Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Procedure Manual and an interview with the Technical Consultant, the Laboratory Director failed to approve the procedure for the Sysmex XN-550 Hematology analyzer before use. The findings include: 1. A review of the Procedure Manual revealed a procedure for the Sysmex XN-550, a newly implemented instrument as of 11/16/2021, without signature and date of approval from the Laboratory Director. 2. During an interview on 11/16/2022 at 3:00 PM, the Technical Consultant confirmed the above findings. 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 --