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 documentation and interview with testing personnel #2 (TP), the laboratory failed to ensure that the verification of accuracy for microscopic and macroscopic histopathology examinations performed by 2 of 2 TP were performed at least twice annually, as required for tests not included in subpart I from 04/15/2021 to the date of the survey. Findings include: 1. On the day of the survey, 05/04/2023 at 10: 17 am, the laboratory could not provide documentation that the verification of accuracy for microscopic (Mohs Micrographic surgery slides) and macroscopic (grossing) histopathology examinations was performed at least twice annually from 04 /15/2021 to 05/04/2023. 2. The laboratory performed 8094 histopathology examinations in 2022 (CMS 116 annual volume). 3. TP#2 confirmed the findings above on 05/04/2023 around 11:10 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 --