Updates for Transplant Centers and Cooperative Registries
Up-to-date information on NMDP/Be The Match response to COVID-19
Updated April 5, 2021
On a daily basis, our Business Continuity, Donor Operations and Patient Operations teams review the information coming from the CDC and agencies like the World Marrow Donor Association (WMDA).
Our commitment is to respond quickly to each advisement so you can have confidence that the products you request can be delivered without issue. Please check back frequently.
Click on the topics below to jump to that section:
- Data Comparing IDM Positivity Rates at Workup vs CT (1/14/2021)
- Registries Impacted by COVID-19 Response Reflected in MatchSource (updated 10/22/2020)
- Identify a Backup Donor When Requesting Fresh Product Infusion (updated 8/26/2020)
- CT Process Includes Request for New Buccal Swab Sample from Donor (updated 8/18 /2020)
- Family Member Intermediate HLA Typing to Include Automatic ABO/Rh and CMV Testing (updated 7/9/2020)
- Patient Assistance Program: Fee Waived for HLA Typing for Patients (updated 4/2/2021)
- Donor Product Cryopreservation (updated 7/8/2020)
- Option for Only Health History and Availability Check at CT (updated 6/9/2020)
- Change to Confirmatory Typing Process – Frequently Asked Questions (updated 6/9/2020)
- Reserve Requests for Bone Marrow for Patients in Greatest Need (updated 3/27/2020)
- CIBMTR Request for Data on Cryopreserved Products (updated 5/5/2020)
- Guidance for Cell Therapy Labs Regarding Cryopreservation Bags (updated 4/10/2020)
- Reduced Fee for Related Donor Workup and Collection (updated 4/7/2020)
- Cord Blood Unit Consideration (updated 4/7/2020)
- Donor Product Delivery After 72 Hours Post Collection (updated 4/6/2020)
- Expanded Timeline for Customized Typing of DoD Donors (updated 3/31/2020)
- FastTrack Testing available for HLA lab support (updated 3/24/2020)
- Essential Collections at Apheresis and Collection Centers (updated 3/24/20)
Interim Guidelines and Programs
- Revised Novel Coronavirus (COVID-19) Infection Assessment Questionnaire (updated 4/5/2021)
- Options for Viewing Donor Search Results in MatchSource (updated 12/23/2020)
- Updated CDC Definition of Close Contact for COVID-19 (updated 10/22/2020)
- At-home COVID-19 Testing Available for Donor Screening (updated 10/8/2020)
- Complete and Verify Patient’s HLA Typing Before Final Donor Selection (updated 7/16/2020)
- FDA Guidance on Donor Screening for COVID-19 (updated 10/8/2020)
- Expansion of CMS Accelerated and Advanced Payment Program (updated 4/2/2020)
- COVID-19 Interim Patient Care Guidelines from ASTCT (updated 3/10/2020)
Travel and Logistics
- Product Transport Timelines and Itineraries From Northern EU Countries (updated 7/21/2020)
- International Registries Impacted by Flight and Courier Restrictions (updated 1/6/2021)
- Delivery of Product Itineraries (updated 3/31/2020)
- Provide Case Managers with Up-To-Date Courier Instructions (updated 6/9/2020)
- Courier Transport (updated 3/16/2020)
Resources for Transplant Centers and Patients
- Manuscript Examines Early Impacts of COVID-19 on Donor Product Delivery (updated 12/23/2020)
- Council Advisory Group is Here to Help During COVID-19 (updated 6/2/2020)
- ASTCT COVID-19 Resource Community (updated 3/27/2020)
- COVID-19 Financial Relief for Patients (updated 4/28/2020)
- COVID-19 Education and Counseling Support for Patients (updated 3/24/2020)
Frequently Asked Questions
Data Comparing IDM Positivity Rates at Workup vs CT (1/14/2021)
In November, we asked our transplant center partners for feedback on many of our responses to the COVID-19 pandemic. Some of you shared that you would like to see the return of collecting blood samples at the time of confirmatory typing (CT). While we understand the request, we are unlikely to be able to move back to blood draws at CT in the near future.
With widespread community transmission in many parts of the country, we must limit the chance that a donor will become exposed to COVID-19 and be deferred for collection. Additionally, there continues to be a lack of availability of blood draw sites as many of these are now being used for COVID-19 testing instead and we need to leverage existing slots for workup related activities.
We have been keeping a close eye on data associated with impacts that blood draws at workup versus CT may have on your patient, particularly positive IDM rates. We recognize that a positive IDM at workup would delay your patient’s transplant.
Impact on IDM positivity rates
Fortunately, we have not seen a significant impact on IDM positivity rates since moving away from blood draws at CT. We compared pre-COVID data (Jan. 1, 2019-March 31, 2020) to COVID data (April 1, 2020-early January 2021). Pre-COVID, we saw an IDM positivity rate at CT and workup of 1.61% (excluding positive CMV results). During COVID-19, we have seen an IDM positivity rate at workup of 2.81%, a slight increase from pre-COVID. Both are a very small fraction of the full population of donors during those timeframes.
Impact on ABO and CMV testing
In addition, we reviewed ABO and CMV data comparing blood testing at workup to the buccal swabs currently being used for presumptive testing at CT. Both are showing very similar results. The ABO testing data shows 99% concordance while CMV testing shows 85% concordance.
We will continue to keep an eye on this data and will provide additional updates when needed. We appreciate your continued support and understanding as we work together to provide high-quality products while keeping donor and patient safety top of mind.
Registries Impacted by COVID-19 Response Reflected in MatchSource (updated 1/14/2021)
While all registries have been impacted by the COVID-19 crisis, a small number of registries are experiencing significant challenges exporting products. In an effort to still give our transplant center partners visibility to these graft sources, we will be flagging these sources in MatchSource® effective Wednesday, April 22.
MatchSource will display graft sources from these countries as “Potential Donor” or “Potential Cord” and will prompt you to contact your Case Manager for additional instructions.
Countries with impacted registries include:
We understand it may be valuable to see sources that could be available sometime in the future. Therefore, instead of removing all donor and cord sources from these registries from MatchSource, you will see “Potential Donor” or “Potential Cord” with direction to contact your Case Manager. Provide your Case Manager with the reference number to determine if the donor or cord blood unit can be requested.
