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 and interview with histotechnician, the laboratory failed to ensure that the Potassium Hydroxide reagent was not used past the expiration date. The laboratory performs approximately 15-20 mycology tests annually. Findings Include: 1. Direct observation of Potassium Hydroxide on 1/23/2024 at 12:00 PM, revealed the Potassium Hydroxide, lot number 0043, had an expiration date of 2022-2- 12. 2. Interview with the histotechnician at 12:00 PM on 1/23/2024, confirmed the Potassium Hydroxide was used for patient testing past the 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 --