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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Policy for Retention of MQSA Inspection Test Films

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Note:

The following policy applies only to test films exposed by MQSA inspectors during MQSA inspections. The retention of mammographic films and quality control test films by facilities is covered in separate policies.

Issue:

During a routine MQSA inspection, films are produced while performing different tests, including phantom image evaluation, collimation and compression paddle alignment, darkroom fog, and STEP. These films are evidence of a facility's performance during the inspection, as are copies of QC records and the data entered into the inspection software. For this reason, films should be retained as a record of the inspection findings by State program offices, FDA District Offices, or Regional Offices. However, films present a bigger storage problem than paper records or data recorded in a computer. Copies of paper records are not always made during an inspection, except when problems are found, but films are always produced.

To address this problem, the following FDA policy will apply to the handling and retention of inspection films. Should the following guidance present a problem for a State, the State should contact their Regional Radiological Health Representative (RRHR) or their designated contact in the FDA District Office.

Policy:

Inspection data are routinely obtained from test films taken during an MQSA inspection and are recorded electronically in the MPRIS inspection software. Radiographic images on film, as well as fog and STEP films produced during an inspection, should be identified with the facility name, facility ID number (or inspection ID number), and the inspection date. Additional relevant information (e.g., technique factors used to produce the phantom image film, equipment or room identification for multiple equipment facilities) should be recorded, as appropriate. The identification may be via paper sticker, handwritten, electronic imprint, or other permanent means.

Inspection films will be maintained for the following time:

a) Films documenting a Level 1 noncompliance shall be maintained until the noncompliance is documented as being resolved by a subsequent inspection, plus 2 years.

 NOTE: For phantom image test films, both films (the first phantom image and the backup phantom image) should be maintained.

b) Films documenting Level 2 and Level 3 noncompliances should be maintained until all related noncompliances are documented as being resolved by a subsequent inspection, or 1 year; whichever is longer.

c) All other films (for inspections with no adverse findings) should be maintained for a minimum of 1 year so that they are available for an audit by an MQSA Auditor.