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: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 5/24/24 at 11:53 a.m. one (of one) unopened package of BD Vacutainer Heparin tubes (Lot: 2259074, expiration date 04/01/2024) was observed in the laboratory, available for use beyond their expiraton date. B) In an interview on 05/24/2024 at 11:54 a.m. testing person #1, as listed on the CMS-209 form, confirmed that the items, identified above, had exceeded their expiration date and were available for use. 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 --