|Proceedings of a Workshop—in Brief|
Future of the Nation’s laboratory Systems for Health Emergency Response
Proceedings of a Workshop—in Brief
On March 23–24, 2023, the National Academies of Sciences, Engineering, and Medicine Forum on Medical and Public Health Preparedness for Disasters and Emergencies and the Forum on Microbial Threats hosted a workshop to explore the United States’ laboratory and testing responses to past, present, and potential public health emergencies and to discuss the future of laboratory capabilities, capacities, and coordination for public health emergencies response across public and private entities nationally. During the first day of the workshop, panelists examined the performance of current laboratory systems for public health emergency preparedness and responses. Panelists on the second day explored potential short-term strategies and actions to enhance the capabilities, capacities, and coordination of the laboratory systems for public health emergency preparedness and response. The workshop concluded with a roundtable panel discussion envisioning the ideal structure, characteristics, components, capabilities, and functions of what could be considered a coordinated national laboratory system (NLS), a coordinated system of public and private laboratories, manufacturers, pharmacies, and other entities, that is prepared to respond to future public health threats and emergencies.
This Proceedings of a Workshop—in Brief is structured thematically, rather than sequenced according to the workshop agenda. It summarizes the key points made by the workshop participants during the presentations and discussions and is not intended to provide a comprehensive summary of information shared during the workshop. The views summarized here reflect the knowledge and opinions of individual workshop participants and should not be construed as consensus or recommendations among workshop participants or the members of the Forum on Medical and Public Health Preparedness for Disasters and Emergencies, Forum on Microbial Threats, or the National Academies.
Asha M. George, the executive director of the Bipartisan Commission on Biodefense, set the stage for the workshop when she explained the urgent need for an NLS to expect and plan for multiple disasters and emergencies occurring simultaneously. W. Craig Vanderwagen, the co-founder and director of East West Protection, emphasized that significant change will not be made unless action is taken in a collaborative way. Suzet McKinney, a principal and the director of life sciences at Sterling Bay, expressed
the need for, and challenges associated with, addressing the many deficits in the current laboratory systems.
CURRENT LANDSCAPE OF THE NLS FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS AND RESPONSE
Throughout the two days, panelists identified and defined the nation’s current laboratory systems, components, and stakeholders. Reynolds Salerno, the director of the Division of Laboratory Systems at the Centers for Disease Control and Prevention (CDC), demonstrated the complexity and massive scale of the NLS with his comment “clinical diagnostic and screening testing occurs simultaneously in not only public health laboratories and commercial laboratories but also in hospitals, urgent care centers, pharmacies, nursing homes, schools, correctional facilities, drive-through tent facilities in parking lots, and even in homes.” Jill Taylor, a senior advisor for scientific affairs at the Association of Public Health Laboratories (APHL)1, reiterated the complexity and described the current structure as comprising 10 sectors: (1) government-run public health, (2) hospital and clinical, (3) commercial, (4) academic, (5) community-based (urgent care walk-in clinics, pharmacies, and temporary pop-up sites), (6) over-the-counter (OTC) and home testing methods, (7) One Health, (8) reagent and instrument manufacturers and suppliers, (9) federal government agencies (e.g., the U.S. Food and Drug Administration [FDA], CDC, and the Centers for Medicare & Medicaid Services [CMS]), and (10) national associations that represent and advocate for their members.
Andrew Scott, a senior radiological/nuclear health advisor for the U.S. Department of Homeland Security, described the Integrated Consortium of Laboratory Networks (ICLN),2 including its partners, membership, tools, mission, and the process of matching methods to threat agents identified in a risk assessment. The ICLN partnership includes federal laboratory networks3 and partner agencies that allow the network to manage chemical, biological, radiological, and nuclear (CBRN) events affecting humans, animals, plants, and the environment, and more. In his description of the ICLN, Scott mentioned the utility and exercise of their electronic portal for communication, collaboration, and access to the method repository but noted that it is not representative of all federal laboratory capabilities. Scott further described gaps within the ICLN, including a lack of standardization among laboratory information management systems (LIMS) for which critical fields cannot be linked among various systems, declining radiological expertise and absence of a dedicated radiological network, and the application of nationwide, interagency tabletop exercises that are not fully integrated and do not encompass an “all-hazards” approach.
Dan Harms, Program Manager, Operational Laboratory Policy and Programs and Executive Secretariat, DoD Laboratory Network (DLN), described the DLN,4 which is composed of clinical, public health, and research laboratories in addition to other DoD-specific members. The DLN is also a participant in another national-level network, the CDC’s Laboratory Response Network (LRN).5 Harms explained that the DLN is charged with responding to incidents that occur on DoD installations or as needed for national defense and, when authorized, for Defense Support of Civil Authorities (DSCA), further exemplifying the numerous, diverse laboratory networks operating within the current NLS landscape that address more than just public health.
