Wash. Admin. Code § 246-240-010

Current through Register Vol. 25-01, January 1, 2025

Section 246-240-010 - Definitions, abbreviations, and acronyms

The definitions, abbreviations, and acronyms in this section and in WAC 246-220-010 apply throughout this chapter unless the context clearly indicates otherwise.

(1) "Address of use" means the building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.

(2) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.

(3) "Associate radiation safety officer" means an individual who:

(a) Meets the requirements in WAC 246-240-069 and 246-240-081; and

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

(i) A specific medical use license issued by the department, NRC, or an agreement state; or

(ii) A medical use permit issued by an NRC master material licensee.

(4) "Attestation" means written certification under oath.

(5) "Authorized medical physicist" means an individual who:

(a) Meets the requirements in WAC 246-240-072 and 246-240-081; or

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

(i) A specific medical use license issued by the department, NRC, or an agreement state;

(ii) A medical use permit issued by an NRC master material licensee;

(iii) A permit issued by an NRC or agreement state broad scope medical use licensee; or

(iv) A permit issued by an NRC master material license broad scope medical use permittee.

(6) "Authorized nuclear pharmacist" means a pharmacist who:

(a) Meets the requirements in WAC 246-240-075 and 246-240-081; or

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

(i) A specific license issued by the department, NRC, or an agreement state, that authorizes medical use or the practice of nuclear pharmacy;

(ii) A permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(iii) A permit issued by an NRC or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(iv) A permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

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

(d) Is designated as an authorized nuclear pharmacist in accordance with WAC 246-235-100(2).

(7) "Authorized user" means a physician, dentist, or podiatrist who:

(a) Meets the requirements in WAC 246-240-081 and 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, 246-240-301, or 246-240-399; or

(b) Is identified as an authorized user on:

(i) A department, NRC, or agreement state license that authorizes the medical use of radioactive material; or

(ii) A permit issued by an NRC master material licensee that is authorized to permit the medical use of radioactive material; or

(iii) A permit issued by a department, NRC, or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

(iv) A permit issued by an NRC master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(8) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(9) "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.

(10) "Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with WAC 246-240-125.

(11) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of 10 mega-electron volts and is commonly used for production of short half-life radionuclides for medical use.

(12) "Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

(13) "Dentist" means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

(14) "FDA" means the U.S. Food and Drug Administration.

(15) "High dose-rate remote afterloader" 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.

(16) "Low dose-rate remote afterloader" means a brachytherapy device that remotely delivers a dose rate of less than or equal to two gray (200 rads) per hour at the point or surface where the dose is prescribed.

(17) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or that person's delegate or delegates.

(18) "Manual brachytherapy" means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

(19) "Medical event" means an event that meets the criteria in WAC 246-240-651.

(20) "Medical institution" means an organization in which more than one medical discipline is practiced.

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

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

(23) "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

(24) "Ophthalmic physicist" means an individual who:

(a) Meets the requirements in WAC 246-240-272 (1)(b) and 246-240-081; and

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

(i) Specific medical use license issued by the NRC or an agreement state;

(ii) Permit issued by an NRC or agreement state broad scope medical use licensee;

(iii) Medical use permit issued by an NRC master material licensee; or

(iv) Permit issued by an NRC master material licensee broad scope medical use permittee.

(25) "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.

(26) "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.

(27) "Podiatrist" means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

(28) "Positron emission tomography (PET) radionuclide production facility" means a facility operating an accelerator for the purpose of producing positron emission tomography radionuclides.

(29) "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, an authorized radiation safety officer, or an associate radiation safety officer.

(30) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

(a) In a written directive; or

(b) In accordance with the directions of the authorized user for procedures performed under WAC 246-240-151 and 246-240-157.

(31) "Prescribed dose" means:

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

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

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

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

(32) "Pulsed dose-rate remote afterloader" 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:

(a) Is approximately 1/10th of the activity of typical high dose-rate remote afterloader sources; and

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

(33) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by NRC and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(34) "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.

(35) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

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

(37) "Temporary job site" means a location where mobile medical services are conducted at other than those fixed locations of use authorized by the license.

(38) "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.

(39) "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.

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

(41) "Type of use" means use of radioactive material under WAC 246-240-151, 246-240-157, 246-240-201, 246-240-251, 246-240-301, 246-240-351, or 246-240-501.

(42) "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.

(43) "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 WAC 246-240-060.

Wash. Admin. Code § 246-240-010

Amended by WSR 22-19-084, Filed 9/20/2022, effective 10/21/2022

Amended by WSR 23-21-056, Filed 10/11/2023, effective 11/11/2023

Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-010, filed 1/18/11, effective 2/18/11. Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-010, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-010, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-010, filed 2/6/06, effective 3/9/06; 98-13-037, § 246-240-010, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-240-010, filed 2/21/92, effective 3/23/92.