Updates for Donor, Apheresis/Collection and Recruitment Centers
Up-to-date information on NMDP/Be The Match response to COVID-19
Updated September, 13 2021
Our Business Continuity, Donor Operations and Patient Operations teams continue their daily review of the information coming from the CDC and agencies like the World Marrow Donor Association (WMDA).
As new information becomes available, we will update this page with information to guide you. As always, the health and safety for our donors and patients is our highest priority.
Click on the topics below to jump to that section:
Donor Assessment and Collection
- Update to NMDP/Be The Match process for confirmatory typing (updated 6/1/21)
- Update to NMDP/Be The Match stance on cryopreservation (updated 5/24/21)
- Revised Novel Coronavirus (COVID-19) Infection Assessment Tool (updated 5/18/21)
- Revised Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (updated 4/5/2021)
- Updated CDC Definition of Close Contact for COVID-19 (updated 10/22/2020)
- Cryopreservation Tools Available for Donor Assessment (updated 10/22/20)
- At-home COVID-19 Testing Available for Donor Screening (updated 10/8/2020)
- Guidance on Donor Screening for COVID-19 (updated 10/8/2020)
- Assessing Backup Donors’ Ability to Quickly Proceed to Collection (updated 8/26/2020)
- Standardized Actions for Donors who are Health Care Workers Working with COVID-19 Patients (updated 8/6/2020)
- Confirmatory Typing Process Includes Donor Buccal Swab Sample (updated 6/9/2020)
- Option for Only Health History and Availability Check at CT (updated 6/9/2020)
- Self-Administered Filgrastim Injections Being Piloted During COVID-19 (updated 5/29/2020)
- COVID-19 Testing and Cryopreservation Questions Added to Workup Plan (updated 5/12/2020)
- Contact Your Partner Liaison if Your Center is Testing Donors for COVID-19 (updated 5/12/2020)
- Donor Center Process for Bone Marrow Requests During COVID-19 Pandemic (updated 5/5/2020)
- Donor Communication When Product Will Not Be Infused (updated 4/28/2020)
- Status Code for Donors Unavailable Due to COVID-19 (updated 4/23/2020)
- Signing Workup Documents While Working from Home (updated 4/14/2020)
- Notification of Donor COVID-19 Diagnosis Post-Donation (updated 4/1/2020)
- Essential Collections at Apheresis and Collection Centers (updated 3/24/20)
Travel and Logistics
- Vaccination Requirement for NMDP/Be The Match Couriers (updated 9/13/2021)
- Provide Case Managers with Up-To-Date Courier Instructions (updated 6/9/2020)
- Letter for Donors Under Shelter-In-Place Orders (updated 4/21/2020)
- Preparing Donors for Travel (updated 4/7/2020)
- Support for Overcoming Donor or Courier Travel Restrictions (updated 4/2/2020)
- Assessment of Donor Foreign Travel (updated 4/1/2020)
- Assessment of Donor Travel in the U.S. (updated 4/1/2020)
- Re-evaluation of Donor Travel (updated 3/19/2020)
- COVID-19 Impacts on Vendor Partners (updated 3/19/2020)
- Membership, Engagement, Enrollment and Experience Live Drives Paused (updated 3/26/2020)
- Cancellation of Be The Match Mexico Recruitment Events (updated 3/19/2020)
Resources for Apheresis and Collection Centers, Donor Centers and Donors
- COVID-19 Toolkit for Donor Centers (updated 12/23/2020)
- Manuscript Examines Early Impacts of COVID-19 on Donor Product Delivery (updated 12/23/2020)
- Recording Available: Overview of Changes to COVID-19 Assessment Documents (updated 10/8/2020)
- Recording Available: Donor Center Responsibilities After Cryo Requirement is Relaxed (updated 7/16/2020)
- Register: Aug. 6 Donor Services Webinar Call (updated 7/30/2020)
- On-Demand Webinar: Let’s Talk About It – Talking with Donors in a Time of Unrest (updated 6/25/2020)
- Council Advisory Group is Here to Help During COVID-19 (updated 6/2/2020)
Frequently Asked Questions
- Frequently Asked Questions for Donor Centers and Your Donors (updated 10/8/2020)
- Frequently Asked Questions for Apheresis Centers and Collection Centers (updated 5/12/2020)
Donor Assessment and Collection
Update to NMDP/Be The Match process for confirmatory typing (updated 6/1/21)
Given the rapid decline in cases of COVID-19 in the US, as well as rising rates of vaccination, the National Marrow Donor Program® (NMDP)/Be The Match® has made the decision in partnership with our domestic donor centers to return to collecting blood samples, rather than buccal swabs, for fulfillment of confirmatory typing (CT) requests that have an appointment on or after August 30, 2021.
This change will be in effect for donors who are located within the US and Puerto Rico. Please note: at this time we are only able to accommodate one type of sample request. This means that all CT requests will be fulfilled as a blood sample, and the buccal swab option will be unavailable starting August 30. It is important to note that we are investigating the potential of offering either option, blood sample or buccal swab, in the future but at this time we are only able to accommodate one option with buccal swab now and blood beginning at the end of August. For donor centers using KitMaker, kits created for CT blood samples and IDM draw will resume being charged to your center’s account.
Please reach out to your Case Manager or Partner Liaison (PartnerLiaisons@nmdp.org) for more specifics.
Update to NMDP/Be The Match stance on cryopreservation (updated 5/24/21)
Given the rapid decline in cases of COVID-19 in the US, as well as rising rates of vaccination and easing of travel restrictions, the National Marrow Donor Program® (NMDP)/Be The Match® is now more confident in delivering fresh products collected and delivered within the US. As of today, we ask that you discuss with your teams the ongoing need for cryopreserved products and consider ordering products to be delivered fresh if they are collected within the continental US.
Domestic donors will be asked whether they have been vaccinated for COVID-19 and/or plan to do so. This assessment will occur at both the confirmatory typing stage (CT) and at workup. The results of this assessment for domestic donors will be reported to the Case Manager.
There are scenarios in which a cryopreserved product may still be the safest option for your patient. However, there are also scenarios in which cryopreservation may not be necessary based on review of specific risk-based conditions.
Factors to assess when making the decision for fresh vs. cryopreserved product
Your Case Manager will work with your transplant center to assess whether a product should be cryopreserved or infused fresh. Factors for consideration that would be provided on the Donation Process Notification (DPN) Form include:
- Donor’s registry: Dependent on the donor registry there may be a need to facilitate a cryopreserved product within the country where the donor resides, then ship the product to the transplant center. Alternatively, there may be a recommendation based on the country where the product is coming from, and possible transportation risks that the product should be cryopreserved upon arrival at the transplant center. Your Case Manager will ensure you have those details when requesting a donor from those countries.
- Collection/apheresis center policies: Apheresis or collection center policies on testing asymptomatic donors for COVID-19 or regional/national policies that require testing may vary. The NMDP/Be The Match recommends that only symptomatic donors are tested for COVID-19, however individual institutional policy may dictate otherwise. We are unable to move donors to institutions without those policies at this time.
- Donor vaccination status: Information regarding the donor’s vaccination status will be provided to the transplant center as soon as possible.
- Other donor factors: Any other donor factors that may impact the risk of a fresh product delivery to you.
The ultimate responsibility for patient care and safety rests with your transplant center. We urge you to discuss the relative risk with your team and patient prior to requesting a product be delivered for fresh infusion. If the risks are deemed too high by your center or your Case Manager for specific countries, we will continue to arrange for cryopreservation prior to the initiation of conditioning.
Whether planning for a fresh or cryopreserved product, your transplant center should have a backup plan and communicate that plan to your Case Manager. If you are planning for a fresh product infusion, you must identify a backup source.
When considering the shipment of cryopreserved cord blood or Be The Match BioBank products, keep in mind that reductions in passenger flights and available cargo space may impact the transport of dry shippers. You should plan for shipment times closer to 48 hours for domestic product transport and 4-5 days for international product transport.
The health and safety of patients and donors remains our top priority. As the COVID-19 pandemic situation evolves, we will continue to assess risk factors and make changes as necessary.
Please reach out to your Case Manager for specific case by case information regarding the ability to move forward with a fresh product infusion.
