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: Based on review of 2021, 2022, and 2023 API (American Proficiency Institute) proficiency testing records and interview with TP (testing personnel) #1 on 11/30/23, the laboratory failed to evaluate ungraded and unacceptable proficiency testing results for 3 of 8 hematology test events reviewed. Findings: Review of 2021, 2022, and 2023 API proficiency testing records revealed the laboratory failed to evaluate ungraded and unacceptable proficiency testing results on the following test events to ensure