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 policy, records, and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing in 2024. Findings Include: 1. Review of laboratory policy revealed the policy titled, "Policy on Professional competency", which outlined the policy for bi-annual peer review of histopathology testing performed by the laboratory. The policy indicated the following: "Peer review of 5 randomly selected cases. Performed by BCD #1(board certified dermatopathologist): Semi annually. Record of the above is kept by the laboratory director in the laboratory in a designated folder." 2. Review of laboratory records identified the documents titled "Bi-annual peer review and competency assessment". This document and associated bi-annual peer review was completed for a different laboratory as highlighted in the header of the document. No Bi-annual peer review had been completed for this laboratory in 2024. 3. Interview with LD, on 02-25-2025 at 09:49 am confirmed that the bi-annual peer review was completed for another laboratory that the LD was associated with and that this site had not completed bi-annual peer reviews for 2024 for histopathology. 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 --