Lab leader: ‘I’ve been chasing pipette tips all over the world’
January 2021—Wrestling with rapid test shortfalls and with open laboratory positions. Expecting the post-holiday surge, frustrated by federal level disconnect. That is what Compass Group members were doing and feeling on Dec. 1 last year, when they gathered on Zoom for another conversation about COVID-19, led by CAP TODAY publisher Bob McGonnagle, who asked Renee Ennis, MBA, FHFMA, of TriCore if her lab could handle a surge upon a surge.
“It would be crippling,” she said. “From the perspective of staffing, testing equipment, reagent supplies, collection kits, it would be crippling.”
With Ennis and McGonnagle were Gregory Sossaman, MD, Ochsner Health; Stan Schofield, MaineHealth; Sarah Province, AdventHealth; Joseph Baker, Baylor Scott & White; Steven Carroll, MD, PhD, Medical University of South Carolina; Janet Durham, MD, ACL Laboratories; Dan Ingemansen, Sanford Health; Judy Lyzak, MD, MBA, Alverno Laboratories; Cindi Starkey, MD, PhD, Regional Medical Laboratory; Frank Beylo, BS, MT(ASCP), Inova; Sterling Bennett, MD, MS, Intermountain; Dwayne Breining, MD, Northwell; Heather Dawson, Allina; Darlene Cloutier, MSM, MT(ASCP), HP, Baystate; Clark Day, IU Health; Andy Drury, OhioHealth; John Waugh, MS, MT(ASCP), Henry Ford; and Julie Hess, AdventHealth.
The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies. Here is what they had to say in their last conversation of 2020.
Greg Sossaman, what is the labor situation now at Ochsner? I’ve been told that in some commercial reference labs, sales and marketing people are working in accessioning.
Greg Sossaman, MD, system chairman and service line leader, pathology and laboratory medicine, Ochsner Health, New Orleans: Staffing overall is okay for now. We’re monitoring the physicians, nurses, and others to see who is out, and the number has not risen dramatically, although our positivity rate is rising. In the laboratory itself, the problems are not as bad as they were in early spring, but I anticipate it getting worse.
Stan Schofield, are you more concerned now about your supply chain or your labor availability?
Stan Schofield, president, NorDx, and senior VP, MaineHealth: We’re struggling with entry-level people—laboratory assistants, phlebotomists, data entry, all in the preanalytic area—for expanded COVID volumes. We can handle the testing capacity once it gets in the lab, but the bottleneck remains for registration, answering questions, and people who are not interfaced for computer order entry.
At MaineHealth, 480 people were out today due to COVID exposures or infections. And everyone is concerned about reduction of services in elective cases and redeploying nursing staff to other areas. We have reduced outpatient service center hours to three to four hours a day because of lack of staff.
For reagents, every day is still a scavenger hunt. We’re still doing lab-developed tests, using mostly Thermo Fisher reagents, and that seems to be pretty good. We’ve had a problem getting probes and primers for influenza for a lab-developed assay. And the promised Liat kits for COVID-flu combos produced only 200 tests per week for 12 hospitals. We were told everybody’s going to get plenty of supplies by the end of the year, and it’s not even going to come close.
Our positivity rate and our pure number of tests positive have gone up 10 percent per day for the past three or four days. Our positive rate for symptomatic cases climbed to 8.5 percent this week, which is unprecedented for us. I would say we’re going to hit the guardrails here in about a week.
Sarah Province, what is your recent experience and your prediction?
Sarah Province, director of laboratory operations, AdventHealth, Orlando, Fla.: We’re anticipating a surge here, and we’re running at capacity of 1,000 tests a day on all of our various equipment. We just got our Siemens Versants and Thermo Fisher QuantStudios up and running, so we have more capacity. We have 15 to 20 days’ reagent on hand, which is good, based on our samples coming in. We’ve taken in all testing; we are not sending out at this time. That’s a big accomplishment for us. We’re hoping to get everything out within 48 hours, but our goal is 24.
Sixteen med tech positions are open at this time and we’re struggling to fill them. We’re filling about one to three positions a week, which our recruiters are working hard to do. When we get those people hired into our virology and microbiology laboratories, we’ll be able to add even more capacity, but that’s our limiting factor now.
Joe Baker, are you worried more about diagnostic supplies or people at the moment?
Joseph Baker, VP of laboratory, Baylor Scott & White Health, Dallas: It’s both equally. We’re still struggling. We’re on allocations with most of the vendors we use on testing kits and supplies. We have brought up a number of the panel tests, but like everyone else we’re limited in what we’re getting.
