Fla. Admin. Code R. 64E-5.6011

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Current through Reg. 50, No. 235-239, December 10, 2024

Section 64E-5.6011 - Definitions

(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 the NRC or an agreement state,

2. A medical use permit issued by a NRC master material licensee,

3. A permit issued by a NRC or agreement state broad scope medical use licensee, or

4. A permit issued by a NRC master material license broad scope medical use permittee.

(2) "Authorized user" means:

(a) A physician, dentist, or podiatrist who meets the requirements in Rule 64E-5.658 and subsection 64E-5.649(1), 64E-5.660(1), 64E-5.661(1), 64E-5.662(1), 64E-5.652(1), 64E-5.654(1) or 64E-5.655(1), F.A.C., or

(b) An individual identified for medical use of radioactive materials on:

1. A NRC or agreement state license that authorizes the medical use of radioactive material,

2. A permit issued by a NRC master material licensee that is authorized to permit the medical use of radioactive material,

3. A permit issued by a NRC or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material, or

4. A permit issued by a NRC master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(3) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose by surface, intracavitary, intralumimnal or interstitial application.

(4) "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

(5) "Diagnostic clinical procedures manual" means a collection of written procedures that describes each method by which the licensee shall perform diagnostic clinical procedures, and provides other instructions and precautions related thereto. Each diagnostic clinical procedure shall be approved by the authorized user and shall include the radiopharmaceutical, dosage, and route of administration.

(6) "High dose-rate remote afterloader, " as used in this part, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(7) "Low dose-rate remote afterloader, " as used in this part, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

(8) "Manual brachytherapy, " as used in this part, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually delivered.

(9) "Medical use" means the intentional internal or external administration of radioactive material, or the radiation therefrom, to patients or human research subjects under the supervision of an authorized user.

(10) "Medium dose-rate remote afterloader, " as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(11) "Mobile medical service" means the ability to transport and use radioactive materials for medical use at the client's address.

(12) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(13) "Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user under Chapter 64E-5, Part VI, F.A.C., an authorized medical physicist, an authorized nuclear pharmacist or a RSO under Chapter 64E-5 Part VI, F.A.C.

(14) "Pulsed dose-rate remote afterloader, " as used in this part, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate" range, provided that the source is:

(a) Approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and,

(b) Used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(15) "Radiation Safety Officer" or "RSO" means an individual who:

(a) Meets the requirements in subsection 64E-5.648(1) or paragraph 64E-5.648(3)(a) and Rule 64E-5.658, F.A.C., or

(b) . Is identified as a RSO on a specific medical use license issued by the NRC or an agreement state or a medical use permit issued by a NRC master material licensee.

(16) "Teletherapy physicist" means an individual identified as the qualified teletherapy physicist on a department license.

(17) "Therapeutic dosage" means a dosage of unsealed radioactive materials that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(18) "Therapeutic dose" means a radiation dose delivered from a source containing radioactive materials to a patient or human research subject for palliative or curative treatment.

(19) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(20) "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

Fla. Admin. Code Ann. R. 64E-5.6011

Rulemaking Authority 404.051, 404.061 FS. Law Implemented 404.031, 404.061(2), 404.20, 404.22, 404.30 FS.

New 2-11-10, Amended 12-26-13.