Radiation-Emitting Products

How long must we maintain the actual films from the repeat analysis?

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Because of the various types of films that may be included in a repeat/reject analysis and the various ways that facilities determine which films go into the analysis, the answer depends on the specifics of the situation. The following points cover the major possibilities.

  1. Films that are included in the repeat/reject analysis but were considered by the interpreting physician (IP) to be necessary to interpret the study are considered part of the original mammogram and MUST be maintained for 5/10 years as required in the regulations and the law. 21 C.F.R. 900.12(c)(4)(i). For example, suppose a Rt. MLO film was sub-optimal but contained diagnostic information that was used by the IP to interpret the study. If the IP wanted that film included in the repeat/reject analysis, he or she could do so, but because this Rt. MLO was necessary for the interpretation, it would have to remain with the rest of the study and MUST be kept for 5/10 years. This would be the case even if the facility had done a second Rt. MLO.
  2. If, however, the Rt. MLO was sub-optimal and was not considered to contain any additional diagnostic information over what the repeat Rt. MLO did, then the first Rt. MLO would not have to be considered necessary to interpret the study. In that case, the first Rt. MLO should be included in the repeat/reject analysis but would NOT have to be kept for 5/10 years. Once it was included in the repeat/reject analysis, the actual film could be discarded.
  3. QC films that are included as part of the analysis (e.g., daily processor and weekly phantom), are still governed by applicable regulation and those films that were a necessary part of the QC test should be kept according to the guidance regarding these films (last 30 days for the daily processor QC and the last 12 weeks for the weekly phantom QC).
  4. The written records of the repeat/reject analysis (not necessarily the actual films) MUST be kept as required by the regulations "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." 21 C.F.R. 900.12(d)(2).

Repeat Analysis and Fixer Retention - Quarterly Equipment Quality Control Tests

Page Last Updated: 07/18/2014
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