Summary:
Summary Statement of Deficiencies D0000 An announced initial CLIA survey was conducted at Cutisco Dermatology on July 8, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Cutisco Dermatology was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies are as follows: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a lab tour, review of policies, lack of documentation and interviews, the laboratory failed to document initial validation studies for the MOHS equipment prior to patient testing on 2/11/26. Findings include: 1. During an initial lab tour at 9:05am on 7/08/26, a stain line, cryostat and microscope were noted to be in-use for patient testing. 2. Review of the Mohs Procedure manual revealed an approved policy titled "Initial Validation for Equipment and Staining Accuracy" which included the statement, "Prior to initiating patient testing, a comprehensive validation of all critical Mohs laboratory equipment and processes must be completed and documented in accordance with CLIA regulations." The policy included validation of the cryostat, microscope, auto-stainer, workflow and process. 3. In an interview with the laboratory director/Mohs surgeon at 10:50am on 7/8/26, the director stated that the validation of the equipment was performed but not documented. The director revealed that the equipment validation was performed in the room the equipment was initially set up in but was not repeated after the move to current room. 4. The laboratory documentation provided lacked initial equipment validation data. 5. In an interview with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory director/Mohs surgeon at 11:40am on 7/8/26, it was confirmed that the validation studies were not documented. -- 2 of 2 --