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 7/17/25 at 12:58pm, three (of three) containers of Epredia Resolve Immersion Oil (lot 113323, REF M3004, expiration date 12/2023) were observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 7/17 /25 at 12:59pm testing personnel #1 (as listed on the CMS-209 form), confirmed that the items, identified above, had exceeded their expiration dates and were available for use 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 --