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 peer review records, and interview with the histotechnologist (HT), the laboratory failed to ensure that the verification of accuracy for microscopic examinations for histopathology were performed at least twice annually, as required for tests not included in subpart I in 2022. Findings Include: 1. On the day of the survey, 06/09/2023 at 10:30 am, the laboratory could not provide documentation that the verification of accuracy for histopathology slide examinations stained using immunohistochemical stains, special stains, and hematoxylin and eosin (H&E) were performed at least twice annually in 2022. 2. The laboratory performed 11,506 histopathology examinations in 2022 (annual volume listed on form CMS- 116). 3. The HT confirmed the findings above on 06/09/2023 around 12:00 pm. 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 --