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 test reports, quality control records, and confirmed by the Pathology Department Supervisor at approximately 1:20 pm on 01/24/2022, the laboratory failed to document Hematoxylin and Eosin (H & E) stain quality each day of use for three out of four days of patient testing reviewed from 11/01/2021- 11/30 /2021. The findings include: 1. Patient A had tissue touch prep slides with H & E staining interpreted and reported on 11/02/2021. 2. Patient B had fine needle aspiration slides with H & E staining interpreted and reported on 11/03/2021. 3. Patient C had frozen section slides with H & E staining interpreted and reported on 11 /12/2021. 4. At the time of the survey, the laboratory did not have documentation of 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 --