1. (a) Purpose and scope.

   1. (1) This section provides for the certification of mammography systems and the accreditation of mammography facilities. No person shall use x-ray producing machines for mammography of humans except as authorized in a state certification of mammography systems issued by the agency in accordance with the requirements of this section and in a certificate issued by the United States Food and Drug Administration (FDA).
   2. (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 State Board of Medical Examiners with license in good standing.
   3. (3) In addition to the requirements of this section, all registrants are subject to the requirements of §289.112 of this title (relating to Hearing and Enforcement Procedures), §289.201 of this title (relating to General Provisions), §289.202 of this title (relating to Standards for Protection Against Radiation), §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(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), and §289.226 of this title (relating to Registration of Radiation Machine Use and Services).

2. (b) Definitions. The following words and terms, when used in this section, shall have the following meaning unless the context clearly indicates otherwise.

   1. (1) Accreditation--An official approval of a mammography facility by an accreditation body.
   2. (2) Accreditation body--An entity that has been approved by the FDA under 42 United States Code §263b(e)(1)(A) to accredit mammography facilities.
   3. (3) 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.
   4. (4) Average glandular dose--The value in millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that estimates the average absorbed dose to the glandular tissue extrapolated from free air exposures and based on fixed filter thickness and target material.
   5. (5) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.
   6. (6) 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.
   7. (7) Calibration of machines--The measurement and specification of absorbed dose to a medium, or exposure in air, at a defined point in a radiation beam.
   8. (8) Certification of mammography systems (state certification)--A form of permission given by the agency to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter.
   9. (9) Contact hour--50 minutes of attendance and/or participation in instructor-directed activities.
   10. (10) Continuing education--Acquiring contact hours by attendance and/or participation in lectures, conferences, or seminars; or participation in self-study programs.
   11. (11) Control panel--That part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.
   12. (12) Dedicated mammographic equipment--Equipment that has been specifically designed and manufactured for mammography.
   13. (13) Equipment--(See definition for x-ray equipment).

   14. (14) 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 any or all of the following:

       1. (A) the operation of equipment to produce a mammogram;
       2. (B) processing of film;
       3. (C) initial interpretation of the mammogram; or
       4. (D) maintaining the viewing conditions for that interpretation.
   15. (15) Formal training--Attendance and participation in instructor-directed activities. This does not include self-study programs.
   16. (16) 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.
   17. (17) Interpreting physician--A physician who interprets mammographic images and who meets the requirements of subsection (d)(2)(A) of this section.
   18. (18) Image receptor--Any device, such as a fluorescent screen or radiographic film, 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.
   19. (19) kV--Kilovolt.
   20. (20) kVp--Kilovolt peak.
   21. (21) mA--Milliampere.
   22. (22) Mammogram--A radiographic image produced through mammography.
   23. (23) Mammographic 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. The phantom shall be approved or accepted by the FDA.
   24. (24) Mammography--The use of x-radiation to produce an image of the breast on film, paper, or digital display that may be used to detect the presence of pathological conditions of the breast.

   25. (25) Mammography system--A system that includes the following:

       1. (A) an x-ray unit used as a source of radiation in producing images of breast tissue;
       2. (B) an imaging system used for the formation of a latent image of breast tissue;
       3. (C) an imaging processing device for changing a latent image of breast tissue to a visual image that can be used for diagnostic purposes;
       4. (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;
       5. (E) a medical radiological technologist who performs a mammography; and
       6. (F) a physician who engages in, and who meets the requirements of this section relating to the reading, evaluation, and interpretation of mammograms.
   26. (26) mAs--Milliampere-second.
   27. (27) Medical physicist--A person meeting the qualifications for a medical physicist specified in subsection (d)(2)(C) of this section.
   28. (28) Medical radiological technologist--An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements in subsection (d)(2)(B) of this section.
   29. (29) Mobile services--The utilization of radiation machines in temporary locations for limited time periods. The radiation machines may be fixed inside a mobile van or transported to temporary locations.
   30. (30) Mobile x-ray equipment--(See definition for x-ray equipment).
   31. (31) Optical density (OD)--A measure of the percentage of incident light transmitted through a developed film and defined by the equation.

3. (c) Exemptions.

   1. (1) Mammography machines or cabinet x-ray units used exclusively for examination of breast biopsy specimens are exempt from the requirements of this section. These units are required to meet applicable provisions of §289.226 of this title and §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine).
   2. (2) Xerography systems not used for detection of diseases of the breast are exempt from the requirements of this section. These units are required to meet applicable provisions of §289.226 of this title and §289.227 of this title.
   3. (3) Mammography systems not meeting the AEC requirements of subsection (e)(1)(G) of this section are exempt from this requirement if changes in the facility's technique chart reflect the density settings required to maintain the film density to within plus or minus 0.3 OD when the AEC is utilized. This change shall be addressed in the facility's operating and safety procedures.
   4. (4) Mammography systems used exclusively for invasive interventions for localization or biopsy procedures or other unique mammographic imaging modalities are exempt from the requirements of this section except for those listed in subsection (f)(6) of this section.
   5. (5) All mammography registrants are exempt from the radiation protection program requirements of §289.202(e) of this title.

4. (d) Operational controls for mammographic equipment.

   1. (1) Quality assurance.

      1. (A) Quality assurance program. Each registrant shall have a written, ongoing quality assurance program specific to mammographic imaging covering all components of the diagnostic x-ray imaging system to ensure consistently high-quality images while minimizing patient exposure. Responsibilities under this requirement include the following:

         1. (i) conducting equipment performance monitoring functions;
         2. (ii) analyzing the monitoring results to determine if there are problems requiring correction;
         3. (iii) carrying out or arranging for the necessary corrective actions when results of monitoring quality control tests including those specified in subparagraph (B) of this paragraph indicate the need; and
         4. (iv) maintenance of records documenting the requirements of this paragraph for agency inspection for a minimum of two years.

