center to the patient. The medical director of a contract multiphasic health testing center shall read, interpret, and sign the results before they are released to the patient or may authorize the medical director of the contracting employer to read, interpret, and sign the results before they are released to the patient. Such secondary authorization by the medical director of the contract multiphasic health testing center does not operate to cede liability or responsibility for the test results to the medical director of the contracting employer. As a part of the required interpretation of any results from analyses conducted by a clinical laboratory, the medical director is responsible for determining whether the results indicate further medical advice or intervention is necessary. If the medical director so determines, then a statement to that effect must be included with the results together with a statement that the patient should seek medical advice from her or his physician or the county medical society with specific reference to the society’s name, address, and telephone number. Notification under this subsection must be made by regular mail.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 10, 19, ch. 93-40; s. 25, ch. 93-178; s. 21, ch. 97-98; s. 440, ch. 97-103.
483.312 Notice of fees charged.—A consumer multiphasic health testing center must display at all times in a prominent place at the center a list of all tests and the specific fees charged for those tests. The center must provide to each patient before the collection of a specimen or the administration of a test the specific fees charged for the test.
History.—s. 12, ch. 93-40.
483.314 Collection and transmittal of specimens.—
(1) A center shall forward the specimens collected by it to a clinical laboratory for such analyses as are authorized by the medical director of the center. Multiphasic health testing centers are authorized to conduct dipstick urinalysis and fecal occult blood tests only if such tests are conducted by licensed registered nurses, practical nurses, medical technicians, medical assistants, or clinical laboratory technicians trained to perform and interpret these tests.
(2) Consumer multiphasic health testing centers shall report the results of an analysis directly to the medical director of the center that requested it and shall forward the results to the person from whom the specimen was collected within 5 days after the date the specimen was collected. When test results deviate significantly from established ranges, indicating the presence of a potential pathological condition, the contract multiphasic health testing center must forward the results to the person from whom the specimen was collected and the person’s designated physician within 5 days after the date the specimen was collected. Complete results of contract multiphasic health testing must be forwarded to the medical director of the contracting employer within 30 days after the date the specimen was collected.
(3) A multiphasic health testing center may not collect specimens from the human body where prudent medical practice requires that such specimens only be collected during the course of a physical examination by a physician. The agency, which may consult with the Board of Medicine and the Board of Osteopathic Medicine, shall develop rules to implement this subsection.
(4) A center may not perform or hold itself out to the public as providing for testing for the human immunodeficiency virus (HIV) unless it complies with s. 381.004.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 13, 19, ch. 93-40; s. 25, ch. 93-178.
483.317 Grounds for disciplinary action against centers.—The following acts constitute grounds for which a disciplinary action specified in s. 483.32 may be taken against a center:
(1) Permitting unauthorized persons to perform health testing procedures or to issue reports.
(2) Demonstrating incompetence in the performance of health testing procedures or issuing erroneous reports.
(3) Rendering a report on the results of any measurement or test to a person not authorized by law to receive such information.
(4) Knowingly having professional connection with, or knowingly lending the use of the name of the licensed center or its medical director to, an unlicensed multiphasic health testing center.
(5) Violating or aiding and abetting in the violation of any provision of this part or the rules adopted hereunder.
(6) Failing to file any report required by the provisions of this part or the rules adopted hereunder.
(7) Engaging in false, misleading, or deceptive advertising.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 26, 29, 30, ch. 83-276; ss. 14, 19, ch. 93-40; s. 25, ch. 93-178; s. 197, ch. 2007-230.
483.32 Administrative fines.—
(1) The agency may impose an administrative fine, not to exceed $500 per violation, for the violation of any provision of this part, part II of chapter 408, or applicable rules.
(2) In determining the amount of the fine to be levied for a violation, as provided in subsection (1), the following factors shall be considered:
(a) The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted; the severity of the actual or potential harm; and the extent to which the provisions of this part were violated.
(b) Actions taken by the licensee to correct the violation or to remedy complaints.
(c) Any previous violation by the licensee.
(d) The financial benefit to the licensee of committing or continuing the violation.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 27, 29, 30, ch. 83-276; ss. 15, 19, ch. 93-40; s. 25, ch. 93-178; s. 198, ch. 2007-230.
483.322 Offenses.—It is unlawful for any person to:
(1) Conduct, maintain, or operate a center unless the center is under the direct and responsible supervision and direction of a medical director who meets the qualifications specified in s. 483.308(1).
(2) Violate, or aid and abet in the violation of, any provision of this part or the rules adopted under this part.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; ss. 16, 19, ch. 93-40; s. 25, ch. 93-178; s. 199, ch. 2007-230.
