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 reagents in use and interview with laboratory personnel, the laboratory failed to ensure that expired reagents were removed from use. Findings include: 1. Observation showed on 08/25/2022 at approximately 10:00 AM, one of six tissue marking dyes "purple" had an expiration date of 07/31/2022. 2. In an interview on 08/25/2022 at 10:00 AM, staff confirmed the "purple" dye was expired. Staff confirmed that one of four cases used the purple tissue marking dye while it was expired. 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 --