Summary:
Summary Statement of Deficiencies 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 observation of the laboratory, review of patient testing log, and interview, the laboratory failed to ensure that potassium hydroxide (KOH) and Chlorazol Black E reagents, used for fungal patient testing, were not used past their expiration date in 2024 with seven patients reported. The findings include: 1. Observation of the laboratory on 07.08.2024 at 9:30 a.m. revealed the following expired reagents used for fungal patient testing: - One bottle of EK Industries (EKI), potassium hydroxide 20% (Lot: 210347), expiration date: "2023-02-16" - One bottle of Medical Chemical Corporation, potassium hydroxide 10% (Lot: 7746-01), expiration date: "NOV- 2019" - One bottle of HealthLink, Chlorazol Black E (Lot: 0303), expiration date: "2022-10- 29" - One bottle of HealthLink, Chlorazol Black E (Lot:7044), expiration date: "2019- 02-13" 2. A review of the patient testing log titled "KOH Preparation Log" revealed seven patients tested on the following dates: 03.25.2024 05.21.2024 (two patients) 06.03.2024 06.04.2024 06.05.2024 06.10.2024 3. An interview with the laboratory director on 07.08.2024 at 12:15 p.m. confirmed the laboratory performed patient fugal testing using expired reagents from 03.25.2024 through 06.10.2024. 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 --