Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 127.000 - Licensing Of Mammography Facilities
Requirements
Section 127.019 - Equipment Quality Assurance

(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.

(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:

(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).

(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)

(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.

(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.

(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.

(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.

(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.

(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.