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 Routine Quality Assurance (QA) for Pathologist documentation, the Quality Management Plan, and an interview with the Laboratory Director, the Pathologists failed to verify the accuracy of diagnoses bi-annually as per CLIA requirements. This was noted for two of two Pathologists for the 2024 review period. The findings include: 1. A review of the Routine QA for Pathologist documentation revealed no evidence of 2024 bi-annual review for both Pathologists. 2. A further review of the Quality Management Plan revealed, "Additional accuracy of diagnosis will be assessed in biannual retrospective review." 3. During an interview on 1/27/2026 at 10:32 AM, the Laboratory Director confirmed the above findings. 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 --