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 accuracy verification documentation for the microscopic interpretation of frozen excision specimens and Mohs specimens and interview with the facility personnel on 5/27/26 at 8:00 AM, the laboratory failed to verify the accuracy of frozen excision and Mohs testing performed under the subspecialty of Histopathology at least twice annually during 2025. Findings include: 1. This laboratory performs testing in conjunction with Mohs and frozen excisions under the subspecialty of Histopathology with an annual test volume of 1,200. Testing began on 8/8/25. 2. Accuracy verification documentation reviewed during the survey indicated the laboratory failed to verify the accuracy of the microscopic interpretation of frozen excision specimens and Mohs specimens at least twice annually during 2025. 3. The facility personnel interviewed on 5/27/26 at 8:00 AM confirmed the laboratory failed to verify the accuracy of Histopathology testing at least twice annually during 2025. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Mohs test procedure on 5/27/26 at 8:25 AM and interview with the facility personnel, the laboratory director failed to approve, sign and date the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Mohs test procedure before use. Findings include: 1. The laboratory began testing on 8 /8/25 and performs the microscopic interpretation of Mohs specimens and frozen excisions under the subspecialty of Histopathology, with a reported annual test volume of 1,500. 2. A review of the Mohs test procedure on 5/27/26 failed to include the approval, signature and date of the current laboratory director prior to patient testing on 8/8/25. 3. The facility personnel interviewed on 5/27/26 at 8:25 AM acknowledged that the Mohs Section Procedure was not approved, signed and dated by the current laboratory director before use. -- 2 of 2 --