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Policy for Medical Audit


The medical audit general requirements is addressed in MQSA as the following:

21 CFR 900.12(f)(1): General requirements.  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 physicians mammography report.  Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility.  In addition, any cases of breast cancer among patients imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy. 

Question 1: 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.

Question 4: What records for medical audit and outcome analysis will the MQSA inspector want to review during the annual inspection?

The inspector will ask a facility to document answers to the following questions:

  1. Are ALL positive mammograms entered in the system?

  2. Are biopsy results present or was there a documented attempt to obtain them?

  3. Is there a designated audit interpreting physician? (description follows)

  4. Is the analysis done annually?

  5. Is the analysis done separately for each individual?

  6. Is the analysis done for the facility as a whole?

900.12(f)(3): Audit interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results and for notifying other interpreting physicians of their results and the facility aggregate results. If followup actions are taken, the audit interpreting physician shall also be responsible for documenting the nature of the followup.

Question 1: Does the FDA require that the interpreting physician who reviews the medical outcomes audit data also be responsible for overall facility quality assurance?

No. The regulations do not require that the audit and lead interpreting physicians be the same person.

Question 4: Must the lead and audit physician(s) be listed as interpreting physician(s) at the facility?

Yes. The lead and audit physician(s) must be qualified interpreting physicians and must also be listed as interpreting physician(s) at the facility so that their qualifications can be evaluated at the time of the inspection. 21 C.F.R. 900.12(f)(3), 900.2(u). This does not require that the physician(s) actually interpret mammographic examinations at that specific facility.



The inspectors will be looking for a medical audit policy documenting how the medical audit will be performed.  We will be specifically looking for the mechanism of tracking patients assessed with a “Suspicious”, “Highly Suggested of Malignance”, or recommended for biopsy report.  The documentation should follow the patient from mammogram to biopsy, concluding with how the biopsy results will be documented.  In the event that a patient does not have a biopsy or biopsy results are not obtainable, the facility should document what is done in those instances.


You may ask why the inspector evaluates audits that are two years old.  The reason is the FDA allows one full year to collect data and another full year to analyze the data collected.


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