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 upon observations made during a tour of the laboratory, and interviews with laboratory staff, the laboratory had blood collection tubes available for use after their expiration date in two of two phlebotomy trays used for the collection of blood sample for complete blood cell (CBC) analysis. Findings follow: A) During a tour of the laboratory on 3/11/26 at 11:56 a.m., 12 BD 3.0 ml. EDTA blood collection tubes (lot# 4257248 expiration date 2026-01-31) were observed in one phlebotomy tray, and 13 BD 3.0 ml. EDTA blood collection tubes (lot# 4257248 expiration date 2026-01-31) were observed in a second phlebotomy tray. B) In an interview on 3/11/26 at 11:456 a. m. laboratory personnel ( number11 on the form CMS 209) confirmed that the tubes were expired and 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 --