Summary:
Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 08/21/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of instructions from American Proficiency Institute (API), the laboratory's proficiency testing results from 2024 to 2025, CMS 116, and confirmed in an interview, the laboratory failed to have documentation of self-evaluation of "Not Graded" results for 5 of 5 events reviewed. The findings were: 1. Review of the instructions from American Proficiency Institute (API) revealed "Laboratories are responsible for documenting and performing