Compass points chart the pandemic

So our approach is to try to have the multiplex cartridge-based testing available for all the hospitals that need it for patient cohorting. But of course with what’s gone on with the cartridge-based testing systems, it’s the same factories making the cartridges. And then the manufacturers can load them up with whatever reagents they want. So a number of the vendors have said they’re opening up new factories and they assure us they’ll have enough supply.

The military and other organizations love these test systems because they’re so easy to use. They can grab them by the truckload and the shipload whenever they think they need it. I heard one person, possibly from West Point, in an unguarded moment in a radio interview talk about how they were testing all the cadets daily. I expect that kind of thing is going to continue well into the flu season. So we’re pretty worried about that, because the other thing the clinicians tell us is that in a normal flu season, they don’t test nine out of 10 people who come in with symptoms, because once the flu is prevalent, they pretty much know what they have. They’re thinking they’re probably going to have to test everybody this year. I doubt they’re that disciplined in normal practice, but I’m sure they’re not testing everybody, either. So there are going to be more orders.

But, fingers crossed, based on the information coming in from the Southern Hemisphere, they’re seeing almost no flu season at all so far. And all of the social distancing and masking should have some effect on the propagation of the flu virus. Maybe we’ll get lucky.

John Waugh, do you already have your feelers out for these multianalyte panels?

John Waugh (Henry Ford): We’re looking at the usual suspects that have test systems that are out there. The challenges are going to be in worldwide allocation. If it were only the United States, we’d be okay. But we’ve got the whole rest of the world. And we’ve got all of our hot spots where product gets shipped to prioritize for those areas. But as Dwayne Breining says, people are not going to be terribly troubled about the flu, but if they have respiratory symptoms, everybody is going to want to know if they have COVID. Because that’s the bad actor here. Products that have flu A/B, RSV, and COVID are going to be the ones people want.

Some of those run on large platforms. Some are more rapid tests. But even the ones that are more rapid tests may be 20-minute or 30-minute tests. Typically when we do seasonal influenza testing, we test patients while they’re still in the clinic or urgent care area. The question is, how long do you want to clog people up waiting in those areas, getting close to each other or coughing and sneezing, while you’re waiting for those test results? A lot of the COVID testing right now is not rapid point-of-care testing. It’s going back to the laboratory and being done on big platforms.

Pamela Murphy, how are you implementing the COVID antigen tests, if at all? And what does your supply chain look like at MUSC?

Pamela Murphy, PhD, APRN, system administrator, Pathology and Laboratory Medicine Integrated Clinical Center of Excellence, Medical University of South Carolina Health, Charleston: We are not using any of the antigen tests now. We are doing PCR testing on the Abbott m2000, and we have three of those. Two are old and failing frequently with their use now. We have one Alinity m that we got about two months ago, and we’re getting a second one in the next month or two. In the past few weeks we have run into pipette tip issues, just like almost everyone else. That put a hindrance on our capacity. We’ve now been able to get those back in, but it changes week to week. We are also using the Cepheid Gene­Xpert, but our allocation is limited.

So we are constantly looking at equipment issues, supply chain issues, people issues, not being able to recruit enough to run our testing. And referral labs are waxing and waning as well, as they have had capacity issues as well as people—COVID-positive—issues.

Did you have any idea in March that we would be in August facing the situation we are all facing today?

Dr. Murphy (MUSC): None at all. It’s been very challenging for our team. We are constantly being asked to pivot. Right now the politics play in quite a bit. And so we have been asked to now look at nasal swabbing or saliva testing. And there’s a lot of pressure on our teams to try to validate and make that work. But we are 100 percent NP swabs right now.

Norman Gayle, what is your perspective? Are you in consensus with what you’re hearing from your colleagues, or do you have new wrinkles you’d like to share?

Norman Gayle, VP and chief operating officer, Regional Medical Laboratory, Tulsa, Okla.: It’s interesting to hear that we are all experiencing similar challenges, and without a doubt everything that has been mentioned is common to us here in Oklahoma and the region we serve. No idea whatsoever that we would at this juncture still be in the height of this pandemic from a laboratory testing perspective. And as you all probably are aware, Oklahoma is bordering on the orange-red level now for the past seven days. We’ve crunched out greater than 10,000 tests over the past seven days, and the positive rate has ranged from about 9.2 percent to 14 percent. Our overall positive percentage since day one, which would be March 20, when we rolled out our first test, is now at about 6.2 percent.

