Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) documentation from 2022 through 2025, and an interview with the office manager on June 4, 2026, it was determined that the laboratory failed to verify the accuracy of tests not included in Subpart I at least twice annually, as required by 42 CFR 493.1236(c). The findings include: 1. The surveyors reviewed the laboratory's proficiency testing documentation and found that one out of three testing personnel performing Mycology and Parasitology testing had no documentation for the years 2022, 2023, 2024, and 2025. 2. During an interview on June 4, 2026, the office manager confirmed that Testing Personnel 3 had no accuracy verification (alternative assessment) documentation for PPM KOH preparations, scabies microscopic examinations, and DTM testing for 2022-2025. 3. There was no