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 surveyor observation of reagents currently in use in the laboratory and staff interview, the laboratory failed to ensure expired materials were not used for testing. The findings included: 1. Surveyor observation of reagents in use in the laboratory on 05/19/2026 at 0930 hours identified two bottles of expired reagent: EDM3 Solutions Cholorazol Black E Lot: 3178 expiration date: 2025- 06-27 2. The MA confirmed the findings in an interview conducted on 05/19/2026 at 0945 hours 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 --