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: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory had reagents available for use when they had exceeded their expiration date. Survey findings include: A. During a tour of the laboratory, at 9:50 a.m. on 4/21/2023, the surveyor observed one CDIS Tissue Marking Dye Green (lot # 20161) in the cabinet above the staining area. The dye had an expiration date of 06/30/2022. B. During a tour of the laboratory, at 9:50 a.m. on 4 /21/2023, the surveyor observed one CDIS Tissue Marking Dye Black (lot # 20349) in the cabinet above the staining area. The dye had an expiration date of 12/31/2022. C. In an interview at 9:50 a.m. on 04/21/2023, laboratory personnel #3 (as listed on the entrance/exit conference sheet) confirmed the expired reagents were available for use 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 --