Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's documentation of twice annual verification of accuracy (alternative assessment) for 2017and interviews with the technical supervisors and testing personnel, the laboratory failed to verify the accuracy of the Coryne toxAB RT-PCR test twice annually. The findings include: 1. Review of the 2017 alternative assessment documentation for the Coryne toxAB RT-PCR test revealed that the laboratory failed two alternative assessments for 2017. On June 30, 2017, an alternative assessment was completed for the Coryne toxAB RT-PCR test. Test results revealed two out of two positive controls were reported as undetermined (UND) on the alternative assessment report. The alternative assessment report was reviewed and approved by Technical Supervisor #1 (TS1) and Technical Supervisor #2 (TS2). TS1 noted on the alternative assessment report that new panels should be made due to panel samples showing inhibition. On December 21, 2017, the second alternative assessment was completed by Testing Personnel #2 (TP2) using the same panels from the June 30, 2017 alternative assessment. The panel failed and was retested by TP2 on December 22, 2017. Positive controls failed and no