ML22243A238
| ML22243A238 | |
| Person / Time | |
|---|---|
| Issue date: | 08/30/2022 |
| From: | Office of Nuclear Material Safety and Safeguards |
| To: | State of NM, Environment Dept |
| Poy S | |
| Shared Package | |
| ML22243A198 | List: |
| References | |
| Download: ML22243A238 (36) | |
Text
1 TITLE 20 ENVIRONMENTAL PROTECTION 2 CHAPTER 3 RADIATION PROTECTION 3 PART 7 MEDICAL USE OF RADIONUCLIDES 4
5 20.3.7.1 ISSUING AGENCY: Environmental Improvement Board.
6 [20.3.7.1 NMAC - Rp, 20 NMAC 3.1.1.100, 4/30/2009]
7 8 20.3.7.2 SCOPE: This part contains the requirements and provisions for the medical use of radioactive 9 materials and for issuance of specific licenses authorizing the medical use of radioactive material. These 10 requirements and provisions provide for the radiation safety of workers, the general public, patients and human 11 research subjects. The requirements and provisions of this part are in addition to, and not in substitution for, other 12 parts in this chapter. The requirements and provisions of 20.3.3 NMAC, 20.3.4 NMAC, 20.3.10 NMAC and 20.3.16 13 NMAC apply to applicants and licensees subject to this part unless specifically exempted. Other federal, state or 14 local regulations may apply.
15 [20.3.7.2 NMAC - Rp, 20 NMAC 3.1.7.700, 4/30/2009]
16 17 20.3.7.3 STATUTORY AUTHORITY: Sections 74-1-9, 74-3-5 and 74-3-9 NMSA 1978.
18 [20.3.7.3 NMAC - Rp, 20 NMAC 3.1.1.102, 4/30/2009]
19 20 20.3.7.4 DURATION: Permanent.
21 [20.3.7.4 NMAC - Rp, 20 NMAC 3.1.1.103, 4/30/2009]
22 23 20.3.7.5 EFFECTIVE DATE: April 30, 2009, unless a later date is cited at the end of a section.
24 [20.3.7.5 NMAC - Rp, 20 NMAC 3.1.1.104, 4/30/2009]
25 26 20.3.7.6 OBJECTIVE: This part provides for the medical use and licensing of radioactive materials.
27 [20.3.7.6 NMAC - Rp, 20 NMAC 3.1.1.105, 4/30/2009]
28 29 20.3.7.7 DEFINITIONS:
30 A. "Address of use" means the building or buildings that are identified on the license and where 31 radioactive material may be prepared, received, used or stored.
32 B. "Area of use" means a portion of an address of use that has been set aside for the purpose of 33 preparing, receiving, using or storing radioactive material.
34 C. Associate Radiation Safety Officer (ARSO) means an individual who:
35 (1) Meets the requirements in 10 CFR § 35.50 and 10 CFR §35.59; and 36 (2) Is currently identified as an Associate Radiation Safety Officer for the types of use of 37 byproduct material for which the individual has been assigned duties and tasks by the Radiation Safety Officer on:
38 (a) A specific medical use license issued by the Commission or an Agreement State; 39 or 40 (b) A medical use permit issued by a Commission master material licensee.
41 [C] D. Authorized medical physicist means an individual who:
42 (1) meets the requirements in Subsection B of 20.3.7.714 NMAC, incorporating 10 CFR 43 35.51(a), and Subsection E of 20.3.7.714 NMAC; or 44 (2) is identified as an authorized medical physicist or teletherapy physicist on:
45 (a) a specific medical use license issued by the department, NRC or agreement 46 state; 47 (b) a medical use permit issued by a NRC master material licensee; 48 (c) a permit issued by the department, NRC or agreement state broad scope medical 49 use licensee; or 50 (d) a permit issued by a NRC master material license broad scope medical use 51 permittee.
52 [D] E. "Authorized nuclear pharmacist" means a pharmacist who:
53 (1) meets the requirements in Subsection C of 20.3.7.714 NMAC, incorporating 10 CFR 54 35.55(a), and Subsection E of 20.3.7.714 NMAC; or 55 (2) is identified as an authorized nuclear pharmacist on:
20.3.7 NMAC 1
1 (a) a specific license issued by the department, NRC or agreement state that 2 authorizes medical use or the practice of nuclear pharmacy; 3 (b) a permit issued by a NRC master material licensee that authorizes medical use 4 or the practice of nuclear pharmacy; 5 (c) a permit issued by a department, NRC or agreement state broad scope medical 6 use licensee that authorizes medical use or the practice of nuclear pharmacy; or 7 (d) a permit issued by a NRC master material license broad scope medical use 8 permittee that authorizes medical use or the practice of nuclear pharmacy; or 9 (3) is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that 10 has been authorized to identify authorized nuclear pharmacists; or 11 (4) is designated as an authorized nuclear pharmacist in accordance with Subparagraph (e) of 12 Paragraph (2) of Subsection J of 20.3.3.315 NMAC.
13 [E] F. "Authorized user" means a physician, dentist or podiatrist who:
14 (1) meets the requirements in Subsection E of 20.3.7.714 NMAC and any of the following 15 subsections of 20.3.7.714 NMAC: Subsection F, incorporating 10 CFR 35.190(a); Subsection G, incorporating 10 16 CFR 35.290(a); Subsection H, incorporating 10 CFR 35.390(a); Subsection I, incorporating 10 CFR 35.392(a);
17 Subsection J, incorporating 10 CFR 35.394(a); Subsection L, incorporating 10 CFR 35.490(a); Subsection N, 18 incorporating 10 CFR 35.590(a); or Subsection O, incorporating 10 CFR 35.690(a); or 19 (2) is identified as an authorized user on:
20 (a) a department, NRC or agreement state license that authorizes the medical use of 21 radioactive material; 22 (b) a permit issued by a NRC master material licensee that is authorized to permit 23 the medical use of radioactive material; 24 (c) a permit issued by a department, NRC or agreement state specific licensee of 25 broad scope that is authorized to permit the medical use of radioactive material; or 26 (d) a permit issued by a NRC master material license broad scope permittee that is 27 authorized to permit the medical use of radioactive material.
28 [F] G. Brachytherapy means a method of radiation therapy in which sources are used to deliver a 29 radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal or interstitial 30 application.
31 [G] H. Brachytherapy source means a radioactive source or a manufacturer-assembled source train or 32 a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.
33 [H] I. Client's address means the area of use or a temporary job site for the purpose of providing 34 mobile medical service in accordance with Subsection J of 20.3.7.703 NMAC.
35 [I] J. "Dedicated check source" means a radioactive source that is used to assure the constant 36 operation of a radiation detection or measurement device over several months or years.
37 [J] K. Dentist means an individual licensed by a state or territory of the United States, the District of 38 Columbia or the commonwealth of Puerto Rico to practice dentistry.
39 [K] L. High dose-rate remote afterloader, as used in this part, means a brachytherapy device that 40 remotely delivers a dose rate in excess of 12 grays (1200 rads) per hour at the point or surface where the dose is 41 prescribed.
42 [L] M. Low dose-rate remote afterloader, as used in this part, means a brachytherapy device that 43 remotely delivers a dose rate of less than or equal to two grays (200 rads) per hour at the point or surface where the 44 dose is prescribed.
45 [M] N. Management means the chief executive officer or other individual having the authority to 46 manage, direct or administer the licensee's activities or those persons' delegate or delegates.
47 [N] O. Manual brachytherapy, as used in this part, means a type of brachytherapy in which the 48 brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities 49 that are in close proximity to a treatment site or directly into the tissue volume.
50 [O] P. Medical event means an event that meets the criteria in Paragraph (1) or (2) of Subsection A of 51 20.3.7.716 NMAC.
52 [P] Q. Medical institution means an organization in which more than one medical discipline is 53 practiced.
54 [Q] R. Medical use means the intentional internal or external administration of radioactive material or 55 the radiation from radioactive material to patients or human research subjects under the supervision of an authorized 56 user.
20.3.7 NMAC 2
1 [R] S. Medium dose-rate remote afterloader, as used in this part, means a brachytherapy device that 2 remotely delivers a dose rate of greater than two grays (200 rads) per hour, but less than or equal to12 grays (1200 3 rads) per hour at the point or surface where the dose is prescribed.
4 [S] T. Mobile medical service means the transportation of radioactive material to and its medical use 5 at the client's address.
6 [T] U. NIST means the national institute of standards and technology which is the standards-defining 7 agency of the United States government, formerly the national bureau of standards. It is one of three agencies that 8 fall under the technology administration (www.technology.gov), a branch of the United States commerce 9 department that is devoted to advancing American economic growth through the use of technology.
10 V. Ophthalmic physicist means an individual who 11 (1) Meets the requirements in 10 CFR § 35.433(a)(2) and 10 CFR § 35.59; and 12 (2) Is identified as an ophthalmic physicist on a:
13 (a) Specific medical use license issued by the Commission or an 14 Agreement State; 15 (b) Permit issued by a Commission or Agreement State broad scope 16 medical use licensee; 17 (c) Medical use permit issued by a Commission master material licensee; 18 or 19 (d) Permit issued by a Commission master material licensee broad scope 20 medical use permittee.
21 [U] W. Output means the exposure rate, dose rate or a quantity related in a known manner to these 22 rates from a brachytherapy source or a teletherapy, remote afterloader or gamma stereotactic radiosurgery unit for a 23 specified set of exposure conditions.
24 [V] X. Patient intervention means actions by the patient or human research subject, whether 25 intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the 26 administration.
27 [W] Y. Pharmacist means an individual licensed by a state or territory of the United States, the District 28 of Columbia or the commonwealth of Puerto Rico to practice pharmacy.
29 [X] Z. Physician means a medical doctor or doctor of osteopathy licensed by a state or territory of the 30 United States, the District of Columbia or the commonwealth of Puerto Rico to prescribe drugs in the practice of 31 medicine.
32 [Y] AA. Podiatrist means an individual licensed by a state or territory of the United States, the 33 District of Columbia or the commonwealth of Puerto Rico to practice podiatry.
34 [Z] BB. Positron emission tomography (PET) radionuclide production facility is defined as 35 a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.
36 [AA] CC. Preceptor means an individual who provides, directs or verifies training and 37 experience required for an individual to become an authorized user, an authorized medical physicist, an authorized 38 nuclear pharmacist, [or a] R[r]adiation S[s]afety O[o]fficer, or a Associate Radiation Officer.
39 [BB] DD. Prescribed dosage means the specified activity or range of activity of unsealed 40 radioactive material as documented:
41 (1) in a written directive; or 42 (2) in accordance with the directions of the authorized user for procedures performed 43 pursuant to 20.3.7.704 NMAC and 20.3.7.705 NMAC.
44 [CC] EE. Prescribed dose means:
45 (1) for gamma stereotactic radiosurgery, the total dose as documented in the written 46 directive; 47 (2) for teletherapy, the total dose and dose per fraction as documented in the written 48 directive; 49 (3) for manual brachytherapy, either the total source strength and exposure time or the total 50 dose, as documented in the written directive; or 51 (4) for remote brachytherapy afterloaders, the total dose and dose per fraction as documented 52 in the written directive.
53 [DD] FF. Pulsed dose-rate remote afterloader, as used in this part, means a special 54 type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the 55 high dose-rate range, but:
20.3.7 NMAC 3
1 (1) is approximately one-tenth of the activity of typical high dose-rate remote afterloader 2 sources; and 3 (2) is used to simulate the radiobiology of a low dose-rate treatment by inserting the source 4 for a given fraction of each hour.
5 [EE] GG. Radiation safety officer means an individual who:
6 (1) meets the requirements in Subsection E of 20.3.7.714 NMAC and either Subsection A of 7 20.3.7.714 NMAC, incorporating 10 CFR 35.50(a), or Subsection A of 20.3.3.714 NMAC, incorporating 10 CFR 8 35.50(c)(1); or 9 (2) is identified as a radiation safety officer on:
10 (a) a specific medical use license issued by the department, NRC or agreement 11 state; or 12 (b) a medical use permit issued by a NRC master material licensee.
13 [FF] HH. Stereotactic radiosurgery means the use of external radiation in conjunction with a 14 stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.
15 [GG] II. Structured educational program means an educational program designed to impart particular 16 knowledge and practical education through interrelated studies and supervised training.
17 [HH] JJ. "Teletherapy", as used in this part, means a method of radiation therapy in which 18 collimated gamma rays are delivered at a distance from the patient or human research subject.
19 [II] KK. Temporary job site means a location where mobile medical services are conducted 20 other than those location(s) of use authorized on the license.
21 [JJ] LL. Therapeutic dosage means a dosage of unsealed radioactive material that is intended 22 to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.
23 [KK] MM. Therapeutic dose means a radiation dose delivered from a source containing 24 radioactive material to a patient or human research subject for palliative or curative treatment.
25 [LL] NN. Treatment site means the anatomical description of the tissue intended to receive a 26 radiation dose, as described in a written directive.
27 [MM] OO. Type of use means use of radioactive material under the following sections: 20.3.7.704 28 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 29 20.3.7.713 NMAC.
30 [NN] PP. Unit dosage means a dosage prepared for medical use for administration as a single 31 dosage to a patient or human research subject without any further manipulation of the dosage after it is initially 32 prepared.
33 [OO] QQ. "Written directive" means an authorized users written order for the administration of 34 radioactive material or radiation from radioactive material to a specific patient or human research object, as 35 specified in Subsection G of 20.3.7.702 NMAC.
36 [20.3.7.7 NMAC - Rp, 20 NMAC 3.1.7.701, 04/30/2009; A, XX/XX/2022]
37 38 20.3.7.8 - 20.3.7.699 [RESERVED]
39 40 20.3.7.700 GENERAL REGULATORY REQUIREMENTS:
41 A. Provisions for research involving human subjects.
42 (1) A licensee may conduct research involving human research subjects only if it uses the 43 radioactive materials specified on its license for the uses authorized on the license.
44 (2) If the research is conducted, funded, supported or regulated by a federal agency that has 45 implemented the federal policy for the protection of human subjects (45 CFR Part 46), the licensee shall, before 46 conducting research:
47 (a) obtain review and approval of the research from an institutional review board, 48 as defined and described in the federal policy for the protection of human subjects; and 49 (b) obtain informed consent, as defined and described in the federal policy for the 50 protection of human subjects, from the human research subject.
51 (3) If the research will not be conducted, funded, supported or regulated by a federal agency 52 that has implemented the federal policy for the protection of human subjects, the licensee shall, before conducting 53 research, apply for and receive a specific amendment to its medical use license issued by the department. The 54 amendment request must include a written commitment that the licensee will, before conducting research:
55 (a) obtain review and approval of the research from an institutional review board, 56 as defined and described in the federal policy for the protection of human subjects; and 20.3.7 NMAC 4
1 (b) obtain informed consent, as defined and described in the federal policy for the 2 protection of human subjects, from the human research subject.
3 (4) Nothing in this subsection relieves licensees from complying with the other requirements 4 in this part.
5 B. FDA, federal and state requirements. Nothing in this part relieves the licensee from complying 6 with applicable FDA, other federal and state requirements governing radioactive drugs or devices.
7 C. Implementation.
8 (1) When a requirement in this part differs from the requirement in an existing license 9 condition, the requirement in this part shall govern.
10 (2) A licensee shall continue to comply with any license condition that requires it to 11 implement procedures required by Subsections D, J, K and L of 20.3.7.711 NMAC until there is a license 12 amendment or renewal that modifies the license condition.
13 D. License required.
14 (1) A person may manufacture, produce, acquire, receive, possess, prepare, use or transfer 15 radioactive material for medical use only in accordance with a specific license issued by the department or as 16 allowed in Paragraph (2) of this subsection.