Scott J. Becker, the chief executive officer of APHL,6 described the roles of state and local governmental public health laboratories (PHLs) in the LRN, which currently consists of biological and chemical specialty subnetworks, LRN-B7 and LRN-C,8 respectively. PHL members of the LRN participate in preparedness activities such as method validations, method and instrument trainings, and drills and exercises, he said. All LRN-B laboratories are responsible for providing highly skilled, technical biothreat analyses to support public health
3 The laboratory networks include: the Department of Defense’s Laboratory Network (DLN), the Laboratory Response Network (LRN), the National Animal Health Laboratory Network (NAHLN), the National Plant Diagnostic Network (NPDN), the Food Emergency Response Network (FERN), the Environmental Response Laboratory Network (ERLN), and the Veterinary Laboratory Investigation and Response Network (Vet-LIRN).
emergency responses, but there are three levels of LRN-C member laboratories which are responsible for different functions based on their committed level of capabilities and capacities. For example, Level 3 LRN-C laboratories may perform tasks such as local outreach and sample logistics like packaging and shipping necessary reagents, supplies, and materials to testing laboratories during a response, whereas Level 1 sites must be able to perform sophisticated chemical analyses for an extensive list of targets and provide surge testing in support of CDC response efforts. There is at least one LRN-B and one LRN-C laboratory positioned in each U.S. state.
In providing a broader perspective regarding PHLs, Becker explained that they are part of a complex system composed of state and local governmental laboratories that provide laboratory services for their population. The scope of some of these PHLs is very focused, while others’ services are more diverse and span a variety of disciplines including clinical, food safety, environmental health, animal health, and agriculture and may even encompass applied research. He further distinguished the role of PHLs from those of larger hospital, clinical, and commercial laboratories by their purposes, whom they serve, and why they perform testing, summarizing the differences thus: “[T]he public health lab serves the population within its jurisdiction. Private laboratory services focus on the needs of the individual patient.” Grace Kubin, the director of the Texas Department of State Health Services Laboratory, supported this description of the role of PHLs when she said that they can provide testing services for more populations, such as the under-insured and non-insured, than other providers. Additional contributions by the PHLs were listed by Ewa King, the chief program officer at APHL, who said that these entities also perform ongoing biomonitoring, food contamination investigations and drug overdose surveillance testing, and drinking water analyses.
In Becker’s examination of the NLS in its entirety, he described it as a “system of systems” and explained that the systems of public and private laboratories function together—although in parallel—during “peacetime,” i.e., when providing more routine services, whereas during “wartime,” or public health emergencies, their relationship and collaboration are “vital to providing those services that are needed to determine the extent of the outbreak.” However, Becker continued, there is no “playbook” to guide the transition from “peacetime” to “wartime” and back again. He called for more structure within government and spoke about the need for consistency and predictability in responses.
Becker’s “systems concept” resonated with Salerno’s description of the NLS as complex and massive. Salerno cited numerous examples of surveillance networks, including the National Respiratory and Enteric Virus Surveillance System,9 CaliciNet, FoodNet,10 the Animal Contract Outbreak Surveillance System,11 and the National Wastewater Surveillance System,12 and noted that each actively captures data before an event is even evident. Summarizing, Salerno said that most resulting “responses by these networks resolve themselves through the traditional public health system,” while other, larger responses require involvement from other entities for the necessary testing capacity.
A grimmer perspective regarding the readiness of the NLS was offered by John Griggs, the lab director of the National Analytical Radiation Environmental Laboratory at the U.S. Environmental Protection Agency (EPA), when he described on the nation’s dwindling capability and capacity to respond to radiological and nuclear incidents. He attributed this decline to the retirements of experts compounded by reduced training; outdated instrumentation, equipment, and facilities; and stagnant funding. “This will have dire consequences in responding to a radiological or nuclear terrorist incident or major nuclear accident,” he warned. Similarly, King expressed concern about the decline of capabilities and capacities for radiological and nuclear threat testing, stating that even a small-scale event would overwhelm existing capacity.
9https://www.cdc.gov/surveillance/nrevss/index.html (accessed June 5, 2023).
10https://www.cdc.gov/norovirus/reporting/calicinet/index.html (accessed June 5, 2023).
12https://www.cdc.gov/nwss/wastewater-surveillance.html (accessed June 5, 2023).
Timothy Stenzel, the director of the Office of In Vitro Diagnostics at the FDA, said that in the NLS, the FDA focuses on interactions, collaborations, and contributions to preparedness and response through emergency use authorizations (EUAs)13 for diagnostic tests, medical device reports, and their bioinformatics pipeline; a pipeline that he described as able to offer a good predictive system for the detection of pathogen variants. He added that FDA serves as a resource to laboratories and manufacturers regarding EUA tests and allowable supply and material substitutions for them.
