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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
RULE §289.226Registration of Radiation Machine Use and Services

            (-2-) evidence of registration with the Texas Physician Assistant Board and at least two years of supervised experience in the use of radiation machines in their respective specialty; or

            (-3-) evidence of bachelor's or higher degree in radiologic technology, health physics, or nuclear technology and at least two years of supervised experience in the use of radiation machines; and

          (-b-) additional documentation for a non-practitioner RSO without radiation machine-related credentials, and the following documentation must be provided to be qualified:

            (-1-) an attestation by a physician or qualified department director describing the radiation safety experience and performance of the RSO responsibilities listed in subsection (n) of this section, as applicable, and attestation must include that the RSO has achieved a level of radiation safety knowledge sufficient to function independently as RSO for the medical use for which they are applying; and

            (-2-) documentation of an accredited radiation safety or radiation machine course completion, and the course must be at least 24 credit hours and include the principles of image processing, radiation protections, dose optimization and reduction; biological effects of ionizing radiation; radiology quality control and improvement; and review of Texas Regulations related to radiation as applicable.

      (ii) Academic institutions or research and development facilities shall have RSOs who are faculty or staff members with a bachelor's degree or higher in a radiation-related field and at least two years of supervised experience in the use of radiation machines and the following documentation is also required:

        (I) an attestation by a physician or qualified department director describing the radiation safety experience and performance of the RSO responsibilities listed in subsection (n) of this section, as applicable, and attestation must include that the RSO has achieved a level of radiation safety knowledge sufficient to function independently as RSO for the medical use for which they are applying.

        (II) documentation that the individual has satisfactorily completed 40 hours of education related to safe use of radiation machines from an accredited institution.

      (iii) Industrial radiography operations shall have an RSO who meets the requirements of §289.255(e)(4)(B) of this title.

    (C) The RSO identified on a certificate of registration issued before September 1, 1993, need not comply with the training requirements in this subsection.

    (D) The RSO for an application for registration of an electronic brachytherapy device shall meet the qualifications of this subsection and shall carry out the responsibilities of subsection (n) of this section.

    (E) The department may determine that a person who otherwise meets the RSO qualifications specified in this section is unqualified to be named as the RSO, based on the person's history with ensuring a facility's compliance with the Act and rules of this chapter.

  (4) Any time after the filing of the original application, the department may require additional information to determine if the certificate of registration should be issued or denied.

  (5) An application for a certificate of registration may include a request for a certificate of registration authorizing one or more activities or use locations. Applications for certification of mammography systems shall be made separately.

  (6) Applications and documents submitted to the department may be made available for public inspection except that the department may withhold any document or part thereof from public inspection per §289.231(aa) of this title.

  (7) Each application for a certificate of registration shall be accompanied by the fee prescribed in §289.204 of this title.

  (8) Each application shall be accompanied by a completed RC Form 226-1 (Business Information Form) that shall contain the legal name of the entity or business. Unless exempt per the Business and Commerce Code, Chapter 71, the applicant shall:

    (A) be authorized to conduct business in the State of Texas as listed on the Texas Secretary of State (SOS) website; and

    (B) file an assumed name certificate with the Texas SOS if using an assumed name in their application.

(f) Application for registration for human use of radiation machines.

  (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

    (A) Each person having a radiation machine used in the healing arts shall apply for registration with the department within 30 days after beginning use of the radiation machine, except for mobile services that shall be registered per subsection (g) of this section, and healing arts screening that shall be approved per subsection (h) of this section.

    (B) Each person having an accelerator, therapeutic radiation machine, or electronic brachytherapy device shall apply for and receive a certificate of registration from the department before using the accelerator. A person may energize the accelerator for purposes of installation and acceptance testing before receiving a certificate of registration from the department.

  (2) The applicant shall ensure that radiation machines are operated by individuals qualified by training and experience to use the radiation machines for the purpose requested per this section in such a manner as to minimize danger to occupational and public health and safety.

  (3) An application for healing arts shall be signed by a licensed practitioner. The signature of the administrator, president, or chief executive officer will be accepted instead of a licensed practitioner's signature if the facility has more than one licensed practitioner who may direct the operation of radiation machines. The application shall also be signed by the RSO.

  (4) An application for accelerators or therapeutic radiation machines, including electronic brachytherapy devices, for human use, shall be signed by a physician licensed by the Texas Medical Board. The signature of the administrator, president, or chief executive officer will be accepted instead of a physician's signature if the facility has more than one physician who may direct the operation of radiation machines. The application shall also be signed by the RSO.

