Even before COVID-19 reached pandemic levels, teams at the National Marrow Donor Program® (NMDP)/Be The Match® had their eye on an important part of the cell therapy supply chain—donor collections. Collections from allogeneic donors are critical to getting time-sensitive life-saving cell therapies to patients around the world.
But donors often must fly to the apheresis or marrow collection center for collection. And the majority of apheresis centers—and all marrow collection centers—are in hospitals. Hospitals that were starting to see more and more patients with coronavirus.
Amy Hines, RN, BSN, Director of Collection Experience, NMDP/Be The Match
The organization needed to put plans in place that kept both donor and patient safety front and center, while navigating the uncertainty surrounding the pandemic.
Fortunately, the NMDP/Be The Match—which Be The Match BioTherapies® is part of—has built a diverse collection network over its more than 30-year history. Its 84 apheresis center and 67 marrow collection center partners are spread across the U.S.
We sat down with Amy Hines, RN, BSN, the Director of Collection Services for the NMDP/Be The Match. She explained why that diversity has mattered and how the organization has adapted our operating model to continue our mission to save lives through cellular therapy during this uncertain time.
How has the breadth of the NMDP/Be The Match apheresis and marrow collection center Network allowed the organization to continue donor collections of hematopoietic stem cell products?
One of the biggest challenges that we’ve had to overcome is the speed at which this virus spread. We’re in a situation today where we need to assume the novel coronavirus is in every community, so we’ve needed to be reactive and proactive at the same time. This obviously is a highly unusual situation that evolved very quickly. And it continues to evolve today.
Because of how the COVID-19 pandemic has progressed, it’s really been critical to have a large network of apheresis and marrow collection centers in locations across the United States. Travel restrictions have made it difficult for donors to get to and from certain areas. In addition, donor safety is the highest priority. We don’t want our donors to have to get on airplanes to travel for their collection.
But even with a network of centers in diverse parts of the country, there are challenges. About 70% of our apheresis centers are within hospitals. And, of course, 100% of our marrow collection centers are in hospitals. With the COVID-19 outbreak, hospitals need to divert their resources away from certain activities.
Many have had to make a difficult decision to step back from doing collections for the NMDP/Be The Match. Some apheresis units are being used for patient care. And some apheresis staff are being pulled to other assignments during this crisis.
That means we’re heavily relying on the 30% of apheresis centers who are in blood centers or stand-alone facilities. Fortunately, they’ve really stepped up to the challenge.
How has the NMDP/Be The Match been able to keep up with collections? Have you reduced the number of collections in recent weeks?
We have not reduced the number of collections for patients who need a time-critical hematopoietic stem cell transplant (HSCT). In fact, we’re collecting and delivering product at nearly the same rate as before the coronavirus outbreak.
There are a couple of reasons why we’ve been able to keep pace with requests. Relying on a limited number of apheresis centers for almost 100% of donor collections is a big ask. But they’ve been able to pick them up because other activities have slowed down for now. For example, some of these centers collect for cell and gene therapies or for research organizations that aren’t doing collections right now. So that’s freeing them up to take more NMDP/Be The Match donors.
That’s been awesome. I can’t say enough about the response of our Network apheresis centers.
Additionally, we’re taking a critical look at what we as an organization are asking centers to do. We’re finding places where we can streamline processes. Then the clinicians can just focus on collections, donor safety and product quality.
We’ve also quickly onboarded a few centers that are not currently in the NMDP/Be The Match Network. They are AABB-accredited and/or FACT-accredited, so we know they have quality programs. Donor safety and product quality are our priority, so working with high-quality centers is critical.
These are not normal times. We’ve had to find creative ways to continue to do high-quality collections and deliver products for waiting patients. The apheresis and collection centers, FACT, AABB, donors, transplant centers, patients and the NMDP/Be The Match … we’re all in this together.
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What other operational changes has NMDP/Be The Match made to continue to deliver on the mission to save lives through cellular therapy?
I mentioned earlier that donor safety is a top priority. Another is patient safety. We don’t want to have our donors traveling far from home for their collections. But we also want to ensure that the donors cells arrive when the patients need them. Patients who have a hematopoietic stem cell transplant are immunodepleted before their transplant. We absolutely cannot risk those donor cells not arriving on time.
There are so many reasons that could happen. A donor could become unavailable on collection day because they’re showing symptoms of COVID-19. Changes to flight schedules could delay product pickup. Those are just a couple of reasons.
We’ve been talking about this as an organization from the very beginning. It was clear that we could end up in a situation like we’re in today with the spread of the virus as well as travel impacts. Very early on the NMDP/Be The Match and other registries in the world strongly recommended that patient prep did not start until the donor product arrived at the transplant center. The transplant center would cryopreserve the product and then thaw it once the patient finished conditioning.
We’ve now made cryopreservation a requirement. That has meant operational changes for our organization, as well as the apheresis centers, marrow collection centers and transplant centers.
What did that mean for apheresis centers, marrow collection centers and transplant centers?
For an allogeneic transplant, the product usually ships fresh. So, under normal circumstances, there is a complex process of scheduling the donor’s collection so that the cells can be transported directly to the transplant center for infusion. This meant that quite often we were flying donors to available apheresis or marrow collection centers to be able to align with the infusion day.
The COVID-19 situation has forced a change to that process. We’re trying to find centers that are much closer to a donor’s home. Ideally, the courier will still take the product to the transplant center fresh. Then the transplant center would cryopreserve and store it until infusion day. Some transplant centers don’t have that capability. Some don’t have room in their cell therapy labs for storage.
