Purchased for the pandemic? Rethinking instrumentation

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Schofield

Stan Schofield, I am surprised by how readily people have adapted their COVID instrumentation to do other testing, and even insource some tests as opposed to sending out. What are your thoughts on what you’ve heard?
Stan Schofield, president, NorDx, and senior VP, MaineHealth: We didn’t have to repurpose anything because we were doing laboratory-developed assays. We moved away from Roche as our primary instruments to Hologic for sample-to-answer devices.

People around the country are asking me, “What do you think people are doing with all the equipment?” And I’ve told them that repurposing, redirecting work, and reagent rentals—extending the menu and extending the term, if necessary—it’s all the right stuff.

Budgets, contract labor, continue to be a big issue here, mostly for nursing. The system has cut $125 million out of the health system for capital next year, and we’ve cut 25 percent, from $4 million to $3 million. Cleveland Clinic reported last quarter the loss of $1 billion. Contract labor is not going away—nurses are not going back for $40 an hour. It’s critical financially for every system at every hospital in the country—they can’t solve it.

It seems paradoxical to add to test menus on devices at a time of acute laboratory labor shortages. Some say it’s not a big deal to add another assay to a machine that’s already staffed on shifts. Is that your feeling about it as you’ve been implementing those solutions?
Stan Schofield (NorDx): Absolutely. When it’s a sample-to-answer device, you can get technical support to help set it up from one of the companies. They have the menu and the product. If it is a batch instrument and it’s a laboratory-developed test, it’s more demanding of staff time for development, validation, correlations, and implementation.

Dan Ingemansen of Sanford Health, are you doing a lot of point-of-care testing as Stan describes, sample in and answer out, and what does your next year look like?
Dan Ingemansen, senior director, Sanford Health, Sioux Falls, SD: Across our 100-plus sites, many of which are small hospitals and clinics, we have point-of-care analyzers. We are standardized across most of our platforms. Standardization requires capital, which remains difficult to obtain, especially for new projects.

Regarding our COVID testing equipment, we are continuing to use the Cepheid Gene​Xpert, Abbott Alinity m, and Roche 6800 to internalize new tests and replace aging platforms. We are struggling with a couple of pieces of equipment we purchased because of how niche they are. When we approached COVID, we had to scale and automate our processes—large, high-throughput extractors, liquid handlers, thermal cyclers, et cetera—and we have virtually no use for some of this equipment. The market is saturated with limited buyers. At the same time, they’re being decommissioned, so we have dropped service contracts. Looking forward, we will continue to internalize—we opened a reference laboratory in Sioux Falls right before COVID hit. From a labor perspective, we’re already touching the sample and preparing it for shipment. We feel there’s just as much labor going into preparing the sample to send out and getting results into the system as doing a point-of-care sample-to-answer test.

Tony Bull, what are your plans?
Tony Bull, system administrative officer, Pathology and Laboratory Medicine Integrated Center of Clinical Excellence, Medical University of South Carolina: We are sunsetting our Abbott m2000 RealTime system and transferring to an Alinity m. We have Panthers, but we purchased those with an eye toward what we would do with them at the end of the pandemic, and we’ll repurpose those.

We will continue to do point-of-care COVID testing with the ID Now at our clinics. I think a lot of what we’ll see in the laboratory will be inpatient driven.

What is at the top of your list for an acquisition or a new testing venture for next year?
Tony Bull (MUSC): The system is always looking at further acquisitions, and we have one that’s interesting because it’s for a government-owned hospital, and the county commissioners have insisted it be done in the open, so the newspapers are covering the fact that discussions are going on.

In terms of new testing, we’re working feverishly on a 500-gene panel as well as adding capacity to do fusion testing. We want those in place by the end of the year.

I’m hearing increasingly about the demand to do NGS in-house, if only for the comfort of the clinicians to have a person to talk to. There also seems to be turnaround issues in NGS. I did a webinar with a pathologist who showed the differential between sending it out and doing it in-house, and it was dramatic. Could you comment on that?
Tony Bull (MUSC): Part of the motivation for bringing NGS testing in-house is the turnaround time, and we are looking closely at how long it’s taking us to treat and create care plans for cancer patients. This will help improve that.

Dr. Dysert

Peter Dysert, can you comment on doing NGS in-house versus sending it out?
Peter Dysert, MD, chief, Department of Pathology, Baylor Scott & White Health, Dallas: We’ve been using NGS for some time to do our human leukocyte antigen testing. Medhat Askar [MD, PhD], who joined us from the Cleveland Clinic, was on the forefront of transitioning many of the historic methods used in HLA laboratories to next-gen sequencers. We used a lot of that equipment as a secondary method for COVID testing. We’re ever expanding our NGS capabilities. We just hired someone who is certified by the American Board of Medical Genetics and Genomics, and we have a couple of people working in our cancer center, relative to molecular- and genetic-based diagnosis.

Our percentage of inpatient COVID positives has remained about 24 percent; it represents a more judicious use of the testing because these are people largely presenting to hospitals with symptoms. And in those patients we’ve broken out those who are surveillance only or don’t have signs and symptoms—that positivity rate is about eight percent. We’ve been able to segregate positivity rates based on clinical presentation.

The only piece of equipment we purchased was the Roche 6800 and we’re planning to use it for insourcing.

Tell us about having NGS capability in-house for your cancer patients and oncologists.
Dr. Dysert (Baylor Scott & White): We have site-specific groups of clinicians whom we look to for direction on compliance with NCCN guidelines, for example, under the accreditation processes for cancer centers. We have a couple of molecular genetics pathologists who staff those meetings and listen to and work with clinicians to find the best solution to the clinical issues they’re dealing with.

We look for site-specific, clinical experts to partner with us and help make decisions on which types of technology we want to standardize, and then we go through the process and they make a decision clinically whether to make it a standing, delegated medical order so it doesn’t have to be individually ordered for one patient at a time. It’s done reflexively. We try to standardize on and stick to what appears to have proved worthy of clinical use as a way to control demand.

We also have a popular and growing molecular tumor board. It’s an educational investment on our side, run by a clinical oncologist and our two molecular genetics pathologists. We find there’s an incredible appetite for these busy clinicians to learn more.

Milt Datta, can you comment too on NGS in-house?
Milton Datta, MD, chair of pathology, Abbott Northwestern Hospital, Allina Health, Minneapolis: We’d love to have more depth on the bench and the ability to put more panels together, but we’re focused on using the standardized testing run with automated tests, and we have a committee with the medical oncologists to decide what tests we’re going to run and for which tumor types.

One of the discussions we’re having is about questions related to molecular test interpretation. Do we send them to our molecular pathologists and risk overwhelming them? Or do we use our subspecialty pathology model and expect our subspecialist pathologists to understand the molecular nuance for the tumors in the organs and areas they serve?