Radiation-Emitting Products

Retention of Personnel Records

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Citation:

900.12(a)(4) Retention of personnel records. Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors. Records of personnel no longer employed by the facility should not be discarded until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the MQSA personnel requirements.

Discussion:

All interpreting physicians, radiologic technologists, and medical physicists providing mammography services to the facility must meet the personnel qualification requirements for their respective specialty during the time they provide the service.

For inspection purposes, employees who were hired by the facility since the previous inspection (or all employees in the case of a new facility that has not yet had its first annual inspection) and are no longer at the facility at the time of the inspection, will have their qualifications verified only for the beginning date* of their employment by the facility. Records of past employees that were evaluated during the previous inspection but had left the facility since that date will not be routinely evaluated.

*Note: For employees who left the facility and were rehired more than once since the previous inspection (or since the start of certification for new facilities), records of qualifications will be verified for each of the starting dates within the period described above or until a non-compliance with that qualification is discovered.

Following are four examples:

  1. If the previous inspection date is 2/10/96, the current inspection date is 2/18/97, and a locum tenens interpreting physician (Dr. T) provided services at the facility once for the period from 11/25/96 to 12/6/96, the applicable period for the record review for Dr. T would end on 11/25/96, i.e. on the date Dr. T began providing the temporary service (and submitted a copy of his full qualifications to the facility). The qualification records for the period from 11/25/96 to 12/6/96 will not be checked at this inspection but they would be checked for the first day of employment at the next facility that would subsequently employ the services of Dr. T.
  2. Assume that the facility hired Dr. T again for the periods of 12/23-31/96 and 1/28-31/97. In this case, the qualification records for Dr. T would be verified for 11/25/96, 12/23/96 and 1/28/97.
  3. Assume that Dr. P had been a permanent employee at the facility from 11/1/95 until 2/14/97. Her qualifications would be verified for 2/10/96, which is the previous inspection date. None of her records after 2/10/96 would be reviewed during the present inspection.
  4. If Dr. T was hired again by the facility for one week beginning on 2/17/97, his qualifications would be verified for 2/18/97 (the current inspection date), as they would be for permanent employees.

All facilities are obligated to ensure that all employees (permanent and temporary) providing mammography services at their facility meet MQSA qualification requirements. FDA expects temporary employees (and/or the agencies that provide temporary personnel services) to provide the facility with updated records of all their qualifications, including continuing education and continuing experience records (where applicable) in order for the facility to verify their qualifications before employment. FDA expects these individuals to make the appropriate arrangements with each facility regarding the maintenance of their qualification records during the periods they provide services to the facility.

Questions: 
  1. If a facility has personnel who only worked for a week or two and are now no longer with the facility, should the records for these individuals be retained and, if so, for how long?
  2. Do general supervisors of mammography technologists, medical physicists, or interpreting physicians have to meet any requirements under MQSA?
  3. We use the same locum tenens interpreting physician (or "temporary" radiologic technologist) on a recurring basis throughout the year. Do we need to handle the personnel records for this person differently from our "permanent" interpreting physicians (radiologic technologists)? Which records will be reviewed at the time of our next inspection?
Inspector Instructions: 
  1. Answer the personnel qualification questions with “Y, N, or X,” as appropriate for the verification dates defined in the examples above (“X” denotes not applicable).

  2. If at least 24 months have not passed since an interpreting physician met his/her initial qualifications, the answer for the “continuing experience requirement?” question should be “X.”

  3. If at least 24 months have not passed since a radiologic technologist or medical physicist met his/her initial qualifications or on 7/1/01 (whichever is later), the answer for the continuing experience requirement question should be “X.”

  4. Use the same approach as in the second paragraph to answer the “continuing education” question for all three personnel categories (note in this case that the averaging period is 36 months and the first date this becomes applicable is 10/1/97).

 

Page Last Updated: 08/11/2014
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