What if the laboratory continues to provide mammography calibration services during these 60 days, but then is informed that it has failed the proficiency test. Will the physicists who had their instruments calibrated during that period have to have them recalibrated? Will they have to resurvey any facilities that they might have surveyed during that period?
Yes to both questions, but only in a worst case scenario. FDA believes that this combination of events will occur very rarely. If it does occur, the situation will be reviewed on a case by case basis by FDA to determine what actions are needed to protect the public health. If the magnitude of the test failure is small, indicating that the error that might be introduced into the calibration and thus into the survey results is small, it may be sufficient to alert the physicist to incorporate this error into his/her determinations of whether the dose regulations were met by the facility. The larger the magnitude of the failure, the more extensive will be the corrective actions. In the worst cases, a new calibration and new surveys may be requested or required by the corrective action plan.