New Mexico Administrative Code
Title 20 - ENVIRONMENTAL PROTECTION
Chapter 3 - RADIATION PROTECTION
Part 7 - MEDICAL USE OF RADIONUCLIDES
Section 20.3.7.702 - GENERAL ADMINISTRATIVE REQUIREMENTS
Universal Citation: 20 NM Admin Code 20.3.7.702
Current through Register Vol. 35, No. 6, March 26, 2024
A. Radiation safety officer.
(1) A licensee or licensee's management shall
appoint a radiation safety officer, who agrees, in writing, to be responsible
for implementing a radiation protection program. The licensee, through the
radiation safety officer, shall ensure that radiation safety activities are
being performed in accordance with licensee-approved procedures and regulatory
requirements. A licensee's management may appoint, in writing, one or more
Associate Radiation Safety Officers to support the Radiation Safety Officer.
The Radiation Safety Officer, with written agreement of the licensee's
management, must assign the specific duties and tasks to each Associate
Radiation Safety Officer. These duties and tasks are restricted to the types of
use for which the Associate Radiation Safety Officer is listed on a license.
The Radiation Safety Officer may delegate duties and tasks to the Associate
Radiation Safety Officer but shall not delegate the authority or
responsibilities for implementing the radiation protection program.
(2) A licensee shall establish the authority,
duties and responsibilities of the radiation safety officer in
writing.
(3) A licensee shall
provide the radiation safety officer sufficient authority, organizational
freedom, time, resources and management prerogative to:
(a) identify radiation safety
problems;
(b) initiate, recommend
or provide corrective actions;
(c)
prevent or order the cessation of unsafe operations; and
(d) verify implementation of corrective
actions.
(4) For up to 60
days each year, a licensee may permit an authorized user or an individual
qualified to be a radiation safety officer, under Subsections A and E of
20.3.7.714 NMAC, to function as a
temporary radiation safety officer and to perform the functions of a radiation
safety officer, as provided in Paragraph (3) of this subsection, if the
licensee takes the actions required in Paragraphs (1), (2), (3) and (5) of this
subsection and notifies the department in accordance with Paragraph (2) of
Subsection G of
20.3.7.700 NMAC.
(5) A licensee may simultaneously appoint
more than one temporary radiation safety officer in accordance with Paragraph
(4) of this subsection, if needed to ensure that the licensee has a temporary
radiation safety officer that satisfies the requirements to be a radiation
safety officer for each of the different types of uses of radioactive material
permitted by the license.
B. Authority and responsibilities for the radiation protection program. In addition to the radiation protection program requirements of 20.3.4.404 NMAC, a licensee or licensee's management shall approve in writing:
(1) requests for a license application,
renewal or amendment before submittal to the department;
(2) any individual before allowing that
individual to work as an authorized user, authorized nuclear pharmacist or
authorized medical physicist; and
(3) radiation protection program changes that
do not require a license amendment and are permitted under Subsection E of this
section.
C. Record keeping. A licensee shall retain a record of actions taken under Subsections A and B of this section in accordance with Subsection A of 20.3.7.715 NMAC.
D. Radiation safety committee. Licensees that are authorized for two or more different types of use 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 20.3.7.711 NMAC shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The radiation safety committee shall meet the following administrative requirements.
(1)
The radiation safety committee must include an authorized user of each type of
use permitted by the license, the radiation safety officer, a representative of
the nursing service and a representative of management who is neither an
authorized user, nor a radiation safety officer. The radiation safety committee
may include other members who the licensee considers appropriate.
(2) The radiation safety committee shall meet
at least once each calendar quarter. To establish a quorum and to conduct
business, one-half of the committee's membership shall be present, including
the radiation safety officer and the management's representative.
(3) The licensee shall maintain minutes of
each radiation safety committee meeting, promptly provide each member with a
copy of the meeting minutes and retain one copy for the duration of the
license.
