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 Histology reagents and interview with the Office Manager (OM), the laboratory failed to discard expired Histopathology reagents from January 2024 to 10/29/25. The findings include: 1. Epredia Gill 2 Hematoxylin Lot 117740 expired January 2024 2. Approximately 300 patients were tested with expired reagent. 3. The OM confirmed on 10/29/25 at 1:00 pm that the laboratory used expired reagents. 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 --