Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance (QA) policy, lack of QA records, and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:45 am on 12/07/2021, the laboratory director failed to ensure the technical consultant performed and documented monthly QA audits for 11 out of 11 months from January- November 2021. The findings include: 1. The laboratory's Quality Assurance policy indicated that the technical consultant would conduct audits and document the results in a monthly report. 2. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have monthly technical consultant reports available from January- November 2021. 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 --