Revised Novel Coronavirus (COVID-19) Infection Assessment Tool (updated 5/18/2021)
We have updated the Revised Novel Coronavirus (COVID-19) Infection Assessment Tool (A00916 rev. 5). Donor centers should begin using this assessment on May 25, 2021.
Summary of Changes
A00916, Novel Coronavirus (COVID-19) Infection Assessment Tool (rev. 5), section 4
- Added 21-day deferral for PBSC following viral vector vaccination such as Johnson & Johnson (J&J) vaccine. After discussion with various registries regarding adverse events seen with J&J vaccine, we are updating the criteria for donors to include a new timeline of 21 days deferral for PBSC collection following J&J vaccine or any other viral-vector vaccine.
- Revised Part A’s title to “NOT VACCINATED” and added “Inform CM that donor is not vaccinated.”
- Added in Part B’s title “HAS NOT RECEIVED BOTH DOSES.”
- Clarified in Parts B and C that the specific type of vaccine (if known) should be shared with CM.
You can access the document on the Health History Screening Questionnaires webpage.
If you have any questions, please contact Donor Medical Services at DMS@nmdp.org.
Revised Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (updated 4/5/2021)
We have updated the Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (F01190 rev. 7) and Novel Coronavirus (COVID-19) Assessment Tool (A00916 rev. 4) to better reflect the current state of COVID-19 and vaccination efforts. These updates include guidance on how to handle fully vaccinated donors, effective April 12, 2021. We have also removed the question related to increased COVID-19 risk due to work or social interaction. While we will continue to see possible exposure and/or reporting of COVID-19 symptoms, we believe this guidance will provide a clearer picture for evaluating donors at this time.
Donor centers should begin using these assessments on Monday, April 12. The assessments must be used for all health histories at CT, held for workup and workup.
Access the revised documents, summary of changes, and recorded training Health History Screening Questionnaires webpage starting April 12.
Please note these changes do not impact the management of maternal donors of cord blood. However, the questions may be valuable in your own assessment of donor suitability. Cord blood banks can access the revised HHSQ on the Cord Blood Banks Forms webpage.
Summary of changes to Novel Coronavirus (COVID-19) Infection Assessment Questionnaire, F01190 rev 7
- Removed former question #6 -- Is there any other information regarding your work or social interactions that might increase your risk for getting COVID-19?
- Removed associated instructions to be read to donor re: former question #6.
- Added new question (#5) -- Have you ever been diagnosed or suspected of having COVID-19?
- Added new question (#6) relating to vaccinations and “type” of vaccine.
- Added new question (#7) -- Are you planning on getting a COVID-19 vaccination? (Previously imbedded in question on vaccinations).
- Updated instructions to align with new questions.
- Added instructions to ensure the donor is aware of safety recommendations in COVID-19 Information Sheet for Donors.
Summary of changes to Novel Coronavirus (COVID-19) Assessment Tool, A00916 rev 4
- Added “or recovery” to Quick Reference in “Symptomatic” section, “Tested Positive” situation to determine a TU timeline.
- Added new section 4 related to COVID-19 vaccination and guidance based on vaccination status.
- Section A now addresses donors planning to receive COVID-19 vaccine.
- Section B now addresses donors who are less than or equal to 14 days from final dose of 1- or 2-dose COVID-19 vaccines.
- Section C now addresses donors who are more than or equal to 14 days from final dose of 1- or 2-dose COVID-19 vaccines.
- Defines fully vaccinated as someone who is 14 days or more from final vaccine dose.
- Additional guidance is provided for fully vaccinated donors who report recent COVID-19 exposure and are symptomatic and asymptomatic.
Remember, this assessment tool contains actions you should take based on a donor’s COVID-19 risk, such as reporting symptoms, a positive test, or exposure to others who are infected or had a positive test.
Timeline Recommendations for COVID-19 Vaccination for Donors
While we are providing guidelines for the timing of vaccination as it relates to collection and filgrastim administration, any donor who wants or is required to be vaccinated should receive the vaccine when it is available to them. The NMDP/Be The Match will never ask a donor to delay vaccination if they have the opportunity to receive a COVID-19 vaccine.
Please consult Donor Medical Services (DMS@nmdp.org) if a donor is unable to meet the following timeline recommendations:
- For collection: If possible, the donor should receive the vaccination more than 72 hours before the proposed collection date.
- For filgrastim administration: If possible, the donor should receive the vaccination more than 72 hours before the proposed start of filgrastim to distinguish between possible side effects of the vaccine and filgrastim itself (aches and pains, headaches, etc.).
If you have any questions, please contact Donor Medical Services at DMS@nmdp.org.
Updated CDC Definition of Close Contact for COVID-19 (updated 10/22/2020
On Oct. 21, the CDC updated the definition of close contact for COVID-19 to anyone who was within six feet of an infected person for a total of 15 minutes or more. This means a person may meet the definition of close contact if they have multiple brief encounters with COVID-19-positive people that add up to 15 minutes within 24 hours.
Please refer to the updated CDC definition of close contact when evaluating a potential donor for occupational or social exposure risks.
The revised CDC definition resulted from a report of a correctional facility employee who contracted COVID-19 after having multiple brief exposures to prisoners who were asymptomatic at the time. Read the study in the CDC Morbidity and Mortality Weekly Report.
Cryopreservation Tools Available for Donor Assessment (updated 10/22/20)
A tool has been created for our donor center partners to allow you to quickly see the number of COVID-19 cases in a geographic area where the donor, apheresis center or collection center is located, as well as all information the Partner Liaisons have about a center’s COVID-19 testing requirements.
When you receive a fresh product request, you can use the tool to provide up-to-date information to Case Managers to help transplant centers make informed decisions about proceeding with a fresh product collection or cryopreservation of the product.
Access the tool and training information on the Health History Screening Questionnaires webpage.
At-home COVID-19 Testing Available for Donor Screening (updated 10/8/2020)
We now have an at-home COVID-19 testing option available for donors if your transplant center’s protocols require confirmation of a donor’s SARS-CoV-2 status.
We continue to recommend that asymptomatic donors are not tested for COVID-19 because there is no evidence the virus is transmissible via blood or stem cells. We are making at-home testing available to support transplant centers in meeting protocol requirements as well as the desired time to transplant.
If a transplant center requires donor testing prior to collection, their Case Manager will work with your donor center to arrange for testing. Donor center Coordinators have been trained on this testing option, but your Partner Liaison is available to provide assistance if needed.
Please keep in mind:
- Samples are only shipped Monday-Friday
- Test results are expected (but not guaranteed) within 24-48 hours of lab receipt
- Donor will be tested approximately four days before the start of filgrastim, patient prep or donor collection (whichever comes first)
- We are limiting the number of times testing can be repeated for a donor
If you have any questions, contact your Partner Liaison.
Guidance on Donor Screening for COVID-19 (updated 10/8/2020)
The NMDP/Be The Match does not currently recommend widespread COVID-19 testing for asymptomatic donors prior to donation. However, we now have an at-home COVID-19 testing option available for donors if a transplant center’s protocols require confirmation of a donor’s SARS-CoV-2 status.
As a reminder, on April 1, 2020, the FDA released updated information on COVID-19 for organizations collecting human cell and tissue products (HCT/Ps), including marrow and PBSC. Like other respiratory viruses, there is currently no evidence that COVID-19 is transmitted via blood or stem cell products.
Therefore, the FDA does not recommend laboratory testing to screen asymptomatic donors for COVID-19. Instead, the FDA continues to recommend organizations evaluate potential donors based on known risks.
If a Network apheresis or collection center requires COVID-19 testing per individual institutional policy, we ask that you carefully consider the type and timing of testing to ensure results are received in a timely manner. The testing timeline should take into consideration when the patient prep begins, timing of the filgrastim injections, the schedule of donor travel and the date of donation.
As a reminder, the following procedures are in place for screening donors before and after donation.
We continue to gather additional health and travel information from donors prior to collection at the confirmatory typing, held for workup and workup stages using the amended Health History Screening Questionnaire.
If a donor begins to exhibit COVID-19 symptoms after being cleared to donate and needs COVID-19 testing, the collection could be postponed pending COVID-19 test results. In these situations, please contact your Case Manager immediately for next steps.
