Quality Assurance

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The following year, the Food and Drug Administration was assigned the task of enforcing MQSA by establishing standards, regulations, inspection processes, compliant mechanisms, and penalties for failure to comply with the regulations.

At approximately the same time as MQSA was being enacted, the AHCPR convened a panel to produce clinical practice guidelines on the quality determinants of mammography for interpreting physicians, clinicians, and consumers. The panel considered the entire process involved in providing quality mammography to consumers, including (a) actions before the examination related to scheduling, including triaging patients into screening or diagnostic examinations; (b) appropriate data to collect for the patient’s history; (c) the role of the imaging team, including qualifications; (d) machinery standards, dose limitations, quality control procedures, and the importance of routine evaluation of clinical images and the imaging system; and (e) the communication of results to patients.

The development of these clinical practice guidelines underscores the importance of factors beyond image quality that contribute to a high-quality examination. Among the most important of these factors is communication with patients and referring physicians.

Many studies have demonstrated that clinicians often fail to communicate mammography results to patients. In part, this pattern has been influenced by a tradition of “no news is good news,” but there also is evidence of a failure to communicate abnormal findings. The panel strongly recommended that all women, regardless of whether their mammograms were negative, be informed by the imaging facility of their results. The preferred route suggested was use of a series of standardized letters that stressed subsequent steps, if any, to be taken by the woman, but the panel strongly urged that the method of communication should be tailored to the results of the examination.

For example, the panel firmly discouraged notification of abnormal results initially by mail. Because the advocacy community regarded direct reporting as an important factor in the overall quality assurance of an examination, the requirement for direct reporting was included in the 1998 reauthorization of the MQSA.

In addition to determinants of a high-quality examination, the AHCPR panel addressed the critical issue of assessing outcome data from mammography facilities by use of medical audits. Data (both collected and derived) required for the basic medical audit include (a) the number and type of mammography examinations performed; (b) the recall rate from screening mammography for further evaluation; (c) the PPV of screening mammography, as well as the PPV of patients sent to biopsy for a mammographic abnormality; and (d) the stage of disease at diagnosis and the breast cancer detection rate per 1,000 women screened. A more advanced audit requires linkage to a breast cancer registry, which is not possible in most areas in the United States.

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