| (i) Radiation safety committee (RSC). Licensees of
broad scope and licensees who are 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
under subsection (ddd) of this section shall establish an RSC to oversee
all uses of radioactive material permitted by the license.
(1) The RSC for licenses for medical use with broad
scope authorization shall be composed of the following individuals
as approved by the department:
(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 department:
(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 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 of broad scope, the duties and responsibilities
of the RSC include 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 before implementation.
(4) Records documenting the RSC meetings shall be made
and maintained for inspection by the department in accordance with
subsection (xxx) 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:
(1) an individual who is certified by a specialty board
whose certification process has been recognized by the department,
the NRC, or an agreement state and who meets the requirements in paragraph
(3) of this subsection. The names of board certifications that have
been recognized by the department, the NRC, or an agreement state
are posted on the NRC's Medical Uses Licensee Toolkit web page. 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 whose certification
process has been recognized by the department, 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) an individual who:
(A) holds a post graduate degree and experience to
include:
(i) 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
(ii) 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, and 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
(B) has obtained written attestation that the individual
has satisfactorily completed the requirements in paragraphs (2)(A)
and (3) of this subsection, and is able to independently fulfill the
radiation safety-related duties as an authorized medical physicist
for each type of therapeutic medical unit for which the individual
is requesting authorized medical physicist status, and 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) an individual who 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 department, the NRC or an agreement
state. The names of board certifications that have been recognized
by the department, the NRC, or an agreement state are posted on the
NRC's Medical Uses Licensee Toolkit web page. 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... |