As a reminder, “Potential Donor” or “Potential Cord” will either indicate a COVID-19 impact or an OFAC restriction. We continue to monitor the ability to request donors from our partner registries throughout the world and will update the list of countries as COVID-19 restrictions are added or relaxed.
Identify a Backup Donor When Requesting Fresh Product Infusion (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.
When possible, we continue to recommend cryopreservation of PBSC donor products and some bone marrow products not intended for patients with bone marrow failure syndromes. This is consistent with recent guidelines from the Worldwide Network for Blood and Marrow Transplantation and CIBMTR® (Center for International Blood and Marrow Transplant Research®) guidelines.
When requesting a fresh product infusion, transplant centers must identify a backup donor to mitigate challenges with fresh products.
Please provide your Case Manager with your backup donor plan. If your backup plan involves an unrelated donor or cord blood unit, a CT will need to be requested.
Your Case Manager will inform the donor center that the donor is being requested as a backup. This allows the donor center to assess the donor’s ability to proceed quickly to workup and collection if needed.
There are a number of reasons for these recommendations. For example, pre-procedure COVID-19 testing required by some Network apheresis and marrow collection centers could impact timing in the event of a positive test result close to the scheduled collection. In the past week, there have been two cases in which an asymptomatic donor has tested positive for COVID-19 within 24 hours of the collection.
In addition, some donors have expressed ongoing apprehension about risks associated with moving forward with workup activities and collection during the pandemic. We will likely to continue to see an increased number of donors become temporarily unavailable due to these concerns.
To assist with donor availability, we:
- Recommend typing several donors at one time
- Have modified our assessment tool to ensure that we’re more carefully assessing donor risk factors
Contact your Case Manager if you have any questions. Access the Aug. 26, 2020, Network Announcement for additional details.
CT Process Includes Request for New Buccal Swab Sample from Donor (updated 8/18/2020)
To enhance our ability to serve patients during the COVID-19 pandemic while also meeting the needs of our donors, we are making further updates to our confirmatory typing (CT) process. Effective May 26, we will ask donors from DC001 (NMDP/Be The Match), DC 087 (DoD), DC 125 (Gift of Life) and DC 126 (DKMS-Americas) to provide a sample at CT using buccal swabs ordered through Kitmaker.
We are making this change in response to feedback from our transplant center partners who are seeking further information on donors to aid in decision-making. We first changed the CT process on March 25, 2020. At that time, we removed the blood sample requirement at CT to mitigate the issues of getting a donor into a draw site during the pandemic.
Process when a donor is requested for CT
Placing a CT request will initiate donor contact for a donor availability check and health history screening. The health history screening includes screening for COVID-19 exposure. As a reminder, if a donor screens positive for COVID-19 exposure, the donor will be made temporarily unavailable. During the initial contact, the donor center will also arrange for the collection and shipment of fresh buccal swab samples.
Your Case Manager will email the completed availability check and health history screening to you. The health history screening includes updated information on transfusions, pregnancies and weight.
Information gathered at the CT appointment will be used to communicate the date the buccal swabs are set to arrive at the NMDP/Be The Match Biorepository.
Process for buccal swab testing
The kits sent to the donor include two sets of buccal swabs. The donor mails both sets of swabs to the Biorepository. The Biorepository then forwards two swabs to your transplant center for processing. Your lab can expect to receive swabs within 48 hours after they arrive at the Biorepository so your lab can perform the necessary confirmatory testing. Note: If the swabs are sent to an international lab for testing, shipment may take longer than 48 hours. The two buccal swabs have a collection tip made of a nylon flocking material.
The Biorepository will send the remaining two buccal swabs to a contracted lab for presumptive ABO/Rh and CMV testing. The ABO/Rh and CMV testing results will be shared with you through the “Donor Detail” tab in MatchSource®.
If your center does not wish to perform CT testing and ABO/Rh and CMV are not needed, you can request only the donor health history and availability screening (effective June 15). See below for details on this process.
Cost and additional available testing
The package price for the buccal swab collection and shipment and the ABO/Rh and CMV testing is $750 when the sample is shipped to a domestic lab. If the sample must be sent to an international lab for testing, you will be charged the applicable shipping fees listed on the fee schedule. International shipping fees are not included in the price of the samples.
We have reduced the price because blood draws are no longer included. You will receive an invoice based off the CT appointment date.
If you need additional HLA testing, you can request high-resolution (HR) typing. HR typing results will be processed and charged as normal.
For an urgent search, please contact your Case Manager to move the donor direct to workup. Blood samples will still be drawn at the time of a workup request.
If you have any inflight donors at CT or Held for Workup (HW) on your patient search, your Case Manager will contact you to confirm whether you will need buccal swabs collected.
Family Member HLA Typing to Include Automatic Presumptive ABO/Rh and CMV Testing (updated 7/9/2020)
Starting Monday, July 13, we will automatically include presumptive genetic ABO/Rh and CMV testing when you request family member sample collection and/or HLA typing through Related Donor Services. We are providing family member ABO/Rh and CMV testing at no cost during the COVID-19 pandemic based on feedback from our transplant center partners. We will continue to waive the fee for intermediate HLA typing for family members as well.
Our goal is to provide our transplant center partners with the information you need so you can select or rule out a related donor sooner.
Effective Monday, July 13, we will be reinstating the fee for family member high-resolution typing per the fee schedule.
Sending buccal swab kits for related donor typing
After identifying the family members to be typed, follow the same process as when you request related donor intermediate typing through Related Donor Services. Use your existing consent processes for family members. Then, complete the Related Donor Sample Collection for HLA Typing form (F01033) for each family member who will be typed. Indicate on the form(s) that you are requesting buccal swab testing that will be completed by the NMDP/Be The Match.
Email the form(s) to your Case Manager. Your transplant center does not need to take any additional steps to request ABO/Rh and CMV testing results. Family members will receive two sets of swabs for sample collection and testing will happen automatically.
