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.
(7) Registered nurses licensed under chapter 464 who are determined by the clinical laboratory director of a hospital or hospital-based off-campus emergency department licensed under chapter 395 to be qualified under 42 C.F.R. s. 493.1423 to perform only moderate-level or waiver-level clinical laboratory testing in accordance with s. 395.0091 within the hospital or hospital-based off-campus emergency department with a separate federal Clinical Laboratory Improvement Amendments (CLIA) program clinical laboratory certification under 42 C.F.R. part 493.
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; s. 1, ch. 2022-37.
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 an institutionally 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; s. 18, ch. 2022-71.
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 II
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.
PART III
GENETIC COUNSELING
483.911 Short title.
483.912 Legislative findings and intent.
483.913 Definitions.
483.914 Licensure requirements.
483.915 Licensure renewal and continuing education requirements.
483.916 Prohibitions; penalties.
483.917 Grounds for disciplinary action; penalties.
483.918 Conscience clause.
483.919 Exemptions.
483.911 Short title.—This part may be cited as the “Genetic Counseling Workforce Act.”
History.—s. 1, ch. 2021-133.
483.912 Legislative findings and intent.—The sole legislative purpose for enacting this part is to ensure that every genetic counselor practicing in this state meets minimum requirements for safe practice. The Legislature finds that the delivery of genetic counseling services by unskilled and incompetent persons presents a danger to public health and safety. Because it is difficult for the public to make informed choices related to genetic counseling services and since the consequences of uninformed choices can seriously endanger public health and safety, it is the intent of the Legislature to prohibit the delivery of genetic counseling services by persons who possess less than minimum competencies or who otherwise present a danger to the public.
History.—s. 1, ch. 2021-133.
483.913 Definitions.—As used in this part, the term:
(1) “Department” means the Department of Health.
(2) “Genetic counselor” means a person licensed under this part to practice genetic counseling.
(3) “Scope of practice of genetic counseling” means the process of advising an individual or a family affected by or at risk of genetic disorders, including:
(a) Obtaining and evaluating individual, family, and medical histories to determine genetic risk for genetic or medical conditions and diseases in a patient, his or her offspring, and other family members;
(b) Discussing the features, natural history, means of diagnosis, genetic and environmental factors, and management of risk for genetic or medical conditions and diseases;
(c) Identifying, ordering, and coordinating genetic laboratory tests and other diagnostic studies as appropriate for a genetic assessment;
(d) Integrating genetic laboratory test results and other diagnostic studies with personal and family medical history to assess and communicate risk factors for genetic or medical conditions and diseases;
(e) Explaining the clinical implications of genetic laboratory tests and other diagnostic studies and their results;
(f) Evaluating the client’s or family’s responses to the condition or risk of recurrence and providing client-centered counseling and anticipatory guidance;
(g) Identifying and using community resources that provide medical, educational, financial, and psychosocial support and advocacy;
(h) Providing written documentation of medical, genetic, and counseling information for families and health care professionals; and
(i) Referring patients to a physician for diagnosis and treatment.
History.—s. 1, ch. 2021-133.
483.914 Licensure requirements.—
(1) Any person desiring to be licensed as a genetic counselor under this part must apply to the department on a form approved by department rule.
(2) The department shall issue a license, valid for 2 years, to each applicant who:
(a) Has completed an application.
(b) Is of good moral character.
(c) Provides satisfactory documentation of having earned:
1. A master’s degree from a genetic counseling training program or its equivalent as determined by the Accreditation Council of Genetic Counseling or its successor or an equivalent entity; or
2. A doctoral degree from a medical genetics training program accredited by the American Board of Medical Genetics and Genomics or the Canadian College of Medical Geneticists.
(d) Has passed the examination for certification as:
1. A genetic counselor by the American Board of Genetic Counseling, Inc., the American Board of Medical Genetics and Genomics, or the Canadian Association of Genetic Counsellors; or
2. A medical or clinical geneticist by the American Board of Medical Genetics and Genomics or the Canadian College of Medical Geneticists.
(3) The department may issue a temporary license for up to 2 years to an applicant who meets all requirements for licensure except for the certification examination requirement imposed under paragraph (2)(d) and is eligible to sit for that certification examination.