483.325 Criminal penalties.—
(1) The performance of any of the acts specified in s. 483.322 is a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(2) Any use or attempted use of a forged license under this part is a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
History.—s. 1, ch. 77-48; s. 2, ch. 81-318; ss. 29, 30, ch. 83-276; s. 114, ch. 91-224; ss. 17, 19, ch. 93-40; s. 25, ch. 93-178.
PART II
CLINICAL LABORATORY PERSONNEL
483.800 Declaration of policy and statement of purpose.
483.801 Exemptions.
483.803 Definitions.
483.805 Board of Clinical Laboratory Personnel.
483.807 Fees; establishment; disposition.
483.809 Licensure; examinations; registration of trainees; approval of curricula.
483.811 Approval of laboratory personnel training programs.
483.812 Public health laboratory scientists; licensure.
483.813 Clinical laboratory personnel license.
483.815 Application for clinical laboratory personnel license.
483.817 Renewal of clinical laboratory personnel license.
483.819 Inactive status.
483.821 Periodic demonstration of competency; continuing education or reexamination.
483.823 Qualifications of clinical laboratory personnel.
483.824 Qualifications of clinical laboratory director.
483.825 Grounds for disciplinary action.
483.828 Penalties for violations.
483.800 Declaration of policy and statement of purpose.—The purpose of this part is to protect the public health, safety, and welfare of the people of this state from the hazards of improper performance by clinical laboratory personnel. Clinical laboratories provide essential services to practitioners of the healing arts by furnishing vital information that is essential to a determination of the nature, cause, and extent of the condition involved. Unreliable and inaccurate reports may cause unnecessary anxiety, suffering, and financial burdens and may even contribute directly to death. The protection of public and individual health requires the licensure of clinical laboratory personnel who meet minimum requirements for safe practice. The Legislature finds that laboratory testing technology continues to advance rapidly. The Legislature also finds that a hospital training program under the direction of the hospital clinical laboratory director offers an opportunity for individuals already trained in health care professions to expand the scope of their careers. The Legislature further finds that there is an immediate need for properly trained personnel to ensure patient access to testing. Therefore, the Legislature recognizes the patient-focused benefits of hospital-based training for laboratory and nonlaboratory personnel for testing within hospitals and commercial laboratories and recognizes the benefits of a training program approved by the Board of Clinical Laboratory Personnel under the direction of the hospital clinical laboratory director.
History.—s. 32, ch. 92-58; s. 20, ch. 93-178; s. 162, ch. 97-264.
483.801 Exemptions.—This part applies to all clinical laboratories and clinical laboratory personnel within this state, except:
(1) Clinical laboratories operated by the United States Government.
(2) Laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health service whatsoever.
(3) Persons engaged in testing performed by laboratories that are wholly owned and operated by one or more practitioners licensed under chapter 458, chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, or chapter 466 who practice in the same group practice, and in which no clinical laboratory work is performed for patients referred by any health care provider who is not a member of that group practice.
(4) Respiratory therapists and respiratory care practitioners certified or registered under part V of chapter 468.
(5) Advanced practice registered nurses licensed under part I of chapter 464 who perform provider-performed microscopy procedures (PPMP) in a laboratory setting pursuant to subsection (3).
(6) Persons performing laboratory testing within a physician office practice for patients referred by a health care provider who is a member of the same physician office practice, if the laboratory or entity operating the laboratory within a physician office practice is under common ownership, directly or indirectly, with an entity licensed pursuant to chapter 395.
History.—s. 32, ch. 92-58; s. 21, ch. 93-178; s. 6, ch. 97-91; s. 163, ch. 97-264; s. 136, ch. 2000-318; s. 99, ch. 2018-24; s. 66, ch. 2018-106.
483.803 Definitions.—As used in this part, the term:
(1) “Board” means the Board of Clinical Laboratory Personnel.
(2) “Clinical laboratory” means the physical location in which one or more of the following services are performed to provide information or materials for use in the diagnosis, prevention, or treatment of a disease or the identification or assessment of a medical or physical condition:
(a) Clinical laboratory services, which entail the examination of fluids or other materials taken from the human body.
(b) Anatomic laboratory services, which entail the examination of tissue taken from the human body.
(c) Cytology laboratory services, which entail the examination of cells from individual tissues or fluid taken from the human body.
(3) “Clinical laboratory examination” means a procedure performed to deliver the services identified in subsection (2), including the oversight or interpretation of such services.
