Florida Administrative Code

(1) A licensee shall keep syringes that contain radioactive material to be administered in a radiation shield. Each individual who prepares or administers radiopharmaceuticals shall use a syringe radiation shield unless the use of the shield is contraindicated for that patient. (…

A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield and conspicuously label each vial with the radiopharmaceutical name or its abbreviation. Rulemaking Authority 404.022, 404.051, 40…

(1) A licensee shall survey with a radiation survey instrument at the end of each day of use, or during an assigned shift for facilities operating continuously, all areas where radiopharmaceuticals are routinely prepared for use or administered. (2) A licensee shall survey all ar…

(1) Except as authorized by subsection 64E-5.622(4), F.A.C., a licensee shall not authorize release from confinement for medical care any patient administered a radiopharmaceutical until: (a) The dose rate from the patient is less than 5 millirems (50 µSv) per hour at a distance …

A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation shield and container or an equivalent shield and container. A licensee shall store and use a multidose container in a properly functioning fume hood. Rulemaking Authority 404.022…

(1) A licensee shall hold radioactive material with a physical half life of less than 120 days for decay in storage before disposal as ordinary trash. A licensee is exempt from the requirements of paragraph 64E-5.331(1)(c), F.A.C., of these regulations if: (a) The radioactive mat…

(1) A licensee shall provide oral and written radiation safety instructions to all personnel caring for patients or human research subjects, who cannot be released under Rule 64E-5.622, F.A.C., undergoing radiopharmaceutical therapy or manual brachytherapy. This training shall be…

The licensee shall perform acceptance testing on the treatment planning system of manual brachytherapy therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicabl…

A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion for medical use under the following conditions: (1) When a written directive is not required by subsection 64E-5.6…

A licensee is allowed to use any radioactive material in a diagnostic radiopharmaceutical, or any generator, or reagent kit, for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for medical use under the following conditions: (1) When a writ…

(1) Permissible Molybdenum/Technetium Concentration. (a) A licensee shall not administer a radiopharmaceutical containing more than 0.15 microcurie of molybdenum 99 per millicurie of technetium 99m (5.55 kilo-becquerel of molybdenum 99 per 37 megabecquerel of technetium 99m). (b)…

(1) A licensee shall only administer radioactive aerosols or gases when airborne concentrations are within the limits prescribed by State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012, (see Rule 64E-5.101, F.A.C.) Table I, Column 3, and…

A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical that requires a written directive as described in subsection 64E-5.607(3), F.A.C., and for a therapeutic medical use provided the following is met: (1) For any unsealed radiopharmaceutical inc…

The licensee is allowed to use the sealed sources listed below, provided they are approved by and used as specified in, the Sealed Source and Device Registry, for diagnostic medical uses, or in research in accordance with an active IDE application accepted by the FDA and the requ…

The licensee is allowed to use the brachytherapy sources listed below, provided they are approved by and used as specified in, the Sealed Source and Device Registry for medical uses, or in research in accordance with an active IDE application accepted by the FDA and the requireme…

(1) The licensee shall maintain accountability at all times for all manual brachytherapy sources in storage or use. (a) As soon as possible each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise ve…

(1) Before the first medical use of a brachytherapy source, the licensee shall, using published protocols currently accepted by nationally recognized bodies, determine the following: (a) Source output or activity using a dosimetry system that meets the requirements of subsection …

(1) Only an authorized medical physicist or authorized user qualified to perform procedures described in subsection 64E-5.632(2), F.A.C., shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay mu…

(1) A licensee shall use sealed sources in photon emitting gamma stereotactic radiosurgery units for therapeutic medical uses: (a) As approved in the Sealed Source and Device Registry, or (b) In research in accordance with an active IDE application accepted by the FDA provided th…

(1) Only a person specifically licensed by the NRC or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or o…

(1) Listed below are the safety and instruction requirements for a licensee: (a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended; (b) Permit only individuals approved by the authorized user, RSO, or authorized medical physicist…

(1) A licensee shall control access to the treatment room by a door at each entrance. (2) A licensee shall equip each entrance to the treatment room with an electrical interlock system that shall: (a) Prevent the operator from initiating the treatment cycle unless each treatment …

