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 surveyor observation of laboratory reagents, review of laboratory records and interview with the laboratory director, testing personnel used expired potassium hydroxide (KOH) reagent on patient testing for four of four patients. Findings include: 1. Observation of KOH reagent on January 6, 2023, at 10:38 AM showed the KOH reagent available for use was lot number 4907EZ1, expiration date March 16, 2022. 2. Review of the KOH patient log revealed testing personnel performed KOH testing on: Patient 1: March 29, 2022 Patient 2: November 23, 2022 Patient 3: January 4, 2023 Patient 4: January 4, 2023 3. Interview with the laboratory director on January 6, 2023, at 10:40 AM confirmed testing personnel used expired KOH reagent for patient testing on four of four patients. 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 --