SECTION 404.22. Radiation machines and components; inspection.

• (1) The department and its duly authorized agents may inspect in a lawful manner at all reasonable hours any hospital or other health care facility or other place in the state in which a radiation machine is installed for the purpose of determining whether the facility, the radiation machine and its components, the film and film processing equipment, the techniques and procedures, any mechanical holding devices, the warning labels and signs, the written safety procedures, and the resultant image produced meet the standards of the department as set forth in this chapter and rules adopted pursuant to this chapter. Such rules may include standards for radiation machine performance, surveys, calibrations, and spot checks; requirements for quality assurance programs and quality control programs; standards for facility electrical systems, safety alarms, radiation-monitoring equipment, and dosimetry systems; requirements for visual and aural communication with patients; procedures for establishing radiation safety committees for a facility; and qualifications of persons who cause a radiation machine to be used, who operate a radiation machine, and who ensure that a radiation machine complies with the requirements of this chapter and with rules of the department. If, in the opinion of the department, a radiation machine that fails to meet such standards can be made to meet the standards through an adjustment or limitation upon the stations or range of the radiation machine or through the purchase of a component meeting the standards, the department shall order the owner of the radiation machine to make the necessary adjustment or to purchase the necessary component within 90 days after the date or receipt of the order. However, if the radiation machine cannot be made to meet the standards, the department shall order the owner to cease the use of the radiation machine.
  (2) Any person who enters the state with a radiation machine or component owned by him or her for the purpose of installing and utilizing the radiation machine shall register the radiation machine with the department. The department shall inspect the radiation machine to determine its compliance with the standards and shall approve or disapprove the radiation machine or shall order adjustments to the radiation machine in accordance with the provisions of subsection (1). Each person who installs or offers to install or service radiation machines must register with the department and must apply to the department, on forms furnished by the department, before furnishing or offering to furnish any such service.
  (3) No person shall sell or offer to sell in this state any radiation machine or component thereof which does not meet the standards of the department or which cannot be adjusted to meet such standards in accordance with the provisions of subsection (1).
  (4) The department shall enforce the provisions of this section and may impose an administrative fine, in addition to all other fines and penalties imposed by law, in an amount of $1,000 for each violation of this section.
  (5)(a) The department may charge and collect reasonable fees annually for the registration and inspection of radiation machines pursuant to this section. Such fees shall include the registration fee provided in s. 404.131 and shall be deposited into the Radiation Protection Trust Fund. Registration shall be on an annual basis. Registration shall consist of having the registrant file, on forms prescribed and furnished by the department, information which includes, but is not limited to: type and number of radiation machines, location of radiation machines, and changes in ownership. The department shall establish by rule a fee schedule based upon the actual costs incurred by the department in carrying out its registration and inspection responsibilities, including the salaries, expenses, and equipment of inspectors, but excluding costs of supervision and program administration. The fee schedule shall reflect differences in the frequency and complexity of inspections necessary to ensure that the radiation machines are functioning in accordance with the applicable standards developed pursuant to this chapter and rules adopted pursuant hereto.

  (b) The fee schedule and frequency of inspections shall be determined as follows:

  1. Radiation machines which are used in the practice of medicine, chiropractic medicine, osteopathic medicine, or naturopathic medicine shall be inspected at least once every 2 years, but not more than annually, for an annual fee which is not less than $83 or more than $145 for the first radiation machine within an office or facility and not less than $36 or more than $85 for each additional radiation machine therein.

  2. Radiation machines which are used in the practice of veterinary medicine shall be inspected at least once every 3 years for an annual fee which is not less than $28 or more than $50 for the first radiation machine within an office or facility and not less than $19 or more than $34 for each additional radiation machine therein.

  3. Radiation machines which are used for educational or industrial purposes shall be inspected at least once every 3 years for an annual fee which is not less than $26 or more than $47 for the first radiation machine within an office or facility and not less than $12 or more than $23 for each additional radiation machine therein.

  4. Radiation machines which are used in the practice of dentistry or podiatric medicine shall be inspected at least once every 5 years but not more often than once every 4 years for an annual fee which is not less than $16 or more than $31 for the first radiation machine within an office or facility and not less than $5 or more than $11 for each additional radiation machine therein.

  5. Radiation machines which accelerate particles and are used in the healing arts shall be inspected at least annually for an annual fee which is not less than $153 or more than $258 for the first radiation machine within an office or facility and not less than $87 or more than $148 for each additional radiation machine therein.

  6. Radiation machines which accelerate particles and are used for educational or industrial purposes shall be inspected at least once every 2 years for an annual fee which is not less than $46 or more than $81 for the first radiation machine within an office or facility and not less than $26 or more than $48 for each additional radiation machine therein.

  7. If a radiation machine fails to meet the applicable standards upon initial inspection, the department may reinspect the radiation machine and charge a reinspection fee in accordance with the same schedule of fees as in subparagraphs 1.-6.
  (6)(a) For purposes of this subsection, “mammography” means radiography of the breast for the purpose of enabling a physician to determine the presence, size, location, and extent of cancerous or potentially cancerous tissue in the breast.

  (b) All radiation machines used for mammography shall meet the accreditation criteria of the American College of Radiology or similar criteria established by the department.

  (c) All radiation machines used for mammography shall be specifically designed to perform mammography.

  (d) All radiation machines used for mammography shall be used exclusively to perform mammography.

  The department shall adopt rules to implement the provisions of this subsection.

  (7) Radiation machines that are used to intentionally expose a human being to the useful beam:

  (a) Must be maintained and operated according to manufacturer standards or nationally recognized consensus standards accepted by the department;

  (b) Must be operated at the lowest exposure that will achieve the intended purpose of the exposure; and

  (c) May not be modified in a manner that causes the original parts to operate in a way that differs from the original manufacturer’s design specification or the parameters approved for the machine and its components by the United States Food and Drug Administration.
  (8) A human being may be exposed to the useful beam of a radiation machine only under the following conditions:

  (a) For the purpose of medical or health care, if a licensed health care practitioner operating within the scope of his or her practice has determined that the exposure provides a medical or health benefit greater than the health risks posed by the exposure and the health care practitioner uses the results of the exposure in the medical or health care of the exposed individual; or

  (b) For the purpose of providing security for facilities or other venues, if the exposure is determined to provide a life safety benefit to the individual exposed which is greater than the health risk posed by the exposure. Such determination must be made by an individual trained in evaluating and calculating comparative mortality and morbidity risks according to standards set by the department. To be valid, the calculation and method of making the determination must be submitted to and accepted by the department. Limits to annual total exposure for security purposes must be adopted by department rule based on nationally recognized limits or relevant consensus standards.

History.-s. 1, ch. 80-187; s. 2, ch. 81-133; s. 40, ch. 83-218; ss. 16, 18, ch. 84-190; s. 1, ch. 91-76; s. 4, ch. 91-429; s. 23, ch. 97-103; s. 61, ch. 97-237; s. 25, ch. 98-151; s. 184, ch. 98-166; s. 30, ch. 2000-242; s. 1, ch. 2000-326; s. 7, ch. 2020-133.

Note

Note.-Former s. 381.507.

History.-s. 1, ch. 80-187; s. 2, ch. 81-133; s. 40, ch. 83-218; ss. 16, 18, ch. 84-190; s. 1, ch. 91-76; s. 4, ch. 91-429; s. 23, ch. 97-103; s. 61, ch. 97-237; s. 25, ch. 98-151; s. 184, ch. 98-166; s. 30, ch. 2000-242; s. 1, ch. 2000-326; s. 7, ch. 2020-133.

Note

Note.-Former s. 381.507.