Canterbury DHB

Donor Selection Assessment and Consent

Selection of the Donor

Selection Criteria

• Age - no limits.
• Good general health status.

Procedure

1. Patient contacted to obtain sibling details. Request that they contact all siblings and obtain their consent before forwarding details to the SCT Coordinator.
2. All siblings are contacted, their details are checked, and they are informed about tissue typing blood tests.
3. Tissue typing forms are completed and sent to siblings along with the tissue typing information leaflet.
4. Donor tissue typing results are relayed to the donor first and are only divulged to a third party (eg potential recipient/other family members) after permission has been obtained from the donor.
5. Non-compatible siblings informed and may be invited to join NZBMDR.

Donor Assessment for Allograft - Standard or RIC

1. Meeting with SCT Coordinator to discuss harvest procedure.
2. The potential donor requires a medical history and examination by an “independent” consultant to assess their suitability.
   • The SCT Coordinator writes to this Consultant outlining the proposed date of harvest, recipient’s name and condition and any other relevant information.
   • The Coordinator also attaches the donor consent form and the donor assessment form.
   • The information collected should include parity and number of blood transfusions received, if any.
   • The Donor Medical Assessment Form and Stem Cell Donor Questionnaire should be completed.
3. Normal allogeneic donors are encouraged to be immunised with the current recommended influenza vaccine in the one month prior to stem cell donation.
4. Laboratory tests required pre donation - many of these will already have been done (e.g. tissue typing):
   • Confirmatory typing.
   • CBC + diff and ONCO screen.
   • ABO and Rh typing, red cell antibodies.

     The antibody screen on the patient and donor will identify if there are any clinically significant antibodies other than anti-A and anti-B that may cause minor/delayed haemolysis if RBCs in the graft have the relevant antigens. Minor haemolysis is also possible if the donor has preformed antibodies against the recipient RBC.

     The RBC crossmatch is performed as a final check of compatibility as even though the antibody screen may be negative we need to check for any incompatibility that may result from lesser known antibodies that we may not have ability to detect with our screening cells. This is done only if the recipient plasma is ABO compatible with the donor red cells, otherwise it is a waste of time as we know there is a major ABO incompatibility already.

   • Serology for HBV, HCV, HIV, CMV, Syphilis, Toxoplasma, HSV, VZV, and EBV.
5. Check whether MRSA swabs are needed. See the CDHB Guidelines for the Control of Multidrug Resistant Organisms.
6. Consider whether a chest X-ray is likely to alter management after taking into consideration the patient's age, cardiac risk, and clinical findings. Age by itself is not an indication for CXR.

   Low

   • Good exercise tolerance.
   • No history of angina.
   • No diabetes.
   • No history of previous myocardial infarction or cardiac failure.
   • Normal electrocardiogram.

     Active, asymptomatic patients with prior complete percutaneous coronary revascularisation (PTCA) six months to five years previously, or prior complete surgical revascularisation (CABG) up to five years previously.

   Moderate

   • Known stable ischaemic heart disease (angina on moderate or more exercise, no rest or nocturnal pain and no previous myocardial infarction).
   • History of cardiac failure (but now controlled).
   • Arrhythmias (controlled).
   • More than three risk factors (age over 65, angina, myocardial infarction more than six months previously, hypertension, diabetes, ventricular ectopic beats, and smoking, major emergency surgery).

   High

   • Poorly controlled or unstable ischaemic heart disease.
   • Myocardial infarction within the previous three months.
   • Impaired left ventricular function
   • Signs of cardiac failure (ie. raised jugular venous pressure, third heart sound, pulmonary oedema).
   • Severe aortic stenosis.

   Donors at low cardiac risk should not need any further investigations. Donors at high risk should be referred for anaesthetic/cardiac assessment. Donors with any moderate risk features should have an ECG and CXR and referral for anaesthetic review before a GA.

   ¹Cardiac risk assessment for non-cardiac surgery. FM Stewart. Technical Report to Medical and Allied Professions. No 71. The National Heart Foundation of New Zealand, PO Box 17160, Greenlane, Auckland 1130.

   Note: Bone Marrow Harvest is classified as a low risk procedure.

7. Venous assessment and consent by NZBS for apheresis procedure.
8. The donor must sign the consent form for bone marrow procurement prior to the initiation of the SCT conditioning.

Donor Consent

• Establish donor willingness to donate.
  • Allocate donor to a medical consultant different to that of the patient.
• Items to cover
  • Refer to Consent - Donor Consent Checklist (2310083).
  • Ensure donor participates in information session and receives donor information booklet and adequate counselling on procedures involved.
  • Principle of independent assessment of donor.
  • Requirement for further blood tests.
  • Requirement for virology testing, especially HIV, HBsAg and HCV.
  • Risks of anaesthesia and harvest procedure.
  • Loss of time from normal activities.
  • Possibility of need for allogeneic blood transfusion and potential risks, option of autologous unit.
  • Donors right to withdrawal and consequences for patient if this right is exercised after treatment is started.
  • Influenza immunisation (contraindicated if egg allergy)
  • Possibility of second donation being requested.
  • Information regarding use of G-CSF (if this is a possibility) and apheresis.
  • Access to information about recovery of costs such as travel expenses, with emphasis on donation as a gift without remuneration.
  • Permission is required to enter donor data into any international registries concerning the procedure.
• The donor must sign the consent form for bone marrow procurement prior to the initiation of the SCT conditioning. This should be done at the time of the ‘independent’ consultant assessment. An autologous unit may sometimes be taken from the donor 1-2 weeks before harvest, although it has been generally felt that post operative iron replacement is sufficient. In the case of an unrelated donor the above assessment will be conducted in the appropriate hospital near the place of residence as directed be the relevant Bone Marrow Donor Registry and according to their protocol.

Bone Marrow Harvest

The Schedule for Allogeneic Harvest must be completed.

Donor Follow-up

• Bone marrow donors are given a supply of oral iron and analgesia
• Follow up appointment 2-3 weeks post op. The follow up form is completed at this visit. (If donor is G-CSF primed, the donor will need to be contacted annually for 5 years.)

If the Donor is a Minor or a Mentally Incompetent Adult

There has been much discussion in the literature about the ethics of using children as bone marrow donors. The debate seems to centre on two issues, the determination of whether or not the procedure is in the best interests of the donor, and from whom the consent should be derived. Much of the literature concludes that the psychological benefits to the child outweigh the physical disadvantages of the procedure.

To safeguard the rights of these children, Mumford proposes the following guidelines:

No child may be a donor unless:

• A bone marrow transplant is necessary to allow a chance of significant improvement in the recipient’s condition and no adult donor is available.
• There is a close family bond between the donor and the recipient. This may exclude donations by institutionalised persons who do not know their siblings, or donations to little known cousins or step siblings.
• It appears that they are willing to participate in the procedure.
• A social worker, and the doctor who is to harvest the marrow, should review the child.

For the full article, see Mumford, BJH, 1998.

Topic Code: 8899