Equipment Quality Assurance

(A) Quality Assurance Records for Mammography X-ray Equipment. (1) Records of all quality assurance tests shall be maintained for mammographic x-ray equipment and shall include at least the following: (a) The mammographic x-ray equipment performance evaluation and optimization, including initial acceptance testing (to be completed before patients are exposed with the machine) and subsequent evaluations and testing; (b) Verification that mammographic x-ray equipment is in safe operating order; (c) Subsequent quality assurance test results; (d) Notes regarding changes in operating conditions shall be recorded on the appropriate control charts; (e) Operating levels and control limits for all quality assurance tests shall be indicated on the appropriate control chart; (f) All records shall bear the date the procedure was done and the initials or name of the individual performing the test; (g) Quality assurance tests on the Radiologist workstation monitors shall be done in accordance with manufacturer's requirements; (h) Quality assurance tests on laser hardcopy printers shall be done in accordance with manufacturer's requirements. Records or written logs of maintenance and/or repairs of mammographic x-ray equipment shall be kept for at least three years. All records for a machine shall be kept in a single file at the machine use location. Repair records shall be referenced to quality assurance test results, if applicable. (3) All quality assurance records shall be maintained for a minimum of 24 months and readily available at the use location for review by representatives of the Department. (B) Quality Assurance Records and Requirements for Test Equipment and Mammography Systems. (1) The quality assurance test equipment shall be in good operating order. (2) Records of each repair and/or calibration of quality assurance test equipment shall include the date of repair and/or calibration. (3) Records of each repair and/or calibration of quality assurance test equipment shall be kept for at least three years. (4) Quality assurance tests shall be performed in accordance with manufacturers’ recommendations after the repair and/or replacement of any component of the mammographic x-ray system, prior to using the equipment. (C) Quality Assurance Tests for Equipment. Laser Hardcopy Printer. Quality assurance tests for laser printers, if used by the mammography facility for clinical diagnosis, shall be performed in accordance with the manufacturer's recommendations. (2) Mammography Phantom. (a) Quality assurance tests for image quality in fixed mammography facilities shall be performed weekly. (b) Quality assurance tests for image quality in mobile mammography facilities shall be performed each time the machine has been moved, before beginning examinations of patient at least weekly. (c) Each facility shall utilize a mammography phantom approved or accepted by ACR for performing quality assurance tests for image quality. The following image quality requirements shall be met, for different mammography modalities: 1. For Digital Mammography, manufacturer's specifications or specifications stated in the 2016 ACR Digital Mammography Quality Control Manual, or its revisions. 2. For Digital Breast Tomosynthesis, manufacturer's specifications. 3. For stereotactic breast biopsy, manufacturer's specifications or specifications stated in the 1999 ACR Sterotactic Breast Biopsy Quality Control Manual, or its revisions. (d) Each facility shall take corrective action in the event that quality assurance tests for image quality do not meet the requirements in 105 CMR 127.019(C)(2)(c). (3) Retake Analysis. (a) Quality assurance tests for retake analysis shall be performed as specified by the mammography system manufacturer or at least quarterly. (b) The test tools for performing quality assurance tests on retake analysis are records of rejected images. (c) When performing quality assurance tests for retake analysis, the total number of images and the total number of rejected images used during the test period shall be evaluated for ascertaining the reason for rejection. The rejected images shall be identified in at least the following categories: 1. Technique; 2. Motion; 3. Positioning error; 4. Digital imaging processing; and 5. Clinically significant artifacts (dead pixel clusters on digital detector arrays, shifts of masked spots, etc.). (4) Compression in the Manual and/or Power Modes (a) Quality assurance tests for compression in the manual and/or power modes in fixed mammography facilities shall be performed semi-annually. (b) Quality assurance tests for compression in the manual and/or power modes in mobile mammography facilities shall be performed each time the machine has been moved, but not less than semi-annually. (c) Each facility shall use a push-pull force gauge or a flat bathroom type scale method with accuracy of + 2% of full scale for performing quality assurance tests. (d) When performing the quality assurance test for compression, the maximum compression force shall range from a minimum of 25 to a maximum of 45 pounds in both the manual and power drive modes and shall remain consistent throughout the period of exposure. The compression release mechanism shall be tested at the same interval. (5) Automatic Exposure Control. (a) Quality assurance tests for automatic exposure control (phototiming) at fixed mammography facilities shall be performed at least annually. (b) Quality assurance tests for automatic exposure control (phototiming) at mobile mammography facilities shall be performed at least semi-annually. (6) Kilovolt Peak (kVp) Accuracy. (a) Quality assurance tests for kVp accuracy at fixed mammography facilities shall be performed at least annually. (b) Quality assurance tests for kVp accuracy at mobile mammography facilities shall be performed at least semi-annually. (c) Each facility shall use a non-invasive kVp meter with appropriate calibration procedures or an oscilloscope and voltage divider network to perform quality assurance tests. (d) When performing quality assurance tests for kVp accuracy, the actual (measured) versus indicated kVp shall be maintained as specified by the x-ray equipment manufacturer, but shall not vary from the indicated kVp by greater than 5% from the indicated. (7) Glandular Tissue Dose. (a) Quality assurance tests for glandular tissue dose at fixed mammography facilities shall be performed at least annually. (b) Quality assurance tests for glandular tissue dose at mobile mammography facilities shall be performed at least semi-annually. (c) Each facility shall use an ion chamber or solid state detector calibrated at the energy ranges used in mammography for performing quality assurance tests. (d) When performing quality assurance tests for glandular tissue dose, the technique setting shall be those used for imaging a 4.5 cm compressed breast in the cranio-caudal projection and the measurement point shall be 4.5 cm from the surface of the breast support as appropriate. (e) For mammographic examination of a 4.5 centimeter (cm) thick, compressed breast, consisting of 50% glandular and 50% adipose tissue, the average glandular dose shall be no more than 3 mGy per view. (8) Spatial Resolution. (a) Quality assurance tests for spatial resolution at fixed mammography facilities shall be performed at least annually. (b) Quality assurance tests for spatial resolution at mobile mammography facilities shall be performed at least semi-annually. (9) Half-value Layer (HVL) (a) Quality assurance tests for half-value layer at fixed mammography facilities shall be performed at least annually. (b) Quality assurance tests for half-value layer at mobile mammography facilities shall be performed at least semi-annually. (c) When performing quality assurance tests for half-value layer, the HVL shall be measured with the mammography x-ray unit's compression paddle in place over the ionization chamber or solid state detector. (10) All mammography facilities shall follow the manufacturer's recommendations or the ACR Digital Mammography QC Manual for quality control of all components used for digital image acquisition, digital image processing and digital image display.