17 (2) A specific license is not needed for an individual who:
18 (a) receives, possesses, uses or transfers radioactive material in accordance with the 19 requirements in this chapter under the supervision of an authorized user as provided in Subsection F of 20.3.7.702 20 NMAC unless prohibited by license condition; or 21 (b) prepares unsealed radioactive material for medical use in accordance with the 22 requirements in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as 23 provided in Subsection F of 20.3.7.702 NMAC unless prohibited by license condition.
24 E. Application for license, amendment or renewal.
25 (1) An application must be signed by the applicant or licensee, or a person duly authorized to 26 act for or on their behalf.
27 (2) An application for a license for medical use of radioactive material as described in 28 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 29 NMAC and 20.3.7.713 NMAC must be made by:
30 (a) filing in duplicate of a department form, application for radioactive material 31 license, completed according to the instructions in the form; and 32 (b) submitting written procedures required by Subsections D, J, K and L of 33 20.3.7.711 NMAC, as applicable.
34 (3) An application for a specific license of category 1 and category 2 quantities of radioactive 35 material shall comply with 10 CFR 37. The licensee shall comply with 10 CFR 37 except as follows:
36 (a) any reference to the commission or NRC shall be deemed a reference to the 37 department; 38 (b) 10 CFR 37.5 Definitions of: agreement state, byproduct material, commission 39 and person shall not be applicable, 40 (c) 10 CFR 37.7, 10 CFR 37.9, 10 CFR 37.11(a) and (b), 10 CFR 37.13, 10 CFR 41 37.27(c),10 CFR 37.71, 10 CFR 37.105, and 10 CFR 37.107 shall not be applicable; 42 (d) for any reporting or notification requirements that the licensee must follow in 10 43 CFR 37.45, 10 CFR 37.57, 10 CFR 37.77(a) through (d), and 10 CFR 37.81, the licensee shall use the following 44 address when applicable: New Mexico environment department/RCB, P.O. Box 5469, Santa Fe, NM 87502-5469 45 address information.
46 (4) A request for a license amendment or renewal must be made by:
47 (a) filing in duplicate of a department form, application for radioactive material 48 license, as described in Paragraph (2) of this subsection; and 49 (b) submitting procedures required by Subsections D, J, K and L of 20.3.7.711 50 NMAC, as applicable.
51 (5) In addition to the requirements in Paragraphs (2) and (3) of this subsection, an application 52 for a license or amendment for medical use of radioactive material described in 20.3.7.713 NMAC must also include 53 information regarding any radiation safety aspects of the medical use of the material that are not addressed in 54 sections 20.3.7.702 NMAC and 20.3.7.703 NMAC. The applicant shall also provide specific information on:
55 (a) radiation safety precautions and instructions; 20.3.7 NMAC 5
1 (b) methodology for measurement of dosages or doses to be administered to patients 2 or human research subjects; and 3 (c) calibration, maintenance and repair of instruments and equipment necessary for 4 radiation safety.
5 (6) The applicant or licensee shall also provide any other additional information requested by 6 the department in its review of the application, license renewal or amendment, within 30 days of the request or other 7 time as may be specified in the request.
8 (7) An applicant that satisfies the requirements specified in Subsection B of 20.3.3.314 9 NMAC may apply for a type A specific license of broad scope.
10 F. License amendments. A licensee shall apply for and must receive a license amendment:
11 (1) before it receives, prepares or uses radioactive material for a type of use that is permitted 12 under 20.3.7 NMAC but that is not authorized on the licensees current license issued under this part; 13 (2) before it permits anyone to work as an authorized user, authorized nuclear pharmacist or 14 authorized medical physicist under the license, except:
15 (a) for an authorized user, an individual who meets the definition of an authorized 16 user as defined in 20.3.7.7 NMAC; 17 (b) for an authorized nuclear pharmacist, an individual who meets the definition of 18 an authorized nuclear pharmacist as defined in 20.3.7.7 NMAC; 19 (c) for an authorized medical physicist, an individual who meets the definition of an 20 authorized medical physicist as defined in 20.3.7.7 NMAC; or 21 (d) a physician, podiatrist or dentist who used only accelerator-produced radioactive 22 materials, discrete sources of radium-226, or both, for medical uses or a nuclear pharmacist who used only 23 accelerator-produced radioactive materials in the practice of nuclear pharmacy at a government agency or federally 24 recognized Indian tribe before November 30, 2007 or at all other locations of use in non-licensing state (as defined 25 in 20.3.1.7 NMAC) before August 8, 2009, or an earlier date as noticed by the NRC, and for only those materials 26 and uses performed before these dates; 27 (3) before it changes radiation safety officers, except as provided in Paragraph (4) of 28 Subsection A of 20.3.7.702 NMAC; 29 (4) before it receives radioactive material in excess of the amount or in a different form, or 30 receives a different radioactive material than is authorized on the license; 31 (5) before it adds to or changes the areas of use identified in the application or on the license, 32 including areas used in accordance with either 20.3.7.704 NMAC or 20.3.7.705 NMAC if the change includes the 33 addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery 34 line from the PET radionuclide/PET radioactive drug production area; other areas of use where radioactive material 35 is used only in accordance with either 20.3.7.704 NMAC or 20.3.7.705 NMAC are exempt; 36 (6) before it changes the address(es) of use identified in the application or on the license; and 37 (7) before it revises procedures required by Subsections D, J, K and L of 20.3.7.711 NMAC, 38 as applicable, where such revision reduces radiation safety.
39 G. Notifications.
40 (1) For each individual, no later than 30 days after the date that the licensee permits the 41 individual to work as an authorized user, an authorized nuclear pharmacist or an authorized medical physicist under 42 Paragraph (2) of Subsection F of this section:
43 (a) the licensee shall verify the training and experience and provide the department 44 with a copy the documentation demonstrating the training and experience as listed in the definitions of authorized 45 user, authorized nuclear pharmacist or authorized medical physicist in 20.3.7.7 NMAC; or 46 (b) the licensee shall verify the training and experience and provide the department 47 of a copy of the documentation demonstrating that only accelerator-produced radioactive materials, discrete sources, 48 or both, were used for medical use or in the practice of nuclear pharmacy at a government agency or federally 49 recognized Indian tribe before November 30, 2007 or at all other locations of use in non-licensing states (as defined 50 in 20.3.1.7 NMAC) before August 8, 2009, or an earlier date as noticed by the NRC.
51 (2) A licensee shall notify the department by letter no later than 30 days after:
52 (a) an authorized user, an authorized nuclear pharmacist, radiation safety officer or 53 an authorized medical physicist permanently discontinues performance of duties under the license or has a name 54 change; 55 (b) the licensee permits an authorized user or an individual qualified to be a 56 radiation safety officer, under Subsection A of 20.3.7.714 NMAC, incorporating 10 CFR 35.50 and Subsection E of 20.3.7 NMAC 6
1 20.3.7.714 NMAC, to function as a temporary radiation safety officer and to perform the functions of a radiation 2 safety officer in accordance with Paragraph (4) of Subsection A of 20.3.7.702 NMAC.
3 (c) the licensee's mailing address changes; 4 (d) the licensee's name changes, but the name change does not constitute a transfer 5 of control of the license as described in Subsection B of 20.3.3.317 NMAC; or 6 (e) the licensee has added to or changed the areas of use identified in the application 7 or on the license where radioactive material is used in accordance with either 20.3.7.704 NMAC or 20.3.7.705 8 NMAC if the change does not include addition or relocation of either an area where PET radionuclides are produced 9 or a PET radioactive drug delivery line from the PET radionuclide or PET radioactive drug production area.
10 (3) A licensee shall notify the department by letter no later than 30 days after a calibration, 11 transmission or reference source under Subsection E of 20.3.7.703 NMAC is acquired. The notification shall 12 contain a description of the source, manufacturer name, model and serial number of the source, and the license 13 number of the manufacturer of the specific license issued by the department, NRC or an agreement state under 14 Subsection K of 20.3.3.315 NMAC or equivalent NRC or agreement state requirements.
15 (4) The licensee shall send the documents required in this subsection to the appropriate 16 address identified in 20.3.1.116 NMAC.
17 H. Exemptions Regarding Type A Specific Licenses of Broad Scope. A licensee possessing a type 18 A specific license of broad scope for medical use, issued under 20.3.3.314 NMAC, is exempt from:
19 (1) the provisions of Paragraph 4 of Subsection E of 20.3.7.700 NMAC regarding the need to 20 file an amendment to the license for medical use of radioactive materials, for use described in 20.3.7.713 NMAC; 21 (2) the provisions of Paragraph (2) of Subsection F of 20.3.7.700 NMAC; 22 (3) the provisions of Paragraph (5) of Subsection F of 20.3.7.700 NMAC regarding additions 23 to or changes in the areas of use at the addresses specified in the application or on the license; 24 (4) the provisions of Paragraph (1) of Subsection G of 20.3.7.700 NMAC; 25 (5) the provisions of Subparagraph (a) of Paragraph (2) of Subsection G of 20.3.7.700 26 NMAC for an authorized user, an authorized nuclear pharmacist or an authorized medical physicist; 27 (6) the provisions of Subparagraph (e) of Paragraph (2) of Subsection G of 20.3.7.700 28 NMAC regarding additions to or changes in the areas of use identified in the application or on the license where 29 radioactive material is used in accordance with either 20.3.7.704 NMAC or 20.3.7.705 NMAC; 30 (7) the provisions in Paragraph (3) of Subsection G of 20.3.7.700 NMAC; and 31 (8) the provisions of Paragraph (1) of Subsection I of 20.3.7.702 NMAC.
32 [20.3.7.700 NMAC - Rp, 20 NMAC 3.1.7.700, 4/30/2009; A, 8/10/2021]
33 34 20.3.7.701 [RESERVED]
35 36 20.3.7.702 GENERAL ADMINISTRATIVE REQUIREMENTS:
37 A. Radiation safety officer.
38 (1) A licensee or licensees management shall appoint a radiation safety officer, who agrees, 39 in writing, to be responsible for implementing a radiation protection program. The licensee, through the radiation 40 safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved 41 procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more Associate 42 Radiation Safety Officers to support the Radiation Safety Officer. The Radiation Safety Officer, with written 43 agreement of the licensee's management, must assign the specific duties and tasks to each Associate Radiation 44 Safety Officer. These duties and tasks are restricted to the types of use for which the Associate Radiation Safety 45 Officer is listed on a license. The Radiation Safety Officer may delegate duties and tasks to the Associate Radiation 46 Safety Officer but shall not delegate the authority or responsibilities for implementing the radiation protection 47 program.
48 (2) A licensee shall establish the authority, duties and responsibilities of the radiation safety 49 officer in writing.
50 (3) A licensee shall provide the radiation safety officer sufficient authority, organizational 51 freedom, time, resources and management prerogative to:
52 (a) identify radiation safety problems; 53 (b) initiate, recommend or provide corrective actions; 54 (c) prevent or order the cessation of unsafe operations; and 55 (d) verify implementation of corrective actions.
20.3.7 NMAC 7
1 (4) For up to 60 days each year, a licensee may permit an authorized user or an individual 2 qualified to be a radiation safety officer, under Subsections A and E of 20.3.7.714 NMAC, to function as a 3 temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in Paragraph 4 (3) of this subsection, if the licensee takes the actions required in Paragraphs (1), (2), (3) and (5) of this subsection 5 and notifies the department in accordance with Paragraph (2) of Subsection G of 20.3.7.700 NMAC.
6 (5) A licensee may simultaneously appoint more than one temporary radiation safety officer 7 in accordance with Paragraph (4) of this subsection, if needed to ensure that the licensee has a temporary radiation 8 safety officer that satisfies the requirements to be a radiation safety officer for each of the different types of uses of 9 radioactive material permitted by the license.
10 B. Authority and responsibilities for the radiation protection program. In addition to the 11 radiation protection program requirements of 20.3.4.404 NMAC, a licensee or licensee's management shall approve 12 in writing:
13 (1) requests for a license application, renewal or amendment before submittal to the 14 department; 15 (2) any individual before allowing that individual to work as an authorized user, authorized 16 nuclear pharmacist or authorized medical physicist; and 17 (3) radiation protection program changes that do not require a license amendment and are 18 permitted under Subsection E of this section.
19 C. Record keeping. A licensee shall retain a record of actions taken under Subsections A and B of 20 this section in accordance with Subsection A of 20.3.7.715 NMAC.
21 D. Radiation safety committee. Licensees that are authorized for two or more different types of use 22 of radioactive material under 20.3.7.708, 20.3.7.710 and 20.3.7.711 NMAC or two or more types of units under 23 20.3.7.711 NMAC shall establish a radiation safety committee to oversee all uses of radioactive material permitted 24 by the license. The radiation safety committee shall meet the following administrative requirements.
25 (1) The radiation safety committee must include an authorized user of each type of use 26 permitted by the license, the radiation safety officer, a representative of the nursing service and a representative of 27 management who is neither an authorized user, nor a radiation safety officer. The radiation safety committee may 28 include other members who the licensee considers appropriate.
29 (2) The radiation safety committee shall meet at least once each calendar quarter. To 30 establish a quorum and to conduct business, one-half of the committee's membership shall be present, including the 31 radiation safety officer and the management's representative.
32 (3) The licensee shall maintain minutes of each radiation safety committee meeting, 33 promptly provide each member with a copy of the meeting minutes and retain one copy for the duration of the 34 license.
35 (4) To oversee the use of licensed material, the radiation safety committee shall:
36 (a) review and verify the training and experience documentation (such as the board 37 certification, preceptor statement(s), or any additional required training) and approve or disapprove any individual 38 who is to be listed on a license as an authorized user, an authorized nuclear pharmacist, a radiation safety officer or 39 an authorized medical physicist before submitting a license application or request for amendment or renewal; 40 (b) review and verify the training and experience documentation (such as the board 41 certification, preceptor statement(s), the license or the permit identifying an individual as an authorized user, 42 authorized nuclear pharmacist, authorized medical physicist or a radiation safety officer) and approve or disapprove 43 any individual prior to allowing that individual to work as an authorized user, authorized nuclear pharmacist, a 44 radiation safety officer or an authorized medical physicist; 45 (c) review, on the basis of safety, and approve or disapprove each proposed method 46 of use of radioactive material; 47 (d) review, on the basis of safety, and approve or disapprove with the advice and 48 consent of the radiation safety officer and the management representative, licensees procedures and radiation 49 protection program changes prior to submittal to the department for licensing action; 50 (e) review quarterly records of the radiation protection program indicating non-51 ALARA occurrences and all incidents and medical events involving radioactive material with respect to cause and 52 subsequent actions taken; and 53 (f) review, annually, with the assistance of the radiation safety officer, the radiation 54 protection program.
55 E. Radiation protection program changes.
56 (1) A licensee may revise its radiation protection program without department approval if:
20.3.7 NMAC 8
1 (a) the revision does not require a license amendment under Subsection F of 2 20.3.7.700 NMAC; 3 (b) the revision is in compliance with the requirements in 20.3 NMAC and the 4 license; 5 (c) the revision has been reviewed and approved by the radiation safety officer and 6 licensees management; and 7 (d) the affected individuals are instructed on the revised program before the changes 8 are implemented.
9 (2) A licensee shall retain a record of each change in accordance with Subsection B of 10 20.3.7.715 NMAC.
11 F. Supervision.
12 (1) A licensee that permits the receipt, possession, use or transfer of radioactive material by 13 an individual under the supervision of an authorized user, as allowed by Subparagraph (a) of Paragraph (2) of 14 Subsection D of 20.3.7.700 NMAC, shall:
15 (a) in addition to the requirements in 20.3.10.1002 NMAC, instruct the supervised 16 individual in the licensee's written radiation protection program and quality assurance procedures, written directive 17 procedures, requirements of this chapter and license conditions with respect to the use of radioactive material; 18 (b) require the supervised individual to follow the instructions of the supervising 19 authorized user for medical uses of radioactive material, written radiation protection program and quality assurance 20 procedures established by the licensee, written directive procedures, the requirements in 20.3 NMAC and license 21 conditions with respect to the medical use of radioactive material; 22 (c) require the supervising authorized user to periodically review the supervised 23 individual's use of radioactive material and the records kept to reflect this use; and 24 (d) document the performance of the supervised individual with respect to the 25 medical use of radioactive material.
