Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Dermatology and Skin Cancer Center on April 23, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Virginia Dermatology and Skin Cancer Center was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiency is as follows: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a laboratory tour, procedure and document reviews, and interview, the laboratory failed to ensure the Acid Wash and Eosin dye for Hematoxylin and Eosin (H&E) staining of Mohs micrographic surgery slides were within manufacturer's stated expiration date during 3 of 15 months reviewed with forty-three (43) patients tested. (Review timeframe January 1, 2025 - March 30, 2026.) Findings include: 1. During the initial lab tour at 9:05 am, it was noted that the Thermo Scientific Linistain (SN LS1685A1308) linear stainer was utilized for staining MOHS surgery patient slides. 2. Review of the laboratory's Solution Log for calendar year 2025 through March 30, 2026 revealed the following chemical lots in-use beyond their expiration (exp) dates: Acid Wash, lot # 150442, exp date 5/31/25 (new Acid Wash, lot # 2508322, received 7/10/25); and Eosin, lot # 188534, exp date 12/31/25 (new Eosin, lot # 2519644, received 2/5/26). 3. Review of the MOHS patient logs for the timeframes of 6/01/25 through 7/09/25 and 1/01/26 through 2/4/26 revealed the following testing dates and number of patients tested utilizing expired stain chemicals: 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 -- 6/5/25 - 7 patients, 6/12/25 -9 patients, 6/26/25 - 12 patients, 1/8/26 - 15 patients, a total of forty-three (43) patients. 4. Review of the laboratory's Standard Operating Procedures (SOP) Manual revealed a policy in Section 6. Materials and Equipment whose part B. Storage, Use and Handling contained the following statement: "If chemicals are expired, they are not used and disposed of." 5. The findings above were confirmed in an exit interview at 11:45 am with the primary testing personnel who stated, "stains are changed every 2 months". -- 2 of 2 --