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 histopathology accuracy records review, lack of documentation, and interivew with the office manager, the laboratory failed to verify histopathology test accuracy at least twice annually for 2 of 2 years reviewed, (2019 and 2020). The laboratory performed approximately 7800 histopathology biopsy diagnostic tests per year. Findings include: 1. The laboratory failed to perform test accuracy verification twice annually in 2019 and 2020. 2. In an interview conducted on 01/14/2021 at approximately 4:00 P.M. Staff confirmed the laboratory failed to document they performed a second accuracy verification in 2019 and 2020. 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 --