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 a review of the laboratory policies, patient test records, proficiency testing logs, lack of records, and staff interviews, the laboratory failed to perform twice- annual verification of accuracy for dermatopathology biopsy slide interpretation two of three times in 2024 and 2025, with an estimated annual test volume of 500 patient tests. The findings include: 1. A review of the laboratory policy titled "Proficiency Testing" revealed that "Proficiency testing must be done twice a year, 3-5 specimens each time." The laboratory director noted in the policy that the laboratory "would be resuming challenges in December 2024". 2. A review of the patient test records revealed that patient dermatopathology slide interpretations had been performed as follows: - Patient 11460594 on 12/09/24 - Patient 15802365 on 11/03/25 3. A review of the laboratory verification of accuracy logs titled "Pathologist Quality Control Case Review:" revealed that 10 cases were submitted for 2025 review on 11/01/2025, and 10 cases were submitted for 2026 review on 06/18/2026. 4. There was no documentation of cases submitted for verification of accuracy in December 2024, as stated in the policy, or for a second date in 2025. 5. The laboratory director confirmed the survey findings in an interview on 07/16/2026 at 10:50 a.m. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's twice-annual verification of accuracy reports and staff interview, the laboratory failed to document review of two of two verification of accuracy reports in 2025 and 2026. The findings include: 1. A review of the laboratory's twice-annual verification of accuracy reports revealed no documentation of review after the results were received for the events dated 11/01 /2025 and 06/18/2026. 2. The laboratory director confirmed the survey findings in an interview on 07/16/2026 at 10:50 a.m. -- 2 of 2 --