From the nongovernmental arena, Susan Van Meter, the president of the American Clinical Laboratory Association (ACLA), and Anita Patel, the vice president of pharmacy services development at Walgreens, expanded upon the roles of larger, nongovernmental laboratories and pharmacies in the NLS and described the significance of their private–public partnerships before and during a public health emergency. Beth Marlowe, the senior scientific director and head of research and development of infectious disease and immunology at Quest Diagnostic Infectious Disease, further elaborated on the role that national reference laboratories play in the NLS by describing how they can serve as a resource and partner during public health emergency response because of their national footprint and infrastructure. But partnerships, roles, and responsibilities need to be discussed in advance and early on in the process if they are to be effective and to reduce the initial chaos of responding to an emergency. Reflecting on their involvement in previous responses, Van Meter and Patel discussed how the private sector contributed surge testing, surveillance, early detection, and surge response. Patel specifically described work that CDC conducted with pharmacies throughout the years, beginning in 2009 with the response to the H1N1 pandemic. It was clear that pharmacies could be used for delivery and distribution of therapeutics and vaccines, but COVID-19 required a different response early on when the ability to scale to test was needed. Patel said that these partnerships enhanced health equity through increased access across communities and the digital health experience for the public and public health partners in the COVID-19 response. Van Meter acknowledged that interactions with public entities can be challenging but explained how these partnerships and intensive collaborations are essential for augmenting laboratory capacity during public health emergency response activities, such as those experienced during COVID-19 and Mpox.
EXAMINING FACILITATORS AND BARRIERS TO LABORATORY PUBLIC HEALTH EMERGENCY PREPAREDNESS AND RESPONSE
Workshop speakers examined specific factors that strengthen or restrict public health emergency preparedness and response. As the basis of their discussions and evaluations, panelists used past and current case examples from a broad scope of laboratory responses to public health emergencies, including the Deep Water Horizon oil spill, train derailments with subsequent release of toxic products, e-cigarette or vaping use–associated lung injury (EVALI), zoonotic outbreaks, Mpox, and Candida auris.
Facilitators to Public Health Emergency Preparedness and Response
Christina Egan, the deputy director of the Division of Infectious Diseases and chief of biodefense and mycology laboratories at the Wadsworth Center at the New York State Department of Health, noted that in its response to previous incidents, such as the 2001 Anthrax events, the federal government made funding available to PHLs to enhance capabilities and capacities in various forms, ranging from trained personnel to supplies and instrumentation. Egan elaborated on the benefits from these experiences, such as the establishment of processes, regulatory standards, partnerships, and communications that supported later response efforts, such as the response to Mpox. Kubin later described a similar scenario in her example of the U.S. response to Ebola response. And King also mirrored many of Egan’s points in her example of the PHL response during the EVALI crisis; in particular, she pointed out the significance and contribution of a “coordinated federal response, clear communication to states on response activities, and complex testing” towards the “likely identification of chemical agent responsible.”
Similarly, Joe Annelli, the executive vice president of the National Association of Federal Veterinarians, highlighted collaborative relationships among agencies, networks, and vendors; the availability of standard tests; and funding as factors that contribute to a successful response. However, he extended the scope of these relationships to include laboratories in the animal health arena, which can be a source of information regarding zoonotic diseases. He also spoke about the significance of data from this sector, their value in understanding and preventing human disease, and the criticality of clearly communicating these findings.
Patel and Matthew Binnicker, the director of clinical virology for the Division of Clinical Microbiology of the Department of Laboratory Medicine and Pathology at Mayo Clinic, representing the American Society for Microbiology (ASM),14 expanded the scope of communications and collaborations to include patients and highlighted the existing close relationships that pharmacies and clinical laboratories, respectively, have with patients using their services.
Several panelists from the private sector also spoke about how regulatory flexibility helped their response efforts. Specifically, Patel said that the Public Health Emergency Declaration and Public Readiness and Emergency Preparedness Act15 enabled a robust national testing program through pharmacies, known as the Increasing Community Access to Testing (ICATT) for COVID-19 program,16 which allowed them to effectively reach individuals from underserved communities for testing and vaccination during the COVID-19 pandemic. Lee Fleisher, the chief medical officer and director for the CMS Center for Clinical Standards and Quality, further described how clinical regulatory flexibilities provided by the Clinical Laboratory Improvement Amendments (CLIA)17 during the COVID-19 pandemic, such as allowing remote review of pathology slides and data, the use of alternate collection devices and expired reagents, and expedited review of CLIA applications, aided response activities. However, Scott Shone, the director of the North Carolina State Laboratory of Public Health, described how inconsistency in regulatory standards among sectors creates a patchwork of guidance across districts and further cautioned that relaxing regulatory standards could create risks worthy of consideration.
