By - March 16, 2021
Editor’s Note: It has been just over a year since the SARS-CoV-2 virus, and the ensuing COVID-19 pandemic, swept the nation. In this first of a three-part series looking at how different areas of pathology and laboratory medicine have been affected over the past 12 months, Dr. Gary Procop discusses how advocacy efforts have evolved since the start of the pandemic, and provides insight on what is needed to continue battling COVID-19, as well to be prepared for pandemics in the future.
The healthcare providers of pathology and laboratory medicine have been first responders throughout the COVID-19 pandemic. The American Society for Clinical Pathology (ASCP) represents all these individuals and the Commission on Science, Technology and Public Policy (CTSP) has worked to both assist in the pandemic response, inform our community, and represent and advocate for these healthcare heroes.1 These reflections celebrate some successes in our advocacy efforts, but also disclose shortfalls in the pandemic response, the latter of which are meant for reflection so as to inform planning for a better future.
Three issues presented themselves at the start of the COVID-19 pandemic.
It should be absolutely clear that the Public Health System in the United States is woefully underfunded. Our highest regards go out to the consummate professionals who labor in these fields and have endured for many years without sufficient resources. It should also be clear that it is practically impossible for a public health service to provide the testing resource for all individuals in a respiratory viral pandemic.2 Let us not forget that this group also needs to undertake contact tracing, vaccine distribution and follow-up, while also addressing non-pandemic public health issues (eg, lead poisoning, etc). Finally, direct political interference in public health issues, which varies according to which political party has power, hampers an effective response, shifts priorities and in the end undermines the trust of the public.3,4
The Centers for Disease Control and Prevention (CDC) is optimally positioned and staffed to design, test, and make public assays, like CDC SARS-CoV-2 RT-PCR, for the unfettered use in laboratories that hold the appropriate CLIA certification and accreditation, are qualified, and are already performing tests of similar or greater complexity.5 This approach changes expectations of the Public Health Service and expands testing capacity in a competent manner across the nation. It is, essentially, what had to happen to offer the testing needed to confront this pandemic. Finally, the oversight structure and process for decision making in the public health sector should be reimagined to both protect these individuals from undue political influence, as well as to assure decisions are evidence-based and scientifically sound.
The COVID-19 pandemic presented regulatory issues as well, including:
Posturing between government agencies will likely always occur, but when this posturing endangers the citizens who these agencies serve, then it must end. There has been years of posturing concerning the role of FDA oversight of Laboratory Developed Tests (LDTs).6,7 The prevention of hospital and commercial laboratories to provide SARS-CoV-2 testing early in the pandemic by FDA mandate hindered the response to this pandemic is a fact beyond contestation.2 Furthermore, the inefficient, bureaucratic process for emergency use authorization (EUA) approval by laboratories that were already qualified and accredited to perform testing of equal or greater complexity hindered the pandemic response, endangered the public, and very likely cost lives.8
Enough with the posturing. This Administration and this Congress need to address the oversight and ability of accredited and qualified laboratories to perform LDTs, including tests for agents responsible for pandemics. Medical laboratories are some of the most highly regulated areas in medicine, requiring accreditation and acceptable performance of ongoing proficiency testing challenges. Regulatory guidance should be clear, non-burdensome, and not subject to the whims of administrative change. It should be a matter of law. As a matter of history, once the FDA prohibition of SARS-CoV-2 testing was removed, laboratory-based medical professionals went to work in an unprecedented manner for our nation and its citizens. The request is for this Administration and Congress to define the reasonable regulations required for qualified laboratories to perform LDTs, and then let those that the meet the requirement go to work regardless of the analyte.
