How CDC Enhances Laboratory Quality

Print
Related Pages
CDC Laboratory Quality

CDC laboratories follow our pledge to produce the highest quality scientific data, while ensuring the safety of its staff and the nation.

Supporting CDC Laboratories in Laboratory Quality Efforts

CDC laboratories conduct unique science and provide critical health information that protects the United States against dangerous health threats. High quality laboratory science is essential for CDC to meet its mission.

Scientific data generated or supported by CDC’s laboratories forms the basis of critical public health decision making and policy. CDC has a responsibility to ensure that all CDC laboratory research and development activities, testing processes, and data are the highest quality possible and are traceable, reproducible, documented with appropriate rigor, and meet all applicable regulatory requirements.

In 2019, CDC enacted an agency-wide laboratory quality management policy. This policy formalizes CDC’s commitment to scientific excellence and safety by establishing quality standard requirements for all 200-plus CDC laboratories. Implementing this policy will help CDC laboratories prevent, detect, and remedy errors; increase efficiency; and create safer work environments for laboratory scientists and staff.

To ensure first-rate laboratory quality, CDC has developed a Laboratory Quality Plan. The Laboratory Quality Plan is the result of collaboration between the Laboratory Quality Office (LQO), the Office of Laboratory Science and Safety (OLSS), and Centers within CDC that have laboratories. The Plan has 6 major components:

  1. Three quality management systems: one for CDC infectious disease laboratories, one for non-infectious disease laboratories and one for NIOSH laboratories. Separate quality systems permits more detailed quality specifications tailor-made for different types of CDC laboratories.
  2. Development of a Quality Manual for Microbiological Laboratories (QMML) that describes quality standards for CDC 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.
  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 CDC ID laboratories.
  5. An electronic Quality Management System (eQMS) that is flexible, easy to use and facilitates CDC 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 CDC laboratories (clinical, surveillance, and research); clinical laboratories will be audited to meet CLIA requirements by Center for Medicaid and Medicare Services approved auditors.

Learn how CDC is improving laboratory quality after issues with its original test for SARS-CoV-2.

Building Laboratory Quality Capacity

CDC has ongoing targeted activities to build capacity and advance laboratory quality management across the agency, including piloting electronic tools for the advancement of laboratory quality system management in CDC laboratories.

CDC also provides trainings for laboratory scientists at the agency, in domestic and international public health laboratories, and in clinical laboratories.

A CDC laboratory training facility prepares scientists for future work with infectious agents by training on required safety measures at all biosafety levels, including in two mock high-containment laboratory settings, Biosafety Levels 3 and 4.

CDC is committed to ensuring that Americans can rely on the agency to protect the public’s health and produce accurate, evidence-based science.