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 record review and interview with the technical consultant, the laboratory director failed to sign the current laboratory procedure before it was put into use for the Sysmex XN 430. Findings include: 1. A review of the Sysmex XN 430 procedure revealed that the procedure went into effect in July 2021. The laboratory director did not sign the procedure until January 2022. 2. The laboratory performed approximately 2,500 Chem+8 panels performed on the Abbott i-STAT and complete blood cell counts performed on the Sysmex XN 430 a year. 3. An interview on 02/01/2022, at 2: 40 PM, the technical consultant confirmed the laboratory failed to sign the procedure before use. 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 --