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), as well as interview with the Office Manager (OM), the laboratory failed to remove from inventory expired reagents in the patient specimen processing laboratory. FINDINGS: 1. The surveyor's observations in the specimen processing laboratory confirmed on November 3, 2025, at approximately 11:30 A.M. the following reagents were not removed from inventory. a. One bottle of Black Dye Lot#065614 Exp. April 2020. b. Approximately 600 patients were tested from calendar year 2023 through the survey date. 2. The current, approved SOPs did not include instructions for removal of reagents, solutions, control materials, calibration materials, and other supplies from inventory when they have exceeded their expiration date. 3. OM informed the surveyor that the respective reagents were not utilized for patient specimen processing. 4. OM confirmed the findings on November 3, 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 --