26 (2) A licensee that permits the preparation of radioactive material for medical use by an 27 individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as 28 allowed by Subparagraph (b) of Paragraph (2) of Subsection D of 20.3.7.700 NMAC shall:
29 (a) in addition to the requirements in 20.3.10.1002 NMAC, instruct the supervised 30 individual in the preparation of radioactive material for medical use, as appropriate to that individuals involvement 31 with radioactive material; 32 (b) require the supervised individual to follow the instructions of the supervising 33 authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, 34 the licensee's written radiation protection program and quality assurance procedures, the requirements of 20.3 35 NMAC and license conditions; 36 (c) require the supervising authorized nuclear pharmacist or authorized user to 37 periodically review the work of the supervised individual as it pertains to radiation safety and quality assurance in 38 preparing radioactive material for medical use and the records kept to reflect that work; and 39 (d) document the performance of the supervised individual with respect to the 40 medical use of radioactive material.
41 (3) A licensee who permits supervised activities under Paragraphs (1) and (2) of this 42 subsection is responsible for the acts and omissions of the supervised individual.
43 G. Written directive. Each applicant or licensee under this part, as applicable, shall establish and 44 maintain written directive procedures to provide high confidence that [radioactive] byproduct material or radiation 45 from radioactive material will be administered as directed by the authorized user. The written directive procedures 46 must include written policies and procedures that meet the following specific requirements.
47 (1) A written directive must be prepared, dated and signed by an authorized user before the 48 administration of I-131 sodium iodide of quantities greater than 30 microcuries (1.11 megabecquerels), any 49 therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material. If, 50 because of the emergent nature of the patient's condition, a delay in order to provide a written directive would 51 jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must 52 be documented as soon as possible in writing in the patient's record. A written directive documenting the oral 53 directive must be prepared, dated and signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.
54 (2) A written revision to an existing written directive may be made if the revision is dated 55 and signed by an authorized user before the administration of the dosage of unsealed [radioactive] byproduct 56 material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next 20.3.7 NMAC 9
1 fractional dose. If, because of the patient's condition, a delay in order to provide a written revision to an existing 2 written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable, 3 provided that the oral revision is documented as soon as possible in writing in the patient's record. A revised written 4 directive documenting the oral revision must be prepared, dated and signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of 5 the oral revision.
6 (3) The written directive must contain the patients or human research subject's name and the 7 following information:
8 (a) for any administration of quantities greater than 30 microcuries (1.11 9 megabecquerels) of I-131 sodium iodide: the dosage; 10 (b) for an administration of a therapeutic dosage of unsealed radioactive material 11 other than I-131 sodium iodide: the radioactive drug, dosage and route of administration; 12 (c) for gamma stereotactic radiosurgery: the total dose, treatment site and values for 13 the target coordinate settings per treatment for each anatomically distinct treatment site; 14 (d) for teletherapy: the total dose, dose per fraction, number of fractions and 15 treatment site; 16 (e) for high dose-rate remote afterloading brachytherapy: the radionuclide, 17 treatment site, dose per fraction, number of fractions and total dose; or 18 (f) For permanent implant brachytherapy:
19 (i) Before implantation: The treatment site, the radionuclide, and the total 20 source strength; and 21 (ii) After implantation but before the patient leaves the post-treatment 22 recovery area: The treatment site, the number of sources implanted, the total source strength implanted, and the date; 23 or [for all other brachytherapy, including low, medium and pulsed dose rate remote afterloaders, before 24 implantation: treatment site, the radionuclide and dose; and after implantation but before completion of the 25 procedure: the radionuclide, treatment site, number of sources, total source strength and exposure time (or the total 26 dose).]
27 (g) for all other brachytherapy, including low, medium and pulsed dose rate remote 28 afterloaders: before implantation: the treatment site, [the] radionuclide and dose; and after implantation but before 29 completion of the procedure: the radionuclide, treatment site, number of sources, total source strength and exposure 30 time (or the total dose); and date.
31 (4) A written revision to an existing written directive may be made if the revision is dated 32 and signed by an authorized user before the administration of the dosage of unsealed byproduct material, the 33 brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. If, 34 because of the patient's condition, a delay in order to provide a written revision to an existing written directive 35 would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision 36 must be documented as soon as possible in the patient's record. A revised written directive must be signed by the 37 authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
38 [(4)] (5) The licensee shall retain a copy of the written directive in accordance with Subsection C 39 of 20.3.7.715 NMAC.
40 H. Procedures for administrations requiring a written directive.
41 (1) For any administration requiring a written directive, the licensee shall develop, 42 implement and maintain written procedures to provide high confidence that:
43 (a) the patient's or human research subject's identity is verified by more than one 44 method as the individual named in the written directive before each administration; and 45 (b) each administration is in accordance with the written directive.
46 (2) At a minimum, the procedures required by Paragraph (1) of this subsection must address 47 the following items that are applicable to the licensee's use of radioactive material:
48 (a) verifying the identity of the patient or human research subject; 49 (b) verifying that the administration is in accordance with the treatment plan, if 50 applicable, and the written directive; 51 (c) checking both manual and computer-generated dose calculations; and 52 (d) verifying that any computer-generated dose calculations are correctly transferred 53 into the consoles of therapeutic medical units authorized by 20.3.7.711 NMAC or 20.3.7.713 NMAC.
54 (e) Determining if a medical event, as defined in 20.3.7.716 NMAC and 10 CFR 55 35.3045, has occurred; and 20.3.7 NMAC 10
1 (f) Determining, for permanent implant brachytherapy, within 60 calendar days 2 from the date the implant was performed, the total source strength administered outside of the treatment site 3 compared to the total source strength documented in the post-implantation portion of the written directive, unless a 4 written justification of patient unavailability is documented.
5 (3) A licensee shall retain a copy of the procedures required under Paragraph (1) of this 6 subsection in accordance with Subsection D of 20.3.7.715 NMAC.
7 I. Suppliers of sealed sources or devices for medical use. For medical use, a licensee may only 8 use:
9 (1) sealed sources or devices manufactured, labeled, packaged and distributed in accordance 10 with a license issued under Subsection K of 20.3.3.315 NMAC or equivalent requirements of NRC or an agreement 11 state; 12 (2) sealed sources or devices non-commercially transferred from a 20.3.7 NMAC licensee, a 13 NRC or agreement state licensee; or 14 (3) teletherapy sources manufactured and distributed in accordance with a license issued 15 under 20.3.3 NMAC or the equivalent requirements of NRC or an agreement state.
16 [20.3.7.702 NMAC - Rp, 20 NMAC 3.1.7.702, 04/30/2009; A XX/XX/2022]
17 18 20.3.7.703 GENERAL TECHNICAL REQUIREMENTS:
19 A. Possession, use and calibration of instruments used to measure the activity of unsealed 20 radioactive material. Other than unit dosages of beta-emitting unsealed radioactive material obtained from the 21 manufacturer or preparer, licensed pursuant to Subsection J of 20.3.3.315 NMAC, a medical use licensee authorized 22 to administer radiopharmaceuticals shall possess a dose calibrator, and use it to measure the activity of unsealed 23 radioactive material prior to the administration to each patient or human research subject for diagnostic applications.
24 For therapeutic applications, a medical use licensee authorized to administer radiopharmaceuticals shall possess a 25 dose calibrator, and use it to measure the activity of unsealed radioactive material prior to and after the 26 administration to each patient or human research subject.
27 (1) A licensee shall:
28 (a) check each dose calibrator for constancy with a dedicated check source at the 29 beginning of each day of use; to satisfy the requirements of this section, the check shall be done on a frequently used 30 setting with a sealed source of not less than 10 microcuries (370 kilobecquerels) of radium-226 or 50 microcuries 31 (1.85 megabecquerels) of any other photon-emitting radionuclide; 32 (b) test each dose calibrator for accuracy upon installation and at intervals not to 33 exceed 12 months thereafter by assaying at least two sealed sources containing different radionuclides, the activity 34 of which the manufacturer has determined within five percent of the stated activity, with minimum activity of 10 35 microcuries (370 kilobecquerels) for radium-226 and 50 microcuries (1.85 megabecquerels) for any other photon-36 emitting radionuclide, and at least one of which has a principal photon energy between 100 kiloelectron volts and 37 500 kiloelectron volts; 38 (c) test each dose calibrator for linearity upon installation and at intervals not to 39 exceed three months thereafter over the range of use between 30 microcuries (1.11 megabecquerels), and the highest 40 dosage that will be administered to a patient or human research subject; and 41 (d) test each dose calibrator for geometry dependence upon installation over the 42 range of volumes and volume configurations for which it will be used; the licensee shall keep a record of this test for 43 the duration of the use of the dose calibrator.
44 (2) A licensee shall mathematically correct dosage readings for any geometry or linearity 45 error that exceeds ten percent if the dosage is greater than 10 microcuries (370 kilobecquerels), and shall repair or 46 replace the dose calibrator if the accuracy or constancy error exceeds ten percent.
47 (3) A licensee shall also perform checks and tests required under this subsection, following 48 adjustment or repair of the dose calibrator.
49 (4) Beta-emitting radionuclides. A licensee shall develop quality control procedures and 50 use appropriate instrumentation to measure the radioactivity for beta-emitting radiopharmaceuticals. A licensee may 51 use checks, tests or calibration techniques other than those described in this section for instruments measuring the 52 dosages of beta-emitting unsealed radioactive material if checks, tests or calibration techniques are in accordance 53 with nationally recognized standards or the equipment manufacturers instructions and have been approved by the 54 department.
55 (5) A licensee shall retain a record of each instrument check, test and calibration required by 56 this subsection in accordance with Subsection E of 20.3.7.715 NMAC.
20.3.7 NMAC 11
1 B. Determination of dosages of unsealed radioactive material for medical use.
2 (1) A licensee shall determine and record the activity of each dosage before medical use for 3 diagnostic applications and before and after medical use for therapeutic applications.
4 (2) This determination must be made by:
5 (a) direct measurement of radioactivity pursuant to Subsection A of this section; 6 (b) combination of direct measurement of radioactivity pursuant to Subsection A of 7 this section and mathematical calculations; 8 (c) combination of volumetric measurements and mathematical calculations, based 9 on the measurement made by:
10 (i) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 11 NMAC or equivalent requirement of NRC or agreement state; or 12 (ii) a PET radioactive drug producer licensed under Subsection J of 13 20.3.3.307 NMAC or equivalent NRC or agreement state requirements; or 14 (d) decay correction, for unit dosages of beta-emitting unsealed radioactive 15 material, based on the activity or activity concentration determined by:
16 (i) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 17 NMAC or equivalent NRC or agreement state requirement; 18 (ii) a department, NRC or agreement state licensee for use in research in 19 accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) 20 protocol accepted by FDA; or 21 (iii) a PET radioactive drug producer licensed under Subsection J of 22 20.3.3.307 NMAC or equivalent NRC or agreement state requirements.
23 (3) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the 24 dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more 25 than twenty percent.
26 (4) A licensee shall retain a record of the dosage determination required by this subsection in 27 accordance with Subsection G of 20.3.7.715 NMAC.
28 C. Calibration and check of radiation survey instruments.
29 (1) A licensee shall calibrate the radiation survey instruments used to show compliance with 30 this part and 20.3.4 NMAC before first use, annually and following a repair that affects the calibration.
31 (2) A licensee shall:
32 (a) calibrate all scales with readings up to 1000 millirems (10 millisieverts) per hour 33 with a radiation source; 34 (b) calibrate two separate readings on each scale or decade that will be used to show 35 compliance; and 36 (c) conspicuously note on the instrument the date of calibration.
37 (3) A licensee shall consider a point as calibrated if the indicated exposure rate differs from 38 the calculated exposure rate by no more than twenty percent.
39 (4) A licensee shall check each radiation survey instrument for proper operation with a 40 dedicated check source at the beginning of each day of use.
41 (5) A licensee shall retain a record of each radiation survey instrument calibration in 42 accordance with Subsection F of 20.3.7.715 NMAC.
43 D. Quality control for other equipment. Each licensee shall establish written quality control 44 procedures (checks, tests, calibrations, efficiency measurements, etc.) for equipment used to obtain quantitative 45 radiation measurements for radionuclide studies, described in this part, or radiation safety surveys, necessary to 46 demonstrate compliance with this part and 20.3.4 NMAC. At a minimum, quality control procedures and their 47 frequencies shall be those recommended by the equipment manufacturer.
48 E. Authorization for calibration, transmission and reference sources. Any person authorized by 49 Subsection D of 20.3.7.700 NMAC for medical use of radioactive material may receive, possess and use any of the 50 following radioactive material for check, calibration, transmission and reference use:
51 (1) sealed sources, not exceeding 30 millicuries (1.11 gigabecquerels) each, manufactured 52 and distributed by a person specifically licensed under Subsection K of 20.3.3.315 NMAC or equivalent NRC or an 53 agreement state requirements; 54 (2) sealed sources, not exceeding 30 millicuries (1.11 gigabecquerels) each, redistributed by 55 a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 20.3.7 NMAC 12
1 Subsection K of 20.3.3.315 NMAC, providing the redistributed sealed sources are in the original packaging and 2 shielding and are accompanied by the manufacturer's approved instructions; 3 (3) any radioactive material with a half-life no longer than 120 days in individual amounts 4 not to exceed 15 millicuries (0.56 gigabecquerel);
5 (4) any radioactive material with a half-life longer than 120 days in individual amounts not to 6 exceed 200 microcuries (7.4 megabecquerels) or 1000 times the quantities in 20.3.3.338 NMAC; and 7 (5) technetium-99m in amounts as needed but not to exceed 100 millicuries.
8 F. Requirements for possession of sealed sources and brachytherapy sources.
9 (1) A licensee in possession of any sealed source or brachytherapy source shall follow the 10 radiation safety and handling instructions supplied by the manufacturer and shall maintain the instructions for the 11 duration of source use in a legible form convenient for users.
12 (2) A licensee in possession of a sealed source shall:
13 (a) test the source for leakage before its first use unless the licensee has a certificate 14 from the supplier indicating that the source was tested within six months before transfer to the licensee; and 15 (b) test the source for leakage at intervals not to exceed six months or at other 16 intervals approved by the department, NRC or an agreement state.
17 (3) To satisfy the leak test requirements of this subsection, the licensee shall measure the 18 sample so that the leak test can detect the presence of 0.005 microcurie (185 becquerels) of radioactive material in 19 the sample.
20 (4) A licensee shall retain leak test records in accordance with Paragraph (1) of Subsection H 21 of 20.3.7.715 NMAC.
22 (5) If the leak test reveals the presence of 0.005 microcurie (185 becquerels) or more of 23 removable contamination, the licensee shall:
24 (a) immediately withdraw the sealed source from use and store, cause it to be 25 repaired or disposed of in accordance with the requirements in 20.3.3 NMAC and 20.3.4 NMAC; and 26 (b) file a report within five days of the leak test result in accordance with Subsection 27 C of 20.3.7.716 NMAC.
28 (6) A licensee need not perform a leak test on the following sources:
29 (a) sources containing only radioactive material with a half-life of less than 30 days; 30 (b) sources containing only radioactive material as a gas; 31 (c) sources containing 100 microcuries (3.7 megabecquerels) or less of beta or 32 gamma-emitting material or 10 microcuries (0.37 megabecquerel) or less of alpha-emitting material; 33 (d) seeds of iridium-192 encased in nylon ribbon; and 34 (e) sources stored and not being used; however, the licensee shall test each such 35 source for leakage before any use or transfer unless it has been leak tested within six months, or other frequency 36 approved by the department, NRC or an agreement state, before the date of use or transfer.