From the environmental health perspective, Rob Middleberg, the core laboratory director and senior vice president of quality assurance and regulatory affairs at NMS Labs, spoke about the benefits of having immediate access to validated methods, the ability to develop methods, and a trained workforce to perform the testing. It is not practical to have readily available tests for all of the more than 182 million compounds registered by the Chemical Abstract Service, he noted, and he underscored the significant contribution that comes with collaboration. King said that some have an unrealistic expectation that laboratory capacity should be maintained for all possible chemical and sample combinations. But that is not possible, and, furthermore, chemical analyses often require labor-intensive, non-automated processes; thus a different approach is called for, especially when thousands of tests for various targets are required for a public health emergency response, as was the case in the aftermath of the World Trade Center bombings. In that situation, Middleberg said, his laboratory was asked to “immediately bring up testing to be able to handle 11,000 samples for mercury, beryllium, and PCBs, polychlorinated biphenyls,” and attributed the lab’s success to “good relations, relationships with your vendors, instrument vendors, supply vendors to ramp up in a hurry.” In his closing statements, Middleberg emphasized the necessity of collaborations for successful outcomes, regardless of the sector, when he stated that even if a laboratory has “tests ready for all of the possibilities . . . it’s got to be a group effort.”
Barriers to Public Health Emergency Preparedness and Response
Existing gaps in laboratory capabilities, capacities, and resources that could negatively affect response activities also surfaced throughout workshop discussions. During Andrew Scott’s description of the ICLN, he pointed out that the use of non-uniform LIMS by collaborators and partners created a barrier to data sharing within the
15https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx (accessed June 5, 2023).
17https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA (accessed June 5, 2023).
NLS. This issue, along with the need for a standardized “defined minimum data set” to initiate testing, was described as a challenge that crosses public and private sectors. Scott also said that this deficiency creates another gap by building “a false sense of security, and decision makers need the laboratory data in context,” which was also later emphasized and summarized as “data to information” by Fleisher.
Van Meter’s sentiments on the issue of the defined minimum data set and the need for interoperability were clear in her comment that this is “like the Holy Grail we’ve all been chasing for a long time.” She explained further by saying that reporting requirements in general were a concern for reference laboratories since they “face a myriad of reporting requirements” from the various health agencies with which they interact. Further, laboratories are routinely required to report numerous patient demographic data points despite not possessing this information as these data do not come through to laboratories on test orders. Van Meter stated that an actionable, minimum data set for such information should be established and required to be collected by ordering clinicians. Fleisher also emphasized that poor interoperability in electronic data sharing, reporting requirements, and communication hampered rapid testing, hindered data exchange, and failed to provide accurate data for decision making in response to COVID-19.
Van Meter elaborated by describing other factors that interfere with preparedness and response efforts by commercial laboratories. She explained that these laboratories are expected to engage with other entities during public health emergency events without an assurance of compensation, which is vital to commercial labs. Specifically, Van Meter stressed that “predicatability in reimbursement—that is coding, coverage, and payment—is critical to laboratories making determinations on response efforts,” as reductions made to reimbursement programs, as under the Medicare program where deep cuts in payment to clinical laboratories are scheduled for the next three years, directly affect the ability of commercial laboratories to provide services, ensure capacity, and innovate. Eric Konnick, an associate professor and the associate director of the Genetics and Solid Tumors Laboratory and the director of Genetics Preanalytical Services for the Department of Laboratory Medicine and Pathology at the University of Washington School of Medicine, spoke about this risk undertaken by the private laboratories.
Public entities are also affected by financial obstacles, as King pointed, mentioning specifically the absence of a “coordinated and funded emergency response network for governmental laboratories involved in environmental testing.” She explained that the “EPA eRLN [Environmental Response Laboratory Network]18 and WLA [Water Laboratory Alliance]19 are not funded, underutilized, and not activated for environmental emergencies.” At the PHL level, Shone pointed to the systemic issue of repeated funding shortages. While he described how federal support received in response to previous public health incidents had afforded them solutions, Shone cautioned that “it takes money to keep the capacity running so that we can initially respond” until laboratories with higher capacity and throughput capability are able to assist. “This type of reactive funding is temporary, short-lived, and insufficient for an adequate level of sustained preparedness and response,” he said. Annelli and D. Christian Hassell, the deputy assistant secretary and senior science advisor at the Administration for Strategic Preparedness and Response (ASPR),20 also expressed concerns about the impact of the “short memory” of the federal government on the performance of the NLS.
Other barriers that were discussed by panelists that were not unique to a particular laboratory type included the lack of fully automated platforms/ability to test at scale, workforce shortages, and supply chain issues. Egan, King, and Middleberg indicated that labor-intensive methods and high-throughput testing without automated processing and analytical capacities can delay turnaround time for results reporting and that workforce and supply
18https://www.epa.gov/emergency-response/environmental-response-laboratory-network (accessed June 5, 2023).