Following donation, donors will be contacted at regular intervals: 2 days post; 1 week post; 1 month post; and in between as needed. Additionally, all donors are being counseled to contact their individual Workup Specialists if:
- They are diagnosed with COVID-19
- Learn of exposure to a person diagnosed with COVID-19
- Develop any acute infectious symptoms prior to and following donation
Pre-donation screening and pertinent post-donation findings will be reported to the transplant center. If a donor from DC001 reports a positive COVID-19 diagnosis within 30 days after donation, the NMDP/Be The Match will also notify the apheresis or collection center.
Access our Frequently Asked Question section for information about COVID-19 testing information. You can also contact your Partner Liaison (DonorServicesLiaisons@nmdp.org or AC-CCLiaison@nmdp.org) with questions.
Assessing Backup Donors’ Ability to Quick Proceed to Collection (updated 8/26/2020)
Since we have relaxed the requirement for product cryopreservation, the COVID-19 pandemic continues to impact operations. Scenarios persist in which on-time delivery of fresh product is at risk. Therefore, transplant centers must identify a backup donor when requesting a fresh product infusion for a patient.
The Case Manager will inform your donor center if we receive a CT request for which the donor is intended to serve as the backup to the primary donor for a patient receiving a fresh product. If the primary donor is unable to proceed to collection, your backup donor will need to progress through workup quickly, likely within a week or less.
When you are working with a donor who has been identified as a backup, you will need to assess their ability to be worked up, cleared and collected in an ultra-urgent manner. This is in addition to the regular checks you conduct (HHSQ, availability and swabs as requested) when contacting a donor for CT.
In these cases, we highly recommend you assess the availability of the apheresis or marrow collection center where the backup donor would likely donate. If needed, transfer the donor to a donor center that has an established relationship with that apheresis or marrow collection center. The NMDP/Be The Match has identified cases recently where an early donor center transfer would have improved the turnaround time for ultra-urgent cases.
If you would like assistance in assessing whether a donor center transfer would be helpful for a backup donor or have any questions about the backup donor assessment process, please contact your Partner Liaison at DonorServicesLiaisons@nmdp.org.
Access the Aug. 26, 2020, Network Announcement for additional details.
Standardized Actions for Donors who are Health Care Workers Working with COVID-19 Patients (updated 8/6/2020)
Please reference the updated Novel Coronavirus (COVID-19) Infection Assessment Tool (A00916 rev 1) for current recommendations, effective Aug. 10, 2020.
Health care workers (HCW) who are requested as donors may have different levels of exposure to COVID-19. We have established standardized actions based on different situations for HCWs that depend on their exposures:
Situation 1: HCW with prolonged exposure providing direct care and/or exposure to bodily fluids of one or more confirmed or presumptive COVID-19 cases
Take this action:
- Status as Temporarily Unavailable for 3 months from HHSQ
- Share with Case Manager/transplant center: “TU is estimate; HCW ongoing COVID-19 exposure”
This group includes HCWs or other professionals in acute and long-term care facilities and staff working with ventilators, intubated patients, patients with tracheostomies or anything else that aerosolizes respiratory droplets.
Situation 2: HCW working in medical setting with patients but none with known COVID-19 infection
Take this action:
- Evaluate as any other potential donor assessing for known exposures or their own symptoms
Situation 3: Person living with HCW
Take this action:
- Evaluate as any other potential donor assessing for known exposures or their own symptoms
Situation 4: HCW under Mandatory Medical Quarantine*
Take this action:
- Status as Temporarily Unavailable until quarantine timeline expires
- If their test results are pending, wait until results are known
*Any potential donor under mandatory medical quarantine would be assessed as described.
If it is known that a current donor at workup is an HCW and is in the high-risk category, then the donor should be made Temporarily Unavailable for 3 months. All current and new donors need to be assessed to determine if they fall into category 1. This assessment and these guidelines are due to the understanding that these workers are at higher risk of exposure and that they might be at higher risk for quarantine or illness and then unavailable for donation.
Confirmatory Typing Process Includes Donor Buccal Swab Sample (updated 6/9/2020)
To enhance our ability to serve patients during the COVID-19 pandemic while also meeting the needs of our donors, we are making an additional update to our confirmatory typing (CT) process. As of May 26, 2020, we will ask donors from DC001 and contracted partners to provide a CT sample using buccal swabs ordered through Kitmaker. We are making the change in response to feedback from our transplant center partners.
We first adapted the CT process on March 25, 2020. At that time, we removed blood sample collection as a CT component to limit the number of times a potential donor must visit a draw site to reduce the risk of exposing a donor to COVID-19.
With the newly adapted process, the donor center will check for donor availability, complete the HHSQ with the donor and request the donor provide a CT sample using buccal swabs. Available donors may be requested for CT stages and Held for Workup (with no additional HHSQ needed if the next request is made within 12 weeks). Activities performed at the Workup stage are not impacted by this.
If a transplant center does not wish to perform CT testing and ABO/Rh and CMV are not needed, the transplant center can request only the donor health history and availability screening (effective June 15). See below for details on this process.
Process for obtaining CT buccal swab sample
Starting May 26, Donor Center Coordinators will order buccal swab kits using Kitmaker. Donor centers received training on May 21 on how to order the buccal swab kits. The kits are sent to the donor and include two sets of buccal swabs. The donor mails both sets of buccal swabs to the NMDP/Be The Match Biorepository.
The Biorepository forwards two swabs to the transplant center for processing, and two swabs to a contracted lab for presumptive ABO/Rh and CMV testing. Transplant centers will be able to view the ABO/Rh and CMV results in MatchSource®. Donor centers will be able to see the results in the general demographics area of STAR Link® Web.
Donor centers will not be charged for the buccal swab kits and will continue to receive payment only for donor contact activities.
Please note, donor management partners who do not use STAR Link have been contacted separately to discuss how they can participate in this updated process.
Case Managers, Search Advocates and donor center staff will remain in close contact to maintain a line of sight to the transplant center’s needs.
We have put a variance in place to account for these changes. Reference variance number Varco-WU-0002 in the donor’s file. Contact your liaison (DonorServicesLiaisons@NMDP.ORG) with questions.
Option for Only Health History and Availability Check at CT (updated 6/9/2020)
We recently announced an updated CT process that included buccal swabs for HLA typing and presumptive ABO/Rh and CMV testing. However, not all transplant centers are able to use the buccal swabs for HLA typing. In response to their feedback, we are introducing the additional option for a transplant center to request that only a health history screening and availability check be completed at CT. This is similar to the process that was in effect from March 25 through May 26.
Effective Monday, June 15, the following process will be used when transplant centers only want a health history screening and availability check at CT. At the time of CT request, the transplant center must email the Case Manager or Search Advocate to notify them that they do not require the buccal swabs. The Case Manager or Search Advocate will immediately pass on the notification to your donor center. Your donor center must document this notification.
In these cases, you will not ask the donor to complete a CT buccal swab kit. Instead, your donor center will contact the donor, complete an HHSQ, assess availability and provide relevant information to the Case Manager or Search Advocate.
The donor will then either be released by the transplant center or the donor’s CT request will be canceled and replaced with a Held for Workup or Workup request. The date of the completed HHSQ will be used to calculate whether this type of CT is completed within 7 days. Your donor center will still be paid for donor contact, as well as the CT in 7 days incentive, if applicable.
Please note: if your donor center does not receive notification that only a health history and availability check are required, your donor center is expected to order a buccal swab kit and encourage prompt sample collection and return.
Continue to reference variance number Varco-WU-0002 in your donor files to account for this process. A more detailed process flow will be provided by your Partner Liaison prior to June 15. Please reach out to DonorServicesLiaisons@nmdp.org with any questions.
Self-Administered Filgrastim Injections Being Piloted During COVID-19 (updated 5/28/2020)
During the COVID-19 pandemic, DC001 will begin piloting a new process for the administration of filgrastim during contingency events when a large number of donors may be impacted. In order to limit a donor’s potential exposure to COVID-19, some donors will be instructed on how to self-administer filgrastim injections. Those donors receive prefilled filgrastim syringes.
