Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records, review of laboratory policies and interview with testing personnel (TP #1) 10/06/25, the laboratory failed to review PT results that were scored as "not graded" by API. Findings: Review of 2023 and 2024 API PT records revealed the 2024 API Chemistry - Core - 1st event had three PT scores of "not graded" by API for Bilirubin,Total (TBIL); Samples CH-02, CH-03 and CH-05. There was no documentation the laboratory had reviewed the "not graded" PT scores to determine if the laboratory PT results were within the API expected result range. Review of laboratory policies revealed no policy for