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 review of the Histopathology peer review records and interview with the Laboratory Director (LD), the laboratory failed to verify twice annually the accuracy of the Histopathology Slide examined by 3 of 3 Testing Personnel (TP) in 2020 and 2021. Findings Include: 1. According to the laboratory's Histopathology peer review policy "At least annually, ten cases are selected for peer review". 2. A review of Histopathology peer review records revealed that the laboratory performed verification of accuracy for the Histopathology slides examined by 3 of 3 testing personnel (CMS 209 personnel #1, #2, and #3) once in 2020 and 2021. Verification was not performed twice a year as required. 3. The LD confirmed the above findings during an interview on 08/31/2022 at 10:25 AM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of Histopathology peer review records and interview with the Laboratory Director (LD), the laboratory failed to document the verification activities of the Histopathology Slide examined by 3 of 3 Testing Personnel in 2020 and 2021. Findings include: 1. Review of the Histopathology Slide peer review records revealed that the laboratory failed to provide documentation of verification activities for the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Histopathology Slide peer review in 2020 and 2021 for TP #1, #2, and #3. 2. The document provided by the laboratory only had 'S' written on it. 3. Interview with the Director on 08/31/2022 at 10:40 AM confirmed that the S means Satisfactory, and the verification activities was not documented in detail. -- 2 of 2 --