      2. (B) Quality control. The registrant shall ensure that the following quality control items are performed at least as often as the frequency specified when mammographic equipment is initially installed, replaced, or reassembled after moving. When the results of tests performed in accordance with this subparagraph and subparagraph (C) of this paragraph do not meet the required acceptance criteria, corrective action shall begin within 30 days following the check and completed no longer than 90 days from commencement, unless otherwise authorized by the agency. Clinical images of mammographic examinations shall not be processed using a processor that deviates from the requirements of clause (i) of this subparagraph. A processor, other than the one commonly in use, may be used temporarily provided that the backup processor has been tested according to clause (i) of this subparagraph and meets the requirements of clause (i) of this subparagraph. A phantom image from the mammography system shall be acquired and run in the backup processor and evaluated for acceptable quality according to clause (iv) of this subparagraph, prior to the first patient exposure. Records of the quality control checks, including any correction or repair, shall be maintained for a minimum of two years for inspection by the agency. Films that result from the performance of quality control tests shall be maintained for a minimum of 12 months.

         1. (i) Processor performance shall be evaluated by sensitometric and densitometric means and by developer temperature daily, or on each day of use for mammography, and the results recorded before the first patient exposure. The calibration of the densitometer must be checked every 12 months. Film processors utilized for mammography shall be adjusted to and operated at the specifications recommended by the mammographic film manufacturer, or at other settings such that the sensitometric performance is at least equivalent. For any registrant performing mammography and using film processors at multiple locations, such as a mobile service, each processor shall be subject to the requirements of this clause. Corrective action shall be taken in the event of the following:

            1. (I) deviations exceeding plus or minus 0.15 in OD from established operating levels occur for readings of mid-density and DD on the sensitometric control charts; and/or
            2. (II) base plus fog (B+F) exceeds the established operating level by more than 0.03 OD.
         2. (ii) Darkroom cleaning shall be performed daily.
         3. (iii) Screen cleaning shall be performed weekly.
         4. (iv) Image quality shall be evaluated using a mammographic phantom to comply with subsection (e)(1)(L) of this section at intervals not to exceed one month. Each phantom image and a record of the evaluation of that image shall be maintained at the location where the mammography image was produced or with the radiographic equipment for mobile services.
         5. (v) Equipment observation check shall be performed monthly.
         6. (vi) Analysis of fixer retention in film shall be performed at intervals not to exceed three months.
         7. (vii) Compression device performance (releases, level of force, etc.) shall comply with subsection (e)(1)(J) of this section and shall be performed at intervals not to exceed six months.
         8. (viii) Screen-film contact and screen artifact detection shall comply with subsection (e)(1)(K) of this section and shall be performed at intervals not to exceed six months.
         9. (ix) Uniformity of screen speed shall be performed at intervals not to exceed 12 months.
         10. (x) Beam limiting device alignment shall comply with subsection (e)(1)(D) of this section and shall be performed at intervals not to exceed 12 months.
         11. (xi) kVp accuracy shall comply with subsection (e)(1)(F) of this section and shall be performed at intervals not to exceed 12 months.
         12. (xii) Output reproducibility, mA or mAs linearity shall comply with subsection (e)(1)(N) of this section and shall be performed at intervals not to exceed 12 months.
         13. (xiii) AEC reproducibility and performance (response to kVp and phantom thickness) shall comply with subsection (e)(1)(G) of this section and shall be performed at intervals not to exceed 12 months.
         14. (xiv) HVL shall comply with subsection (e)(1)(H) of this section and shall be performed at intervals not to exceed 12 months.
         15. (xv) The average glandular dose shall comply with subsection (e)(2) of this section and shall be performed at intervals not to exceed 12 months and within 60 days after a tube or tube insert replacement.
         16. (xvi) Evaluation of focal spot performance shall comply with subsection (e)(1)(E) of this section and shall be performed at intervals not to exceed 12 months.

      3. (C) Additional quality control requirements. When deviations are found, corrections or repairs shall be made in accordance with subparagraph (B) of this paragraph.

         1. (i) A repeat analysis on clinical images repeated or rejected shall be performed and documented at intervals not to exceed three months. Corrective action shall be taken if the retake rate for the facility exceeds 5.0%. Test films, cleared films, or film processed as a result of exposure of a film bin are not to be included in the count for repeat analysis. Films included in the repeat analysis are not required to be kept after completion of the analysis.
         2. (ii) Means shall be provided to block extraneous light from the viewer's eye when the illuminated surface of the viewbox is larger than the film size or area of clinical interest. Viewbox uniformity and condition of devices used to block extraneous light shall be checked at intervals not to exceed six months.
         3. (iii) Darkroom integrity shall be checked at intervals not to exceed six months. Darkroom fog levels shall not exceed 0.05 OD when sensitized film is exposed to darkroom conditions with safelight on for two minutes. Film shall be sensitized by exposing it to x-radiation so that after processing an OD of 1.2-1.6 is achieved.

      4. (D) Retention of clinical images. A registrant shall maintain and make available to a patient of the facility any original mammograms performed at the facility until the earlier of either:

         1. (i) the fifth anniversary of the mammography;
         2. (ii) the tenth anniversary of the mammography, if an additional mammogram of the same patient is not performed by the facility; or
         3. (iii) at the request of the patient, the date the patient's medical records are forwarded to another medical institution, to a physician of the patient, or to the patient. If the medical records are permanently forwarded, this institution or physician shall maintain and become responsible for the original film until the fifth or tenth anniversary as specified in clauses (i) and (ii) of this subparagraph.

