The May 11 expiration of the federal Public Health Emergency for COVID-19 provides new impetus for laboratories to offer more molecular testing, address the staffing shortage, and leverage existing equipment in innovative ways as they navigate the post-pandemic world.
By Ann H. Carlson
Since the COVID virus was first detected in the United States in early 2020, clinical laboratories across the country have devoted most of their resources to providing essential testing for the virus. After three years dedicated primarily to processing more than 1 billion COVID tests nationwide1, however, U.S. laboratories are now actively exploring how to expand their offerings and their profitability as the pandemic enters the endemic phase and the U.S. enters the post-pandemic phase.
“Before vaccines, testing was the only defense that we had against the virus,” says Manoj Gandhi, MD, PhD, senior medical director of genetic testing services for Thermo Fisher Scientific. “Obviously, we still have the technologies, the infrastructure, the capital expenditure, and the resources in place that we put into this. So, labs really are looking at where to go from here.”
Repurposing the Laboratory for the Post-Pandemic World
While PCR testing for COVID is here to stay, the broad accessibility of COVID vaccines and at-home rapid-antigen tests have reduced demand for COVID testing in clinical labs across the board. The May 11 expiration of the federal Public Health Emergency for COVID-19 provides new impetus for laboratories to parlay the experiences, equipment, and resources they acquired during the pandemic into new testing avenues that can boost revenues.
“Right now, we’re really trying to find our new normal,” says Rachele Moore, MBA, MLS (ASCP), executive director of Laboratory Services for Aultman Health Foundation in Canton, Ohio, and a member of CLP’s editorial advisory board. “How can we standardize? How can we reposition our resources?”
One of the major factors in these decisions is funding. “Everyone lost money last year,” Moore notes. “So, it’s trying to figure out how to optimize our existing resources, because we have to do more with less. Volumes are high right now, especially in my laboratory, which has been great because we need that increased revenue to make money to reinvest into our laboratories. It’s been a little challenging for labs just because everything is ending—no more [reimbursement] from the government.”
Before COVID-19 vaccines were available, Sewanee: The University of the South, Sewanee, Tenn., developed an on-campus laboratory to offer the mandatory testing required to successfully keep the small liberal arts college open during the pandemic.
“I think this coming year is going to be our biggest challenge,” says Alyssa Summers, PhD, technical supervisor for the Sewanee Molecular Diagnostics Laboratory, associate professor of biology, and director of the Office of Medical and Health Programs at Sewanee. “As we’re not doing as many COVID tests, the university doesn’t need us in that regard, and certainly there’s an expense to keep a lab.”
Next year, Summers says the laboratory plans to expand their infectious disease testing to include sexually transmitted infections (STIs) and urinary tract infections (UTIs). She notes that the lab is already creating LDTs for these infections. With her background in cancer research, Summers also hopes to move into next-generation sequencing (NGS), cancer hereditary panels, and genetic markers in the coming year.
“We are rural, so we’re aiming to work with our community and maybe other local institutions to be able to offer quick turnaround times,” she says. “We really want to think of the laboratory as supporting our community both here on campus and our external community of Sewanee.”
Leveraging Molecular Testing
Looking to the post-pandemic world, most laboratories are concentrating on repurposing existing processes, such as molecular testing capabilities. Molecular testing—which had not been widely adopted by laboratories prior to the pandemic—was a game-changer in the response to COVID-19 all over the world.
“The expansion and automation of molecular testing in response to the COVID pandemic left laboratories with equipment and staff trained and ready for rapid response to new COVID variants or other new pathogens,” says Eric Hrimech, head of diagnostics in North America for Siemens Healthineers. “Access to this equipment allows for the expansion of molecular tests, the confirmation of infectious disease antigen or antibody test/panels, and the identification of variants and genotypes that may assist with identifying appropriate antiviral therapies.”
Although the versatility of molecular testing was understood before the pandemic, the barrier to entry had seemed prohibitive to some laboratories.
“COVID opened the floodgates for molecular testing,” Gandhi says. “A lot of people felt like molecular was a very difficult technology. They shied away because they either didn’t understand it or thought it was too expensive. COVID democratized molecular for us.”
According to Gandhi, the hard work of onboarding molecular testing during the pandemic will make the transition to non-COVID-related testing much easier in the post-pandemic world. Laboratorians who have mastered PCR testing for COVID, for example, can easily test for STIs or UTIs using the same technology and training.
“It’s very transferrable to different areas,” Gandhi notes. “The sample type might be different, but the preparations, the workflows, and the fundamental principle still stays the same.”
In early 2020, Quest Diagnostics invested heavily in its molecular platforms to be able to process high volumes of COVID-19 samples.
“Now, where feasible, we are pivoting many of these investments to non-COVID-related applications,” says Catherine T. Doherty, senior vice president of regional businesses at Quest Diagnostics.
One example is in women’s health. The pandemic accelerated Quest’s plans to replace the Hologic Tigris platform with new Hologic Panthers to increase efficiency. “We expect our women’s health testing to benefit from the improved efficiency and turnaround time provided by these platforms,” Doherty says. “This includes tests for HPV, chlamydia, gonorrhea, and trichomonas.”
The company is also investing in advanced diagnostics, particularly in areas that include NGS and mass spectrometry. “We anticipate investing more in advanced diagnostics, genomics, and oncology this year,” Doherty says. “We are also working with health plans on more value-based care initiatives where we help them realize greater value from the laboratory services utilized by their members and providers.”
