For POC molecular, pauses, plans, and testing precautions

Amy Carpenter Aquino

January 2021—The use of molecular assays at the point of care is exciting but a bit scary.

That’s how Raquel Martinez, PhD, D(ABMM), director of clinical and molecular microbiology at Geisinger Medical Laboratories, described the state of the science for molecular infectious disease POC testing when she spoke in a virtual AMP session in November with Omai Garner, PhD, D(ABMM), of UCLA Health.

“There are many ways for these molecular tests to go wrong, so testing sites need to introduce these tests carefully,” Dr. Martinez said, emphasizing the benefit to bringing highly sensitive molecular testing to the point of patient care.

When laboratories are not in control of the testing, she noted, there can be gaps in the understanding of environmental requirements, workflow, cleaning protocols, biosafety, and compliance.

“You know that feeling when you’re in the passenger seat and your foot is trying to hit the brakes and you realize you’re not the driver? It’s kind of like that,” she said. “As a laboratorian, I think that understanding the total testing process from sample to answer should be as well controlled at the point of care as it is in the laboratory.”

COVID-19 has temporarily forced the brakes on some infectious disease molecular POC testing initiatives at Geisinger, but the laboratory is still looking ahead with plans to introduce new biosafety precautions into the urgent care laboratory space and to take testing on the road with mobile units.

Since phasing out antigen POC testing in early 2013, Geisinger has been on a steady path of expanding molecular POC testing throughout its outpatient sites. In late 2016, Geisinger placed the Cepheid Xpert Flu/RSV XC in eight rapid response labs during the first phase of its FluWorks program. The strategy behind FluWorks was to distribute the fastest and most accurate tests throughout Geisinger’s 45-county service area while directing noncritical patients away from the emergency departments, saving emergency services for those who need them most and helping to keep wait times low.

Data reported in 2019 by Donna M. Wolk, MHA, PhD, D(ABMM), and colleagues at Geisinger showcased the program’s successes and how “implementing a molecular point-of-care testing algorithm can significantly impact outpatient outcomes,” Dr. Martinez said. “A 70 percent improvement in the collect-to-result time was observed in the study as well as a 15 percent reduction in antiviral utilization” (Hernandez DR, et al. Diagn Microbiol Infect Dis. 2019;94[1]:28–29).

In 2018, in phase two of the FluWorks program, molecular POC instruments were placed in Geisinger’s 23 urgent care centers.

Staff training in molecular microbiology, testing techniques, and template containment were key to the successful molecular POC testing implementation, Dr. Martinez said. Geisinger made and placed molecular workstations at each regional response laboratory to serve as a replacement for a traditional molecular dead-air box, which can be large and costly. “The workstation can withstand Clorox cleaning. We created the molecular workstations to ensure we had an additional level of containment for biosafety and for template control, should there be a spill.”

Geisinger’s path to molecular POC testing has had its share of speed bumps, starting with a thanks-but-no-thanks response from emergency medicine colleagues. “They originally declined molecular point of care,” citing lack of space near the EDs to triage patients to a non-ED route. For that reason, Geisinger Medical Laboratories is exploring mobile testing units, to be parked outside busy EDs for triage.

In addition, partnering with its community medicine team had a predictable negative impact on the laboratory’s revenue and productivity metrics. “We realized that without the laboratory team performing the tests, the revenue would move outside the laboratory,” Dr. Martinez said. And moving billable tests to another division had an impact on productivity metrics. “We knew it was the right thing to do and made plans to find a way to share and balance revenue and productivity in the future.”

The laboratory had to navigate different supply chains for inpatient and POC outpatient tests. And it took time to manage the extensive CLIA certificate applications for so many sites.

The laboratory hit its largest speed bump in 2020, when COVID-19 “caused us to put the brakes on a few things,” she said. “Because of the increased need for biosafety, we discontinued molecular point of care in our clinics, in the areas that could not confirm ample negative pressure in separate urgent care laboratory space. We felt that was an important requirement.” Geisinger is working to implement new negative pressure space where it’s needed. In the meantime, she said, “none of our remote testing sites are performing molecular point-of-care tests.”

“We also partnered with our chemistry point-of-care director, which is separate from the microbiology group, and together we decided to stop offering rapid strep testing as a point-of-care test in our clinic sites because of the increased risk for exposure to COVID-19,” Dr. Martinez said. “This is because traditionally, the rapid strep tests were performed out in the open, not under a hood or in a molecular workstation.” Rapid strep is performed now only in the hospital laboratories “while we reexamine the remote testing space.”

Because of the higher costs of using advanced practitioners, molecular POC testing will transition to phlebotomists and laboratory assistants as much as possible. But no matter who performs testing, Dr. Martinez said, having a molecular microbiologist oversee molecular POC testing at each site is non-negotiable. “We feel strongly that a dedicated microbiologist is required when venturing into molecular point of care.”

Looking past COVID-19, Geisinger’s laboratory is joining forces with its point-of-care and care gap teams to “take the show on the road” with its mobile clinic, Dr. Martinez said. “We are currently using a bus for health care screenings and disease prevention,” with services such as blood pressure readings and weight measurements to help meet health insurance and HEDIS measures.

“But in the future, we plan to offer A1c screenings and other point-of-care tests via the mobile bus,” she said. “The bus will be staffed with a phlebotomist, and we’ve discussed adding molecular point-of-care testing for infectious disease.”

Plans are also underway for special mobile units dedicated to delivering infectious disease POC testing. “We’re really excited about that. The Geisinger laboratory outreach vehicles”—known as LOVs—“are smaller vans and would not include patient appointments other than for testing. We plan to use it for deployments to areas where there may be outbreaks, such as specific facilities undergoing COVID-19 outbreaks, or to universities that would like us to do other types of screenings.”

For laboratories thinking about implementing COVID-19 POC testing, “I suggest that your infrastructure needs to be very strong before you even consider launching something as high impact as COVID-19 point-of-care testing,” said Dr. Garner, director of point-of-care testing and section chief, clinical microbiology, UCLA Health.

He and his UCLA colleagues have been working to bring up COVID-19 PCR testing and make it widely available for patients at UCLA Health, he said. “We’ve also been considering how we think about antigen testing or even point-of-care molecular testing and its usefulness within this space.” As the headlines have shown, he said, whether they’re about the White House or Nevada nursing homes, which had false-positive problems, “there have been relatively newsworthy, large-scale problems with point-of-care testing.”

All the more reason for a solid POC testing infrastructure, which is what he spoke about in the AMP session.

In the clinical laboratory, “there are structures in place to make sure the test result is as accurate as possible for patient care,” and POC testing falls outside that structure.