Source: https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=P&p_rloc=192252&p_tloc=14942&p_ploc=1&pg=2&p_tac=&ti=25&pt=1&ch=289&rl=251
Timestamp: 2019-04-20 18:23:36+00:00

Document:
(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.
(B) additional mammography review without interpretation.
(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.
(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.
(B) with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations.
(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.
(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.
(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.

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