Most U.S. laboratories have recently pivoted to using molecular testing to screen for respiratory viruses such as flu and RSV, which surged last winter as lockdowns eased. Gandhi also sees the potential to screen for arboviruses, such as zika and dengue fever, as well as for uses outside of detecting infectious diseases.
“PCR technology can also be used for select oncology,” says Gandhi, who cites screening for the BCR-ABL rearrangement in leukemia and for BRAF mutations in melanoma as examples. “Not everything needs to be done on NGS. You can certainly use some select applications in oncology that you can put on a PCR instrument and just keep it extremely targeted to that application.”
There are also implications for precision healthcare. “PCR technology is even used in pharmacogenomics,” Gandhi says. “You can use the same platform to actually figure out how a patient would respond to a specific type of treatment based on their genomic profile.”
With laboratories looking for creative ways to expand their testing capabilities beyond COVID-19, Gandhi is also excited about the potential of molecular testing to provide better health equity around the world, now that this technology is more available in poorer countries that did not have access to it prior to the pandemic.
“Molecular is something that you can use in a lot of different areas,” Gandhi says. “COVID was just the beginning, and it should hopefully open a lot of the doors for future advancements in the field.”
Addressing Staff Shortages
The rigors of providing round-the-clock testing to patients took a heavy toll on an already strained workforce, and the shortage of medical technologists continues to plague laboratories across the country.
One part of the solution in the post-pandemic world is to invest in automation. “As laboratories continue to struggle with retention and rebalancing staffing demands, machine-learning algorithms and artificial intelligence tools are increasingly critical for analyzing large amounts of clinical data and improving clinical decision-making,” Hrimech says. “Adopting integrated data solutions while maintaining secure patient and institutional privacy is essential.”
Remote viewing capabilities, instrument accessibility, and service are other areas of growth.
“Remote capabilities are becoming more common and of greater use to laboratory staff who find themselves stretched thin or are needing to oversee multiple lab sites,” Hrimech adds. “Whether a lab director wants to validate patient results or oversee an entire health network’s instrument operations remotely, there is an increased comfort level now in implementing remote capabilities.”
Doherty says that investing in automation and artificial intelligence at Quest Diagnostic has improved lab productivity by 15%. “To address labor strains in certain areas, and to increase efficiencies, we’ve invested in more automation technologies, particularly in areas like microbiology and cytogenetics,” she says. “It’s our hope that by leveraging automated solutions effectively, we can provide more time back in the day of our hardworking staff, whose energies can be dedicated to more meaningful tasks.”
While automation is one important piece of the solution, investing in the human workforce is key to replenishing interest in the field over time.
“We need the public and our funders to understand that you don’t grow a medical laboratory professional overnight,” says Rodney E. Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, university distinguished regents’ professor and chair of the clinical laboratory science program at Texas State University, San Marcos, Texas. “It is one of the most rigorous and difficult majors to complete. So, not only must we recruit better, but we must retain better. Salary increases, better working conditions, flexibility of scheduling, loan forgiveness, and other measures can help with ability to retain and produce more professionals.”
With a limited staffing budget for the laboratories in her network of smaller community hospitals in rural Ohio, Moore relies on a combination of cross-training, partnering with nearby colleges, and old-fashioned recruiting to optimize staffing resources. “We are targeting that barista who works at Starbucks and has that bachelor’s in biology and can’t get a job,” she says. “We say, ‘Hey, want to come work in a lab? We’ll train you.’ And we’ve had a lot of success with that.”
So far, Moore has not had to tap medical travelers to fill staffing needs, and she hopes to keep it that way. “We’re trying to figure out how to improve employee engagement,” she says. “How do we make this the best place to work? How do we make this an environment where people want to come and work with us?”
Meeting the Challenges Ahead
While laboratories wrestle with ongoing staffing and supply-chain issues, perhaps their biggest concern is reimbursement in the post-pandemic world.
This is top of mind for Summers, who is working to expand the Sewanee lab to offer more resources to the community. “It’s really important to be in-network with an insurance company to really be marketable to clinics, because they want their patients to not have to pay exorbitant fees,” she says. “So, we’re still trying to figure out the best way forward in that. The biggest challenge is pivoting and making those partnerships with our community hospitals and community healthcare professionals. I kind of feel like we’re one of those independent bookstores against Amazon.”
Gandhi notes that labs may also run into reimbursement issues when coming up with new ways to use their existing molecular testing capabilities. “I’m a little bit concerned about the reimbursement part, especially for labs in the United States,” he says. “I don’t want it to curb the innovation or the access to patients.”
Laboratorians can be more proactive by contributing evidence demonstrating the effectiveness of new testing. “One of the things we have heard from the payors is that they need more evidence to justify the use of [these panels],” Gandhi says. “When you look at the literature, they obviously have a point that the evidence seems to be a little scarce. I think we, as a lab community, need to generate more evidence.”
Despite these challenges, Moore notes that one silver lining is that laboratories are no longer “siloed” within larger health care organizations. After depending on laboratories to help stem the pandemic, administrators now look to laboratorians for regular input and collaboration.
“We’re talking more,” she says. “I’ve been in more meetings now than ever, but it’s good. They want you to be part of the conversation. They want to know how the decisions are going to impact the lab because they understand our importance now and understand how integral we are to the healthcare delivery system.”
Ann H. Carlson is a regular contributor to CLP.
Reference
- Centers for Disease Control and Prevention. COVID Data Tracker. Atlanta, GA: US Department of Health and Human Services, CDC; 2023, May 03. https://covid.cdc.gov/covid-data-tracker