      5. (E) Interpretation of clinical images. Each facility shall prepare a written report of the results of any mammography examination. Such report shall be completed as soon as reasonably possible and shall be:

         1. (i) signed by the interpreting physician or signed by electronic signature by the interpreting physician;
         2. (ii) maintained in the mammography patient's medical record in accordance with clauses (i) and (iii) of this subparagraph. A facility is not required to maintain copies of the lay person summary; and

         3. (iii) provided as follows:

            1. (I) to the mammography patient's physician(s);
            2. (II) if the mammography patient's physician is not available, the report shall be sent directly to the mammography patient and shall include a summary written in language easily understood by a lay person; or
            3. (III) if the patient is self-referred, such report shall comply with the provisions of paragraph (4) of this subsection.
      6. (F) Follow-up on interpretation of clinical images. Each facility shall establish procedures for reviewing outcome data from all mammography performed, including follow-up on the disposition of positive mammograms and correlation of surgical biopsy results with mammogram reports.

      7. (G) Processing of mammographic images. Each registrant shall utilize the same processor for clinical mammographic and mammographic phantom images. Clinical images shall be processed within an interval not to exceed 24 hours from the time the first clinical image is taken.

         1. (i) Each clinical image shall be marked by a film flasher device, lead marker, or printed label in a non-critical area on the film. The information shall include, but is not limited to, facility name, patient's name, and the date of the film.
         2. (ii) Information shall also be maintained for each clinical image by utilizing a label on each film, recording on the film jacket, or maintaining a log or other means. The information shall include, but is not limited to, compressed breast thickness or degree of compression, and kVp.

         3. (iii) Facilities utilizing batch processing shall:

            1. (I) use a container to transport clinical images that will protect the film from exposure to light and radiation;
            2. (II) maintain a log to include each patient name and unique identification number, date and time of the first exam of each batch, and date and time of batch development.
      8. (H) Xerography. Processing equipment for xerography shall be evaluated daily on each day of use before the first mammography patient exposure. Processing and maintenance of equipment shall be performed in accordance with manufacturer's recommendations. Xerography systems shall comply with all the requirements for mammography in this subsection and in subsection (e) of this section except for the following: subparagraphs (B)(i)-(iii), (vi), (viii), and (ix); (C)(ii) and (iii); and (G) of this paragraph.

   2. (2) Personnel qualifications.

      1. (A) Interpreting physician. Each physician interpreting mammograms shall:

         1. (i) hold a current Texas license issued by the Texas State Board of Medical Examiners and be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or one of the other bodies approved by the FDA to certify interpreting physicians or have equivalent formal training and experience;
         2. (ii) have had 40 hours of documented continuing medical education credits in mammography. (Continuing education credits shall be approved by the Accreditation Council for Continuing Medical Education or the Committee on Continuing Medical Education of the American Osteopathic Association.) Forty hours specifically devoted to mammography during residency will be accepted if documented in writing by the radiologist, and if the residency program has been approved by the Accreditation Council for Graduate Medical Education or the Council on Postdoctoral Training of the American Osteopathic Association;

         3. (iii) have initial experience six months preceding application in reading and interpreting mammograms from the examinations of:

            1. (I) at least 240 mammography patients as a qualified interpreting physician; or
            2. (II) at least 240 mammography patients under the direct supervision of a qualified interpreting physician; and

         4. (iv) have the following continuing experience:

            1. (I) reading and interpreting mammograms from the examination of an average of at least 40 mammography patients per month over 24 months; and
            2. (II) participating in education programs, either by teaching or completing an average of at least five continuing medical education credits in mammography per year at intervals not to exceed three years.
      2. (B) Operators of equipment. The x-ray mammographic machines shall be operated by an individual currently certified as a medical radiologic technologist under Texas Civil Statutes, Article 4512m and who has completed a minimum of 40 hours of formal mammographic training as outlined in subsection (z)(1) of this section or an individual who qualified as an operator of equipment prior to August 10, 1998. Medical radiologic technologists shall accumulate an average of at least five continuing education hours per year in the technical aspects of mammography at intervals not to exceed three years.
      3. (C) Medical physicist. The person evaluating the performance of mammographic systems in accordance with this section shall hold a current Texas license under the Medical Physics Practice Act, Article 4512n, in diagnostic radiological physics. The person must also be registered with the agency in accordance with §289.226(e) of this title and the Texas Radiation Control Act unless exempted by §289.226(b)(6) of this title. The person must participate in education programs, either by teaching or completing an average of at least five continuing medical education credits in mammography per year at intervals not to exceed three years.

   3. (3) Personnel responsibilities.

      1. (A) Supervising physician responsibilities shall include the following:

         1. (i) to provide oversight and direction for all aspects of the quality assurance program;
         2. (ii) to ensure that technologists have adequate training in mammography and continuing education;
         3. (iii) to arrange staffing and scheduling so that adequate time is available to carry out the quality control tests and to record and interpret the results;
         4. (iv) to select a medical physicist who will administer the program and perform the physicists' tests;
         5. (v) to select a technologist to perform the quality control tests;
         6. (vi) to review the technologists' quality control test results at least every three months, or more frequently if consistency has not yet been achieved; and
         7. (vii) to review the physicists' results annually or more frequently when needed.

      2. (B) Equipment operators' responsibilities shall include performing and recording the results of the following tests or tasks at the frequency indicated. The facility may assign the responsibility for individual tasks within the quality assurance program to a quality control technologist.

