FDA releases new mammo standard

The U.S. Food and Drug Administration (FDA) has approved an alternative standard to the Medical Outcomes Audit requirement, part of the Mammography Quality Standards Act (MQSA).

According to the American College of Radiology (ACR) of Reston, VA, the new alternative standard allows multiple mammography facilities to combine their medical outcomes audits if they meet certain criteria.

The approved alternative states:

  • Each facility 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 [21 CFR 900.12(f)].
  • Each facility 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 [21 CFR 900.12(f)(1)].

The details are posted on the FDA's Web site.

Related Reading

Number of U.S. mammo facilities drops, September 2, 2009

ACR reports statistics on mammo complaints, May 18, 2009

ACR introduces National Mammography Database, May 7, 2009

ACR, ARRS wrap up integration deal, May 5, 2009

ACR weighs in on industry relationships, April 30, 2009

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