CONTROL OF RADIATION HAZARDS

All fluoroscopic x-ray systems shall meet the following requirements: (1) Limitation of the Useful Beam. (a) The fluoroscopic tube shall not produce x-rays unless the primary protective barrier is in position to intercept the entire cross section of the useful beam. (b) A means s…

(1) Beam Limitation. The useful beam shall be limited to the area of clinical interest. (a) General Purpose Stationary and Mobile X-Ray Systems. 1. A means for stepless adjustment of the size of the x-ray field shall be provided. 2. Means shall be provided for visually defining t…

(1) Source-to-Skin Distance. X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit source-to-skin distance to not less than: (a) Eighteen centimeters if operable at or above 50 kVp, or (b) Ten centimeters if not operable above 50 kV…

(1) Equipment Requirements. (a) Leakage Radiation. When the tube is operated at its leakage technique factors, the leakage radiation shall not exceed the value specified at the distance specified for the following classification of that x-ray system: 1. Contact Therapy Systems. L…

(1) Definitions. In addition to the definitions in Rule 64E-5.501, F.A.C., the following definitions shall apply to this section: (a) "Applicator" means a structure which determines the extent of the treatment field at a given distance from the virtual source. (b) "Beam scatterin…

(1) Applicable Regulations. Veterinary medical x-ray operations shall conform with requirements of the following sections of these regulations: (a) Rule 64E-5.502, F.A.C., General Requirements, except subparagraphs 64E-5.502(1)(a)5., 6., 7., 8., F.A.C. (b) Rule 64E-5.503, F.A.C.,…

(1) Mammographic medical x-ray systems shall meet the requirements of Rules 64E-5.502 and 64E-5.503, F.A.C. Registrants who provide mammography services shall: (a) Have a written quality assurance program specific to mammography imaging that includes an equipment quality control …

(1) Exemptions. (a) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from registration registration requirements if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 mR (5 µSv) per hour…

(1) Radioactive materials shall not be manufactured, produced, acquired, received, possessed, prepared, used, or transferred for medical use except as provided in a specific license. (2) Any licensee who is licensed for one or more of the medical uses in Rule 64E-5.626, 64E-5.627…

(1) "Authorized medical physicist" means an individual who meets the requirements: (a) Specified in subsection 64E-5.656(1) and Rule 64E-5.658, F.A.C., or (b) Is identified as an authorized medical physicist or teletherapy physicist on: 1. A specific medical use license issued by…

A licensee shall apply for and receive a license amendment or departmental approval: (1) Before using radioactive material for a method or type of medical use not permitted by the license; (2) Before permitting anyone, except a visiting authorized user, visiting authorized medica…

A licensee shall notify the department in writing within 30 days when the licensee changes its mailing address or when an authorized user, RSO, authorized nuclear pharmacist, or authorized medical physicist permanently discontinues performance of their duties under the licensee. …

(1) Each licensee shall develop and implement a written program to maintain radiation doses and releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable as provided in Rule 64E-5.303, F.A.C. (2) The management, radiation safety officer, …

(1) A licensee shall appoint a RSO who agrees in writing to be responsible for implementing the radiation safety program. The licensee, through the RSO, shall ensure that radiation safety activities are performed with approved procedures and regulatory requirements in the daily o…

(1) Each license listed below shall establish a radiation safety committee to oversee the use of radioactive materials; (a) Medical institutions as defined in Rule 64E-5.101, F.A.C., or (b) Other licenses authorized for any of the following medical uses: 1. Subsection 64E-5.627(2…

(1) A licensee shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to: (a) Identify radiation safety problems; (b) Initiate, recommend, or provide solutions; (c) Require and verify implementation of corr…

(1) Supervision of a physician in training to become an authorized user: (a) A licensee who permits the receipt, acquisition, possession, use, preparation, or transfer of radioactive material by a physician in training under the supervision of an authorized user as allowed by par…

(1) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's license for 60 days each year if: (a) The licensee has a copy of a license issued by the department, the NRC, or an agreement state that identifies th…

The department shall license mobile medical services or clients of such services. The mobile medical service shall be licensed if the service receives, uses or possesses radioactive material. The client of the mobile medical service shall be licensed if the client receives or pos…

(1) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide a high confidence that radioactive material or radiation from radioactive material will be administered as directed by the authorized user. …

A licensee shall use for medical use only: (1) Radioactive material manufactured, labeled, packaged, and distributed as specified in a license issued by the department or by another agreement state, a licensing state or the U.S. Nuclear Regulatory Commission; (2) Generators and r…

Each licensee shall establish written quality control procedures for all equipment used to obtain images or information from radionuclide studies. The procedures shall be recommended by equipment manufacturers or be approved by the department. The licensee shall perform quality c…

(1) A medical use licensee authorized to administer radiopharmaceuticals shall possess a dose calibrator and use it to measure the amount of activity administered to each patient or human research subject. (2) A licensee shall check each dose calibrator before use each day of use…

A licensee shall ensure that the survey instruments used to comply with this part have been calibrated before first use, at least every 12 months, and after repair. (1) A record shall be made of each calibration, which shall include: (a) A description of the source used; (b) The …

(1) The licensee shall determine by assay or direct measurement within 30 minutes before each radiopharmaceutical dosage and record the activity of each dosage before medical use. A record of the assay shall be made which shall include: (a) The generic name, trade name, or abbrev…

Any person authorized by Rule 64E-5.601, F.A.C., for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration, transmission and reference use: (1) Sealed sources that: (a) Do not exceed 1.11 GBq (30 mCi) each, man…

(1) A licensee who possesses any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the department and shall maintain the instructions for the duration of source use…

(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…