The Role of the Division of Laboratory Systems (DLS) in Laboratory Preparedness and Response
The DLS mission is to strengthen the nation’s clinical and public health laboratory system by continually improving quality and safety, informatics and data science, and workforce competency. The 260,000 Clinical Laboratory Improvement Amendments (CLIA) certified laboratories in the United States are on the frontline of patient care and emergency response, and DLS is uniquely positioned to leverage existing relationships with principal stakeholders in the clinical laboratory community.
Infectious disease outbreaks, even small or remote ones, may be a global threat and require a swift public health response. Accurate, accessible, and robust diagnostic tests are critical for patient management and public health response. DLS is developing a preparedness repository, in partnership with CDC’s Division of Scientific Resources (DSR) and Center for Preparedness and Response (CPR), to facilitate access to specimens and materials that may be difficult to obtain during a response. These specimens and materials would be used to improve rapid development, performance characterization, and implementation of Emergency Use Authorization (EUA) tests during a response. The CDC Biorepository has the expertise, infrastructure, and relationships to support the creation and maintenance of a centralized, national preparedness repository.
Previous public health emergencies, such as Zika and Ebola, identified the critical need for CDC, Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS) to collaborate more seamlessly in developing and deploying emergency use diagnostic assays. Through the Tri-Agency Task Force for Emergency DiagnosticsCdc-pdfExternal (TTFED), DLS, FDA, and CMS will collaborate to develop a standardized process for rapid deployment and implementation of diagnostic tests during public health emergencies.
DLS is taking a systems approach to develop increased diagnostic testing capacity nationwide, especially during public health emergencies. The lack of adequate laboratory testing capacity was evident during the response to the Zika outbreak in 2016. To address this issue, DLS is developing formal partnerships with large commercial laboratories to provide substantially increased testing capacity in advance of the next emerging infectious disease outbreak. DLS can also provide guidance and training to advance quality testing, effective reporting, and safe practices to build surge capacity infrastructure.
Using the DLS Laboratory Outreach Communication System (LOCS), CDC can provide consistent and timely communication to clinical partners during an emergency response. Currently, LOCS is a functional CDC mailbox (LOCS@cdc.gov) managed by DLS technical experts, designed to update and answer questions from clinical laboratories across the nation. LOCS will be available to deliver messages from the Joint Information Center, the Emergency Operations Center (EOC), and CDC programs during emergencies, and in coordination with state public health laboratories. LOCS will also facilitate requests for additional laboratory surge capacity in collaboration with the EOC Laboratory Task Force.