Or. Admin. R. 333-116-0020

Current through Register Vol. 63, No. 9, September 1, 2024

Section 333-116-0020 - Definitions

As used in this division, the following definitions apply:

(1) "Address of use" means the building or buildings identified on the license as the location(s) where radioactive material may be received, used, or stored.

(2) "Area of use" means location(s) at the address of use set aside for the purpose of receiving, using or storing radioactive material.

(3) "Associate Radiation Safety Officer" means an individual who:

(a) Meets the requirements in OAR 333-116-0640 and 333-116-0760; and

(b) Is currently identified as an Associate Radiation Safety Officer for the types of use of byproduct materials 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 Authority, U.S. Nuclear Regulatory Commission, or an Agreement State; or

(B) A medical use permit issued by the U.S. Nuclear Regulatory Commission master material licensee.

(4) "Attestation" means required training, experience and appropriate board certification is validated using the Nuclear Regulatory Commission's form 313A.

(5) "Authorized Medical Physicist" means an individual who:

(a) Meets the requirements in OAR 333-116-0730, or 333-116-0905 and 333-116-0760; or

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

(A) A specific medical use license issued by the Authority or an Agreement State or the US Nuclear Regulatory Commission;

(B) A medical use permit issued by a Commission master material licensee;

(C) A permit issued by a Commission or Agreement State broad scope medical use licensee; or

(D) A permit issued by a Commission master material license broad scope medical use permittee.

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

(a) Meets the requirements in OAR 333-116-0910.

(b) Is identified as an authorized nuclear pharmacist on an Authority, Agreement State, or U.S. Nuclear Regulatory Commission license that authorizes the use of radioactive material in the practice of nuclear pharmacy;

(c) Is identified as an authorized nuclear pharmacist on a license issued by an Authority, Agreement State, or U.S. Nuclear Regulatory Commission specific licensee of broad scope that is authorized to permit the use of radioactive material in the practice of nuclear pharmacy; or

(d) Is approved as an authorized nuclear pharmacist by a nuclear pharmacy licensed (authorized) by the Authority, the U.S. Nuclear Regulatory Commission, or an Agreement State to approve authorized nuclear pharmacists.

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

(a) Meets the requirements listed in OAR 333-116-0660, 333-116-0670, 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0690, 333-116-0700, 333-116-0710, 333-116-0720, and 333-116-0740;

(b) Is identified as an authorized user on an Authority, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license that authorizes the medical use of radioactive material; or

(c) Is identified as an authorized user on a permit issued by an Authority, Agreement State, or U.S. Nuclear Regulatory Commission licensee of broad scope that is authorized to permit the medical use of radioactive material.

(8) "Black Box" means the radiopharmaceutical production purification system used in a PET facility.

(9) "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.

(10) "Brachytherapy source" means an individual sealed source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose of radiation within a few centimeters, by surface, intracavitary, or interstitial application that is not designed to be disassembled by the user.

(11) "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. This source may also be used for other purposes.

(12) "Dental use" means the intentional external administration of the radiation from radioactive material to human beings in the practice of dentistry in accordance with a license issued by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(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) "Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

(15) "High dose-rate remote afterloader" means a device that remotely delivers a brachytherapy source, with a dose rate in excess of two gray (200 rad) per hour, to the point or surface where the dose is prescribed.

(16) "Human Research Subject" means a living person that an authorized user, conducting research, obtains data resulting from the intentional internal or external administration of radioactive material, or the radiation from radioactive material, to the individual. For the purpose of these rules, unless otherwise noted, the term patient applies to a human research subject.

(17) "Low dose-rate remote afterloader" means a device that remotely delivers a brachytherapy source, with a dose rate of less than two gray (200 rad) per hour, to the point or surface where the dose is prescribed.

(18) "Management" means the chief executive officer or that individual's designee.

(19) "Manual Brachytherapy", as used in this part, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed on, or in close proximity, to the treatment site or inserted directly into the tissue volume.

(20) "Medical Event" means an event that meets the criteria in OAR 333-116-1000.

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

(22) "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.