         1. (i) Processor quality control shall be performed daily in accordance with paragraph (1)(B)(i) of this subsection.
         2. (ii) Darkroom cleaning shall be performed daily.
         3. (iii) Screen cleaning shall be performed weekly.
         4. (iv) Image quality using a mammographic phantom shall be performed monthly in accordance with paragraph (1)(B)(iv) of this subsection.
         5. (v) Equipment observation check shall be performed monthly.
         6. (vi) Repeat film analysis shall be performed quarterly in accordance with paragraph (1)(C)(i) of this subsection.
         7. (vii) Analysis of fixer retention in film shall be performed quarterly. The estimated amount of residual hypo shall be 0.05 grams per square meter (5 micrograms per square centimeter) or less.
         8. (viii) Viewbox uniformity and condition of devices used to block extraneous light shall be checked semiannually in accordance with paragraph (1)(C)(ii) of this subsection.
         9. (ix) Compression device performance shall be checked semiannually and shall be in accordance with subsection (e)(1)(J) of this section.
         10. (x) Darkroom integrity shall be checked semiannually and shall be in accordance with paragraph (1)(C)(iii) of this subsection.
         11. (xi) Screen-film contact shall be checked semiannually and shall be in accordance with subsection (e)(1)(K) of this section.

      3. (C) Medical physicists' responsibilities include the following:

         1. (i) conducting an annual on-site mammography survey of the entire mammography system (excluding personnel) while the medical physicist is physically present, to include performance of the following:

            1. (I) alignment of beam limiting device in accordance with subsection (e)(1)(D) of this section;
            2. (II) evaluation of focal spot performance in accordance with subsection (e)(1)(E) of this section;
            3. (III) kVp accuracy in accordance with subsection (e)(1)(F) of this section;
            4. (IV) beam quality assessment (HVL measurement) in accordance with subsection (e)(1)(H) of this section;
            5. (V) AEC performance in accordance with subsection (e)(1)(G) of this section;
            6. (VI) uniformity of screen speed;
            7. (VII) average glandular dose in accordance with subsection (e)(2) of this section;
            8. (VIII) output reproducibility, mA and mAs linearity in accordance with subsection (e)(1)(N) of this section;
            9. (IX) image quality evaluation in accordance with subsection (e)(1)(L) of this section;
            10. (X) artifact evaluation; and
         2. (ii) performing a survey that verifies that the mammographic unit meets the equipment standards in subsection (e)(1) of this section and the average glandular dose meets the requirements of subsection (e)(2) of this section on equipment that is initially installed, replaced, or reassembled after moving; and
         3. (iii) verifying the average glandular dose within 60 days of replacement in accordance with subsection (e)(2) of this section on mammographic units that have had a tube or tube insert replaced.

      4. (D) The medical physicist shall provide the following to the facility:

         1. (i) a written report of the results of the tests listed in subparagraph (C) of this paragraph;
         2. (ii) written recommendations for corrective actions according to the test results; and
         3. (iii) a review of the test results with the supervising physician or his/her designee and the technologist(s) performing the quality control.
      5. (E) Records of the survey listed in subparagraph (C)(i) of this paragraph shall be maintained by the facility for seven years.

   4. (4) Self-referral mammography. Any person proposing to conduct a self-referral mammography program shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the following information:

      1. (A) the number and type of views (or projections);
      2. (B) the age of the population to be examined and the frequency of the exam following established, nationally recognized criteria, such as those of the American Cancer Society, American College of Radiology, or the National Council on Radiation Protection and Measurements;

      3. (C) written procedures to include methods of:

         1. (i) advising individuals of the results of the self-referral mammography procedure and any further medical needs indicated. If a report is sent to the mammography patient, it shall include a summary written in language easily understood by a lay person;
         2. (ii) advising private physicians of the results of the self-referral mammography procedure and any further medical needs indicated;
         3. (iii) follow-up to confirm that mammography patients with positive findings and mammography patients needing repeat exams have received proper notification; and
         4. (iv) follow-up to confirm that practitioners have received proper notification of patients with positive findings needing repeat exams; and
      4. (D) methods for educating mammography patients in breast self-examination techniques and on the necessity for follow-up by a physician.

   5. (5) Records required to be kept with units authorized for mobile services.

      1. (A) In addition to the requirements of §289.203(b) of this title, copies of the following shall be kept with units authorized for mobile services:

         1. (i) operating and safety procedures in accordance with paragraph (7) of this subsection;
         2. (ii) medical radiologic technologists' credentials;
         3. (iii) current quality control records for at least the last 90 calendar days for on-board processors in accordance with paragraph (1) of this subsection;
         4. (iv) current §289.112 of this title, §289.201 of this title, §289.202 of this title, §289.203 of this title, §289.226 of this title, and §289.230 of this title;
         5. (v) copy of certification of mammography system;
         6. (vi) certification of inspection or notice of failure from last inspection if applicable; and
         7. (vii) copy of mammography facility accreditation.
      2. (B) All other records required by this section shall be maintained at a specified location for inspection by the agency.