(4) “Clinical laboratory personnel” includes a clinical laboratory director, supervisor, technologist, blood gas analyst, or technician who performs or is responsible for laboratory test procedures, but the term does not include trainees, persons who perform screening for blood banks or plasmapheresis centers, phlebotomists, or persons employed by a clinical laboratory to perform manual pretesting duties or clerical, personnel, or other administrative responsibilities.
(5) “Clinical laboratory trainee” means any person having qualifying education who is enrolled in a clinical laboratory training program approved pursuant to s. 483.811 and who is seeking experience required to meet minimum qualifications for licensing in this state. Trainees may perform procedures under direct and responsible supervision of duly licensed clinical laboratory personnel, but they may not report test results.
(6) “Department” means the Department of Health.
(7) “Licensed practitioner of the healing arts” means a physician licensed under chapter 458, chapter 459, chapter 460, or chapter 461; a dentist licensed under chapter 466; or a person licensed under chapter 462.
(8) “Public health laboratory scientist” means any licensed director, supervisor, technologist, or technician engaged in laboratory testing of human specimens in a state, county, or municipal public health laboratory.
History.—s. 32, ch. 92-58; s. 175, ch. 94-218; s. 7, ch. 97-91; s. 164, ch. 97-264; s. 145, ch. 99-397; s. 100, ch. 2018-24.
483.805 Board of Clinical Laboratory Personnel.—
(1) There is created within the department the Board of Clinical Laboratory Personnel, composed of seven members appointed by the Governor and confirmed by the Senate.
(2)(a) Five members of the board shall be persons licensed under this part, as follows:
1. At least one member shall be a practicing clinical laboratory director.
2. At least two members shall be practicing clinical laboratory supervisors.
3. Two members shall be practicing clinical laboratory personnel.
(b) Two members of the board shall be citizens of the state who have never been licensed health care practitioners and who are not, and have never been, licensed as clinical laboratory personnel and who are in no way connected with the practice of such profession.
(3) Within 90 days after July 1, 1992, the Governor shall appoint two members for a term of 2 years, two members for a term of 3 years, and three members for a term of 4 years. As terms of the initial members expire, the Governor shall appoint successors for terms of 4 years and such terms shall expire on October 31. A member whose term has expired shall continue to serve on the board until such time as a replacement is appointed. No member shall serve for more than the remaining portion of a previous member’s unexpired term, plus two consecutive 4-year terms of the member’s own appointment thereafter.
(4) The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part conferring duties upon it.
(5) All provisions of chapter 456 relating to activities of regulatory boards shall apply to the board.
(6) The board shall maintain its official headquarters in Tallahassee.
History.—s. 32, ch. 92-58; s. 176, ch. 94-218; s. 135, ch. 98-166; s. 155, ch. 98-200; s. 195, ch. 2000-160.
483.807 Fees; establishment; disposition.—
(1) The board, by rule, shall establish fees to be paid for application, examination, reexamination, licensing and renewal, registration, laboratory training program application, reinstatement, and recordmaking and recordkeeping. The board may also establish, by rule, a delinquency fee. The board shall establish fees that are adequate to ensure the continued operation of the board and to fund the proportionate expenses incurred by the department in carrying out its licensure and other related responsibilities under this part. Fees shall be based on departmental estimates of the revenue required to implement this part and the provisions of law with respect to the regulation of clinical laboratory personnel.
(2) The nonrefundable application fee may not exceed $200.
(3) The examination fee shall be in an amount which covers the costs of obtaining and administering the examination and shall be refunded if the applicant is found ineligible to sit for the examination. The combined fees for initial application and examination may not exceed $200 plus the actual per applicant cost to the department for developing, administering, or procuring the licensure examination.
(4) The initial license fee may not exceed $100.
(5) The fee for licensure by endorsement may not exceed $100.
(6) The biennial renewal fee may not exceed $150.
(7) The fee for application for an inactive status license or for reactivation of an inactive status license may not exceed $50.
(8) The initial application fee for registration of a trainee shall not exceed $20.
(9) The initial application and renewal fee for approval as a laboratory training program may not exceed $300. The fee for late filing of a renewal application shall be $50.
(10) All fees shall be established, collected, and deposited in accordance with s. 456.025.
History.—s. 32, ch. 92-58; s. 243, ch. 94-119; s. 136, ch. 98-166; s. 146, ch. 99-397; s. 196, ch. 2000-160; s. 9, ch. 2001-277.
483.809 Licensure; examinations; registration of trainees; approval of curricula.—
(1) LICENSING.—The department shall provide biennial licensure of all clinical laboratory personnel who the board certifies have met the requirements of this part. The license of any person who fails to pay a required fee or otherwise fails to qualify within 60 days after the date of expiration of such license shall be automatically canceled without notice or further proceedings unless the individual has made application for inactive status pursuant to s. 483.819.
