| (III) paragraph (4)(C) of this subsection describing compression device performance; (IV) paragraph (5)(F) of this subsection describing dosimetry; (V) paragraph (7) of this subsection describing quality control tests of other modalities; and (VI) paragraph (8) of this subsection describing quality control tests for mobile mammography machines. (iii) If components in the remaining quality assurance tests in subsection (v) of this section fail, corrective action shall be taken within 30 days of the test date. (C) Documentation of the tests and the corrective actions described in subparagraph (B) of this paragraph shall be maintained in accordance with subsection (ee) of this section. (10) Surveys. At least once a year, each facility shall undergo a survey by a medical physicist or by an individual under the direct supervision of a medical physicist. (A) At a minimum, this survey shall include the following: (i) performance of tests to ensure that the facility meets the quality assurance requirements of the weekly phantom image quality test described in paragraph (2) of this subsection, the annual tests described in paragraph (5) of this subsection, and if applicable, quality control tests as described for other modalities in paragraph (7) and for mobile service operations as described in paragraph (8) of this subsection; and (ii) evaluation of the adequacy of the results of all tests conducted by the facility as well as written documentation of any corrective actions taken and their results in accordance with paragraphs (1) - (4) of this subsection, and, if applicable, paragraphs (7) and (8) of this subsection. (B) The medical physicist shall provide a written survey report to the facility within 30 days of the date of the survey. The report shall include a summary of the test performed, all test conditions, specifications, results and recommendations for corrective actions, in accordance with subparagraph (A)(i) and (ii) of this paragraph. (C) If the following tests indicate deficiencies, the physicist shall give a preliminary oral or written report to the facility within 72 hours of the survey: (i) processor quality control in accordance with paragraph (9)(B)(i)(I) of this subsection; (ii) phantom images, screen-film contact, compression device performance, or dosimetry in accordance with paragraph (9)(B)(ii)(I) - (IV) of this subsection; (iii) quality control tests for other modalities, if applicable, in accordance with paragraph (9)(B)(ii)(V) of this subsection; or (iv) quality control tests for mobile mammography machines, if applicable, in accordance with paragraph (9)(B)(ii)(VI) of this subsection. (D) The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey. (E) The survey report shall be maintained by the registrant in accordance with subsection (ee) of this section. (11) Mammography equipment evaluations. Additional evaluations of mammography machines or image processors shall be conducted whenever a new mammography machine or processor is installed, a mammography machine or processor is disassembled and reassembled at the same or a new location, major components of mammography machine are changed or repaired, or a processor is overhauled or reconditioned. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in this subsection and subsection (s) of this section. (A) All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. (B) The mammography equipment evaluation and dosimetry shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist. (12) Facility cleanliness. The registrant shall establish and implement adequate protocols for maintaining darkroom, screen, and view box cleanliness and shall document that all cleaning procedures are performed at the frequencies specified in the protocols. (13) Calibration of air kerma measuring instruments. Instruments used by medical physicists in their annual survey to measure the air kerma or air kerma rate from a mammography machine shall be calibrated at least once every two years and each time the instrument is repaired. The instrument calibration must be traceable to a national standard and calibrated with an accuracy of plus or minus 6.0% (95% confidence level) in the mammography energy range. (14) Infection control. Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall: (A) comply with all applicable federal, state, and local regulations pertaining to infection control; and (B) comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or (C) if adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available. (w) Quality assurance - mammography medical outcomes audit. Each registrant shall establish and maintain a mammography medical outcomes audit program to follow-up positive mammographic assessments and to correlate pathology results with the interpreting physician's findings. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms. (1) General requirements. Each registrant shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy. (2) Frequency of audit analysis. The facility's first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified or 12 months after April 28, 1999, whichever date is the latest. This audit analysis shall be complete within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every 12 months. These shall be maintained in accordance with subsection (ee) of this section. (3) Reviewing interpreting physician. Each lead interpreting physician or an interpreting physician designated by the lead interpreting physician shall review the medical outcomes audit data at least once every 12 months. This individual shall analyze the results of the audit and shall be responsible for the following: (A) recording the dates of the audit period(s); (B) documenting the results; (C) notifying other interpreting physicians of their results and the registrant's aggregate results; and (D) documenting any follow up actions and the nature of the follow up. (x) Mammographic procedure and techniques for mammography of patients with breast implants. Each registrant shall have a procedure to inquire whether or not the patient has breast implants prior to the mammographic exam. Except where contraindicated, or unless modified by a physician's directions, patients with breast implants shall have mammographic views to maximize the visualization of breast tissue. (y) Complaints. Each accredited facility shall do the following: (1) establish a written procedure for collecting and resolving consumer complaints; (2) maintain a record of each serious complaint received by the facility in accordance with subsection (ee) of this section; and (3) report unresolved serious complaints to the facility's FDA-approved accreditation body within 30 days of receiving the complaint. (z) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body. (aa) Additional mammography review, targeted clinical reviews, and patient notification. Cont'd... |
