Lab Matters Spring 2020 - Page 27

PUBLIC HEALTH PREPAREDNESS AND RESPONSE Paved the Way for Regulatory Changes to Meet Testing Demand • Contacted FDA to seek enforcement discretion and proposed solutions to ensure quality testing and timely results. • Encouraged member laboratories (e.g. New York State, New York City) to submit requests to FDA for an emergency use authorization (EUA) of their assays. Communicated Credible Information at a Rapid Pace Collaborated with CDC to convene weekly calls with public health laboratories to provide timely response information and facilite communications among public health laboratories, APHL, CDC, FDA, HHS and CMS. Issued Lab Alerts, developed a website, and participated in dozens of media interviews about public health laboratory testing capabilities. Strengthened Data Infrastructure Provided a dedicated technical assistance team (project manager, vocabulary terminologist and data integration lead) to support 57 public health laboratories as they modify their PHLIP data feed to include COVID-19 test results. Held educational webinars on COVID-19 biosafety andl lessons learned, risk assessments and how to safely and securely handle respiratory and other specimens from persons under investigation (PUIs). Collaborated with Partners to Educate Congressional Staff and Policy Makers on Funding Needs Provided informatics guidance and updated FAQs following the removal of the N3 target, and worked on creating Viral Transport Media Protocols and QIAGEN EZ1 Virus 2.0 Kit Use tools for members. Worked closely with CDC data messaging leads to develop clear guidance, a streamlined validation process and a technical assistance mechanism. On February 24, APHL, ASTHO, NACCHO and CSTE sent letters to Congress requesting emergency supplemental funding to support COVID-19 response. Through its various funding structures, CDC has provided the following assistance to state, local, territorial public health laboratories and health departments: • $25 million redirected from internal activities • $739.8 million from the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 through the Public Health Crisis Response Cooperative Agreement • $641 million through the Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases Cooperative Agreement (ELC) • $10.25 billion from the Paycheck Protection Program and Health Care Enhancement Act through the ELC to develop, purchase, administer, process and analyze COVID-19 tests, conduct surveillance, trace contacts and other related activities. PublicHealthLabs @APHL Spring 2020 LAB MATTERS 25