Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Base on review of the American Proficiency Institute (API) Proficiency Testing(PT) summary reports, the laboratory failed to review and evaluate the API hematology PT results for second events in 2021. FINDINGS: 1. The API PT summary report was not signed as reviewed and evaluated. 2. Confirmed on an interview with laboratory supervisor on 3/31/2022 approximately 11:00am. 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 the review of laboratory's API PT record second event of year 2021, the laboratory failed to document evaluation and verification activities including review of all unsatisfactory scores and the