Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Vero Beach - Iconic Dermatology on April 22, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 review of the procedure manual, peer review records, and interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain, at least twice annually in 2023 and 2024. Findings: Review of the procedure titled, Quality Assurance Proficiency Testing Program (In - House) stated "every six months we will send slides for review . . . . " Review of the laboratory personnel report, signed and dated by the Laboratory Director on 04/15/2025 showed there were two high complexity testing personnel. Review of the peer review recorded showed peer review for the Laboratory Director (Testing Personnel A) was performed on 2 cases from 2023 on 03/04/2025 and three cases from 2024 performed on 3/13/25. Review of peer review recorded showed the peer review for Testing Personnel B was performed on 2 cases from 2023 on 01/15 /2025 and three cases from 2024 performed on 3/13/25. During an interview on 04/22 /2025 at 2:40 PM, the Laboratory Director acknowledged peer review of the slides was not done twice per year. 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 --