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 policy, lack of documentation and interview with Testing Personnel #2 (TP#2), the laboratory failed to verify at least twice annually the accuracy of microscopic histopathology examinations performed for 2 of 2 years in 2023 and 2024. Findings: 1. The laboratory's Proficiency Testing policy states "semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our for a microscopic examination by a Board Certified Pathologist." 2. On the day of survey, 02/19/2025 at 10:00am, the laboratory failed to provide documentation for the verification of accuracy performed at least twice annually for microscopic histopathology examinations performed in 2023 and 2024. 3. The laboratory performed 1550 microscopic histopathology examinations in 2023. 4. The laboratory performed 1204 microscopic histopathology examinations in 2024. 5. TP#2 confirmed the above findings on 02/19/2025 at 10:09 am. 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 --