After we receive the results from the lab, your center will receive an email with the HLA typing report and a second email with the ABO/Rh and CMV testing results for each family member. Please note this result is considered presumptive only and the ABO/Rh and CMV must be completed on a blood sample prior collection to confirm the result.
The program is available for family members in the U.S. and abroad. Contact your Case Manager if you have any questions.
If a family member is a match or you are pursuing a haploidentical donor, we can also assist you with related donor workup and collection. We have significantly reduced this fee during COVID-19 to help you get more patients to transplant.
Patient Assistance Program: Fee Waived for Initial HLA Typing for Patients (4/2/2021)
During the COVID-19 outbreak, we are facilitating in-home swab collections that may be used for initial HLA typing for patients. Our goal is to assist transplant centers that are experiencing challenges obtaining HLA typing. To provide the best assistance, we are waiving the fee for high-resolution patient HLA typing.
Sending buccal swab kits for in-home patient typing
If you need in-home patient typing, follow your existing consent processes for patients. Then, email your case manager to request that a typing kit be sent to your patient’s home. Include the following information in the email:
- Patient name
- Date of birth
- Mailing address
- Phone number
- Is related donor testing also being requested?
- If yes, number of related donors:
- Transplant center (TC)
- TC contact
- TC contact email
The NMDP/Be The Match will send the HLA typing kit to the patient via FedEx.
Getting the HLA testing results
After swabbing, patients return the buccal swab kit to our contract lab. The NMDP/Be The Match will send your transplant center the HLA typing results after receipt from the lab.
If you have any questions, contact your Case Manager.
Update regarding new CT policy and Patient Assistance Program
The Patient Assistance program provides initial typing for patients and although the typing provided is high-resolution, the transplant center is responsible for providing one set of high resolution typing that meets the specified criteria for patients under P00079, NMDP Policy for HLA Confirmatory Typing Requirements for Unrelated Adult Donors and HLA Typing Requirement for Patients.
Donor Product Cryopreservation (updated 7/8/2020)
Your transplant center may request a fresh product infusion for collections scheduled on or after Aug. 10, 2020.
We made the decision to begin relaxing the cryopreservation requirement based on evolving domestic and global scenarios, as well as feedback from our Network partners. Access the July 8 Network Announcement for factors that went into this decision. We continue to monitor these factors daily.
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 include:
- The donor’s registry
- Geographic location of the donor and associated risk of contracting COVID-19
- Apheresis or collection center policies on testing asymptomatic donors for COVID-19 or regional/national policies that require testing
- 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, we will continue to arrange for cryopreservation prior to the initiation of conditioning.
Product delivery cannot be absolutely guaranteed on Day 0. Therefore, 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 donor at CT.
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.
Option for Only Health History and Availability Check at CT (updated 6/9/2020)
Effective Monday, June 15, your center can request a donor health history screening and availability check, without buccal swabs, at CT for donors from DC001 and contracted partners. Request this option when your center does not need swabs for CT testing and ABO/RH and CMV testing are not needed. We are making the change in response to feedback from our transplant center partners.
To request only the health history screening and availability check, request a CT and immediately email your Case Manager with the request for no buccal swabs. This will allow the Case Manager to follow up with the donor center. If your Case Manager does not receive your request quickly, we may not be able to stop the collection of buccal swabs.
As always, your Case Manager will email the completed availability check and health history screening to you. The health history screening includes updated information on transfusions, pregnancies and weight. If a donor screens positive for COVID-19 exposure, the donor will be made temporarily unavailable.
We are offering the health history screening and donor availability check at no charge to you.
Reserve Requests for Bone Marrow for Patients in Greatest Need (updated 5/5/2020)
Some health care organizations are starting to do more outpatient elective surgical procedures as states begin to ease some COVID-19 restrictions. However, securing bone marrow harvest slots will continue to be extremely difficult as health care organizations have a backlog of surgeries. For the foreseeable future, we will continue to have only a limited number of bone marrow slots available to us.
When you are requesting a graft source for your patient, please continue to consider requesting peripheral blood stem cells (PBSC) unless there is available data to support a survival advantage to bone marrow.
We anticipate that blood centers and apheresis centers that are not in hospital settings will experience fewer disruptions to their services. Currently, it is more likely we can secure a collection date when you request PBSC.
If your center is willing to accept either a PBSC product or a bone marrow product, please reflect this on the workup request form. For new workup requests that have PBSC listed as a second-choice product, the donor center will assess the situation and communicate through your Case Manager if we are unable to secure a bone marrow collection slot. In these situations, we will likely shift to a PBSC collection.
Access the March 26, 2020, Network Announcement for additional details and data points. If you have any questions, please reach out to your Case Manager.
CIBMTR Request for Data on Cryopreserved Products (updated 5/5/2020)
Providing high-quality stem cell products to patients who need transplant remains a top priority for the NMDP/Be The Match during the global coronavirus pandemic. The pandemic has required changes to our standard processes, specifically the cryopreservation of marrow and PBSC products. 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), and/or
- on the day of product thaw and infusion.
If you have questions or concerns about providing product viability testing information, please reach out to your Case Manager for clarification.
Guidance for Cell Therapy Labs Regarding Cryopreservation Bags (updated 4/10/2020)
Starting March 30, 2020, the NMDP/Be The Match required the cryopreservation of stem cell products for transplant patients. The requirement was enacted to ensure patient safety given the challenges COVID-19 presents in the collection and delivery of products. The requirement will increase the use of cryopreservation bags in cell therapy labs. These bags have been described as “supply challenged” in the past year.
The NMDP/Be The Match understands that cell therapy labs use a variety of primary cryo-bag suppliers and sizes of bags in their normal operations. We have contacted multiple bag vendors (Origen, Miltenyi Biotec, Charter Medical, Saint-Gobain) to alert them of the likely increased demand for their products in the short term. Each have different degrees of backlog and delivery estimates of new product.
During these unique circumstances, please consider the following guidance to help you maintain your supply of cryopreservation bags.
Contact your vendor of choice early and provide the vendor with your estimated needs for the next 6 months. This will help them plan production timelines for delivery. They can also explore other SKUs that may work for your needs that have better availability.
Seek an alternate vendor to use as a backup. Labs in our transplant Network use bags from the various vendors listed above and may be willing to share their experience as you consider vendors.
