Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Premier Dermatology, PC (Winchester) on April 4, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, quality control (QC) records, patient logs, and interview, the laboratory failed to document daily Hematoxylin and Eosin (H&E) stain acceptability for two (2) days with twenty-two (22) patient Mohs slides stained/processed/evaluated during the twenty-one (21) months reviewed from June 2023 until the date of the survey on April 4, 2025 The findings include: 1. Review of the laboratory's Quality Control procedure revealed that a control slide is to be made and evaluated each day a frozen section is prepared. 2. Review of the QC records from June 2023 to April 4, 2025 revealed a lack of H&E control slide documented for the following 2 dates: 05/09/2024 and 09/25/2024. 3. Review of the laboratory's Mohs patient logs revealed the following number of patient Mohs slides stained/ processed/evaluated on the 2 days lacking QC slide documentation: 05/09/2024 - 12 patient slides, 09/25/2024 - 10 patient slides. A total of 22 patients slides. 4. In an exit interview with the Laboratory Director and Clinic Manager on April 4, 2025 at 10:50 AM, the above findings were confirmed. 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 --