As defined by the laboratory PT plan, all PT results must be reviewed within 30 days by appropriate personnel, including the laboratory director or designee. As per regulations, systematic reviews of PT reports by the testing personnel and laboratory director or designee will include attention to areas of testing that did not perform as expected for a single event or as indicated by subtle shifts and trends over time. Any aberrant results may reflect factors that could affect patient test results.
The terminology for the final reporting of a single analyte is:
- Acceptable
- Unacceptable
- Unscored/ungraded
The terminology for reporting overall event results is:
- Satisfactory
- Unsatisfactory
Results that are acceptable and scored as 100% are reviewed, signed by the laboratory director or designee and appropriate laboratory staff, and filed as a permanent record. Acceptable results indicate that reported results are close to peer group values and that patient results are accurately reported for acceptable analytes.
Acceptable results scored as <100%, unacceptable, ungraded, or lack of consensus must have a review, evaluation, and corrective action performed, documented, and the documentation retained.
Some PT events are not formally graded for reasons including:
- Intended as an educational challenge
- Lack of participant or referee consensus
- Number of enrolled participants is less than ten for a quantitative test or less than five if qualitative
- Sample integrity problem
Unscored/Ungraded results must be evaluated for accuracy by comparison with the evaluation report provided by the proficiency testing provider.
Investigative steps and corrective action must be performed and documented. Root cause analysis should be performed to include all phases of testing. Corrective action should include staff retraining for appropriate procedures and protocols and patient chart review for the time frame surrounding the PT testing until result reporting is complete. Follow-up in the form of audits as part of the quality assessment plan (QAP) will evaluate whether the corrective action was effective. If proven ineffective, additional remedial corrective action must be performed and documented.