Collaborate with other cell therapy labs in the Network to share extra supplies of bags with labs experiencing a critical shortage. Many vendors are enforcing maximum purchase volumes to eliminate bulk-buying shortages. Collaboration among our Network may be necessary in the short-term.
As we experience supply and demand challenges, we appreciate all the efforts and collaboration to ensure patients get the life-saving therapies they need. We will continue to monitor the cryopreservation requirement and stay in communication with vendors and transplant centers/cell therapy labs.
Please contact your NMDP/Be The Match Case Manager if your lab needs specific assistance.
Reduced Fee for Related Donor Workup and Collection (updated 4/7/2020)
During the COVID-19 outbreak, it may be difficult or impossible for a related donor to travel far from home for collection. We have taken the following actions to assist all of our transplant center partners with related donor workups and collections through Related Donor Services:
- We reduced the workup and collection fee to $15,000 for all fully matched and haploidentical related donors in the U.S. and Mexico during the COVID-19 outbreak.
- We are waiving the requirement to have a signed Related Donor Services agreement in place for a transplant center to receive the reduced fee.
- We will start working with your center no matter where you are in the process (e.g., workup has taken place but you need assistance with collection).
We can assist you with a fully matched or haploidentical related donor transplant. When we partner together, we can eliminate travel barriers for your related donors and help you to get your patients to transplant in the timeframe you need.
Cord Blood Unit Consideration (updated 4/7/2020)
There may be situations when a donor center may decide the donor is unable to proceed with collection immediately based on the donor’s exposure. A cord blood unit could be a consideration if this occurs.
Cord blood units are readily available for use, lack the inherent donor issues related to infection or exposure to coronavirus, and are not limited by travel restrictions. Our Cord Blood Consultation Service is also available for CBU selection and clinical support.
We also offer Cord Blood Practice Units that you can request from our Network cord blood banks. They are available for practicing thaw procedures (these units are not viable for transplant). Your center can request up to three units at a time. There is no cost to your center.
The cord blood bank will ship the units to your center in a dry shipper, along with the thaw protocol and Practice Unit Data Form (F00204). Please complete and return the form to firstname.lastname@example.org after finishing the thaw process.
Request practice units by completing the Request for Cord Blood Practice Units form (F00206) and emailing it to email@example.com.
For additional information about CBU thawing best practices, access our Cord Blood Thawing presentation . You’ll hear from John D. McMannis, PhD, Executive Vice President, Mesoblast; Donna Regan, Director, Customer Ready Products, NMDP/Be The Match; and Joanne Kurtzberg, MD, Duke University.
Contact your Case Manager if you have any questions.
Donor Product Delivery After 72 Hours Post Collection (updated 4/6/2020)
Current travel restrictions may occasionally result in products being delivered to your center more than 72 hours after the end of product collection. If a hematopoietic cell product arrives at your center more than 72 hours after collection, NMDP/Be The Match strongly recommends you process and cryopreserve these products according to your standard protocols. This includes obtaining pre- and post-cryopreservation cell counts and viability that may be analyzed for product quality prior to subsequent infusion.
While there is limited data on cell viability for product stored after 72 hours, the rate of decrease up to that time suggests a small amount of additional time should not cause a sharp drop off in viability, cell recovery or colony-forming units (CFU). In a study by Kao and colleagues 1, the majority of PBSC and marrow products stored for 72 hours at 4C were able to maintain a:
- Total cell viability over 75%
- Total viable CD34 cell recovery over 80%
- CFU recovery over 60%
It is important to remember NMDP/Be The Match products do not have expiration times. Rather, NMDP/Be The Match standards indicate that marrow, PBSC and MNC products shall be infused as soon as feasible.
Ideally, marrow and PBSC should be infused within 48 hours of collection, but that is not required. In practice, infusion may occur up to 72 hours from collection. Since there is no product expiration date, infusion and cryopreservation at greater than 72 hours is not a deviation from NMDP/Be The Match standards and does not require regulatory reporting to the FDA.
Products collected at international centers are labeled per their country of origin requirements. Some of the labeling elements may vary from products collected at domestic NMDP/Be The Match centers.
- Kao GS, Kim HT, Daley H, Ritz J, Burger SR, Kelley L, Vierra-Green C, Flesch S, Spellman S, Miller J, Confer D. Validation of short-term handling and storage conditions for marrow and peripheral blood stem cell products. Transfusion. 2011 Jan;51:137-147.
Expanded Timeline for Customized Typing of DoD Donors (updated 3/31/2020)
If you need customized HLA typing for Department of Defense (DoD) donors, please allow for an expanded timeline. The lab that conducts customized HLA typing for DoD donors will only process results on Wednesdays. The change is due to a statewide shutdown for COVID-19. Expect extended timeframes for receiving results.
FastTrackSM Testing available for HLA lab support (updated 3/24/2020)
If your hospital lab resources are stretched thin due to COVID-19 testing, FastTrack Testing can help your center process new samples and alleviate stress on your lab staff. The turnaround time for FastTrack Testing is three days or fewer.
If you need assistance with HLA typing, please reach out to your Case Manager.
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 absolutely essential and life-saving therapy to those most in need.
Interim Guidelines and Programs
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. Donor centers should begin using these assessments on Monday, April 12.
Donor centers use Form F01190 at the time of the Heath History Screening Questionnaire. Donor centers use the Assessment Tool A00916 when a donor reports risk during the completion of F01190 or at any time during the assessment process. Access the summary of changes to our assessment process at the time of donor CT, HW and workup.
Options for Viewing Donor Search Results in MatchSource (updated 12/23/2020)
We are working to reduce logistical challenges that put a patient’s transplant at risk during the COVID-19 pandemic. As part of this effort, we are encouraging U.S.-based transplant centers to consider U.S.-based donors first in their source selection. Some of our international partners have taken a similar approach in their countries.
As a default, MatchSource® displays domestic donor search results using a pre-applied filter that shows only U.S.-based donors (including Puerto Rico). You can turn off the U.S.-Donors Only filter and save that preference as your default.
