Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of McLean on July 9, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited 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: A. Based on a review of the "Laboratory Chemical Inventory" log, laboratory tour, policy and procedure manual, patient accession log and interviews, the laboratory failed to ensure the Eosin stain utilized for staining Mohs and biopsy specimens was within the manufacturer's expiration date during twelve (12) of twenty-four (24) months with one-thousand three-hundred and seventy four (1374) patient specimens stained/tested (Review timeframe July 31, 2024 - July 9, 2026). The findings include: 1. A review of the "Laboratory Chemical Inventory" log revealed an expired LabStat Eosin stain (lot number 177398 exp 07/31/2025) documented as in use on 04/04/2025 until the date of the survey on 07/09/2026. There were no other lots of Eosin stains listed as in use on the laboratory's log. 2. During a laboratory tour with the Mohs Tech on July 9, 2026, at 10:30 AM, the surveyor observed a one-gallon container of expired StatLab Eosin stain (lot # 177398 exp 07/31/2025) marked with an open date of 04/04 /2025. No additional containers of Eosin stain were observed. The surveyor inquired with the Mohs Tech about additional lots of Eosin stain. The Mohs Tech provided no additional containers of Eosin stain for review. 3. Review of the laboratory's patient logs from August 1, 2025 to July 9, 2026 (212 surgery dates), revealed 1374 patient specimens were stained utilizing the expired Eosin stain. 4. A review of 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's policy and procedure manual revealed a policy, "Reagent Storage, Use and Handling"with the statement, "Do not use reagents after expiration date." 5. In an exit interview with the Mohs tech and licensed practical nurse on July 9, 2026, at 11: 00 AM, the above findings were confirmed. B. Based on a review of the "Laboratory Chemical Inventory" log, a laboratory tour, policy and procedure manual, patient accession log and interview, the laboratory failed to ensure the Hematoxylin stain utilized for staining dermatologic biopsy and Mohs specimens was within the manufacturer's expiration date during one (1) or twenty-four (24) months with one- hundred ninety (190) patient specimens stained/tested (Review timeframe from July 31, 2024 - July 9, 2026). The findings include: 1. A review of the "Laboratory Chemical Inventory" log revealed an expired LabStat Hematoxylin stain (lot number 157183 exp 01/30/2024) documented as in use on 06/08/2026 until the date of the survey on 07/09/2026. There were no other lots of Hematoxylin stains listed as in use on the laboratory's log. 2. During a laboratory tour with the Mohs Tech on July 9, 2026, at 10:30 AM, the surveyor observed no Hematoxylin stored in the laboratory's flammable cabinet. The surveyor inquired with the Mohs Tech as to the location of the in-use Hematoxylin stain. The Mohs Technician stated, "There is no Hematoxylin stain. I ordered more stain. It should arrive today." 3. Review of the laboratory's patient logs from June 8, 2026 to July 9, 2026 (22 surgery dates), 190 patient specimens were stained utilizing the expired Hematoxylin stain. 4. A review of the laboratory's policy and procedure manual revealed a policy, "Reagent Storage, Use and Handling" with the statement, "Do not use reagents after expiration date." 5. In an exit interview with the Mohs Tech and licensed practical nurse on July 9, 2026, at 11: 00 AM, the above findings were confirmed. -- 2 of 2 --