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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
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.

Cont'd...

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