(2) EXAMINATIONS.—The department shall conduct examinations required by board rules to determine in part the qualification of clinical laboratory personnel for licensure. The board by rule may designate a national certification examination that may be accepted in lieu of state examination for clinical laboratory personnel or public health scientists.
(3) REGISTRATION OF TRAINEES.—The department shall provide for registration of clinical laboratory trainees who are enrolled in a training program approved pursuant to s. 483.811, which registration may not be renewed except upon special authorization of the board.
(4) APPROVAL OF CURRICULUM IN SCHOOLS AND COLLEGES.—The board may approve the curriculum in schools and colleges offering education and training leading toward qualification for licensure under this part.
History.—s. 32, ch. 92-58; s. 165, ch. 97-264; s. 147, ch. 99-397.
483.811 Approval of laboratory personnel training programs.—
(1) The board shall approve clinical laboratories for training programs upon presentation of satisfactory evidence that such laboratories are adequately staffed by qualified personnel and comply with rules adopted by the board to ensure that such laboratories provide training in clinical laboratory techniques adequate to prepare individuals to meet the requirements for licensure under this part.
(2) The board shall adopt rules for training programs, including, but not limited to, rules relating to curriculum, educational objectives, evaluation procedures, personnel licensure requirements, preentry educational requirements, and length of clinical training.
(3) A clinical laboratory operated by one or more practitioners who hold the facilities of the laboratory out as available for the performance of diagnostic tests for other practitioners or their patients is subject to the provisions of this part.
(4) The board shall approve training programs for laboratory technicians in a hospital or clinical laboratory which programs are under the supervision of a clinical laboratory director. The training must be accepted in lieu of educational requirements for licensure, but a trainee must have a high school diploma or its equivalent. Any person who completes a training program must pass, before licensure, an examination given by the department.
(5) The department may inspect laboratory personnel training programs.
(6) If the board finds that an approved program no longer meets the required standards, the department may rescind the approval.
History.—s. 32, ch. 92-58; s. 22, ch. 93-178; s. 8, ch. 97-91; s. 5, ch. 2000-154.
483.812 Public health laboratory scientists; licensure.—
(1) Applicants at the director level in the category of public health shall qualify under s. 483.824.
(2) Applicants at the supervisor level in the category of public health who are certified by the National Registry in Clinical Chemistry or the American Society for Microbiology, licensed as a technologist, and have 5 years of pertinent clinical laboratory experience may qualify by passing the state-administered supervision and administration examination.
(3)(a) A technologist applicant for licensure in the category of public health microbiology, with a baccalaureate degree in one of the biological sciences from an accredited institution, may use the American Society for Microbiology or the National Registry in Microbiology Certification in Public Health Microbiology to qualify for a technologist license in public health microbiology. Such a technologist may work in a public health microbiology laboratory.
(b) A technologist applicant for licensure in the category of public health chemistry, with a baccalaureate degree in one of the chemical, biological, or physical sciences from an accredited institution, may use the National Registry of Clinical Chemistry Certification to qualify for a technologist license in public health chemistry. Such a technologist may work in a public health chemistry laboratory.
(c) A technician applicant for licensure in the category of public health, with a baccalaureate degree in one of the chemical or biological sciences from an accredited institution, may obtain a 2-year conditional public health technician license, which may be renewed once. Such a technician may perform testing only under the direct supervision of a licensed pathologist, director, supervisor, or technologist.
(4) A person licensed by the Board of Clinical Laboratory Personnel may work in a public health laboratory at the appropriate level and specialty.
History.—s. 166, ch. 97-264; s. 148, ch. 99-397.
483.813 Clinical laboratory personnel license.—A person may not conduct a clinical laboratory examination or report the results of such examination unless such person is licensed under this part to perform such procedures. However, this provision does not apply to any practitioner of the healing arts authorized to practice in this state. The department may grant a temporary license to any candidate it deems properly qualified, for a period not to exceed 1 year.
History.—s. 32, ch. 92-58; s. 9, ch. 97-91; s. 167, ch. 97-264; s. 149, ch. 99-397; s. 101, ch. 2018-24.
483.815 Application for clinical laboratory personnel license.—An application for a clinical laboratory personnel license shall be made under oath on forms provided by the department and shall be accompanied by payment of fees as provided by this part. A license may be issued authorizing the performance of procedures of one or more categories.
History.—s. 32, ch. 92-58.
483.817 Renewal of clinical laboratory personnel license.—
(1) The department shall renew a license upon receipt of a renewal application and fee and upon certification by the board that the licensee has demonstrated her or his competence.
