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U.S. Department of Health and Human Services

Radiation-Emitting Products

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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?

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Digitization and storage of paper QC records, MEE and annual physics survey reports, and personnel documentation is acceptable if the following conditions are met:

  1. The digitized data is easily accessible for review by the inspector during MQSA inspections. Failure to have records available at the time of inspection may result in a citation.
  2. The digitized record needs to look like the original paper record, including any handwritten signatures or annotations that may be on the original record.
  3. The facility has the capability of printing a hardcopy from the digitized records. While this will not generally be necessary, the facility must retain this capability for those cases where the inspector needs to take a hardcopy for further evaluation or to verify or document a noncompliance.
  4. The facility maintains the original paper charts and records of QC tests performed by the radiologic technologist. These original paper QC records must be maintained for the time frame required by the regulations.
  5. For all other digitized records, the digitized data must be maintained for the time frame required by the regulations.

Note:

  1. Records that require, but lack adequate identification of who performed the test, survey, etc., are not acceptable.
  2. Some mammography units and QC test measurement devices are automated and electronically store the QC test data. In addition, some facilities may record their QC data on computer, rather than using handwritten charts or tables. In these cases, the facility may maintain either the electronic data or a hardcopy printout of the data. In such cases, conditions 1, 3, and 5 above apply.
  3. State laws may impose more stringent requirements for the retention of these records. A facility may want to check with the State regarding its requirements.

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