   6. (6) Records required at authorized use locations. Copies of the following shall be kept at authorized use locations:

      1. (A) operating and safety procedures in accordance with paragraph (7) of this subsection;
      2. (B) quality assurance program in accordance with paragraph (1) of this subsection;
      3. (C) credentials for interpreting physicians operating at that location in accordance with paragraph (2)(A) of this subsection;
      4. (D) credentials for medical radiologic technologists operating at that location in accordance with paragraph (2)(B) of this subsection;
      5. (E) quality control records in accordance with paragraph (1) of this subsection;
      6. (F) training and continuing education records for interpreting physicians and medical radiologic technologists operating at that location in accordance with paragraph (2)(A) and (B) of this subsection;
      7. (G) current physicist annual survey of the mammography system;
      8. (H) current §289.112 of this title, §289.201 of this title, §289.202 of this title, §289.203 of this title, §289.204 of this title, §289.226 of this title, and §289.230 of this title;
      9. (I) copy of certification of mammography system;
      10. (J) certification of inspection or notification of failure if applicable;
      11. (K) records of receipts, transfers, and disposal in accordance with paragraph (10) of this subsection;
      12. (L) calibration, maintenance, and modification records in accordance with paragraph (13) of this subsection; and
      13. (M) copy of mammography facility accreditation.
   7. (7) Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures that shall be made available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. These procedures shall include a quality assurance program in accordance with paragraph (1) of this subsection.
   8. (8) Occupational dose limits and personnel monitoring. Except as otherwise exempted, all individuals who are associated with the operation of a radiation machine are subject to the occupational dose requirements of §289.202(f), (j), (l), and (m) of this title regarding dose limits to individuals and the personnel monitoring requirements of §289.202(q) of this title.
   9. (9) Technique Chart. A chart or manual shall be provided or electronically displayed in the vicinity of the control panel of each machine that specifies technique factors to be utilized versus patient's anatomical size. The technique chart shall be used by all operators.
   10. (10) Receipt, transfer, and disposal of mammographic machines. Each registrant shall maintain records showing the receipt, transfer, and disposal of mammographic machines. These records shall include the date of receipt, transfer, or disposal, the name and signature of the individual making the record, and the manufacturer's model and serial number from the control panel of the mammographic machine. Records shall be maintained for inspection by the agency until the certification of mammography system is terminated.
   11. (11) Viewing system. Windows, mirrors, closed circuit television, or an equivalent system shall be provided to permit the operator to continuously observe the patient during irradiation. The operator shall be able to maintain verbal, visual, and aural contact with the patient.
   12. (12) Exposure of individuals other than the patient. Only the staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiation exposure.
   13. (13) Calibration, maintenance, and modifications. Each registrant shall maintain records showing calibrations, maintenance, and modifications performed on each mammographic machine. These records shall include the date of the calibration, maintenance, or modification performed, the name of the individual making the record, and the manufacturer's model and serial number of the control panel of the mammographic machine. These records may be maintained in electronic format.

5. (e) Mammographic x-ray systems.

   1. (1) Equipment standards. Only x-ray systems meeting the following standards shall be used:

      1. (A) System design. The equipment shall have been specifically designed and manufactured for mammography in accordance with 21 Code of Federal Regulations (CFR) 1010.2, 1020.30, and 1020.31.
      2. (B) Image receptor. The image receptor systems and their individual components shall be specifically designed for mammography.
      3. (C) Target/Filter. The x-ray system shall have the capability of providing kVp/target/filter combinations compatible with image receptor systems meeting the requirements of subparagraph (B) of this paragraph.
      4. (D) Collimation. The mammographic system shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than 2.0% of the SID. The collimated light field edges shall not differ from the respective edges of the x-ray field along either the length or the width of the visually defined field by more than 2.0% of the SID.
      5. (E) Evaluation of focal spot performance: Focal spot performance shall be evaluated by measuring both parallel and perpendicular to the anode-cathode axis and determining whether they are in compliance with manufacturer-provided and National Electrical Manufacturers Association specifications. Focal spot performance also may be evaluated by determining limiting resolution by using a high-contrast resolution pattern. All focal spot dimensions shall be measured.
      6. (F) Accuracy of kVp. The actual kVp shall meet manufacturer's specifications or in the absence of manufacturer's specifications shall be within plus or minus 5.0% of the indicated kVp.
      7. (G) Automatic exposure control performance.

6. (f) Certification requirements. In addition to the requirements of §289.226(c) and if applicable, (g) of this title, each applicant shall comply with the following.

   1. (1) Each person having a mammographic x-ray unit shall apply for and receive certification for the mammography system from the agency before beginning use of the mammographic x-ray unit on humans.
   2. (2) An application for mammography certification must be signed by a licensed physician. The signature of the applicant and the radiation safety officer (RSO) shall also be required.
   3. (3) An applicant for certification must obtain a certification on each mammography system that is used by the applicant or the applicant's agent (for the purposes of the requirements of this paragraph, the word "used" refers to the entity other than the technologist that directs the application of radiation to humans). An application for mammography system certification may contain information on multiple mammography x-ray units. Each x-ray unit must be identified by referring to the machine's manufacturer, model number, and serial number of the control panel. An applicant or applicant's agent shall provide proof of current accreditation by an accreditation body approved by the FDA on forms prescribed by the agency or submit an application for accreditation in accordance with subsection (p) of this section.
   4. (4) The applicant shall be qualified by reason of training and experience to use the mammographic machines for the purpose requested in accordance with this chapter in such a manner as to minimize danger to public health and safety.