19https://www.epa.gov/waterlabnetwork/learn-about-water-laboratory-alliance (accessed June 5, 2023).
chain shortages compound these gaps. Scott said that the ICLN is “a little bit resource constrained,” as he is the single federal staff member. Van Meter highlighted the pervasiveness of the workforce issue with, “You can’t talk about clinical laboratories these days without noting the workforce challenges that we are all facing,” she said. Similarly, Becker described supply chain concerns as “a huge bottleneck for every part of this sector.” Shone identified another critical takeaway regarding supply chains when he described how essential diagnostics, such as newborn screening and diagnoses of sexually transmitted diseases, were compromised during surge emergency response testing experienced during the COVID-19 pandemic. PHLs are responsible for providing diverse testing services to an entire population, and, he said, “We can’t jeopardize the ability to test for [human immunodeficiency virus] HIV or for prenatal syphilis because the same pipette tips or the same plates are used.” In the PHL realm, he added, it is not just about preparedness and response, but the sustainability of all critical functions and services.
EXPLORING SHORT-TERM STRATEGIES TO STRENGTHEN THE NATION’S LABORATORY SYSTEMS FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS AND RESPONSE
George reset the stage for the second day of the workshop and challenged the panelists to look forward beyond the gaps and obstacles and towards potential actions to improve the current state of the NLS (Box 1).
Identifying Short-Term Strategies for Surveillance and Early Detection
Panelists discussed a number of potential short-term strategies to enhance laboratory capability, capacities, and coordination related to the surveillance and early detection of public health threats and to address gaps and improve the integration of multi-source surveillance systems with national surveillance systems.
Salerno described the use of impact “testing scenarios” (essentially algorithm-based laboratory testing responses), originating from general scenarios that shape laboratory and testing responses based on whether a disease is known or unknown, transmission occurs via the respiratory route, treatments are available, and the health outcome (morbidity/mortality) data are available. Salerno offered a conceptual framework for evaluating laboratory system response in which various entities, ranging from federal agencies through academia, are assessed in the phases of surveillance, the initial response, the initial surge response, the expanded surge response, and recovery. He proposed that further examination of the framework’s concepts and contributors could ultimately lead to strategies encompassed in the CDC National Roadmap [the Strategic Framework].21 Gigi Kwik Gronvall, a senior scholar at Johns Hopkins Center for Health Security and an associate professor in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health, also spoke about the importance of meaningful drills and exercising the capability of the public–private interface for preparedness.
Tracey Goldstein, the chief of the Emerging Threats Division of the Office of Infectious Diseases within the Bureau for Global Health at the U.S. Agency for International Development, stressed the importance of further developing partnerships across sectors and, more specifically, making the animal health system as strong as the human health system. She and Annelli spoke about the significant role of animal health and of the surveillance of zoonotic diseases and lineages in reducing the time from identifying a related incident to making informed response decisions, and, building on this, they argued for moving towards a more holistic, One Health22 approach. As Annelli explained, the current NLS relies on a more passive approach that is partnership-based. Goldstein suggested using these existing partnerships and enhancing targeted animal health surveillance tools on a global level as a strategy for garnering more information about changes that could subsequently affect human health. Goldstein said that this surveillance and monitoring tactic coupled with the implementation of pan-assays, or agnostic assays, and the sharing of data across borders to warn communities could ultimately prevent spillover of animal disease to humans and reduce the likelihood of human disease.
21https://www.cdc.gov/csels/dls/strategic-framework.html (accessed June 5, 2023).
Adi V. Gundlapalli, the chief public health informatics officer of the Office of Public Health Data, Surveillance, and Technology at CDC, demonstrated how information captured on a clinical laboratory test order can serve as a “rich data source.” He addressed the gap in having comprehensive data, since, in general, data sharing with CDC is voluntary. “Without mandatory reporting requirements, the responsibility for identifying and communicating key critical elements falls to astute clinicians and laboratorians,” he said. Gundlapalli proposed short-term strategies for public health that encompass these aspects, specifying the need for additional data that link patient data with vaccine history, distinguish data from a single individual and associated samples (i.e., one person versus multiple specimen types from the person), and produces longitudinal data encompassing multiple testing results for a single patient over time. He also supported pathogen-agnostic testing and concluded with a suggestion to implement the CDC’s Public Health Data Strategy.23 The goals of this approach are to (1) strengthen the core of public health data, (2) accelerate access to analytic and automated solutions to support public health investigations, (3) visualize and share actionable insights to inform public health action, and (4) advance more open and interoperable public health data.
