900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including followup on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician’s 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 followup on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.
Approved Alternative Standard:
- What are the MQSA requirements for a medical audit and outcome analysis recordkeeping system?
- What criteria will FDA use to determine that facilities meet the MQSA requirements for the medical outcomes audit program?
- What statistical outcome data and biopsy results should facilities collect?
- What records for medical audit and outcome analysis will the MQSA inspector want to review during the annual inspection?
- Which mammograms must be included in the medical outcomes audit system?
- How often should follow-up on surgical and/or pathology results be conducted for patients with positive mammograms?
- Will the FDA maintain the confidentiality of any patient's surgical and/or pathology results which may be seen during an inspection?
- Must facilities differentiate screening from diagnostic studies when analyzing their medical outcomes audit data?
- Our radiology practice consists of several separately certified mammographic facilities. Is it permissible to combine our medical outcomes audit for all our facilities, or must it be broken down for each facility?
- Must a facility establish a "system" to identify their false negative examinations?
- If a facility issues "addendum" or "comparison" reports, do these new reports have to be included in the medical audit?
- An interpreting physician has left our facility since completing our last medical audit. Does he/she still have to be included in this year's medical audit?
- We used a locum tenens interpreting physician during the year, but only for a short time. Does he/she still have to be included in our medical audit?
- How should "false negatives" be included in the medical audit?
- If a facility becomes aware of breast cancer in a patient whose mammogram was performed more than one year ago, do they still have to review that mammogram and include it in the audit?
- Are medical outcomes audit data collected during facility inspections used in a national database?