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 10/24/25 at 1:23pm, two (of four) containers of "DRI Creatinine- Detect7.5 mg/dL Control" (Microgenics Corporation, lot 75247101, REF 100274, expiration date 8/31/25) and one (out of two) "DRI Multi-Drug Urine Calibrator 2" (Microgenics Corporation, lot 75293504, REF 1592, expiration date 9/30/25) were observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 10/24/25 at 1:25pm the lab director confirmed that the items, identified above, had exceeded their expiration date 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 --