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 observation of laboratory supplies during the laboratory tour, review of patient results and interview with the laboratory director (LD), the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory supplies during the laboratory tour on May 27, 2026 showed one opened bottle of Delasco 10% Potassium Hydroxide (KOH) Lot # K19733 expiration date 07/31/2022 still in use. 2. Review of patient results showed the laboratory performs approximately 101 KOH patient tests annually. 3. Interview with the LD on May 27, 2026, at 08:45 AM confirmed the laboratory failed to ensure laboratory supplies were not used when they had exceeded their 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 --