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, record review, and interview with the Technical Consultant (TC), the laboratory failed to ensure that quality control materials were not available for use beyond their expiration dates. Findings include: 1. During a tour of the laboratory conducted on 12/17/2025 at 10:30 AM, the surveyor observed one (1) unopened vial of High Level Refractol (Lot# K36089) with an expiration date of 11/30 /2025. The expired vial was stored alongside ten (10) unexpired vials of High Level Refractol (Lot# K306763), expiration date 01/31/2027. 2. A review of the laboratory's policy titled Digital Refractometer Activities on page 3 of 3 revealed in the section titled Control Reading, "Inspect the control vial for suitability - Control is not expired ...". 3. A review of the laboratory's policy titled Reagent and Vaccine Check on page 1 of 2 revealed in the section titled Expired Reagents, Controls or Vaccines, "Discard any expired reagents and controls by placing them in a sharp's container.". 4. An interview was conducted on 12/17/2025 at 10:35 AM with the TC confirmed that an expired control was available for use to test 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 --