| (A) authorized users from each type of use of radioactive
material authorized on the license;
(B) the RSO;
(C) a representative of nursing service;
(D) a representative of management who is neither an
authorized user nor the RSO; and
(E) may include other members as the licensee deems
appropriate.
(2) The RSC for licenses for medical and veterinary
use authorized for two or more different types of uses of radioactive
material in accordance with subsections (kk), (rr), and (ddd) of this
section, or two or more types of units in accordance with subsection
(ddd) of this section shall be composed of the following individuals
as approved by the agency:
(A) an authorized user of each type of use permitted
by the license;
(B) the RSO;
(C) a representative of nursing service, if applicable;
(D) a representative of management who is neither an
authorized user nor the RSO; and
(E) may include other members as the licensee deems
appropriate.
(3) Duties and responsibilities of the RSC.
(A) For licensees without broad scope authorization,
the duties and responsibilities of the RSC include, but are not limited
to, the following:
(i) meeting as often as necessary to conduct business
but no less than three times a year;
(ii) reviewing summaries of the following information
presented by the RSO:
(I) over-exposures;
(II) significant incidents, including spills, contamination,
or medical events; and
(III) items of non-compliance following an inspection;
(iii) reviewing the program for maintaining doses ALARA,
and providing any necessary recommendations to ensure doses are ALARA;
and
(iv) reviewing the audit of the radiation safety program
and acting upon the findings.
(B) For licensees with broad scope authorization, the
duties and responsibilities of the RSC include, but are not limited
to, the items in subparagraph (A) of this paragraph and the following:
(i) reviewing the overall compliance status for authorized
users;
(ii) sharing responsibility with the RSO to conduct
periodic audits of the radiation safety program;
(iii) developing criteria to evaluate training and
experience of new authorized user applicants;
(iv) evaluating and approving authorized user applicants
who request authorization to use radioactive material at the facility;
and
(v) reviewing and approving permitted program and procedural
changes prior to implementation.
(4) Records documenting the RSC meetings shall be made
and maintained for inspection by the agency in accordance with subsection
(www) of this section. The record shall include the date, names of
individuals in attendance, minutes of the meeting, and any actions
taken.
(j) Training for an authorized medical physicist. Except
as provided in subsection (l) of this section, the licensee shall
require the authorized medical physicist to be an individual who:
(1) is certified by a specialty board whose certification
process has been recognized by the agency, the NRC, or an agreement
state and who meets the requirements in paragraphs (2)(C) and (3)
of this subsection. (The names of board certifications that have been
recognized by the agency, the NRC, or an agreement state appear on
the NRC's web page at https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html).
To have its certification process recognized, a specialty board shall
require all candidates for certification to meet the following:
(A) hold a master's or doctor's degree in physics,
medical physics, other physical science, engineering, or applied mathematics
from an accredited college or university;
(B) complete two years of full-time practical training
and/or supervised experience in medical physics as follows:
(i) under the supervision of a medical physicist who
is certified in medical physics by a specialty board recognized by
the agency, the NRC, or an agreement state; or
(ii) in clinical radiation facilities providing high-energy,
external beam therapy (photons and electrons with energies greater
than or equal to 1 million electron volts) and brachytherapy services
under the direction of physicians who meet the requirements for authorized
users in subsections (l), (zz) or (ttt) of this section; and
(C) pass an examination administered by diplomates
of the specialty board that assesses knowledge and competence in clinical
radiation therapy, radiation safety, calibration, quality assurance,
and treatment planning for external beam therapy, brachytherapy, and
stereotactic radiosurgery; or
(2) holds a post graduate degree and experience to
include:
(A) a master's or doctor's degree in physics, medical
physics, other physical science, engineering, or applied mathematics
from an accredited college or university; and
(B) completion of one year of full-time training in
medical physics and an additional year of full-time work experience
under the supervision of an individual who meets the requirements
for an authorized medical physicist for the type(s) of use for which
the individual is seeking authorization. This training and work experience
shall be conducted in clinical radiation facilities that provide high-energy,
external beam therapy (photons and electrons with energies greater
than or equal to 1 million electron volts) and brachytherapy services
and shall include:
(i) performing sealed source leak tests and inventories;
(ii) performing decay corrections;
(iii) performing full calibration and periodic spot
checks of external beam treatment units, stereotactic radiosurgery
units, and remote afterloading units as applicable; and
(iv) conducting radiation surveys around external beam
treatment units, stereotactic radiosurgery units, and remote afterloading
units as applicable; and
(C) has obtained written attestation that the individual
has satisfactorily completed the requirements in paragraph (3) of
this subsection and paragraphs (1)(A) and (1)(B) or (2)(A) and (2)(B)
of this subsection, and has achieved a level of competency sufficient
to function independently as an authorized medical physicist for each
type of therapeutic medical unit for which the individual is requesting
authorized medical physicist status. The written attestation shall
be signed by a preceptor authorized medical physicist who meets the
requirements in subsection (l) of this section, this subsection, or
equivalent NRC or agreement state requirements for an authorized medical
physicist for each type of therapeutic medical unit for which the
individual is requesting authorized medical physicist status; and
(3) has training for the type(s) of use for which authorization
is sought that includes hands-on device operation, safety procedures,
clinical use, and the operation of a treatment planning system. This
training requirement may be satisfied by satisfactorily completing
either a training program provided by the vendor or by training supervised
by an authorized medical physicist authorized for the type(s) of use
for which the individual is seeking authorization.
(k) Training for an authorized nuclear pharmacist.
Except as provided in subsection (l) of this section, the licensee
shall require the authorized nuclear pharmacist to be a pharmacist
who:
(1) is certified by a specialty board whose certification
process has been recognized by the agency, the NRC or an agreement
state and who meets the requirements of paragraph (2)(C) of this subsection.
(The names of board certifications that have been recognized by the
agency, the NRC, or an agreement state appear on the NRC's web page
at https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html).
To have its certification process recognized, a specialty board shall
require all candidates for certification to:
(A) have graduated from a pharmacy program accredited
by the Accreditation Council for Pharmacy Education (ACPE) or have
passed the Foreign Pharmacy Graduate Examination Committee (FPGEC)
examination;
(B) hold a current, active license to practice pharmacy
in the State of Texas;
(C) provide evidence of having acquired at least 4000
hours of training/experience in nuclear pharmacy practice. Academic
training may be substituted for no more than 2000 hours of the required
training and experience; and
Cont'd... |
