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 surveyor review of procedures and interview with the laboratory director, two of three procedures reviewed did not show the director had approved, signed, and dated the procedures before use. Findings include: 1. Review of three laboratory test procedures including the 'UWMF Urine Microscopic Analysis Procedure' and the 'UWMF Satellites Sysmex XS-1000i Procedure' showed no evidence the laboratory director approved, signed, and dated the procedures for urine microscopic analysis or testing on the Sysmex XS-1000i. 2. Interview with the laboratory director on June 15, 2023, at 2:00 PM confirmed the two procedures did not show the director had approved the procedures for 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 --