All steps in the PT process, from sample arrival through all follow-up action(s), must be traceable with well-prepared documentation. The laboratory must retain records of all primary data from PT events. Retention of these documents is important for follow up and corrective action. Data to be retained includes but is not limited to:
- QC results
- Lot numbers and expiration dates of reagents and kits
- Calibration data
- Instrument printouts, worksheets, logs, and recording tools
- All images (eg, photographs, slides, scanned copies)
- Records of communication with PT providers
- Copy or originals of the PT results on the test result form or electronic submissions
- Attestation statement signed by laboratory director or designee and all testing personnel for the PT event
- Final results
- Review of the evaluation report received from the PT program
- Corrective action and investigation records (if applicable)
All PT records must be retained for a minimum of two years and the time periods specified by regulatory and accreditation requirements per analyte. These records may be reviewed by the surveyor at the next survey or accreditation visit.
Communication and testing personnel staff review of PT performance is required since the results provide information on the laboratory’s performance. Communicating PT results provides training and information on interpretation and understanding of PT results and trends. PT data and samples following submission deadline can be incorporated into the laboratory competency assessment, training, and continuing education.