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 assessment plan and review of 2019, 2020, 2021, and 2022 quality assessment monitors 5/12/22, the laboratory director failed to ensure the quality assessment program was maintained to assure the quality of the laboratory services offered. Findings: The laboratory's "Quality Assessment Plan" states "... V. PROCESSES / PROGRAM COMPONENTS Quality Assessment Activities ... 4. Testing personnel, the Laboratory Director, Technical Consultant and Clinic Administrator shall review and sign the completed monitors. Review of 2019, 2020, 2021, and 2022 quality assessment monitors revealed many of the monitors had not been signed by all personnel required to review them. Many of the signatures did not include dates to show when the monitors were reviewed. Examples: 1. 2019 - 3rd and 4th quarter monitors signed by the laboratory director and the clinic administrator, but signatures not dated. 2. 2020 - 1st, 2nd, and 3rd quarter monitors not signed by the laboratory director or the clinic administrator. 4th quarter monitor and the Annual General Laboratory Assessment not signed by the laboratory director, the clinic administrator, or the technical consultant. 3. 2021 - 1st, 2nd, 3rd, and 4th quarter monitors not signed by the technical consultant. 4th quarter monitor not signed by the laboratory director. Clinic administrator and laboratory director signatures not dated on the 1st, 2nd, and 3rd quarter monitors. 4. 2022 - 1st quarter monitor signed by the laboratory director and clinic administrator, but signatures not dated. 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 --