Laboratory Quality Improvement Activities
One of CDC’s critical roles as a public health agency is to develop diagnostic test methods for novel viruses like SARS-CoV-2, and to provide these validated test methods to the public health community.
There were mistakes in how the original test for SARS-CoV-2 was developed and manufactured. CDC started analyzing what went wrong soon after test problems were reported by state public health laboratories. In February 2020, CDC used enhanced quality control measures to get a functional COVID-19 diagnostic test out to public health laboratories as soon as possible after issues with the first test were identified. Since then, we have taken additional steps to address those issues and have continued a rigorous review process for quality improvements.
CDC maintains this focus on continual quality improvement in laboratories to ensure that the American public can rely on the agency to produce accurate, evidence-based science and protect the nation’s health.
Enhanced quality control measures were used 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 testing for infection by all three viruses at the same time.
The steps CDC is taking to address issues related to development of its initial COVID-19 diagnostic test and assure laboratory quality will:
- Require all CDC-developed test methods for infectious disease surveillance and diagnosis to have additional, clearly defined approval criteria and management review.
- CDC developed guidance that includes a checklist to be considered during assay development. It incorporates test development categories (Concept, Risk, Safety, Costs, Method, Performance, Data, and Monitoring) with several questions for scientists to consider throughout the laboratory test development and deployment process.
- CDC is also in the process of developing a charter for a new test review board that will review and approve all new CDC infectious disease laboratory tests deployed external to the agency.
- The review process will include review of all data for assay development and validation by subject matter experts outside of the program implementing the test to ensure an objective review.
- Require all CDC laboratories to be accredited to an appropriate internationally recognized, competency based technical standard by October 1, 2024.
- CDC is committed to funding this accreditation initiative with approximately $80 million from the Public Health and Social Services Emergency Funds (PHSSEF).
- CDC-developed diagnostic test kits must be manufactured and distributed under the appropriate rigorous U.S. regulatory requirements. These activities will also be certified to international standard ISO 13485.
- Laboratories that are validating a CDC diagnostic test kit to make sure that it is suitable for its intended use must be accredited to ISO/IEC 17025 for that test method.
- Require that test methods designed for use by infectious disease public health laboratories are compatible with testing technology platforms commonly used by these laboratories.
- CDC used these criteria when developing its influenza A and B and SARS-CoV-2 laboratory test.
- Upgrade and modernize the information systems that manage specimen and sample data, test results, and quality control processes for CDC infectious disease laboratories. These updates will:
- Provide capacity to rapidly and efficiently report test results to public health partners.
- Support the implementation of the laboratory accreditation initiative.
- Require documentation and development of quality control procedures for all CDC-developed and -deployed infectious disease test methods and kits.
- Ensure full regulatory compliance of all laboratory functions and activities.