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 lack of accuracy verification documentation for review and interview with the laboratory director, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2022 and 2023. Findings include: 1. The laboratory performs the following histopathology stains on patient specimens: Hematoxylin and Eosin (H&E), Heliobacter Pylori (H. Pylori), and Periodic-Acid Schiff (PAS). 2. No documentation was presented for review during the survey conducted on 8/6/2024 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of histopathology specimens at least twice annually during 2022 and 2023. 3. The laboratory director interviewed on 8/6/2024 at 9:45 AM confirmed that the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2022 and 2023. 4. The laboratory's approximate annual test volume under the subspecialty of Histopathology is 50,672. 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 --