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 interview with technical supervisor (TS) #2 on 7/23/2024, the laboratory failed to discard materials that had exceeded their expiration dates and were available for use in patient testing. Findings: 1. At approximately 12:30 P.M., the surveyor observed 14 Becton Dickinson (BD) Blue top Vacutainer blood collection tubes with Lot Number 3257668 and expiration date 2024-06-30 in a cup in the Phlebotomy Collection Station inside the laboratory. 2. At approximately 12:30 P. M., the surveyor observed 1 BD Green top Vacutainer blood collection tube with Lot Number 2347082 and expiration date 2024-04-30 in a cup in the Phlebotomy Storage closet in the laboratory. The expired BD blood collection tubes were given to TS #2 who, during an interview at 12:30 P.M., confirmed that they had exceeded their expiration dates. The expired tubes were immediately discarded in the laboratory's biohazard container. 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 --