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 three Beckman Access 2 procedures and interview with the Regional Laboratory Director (Staff A), the Laboratory Director (Staff B) had not approved, signed, and dated two of the three reviewed procedures that were in use since patient testing began in October 2023. Findings include: 1. Review of electronic copies of three random procedures for the Beckman Access 2 analyzer showed no evidence the current laboratory director (Staff B) had approved two of the three procedures. "Running Patient Samples" and the "Weekly Maintenance" procedures showed no evidence of director approval prior to use for patient testing. 2. Interview with Staff A on April 17, 2024, at 10:45 AM confirmed the laboratory director had not approved, signed, and dated all laboratory procedures before use when patient testing started in October 2023. 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 --