Fighting Pandemics Requires Stronger Data Systems and Laboratory Infrastructure
Dear Chair Murray and Ranking Member Burr:
On behalf of the American Society for Microbiology (ASM), one of the largest life science societies comprised of more than 30,000 researchers and health professionals, we thank you for your leadership on preparing the United States for future public health emergencies. We strongly support the $30 billion investment in pandemic preparedness proposed in the American Jobs Plan. If invested appropriately—in diagnostics, the strategic national stockpile, integrated data systems, laboratory response capacity and training personnel for epidemic and pandemic response—this funding will go a long way towards protecting Americans from future pandemics.
ASM is committed to working with the Congress and the Administration to bolster the systems and infrastructure needed to handle both pressing health threats and the inevitable outbreaks of the future. Many of our members, including those in clinical laboratories, have been on the front lines of the COVID-19 pandemic. While ASM members in clinical laboratories have had the most immediate connection to the crisis, our members also work in research areas critical to our long-term strategy for responding to future pandemics, including basic biomedical research and vaccine and therapeutic development. This research infrastructure also should be strengthened in a broader infrastructure package and specifically, research relief should be provided to assist with recovery for those projects disrupted by pandemic closures.
Our response and ultimate recovery from COVID-19 and readiness for future pandemics depends on a multi-faceted, coordinated effort at the federal, state and local levels and across many sectors of society. The federal government plays an indispensable role in this effort, given that it has the resources, coordinating ability and public platform to lead our nation through times of crisis. The government also needs the capacity and expertise of the private sector, including academic and commercial laboratories, in times of crisis.
Below are our recommendations to invest $30 billion across the following areas: (1) the clinical microbiology workforce; (2) supply chain infrastructure and transparency; (3) laboratory surge capacity and data systems integration; and (4) the Strategic National Stockpile.
Support a Strong Clinical Microbiology Laboratory Workforce
Accurate and reliable diagnostic tests, a steady supply of testing materials and a connected network of labs are useless without skilled personnel to staff the labs and oversee and perform the tests. In 2016, the Bureau of Labor Statistics predicted we needed 12,000 new clinical laboratory professionals each year to meet rising demand. That includes clinical microbiologists—highly trained scientists with PhDs or medical degrees. Prior to the COVID-19 pandemic, a mere 5,000 laboratory professionals entered the work force annually, and clinical microbiology laboratories had more than 10 percent vacancies. The pandemic only made this situation worse.
Personnel are infrastructure, and Congress should consider measures to boost recruitment to fill workforce shortages and measures to ensure that we do not lose key personnel amidst a crisis. We could rapidly scale-up testing by enacting a biomedical version of the National Guard to mobilize scientists. Furthermore, any new proposals aimed at shoring up health-related emergency responders should include clinical microbiologists working in labs and testing for pathogens like SARS-COV-2. These labs require individuals with highly specialized training to conduct and analyze the tests that, in a crisis, will help determine not only who is infected, but also help us better understand the spread of the pathogen. Unless we address the clinical laboratory staffing shortages that have developed over the past several years, we will experience another testing crisis in the future as already-stretched labs will be unable to process the workload. In addition to the exponential increase in workload for laboratories during a pandemic, understaffed labs will be pulled away from other essential testing functions. The federal government can provide the incentives, educational and training support for this profession, which currently does not benefit from federal program support.
Establish a National Supply Chain Data System
A national testing strategy is essential in a crisis so that we can maximize the utilization of testing when it is needed most. A comprehensive national database will ensure that all partners in an emergency response have transparency into the supply chain at a national level. The federal government should fund development of a large scale, coordinated system to connect the public, clinical, commercial and industrial sectors to ensure sufficiently robust supply lines, transparency about when and where shortages exist and for what materials, and transparency around supply allocations. This will enable public health entities, manufacturers and clinical laboratories to plan ahead (minimizing the need for real-time decision-making), and more effectively leverage the power of testing to combat an outbreak.
When the demand for testing increased in the spring of 2020, clinical laboratories were unable to fully deploy testing due to unpredictable shortages. A lack of testing supplies coupled with anxiety over the potential to exhaust existing supplies hindered our ability to bring the pandemic under control. Beyond reagents, there were shortages of transport media and plastics, affecting tests developed and offered by independent, hospital and academic-based laboratories. A comprehensive system with near real time data will give line of sight to all laboratories as to the status of multiple supply chains and allow for effective planning and appropriate resource allocation.
Enable a Public-Private Laboratory Network to Provide Surge Capacity
We have learned that it takes multiple partners to provide the required level of testing needed during a public health emergency such as COVID-19. We need to maximize testing by public, academic, hospital-based and independent laboratories for all purposes, from prevention, to patient care, to surveillance and reference. The “surge capacity” that a coordinated and inclusive public-private partnership can provide is crucial in a public health emergency.
The National Guard concept referenced above is applicable here too, and it would support a rapid response force of laboratories staffed with microbiologists and other scientists who could help reinforce the health care system during pandemics. This would let hospital and academic laboratories serve as the backbone for medical diagnoses in a pandemic. These laboratories are critical, because an estimated 70% of medical decisions are based on diagnostic tests. As we envision the laboratory of the future, we also need to ensure that laboratory personnel have access to training in next generation sequencing techniques. We have learned from the pandemic and specifically, SARS-CoV-2 variants, that the skills and technology to do whole genome sequencing of pathogens is an important role in a laboratory response.
The CDC Laboratory Response Network (LRN) should be expanded to include qualified academic, hospital and independent labs that can serve as a “backstop” at the early stages of a pandemic when we are almost wholly dependent on public health labs and CDC. However, funding is needed for private sector laboratories to be a part of this network because current laboratory information systems do not universally integrate with public health departments that rely on laboratory data, as we have seen during the COVID-19 pandemic. There is a cost to private laboratories who want to connect to these systems—an upfront cost that can be a hindrance to many smaller and academic laboratories. Laboratories (both public and private) are a critical component of any public health response and should be integrated into our public health infrastructure.
Further, we must have a robust, healthy and stable laboratory infrastructure. Unfortunately, our laboratory infrastructure is being decimated by ongoing cuts to the Clinical Laboratory Fee Schedule. Payments to clinical labs have been cut drastically over the past four years as a result of the Protecting Access to Medicare Act of 2014. These cuts have hampered labs ability to invest in research and development and set the industry back at a time when it was most needed. When labs are financially stable they can absorb the additional work required and make up for potential lost resources during an emergency.
Strengthen the Strategic National Stockpile
Increased funding for the Strategic National Stockpile (SNS) ($4 billion over 4 years) will diversify the supply chain to include diagnostics and supplies, such as testing kits, swabs, pipette tips and reagents. Clinical testing supply shortages plagued laboratories over the course of the pandemic, with a tremendous impact on our ability to test for COVID-19. The diversion of resources to meet that demand also prevented necessary testing for “routine” infectious diseases such as sexually transmitted infections, strep throat and urinary tract infections. Diagnostics enable and inform all aspects of infectious disease outbreak management—from surveillance and detection, to response, containment and recovery. As such, we must ensure that diagnostic supplies and ancillary provisions receive the same attention in our preparedness efforts as medical countermeasure.
We deeply appreciate your strong and steadfast leadership, and your pursuit of legislation and multi-year funding that will protect our nation from future pandemics and other health and economic threats. ASM stands ready to work with you to help improve the systems we have in place today, and to develop the solutions that will help address tomorrow’s challenges.
Stacey Schultz-Cherry, Ph.D
Chair, ASM Public and Scientific Affairs Committee
Stefano Bertuzzi, PhD, MPH
Chief Executive Officer