Sam Scarpino, the director of artificial intelligence (AI) and life sciences at Northeastern University and former vice president of pathogen surveillance at The Rockefeller Foundation, spoke about what is currently working in the laboratory system and what can be accomplished with “some coordination and funding.” He suggested capitalizing on the competent and well-equipped university laboratories that were built up during the COVID-19 pandemic and are now essentially in standby mode. Using the existing capabilities and capacities of these laboratories to perform localized, high-throughput testing would ease some of the burden placed on PHLs to perform surge testing. Similarly, with more laboratories now performing wastewater surveillance—which Scarpino noted is relatively inexpensive, with the samples being less complex than human specimens with regards to regulation and inactivation protocols—there is a large amount of data available to guide public health action. He acknowledged that the issue of data interoperability would still need to be addressed, to which Goldstein added that it will also be important to develop an understanding of how humans and animals are connected so that necessary changes or interventions can be implemented before an outbreak occurs. Scarpino countered by offering his third and final recommendation—that AI should be applied as a tool for decision makers. While he acknowledged that this would require the training of decision makers, he suggested that it would free up human resources from performing data manipulations and other analytics and improve interoperability to support investigations and enable others to focus on collecting additional samples and messaging.
Lauren Sauer, the director of the Special Pathogens Research Network at the National Emerging Special Pathogens Training and Education Center and an associate professor in the Department of Environmental, Agricultural, and Occupational Health within the Global Center for Health Security, College of Public Health at the University of Nebraska Medical Center, and Colleen Kraft, a professor in the Department of Pathology and Laboratory Medicine of the Division of Infectious Diseases, an associate medical officer at Emory University Hospital, and current ASM president, proposed improvements in or detection through ASPR- and CDC-funded special pathogens treatment centers24 to focus on readiness and early outbreak detection. Sauer and Kraft spoke about the utility of these centers for carrying out more rapid diagnostics through agnostic testing or panel testing that can facilitate rule-out capabilities, early detection, and patient treatment. Sauer suggested that incorporating incentives to invest in systems will be necessary for a consistent plan, one that does not change with the next outbreak. Kraft further commented that national testing should not be the sole responsibility of CDC.
23https://www.cdc.gov/ophdst/public-health-data-strategy/index.html (accessed June 5, 2023).
24https://netec.org/for-researchers/about-the-special-pathogens-research-network/ (accessed June 5, 2023).
Identifying Short-Term Strategies for Acceleration, Surge, and long-Term Response
Panelists also explored short-term strategies to enhance laboratory capabilities, capacities, and coordination focused on acceleration, surge, and long-term responses that could be achieved in the next 3 to 5 years. Many suggestions were offered in direct response to previously identified gaps. For example, Konnick offered the following potential strategies: (1) using all types of clinical laboratories, (2) distributing supplies and control materials for assay validation to laboratories based on geographical disease prevalence, (3) allowing for regulatory flexibilities, and (4) providing reimbursement to laboratories, including coding, broad coverage, and payment.
Mara Aspinall, a professor of practice at the Forensic Science Center of the College of Health Solutions at Arizona State University, added non-laboratory entities to the list of partners to be considered, including test manufacturers, physician associations, patient associations, and educational institutions; by contrast, Binnicker offered a more targeted approach in which four to five strategic diagnostic test manufactures that could serve as a “go-to” for novel emerging infectious diseases are approached during “peacetime” and cited the Prepare for and Response to Existing Viruses, Emerging New Threats (PREVENT) and Pandemics Act25 as providing an opportunity for contacts between government and private entities. Stenzel agreed with this proposal and even suggested that pre-arrangements with a small group of diverse manufacturers could be used to pre-position kits, supplies, and materials to laboratories while their new tests are under FDA review. That way, the laboratories could immediately start testing samples if and when FDA authorization was achieved. Konnick presented data from the Association for Molecular Pathology that showed academic laboratories were able to offer SARS-CoV-2 clinical testing several weeks before manufacturers or larger laboratories, and local testing returned results much more quickly than reference laboratories, stating that this capacity should not be compromised by other efforts.
Regarding testing kits, test components, and other related supplies, Gronvall and Stenzel agreed that the Strategic National Stockpile (SNS) needs to be more robust. And, again, Stenzel and Aspinall expanded the concept to include engagement with manufacturers and developers during peacetime. This approach, they suggested, would identify critical materials to be included in the SNS and therefore to be available to laboratories in the event of a public health emergency. But having the right equipment in the laboratory for these tests are also a consideration, Stenzel and Binnicker added. Stenzel encouraged capitalizing upon instrumentation already available in most laboratories and respecting their space limitations. Shone raised the importance of also reaching out to other, less conventional entities that may be a resource during supply shortages, and he described the resourcefulness that North Carolina’s state PHL procurement team displayed in successfully identifying a source of flocked swabs at Walmart during the COVID-19 pandemic.