On the staffing side we had more than 100 lab openings within our system last week, and about 50 percent of them are med techs. We’re struggling on both the technical and preanalytical sides. We have several staff on furlough, including a number of lab leaders. Our positivity rate now within the system is more than 18 percent, and we’re going to see that rise. We’ve seen no impact on our elective surgeries. We remain strong there. Positivity rate on our electives remains about 1.2 percent.
Anyone with a positivity rate that is steady or in decline?
Steven Carroll, MD, PhD, chair, Department of Pathology and Laboratory Medicine, Medical University of South Carolina: Our positivity rate is still relatively low—about eight percent. We do have concerns about personnel. Supplywise, though, we seem to be doing okay. Having said that, we’re holding our breath because it’s just a matter of time before the surge gets to us here. So Pamela Murphy [PhD, APRN, system administrator] and I are spending a lot of time trying to build up our capacity.
Janet Durham, what’s going on in ACL’s area?
Janet Durham, MD, medical director, Wisconsin operations, ACL Laboratories, and president, Great Lakes Pathologists, West Allis, Wis.: We are surging here. The systems have asked to limit the elective procedures that would require an inpatient bed, though we still haven’t seen that take effect. We’re able to keep up with the testing so far. We’re trying to bring in some of the testing that had been sent out so we can have more control over the turnaround time. But the increase in the positivity rates is affecting our ability to use our pooled testing. We’re being cautious and hoping that things will get better soon, but we’re holding our own right now.
It’s clear no one’s going to get much rest this month. Dan Ingemansen, what are your rates of testing in the Sanford system?
Dan Ingemansen, senior director, laboratory, Sanford Health, Sioux Falls, SD: South Dakota has been in the spotlight for the past month with its lack of mandates. As a system, we’re running now about 25 percent, but a week ago we were up to 30 to 35 percent.
Supplies are still pretty available, though we do not have the mainstream equipment like Roche and Hologic. We’ve partnered with Abbott and brought in a couple of the Alinity m. We’ve been doing well with them and continuing to invest more in the non-mainstream channels, like the PerkinElmer Chemagic 360s and Applied Biosystems 7500s. Both have been installed and perform well. The lower limits of detection are top-notch.
Judy Lyzak, I believe you have a comment about supply.
Judy Lyzak, MD, MBA, VP of medical affairs, Alverno Laboratories, Indiana and Illinois: We struggle with our Abbott ID Now supply chain, and last week we hit the worst-case scenario—we had been allotted our 160 kits, and they were nowhere to be found. So one by one, all of our hospitals ran out of the ID Now kits. It was a terrible situation. We finally got some—at the 11th and a half hour—and by then many of our hospitals were out of kits. When that happens, you realize some of the bad behavior that’s going on, how kits were being used off recommendation. Controlling that on a test-by-test, kit-by-kit level is difficult, and we are now to the point where each hospital on its daily incident command call will report to its leadership how many kits were used in the prior 24 hours and what the indications for those kits were. We have become draconian in how we allow those to be used.
Cindi Starkey, are you having similar difficulties with appropriate test utilization?
Cindi Starkey, MD, PhD, laboratory director and chief of molecular pathology, Regional Medical Laboratory, Tulsa, Okla.: We are not. We let our clinicians know at the start how we’re doing with supplies, and we worked with them to come up with a priority plan. So they mark the specimens that are most critical, and we put them on our most rapid platforms first. It’s been a smooth process.
The staffing situation is similar to what others have said—we have been struggling with moving molecular testing to 24/7. We recently brought on more staff, and as everyone knows, it takes a while to get people trained and up to speed. Most difficult is keeping the evening/night and weekend shifts staffed. And I echo the problem of keeping enough people in the processing area. That tends to become a bottleneck when we have volume surges.
Frank Beylo, what’s going on at Inova?
Frank Beylo, BS, MT(ASCP), director, operations and technology, Inova Health System, Falls Church, Va.: We don’t have staffing issues. We’re doing a little more than 1,000 tests a day. We’re still relying on Mayo and Quest, but we’re struggling. Their turnaround times seem to be expanding. We’ve had a couple of calls with their executive leadership to see if we can get better turnaround times, but we haven’t seen them yet.
We are trying to work more with our research department, with the KingFisher extractions, to get that testing done on the weekends. Right now, we use them Monday through Thursday because they don’t work weekends. We just hired a traveler, a contract person, who started today, so our hope is this person will get trained and we’ll be able to expand.
Like everyone else, we’re struggling with our supply of Abbott ID Now.
