Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/21/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the quality manager and center manager at the conclusion of the survey. 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 observation and interview with the quality manager and center manager, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the general storage room on 11/21/2023 at 09:45 am, identified the following expired supplies that appeared to be available for use; (a) 50 Vacuette CAT Serum Separator Clot activator tubes (lot# B2207389) - with an expiration date of 11/01/2023. (2) Interview with the quality manager and center manager 11/21/2023 at 09:45 am confirmed the expired supplies were available for use. 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 --