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 record review, direct observation, and interview with the Technical Consultant, KOH reagent was used for patient testing after exceeding the expiration date. Findings include: 1. KOH reagent lot in use had an expiration date of 3/31/21. 2. Patient record review showed that KOH testing has been performed on 3 patients since 3/31/21. 3. In an interview on 5/11/21 at approximately 11:30 am, the Technical Consultant confirmed that patient testing had been performed using expired 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 --