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 a review of the laboratory ' s proficiency testing (PT) records, and an interview with the laboratory's office manager (not listed on CMS-209 form), the laboratory failed to evaluate and document the evaluation of PT results received from the PT provider, since the laboratory ' s last survey on 02/15/2022. The laboratory performs approximately 2,124,000 tests annually. Findings include: 1. A review of the laboratory's PT records showed that no evaluation or documentation of PT results review were recorded when the laboratory received a score of less than 100% for an analyte. 2. An interview with the laboratory's office manager (not on CMS-209 form) on 06/02/2024 at approximately 4:00 P.M. confirmed that the laboratory did not document any evaluation or