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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP) the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology/Coagulation tests performed with the American Proficiency Institute (API), for 2nd event 2022. The findings include: 1. The laboratory received an unacceptable score for Granulocytes sample HEM-06. 2. There was no documented evidence that the laboratory documented