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 1/14/26 at 12:16 pm, twenty-one Vacuette 4 ml K2E K2EDTA blood collection tubes lot# B23053B8 expiration date 2024-09-03 and thirty-four Vacuette 6ml CAT Serum Clot Activator blood collection tubes lot# B240534C expiration date 2025-10-31were observed in a the laboratory, available for use beyond the expiration date. B) In an interview on 1/14/26 at 12:33 pm the Technical Consultant (TC) (TC on the form CMS 209) 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 --