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 policy review, review of the laboratory's peer review records, and interview with the Medical Laboratory Technician (MLT), the laboratory failed to ensure that the verification of accuracy for microscopic examinations for histopathology was performed at least twice annually, as required for tests not included in subpart I for 1 of 1 year in 2025. Findings Include: 1. On the day of the survey, 02/11/2026 at 10:00 am, review of the laboratory's Proficiency Testing policy stated, "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it out for microscopic examination by a Board Certified Dermopathologist." 2. Further review of the laboratory's peer review records revealed the laboratory failed to ensure the verification of accuracy for histopathology slide examinations were performed at least twice annually for 1 of 1 year in 2025. 3. The laboratory performed 4,439 microscopic slide examinations (histopathology) in 2025 (CMS-116, estimated annual volume, dated 01/20/2026). 4. The MLT confirmed the findings above on 02/11/2026 at 10:15 am. 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 --