(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, Cont'd...
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.

Source Note: The provisions of this §160.17 adopted to be effective July 7, 2016, 41 TexReg 4819