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 a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interviews, the laboratory failed to evaluate the complete blood count with differential (CBC w/Diff) PT results for one of four events reviewed in 2025. The findings include: 1. A review of the laboratory's API PT records revealed no documented review of the performance evaluation for the 2025 Hematology/Coagulation Event One for the CBC w/Diff analytes. 2. An interview with Technical Consultants One and Two on 11/13/2025 at 12:15 p.m. confirmed the survey findings. D5781