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 lack of accuracy verification documentation for Mohs testing and Frozen Biopsy testing and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2022 and 2023. Findings include: 1. The laboratory performs Frozen Biopsy testing and dermatopathology testing in conjunction with the Mohs procedure under the subspecialty of Histopathology with an annual test volume of 755. The laboratory began performing patient testing on 7/6/22. 2. No documentation was presented for review to indicate the laboratory verified the accuracy of dermatopathology testing (performed in conjunction with the Mohs procedure) at least twice annually during 2022 and 2023. 3. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2022 and 2023. 4. The facility personnel interviewed on 12/13/24 at 9: 00 AM confirmed the laboratory failed to verify the accuracy of Mohs testing and Frozen Biopsy testing at least twice annually during 2022 and 2023. 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 --