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 Chlorazol Potassium Hydroxide reagent was not used past the expiration date. The laboratory performs approximately 30 mycology tests annually. Findings Include: 1. Direct observation of Chlorazol Potassium Hydroxide on 9/04 /2024 at 11:50 AM, revealed the Chlorazol Potassium Hydroxide had an expiration date of 2023-12-31. 2. Interview with the histotechnician at 11:55 AM on 9/04/2024, confirmed the Chlorazol 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 --