If the pilot goes well, we will expand the use of donor self-administered injections during contingency events across all network donor centers during a quarterly release schedule.
As DC001 continues to test and evaluate this process, be aware that starting on June 1 apheresis centers may see revised forms in a donor’s record when the donor comes to your center for injections and collection. If the donor is self-injecting at any point, the form changes include the capability for DC001 and apheresis center staff to select options for vials of filgrastim and/or prefilled filgrastim syringes based on specific donor daily needs.
The forms include:
- F01210 Rev 1: Neupogen® (filgrastim) Shipping Information - COVID Edition
- F01211 Rev 1: Neupogen® (filgrastim) Order Form – COVID Edition
- F01212 Rev 1: Neupogen® (filgrastim) Delivery Ticket – COVID Edition
The apheresis center injection process does not change. If an apheresis center administers a donor’s injections, filgrastim will continue to be shipped in vials, not prefilled syringes.
COVID-19 Testing and Cryopreservation Questions Added to Workup Plan (updated 5/12/2020)
Starting May 13, two additional questions will be part of the Workup Plan (F01119) completed by donor centers and provided to transplant centers.
The new questions in the document are as follows:
- Will AC/CC test donor for COVID-19 prior to donation?
- Is the product planned to be cryopreserved?
The two new questions can be found in Section 1 of the Workup Plan. In addition, the questions have been added to Section 1.2 of document A00875, Instructions for Completing the Workup Plan (F01110).
Please remember the answers to the questions are accurate as of the date the form is completed but may change later. If the answers change, donor centers are expected to document changes and notify Case Managers in writing (email is acceptable). Case Managers will be responsible for notifying transplant centers of any changes.
Access the updated documents on the Workup Plan and Instructions webpage on May 13.
Contact Your Partner Liaison if Your Center is Testing Donors for COVID-19 (updated 5/12/2020)
If your apheresis or collection center is testing donors entering your facility for COVID-19, remember to update your NMDP/Be The Match Partner Liaison with this information. This will allow us to account for any concerns with maintaining a patient’s transplant timeline, including a patient’s preparative treatment.
Please provide your Partner Liaison (AC-CCLiaison@nmdp.org) with all pertinent information, including the timing of COVID-19 testing and your institutional processes or requirements. It is critical for your Partner Liaison to have this information so we can work with transplant centers to ensure we can meet the needs of patients.
While the NMDP/Be The Match is not currently testing donors for COVID-19 per FDA guidelines, we respect your organization’s decision to test out of concern for staff and the patients in your care.
If you have any questions, contact your Partner Liaison at AC-CCLiaison@nmdp.org.
Donor Center Process for Bone Marrow Requests During COVID-19 Pandemic (updated 5/5/2020)
During the COVID-19 pandemic, we are asking transplant centers to reserve marrow requests only for patients with the greatest need for this graft source. Securing bone marrow harvest slots continues to be difficult even as some health care systems are resuming outpatient surgical procedures. Effective March 27, 2020, this means donor centers should assume new requests that are marrow only truly need marrow based on the patient status and should proceed accordingly.
As a reminder, for new workup requests that come through indicating marrow as the first choice and PBSC as the second choice, first assess whether a marrow collection facility is in close proximity to the donor. This would allow the donor to avoid or limit their travel.
If you can locate a local facility, try proceeding with securing a marrow collection slot that meets the transplant center’s requested timeline.
If you cannot find a local facility, alert the Case Manager that you will now be proceeding with locating and securing a PBSC collection slot that meets the transplant center’s requested timeline.
Please note, if the product is marrow and not being cryopreserved, be sure the collection facility is aware of this and proceed with caution.
If you have any questions about this change in process, contact your liaison (DonorServicesLiaisons@nmdp.org) for assistance.
Donor Communication When Product Will Not Be Infused (updated 4/28/2020)
With the current requirement to cryopreserve collected products, there is a small risk that a donated product will not be infused as planned. We have seen this occur in a limited number of cases. If this does occur, your Partner Liaison is here to support you in how to deliver this message to a donor and can help you with talking points for this difficult conversation.
A transplant center may make the decision not to infuse a product for a variety of reasons. The Case Manager will notify you if informed about a transplant center’s decision not to infuse the collected product.
If our first notification is a product complaint, our Transplant Medical Services team will be involved in the investigation and your Partner Liaison will support the process. The investigator will inform the donor center, apheresis center or collection center about the issue as part of the investigation. In these cases, it is extremely important for you to talk to your Partner Liaison to discuss the information to share with the donor.
For a product that is not infused, it is possible that it may be requested to be used for anonymous research. In these cases, donor consent is required.
To contact your Partner Liaison, email DonorServicesLiaisons@nmdp.org.
Status Code for Donors Unavailable Due to COVID-19 (updated 4/23/2020)
To ensure we are capturing the full impact of the COVID-19 pandemic on donor availability, we are asking donor centers to use consistent status coding for unavailable donors. Please use the “TU – Other” code for donors who are uncomfortable donating during the COVID-19 pandemic. Also use “TU – Other” for donors who have family commitments due to COVID-19 that prevent them from donating at this time.
The “TU – Other” code should be put in place for 90 to 120 days. Include a note in the donor’s file about the reason for the request to be temporarily unavailable.
If the donor is a health care worker, continue to follow the standardized process for coding and adding notes. You can find this process in the Standardized Actions for Donors who are Health Care Workers Working with COVID-19 Patients section on this webpage.
If you have any questions, contact your Partner Liaison (DonorServicesLiaisons@nmdp.org).
Signing Workup Documents While Working from Home (updated 4/14/2020)
If your Donor Center, Apheresis Center or Collection Center staff are working from home, contact your center’s liaison to discuss approaches to signing documents for workup processes. We have developed general expectations to assist you. However, we recognize circumstances at your center may require a more complex flow.
Notification of Donor COVID-19 Diagnosis Post-Donation (updated 4/1/2020)
If a donor from DC001 reports a positive COVID-19 diagnosis within 30 days after donation, the NMDP/Be The Match will notify the apheresis or collection center.
We will provide the:
- Date of positive test
- Onset of donor symptoms
- Any known exposures if applicable
We are providing this information so apheresis and collection centers can inform health care team members who may have come in close contact with a potentially infectious donor on collection day.
The donor’s Workup Specialist and NMDP/Be The Match Medical Services will notify the apheresis or collection center via email. Donor centers should download and send the Post Donation COVID-19 Positive Notification form to the apheresis or collection centers. Apheresis and collection center staff can download a sample form to familiarize yourself with the information you will receive.
The transplant center will also receive similar information about a donor who receives a COVID-19 diagnosis.
If you have any questions, please email DMS@nmdp.org.
Essential Collections at Apheresis and Collection Centers (updated 3/24/20)
We understand that health systems are under tremendous strain. Many health care organizations are suspending all non-essential care and procedures due to the COVID-19 pandemic. While we anticipate a significant decline in all types of BMT procedures over the next several weeks, we are confident that decisions to move forward with BMT are being made with the best interest of patients in mind. These are the patients whose lives are in greatest jeopardy without BMT and who have the most to benefit from it.
In order to continue to deliver on the promise to connect our donors with their patients, we have urged medical directors and primary coordinators at our partner apheresis and/or marrow collection centers to continue to partner with us in bringing this
Please contact Amy Hines, RN, BSN, Director, Collection Experience, at firstname.lastname@example.org or 231-668-7143 with any questions.
Travel and Logistics
Vaccination Requirement for NMDP/ Be The Match Couriers (updated 9/13/2021)
Starting Sept. 30, 2021, we are requiring that National Marrow Donor Program® (NMDP)/Be The Match® couriers be fully vaccinated for COVID-19. This includes volunteers, staff and third-party couriers.
We are instituting this requirement to comply with the proof of vaccination upon entry required at clinical facilities at which products may be picked up or delivered. In addition, as a healthcare organization we have an obligation to the safety of our Network partners, patients, donors, NMDP/Be The Match staff and volunteers.
