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 record review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) and an interview with the laboratory compliance officer (CCO) on September 17, 2024, the laboratory director (LD) failed to review and document PT results. The findings include: 1. A review of the laboratory's API records for 2022 Event 3 revealed the laboratory received a score of 80% Core Chemistry (Neonatal Bilirubin). The LD failed to complete and document the review and