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 and staff interview on 10/26/2021, the laboratory failed to ensure that the Cell Pack Reagent in use for the Beckman Coultier CBC analyzer had not exceeded the manufacturer's expiration date. Findings include: 1. Observation during a tour of the laboratory on 10/26/2021 revealed that the Cell Pack Reagent in use had expired on 10/09/2021. 2. Testing personnel stated in an interview at 09:17 AM on 10/26/2021 that the laboratory failed to have a system in place to ensure reagents were discarded before exceeding manufacturer's 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 --