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 direct observations, review of current, approved Standard Operating Procedures (SOPs), Quality Control (QC) and analyzer calibration records, as well as interview with the Laboratory Director (LD) the laboratory failed to remove from inventory expired reagents in the patient specimen processing laboratory. FINDINGS: 1. The surveyor's observations in the patient specimen processing laboratory confirmed on May 9, 2025, at approximately 11:30 A.M. the following reagents were not removed from inventory: a. Two packages of total triiodothyronine (TT3), lot: D917412, expiration: August 31, 2024. b. One bottle of diluent concentrate, lot: 1Z80058, expiration: November 30, 2024. 2. The current, approved SOPs did not include instructions for removal of expired reagents and supplies from inventory. 3. The LD confirmed the respective expired reagents were not utilized for patient specimen processing. It was noted analyzer reagent lots and expiration dates were not expired. 4. The LD confirmed the findings on May 9, 2025, at approximately 11:30 A. M. 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 --