Aspinall further elaborated on the benefits of partnerships but stressed the need to communicate frequently and educate partners regarding the strengths and weaknesses of testing. She spoke about the importance of educating providers on the power of diagnostics based on her experiences during the COVID-19 pandemic, in which valuable diagnostic testing did not occur due to a lack of trust in the scientific community and concerns about test accuracy. She and Konnick recommended that continuing medical education for physicians include diagnostics, because, as Aspinall cautioned, “If we lose the trust of the physician community, the providers, and the patients, we’ve lost it all.” In the same vein of educating others and further shortening the time from development to live testing response, Stenzel recommended teaching key developers about the FDA process and requirements to get new tests to market. As an alternative, Stenzel described how the Independent Test Assessment Program26 could be used. Through this program, the review process would be accelerated, and the developers would conduct the
25https://www.congress.gov/bill/117th-congress/senate-bill/3799/text (accessed June 5, 2023).
26https://www.nibib.nih.gov/covid-19/radx-tech-program/ITAP (accessed June 5, 2023).
analytical studies, while the clinical validation would be the responsibility of another entity.
One of Gronvall’s primary proposals for improvements in this response phase was to create a “permanent, private–public testing coordination body.” She explained that such an advisory body would involve stakeholders and serve as a transparent conduit of preparedness activities, would accurately communicate needs, and would ideally facilitate earlier and efficient testing. Gronvall said that many of these recommendations are complemented by the National Academies study Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise.27
CONSIDERING A FUTURE MODEL NATIONAL LABORATORY SYSTEM FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS AND RESPONSE
In the concluding roundtable panel discussion, participants reflected on the entirety of the workshop discussions to articulate the elements, stakeholders, and functions of an ideal NLS structure that would be prepared to respond to future public health threats and emergencies. Joanne Andreadis, the associate director for science in the Office of Readiness and Response at the CDC, moderated the session and charged the panelists to “talk about what we’ve heard previously and think in a very bold way about what a national system might look like.” At the end of her opening remarks, Andreadis referred to one of Scarpino’s earlier suggestions and asked, “[W]hat do we already have that we can immediately build on and make progress on where we don’t have to start from scratch?” framing the issue as “winnable battles.” She then framed the session by asking the panelists to identify two to three “core features” of a model NLS.
Taylor acknowledged at the outset that the model system must provide all populations with equitable services in every type of emergency; therefore, it must be flexible, adaptable, and coordinated. She reflected on Becker’s description of the NLS as a “system of systems” and said that while the roles and responsibilities of stakeholders had been discussed, two important concepts were missing: (1) the dynamic interactions between these systems, which she described as “definitely not static,” and (2) the lack of a “playbook” or flexible decision matrix to guide members of the laboratory community during a public health response. Hassell shared a similar opinion that existing strategies often lack prioritization and corrective actions taken in response to lessons learned from previous responses. Additionally, Taylor said there is a need “to reimagine the laboratory system” as well as a need for a structure within government to bring everything together, and she recommended a “diagnostic playbook” to be used as a decision tool.
Taylor addressed these gaps in her proposal to design a decision matrix that contains the “who does what when, why, and how” during an event, and she described a plan for its development. The first step, she suggested, would be assembling senior representatives from each of the
sectors, a suggestion echoed by Hassell when he said that multiple, diverse stakeholders need to be involved in the development of a NLS. Taylor said that this group would “develop an acceptable governance and operating model, which will allow future collaborative in-depth work that results in a shared vision,” acknowledging that formal agreements would be necessary. With such a model in place, representative subject matter experts (SMEs) would provide input. Taylor elaborated on the importance of broadening the scope of SMEs beyond scientists, suggesting that this group often applies rigid logic and “linear-thinking” and explaining that the participation of SMEs who are also “global-thinkers” should ensure flexibility and make it more likely that adaptability characteristics needed for multiple emergency types are encapsulated in the NLS. The final phase, she said, would include drilling the system at different levels of response to different scenarios.
While Taylor’s focus was primarily on the structure of a model NLS, Jaime Yassif, the vice president of global biological policy and programs at Nuclear Threat Initiative (NTI/bio), suggested a number of core capabilities and characteristics for inclusion: pathogen-agnostic testing, the identification and mitigation of potential obstacles that could limit necessary surge and scale-up capabilities, a digital means of integrated data sharing, and “biosafety and biosecurity by design.” Kubin reinforced the significance of these attributes in her comments about the need for accurate data to guide investigations and make informed, sound public health decisions. Yassif further said that as the system moves forward, preparedness for the “unexpected” (accidental, intentional, and engineered biological threats) and scalability must be considered. Hassell supported Yassif’s sentiments regarding agnostic testing and preparing for the unexpected when he said, “We’ve got to get beyond the list of biological pathogens” and encouraged this approach in the chemical testing laboratories, too, as previously recommended by King. Hassell explained how focusing on historical targets can lead to unpreparedness and illustrated his point with an example about fentanyl, which is not limited to one form but has numerous analogs that could be further manipulated and synthesized.