(1) A licensee shall have a permanent radiation monitor in each teletherapy, medium or high dose rate remote afterloader, or gamma stereotactic radiosurgery room capable of continuously monitoring radiation levels. (2) Each radiation monitor shall be capable of providing visible …

A licensee shall construct or equip each teletherapy, medium or high dose rate remote afterloader, or gamma stereotactic radiosurgery room to permit continuous observation of the patient, or human research subject from the teletherapy unit console during irradiation. Rulemaking A…

(1) Except for low dose-rate remote afterloader source output or where the activity is determined by the manufacturer, a licensee shall have a dosimetry system available for use calibrated by paragraph (a) or (b), below. (a) The system must have been calibrated using a system or …

(1) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit: (a) Before the first medical use of the unit; (b) Before medical use whenever spot-check measurements indicate that the output differs by more…

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each remote afterloader unit: (a) Before the first medical use of the unit; (b)1. Before medical use following replacement of the source or following reinstal…

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each gamma stereotactic radiosurgery: (a) Before the first medical use of the unit; (b)1. Before medical use whenever spot-check measurements ind…

(1) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit at least every month. (2) Spot-checks shall include the determination of: (a) Timer constancy and timer linearity over the range of use; (b) On-off error; …

(1) A licensee authorized to use a remote afterloader unit for medical use shall perform the following spot-checks: (a) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day; (b) Before each patient treatment with a…

(1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform the following spot-checks: (a) Monthly: (b) Before the first use of the unit on a given day; and (c) After each source installation. (2) To satisfy the requirements of paragraph …

(1) A licensee providing mobile remote afterloader service for medical use shall perform the following: (a) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and (b) Account for all sources before departure from …

(1) The licensee shall perform radiation surveys with an operable radiation survey instrument calibrated as provided in Rule 64E-5.615, F.A.C., before medical use, after each installation of a teletherapy source; following repairs to the source(s) driving unit, or other electroni…

(1) The licensee shall perform radiation surveys with an operable radiation survey instrument calibrated as provided in Rule 64E-5.615, F.A.C., to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in …

The licensee shall perform acceptance testing on the treatment planning system of high, medium, low, pulsed dose-rate remote afterloaders, gamma stereotactic, and teletherapy therapy-related computer systems in accordance with published protocols accepted by nationally recognized…

A licensee shall furnish a copy of the records required in Rules 64E-5.643, 64E-5.644, and 64E-5.645, F.A.C., and the output from the teletherapy source expressed as rads (grays) per hour at 1 meter from the source as determined during the full calibration required in Rule 64E-5.…

(1) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at least every 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism. (2) This inspection and…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the RSO as provided in Rule 64E-5.605, F.A.C., to be an individual who: (1) Is certified by a specialty board whose certification process has been recognized by the NRC or an agreement state and who meets th…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a radiopharmaceutical listed in subsection 64E-5.626(1), F.A.C., to: (1) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agre…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user specified in subsection 64E-5.627(1), F.A.C., to: (1) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state and who me…

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.771, Repealed 2-11-10.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a brachytherapy source specified in Rule 64E-5.632, F.A.C., to: (1) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of only strontium 90 for ophthalmic radiotherapy to: (1) Be authorized user under Rule 64E-5.652, F.A.C., NRC or equivalent Agreement State requirements; or (2)(a) Have completed 24 hours…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source in a device specified in Rule 64E-5.631, F.A.C., to be a physician, dentist, or podiatrist: (1) Be certified by a specialty board whose certification process includes a…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source specified in Rule 64E-5.634, F.A.C., to: (1) Be certified by a medical specialty board whose certification process has been recognized by the NRC or an agreement state …

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized medical physicist to: (1) Be certified by a specialty board whose certification process has been recognized by the NRC or an agreement state and who meets the requirements in paragraph 64E-5.6…

(1)(a) An individual identified as a RSO, a teletherapy or medical physicist, or a nuclear pharmacist on a NRC or agreement state license or a permit issued by a NRC or agreement state broad scope licensee or master material license permit or by a master material license permitte…