37 (7) A licensee in possession of sealed sources or brachytherapy sources, except for gamma 38 stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its 39 possession. The licensee shall retain each inventory record in accordance with Paragraph (2) of Subsection H of 40 20.3.7.715 NMAC.
41 G. Labeling of vials and syringes. Each syringe and vial that contains unsealed radioactive material 42 must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the 43 label on the syringe or vial is visible when shielded.
44 H. Surveys for contamination and ambient radiation exposure rate.
45 (1) In addition to the surveys required by 20.3.4 NMAC:
46 (a) a licensee shall survey with a radiation detection survey instrument at the end of 47 each day of use all areas where radiopharmaceuticals are routinely prepared or administered; and 48 (b) a licensee shall survey for removable contamination at the end of each day of 49 use all areas where radiopharmaceuticals requiring written directive are routinely prepared for use or administered.
50 (2) A licensee does not need to perform the surveys required by Paragraph (1) of this 51 subsection in areas where patients or human research subjects are confined when they cannot be released under 52 Subsection I of 20.3.7.703 NMAC.
53 (3) A licensee shall retain a record of each survey in accordance with Subsection I of 54 20.3.7.715 NMAC.
55 I. Release of individuals containing radiopharmaceuticals or permanent implants.
20.3.7 NMAC 13
1 (1) A licensee may authorize the release from its control of any individual who has been 2 administered unsealed radioactive material or implants containing radioactive material if the total effective dose 3 equivalent to any other individual from exposure to the released individual is not likely to exceed 0.5 rem (five 4 millisieverts) (the current revision of the NRC guidance NUREG-1556, volume 9, consolidated guidance about 5 materials licenses: program-specific guidance about medical licenses, describes methods for calculating doses to 6 other individuals and contains tables of activities not likely to cause doses exceeding 0.5 rem (five millisieverts)).
7 (2) A licensee shall provide the released individual or the individuals parent or guardian, 8 with instructions, including written instructions, on actions recommended to maintain doses to other individuals as 9 low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 0.1 10 rem (one millisievert). If the total effective dose equivalent to a nursing infant or child could exceed 0.1 rem (one 11 millisievert), assuming there was no interruption of breast-feeding, the instructions must also include:
12 (a) guidance on the interruption or discontinuation of breast-feeding; and 13 (b) information on the potential consequences, if any, of failure to follow the 14 guidance.
15 (3) A licensee shall maintain a record of the basis for authorizing the release of an individual, 16 in accordance with Paragraph (1) of Subsection J of 20.3.7.715 NMAC.
17 (4) The licensee shall maintain a record of instructions provided to a breast-feeding female in 18 accordance with Paragraph (2) of Subsection J of 20.3.7.715 NMAC.
19 J. Provision of mobile medical service.
20 (1) A licensee providing mobile medical service shall:
21 (a) obtain a letter signed by the management of each client for which services are 22 rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and 23 responsibility of the licensee and the client; 24 (b) check instruments used to measure the activity of unsealed radioactive material 25 for proper function before medical use at each client's address or on each day of use, whichever is more frequent; at 26 a minimum, the check for proper function required by this paragraph must include a constancy check; 27 (c) check radiation survey instruments for proper operation with a dedicated check 28 source before use at each client's address or on each day of use, whichever is more frequent; and 29 (d) before leaving a client's address, survey all areas of use to ensure compliance 30 with the requirements in 20.3.4 NMAC and 20.3.7 NMAC.
31 (2) A mobile medical service may not have radioactive material delivered from the 32 manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive 33 material. Radioactive material delivered to the client must be received and handled in conformance with the client's 34 license.
35 (3) A licensee providing mobile medical services shall retain the letter required in 36 Subparagraph (a) of Paragraph (1) of this subsection and the record of each survey required in Subparagraph (d) of 37 Paragraph (1) of this subsection in accordance with Paragraphs (1) and (2) of Subsection K of 20.3.7.715 NMAC, 38 respectively.
39 K. Storage of volatiles and gases.
40 (1) A license shall store volatile radiopharmaceuticals and radioactive gases in the shipper's 41 radiation shield and container.
42 (2) A license shall store and use a multi-dosage container in a properly functioning fume 43 hood.
44 L. Decay-in-storage.
45 (1) A licensee may hold radioactive material with a physical half-life of less than or equal to 46 120 days for decay-in-storage before disposal without regard of its radioactivity if the licensee:
47 (a) holds radioactive material for decay a minimum of 10 half-lives; 48 (b) monitors radioactive material at the surface before disposal and determines that 49 its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection 50 survey instrument set on its most sensitive scale and with no interposed shielding; 51 (c) removes or obliterates all radiation labels, except for radiation labels on 52 materials that are within containers and that will be managed as biomedical waste after they have been released from 53 the licensee; and 54 (d) separates and monitors each generator column individually with all radiation 55 shielding removed to ensure that its content have decayed to background radiation level before disposal.
20.3.7 NMAC 14
1 (2) A licensee shall retain a record of each disposal permitted under Paragraph (1) of this 2 subsection in accordance with Subsection L of 20.3.7.715 NMAC.
3 [20.3.7.703 NMAC - Rp, 20 NMAC 3.1.7.703, 4/30/2009; A, 6/13/2017]
4 5 20.3.7.704 USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND 6 EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED: Except for 7 quantities that require a written directive under Paragraph (3) of Subsection G of Section 20.3.7.702 NMAC, a 8 licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution or excretion studies 9 that is:
10 A. obtained from:
11 (1) a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC, or 12 equivalent NRC or agreement state requirements; or 13 (2) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or 14 equivalent NRC or agreement state requirements; or 15 B. excluding production of PET radionuclides, prepared by:
16 (1) an authorized nuclear pharmacist; 17 (2) a physician who is an authorized user and who meets the requirements specified in either 18 Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290, or Subsection H of 20.3.7.714 NMAC, 19 incorporating 10 CFR 35.390, and Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290(c)(1)(ii)(G); or 20 (3) an individual under the supervision, as specified in Subsection F of 20.3.7.702 NMAC, of 21 the authorized nuclear pharmacist in Paragraph (1) of this subsection or the physician who is an authorized user in 22 Paragraph (2) of this subsection; or 23 C. obtained from and prepared by a department, NRC or agreement state licensee for use in 24 research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug 25 protocol accepted by FDA; or 26 D. prepared by the licensee for use in research in accordance with a radioactive drug research 27 committee-approved application or an investigational new drug protocol accepted by FDA.
28 [20.3.7.704 NMAC - Rp, 20 NMAC 3.1.7.704, 4/30/2009]
29 30 20.3.7.705 USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND 31 LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED: Except for 32 quantities that require a written directive under Paragraph (3) of Subsection G of 20.3.7.702 NMAC, a licensee may 33 use any unsealed radioactive material prepared for medical for imaging and localization studies use that is:
34 A. obtained from:
35 (1) a manufacturer or preparer licensed pursuant to Subsection J of 20.3.3.315 NMAC or 36 equivalent NRC or agreement state requirements; or 37 (2) a PET radioactive drug producer licensed under Subsection J of 20.3.3.307 NMAC or 38 equivalent NRC or agreement state requirements; or 39 B. excluding production of PET radionuclides, prepared by:
40 (1) an authorized nuclear pharmacist; 41 (2) a physician who is an authorized user and who meets the requirements specified in either 42 Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290, or Subsection H of 20.3.7.714 NMAC, 43 incorporating 10 CFR 35.390, and Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290(c)(1)(ii)(G); or 44 (3) an individual under the supervision, as specified in Subsection F of 20.3.7.702 NMAC, of 45 the authorized nuclear pharmacist in Paragraph (1) of this subsection or the physician who is an authorized user in 46 Paragraph (2) of this subsection; or 47 C. obtained from and prepared by a department, NRC or agreement state licensee for use in 48 research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug 49 protocol accepted by FDA; or 50 D. prepared by the licensee for use in research in accordance with a radioactive drug research 51 committee-approved application or an investigational new drug protocol accepted by FDA.
52 [20.3.7.705 NMAC - Rp, 20 NMAC 3.1.7.705, 4/30/2009]
53 54 20.3.7.706 PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82 AND STRONTIUM-85 55 CONCENTRATIONS:
20.3.7 NMAC 15
1 A. Maximum concentrations. A licensee may not administer to humans a radiopharmaceutical 2 containing:
3 (1) more than 0.15 microcurie of molybdenum-99 per each millicurie of technetium-99m 4 (0.15 kilobecquerel of molybdenum-99 per each megabecquerel of technetium-99m); or 5 (2) more than 0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride 6 injection (0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride); or more than 0.2 7 microcurie of strontium-85 per millicurie of rubidium-82 chloride injection (0.2 kilobecquerel of strontium-85 per 8 megabecquerel of rubidium-82).
9 B. Measurement.
10 (1) A licensee preparing technetium-99m radiopharmaceutical from molybdenum-11 99/technetium-99m generators shall measure the molybdenum-99 concentration [of the first eluate after the receipt 12 of the generator to demonstrate compliance with Subsection A of this section] in each eluate from a generator to 13 demonstrate compliance with Subsection A of this section.
14 (2) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 15 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides 16 strontium-82 and strontium-85 to demonstrate compliance with Subsection A of this section.
17 C. Record keeping. If a licensee is required to measure the molybdenum-99 concentration or 18 strontium-85 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance 19 with Subsection M of 20.3.7.715 NMAC.
20 D. Reporting. The licensee shall report any measurement that exceeds the limits in Subsection A of 21 this section at the time of generator elution, in accordance with subsection D of 20.3.7.716 NMAC and 10 CFR § 22 35.3204.
23 [20.3.7.706 NMAC - Rp, 20 NMAC 3.1.7.706, 04/30/2009, A, XX/XX/2022]
24 25 26 20.3.7.707 CONTROL OF AEROSOLS AND GASES:
27 A. System Requirements.
28 (1) A licensee who administers radioactive aerosols or gases shall do so with a system that 29 shall keep airborne concentrations of the radioactive material, including releases to the environment, within the 30 limits prescribed by 20.3.4 NMAC.
31 (2) The delivery or control system for the radioactive aerosols or gases shall either be 32 directly vented to the atmosphere though an air exhaust or shall provide collection and decay or disposal of the 33 aerosol or gas in a shielded container. Other federal, state or local regulatory requirements shall be met.
34 (3) The licensee shall perform check of the operation of reusable gas collection systems 35 monthly or at other frequency approved by the department.
36 B. Room Requirements.
37 (1) A licensee shall only administer radioactive gases in rooms that are at negative pressure 38 compared to surrounding rooms.
39 (2) The licensee shall perform measurements of ventilation rate at least semiannually or other 40 frequency approved by the department for those areas of use required to operate under a negative pressure.
41 C. Clearance Time.
42 (1) Before receiving, using or storing a radioactive gas, the licensee shall calculate the 43 amount of time needed after a release to reduce the concentration in the area of use to the limits in 20.3.4.461 44 NMAC. The calculation shall be based on the highest activity of gas handled in a single container and the measured 45 available air exhaust rate.
46 (2) A licensee shall post the time calculated in Paragraph (1) of this subsection in the area of 47 use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed or the 48 concentration in the area of use is reduced below the limits in 20.3.4.461 NMAC.
49 D. Record keeping. A copy of the calculations required in Paragraph (1) of Subsection C of this 50 section shall be retained in accordance with Subsection N of 20.3.7.715 NMAC.
51 [20.3.7.707 NMAC - Rp, 20 NMAC 3.1.7.707, 4/30/2009]
52 53 20.3.7.708 USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN 54 DIRECTIVE IS REQUIRED: A licensee may use any unsealed [radioactive] byproduct material identified in 10 55 CFR 35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is [either]:
20.3.7 NMAC 16
1 A. Obtained from a manufacturer or preparer licensed under Subsection J of 20.3.3.315 NMAC 2 or equivalent agreement state or NRC requirements; or 3 B. Prepared by:
4 (1) an authorized nuclear pharmacist; 5 (2) a physician who is an authorized user and who meets the requirements specified in either 6 Subsection G of 20.3.7.714 NMAC, incorporating 10 CFR 35.290, or Subsection H of 20.3.7.714 NMAC, 7 incorporating 10 CFR 35.390; or 8 (3) an individual under the supervision, as specified in Subsection F of 20.3.7.702 NMAC, of 9 the authorized nuclear pharmacist in Paragraph (1) of this subsection or the physician who is an authorized user in 10 Paragraph (2) of this subsection; or 11 C. Obtained from and prepared by a department, NRC or agreement state licensee for use in 12 research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug 13 protocol accepted by FDA; or 14 D. Prepared by the licensee for use in research in accordance with a radioactive drug research 15 committee-approved application or an investigational new protocol accepted by FDA.
16 [20.3.7.708 NMAC - Rp, 20 NMAC 3.1.7.708, 04/30/2009, A, XX/XX/2022]
17 18 20.3.7.709 SAFETY INSTRUCTIONS AND PRECAUTIONS FOR USE OF UNSEALED 19 RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED: In addition to the 20 requirements in 20.3.10.1002 NMAC, the licensee shall provide the following.
21 A. Safety Instructions. A licensee shall provide radiation safety instructions initially and at least 22 annually, to personnel caring for patients or human research subjects who cannot be released under Subsection I of 23 20.3.7.703 NMAC. To satisfy this requirement, the instruction must be commensurate with the duties of the 24 personnel and include:
25 (1) patient or human research subject control; 26 (2) visitor control, including:
27 (a) routine visitation to hospitalized individuals in accordance with Paragraph (1) of 28 Subsection A of 20.3.4.413 NMAC; and 29 (b) visitation authorized in accordance with Subsection F of 20.3.4.413 NMAC; 30 (3) contamination control; 31 (4) waste control; and 32 (5) notification of the radiation safety officer, or their designee, and an authorized user if the 33 patient or the human research subject has a medical emergency or dies.
34 B. Record Keeping. A licensee shall retain a record of individuals receiving safety instructions, as 35 specified in Subsection A of this section, in accordance with Subsection O of 20.3.7.715 NMAC.
36 C. Safety Precautions. For each patient or human research subject who cannot be released under 37 Subsection I of 20.3.7.703 NMAC, a licensee shall:
38 (1) quarter the patient or the human research subject either in:
39 (a) a private room with a private sanitary facility; or 40 (b) a room, with a private sanitary facility, with another individual who also has 41 received therapy with unsealed radioactive material and who also cannot be released under Subsection I of 42 20.3.7.703 NMAC; 43 (2) visibly post the patient's or human research subject's room with a Radioactive Materials 44 sign; 45 (3) note on the door or in the patient's or human research subject's chart where and how long 46 visitors may stay in the patient's or human research subject's room; 47 (4) either monitor material and items removed from the patient's or the human research 48 subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation 49 level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or 50 handle the material and items as radioactive waste; and 51 (5) a licensee shall notify the radiation safety officer, or their designee, and an authorized 52 user, as soon as possible if the patient or human research subject has a medical emergency or dies.
53 [20.3.7.709 NMAC - Rp, 20 NMAC 3.1.7.708, 4/30/2009]
54 55 20.3.7.710 MANUAL BRACHYTHERAPY:
20.3.7 NMAC 17
1 A. Use of sources for manual brachytherapy. [A licensee shall use only brachytherapy sources for 2 therapeutic medical uses.] The regulations of the NRC set forth in 10 CFR 35.400 are hereby incorporated by 3 reference:
4 [(1) as approved in the sealed source and device registry; or 5 (2) in research in accordance with an active investigational device exemption application 6 accepted by the FDA provided the requirements of Paragraph (1) of Section I of 20.3.7.702 NMAC are met.]
7 B. Surveys after source implant and removal.
8 (1) Immediately after implanting sources in a patient or a human research subject, the 9 licensee shall make a survey to locate and account for all sources that have not been implanted.
