CHICAGO—The American Society for Clinical Pathology (ASCP) has declared that the organization is calling on the U.S. federal government to immediately develop and implement a widespread National COVID-19 Diagnostic Laboratory Testing and Support Strategy. Such a strategy could help to mitigate the COVID-19 pandemic, and deter its spread. A plan like this could be used by states, healthcare systems, providers, clinical laboratories and others to better address patient care needs in this crisis.
“It is imperative that we save lives by implementing a national diagnostic testing and support strategy,” said ASCP President Gene P. Siegal, M.D., Ph.D., FASCP. “The federal government has estimated that hundreds of thousands of lives are at stake. Therefore, in order to flatten the curve, we are calling on the federal government to immediately coordinate resources and work with scientists, the public health community, the private sector and state governments to ensure that we reduce and eliminate unnecessary COVID-19 infections and deaths.”
ASCP noted that a strategy like this must include expanded laboratory testing infrastructure, so that healthcare systems and clinical laboratories across the nation will be able to provide appropriate diagnostic testing to all patients, whether or not they have COVID-19 symptoms. Testing is also extremely important for healthcare workers, first responders and other individuals who may have been exposed to the virus.
Widespread, available laboratory testing will be able to provide patients with a reliable diagnostic test when medically appropriate. The ASCP explained that the federal government should also significantly enhance the capabilities of existing surveillance programs to identify outbreaks earlier, so that they can be better contained in the future.
The ASCP has created a guideline for things that a National Diagnostic Laboratory Testing and Support Strategy should, at a minimum, include:
- The public and private health care sectors are called on to work in concert to rapidly expand appropriate and expeditious diagnostic laboratory testing for the virus responsible for COVID-19 (SARS-CoV-2) to the at-risk population, coupled with contact tracing
- Molecular testing is the gold standard for diagnosing COVID-19, and should be the first test of choice for the diagnosis of acute COVID-19 infection. These rapid diagnostics represent the most accurate test methodologies for the detection of the SARS-CoV-2 virus gene sequences during early stage of infection
- The federal government should provide funding to diagnostics manufacturers, clinical laboratories and other entities engaged in diagnostics research to support the development of innovative testing devices or components that improve the accuracy and reliability and/or turnaround time of diagnostic or screening tests for COVID-19
- COVID-19 serology (IgG/IgM) tests should not be used for the acute diagnosis of COVID-19 as it will miss individuals in the early stage of disease progression, including early stage asymptomatic infection, and cannot reliably identify individuals currently infected with the virus
- The integration of accurate and reliable serologic laboratory testing needs to be coordinated with the appropriate experts to ensure that community exposure, prevalence and reliable markers of individual immunity can be accurately and reliably identified
- Provide support for the use of convalescent plasma as a therapeutic modality for patient care by providing adequate reimbursement. Reimbursement should also include remuneration for appropriate donors to help defray their medical costs
- Congress has guaranteed coverage of testing for COVID-19. This guarantee should be extended to cover diagnostic, screening and other COVID-19-related testing costs. For uninsured patients, the federal and state governments should pay for these tests and subsidize their COVID-19 treatment/hospital costs
- The federal government must provide adequate payment for COVID-19 diagnostic and screening tests to ensure clinical laboratories can obtain the financial resources to develop and/or provide these tests
- Support for our nation’s public health, community, academic and private laboratories needs to include a supply chain distribution model that will ensure that laboratory testing supply shortages (e.g., swabs, viral transport media, etc.) are addressed immediately
- Optimized supply chain management must also assure the safety of laboratory teams and all healthcare professionals through the timely availability of personal protective equipment (PPE), including gloves, masks and face shields, gowns or laboratory coats, and respirators (when appropriate) from point of patient specimen collection through laboratory testing
- Financial support should be provided to CLIA-certified anatomic pathology and clinical laboratories during the pandemic and during its immediate aftermath to ensure continued operations to support continuity of patient care. Without such support, the loss of revenue associated with the suspension of elective testing procedures threatens the financial viability of these laboratories and their ability to help expand our nation’s testing capacity
- Financial support, in the form of grants and/or student loan forgiveness, should be provided to pathology residents, medical students and laboratory professionals providing services during the COVID-19 pandemic to defray the costs of academic education and clinical training, to ensure that anatomic pathology and clinical laboratories have access to the skilled workforce needed to remain fully operational
- Expand the authority of the Secretary of Health and Human Services during a declared public health emergency to waive or provide regulatory flexibility with regard to the federal government’s authority over the development of diagnostics and related supplies/components (FDA per the Federal Food, Drug, and Cosmetic Act and CMS per the Clinical Laboratory Improvement Amendments of 1988) and laboratory testing operations (CMS per CLIA)
- Healthcare providers, including pathologists, laboratory professionals and other members of the COVID-19 response healthcare team, are putting themselves at extreme risk and are working long hours providing care for patients in need. The federal government and payers should provide hazard pay for individuals involved in diagnosing, treating and screening patients who may have COVID-19, as well as those professionals who perform forensic pathology and death investigations. These benefits should also be made available to the beneficiaries of healthcare professionals who succumb to COVID-19
- The federal government should provide the Secretary of Health and Human Services with the authority to compel hospitals, public and private laboratories, and other providers to report information, such as laboratory test performance data and patient-specific symptomatic information, pertinent to ensure robust public health surveillance capabilities.
“By implementing a national testing strategy, we can slow the spread of COVID-19. In doing so, we not only help patients, we also alleviate the mounting pressure on healthcare systems across the country,” the ASCP stressed.