Look, wait, buy: labs share instrument plans

With other instrument lines in the laboratory, the choices are a little clearer. Dr. Anthony points to viscoelastic coagulation testing as an example: “There’s an ongoing need for fast intraoperative coagulation testing, and viscoelastic testing can be helpful.” The two key vendors are Haemonetics, which makes TEG, and Instrumentation Laboratory, which now owns ROTEM, the instrument her laboratory uses. “Viscoelastic testing uses whole blood and monitors clotting in real time, so it’s potentially the best method, and it’s advocated as a way to target transfusion therapy because it shows all the different aspects of clotting. And based on the parameters, it can guide you to transfuse certain products instead of others.”

Despite these benefits, she finds that viscoelastic testing is vastly un­derused by laboratories similar to Allina’s. “For example, if someone in the OR wants a fast partial thromboplastin time, that requires spinning the specimen, separating the plasma, then running the test. With viscoelastic testing, on the other hand, you put it right on the instrument and monitor the clot and get information.” The low utilization of viscoelastic testing, in her view, is due to the manufacturers’ choice to issue a graph tracing instead of the numerical parameters of the test results, which physicians prefer based on their experience interpreting prothrombin times and partial thromboplastin times. “We’d like the vendors to adjust their reporting to be more numerical than graphical. We’re looking to change platforms, if necessary, to get the results and reports that are going to be most useful to our physicians.”

One of the newest tests Allina has brought in is the Verigene Enteric Pathogens molecular panel, which has greatly boosted diagnostic capability. “The big change is not just turnaround time,” Dr. Anthony says, “but also the fact that the two most common things we’re finding with the panel are pathogens we didn’t have a useful test for in the past: rotavirus and norovirus. Before, those had to be diagnosed based on clinical symptoms and negative culture results. But now physicians are getting definitive diagnoses of viral gastroenteritis from the tests, and the implementation of the stool culture panel has had a seamless transition that everyone is happy with.”

The laboratory would like to see the same transition in a conversion to molecular streptococcus testing. “We use rapid strep testing and that has advantages for patients, especially children, that we don’t want to lose. We do backup culture for negative results, which detects additional cases of strep, and that’s important.” But since the laboratory now does 80,000 strep tests a year, “The molecular instrumentation is not yet at the scale we would want to make a full conversion. The instruments currently available can’t handle the volume we would need them to. So we’re planning on converting as soon as possible,” Dr. Anthony says.

More progress is being made on next-generation sequencing, which is currently send-out testing for Allina. “We’ve had an interest in NGS for many years,” says John R. Mendiola, PhD, molecular diagnostics technical director with Allina. “But every time we’ve looked, we’ve decided that that particular platform was not right for our lab at the time, and in most cases was not even close. Right now, however, we’re looking seriously, we’ve talked with vendors, and we have a business case we’re presenting. And maybe now is the right time. The emerging clinical utility of many of these markers is becoming more obvious, and we like the automation that has come to the market in the last year or two.” Reproducibility and hands-on time are less of a challenge than they were in previous iterations, he says. In addition, “The proliferation of genetic tests that we’ve been having to send out has driven us to think about more panels versus testing one gene at a time.”

The cost of capital for instrumentation has come down, Dr. Mendiola notes. “It’s still challenging, but less so. In the last few years, the manufacturers have made it much more reasonable to bring NGS in-house than previously. And some of the instruments are now more scaled to a medium-sized lab, so capital is not as difficult an obstacle to surmount. Since we’re looking at about eight tests a week, we think the scalability of the new platforms makes it reasonable to think about bringing the tests in-house.”

There has been a lot of excitement about using NGS for leukemias and solid tumors, he points out. “But to keep our heads from exploding with the complexity, we have focused our initial launch on lung and colon cancer,” on the premise that the panel would be broad enough that the laboratory could quickly adapt the test to different clinical scenarios without having to revalidate. Validation, he notes, will be time-consuming and expensive and has been one of the big hurdles all along. Still, pending approval of the laboratory’s business case and negotiations with vendors, he and others in the laboratory hope NGS might be brought in by the end of the year.