(2) The board shall adopt rules establishing a procedure for the biennial renewal of clinical laboratory personnel licenses.
History.—s. 32, ch. 92-58; s. 244, ch. 94-119; s. 441, ch. 97-103.
483.819 Inactive status.—
(1) A licensee may request that her or his license be placed in an inactive status by making application to the department and paying a fee in an amount set by the board.
(2) A license that has been inactive for more than 1 year may be reactivated upon application to the department. The board shall prescribe, by rule, continuing education requirements as a condition of reactivating a license. The continuing education requirements for reactivating a license may not exceed 15 classroom hours for each year the license was inactive and in no event may exceed 65 classroom hours for all years in which the license was inactive.
History.—s. 32, ch. 92-58; s. 245, ch. 94-119; s. 442, ch. 97-103.
483.821 Periodic demonstration of competency; continuing education or reexamination.—
(1) As part of the license renewal procedure, the board, by rule, shall require each licensee periodically to demonstrate her or his competency by completing, each 2 years, not less than 10 or more than 30 hours of continuing education in programs approved by the board.
(2) The board may allow a licensee to demonstrate her or his competency by reexamination in lieu of satisfying the continuing education requirement.
(3) The board may, by rule, provide for continuing education or retraining requirements for candidates failing an examination two or more times.
History.—s. 32, ch. 92-58; s. 443, ch. 97-103; s. 150, ch. 99-397.
483.823 Qualifications of clinical laboratory personnel.—
(1) The board shall prescribe minimal qualifications for clinical laboratory personnel and shall issue a license to any person who meets the minimum qualifications and who demonstrates that she or he possesses the character, training, and ability to qualify in those areas for which the license is sought.
(2) Personnel qualifications may require appropriate education, training, or experience or the passing of an examination in appropriate subjects or any combination of these, but a practitioner of the healing arts licensed to practice in this state is not required to obtain any license or to pay any fee under this part.
History.—s. 32, ch. 92-58; s. 444, ch. 97-103; s. 168, ch. 97-264; s. 102, ch. 2018-24.
483.824 Qualifications of clinical laboratory director.—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 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.
History.—s. 10, ch. 97-91; s. 151, ch. 99-397; s. 65, ch. 2000-318.
483.825 Grounds for disciplinary action.—
(1) The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
(a) Attempting to obtain, obtaining, or renewing a license or registration under this part by bribery, by fraudulent misrepresentation, or through an error of the department or the board.
(b) Engaging in or attempting to engage in, or representing herself or himself as entitled to perform, any clinical laboratory procedure or category of procedures not authorized pursuant to her or his license.
(c) Demonstrating incompetence or making consistent errors in the performance of clinical laboratory examinations or procedures or erroneous reporting.
(d) Performing a test and rendering a report thereon to a person not authorized by law to receive such services.
(e) Has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the activities of clinical laboratory personnel or involves moral turpitude or fraudulent or dishonest dealing. The record of a conviction certified or authenticated in such form as to be admissible in evidence under the laws of the state shall be admissible as prima facie evidence of such guilt.
(f) Having been adjudged mentally or physically incompetent.
(g) Aiding and abetting in the violation of any provision of this part or the rules adopted hereunder.
(h) Reporting a test result when no laboratory test was performed on a clinical specimen.
(i) Knowingly advertising false services or credentials.
(j) Having a license revoked, suspended, or otherwise acted against, including the denial of licensure, by the licensing authority of another jurisdiction. The licensing authority’s acceptance of a relinquishment of a license, stipulation, consent order, or other settlement, offered in response to or in anticipation of the filing of administrative charges against the licensee, shall be construed as action against the licensee.
(k) Failing to report to the board, in writing, within 30 days that an action under paragraph (e), paragraph (f), or paragraph (j) has been taken against the licensee or one’s license to practice as clinical laboratory personnel in another state, territory, country, or other jurisdiction.
(l) Being unable to perform or report clinical laboratory examinations with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material or as a result of any mental or physical condition. In enforcing this paragraph, the department shall have, upon a finding of the State Surgeon General or his or her designee that probable cause exists to believe that the licensee is unable to practice because of the reasons stated in this paragraph, the authority to issue an order to compel a licensee to submit to a mental or physical examination by physicians designated by the department. If the licensee refuses to comply with such order, the department’s order directing such examination may be enforced by filing a petition for enforcement in the circuit court where the licensee resides or does business. The department shall be entitled to the summary procedure provided in s. 51.011. A licensee affected under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that he or she can resume competent practice with reasonable skill and safety to patients.