The challenges with supplies abound. We have seen some improvements in this area through collaborative efforts with our national laboratory leaders and with the national suppliers. We have three platforms constituting six instruments dedicated to COVID testing: two Abbott m2000s, two DiaSorin MDXs, and two Hologic Panthers. And we just started to install the Abbott Alinity m platform.

Surgeries have returned for the most part to pre-COVID levels. We ran into major national supply shortages over the past two weeks, and it had our surgeons stepping back a bit to reassess the COVID-19 presurgical testing plan.

Epic is in the headlines today because the company has called all its people who have been working at home back to Verona, Wis., to start programming and building, and people are complaining. Stan Schofield, would you like to comment on IT support in the midst of a pandemic?

Stan Schofield (MaineHealth): IT support would be nice if it would ever start. We’re finding that IT projects are still slow; it’s hard to communicate when we’re not easily together. Lots of Zoom and GoToMeeting calls, and things are not happening in a rapid, timely fashion. Reporting requirements are difficult. Ask on order entry—we have 10 elements we have to do for the CDC—every one of these tests that comes in now. And the state of Maine has one setup. We do work in New Hampshire; that state wants a different format for its reports. And it’s problematic to get IT to do any of this kind of thing remotely. So the idea of Epic and people going back to work, or not working—this whole thing is a mess. Most of the time the Epic people do not have a lot of compassion for or understanding of the laboratory’s needs during this pandemic. (Editor’s note: Epic rescinded its requirement for employees to return to the company’s campus this year.)

What will be the lessons learned from COVID as we work our way through this, and what do you foresee as possible major structural changes in the laboratory world, in the laboratory industry, that may arise out of the pandemic?

Dr. Bennett (Intermountain): One of the immediate lessons learned is that we need to maintain inventory levels less lean than we have done in the past. It will be a long time before we go back to something that approximates just-in-time inventory. So we’re trying to build inventory of all lab supplies. I know there’s some expense to that. But also from a long-term perspective, I believe the IVD industry is going to be reexamining how it manages its supply chain as well, to avoid shortages or rolling shortages and to prepare for unanticipated events.

Another lesson we’ve learned is that relationships are really important. We need to make sure we have solid relationships with executives in our health system. We’ve found that the relationships even within the laboratory service have been critical. And in a perverse or an unexpected way, this COVID crisis has helped us organizationally within lab services because we huddle together frequently on issues like managing the inventory of the cartridge-based tests, the rapid tests, making sure people are all on the same page with the information they need. We know each other better, we work together better, and I think we’ll see long-term benefits from that.

We’ve also looked at external relationships with our state public health lab and with ARUP. We have helped each other fill shortages of supplies and reagents and had a cooperative effort that has emphasized the importance for us to be on good terms with people in our community.

Dr. Crawford (Northwell): And I would go in the same direction. Advice given to me long ago was to make your friends before you need them. What we’ve experienced in the past five months by way of community has, I hope, been transformational. We’ve all been friends and we’ve had contacts in various places, including in public health, but this episode makes abundantly clear the need to have strong relationships, personal relationships as best as possible with public health, with the state, and across our national laboratory community.

Something that we discovered in New York, and I understand it has occurred to a certain extent in other states, is an ad hoc consortia of laboratory communities to deal with these issues. For us it was the assembled laboratory leadership of 11 major New York State academic health systems. Although we didn’t specifically help each other meet our direct institutional needs, the advocacy of this consortium with the state was helpful just by way of communication. There are other examples in other states. I also think the relationship with manufacturers can only be strengthened.

This has been a sobering lesson in the fragility of our system. And it isn’t just about pandemics. When the tsunami hit Fukushima, the one plant—I believe it was Roche that made pipettes—was taken out. And it was a dicey time. As laboratory leaders, we have to be much more mindful of that fragility. And while it starts with stockpiling, I think it also includes contingency planning as we move forward. This has been quite a lesson in that regard as well.

Can you foresee any unpleasant long-term changes to the laboratory industry, whether they might be regulatory or having a testing czar of sorts, which I think would be, to say the least, a double-edged sword?

