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TITLE 25 - HEALTH SERVICES
PART 1 - DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289 - RADIATION CONTROL
SUBCHAPTER E - REGISTRATION REGULATIONS
SECTION/RULE §289.234 - Mammography Accreditation
Chapter Review Date 10/30/2023

(a) Purpose. This section provides for the accreditation of mammography machines and facilities. The use of all mammography machines accredited in accordance with this section shall be by or under the supervision of a physician licensed by the Texas Medical Board.(b) Scope. In addition to the requirements of this section, all mammography machines and facilities are subject to the requirements of §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). This section does not apply to an entity under the jurisdiction of the federal government.(c) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.(1) Accreditation--An approval of a mammography machine within a mammography facility by an accreditation body. A facility may be accredited by the agency accreditation body or another United States Food and Drug Administration (FDA)-approved accreditation body.(2) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.(3) Additional mammography review--At the request of the FDA or an accreditation body, a review by the accreditation body of clinical images and other relevant facility information necessary to assess conformation with the accreditation standards. The reviews include the following:(A) additional mammography review with interpretation; or(B) additional mammography review without interpretation.(4) Adverse event--An undesirable experience associated with mammography activities within the scope of this section. Adverse events include but are not limited to:(A) poor image quality;(B) failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and(C) use of personnel who do not meet the applicable requirements of §289.230(r) of this title.(5) Agency accreditation body--For the purpose of this section, the agency as approved by the FDA under