   5. (5) Each applicant shall submit documentation of the following:

      1. (A) proposed quality assurance program in accordance with subsection (d)(1) of this section;
      2. (B) personnel qualifications, including dates of licensure or certification, in accordance with subsection (d)(2) of this section;
      3. (C) model and serial number of each mammographic unit control panel;

      4. (D) evidence of the following by a physicist holding a current Texas license under the Medical Physics Practice Act, Article 4512n with a specialty in Diagnostic Radiological Physics:

         1. (i) each unit meets the equipment standards in subsection (e)(1) of this section; and
         2. (ii) the average glandular dose for one craniocaudal view for each unit does not exceed the appropriate values in subsection (e)(2) of this section; and
      5. (E) self-referral program information in accordance with subsection (d)(4) of this section, if the facility offers self-referral mammography.
   6. (6) An applicant for certification of mammography stereotactic systems or other unique x-ray imaging modalities for mammography shall comply with subsections (d)(1)(A), (B)(xi)-(xiv), and (xvi); (2)(B) and (C); (3)(A)-(C), as applicable; (5) and (6) as applicable; (7)-(13); (e)(1)(E)-(H), and (N); (f) except for the accreditation requirements of FDA in (f)(3); (g)-(i) as applicable; (j)-(n); (o)(2)-(8); and (z)(1) and (2) of this section as applicable. The purpose and scope of this section and the definitions in subsection (b) of this section also apply to certification of these systems.

   7. (7) Applications shall be processed in accordance with the following time periods.

      1. (A) The first period is the time from receipt of an application by the Division of Licensing, Registration and Standards to the date of issuance or denial of the certification or a written notice outlining why the application is incomplete or unacceptable. This time period is 60 days.
      2. (B) The second period is the time from receipt of the last item necessary to complete the application to the date of issuance or denial of the certification. This time period is 30 days.
      3. (C) These time periods are exclusive of any time period incident to hearings and post-hearing activities required by the Government Code, Chapters 2001 and 2002.

   8. (8) Notwithstanding the provisions of §289.204 of this title, reimbursement of application fees may be granted in the following manner:

      1. (A) In the event the application is not processed in the time periods as stated in paragraph (7) of this subsection, the applicant has the right to request of the director of the Radiation Control Program full reimbursement of all application fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.

      2. (B) Good cause for exceeding the period established is considered to exist if:

         1. (i) the number of applications for certification to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;
         2. (ii) another public or private entity utilized in the application process caused the delay; or
         3. (iii) other conditions existed giving good cause for exceeding the established periods.
      3. (C) If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed in accordance with Formal Hearing Procedures, §§1.21-1.34 of this title (relating to the Texas Board of Health).
7. (g) Issuance of certification of mammography systems. Issuance of certification of mammography systems shall be in accordance with §289.226(k) of this title.
8. (h) Specific terms and conditions of certification of mammography systems. Specific terms and conditions of certification of mammography systems shall be in accordance with §289.226(l) of this title.

9. (i) Responsibilities of registrant.

   1. (1) In addition to the requirements of §289.226(m)(2) and (4)-(7) of this title, a registrant shall notify the agency in writing prior to any changes that would render the information contained in the application or the certification of mammography systems inaccurate. These include but are not limited to the following:

      1. (A) name and mailing address;
      2. (B) street address where machine(s) will be used; and
      3. (C) mammographic x-ray units.

   2. (2) The registrant is required to verify and maintain copies of the qualifications of the individuals listed in subparagraphs (A)-(E) of this paragraph. Registrants utilizing relief interpreting physicians or technologists from a temporary service do not need to notify the agency unless these personnel will be at the facility for a period exceeding four weeks. Notification of change in any of the following is required within 30 days of such change.

      1. (A) radiation safety officer;
      2. (B) supervising physician;
      3. (C) interpreting physicians;
      4. (D) operators of equipment;
      5. (E) licensed medical physicist;
      6. (F) processor;
      7. (G) film/screen change; and
      8. (H) changes in the facilities operating and safety procedures or quality control program.

   3. (3) The following criteria applies to new, replacement, or loaner units and units used for clinical trial evaluations.

      1. (A) A facility with an existing certification of mammography system may begin using a new or replacement unit before receiving an updated certification if the paperwork regarding the unit has been submitted to the agency with a licensed medical physicists's report verifying compliance of the new unit with the regulations. The physicist's report is required prior to using the unit on patients.
      2. (B) Loaner units may be used on patients for 60 days without adding the unit to the certification. A licensed medical physicist's report verifying compliance of the loaner unit with this section shall be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use.
      3. (C) Units involved in clinical trial evaluations may be used on patients for 60 days without adding the unit to an existing certification. A licensed medical physicist's report verifying compliance of the loaner unit with this section shall be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use. If the use period will exceed 60 days, the facility shall add the unit to their certification and a prorated fee will be assessed.
      4. (D) No fees will be assessed for loaner units or evaluation periods of 60 days or less.
      5. (E) Loaner units or units involved in clinical trial evaluations are exempt from the inspection requirement in subsection (o)(1) of this section.
   4. (4) Records of training and experience and all other records required by this section shall be maintained for review in accordance with subsection (z)(2) of this section.

10. (j) Expiration of certification of mammography systems.

    1. (1) Except as provided by subsection (l) of this section, each certification of mammography systems expires at the end of the day in the month and year stated on the certificate of registration on the expiration date specified. Expiration of the certification of mammography systems does not relieve the registrant of the requirements of this chapter.

    2. (2) If a registrant does not submit an application for renewal of the certification of mammography systems under subsection (l) of this section, as applicable, the registrant shall on or before the expiration date specified in the certification of mammography systems:

       1. (A) terminate use of all radiation machines;
       2. (B) submit a record of the disposition of the x-ray units; and
       3. (C) pay any outstanding fees in accordance with §289.204 of this title.

11. (k) Termination of certification of mammography systems. When a registrant decides to terminate all activities involving radiation machines authorized under the certification of mammography systems, the registrant shall:

    1. (1) notify the agency immediately;
    2. (2) request termination of the certification of mammography systems in writing;
    3. (3) submit a record of the disposition of the x-ray units; and
    4. (4) pay any outstanding fees in accordance with §289.204 of this title.