10 (2) Immediately after removing the last temporary implant source from a patient or a human 11 research subject, the licensee shall make a survey of the patient or the human research subject with a radiation 12 detection survey instrument to confirm that all sources have been removed.
13 (3) A licensee shall retain a record of the surveys required by Paragraphs (1) and (2) of this 14 subsection in accordance with Subsection P of 20.3.7.715 NMAC.
15 C. Brachytherapy sources accountability.
16 (1) A licensee shall maintain accountability at all times for all brachytherapy sources in 17 storage or use.
18 (2) As soon as possible after removing sources from a patient or a human research subject, a 19 licensee shall return brachytherapy sources to a secure storage area.
20 (3) A licensee shall maintain a record of the brachytherapy source accountability in 21 accordance with Subsection Q of 20.3.7.715 NMAC.
22 D. Safety instructions. In addition to the requirements in 20.3.10.1002 NMAC:
23 (1) the licensee shall provide radiation safety instructions, initially and at least annually, to 24 personnel caring for patients or the human research subjects who are receiving brachytherapy and cannot be released 25 under Subsection I of 20.3.7.703 NMAC; to satisfy this requirement, the instructions must be commensurate with 26 the duties of the personnel and include:
27 (a) the size and appearance of the brachytherapy sources; 28 (b) safe handling of the brachytherapy sources and shielding instructions; 29 (c) a patient or human research subject control; 30 (d) visitor control, including both routine visitation of hospitalized individuals in 31 accordance with Paragraph (1) of Subsection A of 20.3.4.413 NMAC, and visitation authorized in accordance with 32 Subsection F of 20.3.4.413 NMAC; and 33 (e) notification of the radiation safety officer, or their designee, and an authorized 34 user if the patient or human research subject has a medical emergency or dies; 35 (2) a licensee shall retain a record of individuals receiving safety instructions in accordance 36 with Subsection O of 20.3.7.715 NMAC.
37 E. Safety precautions.
38 (1) For each patient or human research subject receiving brachytherapy and cannot be 39 released under Subsection I of 20.3.7.703 NMAC a licensee shall:
40 (a) not quarter the patient or the human research subject in the same room with an 41 individual who is not receiving brachytherapy; 42 (b) visibly post the patient's or human research subject's door with a Radioactive 43 Materials sign; and 44 (c) note on the door or in the patient's or human research subject's chart where and 45 how long visitors may stay in the patient's or human research subject's room.
46 (2) A licensee shall have applicable emergency response equipment available near each 47 treatment room to respond to a source:
48 (a) dislodged from the patient; and 49 (b) lodged within the patient following removal of the source applicators.
50 (3) A licensee shall notify the radiation safety officer, or their designee, and an authorized 51 user as soon as possible if the patient or human research subject has a medical emergency or dies.
52 F. Calibration measurements of brachytherapy sources.
53 (1) Before the first medical use of a brachytherapy source, a licensee shall have:
54 (a) determined the source output or activity using a dosimetry system that meets the 55 requirements of Paragraph (1) of Subsection F of 20.3.7.711 NMAC; 56 (b) determined source positioning accuracy within applicators; and 20.3.7 NMAC 18
1 (c) used published protocols currently accepted by nationally recognized bodies to 2 meet the requirements of Subparagraphs (a) and (b) of this paragraph.
3 (2) Instead of a licensee making its own measurements as required in Paragraph (1) of this 4 subsection, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory 5 accredited by the American association of physicists in medicine that are made in accordance with Paragraph (1) of 6 this subsection.
7 (3) A licensee shall mathematically correct the outputs or activities determined in Paragraph 8 (1) of this subsection for physical decay at intervals consistent with one percent physical decay.
9 (4) A licensee shall retain a record of each calibration in accordance with Subsection R of 10 20.3.7.715 NMAC.
11 G. Decay of strontium-90 sources for ophthalmic treatments.
12 [(1) Only an authorized medical physicist shall calculate the activity of each strontium-90 13 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the 14 activity determined under Subsection F of 20.3.7.710 NMAC.
15 (2) A licensee shall retain a record of the activity of each strontium-90 source in accordance 16 with Subsection S of 20.3.7.715 NMAC.] The regulations of the NRC set forth in 10 CFR 35.433 are hereby 17 incorporated by reference.
18 H. Therapy-related computer systems. The licensee shall perform acceptance testing on the treatment 19 planning system of therapy-related computer systems in accordance with published protocols accepted by nationally 20 recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
21 (1) the source-specific input parameters required by the dose calculation algorithm; 22 (2) the accuracy of dose, dwell time and treatment time calculations at representative points; 23 (3) the accuracy of isodose plots and graphic displays; and 24 (4) the accuracy of the software used to determine sealed source positions from radiographic 25 images.
26 [20.3.7.710 NMAC - Rp, 20 NMAC 3.1.7.709, 04/30/2009; A, XX/XX/2022]
27 28 20.3.7.711 PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS AND 29 GAMMA STEREOTACTIC RADIOSURGERY UNITS:
30 A. Use of a sealed source in a remote afterloader unit, teletherapy unit or gamma stereotactic 31 radiosurgery unit. A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units 32 or gamma stereotactic radiosurgery units for therapeutic medical uses:
33 (1) as approved in the sealed source and device registry; or 34 (2) in research in accordance with an active investigational device exemption application 35 accepted by the FDA provided the requirements of Paragraph (1) of Subsection I of 20.3.7.702 NMAC are met.
36 B. Surveys of patients and human research subjects treated with a remote afterloader unit.
37 (1) Before releasing a patient or a human research subject from licensee control, a licensee 38 shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation 39 detection survey instrument to confirm that the source(s) has been removed from the patient or human research 40 subject and returned to the safe shielded position.
41 (2) A licensee shall retain a record of these surveys in accordance with Subsection P of 42 20.3.7.715 NMAC.
43 C. Installation, maintenance, adjustment and repair.
44 (1) Only a person specifically licensed by the department, NRC or an agreement state shall 45 install, maintain, adjust or repair a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit 46 that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical 47 component that could expose the source(s), reduce the shielding around the source(s) or compromise the radiation 48 safety of the unit or the source(s).
49 (2) Except for low dose-rate remote afterloader units, only a person specifically licensed by 50 the department, NRC or an agreement state shall install, replace, relocate or remove a sealed source or source 51 contained in other remote afterloader units, teletherapy units or gamma stereotactic radiosurgery units.
52 (3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the 53 department, NRC, an agreement state or an authorized medical physicist shall install, replace, relocate or remove a 54 sealed source(s) contained in the unit.
20.3.7 NMAC 19
1 (4) A licensee shall retain a record of the installation, maintenance, adjustment and repair of 2 remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units in accordance with Subsection 3 T of 20.3.7.715 NMAC.
4 D. Safety procedures and instructions for remote afterloader units, teletherapy units and gamma 5 stereotactic radiosurgery units.
6 (1) A licensee shall:
7 (a) secure the unit, the console, the console keys and the treatment room when not 8 in use or unattended; 9 (b) permit only individuals approved by the authorized user, radiation safety officer 10 or authorized medical physicist to be present in the treatment room during treatment with the source(s);
11 (c) prevent dual operation of more than one radiation producing device in a 12 treatment room if applicable; and 13 (d) develop, implement and maintain written procedures for responding to an 14 abnormal situation when the operator is unable to place the source(s) in the shielded position or remove the patient 15 or human research subject from the radiation field with controls from outside the treatment room. These procedures 16 must include:
17 (i) instructions for responding to equipment failures and the names of the 18 individuals responsible for implementing corrective actions; 19 (ii) the process for restricting access to and posting of the treatment area to 20 minimize the risk of inadvertent exposure; and 21 (iii) the names and telephone numbers of the authorized users, the 22 authorized medical physicist and the radiation safety officer to be contacted if the unit or console operates 23 abnormally.
24 (2) A copy of the procedures required by Subparagraph (d) of Paragraph (1) of this 25 subsection must be physically located at the unit console.
26 (3) A licensee shall post instructions at the unit console to inform the operator of:
27 (a) the location of the procedures required by Subparagraph (d) of Paragraph (1) of 28 this subsection; and 29 (b) the names and telephone numbers of the authorized users, the authorized 30 medical physicist and the radiation safety officer to be contacted if the unit or console operates abnormally.
31 (4) Prior to the first use for patient treatment of a new unit or an existing unit with a 32 manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational 33 and safety training is provided to all individuals who will operate the unit. The vendor operational and safety 34 training must be provided by the device manufacturer or by an individual certified by the device manufacturer to 35 provide the operational and safety training.
36 [(4)] (5) A licensee shall provide operational and safety instruction, initially and at least annually, 37 to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties, in:
38 (a) the procedures identified in Subparagraph (d) of Paragraph (1) of this 39 subsection; and 40 (b) the operating procedures for the unit.
41 [(5)] (6) A licensee shall ensure that operators, authorized medical physicists and authorized users 42 participate in drills of the emergency procedures, initially and at least annually.
43 [(6)] (7) A licensee shall retain a record of individuals receiving instruction required by Paragraph 44 (5) of this subsection, in accordance with Subsection O of 20.3.7.715 NMAC.
45 [(7)] (8) A licensee shall retain a copy of the procedures required by Subparagraph (d) of 46 Paragraph (1) and Subparagraph (b) of Paragraph (4) of this subsection in accordance with Subsection U of 47 20.3.7.715 NMAC.
48 E. Safety precautions for remote afterloader units, teletherapy units and gamma stereotactic 49 radiosurgery units.
50 (1) A licensee shall control access to the treatment room by a door at each entrance.
51 (2) A licensee shall equip each entrance to the treatment room with an electrical interlock 52 system that will:
53 (a) prevent the operator from initiating the treatment cycle unless each treatment 54 room entrance door is closed; 55 (b) cause the source(s) to be shielded when an entrance door is opened; and 20.3.7 NMAC 20
1 (c) prevent the source(s) from being exposed following an interlock interruption 2 until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.
3 (3) A licensee shall require any individual entering the treatment room to assure, through the 4 use of appropriate radiation monitors, that radiation levels have returned to ambient levels.
5 (4) Except for low-dose remote afterloader units, a licensee shall construct or equip each 6 treatment room with viewing and intercom systems to permit continuous observation of the patient or the human 7 research subject from the treatment console during irradiation.
8 (5) For licensed activities where sources are placed within the patient's or human research 9 subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or 10 jammed source.
11 (6) In addition to the requirements specified in Paragraphs (1) through (5) of this subsection, 12 a licensee shall:
13 (a) for medium dose-rate and pulsed dose-rate remote afterloader units, require:
14 (i) an authorized medical physicist and either an authorized user or a 15 physician, under the supervision of an authorized user, who has been trained in the operation and emergency 16 response for the unit to be physically present during the initiation of all patient treatments involving the unit; and 17 (ii) an authorized medical physicist and either an authorized user or an 18 individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in 19 the event of an emergency involving the unit, to be immediately available during continuation of all patient 20 treatments involving the unit; 21 (b) for high dose-rate remote afterloader units, require:
22 (i) an authorized user and an authorized medical physicist to be physically 23 present during the initiation of all patient treatments involving the unit; and 24 (ii) an authorized medical physicist and either an authorized user or a 25 physician, under the supervision of an authorized user, who has been trained in the operation and emergency 26 response for the unit, to be physically present during continuation of all patient treatments involving the unit; 27 (c) for gamma stereotactic radiosurgery units, require an authorized user and an 28 authorized medical physicist to be physically present throughout all patient treatments involving the unit; 29 (d) notify the radiation safety officer, or their designee and an authorized user as 30 soon as possible if the patient or human research subject has a medical emergency or dies.
31 (7) A licensee shall have applicable emergency response equipment available near each 32 treatment room to respond to a source which:
33 (a) remains in the unshielded position; or 34 (b) is lodged within the patient following completion of the treatment.
35 F. Dosimetry equipment.
36 (1) Except for low dose-rate remote afterloader sources where the source output or activity is 37 determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this 38 requirement, one of the following two conditions must be met.
39 (a) The system must have been calibrated using a system or source traceable to the 40 NIST and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by 41 the American association of physicists in medicine. The calibration must have been performed within the previous 2 42 years and after any servicing that may have affected system calibration.
43 (b) The system must have been calibrated within the previous 4 years. Eighteen to 44 thirty months after that calibration, the system must have been inter-compared with another dosimetry system that 45 was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the American 46 association of physicists in medicine. The results of the inter-comparison must indicate that the calibration factor of 47 the licensee's system had not changed by more than two percent. The licensee may not use the inter-comparison 48 result to change the calibration factor. When inter-comparing dosimetry systems to be used for calibrating sealed 49 sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as 50 applicable, and sources of the same radionuclide as the source used at the licensee's facility.
51 (2) The licensee shall have a dosimetry system available for use for spot-check output 52 measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been 53 calibrated in accordance with Paragraph (1) of this subsection. This comparison must have been performed within 54 the previous year and after each servicing that may have affected system calibration. The spot-check system may be 55 the same system used to meet the requirement in Paragraph (1) of this subsection.
20.3.7 NMAC 21
1 (3) The licensee shall retain a record of each calibration, inter-comparison and comparison in 2 accordance with Subsection V of 20.3.7.715 NMAC.
3 G. Full calibration measurements on teletherapy units.
4 (1) A licensee authorized to use a teletherapy unit for medical use shall perform full 5 calibration measurements on each teletherapy unit:
6 (a) before the first medical use of the unit; 7 (b) before medical use under the following conditions:
8 (i) whenever spot-check measurements indicate that the output differs by 9 more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive 10 decay; 11 (ii) following replacement of the source or following reinstallation of the 12 teletherapy unit in a new location; 13 (iii) following any repair of the teletherapy unit that includes removal of the 14 source or major repair of the components associated with the source exposure assembly; and 15 (c) at intervals not exceeding one year.
16 (2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration 17 measurements must include determination of:
18 (a) the output within plus or minus three percent for the range of field sizes and for 19 the distance or range of distances used for medical use; 20 (b) the coincidence of the radiation field and the field indicated by the light beam 21 localizing device; 22 (c) the uniformity of the radiation field and its dependence on the orientation of the 23 useful beam; 24 (d) timer accuracy and linearity over the range of use; 25 (e) on-off error; and 26 (f) the accuracy of all distance measuring and localization devices in medical use.
27 (3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 28 20.3.7.711 NMAC to measure the output for one set of exposure conditions. The remaining radiation measurements 29 required in Subparagraph (a) of Paragraph (2) of this subsection may be made using a dosimetry system that 30 indicates relative dose rates.
31 (4) A licensee shall make full calibration measurements required by Paragraph (1) of this 32 subsection in accordance with published protocols accepted by nationally recognized bodies.
33 (5) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of 34 Paragraph (2) of this subsection for physical decay for intervals not exceeding 1 month for cobalt-60, 6 months for 35 cesium-137, or at intervals consistent with one percent decay for all other nuclides.
36 (6) Full calibration measurements required by Paragraph (1) of this subsection and physical 37 decay corrections required by Paragraph (5) of this subsection must be performed by the authorized medical 38 physicist.
39 (7) A licensee shall retain a record of each calibration in accordance with Subsection W of 40 20.3.7.715 NMAC.
41 H. Full calibration measurements on remote afterloader units.
42 (1) A licensee authorized to use a remote afterloader unit for medical use shall perform full 43 calibration measurements on each unit:
44 (a) before the first medical use of the unit; 45 (b) before medical use under the following conditions:
46 (i) following replacement of the source or following reinstallation of the 47 unit in a new location; and 48 (ii) following any repair of the unit that includes removal of the source or 49 major repair of the components associated with the source exposure assembly; 50 (c) at intervals not exceeding one quarter for high dose-rate, medium dose-rate, and 51 pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and 52 (d) at intervals not exceeding one year for low dose-rate remote afterloader units.
