Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a review of the laboratory's American Proficiency Institute (API) instructions, proficiency testing (PT) records from 2025, and staff interview, the laboratory failed to document a self-grade of chemistry analytes not evaluated or scored by the PT company one of three events in 2025 (Event 3). Findings included: 1 Review of the laboratory's policy "Proficiency Testing" stated: "Upon receipt of proficiency test results the following steps are taken: 1. The Laboratory Director or designee reviews the response. a. Results that were not graded must be addressed with documentation." 2. Review of API performance evaluation instructions revealed: "The American Proficiency Institute evaluation reports consist of four parts: Report Cover, Performance Summary, Comparative Evaluation, and Participant Data Summary. The Performance Summary and Comparative Evaluation are enclosed, and the Participant Data Summary is available on our website. Click on 'Participant Data Summaries' on the left side of the screen, choose a Test Event, and select an analyte and peer group to view the statistics. Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing