Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on observation of the laboratory, a review of the laboratory's procedure manual, Hematoxylin and Eosin (H&E) stain control logs, and staff interviews, the laboratory failed to define the predicted stain characteristics of the H&E stain in 2024 through the survey date (01/08/2026). The findings include: 1. Observation of the laboratory on 01/08/2026 at 9:30 a.m. revealed Hematoxylin (lot 159673) and Eosin (lot 151191) stains and laboratory equipment used to process patient tissue removed during Mohs surgical procedures for histopathology testing. 2. A review of the laboratory's procedure titled "H&E Slide Quality Issues" revealed that the predicted characteristics of the H&E stain quality were not defined. 3. A review of the laboratory's "Daily H&E Control Slide Microscopic Review" log used to document daily stain quality revealed that the predicted characteristics of the H&E stain quality were not documented or defined in 2024 through the survey date (01/08/2026). 4. An interview with the laboratory lead and office manager on 01/08/2026 at 12:00 p.m. confirmed the above survey findings. 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 --