CONTROL OF RADIATION HAZARDS

(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…

The training and experience specified in Rules 64E-5.648, 64E-5.649, 64E-5.650, 64E-5.652, 64E-5.653, 64E-5.654, 64E-5.655, 64E-5.656, 64E-5.657, 64E-5.659, 64E-5.660, 64E-5.661, 64E-5.662 and 64E-5.663, F.A.C., shall have been obtained within the 7 years preceding the date of ap…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized nuclear pharmacist 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.…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of unsealed radioactive materials specified in Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., which require a written directive to: (1) Be certified by a medical specialty board whose ce…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to: (1) Be certified by a medical…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to: (1) Be certified by a medical specialt…

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the parenteral administration requiring a written directive, to: (1) Be an authorized user under Rule 64E-5.660, F.A.C., for uses listed in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(III…

A licensee may use radioactive materials or a radiation source from radioactive materials approved for medical use which is not specifically addressed in Rule 64E-5.626, 64E-5.627, 64E-5.630, 64E-5.631, 64E-5.632 or 64E-5.634, F.A.C., provided the following are satisfied: (1) The…

(1) Safety Device. A device which prevents the entry of any portion of an individual's body into the primary x-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open-beam configurations. A registrant may apply to the Departmen…

(1) Radiation Levels. The local components of an analytical x-ray system shall be located and arranged and shall include sufficient shielding or have access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose …

(1) Procedures. Normal operating procedures shall be written and available to all analytical x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment in any manner other than that specified in the procedures unless such individual has obtain…

(1) Instruction. No person shall be permitted to operate or maintain analytical x-ray equipment unless such person has received instruction in and demonstrated competence as to: (a) Identification of radiation hazards associated with the use of the equipment; (b) Significance of …

(1) No person shall receive, possess, use, transfer, or acquire a particle accelerator facility or a particle accelerator except as authorized by a registration certificate issued by the Department pursuant to these rules. (2) Application for registration shall be made on DH Form…

A registration application for acquisition and use of a particle accelerator or particle accelerator facility will be approved only if the Department determines that: (1) The applicant is qualified by reason of training and experience to use the accelerator in question for the pu…

In addition to the general registration requirements set forth in Rule 64E-5.802, F.A.C., accelerators used for treatment of humans will be registered only if the Department determines that: (1) The applicant agrees to appoint a medical committee of at least two physicians, one o…

(1) The registrant shall not permit any person to act as a particle accelerator operator until such person: (a) Has been instructed in accelerator radiation safety and has demonstrated an understanding thereof; (b) Has received copies of and instructions in this part and the appl…

(1) A radiological physicist, as defined in Rule 64E-5.501, F.A.C., shall be consulted in the design of each particle accelerator installation and shall be responsible for specification of barrier materials and thicknesses. Plans and specifications, along with assumptions and cal…

(1) Instrumentation, readouts and controls on the particle accelerator control console shall be clearly identified and easily discernible. (2) All entrances into a target room or other high radiation area shall be provided with interlocks that shut down the machine under conditio…

(1) All locations designated as high radiation areas, and all entrances to such locations shall be equipped with easily observable warning lights that operate when and only when radiation is being produced. (2) Except in facilities designed for human exposure, each high radiation…

(1) Particle accelerators, when not in operation, shall be secured to prevent unauthorized use. (2) The safety interlock system shall not be used to turn off the accelerator beam except in an emergency or test situation. (3) All safety and warning devices, including interlocks, s…

(1) At each particle accelerator facility capable of producing radioactive materials by activation, the registrant shall provide appropriate portable monitoring equipment which is operable and has been calibrated for the radiations being produced at the facility. Such equipment s…

(1) Means shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to concentrations in excess of the limits specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, Jun…

(1) Each licensee or registrant shall post current copies of the following documents: (a) The regulations in this part and in Part III; (b) The license, conditions or documents incorporated into the license by reference and amendments thereto; (c) The operating procedures applica…

(1) All individuals who in the course of employment are likely to receive an occupational dose in excess of 100 millirem (1mSv) in a year: (a) Shall be kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's facility; (b) Shall be …