History.—s. 1, ch. 2021-133.
483.915 Licensure renewal and continuing education requirements.—
(1) The department shall renew a license upon receipt of a renewal application.
(2) The department shall adopt by rule continuing education requirements consistent with nationally accepted standards of the American Board of Genetic Counseling, Inc.
History.—s. 1, ch. 2021-133.
483.916 Prohibitions; penalties.—
(1) A person may not:
(a) Make a false or fraudulent statement in any application, affidavit, or statement presented to the department.
(b) Practice genetic counseling or hold himself or herself out as a genetic counselor or as being able to practice genetic counseling or to render genetic counseling services without a license issued under this part unless exempt from licensure under this part.
(c) Use the title “genetic counselor” or any other title, designation, words, letters, abbreviations, or device tending to indicate that the person is authorized to practice genetic counseling unless that person holds a current license as a genetic counselor issued under this part or is exempt from licensure under this part.
(2) A person who violates this section commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
History.—s. 1, ch. 2021-133.
483.917 Grounds for disciplinary action; penalties.—
(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 under this part by fraudulent misrepresentation.
(b) Having a license revoked, suspended, or otherwise acted against, including the denial of licensure in another jurisdiction.
(c) Being convicted or found guilty of, or entering a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction which directly relates to the practice of genetic counseling, including a violation of federal laws or regulations regarding genetic counseling.
(d) Making or filing a report or record that the licensee knows is 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 impede or obstruct such filing. Such reports or records include only reports or records that are signed in a person’s capacity as a licensee under this part.
(e) Knowingly advertising services related to genetic counseling in a fraudulent, false, deceptive, or misleading manner.
(f) Violating a previous order of the department entered in a disciplinary hearing or failing to comply with a subpoena issued by the department.
(g) Practicing with a revoked, suspended, or inactive license.
(h) Gross or repeated malpractice or the failure to deliver genetic counseling services with that level of care and skill which is recognized by a reasonably prudent licensed genetic counselor as being acceptable under similar conditions and circumstances.
(i) Unprofessional conduct, including, but not limited to, any departure from or failure to conform to the minimal prevailing standards of acceptable practice under this part and department rule, including, but not limited to, any of the following:
1. Practicing or offering to practice beyond the scope permitted by law or accepting and performing genetic counseling services the licensee knows, or has reason to know, he or she is not competent to perform.
2. Failing to refer a patient to a health care practitioner as defined in s. 456.001 if the licensee is unable or unwilling to provide genetic counseling services to the patient.
3. Failing to maintain the confidentiality of any information received under this part or failing to maintain the confidentiality of patient records pursuant to s. 456.057, unless such information or records are released by the patient or otherwise authorized or required by law to be released.
4. Exercising influence on the patient or family in such a manner as to exploit the patient or family for financial gain of the licensee.
(j) Violating this part or chapter 456, or any rules adopted pursuant thereto.
(2) The department may enter an order denying licensure to or imposing penalties against any applicant for licensure or any licensee who is found guilty of violating subsection (1) or s. 483.916.
History.—s. 1, ch. 2021-133.
483.918 Conscience clause.—This part may not be construed to require any genetic counselor to participate in counseling that conflicts with his or her deeply held moral or religious beliefs. The licensing of a genetic counselor may not be contingent upon participation in such counseling. A counselor’s refusal to participate in counseling that conflicts with his or her deeply held moral or religious beliefs may not form the basis for any claim of damages or for any disciplinary action against the genetic counselor, provided the genetic counselor informs the patient that he or she will not participate in such counseling and offers to direct the patient to the online health care practitioner license verification database maintained by the department.
History.—s. 1, ch. 2021-133.
483.919 Exemptions.—This part does not apply to:
(1) Commissioned medical officers of the United States Armed Forces or the United States Public Health Service while on active duty or while acting within the scope of their military or public health responsibilities.
(2) A health care practitioner as defined in s. 456.001, other than a genetic counselor licensed under this part, who is practicing within the scope of his or her training, education, and licensure and who is doing work of a nature consistent with such training, education, and licensure.
