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RULE §289.230Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography

(a) Purpose.

  (1) This section provides for the certification of mammography systems and mammography machines used for interventional breast radiography. No person shall use radiation machines for mammography of humans or for interventional breast radiography except as authorized in a certification issued by the agency in accordance with the requirements of this section. Certification by this agency includes certification of mammography systems and facilities that have received accreditation by the agency accreditation body or by another United States Food and Drug Administration (FDA)-approved accreditation body and certification of mammography machines used for interventional breast radiography.

  (2) The use of all mammography machines certified in accordance with this section shall be by or under the supervision of a physician licensed by the Texas Medical Board.

(b) Scope.

  (1) In addition to the requirements of this section, all registrants are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §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), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation). Mammography facilities choosing to be accredited by the agency accreditation body will be subject to §289.234 of this title (relating to Mammography Accreditation).

  (2) The procedures found in §289.205 of this title for modifications, suspensions, revocations, denials, and hearings regarding certificates of registration are applicable to certifications issued by the agency.

  (3) This section does not apply to an entity under the jurisdiction of the federal government.

  (4) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, 45 Code of Federal Regulations (CFR), Parts 160 and 164) may be subject to privacy standards governing how information that identifies a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department making a referral of a potential violation to the United States Department of Health and Human Services.

(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 FDA-approved accreditation body.

  (2) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.

  (3) Action limit--The minimum or maximum value of a quality assurance measurement representing acceptable performance. Values less than the minimum or greater than the maximum action limit indicate that corrective action must be taken by the facility.

  (4) Additional mammography review (includes targeted clinical image reviews)--At the request of the agency certification body or an FDA-approved accreditation body, a review by the FDA-approved accreditation body of clinical images and other relevant facility information necessary to assess conformation with the accreditation standards. The reviews include the following:

    (A) clinical image review with interpretation; or

    (B) clinical image review without interpretation.

  (5) 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 subsection (r) of this section.

  (6) Agency accreditation body--For the purpose of this section, the agency as approved by the FDA under Title 21, CFR, §900.3(d) to accredit mammography facilities in the State of Texas.

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

  (8) Air kerma--The kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For x-rays with energies less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad. In air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of exposure.

  (9) Automatic exposure control (AEC)--A device that automatically controls one or more technique factors in order to obtain at preselected locations a required quantity of radiation.

  (10) Average glandular dose--The average absorbed dose accruing to the glandular tissue of the breast.

  (11) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.

  (12) Breast implant--A prosthetic device implanted in the breast.

  (13) Calendar quarter--Any one of the following time periods during a given year: January 1 - March 31, April 1 - June 30, July 1 - September 30, or October 1 - December 31.

  (14) Calibration of instruments--The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument.

  (15) Category I continuing medical education units (CMEU)--Educational activities designated as Category I and approved by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, a state medical society, or an equivalent organization.

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

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

  (18) Contact hour--An hour of training received through direct instruction.

  (19) Continuing education unit (CEU)--One contact hour of training.

  (20) Control panel--That part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for setting the technique factors.

  (21) Direct instruction--Instruction that includes:

    (A) face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or

    (B) the administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).

  (22) Direct supervision--Oversight of operations that include the following.

    (A) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's record.

    (B) During performance of a mammography examination, the supervising medical radiologic technologist is present to observe and correct, as needed, the individual who is performing the examination.

    (C) During performance of a survey of the registrant's equipment and quality assurance program, the supervising medical physicist is present to observe, and correct, as needed, the individual who is conducting the survey.

  (23) Established operating level--The value of a particular quality assurance parameter that has been established as an acceptable normal level by the registrant's quality assurance program.

  (24) 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.

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

  (26) Final assessment categories--The overall final assessment of findings in a report of a mammography examination, classified in one of the following categories:

    (A) "negative" indicates nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained);

    (B) "benign" is also a negative assessment;

    (C) "probably benign" indicates a finding(s) that has a high probability of being benign;

    (D) "suspicious abnormality" indicates a finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

    (E) "highly suggestive of malignancy" indicates a finding(s) that has a high probability of being malignant;

    (F) "known biopsy proven malignancy" indicates appropriate action should be taken;

    (G) "post procedure mammogram" indicates a mammogram to confirm the deployment and position of a breast tissue marker; or

    (H) "incomplete" indicates there is a need for additional imaging evaluation and/or prior mammograms for comparison. Reasons why no assessment can be made shall be stated by the interpreting physician.

  (27) First allowable time--The earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body.

  (28) Formal training--Attendance and participation in direct instruction. This does not include self-study programs.

  (29) Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. In this definition, the contribution of all scattered radiation, other than any that might be present initially in the beam concerned, is deemed to be excluded.

  (30) 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.

  (31) Image receptor--Any device that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

  (32) Institutional review board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.

  (33) Interpreting physician--A licensed physician who interprets mammographic images and who meets the requirements of subsection (r)(1) of this section.

  (34) Interventional breast radiography--Imaging of a breast during invasive interventions for localization or biopsy procedures.

  (35) Investigational device exemption--An exemption that allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a 510(k) Premarket Notification submission to FDA.

  (36) Kerma--The sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.

  (37) Laterality--The designation of either the right or left breast.

  (38) Lead interpreting physician--The interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements of subsections (u), (v), and (w) of this section.

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

  (40) Mammographic modality--A technology for radiography of the breast. Examples are screen-film mammography and full-field digital mammography.

  (41) 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 subsection (gg) of this section; or

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

  (42) 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


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