What are the MQSA requirements for a medical audit and outcome analysis recordkeeping system?

Each facility must have a system to track positive mammograms and a process to correlate the findings with biopsy results. Positive mammograms are those with final assessment categories of "Suspicious" or "Highly suggestive of malignancy." The basic elements of a mammography medical audit system are: (1) a definition of positive mammograms requiring follow-up, (2) a method to follow-up positive mammograms, (3) a system to attempt to collect pathology results for all biopsies performed, (4) methods to correlate pathology results with the final assessment category indicated by the interpreting physicians, (5) a method to include any cases of breast cancer among patients imaged at the facility that subsequently became known to the facility, and (6) review of medical outcomes audit data for the aggregate of interpreting physicians as well as each individual interpreting physician at least once every 12 months. MQSA leaves it up to each facility to develop or use a tracking system that works best for them. This system must include a set of procedures to track mammograms, determine whether biopsies were done on the patient, determine (at a minimum) whether the biopsy specimen was benign or malignant, and report this information back to the interpreting physician. The system may be manual or computerized. An adequate follow-up system is one that has potential to obtain pathology information on all patients with positive mammograms. If a facility enters all positive mammograms into a log, but does not gather pathology information of all these patients, the facility is said to have a mechanism of tracking positive mammograms but not an adequate follow-up system. The system can be shared with other facilities. It can be part of the system of a state, university, private company, or other institution that tracks results. Shared systems are allowed as long as the feedback to each facility is provided to the interpreting physician so that he/she can judge the accuracy of the interpretation.