“If one does not know to which port one is sailing, no wind is favorable.”—Lucius Annaeus Seneca
The ASCP and its Commission on Science, Technology and Public Policy has advocated for evidence-based, best practices and enhanced responses throughout the COVID-19 pandemic, which are actions that continue to this day. These have included interactions with FDA, CDC, AMA and the White House COVID-19 Taskforce. Guidance has been provided to our members and the nation through Town Halls, the written word (eg, Critical Values articles), and advocacy efforts from the grassroots up.9
The response of our nation to this pandemic provides many lessons concerning what not to do going forward. Foremost among these is the need for a coordinated, evidence-based response to any future pandemic. This is the reason that ASCP has consistently called for and lobbied for a national testing strategy.10 By way of example, a significant amount of time was wasted discussing the use for serology testing for the diagnosis of COVID-19 early in the pandemic.11 Furthermore, political propaganda promoted tests and therapeutics prior to a thorough review of scientific evidence, which promoted paths that in some instances ended in blind alleys (eg, hydroxychloroquine therapy), which wasted precious time and resources.12,13
This would never have occurred if a collective of experts guided the national testing strategy. These experts know, for example, that serologic tests are not useful for the diagnosis of acute influenza or other respiratory viral infections, and would direct the nation to a molecular diagnostic strategy, which is the current standard of care. Furthermore, they would consider performance characteristics of each test, such as the limit of detection, and make recommendations concerning the optimal testing strategies for different scenarios (eg, hospital admission versus outpatient testing), recognizing that one size does not fit all. They would also provide guidance regarding antigen testing and explain the potential pitfalls of testing asymptomatic individuals; the guidance provided by CDC on these latter topics is acknowledged and has been very useful to the national response.14
The theme of national unpreparedness extends to the national supply chain including but also extending beyond the commercial availability of tests.15 Shortages have extended to plastics, ventilators, and general purpose reagents that have affected laboratory tests other than tests for SARS-CoV-2.
When a pandemic appears possible (ie, a highly transmissible pathogen has extended beyond national boundaries), then (or before then) commercial test manufacturers should be incentivized to develop assays, boost production, and stockpile materials for a coordinated national response. The availability of quick and accurate testing early in an epidemic is the tool that guides isolation and quarantine, makes possible contact tracing, and when used effectively can stop community spread.16
A retrospective analysis is needed concerning the inventory required for a robust response to a national emergency. Governmental incentives could be used to encourage manufacturers in this direction, and coordinated use with the rotation of inventory could minimize waste. Additionally, denotation of which manufacturers will be commissioned through the Defense Production Act, with known expectations, could also be incentivized by the government, so that this does not have to be done without forethought and preparation.
The laboratories that had made investments in laboratory personnel and infrastructure were able to most rapidly and appropriately respond to the pandemic. Healthcare institutions that decided to outsource most of their laboratory services, rather than investing in these resources, had no ability to test at a local level until commercially available, easy-to-use assays became available. Patients in these centers had to wait weeks for test results early in the pandemic, because of backlogs at reference laboratories. It is not possible to stop the spread of a highly transmissible pathogen when test results are significantly delayed.
Recognition of the added contribution of a strong pathology and laboratory medicine presence to healthcare delivery, which expands beyond COVID-19, is the first step in building local capability. This, in part, is the responsibility of the pathologist and laboratory professional, who because of their contributions to healthcare providers and administrators alike, are viewed as indispensable. This should translate into capital and personnel investment in building laboratory infrastructure, which provides opportunities to medical laboratory scientists, phlebotomist and numerous supportive personnel. Buy local and build local, whenever possible, when it comes to the laboratory and it will pay dividends for both routine care delivery and when heroic efforts are needed during a pandemic.
A coordinated public health effort, which is likely best accomplished through public-private sector partnerships, is necessary to monitor the genomic changes that are occurring in the SARS-CoV-2 virus. Knowledge of these changes is critical for an understanding of reinfection by this virus, and infection following vaccination (ie, real world vaccine efficacy). Additionally, this information is critical for an understanding of enhanced virus transmissibility, potentially enhanced virulence, resistance to monoclonal antibody and convalescent plasma therapies, and vaccine coverage. Viral genomic changes that alter the protein structure to which antibodies are generated through vaccination need to be understood so that complementary modifications can be made in vaccine production.
Many missteps have been made in the response to this pandemic. This is an opportunity not to make another, by effectively testing for, thoroughly monitoring, and appropriately responding to the genomic changes in this virus.17,18
Reflection and the acknowledgement of shortcomings are the first steps necessary for improvement. A better response is possible next time—and there will be a next time, as viruses continue to evolve and humans continue to infringe upon natural environments and alter ecosystems. Investment, preparation and planning, and adhering to the guidance of experts freed from political influence is the path forward to curtail an epidemic before it becomes pandemic.
ASCP Chair of the CTSP