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 and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 1/07/25 at 11:20 am, one (of one) opened container of SCS1000 Hematology Calibrator (lot 4107, REF 217685, Sysmex, expiration date 5/19/24) was observed in the laboratory, available for use beyond the expiraton date. B) In an interview on 1/7/25 at 11:24 am the lab director, confirmed that the item, identified above, had exceeded the expiration date and was available in the laboratory. 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 --