Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 and interview with the histotechnician, the laboratory failed to ensure that the Tissue Marking Dyes were not used past the expiration dates. The laboratory performed approximately 1500 histopathology tests annually. Findings Include: 1. Direct observation at 11:40 AM on 4/9/2026 of Avantik tissue marking dyes revealed 5 tissue marking dyes past the expiration dates. 1. Yellow Tissue Marking Dye, lot number 169469, had an expiration date of 2025-03-31. 2. Green Tissue Marking Dye, lot number 168109, had an expiration date of 2025-03-31. 3. Orange Tissue Marking Dye, lot number 167159, had an expiration date of 2025-02- 28 4. Red Tissue Marking Dye, lot number 168107 had an expiration of 2025-02-28. 5. Blue Tissue Marking Dye, lot number 166704, had an expiration date of 2025-01- 31. 6. Interview with the histotechnician at 11:40 AM on 4/9/2026 confirmed the Tissue Marking Dyes were used for patient testing past the expiration dates. 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 --