(23) "Ministerial change" means a change that is made, after ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making a discretionary judgment about whether those requirements should apply in the case at hand.

(24) "Mobile nuclear medicine service" means the transportation and medical use of radioactive material.

(25) "Nuclear Pharmacist" means an authorized nuclear pharmacist, as defined in OAR 333-116-0020, who has received additional training, pursuant to OAR 333-116-0910 in the management and handling of radiopharmaceutical drugs and is authorized by license to receive, use, transfer, and dispose of such radiopharmaceutical drugs.

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

(a) Meets the requirements in OAR 333-116-0447 and OAR 333-116-0760; and

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

(A) Specific medical use license issued by the Authority, U.S. or Nuclear Regulatory Commission, or an Agreement State.

(B) Permit issued by an Agreement State, Authority, or U.S. Nuclear Regulatory Commission broad scope medical use licensee.

(C) Medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; or

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

(27) "Output" means the exposure rate, dose rate or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

(28) "Patient Intervention" means actions taken by a patient or human research subject, whether intentional or unintentional, interrupt or terminate the administration of radioactive materials or radiation.

(29) "PET" means Positron Emission Tomography.

(30) "PET Isotope Nuclear Pharmacy" means a licensed facility that compounds radiopharmaceuticals using positron emitting isotopes for use at licensed medical facilities.

(31) "PET cyclotron facility" means a facility that manufactures short-lived radioisotopes for use in compounding radiopharmaceuticals at a PET Isotope Nuclear Pharmacy.

(32) "PET Medical Facility" means a clinical nuclear medicine facility that utilizes positron-emitting isotopes for diagnostic imaging.

(33) "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.

(34) "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.

(35) "Podiatric use" means the intentional external administration of the radiation from byproduct material to human beings in the practice of podiatry in accordance with a license issued by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(36) "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.

(37) "Positron Emission Tomography (PET) facility" means a facility comprised of an accelerator that produces positron-emitting isotopes, a radiopharmacy that specializes in preparation of PET radiopharmaceuticals, and/or a clinic that uses PET isotopes for medical diagnostic purposes.

(38) "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 an Associate Radiation Safety Officer. The preceptor must have previously met all of the applicable requirements and be so named on a radioactive materials license issued by the Authority, the Nuclear Regulatory Commission, an Agreement State or licensing state.

(39) "Prescribed dosage" means the specified activity or range of activity of a radiopharmaceutical or radioisotope as documented:

(a) In a written directive; or

(b) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.

(40) "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.

(41) "Pulsed dose-rate remote afterloader" means a special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose rate" range, but is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour.

(42) "Radiation Safety Officer" means an individual who:

(a) Meets the requirements in OAR 333-116-0640, 333-116-0650, 333-116-0740 and 333-116-0760; or

(b) Is identified as a Radiation Safety Officer on:

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

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

(43) "Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

(44) "Stereotactic Radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a dose to a tissue volume.

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

(46) "Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

(47) "Teletherapy physicist" means the individual identified as the qualified teletherapy physicist on an Authority license.

(48) "Therapeutic Dosage" means a dosage of unsealed byproduct material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(49) "Therapeutic Dose" means a radiation dose delivered from a source containing byproduct material to a patient or human research subject for palliative or curative treatment.

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

(51) "Unit dosage" means a dosage intended for medical use in a single patient or human research subject that has been obtained from a manufacturer or preparer licensed by the Authority as a nuclear pharmacy.

(52) "Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.

(53) "Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in OAR 333-116-0125(1)(e), containing the following information:

(a) For any administration of quantities greater than 1.11 megabecquerels (30 uCi) of either sodium iodide I-125 or I-131: the dosage;

(b) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration;

(c) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;

(d) For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period;

(e) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or

(f) For all other brachytherapy:

(A) Prior to implantation: the radioisotope, number of sources, and source strengths; and

(B) After implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

Or. Admin. R. 333-116-0020

HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 25-2016, f. 8-26-16, cert. ef. 9/1/2016; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021; PH 172-2022, amend filed 08/11/2022, effective 8/20/2022

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807