53 (2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration 54 measurements must include, as applicable, determination of:
55 (a) the output within plus or minus five percent; 56 (b) source positioning accuracy to within plus or minus 1 millimeter; 20.3.7 NMAC 22
1 (c) source retraction with backup battery upon power failure; 2 (d) length of the source transfer tubes; 3 (e) timer accuracy and linearity over the typical range of use; 4 (f) length of the applicators; and 5 (g) function of the source transfer tubes, applicators and transfer tube-applicator 6 interfaces.
7 (3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 8 20.3.7.711 NMAC to measure the output.
9 (4) A licensee shall make full calibration measurements required by Paragraph (1) of this 10 subsection in accordance with published protocols accepted by nationally recognized bodies.
11 (5) In addition to the requirements for full calibrations for low dose-rate remote afterloader 12 units in Paragraph (2) of this subsection, a licensee shall perform an autoradiograph of the source(s) to verify 13 inventory and source(s) arrangement at intervals not exceeding one quarter.
14 (6) For low dose-rate remote afterloader units, a licensee may use measurements provided by 15 the source manufacturer that are made in accordance with Paragraphs (1) through (5) of this subsection.
16 (7) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of 17 Paragraph (2) of this subsection for physical decay at intervals consistent with one percent physical decay.
18 (8) Full calibration measurements required by Paragraph (1) of this subsection and physical 19 decay corrections required by Paragraph (7) of this subsection must be performed by the authorized medical 20 physicist.
21 (9) A licensee shall retain a record of each calibration in accordance with Subsection W of 22 20.3.7.715 NMAC.
23 I. Full calibration measurements on gamma stereotactic radiosurgery units.
24 (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 25 perform full calibration measurements on each unit:
26 (a) before the first medical use of the unit; 27 (b) before medical use under the following conditions:
28 (i) whenever spot-check measurements indicate that the output differs by 29 more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive 30 decay; 31 (ii) following replacement of the sources or following reinstallation of the 32 gamma stereotactic radiosurgery unit in a new location; and 33 (iii) following any repair of the gamma stereotactic radiosurgery unit that 34 includes removal of the sources or major repair of the components associated with the source assembly; and 35 (c) at intervals not exceeding one year, with the exception that relative helmet 36 factors need only be determined before the first medical use of a helmet and following any damage to a helmet.
37 (2) To satisfy the requirement of Paragraph (1) of this subsection, full calibration 38 measurements must include determination of:
39 (a) the output within plus or minus three percent; 40 (b) relative helmet factors; 41 (c) isocenter coincidence; 42 (d) timer accuracy and linearity over the range of use; 43 (e) on-off error; 44 (f) trunnion centricity; 45 (g) treatment table retraction mechanism, using backup battery power or hydraulic 46 backups with the unit off; 47 (h) helmet microswitches; 48 (i) emergency timing circuits; and 49 (j) stereotactic frames and localizing devices (trunnions).
50 (3) A licensee shall use the dosimetry system described in Paragraph (1) of Subsection F of 51 20.3.7.711 NMAC to measure the output for one set of exposure conditions. The remaining radiation measurements 52 required in Subparagraph (a) of Paragraph (2) of this subsection of this subsection may be made using a dosimetry 53 system that indicates relative dose rates.
54 (4) A licensee shall make full calibration measurements required by Paragraph (1) of this 55 subsection in accordance with published protocols accepted by nationally recognized bodies.
20.3.7 NMAC 23
1 (5) A licensee shall mathematically correct the outputs determined in Subparagraph (a) of 2 Paragraph (2) of this subsection at intervals not exceeding 1 month for cobalt-60 and at intervals consistent with one 3 percent physical decay for all other radionuclides.
4 (6) Full calibration measurements required by Paragraph (1) of this subsection and physical 5 decay corrections required by Paragraph (5) of this subsection must be performed by the authorized medical 6 physicist.
7 (7) A licensee shall retain a record of each calibration in accordance with Subsection W of 8 20.3.7.715 NMAC.
9 J. Periodic spot-checks for teletherapy units.
10 (1) A licensee authorized to use teletherapy units for medical use shall perform output spot-11 checks on each teletherapy unit once in each calendar month that include determination of:
12 (a) timer accuracy and timer linearity over the range of use; 13 (b) on-off error; 14 (c) the coincidence of the radiation field and the field indicated by the light beam 15 localizing device; 16 (d) the accuracy of all distance measuring and localization devices used for medical 17 use; 18 (e) the output for one typical set of operating conditions measured with the 19 dosimetry system described in Paragraph (2) of Subsection F of 20.3.7.711 NMAC; and 20 (f) the difference between the measurement made in Subparagraph (e) of this 21 paragraph and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at 22 last full calibration corrected mathematically for physical decay).
23 (2) A licensee shall perform measurements required by Paragraph (1) of this subsection in 24 accordance with written procedures established by the authorized medical physicist. That individual need not 25 actually perform the spot-check measurements.
26 (3) A licensee shall have the authorized medical physicist review the results of each spot-27 check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the 28 results of each spot-check.
29 (4) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-30 checks of each teletherapy facility once in each calendar month and after each source installation to assure proper 31 operation of:
32 (a) electrical interlocks at each teletherapy room entrance; 33 (b) electrical or mechanical stops installed for the purpose of limiting use of the 34 primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and 35 operation of the beam on-off mechanism);
36 (c) source exposure indicator lights on the teletherapy unit, on the control console, 37 and in the facility; 38 (d) viewing and intercom systems; 39 (e) treatment room doors from inside and outside the treatment room; and 40 (f) electrically assisted treatment room doors with the teletherapy unit electrical 41 power turned off.
42 (5) If the results of the checks required in Paragraph (4) of this subsection indicate the 43 malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as 44 may be necessary to repair, replace or check the malfunctioning system.
45 (6) A licensee shall retain a record of each spot-check required by Paragraphs (1) and (4) of 46 this subsection, and a copy of the procedures required by Paragraph (2), in accordance with Subsection X of 47 20.3.7.715 NMAC.
48 K. Periodic spot-checks for remote afterloader units.
49 (1) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-50 checks of each remote afterloader facility and on each unit:
51 (a) before the first use of a high dose-rate, medium dose-rate or pulsed dose-rate 52 remote afterloader unit on a given day; 53 (b) before each patient treatment with a low dose-rate remote afterloader unit; and 54 (c) after each source installation.
20.3.7 NMAC 24
1 (2) A licensee shall perform the measurements required by Paragraph (1) of this subsection 2 in accordance with written procedures established by the authorized medical physicist. That individual need not 3 actually perform the spot check measurements.
4 (3) A licensee shall have the authorized medical physicist review the results of each spot-5 check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the 6 results of each spot-check.
7 (4) To satisfy the requirements of Paragraph (1) of this subsection, spot-checks must, at a 8 minimum, assure proper operation of:
9 (a) electrical interlocks at each remote afterloader unit room entrance; 10 (b) source exposure indicator lights on the remote afterloader unit, on the control 11 console, and in the facility; 12 (c) viewing and intercom systems in each high dose-rate, medium dose-rate and 13 pulsed dose-rate remote afterloader facility; 14 (d) emergency response equipment; 15 (e) radiation monitors used to indicate the source position; 16 (f) timer accuracy; 17 (g) clock (date and time) in the unit's computer; and 18 (h) decayed source(s) activity in the unit's computer.
19 (5) If the results of the checks required in Paragraph (4) of this subsection indicate the 20 malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as 21 may be necessary to repair, replace or check the malfunctioning system.
22 (6) A licensee shall retain a record of each check required by Paragraph (4) of this subsection 23 and a copy of the procedures required by Paragraph (2) of this subsection in accordance with Subsection Y of 24 20.3.7.715 NMAC.
25 L. Periodic spot-checks for gamma stereotactic radiosurgery units.
26 (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 27 perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:
28 (a) monthly; 29 (b) before the first use of the unit on a given day; and 30 (c) after each source installation.
31 (2) A licensee shall:
32 (a) perform the measurements required by Paragraph (1) of this subsection in 33 accordance with written procedures established by the authorized medical physicist; that individual need not actually 34 perform the spot check measurements; 35 (b) have the authorized medical physicist review the results of each spot-check 36 within 15 days; the authorized medical physicist shall notify the licensee as soon as possible in writing of the results 37 of each spot-check.
38 (3) To satisfy the requirements of Subparagraph (a) of Paragraph (1) of this subsection, spot-39 checks must, at a minimum:
40 (a) assure proper operation of:
41 (i) treatment table retraction mechanism, using backup battery power or 42 hydraulic backups with the unit off; 43 (ii) helmet microswitches; 44 (iii) emergency timing circuits; and 45 (iv) stereotactic frames and localizing devices (trunnions); and 46 (b) determine:
47 (i) the output for one typical set of operating conditions measured with the 48 dosimetry system described in Paragraph (2) of Subsection F of 20.3.7.711 NMAC; 49 (ii) the difference between the measurement made above (Item (i) of 50 Subparagraph (b) of Paragraph (3) of Subsection L of 20.3.7.711 NMAC) and the anticipated output, expressed as a 51 percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for 52 physical decay);
53 (iii) source output against computer calculation; 54 (iv) timer accuracy and linearity over the range of use; 55 (v) on-off error; and 56 (vi) trunnion centricity.
20.3.7 NMAC 25
1 (4) To satisfy the requirements of Subparagraphs (b) and (c) of Paragraphs (1) of this 2 subsection, spot-checks must assure proper operation of:
3 (a) electrical interlocks at each gamma stereotactic radiosurgery room entrance; 4 (b) source exposure indicator lights on the gamma stereotactic radiosurgery unit, on 5 the control console, and in the facility; 6 (c) viewing and intercom systems; 7 (d) timer termination; 8 (e) radiation monitors used to indicate room exposures; and 9 (f) emergency off buttons.
10 (5) A licensee shall arrange for the repair of any system identified in Paragraph (3) of this 11 subsection that is not operating properly as soon as possible.
12 (6) If the results of the checks required in Paragraph (4) of this subsection indicate the 13 malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as 14 may be necessary to repair, replace or check the malfunctioning system.
15 (7) A licensee shall retain a record of each check required by Paragraphs (3) and (4) and a 16 copy of the procedures required by Paragraph (2) of this subsection in accordance with Subsection Z of 20.3.7.715 17 NMAC.
18 M. Additional technical requirements for mobile remote afterloader units.
19 (1) A licensee providing mobile remote afterloader service shall:
20 (a) check survey instruments before medical use at each address of use or on each 21 day of use, whichever is more frequent; and 22 (b) account for all sources before departure from a client's address of use.
23 (2) In addition to the periodic spot-checks required by Subsection K of 20.3.7.711 NMAC, a 24 licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit 25 before use at each address of use. At a minimum, checks must be made to verify the operation of:
26 (a) electrical interlocks on treatment area access points; 27 (b) source exposure indicator lights on the remote afterloader unit, on the control 28 console, and in the facility; 29 (c) viewing and intercom systems; 30 (d) applicators, source transfer tubes and transfer tube-applicator interfaces; 31 (e) radiation monitors used to indicate room exposures; 32 (f) source positioning (accuracy); and 33 (g) radiation monitors used to indicate whether the source has returned to a safe 34 shielded position.
35 (3) In addition to the requirements for checks in Paragraph (2) of this subsection, a licensee 36 shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment 37 before use at each address of use.
38 (4) If the results of the checks required in Paragraph (2) of this subsection indicate the 39 malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as 40 may be necessary to repair, replace or check the malfunctioning system.
41 (5) A licensee shall retain a record of each check required by Paragraph (2) of this subsection 42 in accordance with Subsection AA of 20.3.7.715 NMAC.
43 N. Radiation surveys.
44 (1) In addition to the survey requirements in Subsection H of 20.3.7.703 NMAC and 45 20.3.4.416 NMAC, a person subject to this section shall make surveys to ensure that the maximum radiation levels 46 and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do 47 not exceed the levels stated in the sealed source and device registry.
48 (2) The licensee shall make the survey required by Paragraph (1) of this subsection at 49 installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit or other 50 electronic or mechanical component that could expose the source, reduce the shielding around the source(s) or 51 compromise the radiation safety of the unit or the source(s).
52 (3) A licensee shall retain a record of the radiation surveys required by Paragraph (1) of this 53 subsection in accordance with Subsection BB of 20.3.7.715 NMAC.
54 O. Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.
55 (1) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully 56 inspected and serviced during source replacement [or at intervals not to exceed 5 years, whichever comes first,] to 20.3.7 NMAC 26
1 assure proper functioning of the source exposure mechanism and other safety components. The interval between 2 each full inspection servicing shall not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each 3 gamma stereotactic radiosurgery unit.
4 (2) This inspection and servicing may only be performed by persons specifically licensed to 5 do so by the department, NRC or an agreement state.
6 (3) A licensee shall keep a record of the inspection and servicing in accordance with 7 Subsection CC of 20.3.7.715 NMAC.
8 P. Therapy-related computer systems. The licensee shall perform acceptance testing on the treatment 9 planning system of therapy-related computer systems in accordance with published protocols accepted by nationally 10 recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:
11 (1) the source-specific input parameters required by the dose calculation algorithm; 12 (2) the accuracy of dose, dwell time and treatment time calculations at representative points; 13 (3) the accuracy of isodose plots and graphic displays; 14 (4) the accuracy of the software used to determine sealed source positions from radiographic 15 images; and 16 (5) the accuracy of electronic transfer of the treatment delivery parameters to the treatment 17 delivery unit from the treatment planning system.
18 [20.3.7.711 NMAC - Rp, 20 NMAC 3.1.7.710, 04/30/2009; A, XX/XX/2022]
19 20 20.3.7.712 SEALED SOURCES FOR DIAGNOSIS:
21 A. Use of sealed sources for diagnosis. A licensee shall use only sealed sources for diagnostic 22 medical uses [as approved in the sealed source and device registry] if the sealed sources are approved in the Sealed 23 Source and Device Registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses 24 that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the 25 radiation safety conditions and limitations described in the Sealed Source and Device Registry.
26 B. A licensee must only use medical devices containing sealed sources for diagnostic medical uses if 27 both the sealed sources and medical devices are approved in the Sealed Source and Device Registry for diagnostic 28 medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed 29 in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and 30 limitations described in the Sealed Source and Device Registry.
31 C. Sealed sources and devices for diagnostic medical uses may be used in research in accordance 32 with an active Investigational Device Exemption (IDE) application accepted by the U.S. Food and Drug 33 Administration provided the requirements of 10 CFR § 35.49(a) are met.
34 [B] D. Survey instrument. A licensee authorized to use radioactive material as a sealed source for 35 diagnostic purposes shall have available for use a portable radiation survey meter capable of detecting dose rates 36 ranging from 0.1 millirem (1 millisievert) per hour to 1000 millirems (10 millisieverts) per hour. The instrument 37 shall be operable and calibrated in accordance with section Subsection C of 20.3.7.703 NMAC.
38 [20.3.7.712 NMAC - Rp, 20 NMAC 3.1.7.711, 04/30/2009; A, XX/XX/2022]
39 40 20.3.7.713 OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM 41 RADIOACTIVE MATERIAL: A licensee may use radioactive material or a radiation source approved for 42 medical use which is not specifically addressed in 20.3.7.704 NMAC through 20.3.7.712 NMAC of this part if:
43 A. the applicant or licensee has submitted the information required by Paragraph (2) through (4) of 44 Subsection E of 20.3.7.700 NMAC; and 45 B. the applicant or licensee has received written approval from the department in a license or license 46 amendment and uses the material in accordance with the requirements and specific conditions the department 47 considers necessary for the medical use of the material.
48 [20.3.7.713 NMAC - N, 4/30/2009]
49 50 20.3.7.714 TRAINING REQUIREMENTS:
51 A. Radiation safety officer and Associate Radiation Safety Officer. The regulations of the NRC 52 set forth in 10 CFR 35.50 are hereby incorporated by reference.
