Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on 01/28/2026. The facility was not found to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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, facility policy review and interview; the facility failed to ensure they did not use drug free urine reagent that was beyond the manufacturer's expiration date. This was noted for 1 of 1 container observed. Findings included: During an observation on 01/28/2026 at 10:30 A.M., a large jug of expired drug-free urine reagent was observed in the refrigerator labeled with an expiration date of 12/31/2024. Review of a facility policy titled, "General Laboratory Policies and Procedures," dated 08/14/2025, revealed "All reagents, controls and kits must be properly discarded when they reach their expiration date." During an interview on 01/28/2026 at 10:30 A.M., the General Supervisor (GS) stated that the drug-free urine reagent was used as a blank for liquid chromatography- mass spectrometry testing and as a diluent for calibrators. The GS confirmed that the expired drug-free urine reagent was in use for patient testing throughout the year 2025. 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 --