What the vaccination requirement means for couriers
Fully vaccinated is defined as:
- two weeks or more after receiving a second dose in a 2-dose COVID-19 series, or
- two weeks or more after receiving a single-dose COVID-19 vaccine (Johnson and Johnson/Janssen)
Couriers must be prepared to show proof of vaccination at any time during the courier trip. Examples of vaccination proof include:
- Complete COVID-19 vaccination card
- A clear image of the vaccination card on a phone
- COVID-19 vaccination record on a mobile app
- Digital COVID-19 vaccination QR code
Note: Some states may require vaccination cards, so couriers should plan to check local requirements in advance.
Network partners who provide couriers for NMDP/Be The Match transports are expected to be compliant with this courier vaccination requirement. There will be no exceptions. We understand some couriers may not yet be fully vaccinated and ask they refrain from accepting trips until they have done so. This is consistent with our commitment to our patients, donors and each other, and will ensure avoidance of being turned away. Please disseminate this information to the appropriate leaders and staff in your organization as necessary.
Provide Case Managers with Up-To-Date Courier Instructions (updated 6/9/2020)
As travel restrictions and apheresis and collection center restrictions continue to change throughout the COVID-19 pandemic, the NMDP/Be The Match is providing couriers for all products unless specific circumstances prevent that. Therefore, it is extremely important for cooperative registries and donor centers to provide up-to-date courier instructions to your Case Manager. We want to make sure couriers secured by the NMDP/Be The Match can safely transport the product without delay.
Please tell the NMDP/Be The Match Case Manager about any details associated with the pick up of the product that may be beneficial for the courier. For example:
- Special locations for pick up of the product
- Particular hours of operation that may be established
- The product exchange must occur at a specific airport
- The courier cannot leave the arrival airport
- The courier cannot travel domestically within your country
- The courier must undergo COVID-19 testing at the airport
Your Case Manager may reach out to validate pick-up instructions prior to requesting/providing an itinerary. Contact your Case Manager if you have any questions.
Letters for Donors and Companions Under Shelter-In-Place Orders (updated 4/21/2020)
Many states are enacting shelter-in-place orders to help contain the spread of COVID-19. To ensure donors do not have issues getting to and from appointments, we have developed a letter for donors and their companions to carry with them when they need to leave home for donation-related appointments (e.g., workup or collection).
If local authorities stop a donor, the donor should show the officer the letter.
Download the Donor Travel Letter and Donor Companion Travel Letter from the “Resources and Information for Donors” webpage. Then, fill in the appropriate information and send it to the donor.
State-specific letters for donors and companions during the COVID-19 pandemic
Some states have different requirements for their documentation. Please use the state-specific documents on the “Resources and Information Donors” webpage in place of the general documents for donors and companions traveling in these states:
Preparing Donors for Travel (updated 4/7/2020)
Donor travel for pre-donation appointments and collection could be impacted, whether your donors are traveling by car or plane. Use the following recommendations to help your donors prepare for all situations and stay on track for donation.
Check with your donors and their companions to see if their location requires documentation for being out of the house during local or statewide shelter-in-place orders. Provide them with the general letter or state-specific letter to carry with them. Download the appropriate Donor Travel Letter and Donor Companion Travel Letter.
Cloth face coverings
Per the CDC guidelines, we recommend donors and their companions use a cloth face covering in public settings when social distancing is difficult. Connect with your donors and their companions to make sure they have access to cloth face coverings. If they do not, please provide masks for them and/or provide them with instructions on how to make them at home. The CDC website provides sew and no-sew tutorials.
Arrival instructions and companion restrictions
Apheresis and collection centers are evolving their response to COVID-19. The center may have changed arrival instructions. Some may no longer allow companions to accompany donors. Check with the apheresis or collection centers before your donors’ visits and provide your donors with the most up-to-date information about screening, what to expect and any additional instructions about the center's COVID-19 protocols.
Some states have set up checkpoints that may impact travel times. If your donors are driving to any of their appointments and crossing state lines, encourage them to educate themselves about any potential traffic disruptions while planning their trip.
Support for Overcoming Donor or Courier Travel Restrictions (updated 4/2/2020)
As states and cities continue to tighten travel restrictions, freedom of movement may become restricted for our donors and couriers. The NMDP/Be The Match Emergency Preparedness Team (EPT) is available to intervene.
The team’s goal is to assist donors and couriers who are faced with restrictions that make travel for our life-saving mission seem impossible. If you have a specific donor or courier who is facing a COVID-19-related travel impact within up to 48 hours (including those facing immediate impacts), use our “Request for Assistance for Donor/Courier” template. The template is also available on our Resources and Information for Donors webpage.
Copy and paste the information from the template into an email, fill out the necessary information and send the email to DonorServicesLiaisons@nmdp.org.
Our Partner Liaisons will coordinate assistance with the EPT upon receiving your email.
Assessment of Donor Foreign Travel (updated 4/1/2020)
While the CDC Travel Recommendations by Country recently changed to a Level 3 Health Notice or Travel Health Notice for all countries, there are no planned changes to the F01190, Novel Coronavirus (COVID-19) Infection Assessment Questionnaire.
It remains important to collect information on donor travel outside the U.S. and report this information to the transplant center.
With all countries at a Level 3, this means the Case Manager and transplant center must be notified about any donor who has traveled anywhere outside the U.S. in the past 30 days or plans to travel outside the U.S. in the upcoming two months.
As the outbreak is contained, countries will begin to move to Level 1 and 2 Notices. The F01190, Novel Coronavirus (COVID-19) Infection Assessment Questionnaire contains a link to the CDC Travel Recommendation by Country webpage.
Assessment of Donor Travel in the U.S. (updated 4/1/2020)
With the extensive spread of the COVID-19 infection in the U.S., there are currently no plans to gather or report donor travel to specific locations in the U.S. Because the virus is in all 50 states, it is reasonable to assume most people have had some type of exposure to COVID-19. While there are “hot spots” in the U.S., these locations change rapidly.
We will continue to use the F01190, Novel Coronavirus (COVID-19) Infection Assessment Questionnaire at the confirmatory typing, held for workup and workup stages. Transplant centers will be notified if a donor reports close contact to a person with presumed or suspected COVID-19 infection but is not reporting symptoms themselves.
Re-evaluation of Donor Travel (updated 3/19/2020)
To mitigate travel issues that could arise for donors before and after donation, the NMDP/Be The Match is re-evaluating where donors are traveling for collection. At this time, we are working to move donors’ collections to centers as close to their home as possible.
We recommend all Network donor centers also evaluate donor travel to decrease any potential travel issues. We also recommend having donors collect locally whenever feasible.
Consider working with your Case Managers to develop the best plan to meet patient and donor needs. Please reach out to your Partner Liaisons if you need assistance with alternative plans.
COVID-19 Impacts on Vendor Partners (updated 3/19/2020)
The NMDP/Be The Match has been in communication with our vendor partners to discuss the COVID-19 impact to their operations across the country:
- FedEx has reported they may encounter delays impacting shipments.
- LabCorp has reported that some Patient Service Centers (PSC) are closing for an undetermined length of time due to COVID-19 concerns. LabCorp leadership will provide updates on further closures.
- Concentra has no plans to reduce the number of NMDP/Be The Match donors they see for physical exams.
However, we do not foresee that the above changes will have significant impact on our operations.
Membership, Engagement, Enrollment and Experience Live Drives Paused (updated 3/26/2020)
The NMDP/Be The Match is extending the pause of all live drive recruitment activities through April 30, 2020. Our leadership will not deploy employees, contractors or volunteers to participate in live drive activities during this timeframe.
Recruitment through online registration will continue during this time. We encourage our Network partners to mobilize mission advocates, drive sponsors and other community supporters to take part in the #Couch2Cure campaign.
We will provide Account Managers and Network partners with tools and training on how to shift recruitment efforts to online activities.
Cancellation of Be The Match Mexico Recruitment Events (updated 3/19/2020)
All Be The Match Mexico recruitment events have been canceled through April 19. These dates align with the message to the public from Mexican government officials urging all schools, corporations and public events to extend their spring break (holy week vacations) from two weeks to one month. This cancellation includes all recruitment activity.
