This information provides guidance to the transplant sector during the COVID-19 crisis period. The latest information is shown below.
There have been a number of instances of cryopreserved cells being received with low post-thaw viability.
It is strongly recommended conditioning is not commenced until the post-thaw viability is confirmed.
12 August 2020 Communique on the easing of COVID-19 arrangements for unrelated BMT
At an early stage in the pandemic, CABG recommended routine pre-donation COVID-19 testing of all Australian HPC donors – including those assessed as asymptomatic and low-risk. This was in line with the approach taken in Australia across other organ and tissue donations (living and deceased); however was noted as being in contrast with the international WMDA recommendations. Having closely observed the subsequent impacts of COVID-19 in the Australian community, CABG has reviewed this earlier advice and now considers it appropriate to recommend that routine COVID-19 pre-donation testing should not be considered mandatory in Australia and should be based on clinical need.
All donors will continue to undergo a health risk assessment process through ABMDR’s COVID Response Centre, and donors who report contact with a confirmed case will continue to be deferred for 4 weeks following the date of last contact; donors with a history of COVID-19 infection will continue to be deferred for at least 28 days after recovery. If the patient’s need for transplant is urgent, the donor is completely well and there are no suitable alternative donors, earlier collection may be considered if local requirements permit, subject to careful risk assessment.
Following satisfactory completion of the Health & Availability Check during donor selection, donors outside of Victoria are permitted to undergo blood draws for HLA verification and infectious disease testing purposes prior to donor workup. Donors within Victoria (only) will require blood draws to be deferred until workup (combined VT/Workup). ABMDR will continue to monitor the situation in other states.
ABMDR can arrange for swabs to be sent to, and tested for, matched Victorian donors as a “pre-verification check” of HLA and to provide an indication of CMV status (if CMV data is absent), if requested. This would not replace the need to conduct the full suite of verification and infectious disease testing at workup.
Current arrangements to provide extended typing of donors prior to the Health & Availability Check, including completion of any missing donor enrolment data (i.e. blood type and CMV) will continue where required.
CABG will continue to monitor risk assessment outcomes and general community transmission rates to identify if further changes to this advice are required.
The following new arrangement is being implemented.
While cryopreserved cell delivery is generally arranged for business hours, due to potential flight/customs delays this cannot be guaranteed. Having transplant centre staff available to receive products outside of business hours at short notice if required is strongly recommended. The 24-hour contact information of all transplant centre laboratories is now being provided to couriers to support this.
The following existing arrangements remain unchanged.
Donor safety remains our priority.
In the current context, safety includes minimising donors’ potential exposure to COVID risks, by minimising their face-to-face interactions, supporting social distancing and supporting their self-isolation prior to collection (where possible).
Donor travel is to be minimised.
Donors will not be requested to attend blood draws for extended typing purposes. Extended typing is being undertaken prior to the Health & Availability Check using stored samples for low-resolution typed Australian donors that appear in a search report for an Australian patient, and to complete missing donor enrolment data (e.g. blood type and CMV results). Where a stored sample is not available, ABMDR’s COVID Response Centre can arrange for donors to provided with swabs.
ABMDR and international registries have implemented COVID-19 and health screening for all Australian donors, to identify risk factors prior to verification testing and workup.
It is inevitable that, over time, an increasing proportion of donors will present with COVID-19 risk factors. ABMDR, along with most international registry partners, have implemented health screening to assess these risks.
Workup of Australian donors.
Where a clinical need has been identified for the donor to undergo COVID-19 testing, such testing is not to take place in public COVID testing clinics.
The time between workup and G-CSF/collection is to be minimised for Australian donors.
This will mitigate the risk of the donor being exposed to COVID-19 between workup and collection. This will involve:
- donors being “provisionally” cleared at the workup appointment (where appropriate) on the basis of the examination;
- workup blood testing and COVID-19 testing (conducted during the workup appointment) is to be prioritised to return results on the same or next day where feasible;
- arrangements being made for the donor to commence G-CSF upon receiving the bulk of the test results – with self-administration of G-CSF to be encouraged; and
- any blood tests that take longer are to be considered “pending” where they are not expected to affect donor safety. The risk that a “pending” test like haemoglobinopathy screening could unexpectedly return an abnormal result may be, on balance, acceptable to a transplant centre.
Verification / day-of-collection testing for international donors.
All testing of international donor samples is to occur in the donor’s country of origin wherever feasible. The following lists the standard ‘day of collection’ test requests which will be made for international apheresis collections:
- ABO group and antibody screen
- Red blood cell phenotype
- CD34 enumeration
- CD3 enumeration
- Microbial testing
Donors should not proceed to G-CSF / collection unless there is a confirmed expectation that their gift will be used.
ABMDR will implement a confirmation protocol with transplant centres, before key donor exposure points. This will require confirmation that the patient is a high priority (as per BMTSANZ’s guidance); and that the transplant centre holds a reasonable expectation that the transplant will proceed, taking into account each institution’s latest forecast of COVID impacts on their BMT programs.
Where there is doubt about the transplant proceeding, preferred donors can be ‘reserved’ for the patient.
Australian donors should be supported to self-isolate prior to collection.
It is acknowledged that some donors will be unable to self-isolate due to work and family commitments. However, a discussion with the donor on their support requirements – e.g. medical certificates – is encouraged.
It is required that all international collections are cryopreserved at source and patient conditioning does not commence until cells are safely received. Further, it is strongly recommended that the viability of the cryopreserved product is confirmed by the transplant centre prior to commencing patient conditioning.
The cryopreservation of cells from international donors is required prior to shipment to Australia – there is no prospect of delivering these cells ‘fresh’. ABMDR has negotiated arrangements with ZKRD (for EU/UK donors) and NMDP (for US donors) to cryopreserve cells and ship to Australia. ABMDR will advise you about these arrangements when you need to import cells. The CRC is monitoring the success of these arrangements.
Cryopreservation and freighting increases the risk of cell damage. Where such issues occur and result in a significant reduction in product quality, they are to be reported as a S(P)EAR for monitoring purposes. There have been five incidents of cells being received with low post-thaw viability counts.
ABMDR has some arrangements in place to support the transport of fresh cells within Australia. For those wishing to arrange their own transport, several states and territories have their own border requirements. Couriers must check local requirements before travel – known websites are:
- QLD: www.qld.gov.au/border-pass
- WA: www.wa.gov.au/government/arrivals
- NT: coronavirus.nt.gov.au/travel
- TAS: coronavirus.tas.gov.au/travellers-and-visitors/coming-to-tasmania
- SA: www.coronavirus.sa.gov.au/restrictions-and-responsibilities/travel-restrictions
It is strongly recommended that PBSC be requested over bone marrow, where possible.
Operating theatre capacity for bone marrow collections has become critical in a number of countries; some countries are no longer accepting requests for bone marrow.
Each donation should be considered irreplaceable.
In the current circumstances, it is not assured that any cells collected for a patient can be replaced, or that subsequent donations can occur.
Poor transport connections and reduced capacity issues are reducing the flexibility to manage unexpected collection issues – e.g. when a second day of collection is requested to mitigate poor mobilisation. Transplant centres will need to be mindful that the options to manage such eventualities may be limited.