Summary:
Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the quality assessment (QA) records and interview with the laboratory director (LD), the LD did not ensure that the QA plan included review of the maintenance, reagent and quality control (QC) logs. Findings: 1. During the survey the QA records from 2016 through 2017 were reviewed. The records prior to the recertification survey on 03/24/16 included a monthly review of the reagents and QC records to verify that the records were complete. After the recertification survey the LD reviews were performed and documented every 6 months. The reviews only included personnel review and policy and procedural changes. The 6 month review did not include documentation showing that the maintenance, reagent and QC records had been reviewed to verify that the records were complete. 2. During the survey on 03 /01/18 at 11:00 AM the LD confirmed that the QA policies and procedures did not include written instructions for including the review of the maintenance reagents and QC documentation to verify that the records had been reviewed to verify that the records were complete. 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 --