Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient testing records, quality control records, and confirmed by interview with histotechnologist (HT) identifier #1 at 10:30 am on 11/15/2024, the laboratory failed to document Hematoxylin and Eosin (H&E) stain quality each day of use for three out of five days of patient testing reviewed from June 2024. The findings include: 1. Patient A had Mohs surgery performed on 06/14/2024. 2. Patient B had Mohs surgery performed on 06/17/2024. 3. Patient C had Mohs surgery performed on 06/24/2024. 4. At the time of the survey, HT #1 confirmed that the laboratory did not document H&E stain quality for the dates listed above. 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 --