Summary:
Summary Statement of Deficiencies D0000 A CLIA initial survey was conducted for the Vivaskin Dermatology and Aesthetics, PLLC laboratory on 02/13/2026 pursuant to the Clinical Laboratory Improvement Act (CLIA) of 1988 and CLIA regulations at 42 CFR CFR 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 MOHS record review and staff interview with testing personnel (TP1) the laboratory failed to verify at least twice annually the accuracy of MOHS testing in the specialty of Histopathology. Findings include: 1. Record review on 02/13/2026 of the laboratory's MOHS Procedure manual revealed: a. The MOHS procedure manual was reviewed annually by the laboratory director (LD) in January of 2025 and February of 2026. b. The laboratory policy for pathology case review states "3 cases every 6 months" will be sent out for second review. 2. Record review of the MOHS surgeon case review records from January 2025 to date revealed: a. No cases were sent out for review in the year 2025. b. A case review sheet dated 2/ /2026 with three case numbers on it and no other information. 3. Staff interview with TP1 on 2/13/2026 at 11:00 AM confirmed the above findings. TP1 stated "We just sent slides out for review for the first time this month." 4. The laboratory runs 172 Histopathology tests annually. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of