Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed 09/30/19. The findings were reviewed with the quality manager at the conclusion of the survey. 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 records and interview with the regional quality manager, the laboratory failed to document stain reactivity each day of patient testing. Findings include: (1) At the beginning of the survey, the regional quality manager stated to the surveyor the laboratory performed microscopic interpretations of histology specimens stained with H&E (Hematoxylin and Eosin) for diagnosis; (2) The surveyor reviewed records for 11 days of patient testing performed between December 2018 and September 2019. There was no evidence the reactivity of the stain had been observed for 2 of the 11 days reviewed: 12/21/18 and 06/21/19; (3) The surveyor reviewed the records with the regional quality manager who stated the reactivity had been observed but had not been documented. 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 --