Current through Reg. 49, No. 38; September 20, 2024
(a) Content. Recognizing that assessing the
degree of radiation safety is a complex task of balancing radiation risk with
optimizing the benefit of the procedure to the patient, rules are provided that
identify certain specific activities or tests as the practice of medical
physics. The purpose of the Act and the rules is to ensure the radiation safety
of the citizens of Texas by restricting the practice of medical physics to
qualified medical physicists.
(b)
Role of the service engineers. Service engineers, when installing or
maintaining medical equipment, conduct tests or perform activities that are
similar or identical to tests or activities identified in these rules. Such
tests and activities do not constitute the practice of medical physics provided
that:
(1) neither the service engineer nor
his employer represents that the outcome of the test or activity or the intent
of performing the test or activity ensures the radiation safety of the use of
the medical equipment for either the user, the patient, or a member of the
public; and
(2) neither the service
engineer nor his employer concludes that the medical equipment is
radiologically safe, effective or suitable for use on humans based on the tests
or activities performed by the service engineer; and
(3) neither the service engineer nor his
employer certifies that the medical equipment is radiologically safe and
consequently compliant with any state or federal regulation for the control of
radiation; and
(4) the test or
activity performed by the service engineer is required to install, maintain or
repair the medical equipment.
(c) Scope of practice.
(1) The diagnostic radiological physics
specialty services include, but are not limited to, the following:
(A) providing evidence that imaging equipment
continues to meet applicable rules and regulations of radiation safety and
performance standards required by accrediting and regulatory
agencies;
(B) acceptance testing or
monitoring of diagnostic imaging equipment;
(C) evaluating policies and procedures
pertaining to radiation and its safe and appropriate application in imaging
procedures;
(D) providing
consultation in development and management of the quality control
program;
(E) measurement and
characterization of radiation from diagnostic equipment;
(F) specification of instrumentation to be
used in the practice of diagnostic radiological physics;
(G) providing consultation on patient or
personnel radiation dose (effective dose equivalent, fetal dose calculations,
specific organ dose determination, etc.) and the associated risk;
(H) protective shielding design and
evaluation of a diagnostic imaging facility;
(I) conducting performance evaluations of
medical radiologic and fluoroscopic imaging systems which include the following
physical tests and assessments:
(i) kilovolts
peak (kVp) and timer accuracy;
(ii)
exposure reproducibility and linearity;
(iii) exposure geometry, e.g. source to image
distance (SID) and collimation;
(iv) entrance skin exposure and exposure
rate;
(v) beam quality;
(vi) image quality; and
(J) use of assistants by the licensed medical
physicist in accordance with the following: the medical physicist may be
assisted by other properly trained individuals in obtaining test data for
performance monitoring. These individuals must be properly trained and approved
by the medical physicist in the techniques of performing the tests, the
function and limitations of the equipment and test instruments, the reasons for
the tests, and the importance of the test results. The tests will be performed
by or under the general supervision of the medical physicist, who is
responsible for and must review, interpret, and approve all data and provide a
signed report.
(2) The
therapeutic radiological physics specialty services include, but are not
limited to, the following:
(A) development of
specifications for radiotherapy treatment and simulation equipment;
(B) development of procedures for testing and
evaluating performance levels of radiotherapy treatment and simulation
equipment;
(C) acceptance testing
of radiotherapy treatment and simulation equipment;
(D) calibration and characterization of
radiation beams from therapeutic equipment including radiation quantity,
quality, and distribution characteristics, and assessment of the mechanical and
geometric optics for proper placement of the beam;
(E) providing documentation that radiotherapy
treatment and simulation equipment meet accreditation and regulatory compliance
requirements;
(F) calibration
and/or verification of the physical and radiological characteristics of
brachytherapy sources;
(G)
specification of the physics instrumentation used in the measurement and
performance testing of therapeutic equipment;
(H) acceptance testing, management, and
supervision of computer systems used for treatment planning and calculation of
treatment times or monitor units. This includes measurement and input of
dosimetry data base and verification of output for external beam radiotherapy
and brachytherapy;
(I)
implementation and management of dosimetric and beam delivery aspects of
external beam and brachytherapy irradiation. External beam delivery aspects
include treatment aids, beam modifiers, and geometrical arrangements. Special
procedures are included for both external beam (e.g. radiosurgery, total body
irradiation, total skin irradiation, intraoperative therapy) and brachytherapy
(e.g. high dose rate, pulsed dose rate and radiolabeled
microspheres);
(J) provision of
consultation to the physician in assuring accurate delivery of prescribed
radiation dosage to a specific human patient, and the associated
risk;
(K) development and
management of quality control program for a radiation treatment facility that
includes applicable facility accreditation requirements, and the review of
policies and procedures pertaining to therapeutic radiation and its safe and
appropriate use;
(L) development
and/or evaluation of a radiation safety program in a therapeutic radiation
facility including written procedures for the protection of patients, workers,
and the public; and
(M) protective
shielding design and radiation safety surveys in a radiotherapy
facility.
