Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Luminary Dermatology PA on 03/03/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 record review and staff interview, the laboratory failed to verify the accuracy twice annually, for two of two years reviewed for slide interpretation for the subspecialty of Histopathology. Findings include: 1. The laboratory's Quality Assurance/Proficiency Testing forms were reviewed for 2024 and 2025. The forms were used to document twice annual verification of testing for slide interpretation of hematoxylin and eosin stained human tissue. Proficiency Testing (Peer review) was completed 12/19/2024. No other documention was present for 2024 or 2025. 2. Interview with the Laboratory Director, via electronic communication on 03/03/2026 at 9:38 p.m. confirmed peer review was only completed once in 2024 and was not completed for 2025. 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 --