All final PT results must be maintained for a minimum of two years. The results are reviewed within 30 days of receipt by the laboratory director or designee (document review with signatures and date). As per good laboratory practice, all results should also be reviewed by staff members and the review documented.
Corrective action must be completed for PT scored with the:
- Any value less than 100%
- Any failed event or analyte
- Any result documented as unscored or lack of consensus
The overall scoring will read "acceptable" or "unacceptable." An "acceptable" score does not imply that no corrective action is required. Analytes scoring 80% or more will not trigger the "unacceptable" result and each analyte must be assessed and corrective action completed, if required.
Corrective action is performed as per the specific event/analyte or result noted. Any or all of the following steps may be utilized, as appropriate, depending on the specific situation:
- Review of all clerical documentation to include, but not limited to:
- Transcription errors of results onto manually submitted worksheets or into the online system
- Incorrect test method chosen
- Incorrect units used for submission
- Repeat testing on original samples, if samples were retained and remain intact, including:
- Comparison of repeat testing to correct result ranges
- Comparison to peer results posted by a commercial provider
- Review of possible technical issues, including:
- Out-of-range quality control on the day of testing
- Out-of-date calibration on the day of testing
- Maintenance not being performed as per schedule
- Other performance issues on the day of testing or the surrounding time frame
- Unscored events: Review to include a comparison of obtained results to the expected values and a comparison to the expected results. Document review, findings, and further corrective action as determined by the review.
- Lack of consensus: Review results obtained as compared to expected results. Document review, findings, and further corrective action as determined by the review.
- Staff retraining and review. Staff should review all of the results for all events to understand events and results. Also retrain staff, as needed, and document the review and retraining.
- Review of patient testing to determine that no patients were affected.
- Remedial or off-schedule events may be ordered and completed if two consecutive or two out of three failures have occurred.
Document all corrective actions performed and signed by the laboratory director.