(3) The
medical nuclear physics specialty services include, but are not limited to, the
following:
(A) development of procedures for
continuing evaluations of performance levels of radionuclide imaging devices
and ancillary equipment;
(B)
providing evidence that radionuclide imaging equipment continues to meet
applicable rules and regulations of performance and radiation safety required
by accrediting and regulatory agencies;
(C) acceptance testing of radionuclide
imaging equipment;
(D) development
and/or evaluation of a radiation safety program in a nuclear medicine
facility;
(E) determination of
radiation shielding necessary to protect workers, patients, and the public in a
nuclear medicine facility;
(F)
development of specifications for radionuclide imaging instrumentation or
equipment;
(G) development and
monitoring of a quality control program for radionuclide imaging equipment,
computers and other patient related radiation detectors such as uptake probes,
well counters and dose calibrators;
(H) providing consultation on patient or
personnel radiation dose (effective dose equivalent, fetal dose calculations,
specific organ dose determination, etc.) and the associated risk;
(I) evaluating policies and procedures
pertaining to the safe and appropriate application of radionuclides;
(J) specification of instrumentation used in
the practice of medical nuclear physics;
(K) verification of calculated radiation
absorbed doses from unsealed radioactive sources and radiolabeled microspheres
and the provision of consultation to the physician in assuring accurate
delivery of prescribed radiation dosage to a specific human patient and the
associated risk in therapeutic nuclear medicine procedures; and
(L) use of assistants by the licensed medical
physicist in accordance with the following: the medical physicist may be
assisted by other properly trained individuals in obtaining test data for
performance monitoring. These individuals must be properly trained and approved
by the medical physicist in the techniques of performing the tests, the
function and limitations of the equipment and test instruments, the reasons for
the tests, and the importance of the test results. The tests will be performed
by or under the general supervision of the medical physicist, who is
responsible for and must review, interpret, and approve all data and provide a
signed report.
(4) The
medical health physics specialty services include, but are not limited to, the
following:
(A) planning and design of
radiation shielding needed to protect workers, patients, and the general public
from radiation produced incident to the diagnosis or treatment of humans. This
includes calculation of required shielding thickness, selection of shielding
material and specification of source-shield geometry;
(B) assessment and evaluation of installed
shielding, installed shielding apparatus or portable shielding designed to
protect workers, patients, and the general public from radiation produced
incident to the diagnosis or treatment of humans. Such evaluation specifically
includes determination of whether the shielding is adequate to ensure
compliance with state or federal regulatory requirements for limiting the
effective dose equivalent and organ dose equivalent of medical radiation
workers and members of the public. This includes the selection of appropriate
radiation measurement instrumentation to conduct such evaluation as well as the
methodology to be employed;
(C)
providing consultation, by which determination of the presence and extent of
any radiological hazard, in any controlled, restricted, uncontrolled or
unrestricted area, resulting from the use of ionizing radiation or
radioactivity in the treatment or diagnosis of disease in humans, is made. This
includes the design, conduct, and evaluation of results of radiation surveys of
health care facilities and the immediate environs intended to determine whether
occupancy by medical radiation workers, patients, and members of the public is
compliant with state and federal regulations for the control of ionizing
radiations. A survey includes the directing of physical measurements of
radiation levels and radioactivity, the interpretation of those measurements,
and the provision of any conclusions or recommendations intended to limit or
prevent exposure of workers, members of the public, and patients;
(D) performing dose and associated risk
assessment in which an effective dose equivalent, committed effective dose
equivalent, organ dose equivalent, or committed organ dose equivalent is
determined by measurement or calculation or both, to any worker, member of the
public, fetus or patient who received exposure to ionizing radiation or
radioactivity from radiation sources used to treat or diagnose disease in
humans. This does not include either the prospective or retrospective
determination of absorbed doses to patients undergoing radiation
therapy;
(E) consultation which
consists of the evaluation or assessment of the radiation safety aspects of
policies or procedures which pertain to the safe and appropriate use of
radiation or radioactivity, administered to human research volunteers or used
to treat or diagnose conditions in humans, when such evaluation or assessment
provides conclusions or recommendations regarding dose equivalent assessment,
the overall radiation safety afforded to individuals resulting from activities
conducted in compliance with the evaluated policies or procedures, or the
compliance of any or all provisions of the policies or procedures with either
state or federal regulatory requirements for the control of radiation;
and
(F) use of assistants by the
licensed medical physicist in accordance with the following: the medical
physicist may be assisted by other properly trained individuals in obtaining
test data for performance monitoring. These individuals must be properly
trained and approved by the medical physicist in the techniques of performing
the tests, the function and limitations of the equipment and test instruments,
the reasons for the tests, and the importance of the test results. The tests
will be performed by or under the general supervision of the medical physicist,
who is responsible for and must review, interpret, and approve all data and
provide a signed report.