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 of laboratory testing supplies and interview with the laboratory representative; the laboratory failed to ensure four of four margin marking dyes used for the subspecialty of histopathology were not used when they had exceeded their expiration date. Findings Include: 1. Upon a tour of the laboratory on 10/29/2024, at 1:57 pm, direct observation of laboratory testing supplies found four of four margin marking dyes, used for demonstrating tissue margins in the grossing process of histopathology, to be expired. Margin Marker Dye: Lot: Expiration: Yellow - GR2056-Y 066896 05/2020 Blue - GR2056-BL 065745 04/2020 Black - GR2056-BK 066247 05/2020 Green - GR2056-GN 066611 04/2020 2. On survey date 10/29/2024, at 2:31 pm, the laboratory representative confirmed four of four margin marking dyes were 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 --