(4) To oversee the use of
licensed material, the radiation safety committee shall:
(a) review and verify the training and
experience documentation (such as the board certification, preceptor
statement(s), or any additional required training) and approve or disapprove
any individual who is to be listed on a license as an authorized user, an
authorized nuclear pharmacist, a radiation safety officer or an authorized
medical physicist before submitting a license application or request for
amendment or renewal;
(b) review
and verify the training and experience documentation (such as the board
certification, preceptor statement(s), the license or the permit identifying an
individual as an authorized user, authorized nuclear pharmacist, authorized
medical physicist or a radiation safety officer) and approve or disapprove any
individual prior to allowing that individual to work as an authorized user,
authorized nuclear pharmacist, a radiation safety officer or an authorized
medical physicist;
(c) review, on
the basis of safety, and approve or disapprove each proposed method of use of
radioactive material;
(d) review,
on the basis of safety, and approve or disapprove with the advice and consent
of the radiation safety officer and the management representative, licensee's
procedures and radiation protection program changes prior to submittal to the
department for licensing action;
(e) review quarterly records of the radiation
protection program indicating non-ALARA occurrences and all incidents and
medical events involving radioactive material with respect to cause and
subsequent actions taken; and
(f)
review, annually, with the assistance of the radiation safety officer, the
radiation protection program.
E. Radiation protection program changes.
(1) A licensee may revise its
radiation protection program without department approval if:
(a) the revision does not require a license
amendment under Subsection F of
20.3.7.700 NMAC;
(b) the revision is in compliance with the
requirements in 20.3 NMAC and the license;
(c) the revision has been reviewed and
approved by the radiation safety officer and licensee's management;
and
(d) the affected individuals
are instructed on the revised program before the changes are
implemented.
(2) A
licensee shall retain a record of each change in accordance with Subsection B
of 20.3.7.715
NMAC.
F. Supervision.
(1) A licensee that
permits the receipt, possession, use or transfer of radioactive material by an
individual under the supervision of an authorized user, as allowed by
Subparagraph (a) of Paragraph (2) of Subsection D of
20.3.7.700 NMAC, shall:
(a) in addition to the requirements in
20.3.10.1002 NMAC, instruct the
supervised individual in the licensee's written radiation protection program
and quality assurance procedures, written directive procedures, requirements of
this chapter and license conditions with respect to the use of radioactive
material;
(b) require the
supervised individual to follow the instructions of the supervising authorized
user for medical uses of radioactive material, written radiation protection
program and quality assurance procedures established by the licensee, written
directive procedures, the requirements in 20.3 NMAC and license conditions with
respect to the medical use of radioactive material;
(c) require the supervising authorized user
to periodically review the supervised individual's use of radioactive material
and the records kept to reflect this use; and
(d) document the performance of the
supervised individual with respect to the medical use of radioactive
material.
(2) A licensee
that permits the preparation of radioactive material for medical use by an
individual under the supervision of an authorized nuclear pharmacist or
physician who is an authorized user, as allowed by Subparagraph (b) of
Paragraph (2) of Subsection D of
20.3.7.700 NMAC shall:
(a) in addition to the requirements in
20.3.10.1002 NMAC, instruct the
supervised individual in the preparation of radioactive material for medical
use, as appropriate to that individual's involvement with radioactive
material;
(b) require the
supervised individual to follow the instructions of the supervising authorized
user or authorized nuclear pharmacist regarding the preparation of radioactive
material for medical use, the licensee's written radiation protection program
and quality assurance procedures, the requirements of 20.3 NMAC and license
conditions;
(c) require the
supervising authorized nuclear pharmacist or authorized user to periodically
review the work of the supervised individual as it pertains to radiation safety
and quality assurance in preparing radioactive material for medical use and the
records kept to reflect that work; and
(d) document the performance of the
supervised individual with respect to the medical use of radioactive
material.
(3) A licensee
who permits supervised activities under Paragraphs (1) and (2) of this
subsection is responsible for the acts and omissions of the supervised
individual.
G. Written directive. Each applicant or licensee under this part, as applicable, shall establish and maintain written directive procedures to provide high confidence that byproduct material or radiation from radioactive material will be administered as directed by the authorized user. The written directive procedures must include written policies and procedures that meet the following specific requirements.
(1) A written
directive must be prepared, dated and signed by an authorized user before the
administration of I-131 sodium iodide of quantities greater than 30 microcuries
(1.11 megabecquerels), any therapeutic dosage of unsealed radioactive material
or any therapeutic dose of radiation from radioactive material. If, because of
the emergent nature of the patient's condition, a delay in order to provide a
written directive would jeopardize the patient's health, an oral directive is
acceptable. The information contained in the oral directive must be documented
as soon as possible in writing in the patient's record. A written directive
documenting the oral directive must be prepared, dated and signed by the
authorized user within 48 hours of the oral directive.
