Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the Linistat Automated Stainer during the laboratory tour, and interview with the practice manager (PM), the laboratory failed to appropriately label stain reagents with proper identification. Findings: 1. Observation of the Linistat Automated Stainer during the laboratory tour on January 21, 2026, showed no labels on each reservoir to identify the staining reagents in use. 2. Interview with the PM on January 21, 2026, at 9:00 AM confirmed the laboratory failed to appropriately label staining reagents in 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 --