Summary:
Summary Statement of Deficiencies D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of Sysmex XE-2100D, BacT/ALERT, BioRad Manual IH Gel System, BioRad antibody identification (ID) reagents, Quotient antibody ID panel cells in BioRad gel, BioRad Papain, COBE 2991, and IH-Incubator L verification procedures and interview with the laboratory director (LD), the laboratory director (LD) failed to ensure that verification procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method prior to patient testing. Findings: 1. Review of verification procedures for the Sysmex XE-2100D hematology analyzer and the BacT/ALERT blood culture analyzer in the processing testing lab showed no documentation that the verification procedures were adequate, reviewed and approved by the laboratory director to determine the accuracy, precision, reportable range and reference range verification. 2. Review of verification procedures for the BioRad Manual IH Gel System, BioRad antibody identification (ID) reagents, Quotient antibody ID panel cells in BioRad gel, BioRad Papain, COBE 2991, and IH-Incubator L in the reference testing lab showed no documentation that the verification procedures were adequate, reviewed and approved by the laboratory director to determine the accuracy, precision, reportable range and reference range verification. 3. Interview with the LD on July 13, 2021 at 10:00 AM confirmed the LD failed to ensure that verification procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method prior to patient testing. D6091 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require