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 a review of the slide quality records and an interview with the laboratory technician, the laboratory failed to check the adequacy of the routine Hematoxylin and Eosin stain each day for intended response. This was noted on 8 of 60 days reviewed by the surveyor. The findings included: 1. A review of the slide quality records revealed that the slide quality was not documented on the following days: 07/06/2018, 07/11/2018, 07/27/2018, 08/01/2018, 09/19/2018, 12/21/2018, 08/30/2019, and 11/13 /2019. 2. During an interview on 11/20/2020 at 11:20 AM, the laboratory technician confirmed the Laboratory Director (the testing personnel) did not document the slide quality on dates 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 --