One of the things that works well for us is we have one universal orderable for everything, and it doesn’t matter what platform we run it on, so we don’t have to cancel and reorder. It’ll run on any analyzer and result accordingly, and that helps us because in the beginning, until we got to that point, we were canceling for one platform, and then the physicians were in an uproar because they thought we canceled their test. We told them we were going to reorder it under something else, but it took a while for them to catch on, so we finally went this route.
Sterling Bennett, you told us in a recent call about the difficulties with supplies in some of the smaller Utah hospitals. Have those problems been alleviated to any extent? And what about the available laboratory labor, in the testing sites—the virology and microbiology labs—and in accessioning?
Sterling Bennett, MD, MS, medical director, Intermountain Healthcare central laboratory, Salt Lake City: What I brought up was that some of the suppliers, like Cepheid, had been instructed to allocate certain quantities of rapid tests to some of the critical-access hospitals, and that has since been lifted, so the distribution is more aligned now with where our test demand is, although, like everyone else, we can’t get nearly as many of the rapid tests as we would like to have. We don’t see that changing anytime soon. So our IT folks have been helpful. There’s one COVID test to order on the hospital information system, and then a fairly substantial body of rules are engaged on the back end to determine whether the patient gets a rapid test or a standard test.
Our labor situation is stable. We have been able to staff the specimen receiving and molecular areas. But in recent weeks we’ve had to redeploy some staff members from other areas of the lab, like quality assurance, and from some outlying hospitals. We had to do that in a major way in the summer, when the surge caught us flatfooted, and we haven’t had to redeploy to the same degree, but we are using redeployment and we’re constantly recruiting. We’ve more than doubled the size of our molecular department. We’re testing between 4,000 and 6,000 samples per day, though that’s going up—we brought in 7,000 samples yesterday.
Dwayne Breining, what’s the situation for Northwell in terms of the supply chain, the positivity rates you’re seeing in the vast network you serve, and labor?
Dwayne Breining, MD, executive director, Northwell Health Laboratories, New York: We’re running just about every commercially available assay there is on every platform. Every one of them has allocation limits. We’re getting the maximum that anyone will give us.
As others have said, the ID Now supply has been unpredictable. It’s never what you expect it to be. But even with some of the more stable suppliers, there have been a few bumps in the road in the past week or so.
In the New York region now, we’re in a state of mild panic with what’s going on with the holidays. We’re seeing our rates starting to increase. We’re up to about six percent positivity with the testing we’re doing, and that includes a lot of community testing, so that’s where there’s potential for broader spread.
Staffing has been stressed. We’ve been pretty much doing this non-stop since March—the same staff.
The preanalytic work—with these nasal swabs, the amount of aliquoting and handling that has to be done is a challenge. We could increase the staff by 10 times on that front end and still not feel like we had enough to push everything through, so we’re doing the best we can. The demand has never been higher than it is now. We’re routinely seeing about 10,000 orders a day. We haven’t had to shut down any particular areas of testing, but we’re setting up contingency plans. For instance, who could get a multiplex flu panel, who gets a rapid versus a send-out. If we have to launch those, we will do so as the supply chains possibly change.
Heather Dawson, do you see light at the end of the tunnel, or are you in the same boat as the others?
Heather Dawson, VP of laboratory services, Allina Health, Minneapolis: We’re in the same boat as everyone else. We brought large platforms in on November 2 and ran 100 percent of our testing in-house for four days, and then on November 6 we exceeded our capacity and started sending out again. We run about 2,300 tests in-house daily across the system. The rest is going to LabCorp. Mayo sits on our state calls twice weekly and is just getting pounded. They’re hiring and hiring, and they appear to be putting Minnesota state testing in queue first. This is probably the first time I’ve experienced Mayo feeling like it is in the same boat as the rest of us locally. I don’t know if that’s encouraging or not, but everyone’s on the same page, at the very least.
Do you think you can withstand the expected surge?
Heather Dawson (Allina): We won’t be able to absorb additional capacity. We’re trying to pull a night shift into our molecular lab. If we can get them in through the agencies and stand it up, at most we’ll bring in an additional 600 tests per day. So I suspect we’ll go back to load balancing between LabCorp and Mayo for send-outs, as opposed to just LabCorp, when the surge hits in 10 days. But we’re running an 18 to 25 percent positivity rate, and we have not started pooling but are looking at it, as long as the preoperative positivity rate, which is still under five percent, doesn’t creep up too high.
Darlene Cloutier, what’s going on in Western Massachusetts?
