Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not document that the first slide reviewed for each day of hematoxylin and Eosin (H & E) staining for histopathology testing met the intended reactivity characteristics for the stain (this would include documentation of unsatisfactory staining characteristics and