Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. 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 laboratory twice annual accuracy assessment documentation, and confirmed in interview, the laboratory failed to perform twice annual accuracy assessments in dermatopathology for two of two occurrences in 2024. Findings included: 1. Review of laboratory, "Quality Assurance Review" documentation in 2024, revealed the laboratory failed to perform twice annual accuracy assessments in dermatopathology for two of two occurrences needed in 2024. The laboratory was asked to provide the two of two assessments performed in 2024, and none were provided. 2. In an interview on 08/20/2025 at 10:20 AM in the laboratory office, the sales manager for the facility confirmed the laboratory failed to perform twice annual accuracy assessments for two of two occurrences in 2024. 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 --