  (5) Each applicant for accelerators, therapeutic radiation machines, and electronic brachytherapy devices, shall submit:

    (A) operating and safety procedures as described in §289.229(h)(1)(G) of this title;

    (B) credentials:

      (i) units operating above 1 MeV and electronic brachytherapy devices shall submit credentials for a Board-Certified Radiation Oncologist; or

      (ii) units under 1 MeV shall submit credentials for a Board-Certified Dermatologist or Board-Certified Radiation Oncologist;

    (C) a copy of the most current record of surveys, calculations, and quality assurance checks on each device; and

    (D) a floor plan of the physical facility.

(g) Application for registration of mobile service operations.

  (1) In addition to the requirements of subsections (e) and (f) of this section or §289.230 of this title, as applicable, each applicant shall apply for and receive authorization from the department before beginning mobile service operations.

  (2) The following shall be submitted:

    (A) an established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number;

    (B) a sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed machine inside, furnish the floor plan indicating protective shielding and the operator's position; and

    (C) a current copy of the applicant's operating and safety procedures regarding radiological practices for the protection of patients, operators, employees, and the general public.

(h) Application for registration of healing arts screening.

  (1) In addition to the requirements of subsections (e) and (f) of this section, each applicant shall apply for and receive authorization for healing arts screening before initiating a screening program.

  (2) Persons requesting approval from the department for healing arts screening programs shall submit:

    (A) name and address of the applicant;

    (B) diseases or conditions for which the x-ray examinations are to be used in diagnoses;

    (C) a detailed description of the x-ray examinations proposed in the screening program;

    (D) a description of the population to be examined in the screening program, for example, age, sex, physical condition, and other appropriate information;

    (E) for mobile screening operations, location(s) where radiation machines are maintained;

    (F) operating and safety procedures as follows:

      (i) for all radiation machines (except bone densitometers) to include:

        (I) an evaluation of the radiation machines to be used in the screening program;

        (II) documentation that the evaluation was performed by a licensed medical physicist with a specialty in diagnostic medical physics;

        (III) the evaluation shall show that the machines satisfy all requirements of this chapter;

      (ii) for bone densitometers, the manufacturer's evaluation of the radiation machine(s) to be used in the screening program;

    (G) documentation for verification of the following procedures:

      (i) a method of recommending a means of selecting a physician for patients who do not have a physician;

      (ii) a description of the procedures to be used in advising the individuals screened and their physicians of the results of the screening procedure and any further medical needs indicated; and

      (iii) a description of the procedures for the retention or disposition of the radiographs and other records about the x-ray examinations.

  (3) Screening standards/procedures shall meet national standards such as the American College of Radiology or other national standards.

(i) Application for registration of radiation machines for non-human use, including use in morgues, forensic medicine or investigations, and educational facilities.

  (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

    (A) Each person having an accelerator for non-human use shall apply for and receive a certificate of registration from the department before beginning the use of the accelerator. A person may energize the accelerator for purposes of installation and testing before receiving a certificate of registration from the department.

    (B) Each person having an accelerator for non-human use shall submit:

      (i) operating and safety procedures as described in §289.229(f)(3)(B) of this title; and

      (ii) a description of the applicant's proposed facilities per §289.229(f)(2) and (f)(3)(A), (D) and (E) of this title.

  (2) Each person having a radiation machine for non-human use, other than those specified in paragraph (1)(A) of this subsection and those used for industrial radiographic operations as defined in §289.255 of this title, shall apply for registration with the department within 30 days after beginning use of the machine.

  (3) Each applicant for use of radiation machines in industrial radiographic operations shall submit the information required in §289.255(t)(1) of this title and receive a certificate of registration from the department before beginning use of the machine(s).

  (4) An application for the uses specified in this subsection shall be signed by the applicant, registrant, or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO.

(j) Application for registration of radiation machine services.

  (1) In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

    (A) Each person who intends to provide radiation services described in subsection (b)(11) of this section shall apply for and receive a certificate of registration from the department before providing the service.

    (B) An application for radiation services shall be signed by the applicant or registrant or a person duly authorized to act for and on the applicant's or registrant's behalf. The application shall also be signed by the RSO.

  (2) The applicant shall document the qualifications of the specific training and experience that qualifies each individual to perform the service as follows:

    (A) for individuals performing assembly, installation, or repair of radiation machines in subsection (b)(11)(E) of this section, document the qualifications listed in paragraph (5) of this subsection;

Cont'd...

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