This enhancement allows you to set your preference to what works best for your center’s donor searches—using the U.S.-Donors Only filter or expanding the view to include all donor search results as your default. You can toggle back and forth between the two views regardless of the default that is set.
Please continue to give additional consideration to the current challenges of international travel. If you have the option to give preference to U.S.-based donors, we encourage you to do so to reduce the risk of delay in getting a donor product to your patient.
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.
Donor centers have been asked to 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.
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 your center requires donor testing prior to collection, let your Case Manager know. Your Case Manager will work with the donor center to arrange for testing. Coordinators at contracted donor centers have been trained on this testing option. Partner Liaisons are available to provide assistance if needed.
When requesting at-home COVID-19 testing for a donor 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
At-home testing is available for donors in the United States. If you would like an international donor to have COVID-19 test, talk to your Case Manager. Your Case Manager will contact the international donor registry to determine if COVID-19 testing can be completed.
If you have any questions, contact your Case Manager.
Complete and Verify Patient’s HLA Typing Before Final Donor Selection (updated 7/16/2020)
On July 13, the WMDA issued a rapid alert after receiving three reports of serious incidents that occurred because final donor selection occurred before the patient’s extended or verification typing had been performed. With the start of patient conditioning being delayed with the use of cryopreserved product, there is an increased risk that final checks of the patient’s eligibility are also delayed.
The NMDP/Be The Match endorses the WMDA’s recommendation that the patient’s HLA-typing is completed and verified before final donor selection. In addition, the donor should not start the donation procedure until the transplant center has confirmed final donor section and confirmed the patient’s eligibility for the scheduled transplant.
FDA 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 your transplant center’s protocols require confirmation of a donor’s SARS-CoV-2 status.
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.
Some Network apheresis centers and collection centers require COVID-19 testing per individual institutional policy. Starting May 13, the Workup Plan your transplant center receives will include information on whether the apheresis or collection center will perform COVID-19 testing on the donor prior to donation. It will also include information on whether the product will be cryopreserved.
As a reminder, the following procedures are in place for screening donors before and after donation.
We are gathering additional health and travel information from donors at the confirmatory typing, held for workup and workup stages using the amended Health History Screening Questionnaire.
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 your transplant center.
Expansion of CMS Accelerated and Advanced Payment Program (updated 4/2/2020)
The Centers for Medicare & Medicaid Services (CMS) has expanded its accelerated and advanced payment program for Medicare providers during the COVID-19 pandemic. It has also streamlined the process for accelerated and advanced payment requests.
Most providers and suppliers can request all their Medicare pay for a three-month period. Inpatient acute care hospitals, children’s hospitals and certain cancer hospitals can request all their Medicare pay for a six-month period. In addition, critical access hospitals can request up to 125% of their pay for a six-month period.
To obtain the accelerated payments, hospitals must make a request to the Health and Human Services (HHS) Secretary. Then, the HHS Secretary may do any of the following:
- Make accelerated payments on a periodic or lump sum basis
- Increase the maximum amount of payment to the hospital under the program from 70 to 100% (125% for critical access hospitals) of interim net reimbursement
- Extend the accelerated payment period up to six months, meaning eligible hospitals can request a six-month advanced lump sum or periodic payment
There is flexibility on the back end for hospitals to repay any amounts owed. The HHS Secretary may also extend the accelerated payment program beyond the COVID-19 pandemic period.
COVID-19 Interim Patient Care Guidelines from ASTCT (updated 3/10/2020)
The American Society for Transplantation and Cellular Therapy’s (ASTCT) Infectious Disease SIG released COVID-10 interim patient care guidelines. The guidelines are intended to assist clinicians with the diagnosis and management of COVID-19 in transplant
and cellular therapy patients.
The guidelines will be updated as new information becomes available. Access the ASTCT COVID-19 Interim Patient Care Guidelines.
Travel and Logistics
Product Transport Timelines and Itineraries From Northern EU Countries (updated 11/20/2020)
Many of our transplant center partners have contacted us with questions and feedback about product transport times and the timeframe for receiving your itineraries for products coming from certain EU countries. Because your transplant center can now request a fresh product infusion for collections scheduled on or after Aug. 10, we want to ensure you have the information you need to better anticipate the day of infusion (or day 0) and make informed decisions on fresh versus cryopreserved products for your patients.
We are using a hub-and-spoke transport method to provide a consistent way to import products from certain countries in the EU, including Germany, Poland, the Netherlands, Sweden, Belgium and Austria. We are using the model because passenger flight schedules remain unreliable and there continue to be restrictions on foreign nationals entering the U.S.
Product transport using the hub-and-spoke model takes an average of 48 hours from pickup to delivery. For these transports, you will receive product itineraries as soon as possible, which is approximately one week prior to product collection. We anticipate using the hub-and-spoke model through the end of the calendar year, if not longer.
Currently, exceptions will only be made to the hub and spoke model if the transit time is estimated to be greater than 48 hours or if the patient has a protocol that requires a hand-carried product. Limiting the number of waivers we use for foreign nationals entering the US continues to be important to maintain our ability to deliver international products.
There are scenarios where a cryopreserved product may still be the safest option for your patient. Your Case Manager will discuss your patient cases with you on an individual basis to ensure all product risks are documented to help your center make the best clinical decisions for your patients.
What is the hub-and-spoke model?
The hub-and-spoke model allows us to centralize product delivery from the EU countries mentioned above to Frankfurt, Germany. A cargo flight transports the products together on one flight to the U.S. Once products arrive in the U.S., they are picked up by couriers and delivered to our transplant center partners.
Why are transport timelines longer using the hub-and-spoke model?
The hub-and-spoke model has allowed for consistency in getting products from our partners in northern Europe. However, the transport time has slightly increased to accommodate this consistency. On average, product transport takes an average of 53 hours from product pickup (which is often later than the collection end time) to delivery to our transplant center partners.
We feel confident in the consistent delivery times for products transported via the hub-and-spoke transport method.
Why aren’t centers receiving the product itinerary until a week prior to product collection for those delivered via the hub-and-spoke model?
Hub-and-spoke transports are conducted using cargo flights. Flight schedules for cargo flights are not available until the week prior to the flight. Therefore, we cannot confirm the itinerary for these products until approximately one week prior to product collection.