Dr. Crawford (Northwell): I’ll make two points. The first is regulatory. The relaxation of regulations raises the question of what we should reassemble as the agencies that relaxed the regulations say, “Let’s just go back to the way it was before.” I would argue for a cogent advocacy to examine the regulations that were relaxed and see if we can get a more streamlined regulatory landscape. I’m not saying there should be an absence of regulations, but just examine the pros and cons of what we’ve seen during relaxation. An example is remote sign-out by digital pathology—this has been a very effective option. But it was a rather wild time with the testing EUAs that were issued. Let’s learn from this sequence and be thoughtful as stricter regulations are reinstated.

But my second concern is the landscape over which the laboratory industry travels. On the one hand, the smaller the lab, the more vulnerable it is. The bigger the lab, potentially the more advantages. But I worry about near-patient testing, which is what the smaller labs provide. I think what has been trampled during the COVID-19 sequence is the importance of the labs proximate to patient care and the communities they serve.

I appreciated governor Andrew Cuomo’s recent editorial saying it isn’t just about the big-box labs. He makes specific mention of the 260 non-commercial labs in New York State that are helping to meet the state testing capacity. I’d love to have that broader diversity of laboratories emphasized as we move forward.

Stan Schofield (MaineHealth): One of the things I’d like to see as we go forward is the laboratory not lose the momentum and visibility about its role and importance in health care. For too long we’ve been in the cellar or basement, rats running the wheel. The value of the laboratory has never been greater or more appreciated for those who have been able to deliver the services and the technology. We need to build on that and not let people forget that and be relegated back into a secondary role.

The second part of this is the big threat to the industry. PAMA is still on the books, and it is difficult. Starting this year, it would have been a tough year, and then COVID hit and nobody’s keeping score. But after COVID is over, PAMA’s going to be around again. And if the laboratory is not well established and recognized for its value, the dollars and cents are going to play a heavy hand on lab operations. Take advantage of the visibility and value you have brought to your systems, your hospitals, and your patients about the integral part the laboratory plays in health care, and continue to build on that role.

Dr. Crawford (Northwell): What we do right now is critical, even if we’re still licking our wounds as we recover services. Translating what Stan just said into action is a lift.

Stan Schofield (MaineHealth): It’s a lift, but anything of value is a lift. It’s about executive leadership and more communications. This conversation itself could be the basis of a white paper on the value of the laboratory during the COVID crisis and how laboratories have overcome every challenge, every difficulty to deliver the goods and take care of patients. I don’t have a magic solution. I just don’t want us to lose the opportunity now when the visibility is there. And let’s make sure the visibility is positive rather than negative.

Let me add a wrinkle here. More times than not when laboratories become prominent in public media and public comment, we’ve seen events happen that have had negative consequences. Instead of the Pap mills being shut down, laboratories got CLIA ’88. Do we have the possibility now of a bad outcome because of the prominence people have put on testing, particularly when their understanding of that testing has been inadequately mediated by people who don’t know what they’re talking about?

John Waugh (Henry Ford): Truer words have never been spoken. When you talk about bad outcomes, immediately my mind went to Pap mills and people doing testing on their kitchen table. That’s where CLIA came from. But the outcome there is that the quality in a lot of our laboratories got better. A lot of the information that’s been in the lay press has been challenging. One of the good things that has happened is we learned about the importance of patient populations beyond inpatients and outpatients. Nursing home patients—when a professional athlete can get tested 24 times and grandma in the nursing home can’t get her first test yet, that’s a bit of a challenge. We learned more about the large disparities across a state and across the U.S. in resources and the ability to deliver. The easy and fast relaxation of state, federal, and CLIA regulations where you could do laboratory testing in a police station, at a car wash, anywhere you want. We’re going to have to flip back into a more regulated environment. I don’t think we’re going to be able to continue in that kind of a relaxed fashion and still talk about quality.

We learned in our laboratories that we had the ability to work remotely and do it at a high level. We also learned about the ability to change directions with speed. People said we need PCR testing, and then they said we need more PCR testing. They said, “Okay, we’ve got more PCR testing. What about antibody testing? Can you do antibody testing?” Yes, we can do antibody testing. “What about antigen testing?” We’ve had to chase a lot of different requests to compete and to prepare in different ways.

Susan Fuhrman, do you have opinions or thoughts about these long-term lessons and long-term sequelae of the pandemic for laboratories?

