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 the surveyor's review of Proficiency Testing (PT) records, random selection of fourteen (14) patient reports, and interviews with laboratory director on July 29, 2026, it was determined that the testing personnel did not verify the accuracy of high complexity Histopathology and moderate complexity Mycology tests at least twice annually for the years 2023, 2024, and 2025. The findings included: 1. The laboratory conducted Histopathology testing for Mohs Micrographic Surgery and Mycology using Potassium Hydroxide (KOH) testing, which are not listed in subpart I of the 42 CFR part 493. For test procedures not listed in subpart I, the laboratory must verify the accuracy of the test procedure twice annually. The laboratory director performed the KOH testing, and the Mohs surgeon performed histopathology testing. 2. Laboratory records indicate that peer review was conducted up to 02/09/2023, marking the first event of 2023, and discontinued following this date. 3. On July 29, 2026, at approximately 11:30 a.m., the laboratory director confirmed that the laboratory did not maintain records for accuracy verification of tests at least twice annually during 2023, 2024, and 2025. 4. The laboratory's testing declaration form, signed by the laboratory director on July 27, 2026, stated that the laboratory performed approximately 140 tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --