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 Laboratory Director, the laboratory failed to ensure Hematoxylin and Eosin staining characteristics were acceptable for 10 (01/06/2021, 02/10/2021, 03/23/2021, 04/07/2021, 06/02/2021, 07/19/2021, 08/10 /2021, 09/29/2021, 10/21/2021, and 11/16/2021) of 10 dates when patient test records were reviewed. Findings include: 1. An interview on 12/14/21 at 10:15 am with the Laboratory Director revealed the laboratory does not document the review Hematoxylin and Eosin staining characteristics each day of patient testing. 2. A review of the laboratory's staining records revealed a lack of documentation for the review Hematoxylin and Eosin staining characteristics for the following dates: a. 01/06 /2021 b. 02/10/2021 c. 03/23/2021 d. 04/07/2021 e. 06/02/2021 f. 07/19/2021 g. 08/10 /2021 h. 09/29/2021 i. 10/21/2021 j. 11/16/2021 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 --