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 proficiency testing records and interview with the TC (technical consultant) on 2/28/24, the laboratory failed to evaluate ungraded and unacceptable proficiency testing results for 9 of 17 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