Resources for Apheresis and Collection Centers, Donor Centers and Donors
COVID-19 Toolkit for Donor Centers (updated 12/23/2020)
To support you in having conversations with your donors about staying safe during the COVID-19 pandemic, we’ve created a COVID-19 toolkit for our donor center partners. The toolkit includes a Social Bubble info sheet and the Important COVID-19 Donor Information: For Your Safety sheet.
Social Bubble information sheet
Creating a social bubble can help lower the risk of a donor being exposed to COVID-19. The Social Bubble info sheet provides practical information for donors on:
- What it means to have a social bubble
- How to start a social bubble
- How to have conversations with family and friends about being part of the bubble
- Setting ground rules for the group
Use the information sheet to support your conversation with a donor about creating a social bubble to stay safe for their patient. Be sure to share the info sheet with your donor.
Important COVID-19 Donor Information: For Your Safety sheet
The Important COVID-19 Donor Information: For Your Safety includes specific guidance how to limit COVID-19 exposure risk, including:
- Steps donors can take to minimize their COVID-19 exposure in the days and weeks leading up to donation, while traveling to donate, on donation day and after donation
- What to do if they develop symptoms
- What to do if they are tested for COVID-19 at any point before donation
- What to do if they test positive for COVID-19 within 1 month of donation
Be sure to include your coordinator contact information on the information sheet no later than PE/Clearance. Please encourage your staff to share the document with all donors to help them prepare for donation day.
Please confirm the AC or CC’s COVID policies directly with the center for every workup to provide the most current information to your donor. This allows us to better prepare and inform donors on what to expect.
Access the Social Bubble and Important COVID-19 Donor Information: For Your Safety sheets on the Information Packets webpage.
Manuscript Examines Early Impacts of COVID-19 on Donor Product Delivery (updated 12/23/2020)
Until recently, the COVID-19 pandemic’s effects on the transplant and cell therapy community have not been well-defined. A manuscript published in Transplantation and Cellular Therapy offers the first report on the impact of the COVID-19 pandemic on the ability of the National Marrow Donor Program® (NMDP)/Be The Match® and our Network to safely deliver unrelated donor products early in the pandemic.
The authors analyzed data from the NMDP/Be The Match from March through May 2020. They compared it to data from the three months prior to the pandemic (December 2019 through February 2020), as well as data from March through May 2019.
They found that the NMDP/Be The Match and our Network partners continued to effectively deliver domestic and unrelated donor products to allogeneic transplant patients in similar or shorter timeframes than before COVID-19, despite the many unexpected challenges detailed in the full text. Access the full manuscript.
Recording Available: Donor Center Responsibilities After Cryo Requirement is Relaxed (updated 7/30/2020)
The NMDP/Be The Match is relaxing the requirement for cryopreservation for collections scheduled on or after Aug. 10. This allows transplant centers to infuse fresh product in certain scenarios. However, cryopreservation may continue to be the safest option in some cases, particularly if a donor lives in an area at high-risk for COVID-19 infections.
Donor centers will have an important role in communicating any pertinent risk with a donor proceeding to collection so the transplant center can determine if cryopreservation or a fresh product infusion is the best option for their patient. Donor centers will assess donors for risk and alert the Case Manager if a donor is at increased risk of not being able to donate.
Because there are a number of factors that impact risk—such as residing in a COVID-19 surge area or having COVID-19 positive test—we want to ensure our donor center partners have the guidance and tools to conduct these assessments. Access the training session recording from July 22.
You’ll learn about our expectations for sharing risk information with the Case Managers so transplant centers can make informed decisions about receiving a fresh product or making plans for cryopreservation.
On-Demand Webinar: Let’s Talk About It – Talking with Donors in a Time of Unrest (updated 6/16/2020)
With the COVID-19 pandemic and recent civil unrest, our donors’ mental health is likely under more stress than ever. And, your conversations with donors can be more challenging than ever. Donor mental well-being and the stress and anxiety the donation process may cause are all important considerations for you.
Access the on-demand webinar, “Let’s Talk About It – Talking with Donors in a Time of Unrest,” for tips and strategies for successful conversations with donors during this time.
- Kari McCaw, MBA, Donor Experience Manager
- Laura Vincent, Donor Experience Manager
Council Advisory Group is Here to Help During COVID-19 (updated 6/2/2020)
During the COVID-19 pandemic, remember the Council Advisory Group is here to support you as your voice to NMDP/Be The Match leadership. Members relay questions, concerns and suggestions from the Network and work with leadership to gather input, get clarification and find solutions.
You can contact the Council Advisory Group by emailing email@example.com. You will receive a written response from a Council Advisory Group member. You can also contact the Council Advisory Group Chair, Hope Guidry-Groves, directly at Hgroves@giveblood.org. If you wish to remain anonymous, please note this in your communication and your name will be used only for the purpose of sending you a response.
To learn more about the Council Advisory Group and meet the team members, visit the Council Advisory Group webpage.
Frequently Asked Questions
Frequently Asked Questions for Donor Centers and Your Donors (updated 10/8/2020)
This information will be updated as changes occur. Click on the question to expand the answer.
Donor Center Frequently Asked Questions
What is COVID-19?
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
The first case of COVID-19 in the United States was reported on Jan. 21, 2020. The current count of cases of COVID-19 in the United States is available on the Centers for Disease Control and Prevention’s (CDC) website.
Additional information from the CDC website that you may find useful includes:
Can the virus be transmitted from donor to recipient via blood or stem cells?
At this time, there is no evidence that this virus is transmitted via blood or stem cell products. For this reason, regulatory agencies do not currently recommend or require any action on product testing.
Even if the virus is not transmitted by stem cell products, ill patients in need of transplant can be harmed in other serious ways. This is especially true if a donor is unable to provide a stem cell product in the time needed for that recipient’s treatment or after the recipient has started their preparatory regimen.
How are potential donors being screened for this infection?
We are gathering additional health and travel information from donors at the confirmatory typing, held for workup and workup stages. This information is based on known risks. Transplant centers are informed of any identified risks to allow them to make a risk/benefit decision on whether to proceed with that donor.
Access a summary of the addendum to the Health History Screening Questionnaire:
Should I have my donor tested for COVID-19 prior to donation?
Currently, we are not recommending testing for asymptomatic donors. However, we now have an at-home COVID-19 testing option available for donors if a transplant center’s protocols
require confirmation of a donor’s SARS-CoV-2 status.
If your donor begins exhibiting COVID-19 symptoms post-clearance, please contact your Case Manager and Partner Liaison immediately. A symptomatic donor should be tested prior to patient prep, filgrastim administration or travel.
What should I do if my donor is being collected at an apheresis center or collection center that requires COVID-19 testing?
Please notify the Case Manager and NMDP/Be The Match Partner Liaison when the apheresis center or collection center notifies you about their testing policy for assistance with next steps.
Who orders the COVID-19 test?
If a COVID-19 test is requested outside of testing provided by the collecting apheresis center or collection center, donor centers should work with their Medical Director to order COVID-19 testing through LabCorp or the clinical testing organization
your center uses.
If the apheresis center or collection center requests testing prior to arrival at their center, donor center staff should coordinate with the apheresis center or collection center team to order testing in whatever manner is most efficient.
If the transplant center requests the test for a donor with symptoms or exposure related to COVID-19, NMDP/Be The Match Medical Services should be able to provide an order when appropriate.
What type of test should I order for COVID-19 testing?
Please request a test that can detect acute COVID-19 infection, such as the PCR.
Will the collecting site accept outside COVID-19 test results?
The NMDP/Be The Match will work with centers on a case-by-case basis to determine how testing will be performed before donor travel or patient prep.
What should happen if a donor tests positive at an apheresis center or collection center on the day of donation?
Centers should immediately contact the Workup Coordinator.
What do I do if I’m notified a donor tested positive for COVID-19?
In all instances, you must immediately:
- Notify Case Management at (800) 548-1375 during business hours or (763) 406-4400 after hours, weekends and holidays.
- Notify Transplant Medical Services at firstname.lastname@example.org immediately
- Place the donor in TU status for 30 days
If we are waiting on COVID-19 test results for a donor who is exhibiting symptoms post-PE but prior to collection day, should collection be postponed prior to the donor traveling?
Donors should not travel for any donation activities (physical exam, injections, donation) if they are waiting on COVID-19 test results.
