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Extra resources for Improving Breast Imaging Quality Standards

Sample text

Rationale: A) Several onsite inspection tests are redundant and have exceptionally low rates of failure; quality would not be adversely affected by their elimination because these parameters are monitored regularly. B) Until 2003, FDA required facilities to cease mammography in such cases. In 2003, FDA informed accrediting bodies that they cannot require facilities to cease mammography if their MQSA certificate is still valid. C) FDA has received a number of complaints from patients who were not informed when their facility closed and as a result were unable or unsure of how to access their mammography records.

The 1998 Act reflected several changes from the Act of 1992. For example, facilities were required to provide their patients with a written letter summarizing the results of the mammogram in lay terms. In addition, the original mammography films were to be provided to the patient on request. Currently, nearly 70 percent of facilities pass inspection with no violations, and generally only about 2 percent of issued citations are for the most serious level of violations. GAO and FDA have both concluded that MQSA has significantly improved the quality of mammography over the past decade.

Furthermore, FDA data suggest that the number of interpreting physicians is decreasing. However, no systematic data collection and analysis has been undertaken, making it difficult to assess the current capacity for breast cancer screening and diagnostic services, and even more difficult to plan for the future. Early detection of occult breast cancer is a key element for reducing breast cancer mortality; it is therefore crucial to accurately monitor the capacity of mammography services, as indicated in Recommendation 7, and to ensure adequate access for women.

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