Darlene Cloutier, MSM, MT(ASCP), HP, director of laboratory operations, Baystate Health, Springfield, Mass.: Our focus now is trying to get more capacity for rapid testing. We’re using Cepheid across the system, in our community hospitals as well, but don’t have nearly enough reagent to support the rapid testing we need. So we expanded to antigen testing and are just receiving LumiraDx. We’re going to start implementing it in a targeted way to screen symptomatic patients in the waiting rooms of our EDs. The supply chain for the Abbott ID Now was too inconsistent to rely on that.
Our staffing problem is the same as that of others—difficulty recruiting and maintaining staffing for the front end, and we have at least a dozen med tech vacancies across the system and are having a tough time recruiting for those too.
We’re working now on a partnership with UMass. The Amherst campus has opened a COVID testing laboratory to support student testing, and one of our medical directors is overseeing the CLIA license for that lab. The partnership will bring us additional capacity because one of our challenges is the volume of our employee health testing. We’re doing it in-house now but going through our capacity.
Some have begun to think that the pandemic is not only exacerbating labor problems now, but also possibly in the future. The pandemic and exposure remind many of us who have been around for years of the reluctance of people to enter into the medical technology or laboratory workforce many years ago, attributed in some part to AIDS and hepatitis. Do you have concerns around that for the future?
Darlene Cloutier (Baystate): I guess I would say yes. The front-line staff with phlebotomy, for example—there are a lot of challenges there, a lot of accommodations having to be made because of medical conditions, pregnancies, things like that. In terms of staffing in the laboratories, the pandemic is definitely bringing a different conversation back to the labs that we haven’t had for many years. My staff has requested that when the vaccine becomes available, the laboratory be considered front-line staff and among those to be vaccinated first.
Do you think that will be well received by management at Baystate?
Darlene Cloutier (Baystate): I do.
Clark Day at IU, how are things there?
Clark Day, VP of system laboratory services, Indiana University Health: Similar story. We’re feeling the surge in Indiana, centrally and across the state. We’re able to do about 3,000 or so tests per day in our pathology laboratory. We perform it all centrally for our 17 hospitals across the state. That has surged to more than 4,000 per day on occasion in the past couple of weeks. Our turnaround time spiked, which caused an issue for our providers and patients.
We have about 465 cases in our hospital, but we’ve reduced our patients under investigation or those pending a result to a manageable single-digit level, and that has helped our providers. Twenty-three percent positivity rate, up from about 17 or 18 percent.
I would agree staffing is an issue. It went so far as our HR department deeming lab assistants a critical position. We’ve got a full dashboard capability to monitor open requisitions and hiring. They’ve created an accelerated hiring process, so our own team members don’t have to interview and select candidates. We’ve given them the ability to do that on our behalf. And then we onboard and train.
We’re looking to add capacity, trying to be a bit creative, and launching in the next two weeks on the Agena MassArray instrument. We’re validating it now. We think it’s pretty good. It’s sort of above antigen testing but below the Cepheid in terms of its level of detection and accuracy. We’re going to make sure we get select patient categories assigned to it, but that helps us level load the workflow.
I’m trying to prepare our teams to not be caught flatfooted by the expected surge. We think we can handle 3,000 to 3,500 a day. If it gets consistently in that 4,000 per day range, it’ll be a struggle.
What we’ve done is turn our attention to our own patients and our own team members. We were running about a 60/40 mix of outreach or non-IU Health testing, and we’ve flipped that now and told many of our non-IU Health customers that we can’t take as much from them, that we’re either going to send it out or they have to do more of their own testing. That has helped us regulate the incoming demand.
Andy Drury, how are things at OhioHealth?
Andy Drury, laboratory director, Riverside Methodist Hospital, OhioHealth: We’re running on average about 2,500 tests a day. Roche is our workhorse, but we’re also using DiaSorin and Cepheid and trying to bring on our own agnostic platform, lab-developed EUA test, but we’re stuck waiting for instruments and tips to be delivered.
Last week our positivity rate was 23 to 25. We’ve had about a 34 percent positivity rate in our ambulatory symptomatic population, though this week it’s 41.59, and our asymptomatic ambulatory population is 5.7 percent positive. Our hospital-based symptomatic rate was 30.6 last week, and asymptomatic is 6.2. So we definitely have community spread. And we’re battling supply chain issues. We have had success in deleveraging our hospitals from Abbott over to Liat and Cepheid, so we are running those on all of our admitted patients and in our EDs.
At one point we had close to 90 staff openings; we’re down to about 30 now. Most of our labs are running at about 110 percent productivity, but we have minimal staffing at a couple of smaller care sites, and quarantines there can create urgency for staffing. So we’re closing the gap, but it’s still very real.
Renee Ennis, how about in Albuquerque?