We provide our transplant center partners with more specific information and the itinerary as soon as possible. However, on average, product transport takes about 53 hours from pickup to delivery.
If you have any questions, please contact your Case Manager.
International Registries Impacted by Flight and Courier Restrictions (updated 1/6/2021)
Some of our international registry partners are impacted by flight or courier restrictions due to COVID-19. Most countries outside the EU are either strongly recommending or requiring cryopreservation at the transplant center (rather than infusing upon arrival). Some require that the product be cryopreserved for transport due to flight restrictions.
Notable registry impacts are listed below. Please discuss individual cases with your Case Manager, as border and airline restrictions continue to evolve frequently.
Argentina: Products must come from Argentina cryopreserved
Australia: Products must come from Australia cryopreserved
Brazil: Delays in scheduling product collections due to impacts on collection network; cryopreservation at transplant center required.
Chile: Products must come from Chile cryopreserved
Greece: Several logistical challenges for product deliveries to the U.S.
Israel: Products must be cryopreserved at transplant center upon arrival
Japan: Products must come from Japan cryopreserved
New Zealand: Products must come from New Zealand cryopreserved
Saudi Arabia: Limited flights and product collections; provision of a cryopreserved product may be available in urgent cases
South Africa: Very limited flights with long transport times.
Taiwan: Products must come from Taiwan cryopreserved
Thailand: Products must come from Thailand cryopreserved
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.
Delivery of Product Itineraries (updated 3/31/2020)
We are continuing to work to ensure products are delivered to transplant centers in a timely matter. We are committed to providing your transplant center with product itineraries as early as possible. However, itineraries are not available as early as they have been in the past.
Please note that because itineraries are changing frequently and airlines have limited passenger flights, we are not providing a backup itinerary to transplant centers at this time.
We are closely monitoring each delivery. We will communicate any changes to an itinerary to your transplant center as soon as possible.
Courier Transport (updated 3/16/2020)
On March 16, 2020, NMDP/Be The Match attained a waiver signed by the CDC director regarding courier transport from level 3 countries to the U.S. The waiver directs U.S. Government agencies to allow couriers from CDC level 3 countries—such as countries in Europe—to transport hand-carried products into the U.S. Access the full Network Announcement for further details on product exports from the U.S.
Currently, only NMDP/Be The Match, OnTime and TimeMatters couriers can import product to the U.S. NMDP/Be The Match couriers are in communication with our Logistics team if they have any concerns about product delivery.
Our Network couriers are asked to report:
- Any illnesses while on current or upcoming trips
- Any delays due to entrance restrictions
Couriers will not volunteer for any trips if they have been recently ill.
If your institution has additional measures in place for couriers coming from risk countries, please connect with your Case Manager to ensure a timely product delivery.
Resources for Transplant Centers and Patients
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.
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 firstname.lastname@example.org. 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.
ASTCT COVID-19 Resource Community
ASTCT has developed an online community to connect health professionals in the field with each other and resources.
COVID-19 Financial Relief for Patients (updated 4/29/2020)
Your patients may experience financial barriers to transplant now and in the coming months due to COVID-19. We are providing a $500 financial relief grant to help patients with medical or non-medical expenses during this challenging time. We want to help ensure your patients can maintain their access to life-saving treatment.
Patients do not need a COVID-19 diagnosis to qualify. To be eligible, these requirements must be met:
- If pre-transplant: Your center must be located in the U.S. and have initiated the patient’s formal search with the National Marrow Donor Program® (NMDP)/Be The Match® on or after March 1, 2019 with the intention to move forward with an allogeneic transplant.
- If post-transplant: The patient must have received an unrelated or related transplant facilitated by NMDP/Be The Match on or after March 1, 2019.
This is a one-time financial relief grant. Access grant application.
Additional support is available for patients who have a greater financial need due to COVID-19. Access information on all our patient financial assistance options.
COVID-19 Education and Counseling Support for Patients
Our Patient Support Center is available to offer personalized, confidential support for your allogeneic and autologous transplant patients and their families.
Our team is available to provide general information about transplant, as well as patient-friendly COVID-19 education. The information is tailored for patients pre- and post-transplant and is based on trusted sources, including the CDC and ASTCT.
Our team of certified oncology patient navigators and nurse navigators can help your patients learn about transplant, understand the donor search process, and get answers to financial or insurance questions.
We also offer counseling services for patients and families. COVID-19 is causing heightened anxiety for some individuals, and resources to meet mental health needs may be scarce. Our licensed clinical social workers can help patients cope with emotions around transplant and recovery.
You or your patients can contact our team directly by calling or texting 1 (888) 999-6743 or emailing email@example.com.
Frequently Asked Questions
Frequently Asked Questions for Transplant Centers (updated 11/10/2020)
This information will be updated as changes occur. Click on the question to expand the answer.
Will the NMDP/Be The Match allow higher CD34 collections on prescriptions given the expected cell loss associated with cryopreservation at our transplant center?
Given that the median CD34+ cell dose collected from a G-CSF mobilized donor after one day is close to 7x10^6/kg and the optimal dose for the recipient is > 4.5x10^6/kg (Pulsipher et al, Blood 2009), we do not believe there is a clinical need to request
higher CD34+ cell doses.
If there are special circumstances that may warrant this clinically, please work with your Case Manager . An increase in the requested collection volume may need physician approval.
Additionally, given issues related to donor safety and bone marrow harvesting with higher cell dose collections, we will continue with our current policy as to the maximum volume allowed based on donor weight.
Will you follow up with donors after donation to ensure they have no respiratory symptoms? If there is a concern about possible COVID-19 risk, will our transplant center be informed?
Starting with collections that occurred on or after March 11, 2020, we are screening all domestic donors for symptoms of the virus at 2 days, 1 week and 1 month after collection. If there is a possible COVID-19 risk that occurred within 21 days of collection, our medical team will inform your transplant center of the risk.
Are you testing donors prior to collection to ensure they do not have the COVID-19 virus?
Asymptomatic donors are not automatically being tested. However, 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.
