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 observation of H&E (Hematoxylin & Eosin) Stain used in the Histopathology Processing 7/8/19 room for Frozen Sections, Lack of Stain Quality Documentation each day of patient testing and interview with the Laboratory Director, determined the Stain Quality had not been documented for Frozen Sections for 2018 and 2019. The findings include: 1. Observation of H&E stain in Frozen Section Processing Room 7/8/19 at approximately 1:00 p.m. 2. Lack of H&E stain quality for each day of patient testing for 2018 and 2019. 3. Interview at approximately 2:00 p.m. 7/8/19 with Laboratory Director confirmed that H&E stain quality for Frozen Sections had not been documented for 2018 and 2019. 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 --