Renee Ennis, MBA, FHFMA, chief financial officer, TriCore Reference Laboratories: New Mexico has the top two cities that are hot spots, according to The New York Times, and we have three cities in the top 25 in the country. We’re feeling the pain in terms of staffing. We have a little over 120 positions open—med techs, lab assistants, and other similar positions. We’re dealing with people who are at max capacity. We can’t give them time off to even decompress a bit. And if you’ve been exposed, you’re quarantining.
We’re running on average 3,500 tests per day on 12 different instruments from five manufacturers. One of our concerns is maxing out some of the instrumentation because instruments weren’t made for this type of continuous high throughput. So we’re keeping our eyes on that.
Would you agree with others, Renee, who say that a serious increase on top of the increase could be an event that couldn’t be coped with?
Renee Ennis (TriCore): It would be crippling. From the perspective of staffing, testing equipment, reagent supplies, collection kits, it would be crippling.
John Waugh, we’ve heard much less about labs in the past few weeks and much more about a spike in infection rates and how serious this is. I assume you’re in agreement with everyone on the call that everything is stressed and strained and that it would be difficult to cope with a spike on top of the spike.
John Waugh, MS, MT(ASCP), system VP, pathology and laboratory medicine, Henry Ford Health System, Detroit: I agree with everybody about everything. We are going to see a spike, and it’s not my fortune-telling. It is data from the University of Washington Institute for Health Metrics and Evaluation.
I’ve been chasing pipette tips all over the world. We have had seven different methods running, like a lot of other labs, and seeing those big numbers come at us is challenging.
We’ve moved indoors our outside tent collections at about 10 different locations. Moving from the tent to indoors means you’re no longer in a tent with an NP swab, but now you can go in there, and you’ve got a computer and labels you can print, things like that. So there are logistics pluses, and you get people out of the cold. That has been not a small ballet, to get all that going, and we’re doing seven-day collections at some of our sites.
As a health care institution we’ve been given some slack to not have to follow the state and county guidelines, which are CDC guidelines, that say if you’ve had an exposure, you are to go home for 14 days. For health care workers who remain asymptomatic and masked at work, they can return to work, as long as they stay asymptomatic during that time. It’s a bit of a good news, bad news story because staff feel like they don’t have the same luxury as others of being able to wait it out.
Would someone like to comment on the possible long-term implications of the new political dynamic post-election, and particularly what may happen at the federal level?
Dr. Lyzak (Alverno): I am growing increasingly frustrated by the disconnect I perceive between the federal level and the state and local levels. What I mean by that is the frustration about how we’re being forced into a public health role that we’re not necessarily equipped to serve in, and that happens when you issue a directive that everybody who traveled, everybody who got together with their family, needs to get tested, as Dr. [Deborah] Birx suggested. The implication is that all of us on this call and all of our colleagues have the capacity to be able to expand to that. It’s a public health initiative. We simply don’t.
We were inundated with samples last week with these vague recommendations that if you want to travel, you should get tested, and now we’re dealing with the repercussions. You made the bad choice to travel, and now you have to get tested. A blanket federal statement like that, which doesn’t connect to true boots-on-the-ground operational support, is disappointing. And if that means the federal government has to be a little more engaged, then I guess we’re going to have to see that.
Stan Schofield, what are you expecting from the feds after a new administration comes in?
Stan Schofield (MaineHealth): I think the CDC role will be increased. They’ll be listened to. The new administration will have a greater respect for science. And the role of the laboratory remains strong, and we all need to take advantage of the value we provide and the roles we have played, and make sure people don’t forget that value—and the staff and the sacrifices.
The government was flatfooted and stupid with this, and I think the diagnostic companies were the same. Going forward, everybody’s going to talk an awful lot about fixing it, but little will be done because the cost is too great.
I’m going to conclude by asking Julie Hess to share with us some of the advocacy they’re doing at AdventHealth.
Julie Hess, executive director, laboratory services, AdventHealth, Orlando, Fla.: One of the things that caught us flatfooted is with Florida being a licensure state for our technologists, it has been even more of a challenge to recruit people, although there’s a nationwide shortage. And so we’ve been working with our government relations team to propose legislation for some reciprocity with other states that have licensure. If we could honor the license of another state, that would be helpful.
Another thing that came up in our discussion is it felt like CLIA was not at the table when the government was planning its emergency response, and so even though things were getting EUA and even though a lot of reagents may be flooding the market, there wasn’t a change on what we were required to do as laboratories to make that acceptable for testing in a clinical laboratory. And we feel there’s opportunity for them to be part of that emergency response plan in the future.