(m) Delegating professional responsibilities to a person when the licensee delegating such responsibilities knows, or has reason to know, that such person is not qualified by training, experience, or licensure to perform them.
(n) Violating a previous order of the board entered in a disciplinary proceeding.
(o) Failing to report to the department a person or other licensee who the licensee knows is in violation of this chapter or the rules of the department or board adopted hereunder. However, a person or other licensee who the licensee knows is unable to perform or report on clinical laboratory examinations with reasonable skill and safety to patients by reason of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material, or as a result of a mental or physical condition, may be reported to a consultant operating an impaired practitioner program as described in s. 456.076 rather than to the department.
(p) Making or filing a report which the licensee knows to be false, intentionally or negligently failing to file a report or record required by state or federal law, willfully impeding or obstructing such filing or inducing another person to do so, including, but not limited to, impeding an agent of the state from obtaining a report or record for investigative purposes. Such reports or records shall include only those generated in the capacity as a licensed clinical laboratory personnel.
(q) Paying or receiving any commission, bonus, kickback, or rebate, or engaging in any split-fee arrangement in any form whatsoever with a physician, organization, agency, or person, either directly or indirectly for patients referred to providers of health care goods and services including, but not limited to, hospitals, nursing homes, clinical laboratories, ambulatory surgical centers, or pharmacies. The provisions of this paragraph shall not be construed to prevent a clinical laboratory professional from receiving a fee for professional consultation services.
(r) Exercising influence on a patient or client in such a manner as to exploit the patient or client for the financial gain of the licensee or other third party, which shall include, but not be limited to, the promoting, selling, or withholding of services, goods, appliances, referrals, or drugs.
(s) Practicing or offering to practice beyond the scope permitted by law or rule, or accepting or performing professional services or responsibilities which the licensee knows or has reason to know that he or she is not competent to perform.
(t) Misrepresenting or concealing a material fact at any time during any phase of the licensing, investigative, or disciplinary process, procedure, or proceeding.
(u) Improperly interfering with an investigation or any disciplinary proceeding.
(v) Engaging in or attempting to engage in sexual misconduct, causing undue embarrassment or using disparaging language or language of a sexual nature towards a patient, exploiting superior/subordinate, professional/patient, instructor/student relationships for personal gain, sexual gratification, or advantage.
(w) Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.
(2) The board may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or who is found guilty of violating any provision of s. 456.072(1).
(3) In determining the amount of the fine to be levied for a violation, as provided in subsection (1), the following factors shall be considered:
(a) The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of this part were violated.
(b) Actions taken by the licensee to correct the violation or to remedy complaints.
(c) Any previous violation by the licensee.
(d) The financial benefit to the licensee of committing or continuing the violation.
History.—s. 32, ch. 92-58; s. 445, ch. 97-103; s. 169, ch. 97-264; s. 152, ch. 99-397; s. 46, ch. 2001-277; s. 22, ch. 2005-240; s. 97, ch. 2008-6; s. 22, ch. 2017-41.
483.828 Penalties for violations.—
(1) Each of the following acts constitutes a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084:
(a) Practicing as clinical laboratory personnel without an active license.
(b) Using or attempting to use a license to practice as clinical laboratory personnel which is suspended or revoked.
(c) Attempting to obtain or obtaining a license to practice as clinical laboratory personnel by knowing misrepresentation.
(2) Each of the following acts constitutes a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083:
(a) Knowingly concealing information relating to violations of this part.
(b) Making any willfully false oath or affirmation whenever an oath or affirmation is required by this part.
(c) Leading the public to believe that one is licensed as clinical laboratory personnel, or is engaged in licensed practice as clinical laboratory personnel, without holding a valid, active license.
History.—s. 170, ch. 97-264; s. 59, ch. 2000-318.
PART III
MEDICAL PHYSICISTS
483.901 Medical physicists; definitions; licensure.
483.901 Medical physicists; definitions; licensure.—
(1) SHORT TITLE.—This section may be cited as the “Florida Medical Physicists Act.”
(2) DECLARATION OF LEGISLATIVE POLICY.—The Legislature finds that the practice of medical physics by incompetent persons is a threat to the public health and safety. It is, therefore, the responsibility of this state to protect the public health and safety from the harmful effects of excessive and unnecessary radiation by ensuring that the practice of medical physics is entrusted only to persons who are licensed under this section.
(3) DEFINITIONS.—As used in this section, the term:
(a) “Department” means the Department of Health.
(b) “Diagnostic radiological physics” means the specialty of medical physics which deals with the diagnostic application and safe use of X rays, gamma rays from sealed sources, ultrasonic radiation, radio frequency radiation, or magnetic fields, and the use of equipment associated with the production, use, measurement, and evaluation of the radiation and the quality of the diagnostic image resulting from its production and use.
