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, record review and interview with the Laboratory Director (LD), the laboratory failed to ensure 1 of 2 standard kits for urine drug testing were not used after expiration date for patient testing. Findings include: 1. During the tour of the laboratory on 03/31/2025 at 9:15 am, the surveyor observed 1 box of SCIEX Standards Chemical Kit with Lo/High Concentration for the SCIEX Triple Quad 4500 LCMS (Liquid Chromatography Mass Spectrometer) analyzer for urine drug testing, with an expiration date of 07/25/2024. 2. A review of the laboratory's policy titled "General and Administrative Policies for Laboratory Operation", page 7 of 12, section named "STORAGE AND LABELING OF REAGENTS, STANDARDS, AND CONTROLS", line 4 states, "All reagents, media, standards, and controls must be properly discarded when they exceed their expiration dates." 3. An interview with the LD on 03/31/2025 at 9:42 am confirmed reagents were expired. 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 --