Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 direct observation and an interview with the Laboratory Director (LD), the laboratory failed to replace the Hematoxylin stain after it had exceeded the expiration date and approximately 30 slides had been processed using this stain. Findings include: 1. An observation of the laboratory's reagents and stains on 07/25/2023 at approximately 2:30 PM, revealed one bottle of Gill 3 Hematoxylin stain, lot number 136569, expired on 5/31/2023. 2. An interview with the LD at on 07/25/2023 at approximately 2:30 PM, confirmed that the Hematoxylin stain had expired and had been used for the staining process of approximately 30 histopathology slides. 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 --