53 B. Training for an authorized medical physicist. The regulations of the NRC set forth in 10 CFR 54 35.51 are hereby incorporated by reference.
55 C. Training for an authorized nuclear pharmacist. The regulations of the NRC set forth in 10 56 CFR 35.55 are hereby incorporated by reference.
20.3.7 NMAC 27
1 D. Training for experienced radiation safety officer, teletherapy or medical physicist, 2 authorized medical physicist, authorized user, nuclear pharmacist and authorized nuclear pharmacist. The 3 regulations of the NRC set forth in 10 CFR 35.57 are hereby incorporated by reference.
4 E. Recentness of training. The training and experience specified in Subsections A, B, C, F, G, H, I, 5 J, K, L, M, N and O of this section must have been obtained within the 7 years preceding the date of application or 6 the individual must have had related continuing education and experience since the required training and experience 7 was completed.
8 F. Training for uptake, dilution, and excretion studies. (For use of unsealed radioactive material 9 under 20.3.7.704 NMAC) The regulations of the NRC set forth in 10 CFR 35.190 are hereby incorporated by 10 reference.
11 G. Training for imaging and localization studies. (For use of unsealed radioactive material under 12 20.3.7.705 NMAC) The regulations of the NRC set forth in 10 CFR 35.290 are hereby incorporated by reference.
13 H. Training for use of unsealed radioactive material for which a written directive is required.
14 (For use of unsealed radioactive material under 20.3.7.708 NMAC) The regulations of the NRC set forth in 10 CFR 15 35.390 are hereby incorporated by reference.
16 I. Training for the oral administration of sodium iodide i-131 requiring a written directive in 17 quantities less than or equal to 33 millicuries (1.22 gigabecquerels). The regulations of the NRC set forth in 10 18 CFR 35.392 are hereby incorporated by reference.
19 J. Training for the oral administration of sodium iodide i-131 requiring a written directive in 20 quantities greater than 33 millicuries (1.22 gigabecquerels). The regulations of the NRC set forth in 10 CFR 21 35.394 are hereby incorporated by reference.
22 K. Training for the parenteral administration of unsealed byproduct material requiring a 23 written directive. The regulations of the NRC set forth in 10 CFR 35.396 are hereby incorporated by reference.
24 L. Training for use of manual brachytherapy sources. (For use of radioactive material under 25 20.3.7.710 NMAC) The regulations of the NRC set forth in 10 CFR 35.490 are hereby incorporated by reference.
26 M. Training for ophthalmic use of strontium-90. (For use of radioactive material under 20.3.7.710 27 NMAC) The regulations of the NRC set forth in 10 CFR 35.491 are hereby incorporated by reference.
28 N. Training for use of sealed sources for diagnosis: (For use of radioactive material under 29 20.3.7.712 NMAC) The regulations of the NRC set forth in 10 CFR 35.590 are hereby incorporated by reference.
30 O. Training for use of remote afterloader units, teletherapy units and gamma stereotactic 31 radiosurgery units (For use of radioactive material under 20.3.7.711 NMAC). The regulations of the NRC set forth 32 in 10 CFR 35.690 are hereby incorporated by reference.
33 P. Modifications. The following modifications are made to the incorporated federal regulations in 34 this section.
35 (1) Commission means the department or NRC.
36 (2) Act means the Radiation Protection Act, Sections 74-3-1 through 74-3-16 NMSA 37 1978.
38 (3) Byproduct material means radioactive material as defined in this chapter.
39 (4) 10 CFR 35.100 means 20.3.7.704 NMAC.
40 (5) 10 CFR 35.200 means 20.3.7.705 NMAC.
41 (6) 10 CFR 35.300 means 20.3.7.708 NMAC.
42 (7) 10 CFR 35.400 means 20.3.7.710 NMAC.
43 (8) 10 CFR 35.500 means 20.3.7.712 NMAC.
44 (9) 10 CFR 35.600 means 20.3.7.711 NMAC.
45 (10) At all other locations of use in Subsection D of this section, incorporating 10 CFR 46 35.57 means at all other locations of use in non-licensing state, as defined in 20.3.1.7 NMAC.
47 [20.3.7.714 NMAC - Rp, 20 NMAC 3.1.7.712; A, XX/XX/2022]
48 49 20.3.7.715 RECORDS:
50 A. Records of Authority and Responsibilities for Radiation Protection Programs.
51 (1) A licensee shall retain a record of actions taken by the licensees management in 52 accordance with Subsection C of 20.3.7.702 NMAC for five years. The record must include a summary of the 53 actions taken and a signature of licensee management.
54 (2) The licensee shall retain a copy of both authority, duties and responsibilities of the 55 radiation safety officer as required by Paragraph (2) of Subsection A of 20.3.7.702 NMAC, and a signed copy of 56 each radiation safety officers agreement to be responsible for implementing the radiation safety program, as 20.3.7 NMAC 28
1 required by Paragraph (1) of Subsection A of 20.3.7.702 NMAC, for the duration of the license. The records must 2 include the signature of the radiation safety officer and licensee management.
3 B. Records of Radiation Protection Program Changes. A licensee shall retain a record of each 4 radiation protection program change made in accordance with Subsection E of 20.3.7.702 NMAC for five years.
5 The record must include a copy of the old and new procedures, the effective date of the change and the signature of 6 the licensee management that reviewed and approved the change.
7 C. Records of Written Directives. A licensee shall retain a copy of each written directive as 8 required by Subsection G of 20.3.7.702 NMAC for three years.
9 D. Records for Procedures for Administrations Requiring a Written Directive. A licensee shall 10 retain a copy of the procedures required by Subsection H of 20.3.7.702 NMAC for the duration of the license.
11 E. Records of Calibrations, Test or Checks of Instruments Used to Measure the Activity of 12 Unsealed Radioactive Material. A licensee shall maintain a record of instrument checks, tests and calibrations 13 required by Subsection A of 20.3.7.703 NMAC for three years. The records must include the model and serial 14 number of the instrument, the date of the check, test or calibration, the activity and serial number of the calibration 15 source(s) used for the check, test or calibration, whichever applicable, the results of the check, test or calibration and 16 the name of the individual who performed the check, test or calibration.
17 F. Records of Radiation Survey Instrument Calibrations. A licensee shall maintain a record of 18 radiation survey instrument calibrations required by Subsection C of 20.3.7.703 NMAC for three years. The record 19 must include the model and serial number of the instrument, the date of the calibration, the results of the calibration 20 and the name of the individual who performed the calibration.
21 G. Records of Dosages of Unsealed Radioactive Material for Medical Use.
22 (1) A licensee shall maintain a record of dosage determinations required by Subsection B of 23 20.3.7.703 NMAC for three years.
24 (2) The record must contain:
25 (a) the radiopharmaceutical; 26 (b) the patients or human research subjects name or identification number if one 27 has been assigned; 28 (c) the prescribed dosage, the determined dosage or a notation that the total activity 29 is less than 30 microcuries (1.1 megabecquerels);
30 (d) the date and time of the dosage determination; and 31 (e) the name of the individual who determined the dosage.
32 H. Records of Leaks Tests and Inventory of Sealed Sources and Brachytherapy Sources.
33 (1) A licensee shall retain records of leak tests required by Paragraph (2) of Subsection F of 34 20.3.7.703 NMAC for three years. The records must include the model number, and serial number if one has been 35 assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of 36 the test; the date of the test and the name of the individual who performed the test.
37 (2) A licensee shall retain records of the semi-annual physical inventory of sealed sources 38 and brachytherapy sources required by Paragraph (7) of Subsection F of 20.3.7.703 NMAC for three years. The 39 inventory records must contain the model number of each source, and serial number if one has been assigned, the 40 identity of each source by radionuclide and its nominal activity, the location of each source and the name of the 41 individual who performed the inventory.
42 I. Records of Surveys. A licensee shall retain a record of each survey required by Subsection H of 43 20.3.7.703 NMAC for three years. The record must include the date of the survey, the results of the survey, the 44 instrument used to make the survey and the name of the individual who performed the survey.
45 J. Records of the Release of Individuals Containing Unsealed Radioactive Material or Implants 46 Containing Radioactive Material.
47 (1) A licensee shall retain a record of the basis for authorizing the release of an individual in 48 accordance with Subsection I of 20.3.7.703 NMAC, if the total effective dose equivalent is calculated by:
49 (a) using the retained activity rather than the activity administered; 50 (b) using an occupancy factor less than 0.25 at one meter; 51 (c) using the biological or effective half-life; or 52 (d) considering the shielding by tissue.
53 (2) A licensee shall retain a record that the instructions required by Paragraph (2) of 54 Subsection I of 20.3.7.703 NMAC were provided to a breast-feeding female if the radiation dose to the infant or 55 child from continued breastfeeding could result in a total effective dose equivalent exceeding 0.5 rem (five 56 millisieverts).
20.3.7 NMAC 29
1 (3) The records required by Paragraphs (1) and (2) of this section must be retained for three 2 years after the date of release of the individual.
3 K. Records of Mobile Medical Services.
4 (1) A licensee shall retain a copy of each letter that permits the use of radioactive material at 5 a clients address, as required by Subparagraph (a) of Paragraph (1) of Subsection J of 20.3.7.703 NMAC. Each 6 letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for 7 three years after the last provision of service.
8 (2) A licensee shall retain the record of each survey required by Subparagraph (d) of 9 Paragraph (1) of Subsection J of 20.3.7.703 NMAC for three years. The record must include the date of the survey, 10 the results of the survey, the instrument used to make the survey and the name of the individual who performed the 11 survey.
12 L. Records of Decay-In-Storage. A licensee shall maintain records of the disposal of licensed 13 materials, as required by Subsection L of 20.3.7.703 NMAC, for three years. The record must include the date of 14 the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface 15 of each waste container and the name of the individual who performed the survey.
16 M. Records of Molybdenum-99, Strontium-82 and Strontium-85 Concentrations. A licensee 17 shall maintain a record of the molybdenum-99, strontium-82 and strontium-85 concentration tests required by 18 20.3.7.706 NMAC for three years. The record must include:
19 (1) for each measured elution of technetium-99m, the ratio of the measures expressed as 20 microcuries of molybdenum-99 per each millicurie of technetium-99m (or kilobecquerel of molybdenum-99 per 21 each megabecquerel of technetium-99m), the time and date of the measurement and the name of the individual who 22 made the measurement; or 23 (2) for each measured elution of rubidium-82, the ratio of the measures expressed as 24 microcuries of strontium-82 per millicurie of rubidium-82 (or kilobecquerel of strontium-82 per megabecquerel of 25 rubidium), microcurie of strontium-85 per millicurie of rubidium-82 (or kilobecquerel of strontium-85 per 26 megabecquerel of rubidium), the time and date of the measurement and the name of the individual who made the 27 measurement.
28 N. Records of Gas Controls. A licensee shall maintain the records specified in Subsection D of 29 20.3.7.707 NMAC for 3 years.
30 O. Records of Safety Instructions. A licensee shall maintain a record of safety instructions required 31 by Subsection A of 20.3.7.709 NMAC, Subsection D of 20.3.7.710 NMAC and Subsection D of 20.3.7.711 NMAC 32 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the 33 attendee(s) and the name(s) of the individual(s) who provided the instruction.
34 P. Records of Surveys after Source Implant and Removal. A licensee shall maintain a record of 35 the surveys required by Subsection B of 20.3.7.710 NMAC and Subsection B of 20.3.7.711 NMAC for three years.
36 Each record must include the date and results of the survey, the survey instrument used and the name of the 37 individual who made the survey.
38 Q. Records of Brachytherapy Source Accountability.
39 (1) A licensee shall maintain a record of brachytherapy source accountability required by 40 Subsection B of 20.3.7.710 NMAC for three years.
41 (2) For temporary implants, the record must include:
42 (a) the number and activity of sources removed from storage, the time and date they 43 were removed from storage, the name of the individual who removed them from storage and the location of use; and 44 (b) the number and activity of sources returned to storage, the time and date they 45 were returned to storage and the name of the individual who returned them to storage.
46 (3) For permanent implants, the record must include:
47 (a) the number and activity of sources removed from storage, the date they were 48 removed from storage and the name of the individual who removed them from storage; 49 (b) the number and activity of sources not implanted, the date they were returned to 50 storage and the name of the individual who returned them to storage; and 51 (c) the number and activity of sources permanently implanted in the patient or 52 human research subject.
53 R. Records of Calibration Measurements of Brachytherapy Sources.
54 (1) A licensee shall maintain a record of the calibrations of brachytherapy sources required 55 by Subsection F of 20.3.7.710 NMAC for three years after the last use of the source.
56 (2) The record must include:
20.3.7 NMAC 30
1 (a) the date of the calibration; 2 (b) the manufacturers name, model number and serial number for the source and 3 the instruments used to calibrate the source; 4 (c) the source output or activity; 5 (d) the source positioning accuracy within the applicators; and 6 (e) the name of the individual, the source manufacturer or the calibration laboratory 7 that performed the calibration.
8 S. Records of Decay of Strontium- 90 Sources for Ophthalmic Treatments.
9 (1) A licensee shall maintain a record of the activity of a strontium-90 source required by 10 Subsection G of 20.3.7.710 NMAC for the life of the source.
11 (2) The record must include:
12 (a) the date and initial activity of the source as determined under Subsection F of 13 20.3.7.710 NMAC; and 14 (b) for each decay calculation, the date and the source activity as determined under 15 Subsection G of 20.3.7.710 NMAC.
16 T. Records of Installation, Maintenance, Adjustment and Repair of Remote Afterloader Units, 17 Teletherapy Units and Gamma Stereotactic Radiosurgery Units. A licensee shall retain a record of the 18 installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units and gamma 19 stereotactic radiosurgery units as required by Subsection C of 20.3.7.711 NMAC for three years. For each 20 installation, maintenance, adjustment and repair, the record must include the date, description of the service and 21 name(s) of the individual(s) who performed the work.
22 U. Records of Safety Procedures. A licensee shall retain a copy of the procedures required by 23 Subparagraph (d) of Paragraph (1) of Subsection D of 20.3.7.711 NMAC and Subparagraph (b) of Paragraph (4) of 24 Subsection D of 20.3.7.711 NMAC until the licensee no longer possesses the remote afterloader, teletherapy unit or 25 gamma stereotactic radiosurgery unit.
26 V. Records of Dosimetry Equipment Used with Remote Afterloader Units, Teletherapy Units 27 and Gamma Stereotactic Radiosurgery Units.
28 (1) A licensee shall retain a record of the calibration, inter-comparison and comparisons of 29 its dosimetry equipment done in accordance with Subsection F of 20.3.7.711 NMAC for the duration of the license.
30 (2) For each calibration, inter-comparison or comparison, the record must include:
31 (a) the date; 32 (b) the manufacturers name, model numbers and serial numbers of the instruments 33 that were calibrated, inter-compared or compared as required by Paragraphs (1) and (2) of Subsection F of 34 20.3.7.711 NMAC; 35 (c) the correction factor that was determined from the calibration or comparison or 36 the apparent correction factor that was determined from an inter-comparison; and 37 (d) the names of the individuals who performed the calibration, inter-comparison or 38 comparison.
39 W. Records of Teletherapy, Remote Afterloader and Gamma Stereotactic Radiosurgery Full 40 Calibrations.
41 (1) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit and 42 gamma stereotactic radiosurgery unit full calibrations required by Subsection G of 20.3.7.711 NMAC, Subsection H 43 of 20.3.7.711 NMAC and Subsection I of 20.3.7.711 NMAC for three years, respectively.
44 (2) The record must include:
45 (a) the date of the calibration; 46 (b) the manufacturers name, model number and serial number of the teletherapy, 47 remote afterloader and gamma stereotactic radiosurgery unit(s), the source(s) and the instruments used to calibrate 48 the unit(s);
49 (c) the results and an assessment of the full calibrations; 50 (d) the results of the autoradiograph required for low dose-rate remote afterloader 51 units; and 52 (e) the signature of the authorized medical physicist who performed the full 53 calibration.