Hassell challenged the workshop participants to expand their thinking in ancillary technologies such as AI. He described how such technologies can be used by adversaries to engineer pathogens and synthesize threats outside of the traditional testing scope.
Jonathan Genzen, the chief medical officer at Associated Regional and University Pathologists (ARUP Laboratories) and a Professor at the University of Utah Department of Pathology also addressed characteristics that should be embodied in a model NLS, but he also provided specific approaches to achieve them. For example, Genzen proposed promoting an earlier laboratory response by encouraging innovation, flexibility, and development so that resources are available to be used when needed. Incentivizing the standardization of consumables by manufacturers could allow for compatibility across various automated platforms, which he likened to universal phlebotomy tubes working in different analyzers and pipette tips not being specific to a single instrument. He suggested a similar tactic to enhance the scalability of assays by building in the interoperability of reagents among commercial kits across scalable automated platforms during development. Genzen recommended that processes be simplified and that regulatory requirements be “right-sized” to simplify the management of surge capacity and paperwork, respectively, and he concluded with the concept of federal support to address the workforce shortage.
In his closing remarks, Vanderwagen said that it is time for leadership from the stakeholders—from the laboratories—to develop a solution, “Not a federal solution,” he said. “A national solution.” George expressed similar sentiments and explained that not all the ideas for improvement required funding or federal support. In her concluding statements, George put the onus on the audience and all members in the scientific community to act.
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Urbina, F., F. Lentzos, C. Invernizzi, and S. Ekins. 2023. AI in drug discovery: A wake-up call. Drug Discovery Today 28(1):103410.
DISClAIMER This Proceedings of a Workshop—in Brief has been prepared by Angela Fritzinger, Lisa Brown, and Scott Wollek as a factual summary of what occurred at the meeting. The statements made are those of the rapporteurs or individual workshop participants and do not necessarily represent the views of all workshop participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine.
*The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop—in Brief rests with the institution. The planning committee comprises Asha M. George, Bipartisan Commission on Biodefense; Joanne Andreadis, Centers for Disease Control and Prevention; Benjamin Chan, New Hampshire Department of Health and Human Services; Lee Fleisher, Centers for Medicare and Medicaid Services; Kenra Ford; New York City Health + Hospitals; Jeannette Guarner, Emory University School of Medicine, Joneigh Khaldun, CVS Health; William Meyer, Quest Diagnostics; Andrew Scott, Department of Homeland Security; Jill Taylor, Association of Public Health Laboratories; Brannon Traxler, South Carolina Department of Health and Environmental Control, and Susan Van Meter, American Clinical Laboratory Association.
REVIEWERS To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed by Joneigh S. Khaldun, CVS Health, and Susan Van Meter, American Clinical Laboratory Association. Leslie Sim, National Academies of Sciences, Engineering, and Medicine, served as the review coordinator.
SPONSORS This workshop was partially supported by contracts between the National Academies of Sciences and the Administration for Strategic Preparedness and Response; American Burn Association; American College of Emergency Physicians; American College of Surgeons—Committee on Trauma; American Hospital Association; Association of Public Health Laboratories; Association of State and Territorial Health Officials; Centers for Disease Control and Prevention; Council of State and Territorial Health Officials; Emergency Nurses Association; Healthcare Distribution Alliance; Healthcare Ready; Infectious Diseases Society of America; Mass General Hospital; National Association of Chain Drug Stores; National Association of County and City Health Officials; National Association of Emergency Medical Technicians; National Fire Protection Association; National Highway Traffic Safety Administration; National Institute of Allergy and Infectious Diseases; National Institute of Child Health and Human Development; National Institute of Environmental Health Sciences; Society of Critical Care Medicine; the MITRE Corporation; Trauma Center Association of America; U.S. Department of Defense; U.S. Department of Homeland Security; U.S. Food and Drug Administration; Uniformed Services University of the Health Sciences; University of Nebraska Medical Center. Additionally, this project has been funded in part with Federal funds from the National Institute of Environmental Health Sciences, National Institute of Allergy and Infectious Diseases, National Cancer Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute on Minority Health and Health Disparities and the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Department of Health and Human Services, under Contract no. HHSN263201800029I.
STAFF Lisa Brown, Scott Wollek, Shalini Singaravelu, Matthew Masiello, Aaron Resnick, Michael Berrios, Gina Strohbach, and Rayane Silva-Curran.
For additional information regarding the workshop, visit https://www.nationalacademies.org/event/03-23-2023/future-of-the-nations-laboratory-systems-for-health-emergency-response-a-workshop.
SUGGESTED CITATION National Academies of Sciences, Engineering, and Medicine. 2023. Future of the nation’s laboratory systems for health emergency response: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press. https://doi.org/10.17226/27147.
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