(c) “License” means a certificate issued by the department which authorizes the holder to practice medical physics.
(d) “Licensed medical physicist” means a person who holds a license issued under this section.
(e) “Medical health physics” means the specialty of medical physics which deals with the safe use of X rays, gamma rays, electron or other charged particle beams, neutrons, radionuclides, and radiation from sealed sources, for both diagnostic and therapeutic purposes in human beings and the use of equipment required to perform appropriate tests and measurements that do not involve the direct application of radiation to humans for diagnostic or therapeutic procedures.
(f) “Medical nuclear radiological physics” means the specialty of medical physics which deals with the therapeutic and diagnostic application and safe use of radionuclides, except those used in sealed sources for therapeutic purposes, and the use of equipment associated with the production, use, measurement, and evaluation of radionuclides.
(g) “Medical physics” means the branch of physics which is associated with the practice of medicine. It includes the fields of diagnostic radiological physics, therapeutic radiological physics, medical nuclear radiological physics, and medical health physics.
(h) “Physician” means a doctor of medicine, osteopathic medicine, podiatric medicine, dentistry, or chiropractic medicine who is licensed in this state and who prescribes a radiological procedure.
(i) “Practice of medical physics” means the use of principles and accepted protocols of physics to ensure the correct quality, quantity, and placement of radiation during the performance of a radiological procedure prescribed by a physician which will protect the patient and others from harmful excessive radiation. The term includes radiation beam calibration and characterization quality assurance, instrument specification, acceptance testing, shielding design, protection analysis on radiation-emitting equipment and radiopharmaceuticals, and consultation with a physician to ensure accurate radiation dosage to a specific patient.
(j) “Radiation” means ionizing or nonionizing radiation above background levels which is used to perform a diagnostic or therapeutic medical or dental radiological procedure.
(k) “Radiological procedure” means a test, measurement, calculation, or radiation exposure used in the diagnosis or treatment of diseases or other medical or dental conditions in human beings that includes therapeutic radiation, diagnostic radiation, nuclear magnetic resonance, or nuclear medicine procedures.
(l) “Therapeutic radiological physics” means that specialty of medical physics which deals with the therapeutic application and safe use of X rays, gamma rays, electron or other charged particle beams, neutrons, or radiation from radionuclide sources, and the use of equipment associated with the production, use, measurement, and evaluation of that radiation.
(4) LICENSE REQUIRED.—An individual may not engage in the practice of medical physics, including the specialties of diagnostic radiological physics, therapeutic radiological physics, medical nuclear radiological physics, or medical health physics, without a license issued by the department for the appropriate specialty.
(a) The department shall adopt rules to administer this section which specify license application and renewal fees, continuing education requirements, and standards for practicing medical physics. The department shall require a minimum of 24 hours per biennium of continuing education offered by an organization approved by the department. The department may adopt rules to specify continuing education requirements for persons who hold a license in more than one specialty.
(b) In order to apply for a medical physicist license in one or more specialties, a person must file an individual application for each specialty with the department. The application must be on a form prescribed by the department and must be accompanied by a nonrefundable application fee for each specialty.
(c) The department may issue a license to an eligible applicant if the applicant meets all license requirements. At any time before the department issues a license, the applicant may request in writing that the application be withdrawn. To reapply, the applicant must submit a new application and an additional nonrefundable application fee and must meet all current licensure requirements.
(d) The department shall review each completed application for a license which the department receives.
(e) Upon receipt of an application and fee as specified in this section, the department may issue a license to practice medical physics in this state to a person who is board certified in the medical physics specialty in which the applicant applies to practice by the American Board of Radiology for diagnostic radiological physics, therapeutic radiological physics, or medical nuclear radiological physics; by the American Board of Medical Physics for diagnostic radiological physics, therapeutic radiological physics, or medical nuclear radiological physics; or by the American Board of Health Physics or an equivalent certifying body approved by the department.
(f) A licensee shall:
1. Display the license in a place accessible to the public; and
2. Report immediately any change in the licensee’s address or name to the department.
(g) The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):
1. Obtaining or attempting to obtain a license by bribery, fraud, knowing misrepresentation, or concealment of material fact or through an error of the department.
2. Having a license denied, revoked, suspended, or otherwise acted against in another jurisdiction.
3. Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of medical physics.
4. Willfully failing to file a report or record required for medical physics or willfully impeding or obstructing the filing of a report or record required by this section or inducing another person to do so.
