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 of Surgipath tissue marking and margin dyes, potassium hydroxide (KOH) reagent and interview with testing personnel (TP) #3, the laboratory failed to discard expired tissue marking dyes and KOH reagent. Findings: 1. Observation of Surgipath tissue marking and margin dyes showed: Black tissue marking dye lot # 09132017, expiration date September 2018 still in use. Yellow tissue marking dye lot # 3801754, expiration date March 25, 2020 still in use. Green tissue marking dye lot # 032719, expiration date March 27, 2020 still in use. 2. Observation of Health Link potassium hydroxide (KOH) reagent showed lot # 132816, expiration date September 25, 2014 still in use. 3. Interview with TP #3 on January 11, 2022 at 2:00 PM confirmed the laboratory failed to discard expired tissue marking dyes and KOH reagent. 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 --