Lab Matters Fall 2019 | Page 16

PARTNER PROFILE minutes with Ren Salerno by Nancy Maddox, MPH, writer Reynolds (“Ren”) Salerno, PhD, has an international reputation for excellence in promoting the safe, secure and responsible handling of dangerous biological agents in laboratory settings. Before becoming director of the Centers for Disease Control and Prevention’s (CDC) Division of Laboratory Systems (DLS) in 2016, he served as senior manager for biological sciences and technologies at Sandia National Laboratories, where he oversaw laboratory quality systems, biosafety, biosecurity, biocontainment and infectious disease diagnostics. Salerno is a US delegate to Technical Committee 212 of the International Organization for Standardization and has served on the board of directors of the International Federation of Biosafety Associations (and was previously its vice chairman). He has been a technical advisor to both the World Health Organization and the US Defense Science Board’s Task Force on Deterring, Preventing, and Responding to the Threat or Use of Weapons of Mass Destruction. He currently serves on APHL’s Biosafety and Biosecurity Committee and is the CDC’s liaison to the APHL Board of Directors. Salerno received a bachelor’s degree from Middlebury College and a PhD from Yale University. 14 LAB MATTERS Fall 2019 What prompted your interest in public health? 2014 was a big year for me professionally. Not only did Ebola arrive in the United States, but there were back-to-back biosafety incidents at CDC and biosecurity issues at the National Institutes of Health. These events made us realize that prompt diagnosis, biocontainment, and infection control were critical competencies for all US hospitals and clinical laboratories. At that time, many clinical laboratories in the United States declared that they would refuse to test any suspect Ebola specimen—which I believed was a disregard of their duty that harkened back to the initial response to the HIV crisis of the 1980s. Add all that up, and I suddenly saw a public health career as a real opportunity to support CDC and advance biorisk management in a way I couldn’t do from outside the federal government. How has the field of biorisk management evolved over the last decade? Hopefully, we’re in the midst of a paradigm shift from an agent-based perspective on biosafety to a risk-based perspective—essentially a move from an almost exclusive focus on assessing hazards in a laboratory setting to a broader understanding of what all can go wrong and how best to prevent those things. The historical paradigm is to simply implement the recommended biosafety level (BSL) for the agent you’re working with. This generally makes sense in a research environment where you know what you’re working with, but makes little sense in a clinical or public health laboratory environment where you usually don’t know the agent you’re working with because you’re trying to identify the agent. For example, Ebola is defined as a BSL-4 agent. But, like most clinical laboratories in the US, Dallas Presbyterian—where the first US Ebola patient walked into the emergency room—has no BSL-4 capabilities. By this reasoning, Dallas Presbyterian and almost every other hospital and clinical laboratory in the country would be incapable of testing specimens from a suspected Ebola patient. Yet the clinical laboratory at Dallas Presbyterian successfully tested Ebola specimens from two Ebola patients without transmission to any laboratory staff, and the same was true at Emory, Nebraska and Bellevue— none of which has a BSL-4 laboratory. Biorisk management is not just about the agent; it’s about the people, procedures, training, equipment, instrumentation, environment, and everything else that could possibly contribute to something going wrong. Context matters. All of those elements have to be continually evaluated and managed. Risk assessment, risk mitigation, and performance evaluation must become day-to-day activities, not an annual report that sits on an administrator’s shelf. What major changes in US laboratory systems, public and private, can we expect over the next 10 years? Clinical laboratory testing is big business. We perform 14 billion tests per year in the US, and that number has increased 5 to 10 percent every year over the last decade. That’s greater than the 1 percent average annual growth of the US population. In addition, the number of FDA-approved clinical laboratory tests—not including new genetic testing products—has doubled over the last 20 years. Laboratory testing is becoming increasingly PublicHealthLabs @APHL APHL.org