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RULE §289.234Mammography Accreditation

(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 Title 21, Code of Federal Regulations (CFR), §900.3(d), to accredit mammography facilities in the State of Texas.

  (6) Agency certifying body--For the purpose of this section, the agency, as approved by FDA, under Title 21, CFR, §900.21, that certifies facilities within the State of Texas to perform mammography services.

  (7) Certification--An authorization for the use of a mammography system or the certification of mammography machines used for interventional breast radiography.

  (8) Clinical image--See the definition for mammogram.

  (9) Consumer--An individual who chooses to comment or complain in reference to a mammography examination. The individual may be the patient or a representative of the patient, such as a family member or referring physician.

  (10) Facility--A hospital, outpatient department, clinic, radiology practice, mobile unit, an office of a physician, or other person that conducts breast cancer screening or diagnosis through mammography activities, including the following:

    (A) the operation of equipment to produce a mammogram;

    (B) processing of film;

    (C) initial interpretation of the mammogram; or

    (D) maintaining the viewing conditions for that interpretation.

  (11) FDA-approved accreditation body--An entity approved by the FDA under Title 21, CFR, §900.3(d), to accredit mammography facilities.

  (12) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.

  (13) Image review board--A group of qualified review physicians and other individuals who review the clinical and phantom images and whose qualifications have been established by the accreditation body and the accreditation body's qualifications have been approved by the FDA.

  (14) Interpreting physician--A licensed physician who interprets mammographic images and who meets the requirements of §289.230(r)(1) of this title.

  (15) Mammogram--A radiographic image produced through mammography.

  (16) Mammography--The use of x-radiation to produce an image of the breast that may be used to detect the presence of pathological conditions of the breast. For the purposes of this section, mammography does not include radiography of the breast performed as follows:

    (A) during invasive interventions for localization or biopsy procedures except as specified in §289.230(z) of this title; or

    (B) with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations.

  (17) Mammography machine(s)--A unit consisting of components assembled for the production of x-rays for use during mammography. These include, at a minimum, the following:

    (A) an x-ray generator;

    (B) an x-ray control;

    (C) a tube housing assembly;

    (D) a beam limiting device; and

    (E) supporting structures.

  (18) Mammography system--A system that includes the following:

    (A) an x-ray machine used as a source of radiation in producing images of breast tissue;

    (B) an imaging system used for the formation of a latent image of breast tissue;

    (C) an imaging-processing device for changing a latent image of breast tissue to a visual image that can be used for diagnostic purposes;

    (D) a viewing device used for the visual evaluation of an image of breast tissue if the image is produced in interpreting visual data captured on an image receptor;

    (E) a medical radiologic technologist who performs mammography; and

    (F) a physician who engages in, and who meets the requirements of this section relating to the reading, evaluation, and interpretation of mammograms.

  (19) Medical physicist--An individual who performs surveys and evaluations of mammographic equipment and facility quality assurance programs in accordance with this section and who meets the qualifications in §289.230(r)(3) of this title.

  (20) Medical radiologic technologist (operator of equipment)--An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations, who performs mammography examinations in accordance with this section and who meets the qualifications in §289.230(r)(2) of this title.

  (21) Patient--Any individual who undergoes a mammography examination in a facility, regardless of whether the person is referred by a physician or is self-referred.

  (22) Phantom--A test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.

  (23) Phantom image--A radiographic image of a phantom.

  (24) Radiation machine--For the purposes of this part, radiation machine also means mammography machine.

  (25) Reinstatement fee--The fee in accordance with §289.204(h) of this title charged to reinstate an application for a mammography machine that has been denied accreditation or whose application has been abandoned in accordance with subsection (h)(3) of this section.

  (26) Review physician--An individual who is qualified to review clinical images on behalf of the accreditation body. To be qualified, this individual shall comply with the following:

    (A) meet the interpreting physician requirements of §289.230(r)(1) of this title;

    (B) be trained and evaluated in the clinical image review process for the types of clinical images to be evaluated by a review physician by the accreditation body before designation as a review physician and periodically thereafter; and

    (C) clearly document findings and reasons for assigning a particular score to any clinical image and provide information to the facility for use in improving the attributes for which significant deficiencies were identified.

  (27) Serious adverse event--An adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.

  (28) Serious complaint--A report of a serious adverse event.

  (29) Survey--An on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.

  (30) Targeted clinical image review--A review of a minimum of two sets of "negative" clinical images from a specific date, or date range, at the request of the agency.

(d) Accreditation of mammography facilities.

  (1) All mammography facilities shall be accredited by an FDA-approved accreditation body and shall meet the quality standards in §289.230(r) - (aa) of this title. In order to qualify for certification in accordance with §289.230 of this title, new facilities applying to the agency accreditation body shall receive acceptance of the accreditation application.

  (2) The facility shall submit the following information in addition to the information required in subsection §289.230(f) of this title:

    (A) an application for accreditation on forms and in accordance with accompanying instructions prescribed by the agency accreditation body;

    (B) the appropriate accreditation fee prescribed in §289.204 of this title; and

    (C) evidence that the medical physicist's survey and mammography equipment evaluation in accordance with §289.230(v)(10) and (11) of this title was performed within the following time frames:

      (i) no more than six months before the date of the accreditation application for new facilities seeking accreditation;

      (ii) no more than 14 months before the date of the application for accreditation for facilities changing accreditation to one issued by the agency accreditation body; or

      (iii) no more than 14 months before the date of the application for renewal of accreditation for facilities accredited by the agency accreditation body.

  (3) Upon notification by the agency accreditation body, each applicant shall submit clinical and phantom images directly to the image review board.

(e) Issuance of accreditation of a mammography facility. An accreditation document will be issued when the mammography facility meets the requirements of subsection (d) of this section and §289.204 of this title and becomes accredited by the agency accreditation body. In order for an accreditation to be issued, the agency accreditation body must receive acceptable dose evaluation information from the dosimetry processor and be notified by the image review board that the applicant met the criteria for clinical images and phantom images, and dose evaluation.

(f) Denial or abandonment of an application for accreditation of mammography facilities.

  (1) Any application for accreditation may be denied by the agency accreditation body when the applicant fails to meet established criteria for accreditation in accordance with subsection (d) of this section.

  (2) Before the agency accreditation body denies an application for accreditation, the agency shall give notice of the denial, the facts warranting the denial, and shall afford the applicant an opportunity for a hearing in accordance with §289.205(h) of this title. If no request for a hearing is received by the director of the Radiation Control Program within 30 days of date of receipt of the notice, the agency may proceed to deny. The applicant shall have the burden of proof showing cause why the application should not be denied.

  (3) Action on an accreditation application will be abandoned due to lack of response by the applicant to a request for information by the agency accreditation body. Abandonment of such actions does not provide an opportunity for a hearing; however, the applicant retains the right to resubmit the application and pay a reinstatement fee at any time.

(g) Suspension and revocation of accreditation of mammography facilities.

  (1) Suspension of accreditation of mammography facilities.

    (A) An accreditation of a mammography facility may be suspended or revoked for any of the following reasons:

      (i) any material false statement in the application or any statement of fact required under provision of the Act;

      (ii) conditions revealed by such application or statement of fact or any report, record, inspection, or other means that would warrant the agency accreditation body to refuse to grant an accreditation of mammography facility on an original application; or


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