Summary:
Summary Statement of Deficiencies 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 observation of laboratory supplies during the laboratory tour, review of patient results and interview with the laboratory director (LD), the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory supplies during the laboratory tour on June 2, 2026 showed the following still in use: 1 each Healthlink Potassium Hydroxide (KOH) 20% Lot # 0006 exp 1/6/2022 1 each EDM3 Solutions KOH 10% Lot 2112 exp 4/22/2024 1 each PMS Fungal/Tzanck Stain Lot # K21CE4 exp 12/31 /2023 1 each Healthlink Fungal Tzanck Stain Lot # 4317 exp 11/13/2016 8 each Cover Seal-T Toluene Mounting Media Lot # 0317E13 exp 3/17/2023 4 each Cover Seal-AQ Aqueous Mounting Medium Lot # 108485 exp 10/31/2022 1 each Leica Surgipath SelecTech Define MX-aq Concentrate Lot # 031418 exp 3/14/2020 1 each Pureview pH Blue Working Solution Lot # 2305225 exp 3/5/2025 4 each Reagent Alcohol 95% Lot # 2003755 exp 2/9/2024 2. Review of patient results showed the laboratory performs approximately 65 KOH and 300 histopathology patient tests annually. 3. Interview with the LD on June 2, 2026, at 11:00 AM confirmed the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. 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 --