If a donor is asymptomatic but has answered the risk questions with a “yes” response (traveled to a risk area or exposure to someone who has traveled to a risk area), your transplant center will be notified. These donors are being deferred for 28 days at present.
The recommendation to not test asymptomatic donors is mainly based on the challenges in predicting whether an asymptomatic donor with no history of travel or exposure will become infected with SARS-CoV-2, which causes COVID-19, in the interval between workup and the day of the planned bone marrow harvest or PBSC collection.
At this time, we believe the risk of viral transmission to the recipient via bone marrow or PBSC donation is extremely low. The U.S. Food and Drug Administration (FDA) continues to report 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 Middle East Respiratory Syndrome). Based on this, we do not believe there is a need to test asymptomatic donors without any travel or exposure history.
We have put augmented donor screening measures—which may include travel deferrals—in place. These measures aim to prevent individuals with clinical respiratory infections or exposure history from donating bone marrow or PBSC products, ensuring the safety of the grafts we are supplying.
How long does the NMDP/Be The Match anticipate the new processes (e.g., donor screening measures) will last? Should we delay the transplant dates for all of our recipients in the near future?
We do not recommend that you delay transplants for patients in need. Good planning can help you avoid delays.
Try to identify a suitable volunteer donor as quickly as possible. We will work with you to get the donor collected and the product cryopreserved as soon as possible. It would help to order mostly PBSC at this time, particularly for adults with hematologic malignancies.
Will donors be screened at the confirmatory typing stage?
Yes. We have updated our process so that all domestic donors are asked the same questions at the confirmatory typing, held for workup and workup stages.
If a risk is identified, your transplant center will be notified. This allows you to make more informed risk/benefit decisions. As always, your transplant center will decide whether to proceed with a donor.
Does filgrastim put donors at higher risk of infection?
The NMDP/Be The Match follows all donors of PBSC for adverse events, including signs and symptoms of infection. In over 35,000 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 the risk of infection.
When our center requests donor product cryopreservation, where would the product be cryopreserved?
The NMDP/Be The Match is requesting that a fresh product is delivered to the transplant center and is cryopreserved on site, versus at an external site. If your transplant center is unable to perform this, please work with your Case Manager to identify additional options to perform the cryopreservation and provide storage until you need the product.
Our center has been told we need insurance authorization to cryopreserve a product. What are our options if we are unable to receive that authorization?
We have received information that many centers have been receiving approval from insurance companies to cryopreserve products. However, if you do not receive timely approval, please let your Case Manager know. We want you to be able to cryopreserve the product, and the NMDP/Be The Match is prepared to find a means to reimburse your center should you receive an insurance denial.
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 the confirmatory typing, held for workup and 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
- Develop any acute infectious symptoms prior to and following donation
Does the NMDP/Be The Match provide the ability for transplant centers to request COVID-19 testing for their patients or for related donors when a transplant is not facilitated by NMDP/Be The Match?
No, however, we can provide resources that detail the relationships we have established in order to be able to provide this testing for our donors.
The testing that we currently have set up through LabCorp uses a kit that is ordered through LabCorp Link. Kits ordered through LabCorp Link and Kashi require a contract with their labs. However, Pixel testing kits through LabCorp are available for individuals to order without having an affiliation with an organization or a contract.
If your center has an account with LabCorp, you can ask your LabCorp representative to have the testing option set up so you can order through LabCorp Link.
More information about the Pixel kit can be found here: pixel.labcorp.com
Can we send new workup requests? What if I don’t know the new dates for the transplant that I would like to request?
Yes, we are still committed to serving your patients. Please send new workup requests. If the transplant dates are still tentative, please communicate what is pending with your Case Manager.
What screening is the NMDP/Be The Match providing for couriers?
In order to mitigate risk at local apheresis/collection and transplant centers, we are implementing proper screening of product couriers. Couriers will be asked about exposure to a known COVID-19 patient and about sickness in the past 7 days with diarrhea, vomiting or cold symptoms (including cough, sore throat or runny nose). If either of these are reported, the courier will become unavailable. Couriers are also asked to notify the NMDP/Be The Match if these symptoms occur en route.
How is the NMDP/Be The Match ensuring this screening is occurring for couriers?
If the collection for a U.S. patient occurs on or after March 18, 2020, the NMDP/Be The Match will require our internal Logistics department to manage or provide the transport of the product. The only exception is for DKMS imports transported by the OnTime or TimeMatters courier companies. All U.S. domestic transports will be provided by the NMDP/Be The Match. There may be a few exceptions in this, and they would be communicated on a case-by-case basis.
Why isn’t our transplant center receiving backup itineraries?
Because itineraries are changing frequently and airlines have limited passenger flights, we are not providing a backup itinerary to transplant centers at this time.
We are closely monitoring each delivery. We will communicate any changes to an itinerary to your transplant center. Please be assured that we are continuing to work to ensure products are delivered to your transplant center in a timely matter.
We received a donor product more than 72 hours post collection. Can we still use the product? If so, is it a deviation that must be reported to the FDA?
Current travel restrictions may occasionally result in products being delivered to your center more than 72 hours after the end of product collection. NMDP/Be The Match strongly recommends you process and cryopreserve these products according to your
Ideally, marrow and PBSC should be infused within 48 hours of collection, but that is not required. In practice, infusion may occur up to 72 hours from collection. Since there is no product expiration date, infusion and cryopreservation at greater than 72 hours is not a deviation from NMDP/Be The Match standards and does not require regulatory reporting to the FDA.
Who should our transplant center request reimbursement from for required COVID-19 cryopreservation?
In most cases, we expect the patient’s insurance will cover the cost of cryopreservation. Please submit the cryopreservation reimbursement request to the patient’s insurance first.
If the claim is denied by the patient’s insurer or the patient has no insurance, you may invoice NMDP/Be The Match for the cryopreservation of the product. Please submit evidence of denial or statement regarding lack of insurance with your invoice. All invoices will be reviewed by NMDP/Be The Match prior to payment. We may ask your center for additional information if needed. Access the guidelines for submitting your invoice to NMDP/Be The Match.
If the cryopreservation charges are rolled into the transplant admission DRG, how will our transplant center know if the actual charge for cryopreservation is allowed?