54 X. Records of Periodic Spot Checks for Teletherapy Units.
55 (1) A licensee shall retain a record of each periodic spot-check for teletherapy units required 56 by Subsection J of 20.3.7.711 NMAC for three years.
20.3.7 NMAC 31
1 (2) The record must include:
2 (a) the date of the spot-check; 3 (b) the manufacturers name, model number and serial number of the teletherapy 4 unit, source and instrument used to measure the output of the teletherapy unit; 5 (c) an assessment of timer linearity and constancy; 6 (d) the calculated on-off error; 7 (e) a determination of the coincidence of the radiation field and the field indicated 8 by the light beam localizing device; 9 (f) the determined accuracy of each distance measuring and localization device; 10 (g) the difference between the anticipated output and the measured output; 11 (h) notations indicating the operability of each entrance door electrical interlock, 12 each electrical or mechanical stop, each source exposure indicator light and the viewing and intercom system and 13 doors; and 14 (i) the name of the individual who performed the periodic spot-check and the 15 signature of the authorized medical physicist who reviewed the record of the spot-check.
16 (3) A licensee shall retain a copy of the procedures required by Paragraph (2) of Subsection J 17 of 20.3.7.711 NMAC until the licensee no longer possesses the teletherapy unit.
18 Y. Records of Periodic Spot-checks for Remote Afterloader Units.
19 (1) A licensee shall retain a record of each spot-check for remote afterloader units required 20 by Subsection K of 20.3.7.711 NMAC for three years.
21 (2) The record must include, as applicable:
22 (a) the date of the spot-check; 23 (b) the manufacturers name, model number and serial number for the remote 24 afterloader unit and source; 25 (c) an assessment of timer accuracy; 26 (d) notations indicating the operability of each entrance door electrical interlock, 27 radiation monitors, source exposure indicator lights, viewing and intercom systems and clock and decayed source 28 activity in the units computer; and 29 (e) the name of the individual who performed the periodic spot-check and the 30 signature of the authorized medical physicist who reviewed the record of the spot-check.
31 (3) A licensee shall retain a copy of the procedures required by Paragraph (2) of Subsection 32 K of 20.3.7.711 NMAC until the licensee no longer possesses the remote afterloader unit.
33 Z. Records of Periodic Spot-checks for Gamma Stereotactic Radiosurgery Units.
34 (1) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery 35 units required by Subsection L of 20.3.7.711 NMAC for three years.
36 (2) The record must include:
37 (a) the date of the spot-check; 38 (b) the manufacturers name, model number and serial number for the gamma 39 stereotactic radiosurgery unit and the instrument used to measure the output of the unit; 40 (c) an assessment of timer linearity and accuracy; 41 (d) the calculated on-off error; 42 (e) a determination of trunnion centricity; 43 (f) the difference between the anticipated output and the measured output; 44 (g) an assessment of source output against computer calculations; 45 (h) notations indicating the operability of radiation monitors, helmet microswitches, 46 emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing 47 and intercom systems, timer termination, treatment table retraction mechanism and stereotactic frames and 48 localizing devices (trunnions); and 49 (i) the name of the individual who performed the periodic spot-check and the 50 signature of the authorized medical physicist who reviewed the record of the spot-check.
51 (3) A licensee shall retain a copy of the procedures required by Paragraph (2) of Subsection 52 L of 20.3.7.711 NMAC until the licensee no longer possesses the gamma stereotactic radiosurgery unit.
53 AA. Records of Additional Technical Requirements for Mobile Remote Afterloader Units.
54 (1) A licensee shall retain a record of each check for mobile remote afterloader units required 55 by Subsection M of 20.3.7.711 NMAC for three years.
56 (2) The record must include:
20.3.7 NMAC 32
1 (a) the date of the check; 2 (b) the manufacturers name, model number and serial number of the remote 3 afterloader unit; 4 (c) notations accounting for all sources before the licensee departs from a facility; 5 (d) notations indicating the operability of each entrance door electrical interlock, 6 radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes 7 and transfer tube applicator interfaces and source positioning accuracy; and 8 (e) the signature of the individual who performed the check.
9 BB. Records of Surveys of Therapeutic Treatment Units.
10 (1) A licensee shall maintain a record of radiation surveys of treatment units made in 11 accordance with Subsection N of 20.3.7.711 NMAC for the duration of use of the unit.
12 (2) The record must include:
13 (a) the date of the measurements; 14 (b) the manufacturers name, model number and serial number of the treatment unit, 15 source and instrument used to measure radiation levels; 16 (c) each dose rate measured around the source while the unit is in the off position 17 and the average of all measurements; and 18 (d) the signature of the individual who performed the test.
19 CC. Records of 5-Year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units.
20 (1) A licensee shall maintain a record of the five-year inspections for teletherapy and gamma 21 stereotactic radiosurgery units required by Subsection O of 20.3.7.711 NMAC for the duration of use of the unit.
22 (2) The record must contain:
23 (a) the inspectors radioactive materials license number; 24 (b) the date of inspection; 25 (c) the manufacturers name, model number and serial number of both the treatment 26 unit and source; 27 (d) a list of components inspected and serviced and the type of service; and 28 (e) the signature of the inspector.
29 [20.3.7.715 NMAC - N, 4/30/2009]
30 31 20.3.7.716 REPORTS:
32 A. Report and notification of a medical event.
33 (1) A licensee shall report any event, except for an event that results from patient 34 intervention, in which the administration of [radioactive] byproduct material or radiation from [radioactive]
35 byproduct material, except permanent implant brachytherapy, results in:
36 (a) a dose that differs from the prescribed dose or dose that would have resulted 37 from the prescribed dosage by more than 5 rems (50 millisieverts) effective dose equivalent, 50 rems (0.5 sievert) to 38 an organ or tissue or 50 rems (0.5 sievert) shallow dose equivalent to the skin; and:
39 (i) the total dose delivered differs from the prescribed dose by twenty 40 percent or more; 41 (ii) the total dosage delivered differs from the prescribed dosage by twenty 42 percent or more or falls outside the prescribed dosage range; or 43 (iii) the fractionated dose delivered differs from the prescribed dose, for a 44 single fraction, by fifty percent or more; 45 (b) a dose that exceeds 5 rems (50 millisieverts) effective dose equivalent, 50 rems 46 (0.5 sievert) to an organ or tissue, or 50 rems (0.5 sievert) shallow dose equivalent to the skin from any of the 47 following:
48 (i) an administration of a wrong radioactive drug containing byproduct 49 [radioactive] material; 50 (ii) an administration of a radioactive drug containing radioactive material 51 by the wrong route of administration; 52 (iii) an administration of a dose or dosage to the wrong individual or human 53 research subject; 54 (iv) an administration of a dose or dosage delivered by the wrong mode of 55 treatment; or 56 (v) a leaking sealed source; and 20.3.7 NMAC 33
1 (c) a dose to the skin or an organ or tissue other than the treatment site that exceeds 2 by 50 rems (0.5 sievert) to an organ or tissue and fifty percent or more of the dose expected from the administration 3 defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but 4 migrated outside the treatment site).
5 (d) For permanent implant brachytherapy, the administration of byproduct material 6 or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside 7 the treatment site) that results in 8 (i) The total source strength administered differing by 20 percent or more 9 from the total source strength documented in the post-implantation portion of the written directive; 10 (ii) The total source strength administered outside of the treatment site 11 exceeding 20 percent of the total source strength documented in the post-implantation portion of the written 12 directive; or 13 (iii) An administration that includes any of the following: the wrong 14 radionuclide; the wrong individual or human research subject; sealed source(s) implanted directly into a location 15 discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or a 16 leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.
17 (2) A licensee shall report any event resulting from intervention of a patient or human 18 research subject in which the administration of radioactive material or radiation from radioactive material results or 19 will result in unintended permanent functional damage to an organ or a physiological system, as determined by a 20 physician.
21 (3) The licensee shall notify by telephone the department no later than the next calendar day 22 after discovery of the medical event.
23 (4) The licensee shall submit a written report to the department within 15 days after 24 discovery of the medical event.
25 (a) The written report must include:
26 (i) the licensee's name; 27 (ii) the name of the prescribing physician; 28 (iii) a brief description of the event; 29 (iv) why the event occurred; 30 (v) the effect, if any, on the individual(s) who received the administration; 31 (vi) what actions, if any, have been taken or are planned to prevent 32 recurrence; and 33 (vii) certification that the licensee notified the individual (or the individual's 34 responsible relative or guardian), and if not, why not.
35 (b) The report may not contain the individual's name or any other information that 36 could lead to identification of the individual.
37 (5) The licensee shall provide notification of the event to the referring physician and also 38 notify the individual who is the subject of the medical event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the 39 referring physician personally informs the licensee either that he or she will inform the individual or that, based on 40 medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual 41 without first consulting the referring physician. If the referring physician or the affected individual cannot be 42 reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter. The licensee may not 43 delay any appropriate medical care for the individual, including any necessary remedial care as a result of the 44 medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of 45 the individual who is the subject of the medical event may be made instead to that individual's responsible relative 46 or guardian. If a verbal notification is made, the licensee shall inform the individual or appropriate responsible 47 relative or guardian that a written description of the event can be obtained from the licensee upon request. The 48 licensee shall provide such a written description if requested.
49 (6) Aside from the notification requirement, nothing in this section affects any rights or 50 duties of licensees and physicians in relation to each other, to individuals affected by the medical event or to that 51 individual's responsible relatives or guardians.
52 (7) A licensee shall:
53 (a) annotate a copy of the report provided to the department with the:
54 (i) name of the individual who is the subject of the event; and 55 (ii) social security number or other identification number, if one has been 56 assigned, of the individual who is the subject of the event; and 20.3.7 NMAC 34
1 (b) provide a copy of the annotated report to the referring physician, if other than 2 the licensee, no later than 15 days after the discovery of the event.
3 B. Report and notification of a dose to an embryo, fetus or a nursing child.
4 (1) A licensee shall report any dose to an embryo or fetus that is greater than 5 rems (50 5 millisieverts) dose equivalent that is a result of an administration of radioactive material or radiation from 6 radioactive material to a pregnant individual unless the dose to the embryo or fetus was specifically approved, in 7 advance, by the authorized user.
8 (2) A licensee shall report any dose to a nursing child that is a result of an administration of 9 radioactive material to a breast-feeding individual that:
10 (a) is greater than 5 rems (50 millisieverts) total effective dose equivalent; or 11 (b) has resulted in unintended permanent functional damage to an organ or a 12 physiological system of the child, as determined by a physician.
13 (3) The licensee shall notify by telephone the department no later than the next calendar day 14 after discovery of a dose to the embryo, fetus or nursing child that requires a report in Paragraphs (1) or (2) in this 15 subsection.
16 (4) The licensee shall submit a written report to the department within 15 days after 17 discovery of a dose to the embryo, fetus or nursing child that requires a report in Paragraphs (1) or (2) in this 18 subsection.
19 (a) The written report must include:
20 (i) the licensee's name; 21 (ii) the name of the prescribing physician; 22 (iii) a brief description of the event; 23 (iv) why the event occurred; 24 (v) the effect, if any, on the embryo, fetus or the nursing child; 25 (vi) what actions, if any, have been taken or are planned to prevent 26 recurrence; and 27 (vii) certification that the licensee notified the pregnant individual or mother 28 (or the mother's or child's responsible relative or guardian), and if not, why not.
29 (b) The report must not contain the individual's or child's name or any other 30 information that could lead to identification of the individual or child.
31 (5) The licensee shall provide notification of the event to the referring physician and also 32 notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after 33 discovery of an event that would require reporting under Paragraph (1) or (2) of this subsection, unless the referring 34 physician personally informs the licensee either that he or she will inform the mother or that, based on medical 35 judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first 36 consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the 37 licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any 38 appropriate medical care for the embryo, fetus or for the nursing child, including any necessary remedial care as a 39 result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification 40 may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification 41 is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian that a written 42 description of the event can be obtained from the licensee upon request. The licensee shall provide such a written 43 description if requested.
44 (6) A licensee shall:
45 (a) annotate a copy of the report provided to the NRC with the:
46 (i) name of the pregnant individual or the nursing child who is the subject 47 of the event; and 48 (ii) social security number or other identification number, if one has been 49 assigned, of the pregnant individual or the nursing child who is the subject of the event; and 50 (b) provide a copy of the annotated report to the referring physician, if other than 51 the licensee, no later than 15 days after the discovery of the event.
52 C. Report of a leaking source. A licensee shall file a report within five days if a leak test required by 53 Subsection F of 20.3.7.703 NMAC reveals the presence of 0.005 microcurie (185 becquerels) or more of removable 54 contamination. The report must be filed with the department and it must include the model number and serial 55 number, if assigned, of the leaking source, the radionuclide and its estimated activity, the results of the test, the date 56 of the test and the action taken.
20.3.7 NMAC 35
1 D. Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, 2 and strontium-85 concentrations:
3 (1) The licensee shall notify by telephone the department and NRC Operations Center and 4 the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible 5 concentration listed in 10 CFR § 35.204(a) at the time of generator elution. The telephone report to the department 6 and NRC must include the manufacturer, model number, and serial number (or lot number) of the generator; the 7 results of the measurement; the date of the measurement; whether dosages were administered to patients or human 8 research subjects, when the distributor was notified, and the action taken.
9 (2) By an appropriate method listed in 10 CFR § 30.6(a) of this chapter, the licensee shall 10 submit a written report to the department and appropriate NRC Regional Office listed in 10 CFR § 30.6 of this 11 chapter within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of 12 generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the 13 methodology used to make this dose assessment if the eluate was administered to patients or human research 14 subjects; and the probable cause and an assessment of failure in the licensees equipment, procedures or training that 15 contributed to the excessive readings if an error occurred in the licensees breakthrough determination; and the 16 information in the telephone report as required by paragraph (1) of this section.
17 [20.3.7.716 NMAC - N, 04/30/2009; A, XX/XX/2022]
18 19 HISTORY OF 20.3.7 NMAC:
20 Pre-NMAC History: The material in this part was derived from that previously filed with the commission of 21 public records - state records center and archives.
22 EIB 73-2, Regulations for Governing the Health and Environmental Aspects of Radiation filed 7/9/1973; EIB 73-2, 23 Amendment 1, Regulations for Governing the Health and Environmental Aspects of Radiation filed on 4/17/1978; 24 EIB RPR-1, Radiation Protection Regulations filed on 4-21-80; EIB RPR-1, Amendment 1, Radiation Protection 25 Regulations filed on 10/13/1981; EIB RPR-1, Amendment 2, Radiation Protection Regulations filed on 12/15/1982; 26 and EIB RPR-1, Radiation Protection Regulations filed on 3/10/1989.
27 28 History of Repealed Material: 20 NMAC 3.1 Subpart 7, Radiation Materials And Radiation Machines, Medical 29 Use Of Radionuclides (filed 6/17/1999) repealed 4/30/2009.
30 31 Other History: EIB RPR 1, Radiation Protection Regulations (filed 3/10/1989) was renumbered and reformatted to 32 20 NMAC 3.1, Radiation Materials and Radiation Machines, effective 5/3/1995.
33 20 NMAC 3.1, Radiation Materials and Radiation Machines (filed 4/3/1995) was internally renumbered, reformatted 34 and replaced by 20 NMAC 3.1, Radiation Materials And Radiation Machines, effective 7/30/1999.
35 20 NMAC 3.1 Subpart 7, Radiation Materials And Radiation Machines, Medical Use Of Radionuclides (filed 36 6/17/1999) was reformatted, renumbered and replaced by 20.3.7 NMAC, Medical Use Of Radionuclides, effective 37 4/30/2009.
20.3.7 NMAC 36