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 record review and interview with the General Supervisor (GS), the laboratory failed to ensure predictable staining characteristics of Hematoxylin and Eosin staining for 1 (SAJ2022-165 on 1/25/22) of 1 bladder biopsy reviewed. Findings include: 1. A review of the laboratory's "Daily Assessment of Stain and Prep Quality" policy revealed a section stating, "The pathologist will dictate a description of the quality of the stain and prep into the microscopic section of each report". 2. A review of patient test records revealed Patient SAJ2022-165 had a bladder biopsy reported on 1/25/22 and did not have the description of the quality of staining on the test report. 3. An interview on 5/2/22 at 9:58 am with the GS confirmed the laboratory did not have documentation the stain quality was assessed for the patient 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 --