While most of the laboratory’s molecular testing is set up with capital leases or reagent rentals, the NGS purchase will likely be a capital acquisition, though that arrangement hasn’t been finalized. “We have also been talking to our hospital foundations about some philanthropic support,” Dr. Mendiola notes. There is precedent for that, because about 12 years ago, a local cancer foundation paid half the cost of installing the capillary electrophoresis that the laboratory uses for sequencing. If philanthropic support is forthcoming for NGS, he adds, it can help ease the burden of showing a return on investment.

In contemplating Allina’s next instrumentation in hematology, Diane Hutchinson, MLS(ASCP), says she is in an information-gathering stage, nowhere near ready for a request for proposals. The Sysmex system Allina uses today is a platform that comes in many different models, which can accommodate clinic and hospital needs, and new models have varying functionality. “To me, that’s very appealing as I look at our sites and different patient populations and try to decide what is appropriate for their spaces.”

Beckman Coulter is coming out with a new instrument menu of different-sized models that would also be able to be incorporated at various sites, and Hutchinson plans to look at Abbott’s offerings as well. “There is always new technology that the vendors are trying to present to us. Some work and some don’t. We just take what works the best for us.” A single vendor makes more financial sense, Hutchinson believes. “But I’m never going to say we’re not going to use more than one vendor because it’s more work for me,” she says. “We need to keep all options on the table.”

One information technology feature that Hutchinson is seeking is digital solutions to hematology competency. “We have literally hundreds of hematology users, and personnel competency is a challenge that every system must face with each inspection that comes around.”

Other new IT figures in Allina’s plans as well, as decision support and data analytics are becoming increasingly important in controlling test use, Dr. Anthony says. They are evaluating the CareSelect platform from National Decision Support Company, she says, which has partnered with Mayo Clinic to provide decision support for laboratory orders. “They can interface to our Epic system and provide a package of algorithms and decision support tools you can adapt to your ordering.” Data analytics firm Health Catalyst, in Salt Lake City, already has a charter partnership with Allina. “We have interactive dashboards to monitor and improve blood utilization, test utilization, and lab performance metrics.”

In the molecular arena, Allina has found Epic Beaker provides useful productivity tools, Dr. Mendiola says. “They’ve brought us real leverage and we’re trying to do the same thing with cytogenetics. We’ve had a homegrown workflow and reporting system for a number of years using FileMaker Pro, and we’re in the process of trying to get that into Beaker, but the workflows and reporting are complicated and it’s stretching the functionality of Beaker to get cytogenetics into that. We’ve been working with Epic on cytogenetics to help inform their future development to make it more compatible with those types of esoteric testing with complex workflows.”

If there is a pain point in chemistry from Rothstein’s standpoint, it would probably be ensuring reliability and how well the vendors are responding to the need for reliability. “There have been a lot of advances in automating chemistry instruments, but also a lot of advances in the instrumentation. The vendors are investing a lot in using camera technology to have more reliable sampling and results.” He likes to see advances that ensure reliability, not just produce faster results. “We’re not in the business of selling lab results. We’re in the business of providing that information to physicians, and we need to make sure we’re working well with physicians, rather than bringing in something just because it’s new.”

Other pain points involve other testing the laboratory does not currently provide, Dr. Anthony says. Due to the opioid epidemic, drug screening volume has more than doubled since 2015 with the development of new addiction medicine and pain centers to treat people. “That area of our organization is growing because we want to provide those services for patients. We don’t perform the definitive mass spectrometry drug screening here, but rather than build a new toxicology laboratory, we partnered with nearby Hennepin County Medical Center to perform our drug screens. This type of ‘make or buy’ decision has become crucial when we look at highly specialized testing.”

Developments like these, Dr. Anthony believes, will be important factors as the laboratory decides what equipment will best meet the diagnostic challenges ahead. 

Anne Paxton is a writer and attorney in Seattle.