What should happen if my donor has pending COVID-19 test results and is due to start filgrastim or travel to the apheresis center or collection center?
Donors should not travel for any donation activities (physical exam, injections, donation) if they are waiting on COVID-19 test results.
Can we test for COVID-19 before the donor travels for donation/starts injections?
Currently, we are not recommending testing for asymptomatic donors. If your donor begins exhibiting COVID-19 symptoms post-clearance, please contact your Case Manager and Partner Liaison immediately. A symptomatic donor should be tested prior to patient
prep, filgrastim administration or travel.
Donors should not travel for any donation activities (physical exam, injections, donation) if they are waiting on COVID-19 test results. Please work with Medical Services to consider testing options.
What are the different types of COVID-19 testing, and how can I explain them to my donor?
Currently, there are two main types of tests for COVID-19. You can read more about these options on the CDC website.
Who pays for donor pre-collection COVID-19 testing?
Apheresis or collection centers that are testing donors entering their facility should cover the testing internally according to their testing policies and procedures.
For testing coordinated by the donor center, please submit an Extended Medical Testing Request (F00253). If your donor center has an NMDP/Be The Match P-card, please pay for the kit using the P-card process. If your donor center does not use an NMDP/Be The Match P-card, please provide an invoice for center reimbursement to email@example.com.
Why are some donors required to be tested for COVID-19 and not others?
Some donors need to be tested because they have been exposed to COVID-19 or have symptoms of COVID-19. Additionally, some apheresis centers and collection centers have internal policies and procedures that require any persons entering their facility or receiving care be tested for infection.
What do I do if my donor requests COVID-19 testing?
Currently, we are not recommending testing for asymptomatic donors, which is aligned with FDA recommendations. Please screen your donor using the Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (F01190) and update Case Management as appropriate.
Will you be screening or testing donors after donation? Should we test and/or quarantine the stem cell products?
At this time, there is no evidence that COVID-19 is transmitted via blood, bone marrow or stem cell products. For this reason, NMDP/Be The Match, in conjunction with other regulatory agencies such as the FDA and AABB, does not currently recommend or require product testing or quarantine.
In effort to identify donors who may have or be at risk for contracting the novel coronavirus, the NMDP/Be The Match is screening donors prior to donation at confirmatory typing, held for workup, and formal workup stages.
Following donation, donors will be contacted at regular intervals: 2 days post; 1 week post; 1 month post; and in between as needed. Additionally, all donors are being counseled to contact their individual workup specialists if they are diagnosed with COVID-19, learn of exposure to a person diagnosed with COVID-19, or develop any acute infectious symptoms prior to and following donation.
Pre-donation screening and pertinent post-donation findings will be reported to the transplant center and apheresis/collection center . The NMDP/Be The Match does not recommend delaying transplant to await post-donation findings, product quarantine or product testing. That said, these decisions are at the discretion of the individual transplant center/team.
What information do I need to get from my donor who has tested positive for COVID-19 after donation?Please collect the following information from you donor:
- When were you tested?
- What type of test was done (example: nasal swab, blood test)?
- When did you receive this result?
- Why were you tested (experiencing symptoms, voluntary testing)?
- Are you currently experiencing symptoms?
If my donor tests positive for COVID-19 after donation, will the donor’s cells still be infused?
There is currently no evidence that COVID-19 is transmitted via blood or stem cell products. The patient’s transplant team will make the determination whether to infuse the cells.
What will happen to the patient and the cells if the donor’s cells are not infused because the donor tested positive for COVID-19 after donation?
If the patient’s transplant team makes the determination to not infuse the donor’s cells, they will use a second (back-up) source of stem cells. NMDP/Be The Match will assist the transplant center in locating a back-up source if needed.
Your Partner Liaison will work with you to understand what the transplant center is requesting or recommending regarding the uninfused product and will support any need for donor consent and/or further communications.
What can I tell my donor if they are concerned about passing COVID-19 on to the patient?
Based on the information we have right now, the risk of viral transmission via bone marrow or PBSC donation to the patient is very low. The U.S. Food and Drug Administration reports that there have been no reported or suspected cases of transfusion-transmitted COVID-19 to date. In addition, no cases of transfusion-transmission were ever reported for the other two coronaviruses that emerged during the past two decades (SARS, the Severe Acute Respiratory Syndrome Coronavirus, and MERS-CoV, which causes Mideast Respiratory Syndrome).
Are there any resources available to help my donor after a COVID-19 diagnosis?
Your donor should seek treatment from their primary care physician for all COVID-19 concerns. If your donor is seeking emotional support or would like to talk about their situation as it relates to donation, please use the resources available on the Network Website or connect them with firstname.lastname@example.org for further assistance.
Are there alternatives to donors traveling for donation?
Possibly. As you know, donation is time sensitive. Any delay can negatively impact the recipient’s wellbeing, especially if they have already started myeloablative prep or conditioning.
It may be possible to arrange for donation to occur at a local facility or somewhere within driving distance depending on site availability. In some cases, this may require the donor to undergo repeat testing and/or physical exam for clearance.
We respect our donors’ decisions not to travel if they feel uncomfortable doing so. Please encourage donors to speak up sooner rather than later if they are having second thoughts about traveling for donation so we can look at alternative options.
Your National Marrow Donor Program® (NMDP)/Be The Match® Liaison or Case Manager can assist with the escalation if your center does not have a local collection site.
Do the side effects of filgrastim mimic some signs and symptoms of COVID-19?
The following are the most common/classic symptoms of COVID-19 infection and may appear 2 to 14 days after exposure:
- Shortness of breath
The most common side effects of filgrastim are headache, bone or muscle pain, nausea and fatigue. Less frequently, filgrastim may cause fever or dry cough. Filgrastim does not routinely cause acute shortness of breath. These symptoms typically appear within the first 24 hours of the first injection and continue until a day or two after donation.
How do I assess a potential donor who is quarantined due to exposure to COVID-19?
Any potential donor who is under quarantine due to exposure to known or suspected COVID-19 should be made temporarily unavailable (TU) for 30 days from the start of their exposure. This does not include donors working from home due to personal choice or company-wide policy. Exceptions to this guidance may be considered on a case-by-case basis in consultation with the NMDP/Be The Match and transplant center medical directors.
Quarantine in general means the separation of a person or group of people reasonably believed to have been exposed to a communicable disease but not yet symptomatic from others who have not been exposed so as to prevent the possible spread of the communicable disease.
Are couriers required to quarantine after traveling domestically or internationally with product for NMDP/Be The Match?
NMDP/Be The Match is following the CDC guidelines for both international and domestic travel at this time.
International Travel: The current CDC recommendations include self-quarantine for 14 days and practicing social distancing when returning from high-risk countries. Please check the CDC high risk travel page for regular updates to their list of countries in the Level 3 risk category. Travel FAQs for all international travel at this time are also recommended for review.
Domestic Travel: We provide travel letters from our Legal team as needed for those transiting states where travel is restricted. We recommend making yourself familiar with the CDC guidelines for travel within the United States before making decisions about courier trips.
We are obligated to follow the government’s guidance, and the current guidance is a recommendation of self-quarantine, not a mandatory order for situations where you have potentially been exposed to COVID-19. We ask that all couriers to read the CDC information, work to understand it, and make the appropriate decisions for themselves when accepting courier trips during this time.
Donor Center Frequently Asked Questions – Changes to CT Process
If my donor center has a blood donation file on the donor that shows ABO and CMV results, can we use those?
No. To ensure consistency and avoid confusion, we will use the new process for all donors.
If my donor is willing and able to attend a blood draw, can my center coordinate that process and reimbursement?
We made changes to the CT process to reduce the risk of exposing a donor to COVID-19. Donor centers should use the new process for all donors at CT. This also ensures consistency between centers.
Which lab is providing the ABO/Rh and CMV testing results?
The testing will be performed by laboratories that perform our recruitment testing.
For the new CT buccal swab kits, which date should we input for the Appointment Date field in STARLink?
Please enter the date the donor ships the samples.
Do Kitmaker kits need to be signed for upon delivery?
