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CLIA regulations require that all laboratories retain certain records for a designated period of time, generally two years. It is the laboratory's responsibility to make copies of all results that are submitted to the PT provider.
The following documents should be retained in your PT records files for at least two years:
- The attestation statement, which is found on the front cover of the test kit packet. The statement should be completed with the signature of both the medical director and the testing personnel, as well as the date that the testing was performed. This signed attestation statement should be retained in your PT records files.
- All submitted results and the PT evaluations for each testing event should be kept on file in your PT records.
- Any other PT-related forms and documentation of any special problems or circumstances relating to each PT event should also be kept in the PT records.
- For any PT performance failure, results of investigation and any corrective action should be documented and retained with the records pertaining to that event.