10-144-220 Me. Code R. § G-A-2

Current through 2024-51, December 18, 2024

Section 144-220-G-A-2 - Definitions

As used in this part, the following definitions apply:

Associate radiation safety officer means an individual who:

(1) Meets the requirements in G.50 and G.59; and

(2) Is currently identified as an associate radiation safety officer for the types of use of byproduct material for which the individual has been assigned duties and tasks by the radiation safety officer on:

(a) A specific medical use license issued by the Agency, the Nuclear Regulatory Commission or an Agreement State; or

(b) A medical use permit issued by a Nuclear Regulatory Commission master material licensee.

Authorized medical physicist means an individual who -

(1) Meets the requirements in G.51.A and G.59; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on:

(a) A specific medical use license or equivalent permit issued by the Agency, the Nuclear Regulatory Commission or an Agreement State;

(b) A medical use permit issued by a Nuclear Regulatory Commission master material licensee;

(c) A permit issued by an Agency, Nuclear Regulatory Commission or an Agreement State broad scope medical use licensee; or

(d) A permit issued by a Nuclear Regulatory Commission master medical license broad scope medical use permittee.

Authorized nuclear pharmacist means a pharmacist who:

(1) Meets the requirements in G.55.A and G.59; or

(2) Is identified as an authorized nuclear pharmacist on:

(a) A specific license or equivalent permit issued by the Agency, the Nuclear Regulatory Commission or an Agreement State, that authorizes medical use or the practice of nuclear pharmacy;

(b) A permit issued by a Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(c) A permit issued by an Agency, Nuclear Regulatory Commission or an Agreement State broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) A permit issued by a Nuclear Regulatory Commission master medical license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with Part C.11.I(2)(d).

Authorized user means a physician, dentist, or podiatrist who:

(1) Meets the requirements in G.59 and G.190, G.290, G.390, G.392.A., G.394.A, G.490, G.590, G.690 or G.790; or

(2) Is identified as an authorized user on:

(a) An Agency, Nuclear Regulatory Commission or an Agreement State license that authorizes the medical use of radioactive material;

(b) A permit issued by a Nuclear Regulatory Commission master material licensee that is authorized to permit the use of radioactive material;

(c) A permit issued by an Agency, Nuclear Regulatory Commission, or an Agreement State specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

(d) A permit issued by a Nuclear Regulatory Commission master material licensee broad scope permittee that is authorized to permit the medical use of radioactive material.

Black boxmeans the radiopharmaceutical production purification system used in a cyclotron/ PET facility.

Brachytherapy means a method of radiation therapy in which plated, embedded, activated, or sealed sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

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

Client's address means the area of use or a temporary job site for the purpose of providing mobile nuclear medicine services in accordance with G.31.

High dose-rate remote afterloader means a device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the treatment site.

Low dose-rate remote afterloader means a device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the treatment site.

Manual brachytherapy means a type of therapy in which brachytherapy sources (e.g., seeds, ribbons) are manually applied or inserted.

Medical event means an event that meets the criteria in G.3045.A or B.

Medical institution means an organization in which more than one medical discipline is practiced.

Medical use means the intentional internal or external administration of radioactive material, or the radiation there from, to patients or human research subjects under the supervision of an authorized user.

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

Mobile nuclear medicine service means the transportation of radioactive material to and its medical use at the client's address.

Ophthalmic physicist means an individual who:

(1) Meets the requirements in G.433.A(2) and G.59; and

(2) Is identified as an ophthalmic physicist on a:

(a) Specific medical use license issued by the Agency, the Nuclear Regulatory Commission or an Agreement State;

(b) Permit issued by an Agency, Nuclear Regulatory Commission or Agreement State broad scope medical use licensee;

(c) Medical use permit issued by a Nuclear Regulatory Commission master material licensee; or

(d) Permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee.

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.

Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

Preceptor means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer, or an associate radiation safety officer.

Prescribed dosage means the specified activity or range of activity of unsealed radioactive material as documented:

(1) In a written directive as specified in G.40; or

(2) In accordance with the directions of the authorized user for procedures performed pursuant to G.100, G.200, and G.300.

Prescribed dose means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

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, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

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

Radiation safety officer for medical use means an individual who:

(1) Meets the requirements in G.50.A and G.59; or

(2) Is identified as a radiation safety officer on:

(a) A specific medical use license issued by the Agency, the Nuclear Regulatory Commission, or an Agreement State; or

(b) A medical use permit issued by a Nuclear Regulatory Commission master material licensee.

Radioactive drug means any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in diagnosis, treatment, or prevention of disease or other abnormal condition.

Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

Teletherapy means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

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

Therapeutic dose means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

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

Type of use means use of radioactive material under G.100, G.200, G.300, G.400, G.500, G.600, or G.1000.

Unit dosage means a dosage that:

(1) Is obtained and prepared in accordance with the regulations for uses described in G.100, G.200, G.300, G.400, G.500, G.600, and G.1000; and

(2) Is 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.

Written directive means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in G.15.

10-144 C.M.R. ch. 220, § G-A-2