Radiation-Emitting Products

Quality Assurance Records

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Citation: 

900.12(d)(2): Quality assurance records. The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection, and employee qualifications to meet assigned quality assurance tasks, are properly maintained and updated. These quality control records shall be kept for each test specified in paragraphs (e) and (f) of this section until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.

Questions:
  1. What quality assurance (QA) records must be maintained and for how long?
  2. What should facilities do with QC records for equipment that has been replaced or retired, but was in use after the previous MQSA inspection?
  3. How long do "Personnel Responsibilities," "Technique Charts," and "Procedures for Safety and Protection of Patients & Personnel" records have to be maintained?
  4. Is it acceptable for a technique chart to simply state that the facility is using the unit in its fully automatic AEC mode (e.g., BACE, OPDOSE, AUTO FILTER, AOP, or similar modes) for all routine examinations?
  5. How should facilities retain QA/QC records for equipment (film processors and/or mammographic units) that were in use for a period of time between the previous MQSA inspection and the current inspection, and have since been retired from use and replaced with new equipment?
  6. Must the QC records indicate the actual numerical result of the QC test (e.g. compression, fixer retention) or just whether it passes or fails?
  7. Under the final regulations, must facilities chart the data for quality control tests, such as processor sensitometry or phantom image evaluation?
  8. How long must we maintain our quality assurance records for our FFDM unit?
  9. Can a facility digitize (scan) its paper QC records, MEE and annual physics survey reports, and personnel documentation, keep the digital data in a retrievable format, and then discard the original paper records?

 

Page Last Updated: 08/08/2014
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