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 procedure manuals, interview with the general supervisor (GS), the LD failed to ensure quality assessment (QA) programs were established and to assure the quality of laboratory services provided from February 08, 2021 to the day of survey. Findings Include: 1. On the date of survey, 4/05/2021, the GS could not provide a QA procedure or documentation of periodic evaluation of the laboratory, that assess the laboratory's pre-analytical, analytical, and post-analytical processes from February 08, 2021 to April 05, 2021. . 2. The GS confirmed the findings above on 04/05/2021 around 12:25 pm. 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 --