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 laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 9:40 am on 06/15/2023, the laboratory failed to document Hematoxylin and Eosin stain quality each day of use for one out of four days of patient testing reviewed in May 2023. The findings include: 1. Patient A had histopathology slide interpretation performed on 05/08/2023. 2. At the time of the survey, the laboratory did not have Hematoxylin and Eosin stain quality documentation from 05/08/2023. 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 --