About Us
Vision: Exemplary laboratory practice and systems strengthen clinical care, public health, emergency response, and health equity.
Mission: Improve public health, patient outcomes, and health equity by advancing laboratory systems.
The Division of Laboratory Systems (DLS) advances the quality and safety of clinical and public health laboratory testing and services nationwide. DLS fosters the development of laboratory standards and guidelines and supports regulatory programs. DLS works in partnership with the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) by providing scientific and technical expertise for the Clinical Laboratory Improvement Amendments (CLIA) program.
DLS enhances public health surveillance and response by strengthening the exchange of laboratory data between organizations and systems, and conducting analyses of large laboratory-based datasets. DLS also operates the CDC Biorepository, which preserves valuable specimen collections for public health surveillance, advancing diagnostic and medical research, and supporting emergency responses.
DLS works to improve the knowledge, competency, reliability, and sustainability of the clinical and public health laboratory workforce nationwide. Specifically, DLS supports the clinical and public health laboratory workforce through the development of training products and resources and implementation of competency guidelines for public health laboratory professionals.
Learn about the division’s strategic framework, which will guide its work to advance quality and safety systems, informatics and data science, and training and workforce development.
- 70% of today’s medical decisions depend on 14 billion laboratory tests conducted annually
- There are over 330,000 CLIA-certified laboratories in the United States
- Experts estimate that 40,000–80,000 deaths occur annually from preventable diagnostic errors
- ABSA (American Biological Safety Association) International
- American Association for Clinical Chemistry
- American Clinical Laboratory Association
- American Society for Microbiology
- Association of Public Health Laboratories
- Centers for Medicare & Medicaid Services
- Clinical and Laboratory Standards Institute
- College of American Pathologists
- Food and Drug Administration
- Public Health Informatics Institute
Graber ML, “The incidence of diagnostic error in medicine,” BMJ Qual Saf 2013;22:ii21-ii27.
Leape LL, Berwick DM, and Bates DW, “Counting Deaths Due to Medical Errors—Reply,” JAMA 2002;288(19):2405.
Tehrani, AS Saber, et al., “25-year summary of US malpractice claims for diagnostic errors 1986-2000: an analysis from the National Practitioner Bank,” BMJ Qual Saf, 22, 672-680 (2013).
Winters B, et al. “Diagnostic errors in the intensive care unit: a systematic review of autopsy studies,” BMJ Qual Saf 2012;21:894–902.