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