Laboratory Quality Improvement Activities

CDC strives for first-rate quality standards for laboratories and has developed a Laboratory Quality Plan (LQP) to ensure CDC laboratories produce excellent test methods and test results in both routine and emergency operations. The Laboratory Quality Plan is the result of collaboration between the Deputy Director for Infectious Diseases (DDID), the Office of Laboratory Science and Safety (OLSS), and Centers within CDC that have laboratories. The LQP effectively addresses shortcomings in CDC’s development of its initial COVID-19 diagnostic test (Analysis of the initial lot of the CDC 2019-Novel Coronavirus real-time RT-PCR diagnostic panel)external icon. The LQP has 6 major components:

1. Three quality management systems: one for infectious disease laboratories, one for non-infectious disease laboratories, and one for NIOSH laboratories. Separate quality systems permit more detailed quality specifications tailor-made for different types of laboratories.
2. Development of a Quality Manual for Microbiological Laboratories (QMML) that describes quality standards for CDC’s clinical, surveillance, and research infectious disease laboratories.
3. An Infectious Disease Test Review Board (IDTRB) that reviews laboratory tests developed within CDC before they are shared outside of CDC to be sure the tests meet excellent quality standards and are suitable for their intended purpose. An example of the value of enhanced review occurred in the spring and summer of 2020 when CDC developed and validated a test to detect infection with influenza A and B and SARS-CoV-2, the virus that causes COVID-19. Test kit material performance was verified by multiple additional CDC laboratories to make sure that all the parts of the test performed as expected and were effective and accurate at identifying infectious agents. Three public health laboratories also verified the new test before it was distributed widely to confirm that the test worked well and was user-friendly. The test was successfully used by state and local public health laboratories during the 2020-2021 flu season, allowing them to conserve testing materials in short supply by simultaneously testing for infection by all three viruses.
4. Method expert groups that develop first-rate method validation standards and excellent method documentation requirements for each type of method (e.g., RT-PCR, ELISA) used in ID laboratories.
5. An electronic Quality Management System (eQMS) that is flexible, easy to use, and facilitates laboratory quality activities such as documenting and managing non-conforming events, corrective and preventive actions, training, equipment maintenance, standard operating procedures, and more.
6. Biannual external review of all laboratories (clinical, surveillance, and research); clinical laboratories audited to meet CLIA requirements by Centers for Medicaid and Medicare Services approved auditors.

The Laboratory Quality Plan sets a framework that encourages continuous quality improvement, while providing the quality assurance checks that ensure excellent test results.