Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Forefront Dermatology, SC (Glen Allen) on June 8, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 laboratory tour observations, review of policy and procedure manual, and interviews, the laboratory failed to ensure that their Potassium Hydroxide (KOH) 10% and fungal stain reagents, stored in the microscopy area, were within the manufacturer's stated expiration dates for five (5) of 5 bottles of reagents in use on the date of the inspection June 8, 2023. Findings include: 1. During a laboratory tour of the microscopy area at approximately 10:00 AM on 6/8/23, the inspector noted the following expired reagents stored for use in the dermatology microscopy testing room: One bottle Potassium Hydroxide 10%, Lot Number 0084-00 (manufacturer's printed expiration date 09/30/2022); Two (2) bottles of Delasco Wright-Giemsa Stain, Lot Number K213D2 (manufacturer's printed expiration date 03/31/23); 2 bottles of Delasco Chlorazol Fungal Black Stain, Lot Number K217J1 (manufacturer's printed expiration date of 07/31/2022) and Lot Number K19563 (expiration date of 05/31 /2020). The laboratory inspector inquired if the expired KOH and fungal stain reagents were being used for patient microscopy testing and the nurse practitioner stated: "Yes, they are being used for KOH direct preps, ectoparasite, and tzanck slides". 2. Review of the laboratory's policy and procedure manual revealed a Quality Control Policies and Documentation: Reagents protocol that stated, "All outdated Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State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 -- /expired reagents will be disposed of properly". 3. An interview with the office manager on 6/8/23 at approximately 12:30 PM confirmed the above findings. -- 2 of 2 --