Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 289 - RADIATION CONTROL › Subchapter E - REGISTRATION REGULATIONS › Section 289.234 - Mammography Accreditation

Current through Reg. 49, No. 28; July 12, 2024
(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.