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 laboratory verification of accuracy records and interview with histotechnician 7/15/21, the laboratory failed to verify the accuracy of the Mohs testing and the Melanoma antigen recognized by T cells (MART-1) testing at least twice annually. 1. The laboratory failed to verify the accuracy of the Mohs testing twice annually in 2020. Findings: Review of laboratory verification of accuracy records revealed the laboratory had verified the accuracy of the Mohs testing in February of 2020, but failed to perform a verification of accuracy twice annually as required. Interview with histotechnician at approximately 10:30 a.m. confirmed the laboratory had failed to perform a verification of accuracy for the Mohs testing at least twice in 2020. She stated they thought they would only have to do a verification of accuracy once a year. 2. The laboratory failed to verify the accuracy of the MART-1 testing twice annually in 2020. Findings: Review of laboratory verification of accuracy records revealed no documentation the laboratory had verified the accuracy of the MART-1 testing twice annually in 2020. Interview with histotechnician at approximately 10:30 a.m. confirmed the laboratory had failed to perform a verification of accuracy for the MART-1 testing twice annually in 2020. She stated they did not realize they would have to perform a verification of accuracy for the MART-1 testing. 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 --