(2) A written revision to an existing written
directive may be made if the revision is dated and signed by an authorized user
before the administration of the dosage of unsealed byproduct material, the
brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy
dose or the next fractional dose. If, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive is acceptable, provided that the oral revision is documented as soon
as possible in writing in the patient's record. A revised written directive
documenting the oral revision must be prepared, dated and signed by the
authorized user within 48 hours of the oral revision.
(3) The written directive must contain the
patient's or human research subject's name and the following information:
(a) for any administration of quantities
greater than 30 microcuries (1.11 megabecquerels) of I-131 sodium iodide: the
dosage;
(b) for an administration
of a therapeutic dosage of unsealed radioactive material other than I-131
sodium iodide: the radioactive drug, dosage and route of
administration;
(c) for gamma
stereotactic radiosurgery: the total dose, treatment site and values for the
target coordinate settings per treatment for each anatomically distinct
treatment site;
(d) for
teletherapy: the total dose, dose per fraction, number of fractions and
treatment site;
(e) for high
dose-rate remote afterloading brachytherapy: the radionuclide, treatment site,
dose per fraction, number of fractions and total dose; or
(f) For permanent implant brachytherapy:
(i) Before implantation: The treatment site,
the radionuclide, and the total source strength; and
(ii) After implantation but before the
patient leaves the post-treatment recovery area: The treatment site, the number
of sources implanted, the total source strength implanted, and the date;
or
(g) for all other
brachytherapy, including low, medium and pulsed dose rate remote afterloaders:
before implantation: the treatment site, radionuclide and dose; and after
implantation but before completion of the procedure: the radionuclide,
treatment site, number of sources, total source strength and exposure time (or
the total dose); and date.
(4) A written revision to an existing written
directive may be made if the revision is dated and signed by an authorized user
before the administration of the dosage of unsealed byproduct material, the
brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy
dose, or the next fractional dose. If, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive is acceptable. The oral revision must be documented as soon as
possible in the patient's record. A revised written directive must be signed by
the authorized user within 48 hours of the oral revision.
(5) The licensee shall retain a copy of the
written directive in accordance with Subsection C of
20.3.7.715 NMAC.
H. Procedures for administrations requiring a written directive.
(1) For any administration requiring a
written directive, the licensee shall develop, implement and maintain written
procedures to provide high confidence that:
(a) the patient's or human research subject's
identity is verified by more than one method as the individual named in the
written directive before each administration; and
(b) each administration is in accordance with
the written directive.
(2) At a minimum, the procedures required by
Paragraph (1) of this subsection must address the following items that are
applicable to the licensee's use of radioactive material:
(a) verifying the identity of the patient or
human research subject;
(b)
verifying that the administration is in accordance with the treatment plan, if
applicable, and the written directive;
(c) checking both manual and
computer-generated dose calculations; and
(d) verifying that any computer-generated
dose calculations are correctly transferred into the consoles of therapeutic
medical units authorized by
20.3.7.711 NMAC or
20.3.7.713 NMAC.
(e) Determining if a medical event, as
defined in
20.3.7.716 NMAC and
10 CFR
35.3045, has occurred; and
(f) Determining, for permanent implant
brachytherapy, within 60 calendar days from the date the implant was performed,
the total source strength administered outside of the treatment site compared
to the total source strength documented in the post-implantation portion of the
written directive, unless a written justification of patient unavailability is
documented.
(3) A
licensee shall retain a copy of the procedures required under Paragraph (1) of
this subsection in accordance with Subsection D of
20.3.7.715 NMAC.
I. Suppliers of sealed sources or devices for medical use. For medical use, a licensee may only use:
(1) sealed sources or devices
manufactured, labeled, packaged and distributed in accordance with a license
issued under Subsection K of
20.3.3.315 NMAC or equivalent
requirements of NRC or an agreement state;
(2) sealed sources or devices
non-commercially transferred from a 20.3.7 NMAC licensee, a NRC or agreement
state licensee; or
(3) teletherapy
sources manufactured and distributed in accordance with a license issued under
20.3.3 NMAC or the equivalent requirements of NRC or an agreement
state.
Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
