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 direct observation of laboratory testing supplies and interview with the laboratory representative; the laboratory failed to ensure one of one marking dye mordant and one of five tissue marking dyes used for tissue grossing in the specialty of histopathology were not used when they had exceeded their expiration date. Findings include: 1. Upon a tour of the laboratory on 07/28/2025, at 1:21 pm, direct observation of laboratory testing supplies found one of one marking dye mordant and one of five tissue marking dyes, used for demonstrating tissue margins in the tissue grossing process of histopathology, to be expired. Material: Expiration Date: Marking Dye Mordant 01/2018 Orange Marking Dye 08/2014 2. Interview with the laboratory representative on 07/28/2025, at 2:40 pm, confirmed the laboratory failed to ensure one of one marking dye mordant and one of five tissue marking dyes used for tissue grossing in the specialty of histopathology were not used when they had exceeded their expiration date. 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 --