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 observation and interview with the histotechnician 11/18/24, the laboratory failed to discard supplies that had exceeded their expiration dates. Findings: During a tour of the laboratory at approximately 2:00 p.m., the surveyor observed the following expired supplies in the microscope room adjacent to the laboratory, available for use: 1. 1 bottle of Delasco 1% Toluidine Blue Aqueous Solution, lot #K20CG2 with expiration date 12/31/22; 2. 1 set of Fisherbrand Hema 3, including: a. 1 bottle of Hema 3 Fixative, lot #100035 with expiration date 11/2021; b. 1 bottle of Hema 3 Solution I, lot #100036 with expiration date 2/2022; c. 1 bottle of Hema 3 Solution II, lot #100037 with expiration date 2/2022. During interview at approximately 2:15 p. m., the histotechnician stated she was unaware the supplies were in that location and she was unsure what they were used for. 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 --