12. (l) Renewal of certification of mammography systems.

    1. (1) Application for renewal of certification shall be filed in accordance with this subsection and §289.226(c) and (g) of this title, as applicable.
    2. (2) If a registrant files an application in proper form at least 30 days before the existing certification expires, such existing certification shall not expire until the application status has been determined by the agency.

    3. (3) A certification for a mammographic unit is valid for three years from the date of issuance unless the certification of the facility is revoked prior to such deadlines. This is effective for certificates issued after September 1, 1997.

       1. (A) If a registrant fails to renew the certification by the required date, the registrant may renew the certification on payment of the annual fee and a late fee. If the certification is not renewed before the 181st day after the date on which the certification expired, the registrant must apply for an original certification under this section.
       2. (B) A mammography system may not be used after the expiration date of the certification unless the holder of the expired certification has made a timely and sufficient application for renewal of the certificate as provided in this subsection and §289.226(c) and (g) of this title, as applicable.
13. (m) Modification and revocation of certification of mammography systems. Modification and revocation of certification of mammography systems shall be in accordance with §289.226(q) of this title.
14. (n) Reciprocal recognition of out-of-state certificates of registration. Mammographic x-ray units will not be granted reciprocal recognition and must comply with the requirements of this section.

15. (o) Inspections. In addition to the requirements of §289.201(e) of this title, the following applies to inspections of mammography systems.

    1. (1) The agency shall inspect each mammography system that receives a certification in accordance with this chapter not later than the 60th day after the date the certification is issued.
    2. (2) The agency shall inspect, at least once annually, each mammography system that receives a certification.
    3. (3) To protect the public health, the agency may conduct more frequent inspections than required by this subsection.
    4. (4) The agency shall make reasonable attempts to coordinate inspections in this section with other inspections required in accordance with this chapter for the facility where the mammography system is used.

    5. (5) After each satisfactory inspection, the agency shall issue a certificate of inspection for each mammography system inspected. The certificate of inspection shall be posted at a conspicuous place on or near the place where the mammography system is used. The certificate of inspection shall include the following:

       1. (A) specific identification of the mammography system inspected;
       2. (B) the name and address of the facility where the mammography system was used at the time of the inspection; and
       3. (C) the date of the inspection.

    6. (6) Any Severity Level I violation found by the agency constitutes grounds for posting notice of failure of the mammography system to satisfy agency requirements.

       1. (A) Notification of such failure shall be posted:

          1. (i) on the mammography x-ray unit at a conspicuous place if the violation is machine-related; or
          2. (ii) near the place where the mammography system practices if the violation is personnel-related; and
          3. (iii) in a sufficient number of places to permit the patient to observe the notice.
       2. (B) The notice of failure shall remain posted until the facility is authorized to remove it by the agency. A facility may post documentation of corrections of the violations submitted to the agency along with the notice of failure until approval to remove the notice of failure is received from the agency.

    7. (7) The agency shall require registrants to notify patients on whom the facility performed a mammography during the 30 days preceding the date of the inspection that revealed the failure. The facility shall:

       1. (A) inform the patient that the mammography system failed to satisfy the agency's certification standards;
       2. (B) recommend that the patient have another mammogram performed at a facility with a certified mammography system; and
       3. (C) list the three facilities closest to the original testing facility that have a certified mammography system.
    8. (8) In addition to the requirements of paragraph (7) of this subsection, the agency may require a facility to notify a patient of any other failure of the facility's mammography system to meet the agency's certification standards.

    9. (9) The patient notification shall include the following:

       1. (A) explanation of the mammography system failure to the patient; and
       2. (B) the potential consequences to the mammography patient.
    10. (10) The registrant shall maintain a record of the mammography patients notified in accordance with paragraphs (7) and (8) of this subsection for inspection by the agency. The records shall include the name and address of each mammography patient notified, date of notification, and a copy of the text sent to the individual.

16. (p) Accreditation of mammography facilities.

    1. (1) All mammography facilities shall be accredited by an authorized FDA accreditation body. All facilities applying for and receiving accreditation through the agency shall comply with §289.112 of this title, §289.201(c), (h)-(j), and (l)-(n) of this title, §289.203 of this title, subsections (b), (c)(1)-(3), (d)(1)-(3) and (7)-(13), and (e)(1) and (2) of this section.

    2. (2) In order to be accredited by the agency, the applicant shall submit an application for accreditation on forms and in accordance with accompanying instructions prescribed by the agency.

       1. (A) Each application must be signed by a licensed physician.
       2. (B) The agency may at any time after the filing of the original application, require further statements in order to enable the agency to determine whether the accreditation document should be issued, denied, modified, or revoked.
       3. (C) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with §289.201(n) of this title.
       4. (D) Each application for accreditation shall be accompanied by the fee prescribed in subsection (q) of this section.

       5. (E) Each applicant shall submit documentation of the following:

          1. (i) quality assurance program in accordance with subsection (d)(1) of this section;
          2. (ii) personnel qualifications, training, and experience in accordance with subsection (d)(2) of this section;
          3. (iii) model and serial number of each mammographic unit control panel;
          4. (iv) procedures on clinical image interpretation, patient notification, and patient data tracking; and

          5. (v) evidence of the following by a physicist holding a current Texas license under the Medical Physics Practice Act, Article 4512n with a specialty in Diagnostic Radiological Physics:

             1. (I) each unit meets the equipment standards in subsection (e)(1) of this section; and
             2. (II) the average glandular dose for one craniocaudal view for each unit does not exceed the appropriate values in subsection (e)(2) of this section.

