N.M. Admin. Code § 20.3.7.7

Current through Register Vol. 35, No. 21, November 5, 2024

Section 20.3.7.7 - DEFINITIONS

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

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

C."Associate Radiation Safety Officer (ARSO)" means an individual who:

(1) Meets the requirements in 10 CFR § 35.50 and 10 CFR § 35.59; 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 Commission or an Agreement State; or

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

D."Authorized medical physicist" means an individual who:

(1) meets the requirements in Subsection B of 20.3.7.714 NMAC, incorporating 10 CFR 35.51(a), and Subsection E of 20.3.7.714 NMAC; or

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

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

(b) a medical use permit issued by a NRC master material licensee;

(c) a permit issued by the department, NRC or agreement state broad scope medical use licensee; or

(d) a permit issued by a NRC master material license broad scope medical use permittee.

E."Authorized nuclear pharmacist" means a pharmacist who:

(1) meets the requirements in Subsection C of 20.3.7.714 NMAC, incorporating 10 CFR 35.55(a), and Subsection E of 20.3.7.714 NMAC; or

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

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

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

(c) a permit issued by a department, NRC or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) a permit issued by a NRC master material 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 Subparagraph (e) of Paragraph (2) of Subsection J of 20.3.3.315 NMAC.

F."Authorized user" means a physician, dentist or podiatrist who:

(1) meets the requirements in Subsection E of 20.3.7.714 NMAC and any of the following subsections of 20.3.7.714 NMAC: Subsection F, incorporating 10 CFR 35.190(a); Subsection G, incorporating 10 CFR 35.290(a); Subsection H, incorporating 10 CFR 35.390(a); Subsection I, incorporating 10 CFR 35.392(a); Subsection J, incorporating 10 CFR 35.394(a); Subsection L, incorporating 10 CFR 35.490(a); Subsection N, incorporating 10 CFR 35.590(a); or Subsection O, incorporating 10 CFR 35.690(a); or

(2) is identified as an authorized user on:

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

(b) a permit issued by a NRC master material licensee that is authorized to permit the medical use of radioactive material;

(c) 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

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

G."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.

H."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.

I."Client's address" means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with Subsection J of 20.3.7.703 NMAC.

J."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.

K."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.

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

M."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 two grays (200 rads) per hour at the point or surface where the dose is prescribed.

N."Management" means the chief executive officer or other individual having the authority to manage, direct or administer the licensee's activities or those persons' delegate or delegates.

O."Manual brachytherapy", as used in this part, 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.

P."Medical event" means an event that meets the criteria in Paragraph (1) or (2) of Subsection A of 20.3.7.716 NMAC.

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

R."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.

S."Medium dose-rate remote afterloader", as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than two grays (200 rads) per hour, but less than or equal to12 grays (1200 rads) per hour at the point or surface where the dose is prescribed.

T."Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

U."NIST" means the national institute of standards and technology which is the standards-defining agency of the United States government, formerly the national bureau of standards. It is one of three agencies that fall under the technology administration (www.technology.gov), a branch of the United States commerce department that is devoted to advancing American economic growth through the use of technology.

V."Ophthalmic physicist" means an individual who

(1) Meets the requirements in 10 CFR § 35.433(a)(2) and 10 CFR § 35.59; and

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

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

(b) Permit issued by a Commission or Agreement State broad scope medical use licensee;

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

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

W."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.

X."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.

Y."Pharmacist" 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 pharmacy.

Z."Physician" means a medical doctor or doctor of osteopathy licensed by a state or territory of the United States, the District of Columbia or the commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

AA."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.

BB. "Positron emission tomography (PET) radionuclide production facility" is defined as a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

CC."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, radiation safety officer or a associate radiation officer.

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

(1) in a written directive; or

(2) in accordance with the directions of the authorized user for procedures performed pursuant to 20.3.7.704 NMAC and 20.3.7.705 NMAC.

EE."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.

FF."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.

GG."Radiation safety officer" means an individual who:

(1) meets the requirements in Subsection E of 20.3.7.714 NMAC and either Subsection A of 20.3.7.714 NMAC, incorporating 10 CFR 35.50(a), or Subsection A of 20.3.3.714 NMAC, incorporating 10 CFR 35.50(c)(1); or

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

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

(b) a medical use permit issued by a NRC master material licensee.

HH."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.

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

JJ."Teletherapy", as used in this part, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

KK."Temporary job site" means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

LL."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.

MM."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.

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

OO."Type of use" means use of radioactive material under the following sections: 20.3.7.704 NMAC, 20.3.7.705 NMAC, 20.3.7.708 NMAC, 20.3.7.710 NMAC, 20.3.7.711 NMAC, 20.3.7.712 NMAC and 20.3.7.713 NMAC.

PP."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.

QQ."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 object, as specified in Subsection G of 20.3.7.702 NMAC.

N.M. Admin. Code § 20.3.7.7

20.3.7.7 NMAC - Rp, 20 NMAC 3.1.7.701, 4/30/2009, Amended by New Mexico Register, Volume XXXIV, Issue 03, February 14, 2023, eff. 2/14/2023