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 6/23/26 at 1:05pm, one (of one) containers of "disposable sterile pipet tips with superslik surface for most piettors, vol 1-200uL" (VWR, lot: 40231-710C4- 710AL, REF: 613-0286, Cat# 53503-290, expiration date 2020-03) were observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 6/23/26 at 1:05pm, one (of one) containers of "Bio-Cert pipetter tips, 0.1-20uL" (GMBH, lot: 317730, REF: 702428, expiration date 02/2012) were observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 6/23/26 at 1:07pm the technical supervisor confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory but had not been used for testing patient samples. 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 --