       6. (F) Upon notification by the agency, each applicant shall directly submit the following to the American College of Radiology (ACR) in accordance with their procedures:

          1. (i) clinical images;
          2. (ii) phantom images; and
          3. (iii) processor data.

17. (q) Fees for accreditation of mammography facilities.

    1. (1) Each application for accreditation of a mammography facility shall be accompanied by a nonrefundable fee. No application will be accepted for filing or processed prior to payment of the full amount specified.
    2. (2) A nonrefundable fee in accordance with paragraph (4) of this subsection shall be paid every three years for each accredited mammography unit. The fee shall be paid in full on or before the expiration date of the accreditation document if the facility wishes to remain accredited with the agency.
    3. (3) Fee payments shall be in cash or by check or money order made payable to the Texas Department of Health. The payments may be mailed or made by personal delivery to the Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3189.

    4. (4) Fees for accreditation of mammography facilities are as follows.

       1. (A) The accreditation fee for the first mammography unit is $720.
       2. (B) The accreditation fee for each additional mammography unit is $345.
       3. (C) The fee for reevaluation of clinical images is $220 per unit.
18. (r) Issuance of accreditation of a mammography facility. An accreditation document will be issued when the mammography facility meets the requirements of subsection (p) of this section and becomes accredited by the agency. In order for an accreditation to be issued, the agency must be notified by the ACR that the applicant met the criteria for clinical images, phantom images, and processor quality control.

19. (s) Specific terms and conditions of accreditation of mammography facilities.

    1. (1) Each accreditation document issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements and orders of the agency.
    2. (2) No accreditation document issued by the agency under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person.
20. (t) Responsibilities of an accredited facility. A facility shall notify the agency at least annually of any changes that would render the information contained in the application inaccurate.

21. (u) Expiration and renewal of accreditation of mammography facilities.

    1. (1) The accreditation shall expire on the date specified on the accreditation document.
    2. (2) Application for renewal of accreditation shall be filed in accordance with subsection (p) of this section and subsection (q) of this section.
    3. (3) If a registrant files an application in proper form at least 30 days before the existing accreditation expires, such existing accreditation shall not expire until the application status has been determined by the agency.
    4. (4) Accreditation for a mammographic facility is valid for three years from the date of issuance, unless accreditation of the facility is revoked prior to such deadline.
    5. (5) Issuance of renewal of accreditation shall be in accordance with subsection (r) of this section.

22. (v) Denial of accreditation of mammography facilities.

    1. (1) Any application for accreditation may be denied by the agency when the applicant fails to meet established criterion for accreditation or fails to respond to requests for information. Agency action on an application will be abandoned due to lack of response by the applicant. Abandonment of such actions does not provide an opportunity for a hearing; however, the applicant retains the right to resubmit the application at any time.
    2. (2) Before the agency denies an application for accreditation, the agency shall give notice by personal service or by certified mail, return receipt requested, of the intent to deny, the facts warranting the denial, and afford the applicant an opportunity for a hearing. If no request for a hearing is received by the director of the Radiation Control Program within 30 days of personal service or the date of mailing, the agency may proceed to deny. The applicant shall have the burden of proof showing cause why the application should not be denied.

23. (w) Modification and revocation of accreditation of mammography facilities.

    1. (1) Any accreditation document may be revoked, suspended, or modified, in whole or in part, for any of the following:

       1. (A) any material false statement in the application or any statement of fact required under provisions of the Act;
       2. (B) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant an accreditation document on an original application; or
       3. (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the accreditation document, or order of the agency.
    2. (2) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no accreditation document shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the accredited facility in writing and the accredited facility shall have been afforded an opportunity to demonstrate or achieve compliance with all lawful requirements.

24. (x) On-site facility visit. Each accredited facility shall:

    1. (1) afford the agency, at all reasonable times, opportunity to audit the facility where mammography equipment or associated equipment is used or stored; and
    2. (2) make available to the agency for inspection, upon reasonable notice, records maintained in accordance with this chapter.
25. (y) Complaints. Each facility shall post the following address where complaints may be filed with the Texas Department of Health, Bureau of Radiation Control, Mammography Accreditation Program, 1100 West 49th Street, Austin, Texas 78756-3189.

26. (z) Appendices.

    1. (1) Subjects to be included in mammography training shall include, but not be limited, to the following:

       1. (A) anatomy and physiology of the female breast that shall include:

          1. (i) mammary glands;
          2. (ii) external anatomy;
          3. (iii) retromammary space;
          4. (iv) central portion;
          5. (v) cooper's ligament;
          6. (vi) vessels, nerves, lymphatics; and

          7. (vii) breast tissue:

             1. (I) fibro-glandular;
             2. (II) fibro-fatty;
             3. (III) fatty; and
             4. (IV) lactating;

       2. (B) mammography positioning that shall include actual positioning of patients and/or models as follows:

          1. (i) craniocaudal;
          2. (ii) mediolateral oblique;
          3. (iii) supplemental;
          4. (iv) magnification;
          5. (v) errors in positioning;
          6. (vi) postoperative breast and the augmented breast;
          7. (vii) breast localization and specimen radiography; and
          8. (viii) use of compression;
       3. (C) technical factors;
       4. (D) film evaluation and critique;
       5. (E) pathology; and
       6. (F) quality assurance program.
    2. (2) Time requirements for record keeping shall be in accordance with the following chart.

Source Note:The provisions of this §289.230 adopted to be effective October 1, 1995, 20 TexReg 6656; amended to be effective August 9, 1998, 23 TexReg 7810.