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 the lack of stain quality documentation and staff interview, the laboratory failed to document the reactivity of the hematoxylin and eosin (H & E) stain on biopsy slides each day slides were read in 2020 and approximately 600 patient slides are read annually. Findings include: a. No record of stain quality from biopsy slides was available for review during the survey. b. Staff confirmed that no stain quality of biopsy slides had been documented each day the slides were read in 2020. 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 --