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 staff interview, the facility failed to maintain daily quality control (QC) slide documentation for Cytology stains for two out of two years reviewed ( 2017-2019). The findings included: Review of QC documentation showed no record for the quality of the Cytology stains used during Fine Needle Aspiration Biopsy . Interview with the Nurse Manager on 05/01/19 at 10:30 AM confirmed that no record was being kept that documented the quality of the Cytology stains used during the Fine Needle Aspiration Biopsy procedures. 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 --