At that point we’re working with our apheresis and marrow collection centers to say, “You’re collecting the product. Can you also cryopreserve?” If they can’t, we take the product to a center that can cryopreserve. That’s adding another leg into our normal process, but it’s happening.
It must happen because it’s super critical to give the transplant center the buffer of time to make sure the product is on site before they prep the patient. We just can’t take any chances.
Our Logistics team is moving mountains to get cell therapy products where they need to go when they need to get there. But they also recently shared with us that there was one product itinerary that went through 22 changes. Too many changes are happening on a daily basis for us to do this any other way.
When the organization made the decision to move collections to centers ideally within driving distance of the donor, how many collections did you need to be relocate or reschedule?
It was significant. It took an amazing amount of teamwork and coordination. We were asking apheresis centers to step in rather urgently to help. And we also had to coordinate with the donor’s schedule.
It took some creative thinking to say, “How can we get a donor from point A to point B? Where is a center that might be able to take that donor?” It’s so strange that we’re not looking at flight schedules anymore. We’re looking at physical maps to say, “How long of a drive is it from Portland, Oregon, to Seattle, Washington?” and things like that.
Initially, the focus really was to try to limit donor travel and get them somewhere closer. As hospitals started to divert their resources away from apheresis and marrow collections, it created new challenges. Many centers were able to collect the donors already on their schedules. They just can’t take any more.
But some had to stop collecting donors almost immediately. They didn’t want to do this, but their hospital’s circumstances changed quickly.
Quite a lot of shifting has happened. But centers truly have stepped up to the challenge. It’s been super impressive.
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Most states and some individual cities have stay-at-home, or shelter-in-place, orders in effect to try to flatten the COVID-19 curve. How has that impacted the organization’s ability to continue donor collections?
Transplant centers are looking at each individual patient’s case to determine if HSCT is in the patient’s best interest right now. There are many whose lives are in the greatest jeopardy without HSCT. They have a critical need for their donor’s stem cells. That means a donor can leave their home to go to appointments related to their donation and for their collection.
We developed a letter for donors and their companions to carry with them when the do need to leave home for donation-related appointments. We want to ensure they don’t have any issues getting to and from appointments. If local authorities happen to stop a donor, the donor can show the officer the letter. Some states have specific requirements, so we’ve developed state-specific letters in those instances.
Many donors do have questions about why they’re being asked to go out when they’re being told to stay at home. We work with each donor individually to answer those questions. There are some donors who find themselves in a position where they just can’t donate anymore. It’s a very difficult decision. But we understand they need to make the decision that is right for them and their families.
Donors truly have stepped up though. Many, many of them are still able to go on to donate. That’s been amazing.
Are donors concerned about how you’re keeping them safe? Have apheresis centers made changes during this time of social distancing?
Donors do have questions, of course. This is an unprecedented time for all of us. Each donor has a contact at one of our donor centers that they can reach out to at any time. That’s true even when we’re not dealing with the COVID-19 pandemic.
In addition, our apheresis centers are sharing information with one another and with donor centers on steps they’ve taken to keep donors safe.
For example, our Be The Match Seattle Collection Center team put together a short video for the Workup Specialists at one of our Donor Centers. The Workup Specialists can use the information to explain to donors how we keep them safe.
Our Partner Liaisons make outreach to centers and centers are making outreach to them to say, “This is what we’re doing to protect donors.” For example, they immediately take donors back to a private room. They’re checking in at different entrances. They separate donors from the rest of the activity at the center. The donor is one-on-one with a nurse. And obviously, they’re cleaning the room thoroughly before and after the collection.
Our centers are doing everything they can to limit a donor’s exposure both to people and to surfaces.
You mentioned the Be The Match Seattle Collection Center. The Seattle-area was the first in the country to experience COVID-19 community spread. How did that impact collections at the Be The Match Seattle Collection Center?
The Seattle Collection Center has never closed. When the outbreak began in Seattle, we did have several collections on the calendar with donors who were flying in from out of state. We immediately made the decision to reschedule those collections at a different collection center. We were not going to risk the safety of a donor by flying them to Seattle.
However, there are still donors in the Seattle area. And many donors within driving distance. They could go to Seattle to have their physical exams or collection.
The Be The Match Seattle Collection Center is unique in that it is a completely independent facility. It is not located in a hospital or in a busy blood center. It stands alone. Donors are coming in off the street directly into our facility. They head straight back to one of our four apheresis collection rooms.
The only people who go into the room are the donor, the nurse and, occasionally, the Donor Navigator will step in to bring the donor something to eat or something to drink. Donors have limited exposure to other people.
Part of the reason NMDP/Be The Match established the collection center in Seattle and the Be The Match—Gift of Life Collection Center in Boca Raton, Florida, was so we would have collection capacity when we needed it. We’ve been thankful to have these centers as options for our donors who are within driving distance.
When you look at our organizational response throughout the COVID-19 pandemic, what are you most proud of?
This organization has done what it always does when faced with a challenging situation. People have stepped up to figure things out. It’s been amazing to watch the entire organization, regardless of your role, being engaged in the solution.
We’ve had to step out of our comfort zones to find creative—but safe and effective—solutions. We’re still doing it. Despite all of the obstacles in front of us, we’re still delivering for our patients.
Cell collection network depth matters
Partnering with an organization with an extensive cell collection network can help companies overcome unexpected challenges to collection. Explore how Be The Match BioTherapies helps cell and gene therapy companies develop and manage apheresis collection networks.