Susan Fuhrman, MD, president, CORPath, Department of Pathology and Laboratories, OhioHealth Riverside Methodist Hospital, Columbus: The laboratory has come out of this looking pretty darn good in most places, particularly hospital and health system laboratories. We’ve taken on the challenge. We’ve flexed remarkably. We’ve developed great relationships with all kinds of people with whom we previously hadn’t had an opportunity to relate. And we don’t want to lose that momentum. This is a great opportunity for laboratorians and pathologists to stand up and take a bow, and we need to be out there to do it.

From my own standpoint, I can’t believe how fast my IT department can switch around orders and specimen types. And we’re going from dry swabs to wet swabs, from oral to nasal, on a dime. Things that took me months to get through they can do overnight, which makes me realize that it’s definitely a matter of priorities and resource allocation. These things are technologically possible and they can happen.

The same is true of resources. If I need something related to COVID testing, I just have to tell my story and it’ll happen. That’s another thing we don’t want to lose. We know now that these things can happen, and we need to be able to tell our stories well so that we don’t lose the attention we’ve had, which is good attention. We’ve shown what we can do and how key we are to the provision of medicine in this country. It’s a big opportunity.

Jim Crawford, give us your thoughts about how not to lose this momentum. You’ve given as much thought to this as anyone I know in the past three to five years.

Dr. Crawford (Northwell): It starts with your own corporate health system stakeholders, I would hope your payers, most certainly your medical practice community, and very definitely your consumers. So it’s a local and regional activity. That’s long before we go to Albany or Washington. Our relationships with our most immediate stakeholders are the foundation upon which we stand. Certainly the Compass Group represents that principle.

To address what Stan said about taking advantage of the visibility and value and building on it, my thinking is that this is a public relations challenge first. On the one hand it’s professional. Our medical colleagues and our corporate colleagues have learned more about laboratory medicine in the past five months than they thought was possible, and they’re still novices. That could continue.

But we are about to enter into the world of false-positives and false-negatives, so our relationship with our communities is critical if we’re going to navigate into the fall. This is not business; this is public relations. I can’t say I have a strategy for educating the broad public on false-positives and false-negatives. But it is upon us. I’d love to have people thinking about it, because we’re going to have visibility that could be upside or downside, depending on the way it plays out.

Some people have asked, Why doesn’t pathology and laboratory medicine have a Dr. Fauci? Greg Sossaman, would you care to answer that?

Dr. Sossaman (Ochsner): That’s a good question. Normally we rely on our professional organizations to play the national role. Traditionally we haven’t had any pathologists who have ascended the ladder from an administrative standpoint at the NIH or CDC—not to say that we couldn’t, but we haven’t. We’ve had high-profile pathologists in leadership positions in the AMA and in other areas, but not within the NIH. It’s possible we don’t have as much basic research on the pathology side that coincides with interest from the NIH and CDC.

Stan Schofield and Sterling Bennett, what is your take on why we don’t have a Dr. Fauci?

Stan Schofield (MaineHealth): We’ve never had something in pathology that impacted the whole population, and that’s where Dr. Fauci comes in. He is truly the expert. We’ve not evolved into epidemiologic, population studies, any of that. We have really smart people, but we don’t deal with public policy and/or populations or do research around infectious disease that lends itself to the promotional opportunity for an expert to go on TV or support the government as an expert. If we had a pathologic disorder or a cancer that was running everywhere, we might have someone like that. It’s just not normally our field of expertise. And pathologists have had supporting roles in infectious disease, microbiology, and virology but not top leadership roles. It just hasn’t evolved that way.

Yes, I sometimes have to remind people that Dr. Fauci cut his teeth in the AIDS epidemic, so he’s seen this movie before, including the political elements, although I don’t think, even in his wildest dreams, he would have thought he’d see the political elements he’s seeing today. Sterling Bennett, your thoughts?

Dr. Bennett (Intermountain): The short answer is we haven’t united behind someone and put that person forward as a spokesperson.

I’d like to echo what Norman Gayle said about the value of the community of the Compass Group and being able to get together and share the experiences we’ve had. It’s one thing to think we’re going through something alone and there’s something wrong with us because we have all these problems. But when we can see our peers who we know are expert in what they do and are individuals we try to model in our own practice and they’re experiencing the same things, there’s both a level of comfort there and an opportunity to confer with one another to get better ideas about what we can do to navigate this thorny path.