5. Making misleading, deceptive, or fraudulent representations in or related to the practice of medical physics.
6. Willfully failing to report any known violation of this section or any rule adopted thereunder.
7. Failing to perform any statutory or legal obligation placed upon a licensee.
8. Aiding, assisting, procuring, employing, or advising any unlicensed person to practice medical physics contrary to this section or any rule adopted thereunder.
9. Delegating or contracting for the performance of professional responsibilities by a person when the licensee delegating or contracting such responsibilities knows, or has reason to know, such person is not qualified by training, experience, and authorization to perform them.
10. Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities the licensee knows, or has reason to know, the licensee is not competent to perform.
11. Gross or repeated malpractice or the inability to practice medical physics with reasonable skill and safety.
12. Judicially determined mental incompetency.
13. Being unable to practice medical physics with reasonable skill and safety because of a mental or physical condition or illness or the use of alcohol, controlled substances, or any other substance which impairs one’s ability to practice.
a. The department may, upon probable cause, compel a licensee to submit to a mental or physical examination by physicians designated by the department. The cost of an examination shall be borne by the licensee, and the licensee’s failure to submit to such an examination constitutes an admission of the allegations against the licensee, consequent upon which a default and a final order may be entered without the taking of testimony or presentation of evidence, unless the failure was due to circumstances beyond the licensee’s control.
b. A licensee who is disciplined under this subparagraph shall, at reasonable intervals, be afforded an opportunity to demonstrate that the licensee can resume the practice of medical physics with reasonable skill and safety.
c. With respect to any proceeding under this subparagraph, the record of proceedings or the orders entered by the department may not be used against a licensee in any other proceeding.
14. Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.
(h) The department may enter an order denying licensure or imposing any of the penalties in s. 456.072(2) against any applicant for licensure or licensee who is found guilty of violating any provision of subsection (1) of this section or who is found guilty of violating any provision of s. 456.072(1).
(i) The department may not issue or reinstate a license to a person it has deemed unqualified until it is satisfied that such person has complied with the terms and conditions of the final order and that the licensee can safely practice medical physics.
(j) Upon receipt of a complete application and the fee set forth by rule, the department may issue a physicist-in-training certificate to a person qualified to practice medical physics under direct supervision. The department may establish by rule requirements for initial certification and renewal of a physicist-in-training certificate.
(k) Upon proof of a completed residency program and receipt of the fee set forth by rule, the department may issue a temporary license for no more than 1 year. The department may adopt by rule requirements for temporary licensure and renewal of temporary licenses.
(5) FEES.—The fee for the initial license application shall be $500 and is nonrefundable. The fee for license renewal may not be more than $500. These fees may cover only the costs incurred by the department to administer this section. By July 1 of each year, the department shall determine whether the fees are insufficient to administer this section.
(6) DISPOSITION OF FEES.—The department shall deposit all funds received into the Medical Quality Assurance Trust Fund.
(7) PENALTY FOR VIOLATIONS.—It is a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, to:
(a) Practice or attempt to practice medical physics or hold oneself out to be a licensed medical physicist without holding an active license.
(b) Practice or attempt to practice medical physics under a name other than one’s own.
(c) Use or attempt to use a revoked or suspended license or the license of another.
(8) EXEMPTIONS.—This section does not apply to:
(a) A physician who is licensed by this state to the extent that the physician practices within the scope of the physician’s training, education, and licensure;
(b) A person who is licensed under part IV of chapter 468 to the extent that the person practices within the scope of the person’s training, education, and licensure;
(c) A person who performs beam calibration and characterization, quality assurance, instrument specification, acceptance testing, shielding design, or protection analysis on radiation-emitting equipment or radiopharmaceuticals in connection with procedures that are not involved with the diagnosis or treatment of disease or other medical or dental conditions in humans;
(d) A person who is employed by a federal or state regulatory agency and is performing duties within the scope of the person’s employment;
(e) A student or intern who practices medical physics in conjunction with a program at an accredited college or university to the extent that the student or intern is adequately supervised by a licensed medical physicist or licensed physician; or
(f) A dentist or any person working under the dentist’s supervision pursuant to chapter 466 to the extent that the dentist or the person supervised by the dentist is practicing within the scope of his or her training, education, and licensure.
History.—ss. 3, 5, ch. 95-231; s. 446, ch. 97-103; s. 171, ch. 97-264; ss. 137, 218, 247, 286, ch. 98-166; s. 153, ch. 99-397; s. 69, ch. 2000-158; s. 197, ch. 2000-160; s. 60, ch. 2000-318; s. 48, ch. 2001-277; s. 80, ch. 2002-1; s. 23, ch. 2005-240; s. 98, ch. 2008-6; s. 30, ch. 2016-230.