Summary:
Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the alternate proficiency testing (PT) policy and PT sample evaluation and interview with the technical supervisor (TS), the laboratory failed to document the procedure followed, the evaluation criteria followed, and the evaluation results for alternate PT performed in April 2021. Findings: 1. The policy titled "Alternate Proficiency Assessment" was reviewed. 2. The "Procedure" section of the document stated that for analytes that are not available from approved PT programs, the laboratory will perform split-sample testing with another accredited laboratory every 6 months. This section further stated that the laboratory will "develop procedures for evaluations of proficiency results including instructions for all relevant stages of the testing event (Pre-analytic, analytic, and post-analytic), reporting format, answer choices, and definition of the "correct" result. The range of acceptability for each quantitative/qualitative analyte, or parameter should be determined prior to initiation of the testing procedure ...Investigate unacceptable performance and initiate