This depends. Kits usually don’t need to be signed for when delivered to a donor’s home, but they may need to be signed for if delivered to a lab or hospital. Due to COVID-19, some FedEx drivers may also skip asking for a signature.
It sounds like there will be a delay in getting these samples to transplant centers with the added stop of the Biorepository. How are you addressing this?
There is an extra step in this process compared to the former method of shipping CT blood samples. However, the kits have a very quick turnaround time of less than a day at the Biorepository. Once received at the Biorepository, the kits are inspected and sent to the transplant center on the same day via priority overnight shipping.
Does NMDP/Be The Match have a new variance in place for the buccal swab versus no draw at CT?
Yes, please note the NMDP/Be The Match variance number Varco-WU-0002 for this new process. Please follow your internal SOP/quality system if an additional internal variance number is necessary for your center.
Can transplant centers order a CT without the buccal swabs?
No. To be consistent with the process for all centers, the modified process will be used for all donors.
What if transplant centers want to order a CT with buccal swabs for a donor who has already been requested at CT prior to May 26?
We will ask transplant centers to submit a new CT request on or after May 26.
Are we still being reimbursed for the CT sample collections and CT in seven days under this new process?
Centers are reimbursed for contact and if they get the appointment date within seven days of the request, but not for sample collection.
Donor Frequently Asked Questions
I am concerned about traveling for donation. What can I do to protect myself?
We understand you may be concerned about air travel and exposing yourself to potential risks. If traveling for donation will affect your ability to return to work or other duties, let us know right away. We will look for alternative options for your donation.
Be The Match is monitoring travel recommendations from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) and travel guidelines accordingly. At this time, the CDC has not restricted travel within the United States.
You may want to review the actions your airline is taking to reduce their passengers’ exposure to the virus. Your airline’s website should provide this information.
You can find additional information about risk locations on the CDC website:
When you travel, the CDC recommends taking the following precautions:
- Avoid contact with sick people.
- Clean and disinfect frequently touched objects and surfaces using a regular household cleaning spray or wipe.
- Avoid touching your eyes, nose or mouth with unwashed hands.
- Clean your hands often by washing them with soap and water for at least 20 seconds or using an alcohol-based hand sanitizer that contains 60-95% alcohol. Soap and water should be used if hands are visibly dirty. It is especially important to wash your hands after going to the bathroom; before eating; and after coughing, sneezing or blowing your nose.
- Everyone wear a cloth mask over the nose and mouth when in public places, including when traveling.
The CDC website provides additional information on everyday preventive actions you can take to help prevent the spread of respiratory diseases:
Are there alternatives to traveling for donation?
If you feel uncomfortable traveling, we respect your decision. However, it is extremely important that you tell us right way so we can look for alternatives. Donation is time-sensitive, and any delay can have a negative impact on the recipient’s wellbeing.
It may be possible to arrange for donation to occur somewhere within driving distance. This may require that you have repeat testing and/or physical exam.
(Note for donor centers: Information on safe travel is provided in the question above.)
Should I wear a mask during workup, travel and/or the donation itself?
Yes, the CDC now recommends that everyone wear cloth face coverings when in a community setting, especially when you may be near people. Please note, these face coverings are not a substitute for social distancing, but to protect others from asymptomatic infected people.
From what is known, the transmission of the coronavirus is generally limited to the distance you cough or sneeze. This is about six to eight feet. If a person with flu-like symptoms wears a mask, they will sneeze into the mask instead of the air around them.
For a healthy person, wearing a mask is not guaranteed to protect you against any virus, especially if the mask doesn’t fit properly. The coronavirus particles are smaller than those filtered by most masks, so they won’t necessarily block them. For more information on cloth face coverings, please visit the CDC’s Cloth Face Covers FAQs.
The CDC recommends appropriate handwashing as the most effective way to minimize exposure. Learn more about the five steps you can take to reduce the spread of illness and stay healthier:
What is cryopreservation of stem cells and why is it being recommended for my donation?
Cryopreservation is the freezing of stem cells. After your donation, your cells will be sent to your recipient’s transplant center. The transplant center will freeze and store your cells until the recipient is ready for transplant.
Due to the rapidly evolving nature of this pandemic and the travel and health logistics affected, the transplant center may ask that your cells are cryopreserved after your donation. This allows you to make your donation before a patient begins their time-sensitive preparation regimen. It helps transplant centers avoid any issues that could occur if you are unable to donate on the prearranged date.
What happens if I get sick during travel for donation?
Be The Match will cover the costs for your assessment, testing and/or treatment of your illness if you acquire COVID-19 or any other infection as a result of travel for donation.
Does bone marrow or stem cell donation compromise my immune system? Will I be at increased risk of contracting an infection or having trouble fighting an infection after donation?
No – we do not have any evidence to show that bone marrow or stem cell donation negatively affects a donor’s immune function or makes them more prone to illness after donation. Volunteer donors tend to be at lower risk of infection than the general population due to being young and healthy. A donor’s risk contracting COVID-19 or other infections is no greater than other adults in their age range.
As always, we strongly encourage good hygiene practices to keep you safe and free of infection.
Does filgrastim put me at a higher risk of infections?
The NMDP/Be The Match follows all donors of PBSC for adverse events, including signs and symptoms of infection. In over 75,000 donors, we have not seen an increase in infections in our donors. In transplant patients, filgrastim is actually used to increase the white blood cell count to speed engraftment and reduce risk of infection.
Frequently Asked Questions for Apheresis Centers and Collection Centers (updated 5/12/2020)
This information will be updated as changes occur. Click on the question to expand the answer.
When Processing Product for a Transplant Center
Does the NMDP/Be The Match have any requirements for how the product is processed/cryopreserved?
No, we expect your center to follow your own internal processes and procedures.
What additional testing should I do on the product?
We expect your center to conduct all testing in accordance with the NMDP/Be the Match product analysis document and any additional testing required by your center’s internal processes and procedures.
Additionally, to honor our commitment to quality, the CIBMTR may request additional information about a cryopreserved product. These requests include, but are not limited to, viability testing. The CIBMTR may ask your center for viability data at various timepoints, such as:
- On receipt of product from the courier
- Immediately after cryopreservation on an attached segment (but before day of product infusion)
If you have any questions or concerns about providing product viability testing information, please reach out to your Partner Liaison Partnerliaisons@nmdp.org for clarification.
What results do I document on the NMDP/Be The Match product analysis?
The results documented on the F770 (HPC-A) or F772 (HPC-M) should be those of the standard post-processing product.
How much will our center be reimbursed for cryopreservation and storage of the product and how do I bill for this?
Your partner liaison will connect with your center to provide this information.
How do I label the product?
We expect your center to follow ISBT 128 labeling processes for all cryopreserved products.
Your PBSC protocol states that cryopreservation should only be done at the transplant center. Is there a variance for this and how can I get a copy?
A variance will be provided to you.
From whom should our apheresis or marrow collection center request reimbursement for required COVID-19 cryopreservation?
The NMDP/Be The Match will reimburse your apheresis or marrow collection center for costs related to required COVID-19 cryopreservation. Your center should submit an itemized invoice to the NMDP/Be The Match. All invoices will be reviewed by NMDP/Be The Match prior to payment. Your center may be asked for additional information if needed. Access the guidelines for submitting your reimbursement request to the NMDP/Be The Match.
Cryopreservation Storage/Shipment When Storing/Shipping Product for a Transplant Center
How long am I expected to store the product on behalf of the transplant center?
The Case Manager will discuss a proposed shipment date with the transplant center at the time of the cryopreservation request and inform your center. The typical turn-around time thus far is 2-5 days.
Who is making the arrangements for the product to go to the transplant center?
The NMDP/Be The Match will coordinate the pickup and shipment of the cryopreserved product.
Are we required to provide our own shipping container?
We may ask if your center has availability to provide your own shipping container. If it is not feasible, the NMDP/Be The Match will provide one to your Center.
What source documents do we need to provide to the transplant center to explain the processing and pre/post product testing?
We expect that your center will provide the transplant center with the document you normally provide the end user of a cryopreserved product ex (e.g., process, additives, sterility, etc.). REMINDER: You must redact the donor’s PPI from all source documents and include the donor’s GRID on each document.