This may be difficult to determine. Therefore, we recommend that your transplant center contact the insurance provider for documentation of reimbursement or denial of reimbursement. If reimbursement was denied, submit the invoice for cryopreservation to NMDP/Be The Match. See the above question for more details on submitting your reimbursement request.
Frequently Asked Questions About Change to Confirmatory Typing Process (updated 5/22/2020)
What if my center does not want the buccal swabs for CT testing but we still want ABO/Rh and CMV?
We recognize that some centers only want ABO/Rh and CMV testing and we are investigating ways to accomplish this. Until that process is established, our process requires us to send buccal swabs in order to test for ABO/Rh and CMV. If you are interested in ABO/Rh and CMV typing only, we encourage you to reach out to your Case Manager. While additional options are being evaluated, please remember your lab is not required to complete typing on samples you receive.
What if my center does not want the buccal swabs for CT testing, ABO/Rh and CMV but still wants the donor availability check and health history screening?
Effective June 15, if you are interested in only a donor availability check and health history screening, please request a CT on the donor you’re interested in and immediately reach out to your Case Manager to let them know the request is for a donor
availability check and health history screening only. If your Case Manager is not notified soon enough, we may not be able to stop the collection of the buccal swabs.
Your Case Manager will email the completed availability check and health history screening to you.
What should I do if my lab is unable to perform typing from buccal swab samples?
We can perform typing at an NMDP/Be The Match lab and send the results to you if your lab cannot complete the testing. Our testing lab is ASHI accredited and the typing results will count as a CT per the NMDP/Be The Match CT policy.
If you choose this option, all your CT samples will be sent to this lab and there will be an additional cost to perform the typing. Please contact your Case Manager to confirm the price and arrange this option.
Alternatively, if your lab is interested in setting up the ability to extract DNA from buccal swabs we can assist. Please contact Dr. Neng Yu, Director of Clinical HLA (Neng.Yu@nmdp.org).
What type of material is used to make the buccal swabs?
The buccal swabs are nylon flocked swabs produced by COPAN. If your lab would like to test the DNA extraction prior to testing actual donor samples, we can send your lab a sample kit. Contact your Case Manager if you would like a sample kit sent to
The applicator is a DNA-free, reinforced regular swab. Additional buccal swab dimension specifications are below.
- Stick length: 150.0 mm ± 1.0 mm
- Diameter handle part: 2.5 mm ± 0.10 mm
- Plastic tip diameter: 3.00 mm ± 0.05 mm
- Fibre tip length: 17.00 mm ± 2.00 mm
- Fibre tip diameter: 5.50 mm ± 0.50 mm
- Total length: 151.0 mm ± 2.0 mm
Storage temperature: 2/30˚C – DO NOT FREEZE
Shelf life: 36 months
Are we limited on the number of donors we can request through this process?
There is no limit. You can request as many donors as you need to find the best match for your patient.
What if I need additional swabs to perform testing?
If you need additional samples after receiving the initial swabs, please reach out to your Case Manager for assistance. We would like to understand why you need additional swabs so we can improve our process. In addition, your Case Manager can work with you to request another CT to ensure you’re able to get the samples you need.
How do I get buccal swabs for donors that I’ve already requested for CT or HW?
For inflight donors at CT, please contact your Case Manager and we can arrange buccal swabs to be collected.
For inflight donors at HW, please request a CT on this donor if you would like to have buccal swabs collected. Or, contact your Case Manager for help requesting the CT.
Can related donors be tested for ABO/Rh and CMV with this new process?
Starting Monday, July 13, we will automatically include ABO/Rh and CMV testing when you request family member sample collection and HLA typing through Related Donor Services. Our goal is to provide our transplant center partners with the information you need to earlier so you can select or rule out a related donor sooner.
Is the NMDP/Be The Match starting FastTrack Search again now that we are able to collect buccal swabs for CT testing?
FastTrack Search is still currently not an option we can offer because we are unable to provide IDM results. We will continue to assess interest in the program and determine when we can restart the program.
What if we are concerned that buccal samples could be higher risk for COVID-19? Is the NMDP/Be The Match quarantining the samples prior to shipping to our labs? Is it possible for the NMDP/Be The Match to extract the DNA and send to us?
NMDP/Be The Match does a three-day quarantine for our recruitment and customized typing samples. Under this process there would be a minimum of two to three days that pass before the samples reach you.
If you are concerned about the risk for COVID-19, your lab could add additional quarantine days to your process or process the sample under a biological hood.
We do not currently have the capability to extract DNA on your behalf.
What if my transplant center needs antigen typing for donors who have a PRA? This would determine which donor to request for workup.
Currently, we can’t guarantee that a donor would be able to safely provide a blood sample. If a specific patient case requires this testing, please reach out to your Case Manager. On a case-by-case basis, we will attempt to understand if we can safely have the donor drawn.
Will the NMDP/Be The Match be expediting CT draws at workup (i.e., doing CT draws early in the workup process to allow for transplant center HLA lab time)?
Yes, donor centers will be working to schedule the blood draws as quickly as possible after receipt of a workup request. We can also use FastTrack Testing to get the CT results in three days.
In urgent situations, can there be donor contact with high resolution (HR) typing?
If there is a stored sample, HR typing requests are sent to the Biorepository, the samples are sent to the laboratory and typing occurs. If there is no stored sample, donor centers would contact the donor (perform availability check and HHSQ if not already completed) and ship a buccal swab kit to the donor. The kit would be returned to the Biorepository and typing lab.
What kind of information do transplant centers receive from the HHSQ? Only information which is relevant to suitability or eligibility changes?
All relevant information regarding donor eligibility and suitability changes will be conveyed to the transplant center. You will also be notified if the contact has been completed and there is no relevant information identified impacting suitability and/or eligibility.
Will HR typing be performed on previously stored material, or will a new buccal swab always be required?
We will continue to use the current process for HR typing. If a swab does not exist, the donor center will ship a buccal swab kit to the donor. The donor will return the kit and the swab will be tested.
If you have questions about our response to COVID-19 and the impacts to your transplant center, your patients or their donors, contact your Case Manager.