Special Report

Bone Marrow Transplantation (2008) 42, 9–14; doi:10.1038/bmt.2008.76; published online 24 March 2008

Haematopoietic stem cell donor registries: World Marrow Donor Association recommendations for evaluation of donor health

N Sacchi1, P Costeas2, L Hartwell3, C K Hurley4, C Raffoux5, A Rosenmayr6 and H Greinix7 on behalf of the Quality Assurance and Clinical Working Groups of the World Marrow Donor Association

  1. 1Italian Bone Marrow Donor Registry, Genova, Italy
  2. 2The Cyprus Bone Marrow Donor Registry, Nicosia, Cyprus
  3. 3The Anthony Nolan Bone Marrow Trust, London, UK
  4. 4Department of Oncology, Georgetown University Medical School, Washington, DC, USA
  5. 5France Greffe de Moelle, Paris, France
  6. 6Austrian Bone Marrow Donor Registry, Vienna, Austria
  7. 7Department of Internal Medicine I, Bone Marrow Transplantation, Medical University of Vienna, Vienna, Austria

Correspondence: Dr N Sacchi, Italian Bone Marrow Donor Registry, EO Ospedali Galliera, Via Volta 19, 16128 Genova, Italy. E-mail: nicoletta.sacchi@ibmdr.galliera.it

Received 13 June 2007; Revised 21 December 2007; Accepted 6 February 2008; Published online 24 March 2008.

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Abstract

The ability to identify unrelated haematopoietic stem cell donors in one country for recipients in another country requires cooperation and standardization in many areas. The donor assessment and testing are very important issues affecting quality and safety of donation. This special report details the World Marrow Donor Association's recommended procedures regarding the medical evaluation of donors, with the intent to protect the volunteer from the risk to damage his health and to offer the recipient the appropriate quality of stem cells. This document describes criteria for permanent or temporary deferral, guidelines for risk evaluation of infectious disease, examples of conditions requiring assessment and questionnaires designed to elicit relevant information about a donor's medical history and general health.

Keywords:

unrelated donors, stem cell donation, eligibility

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Introduction

One of the objectives of the World Marrow Donor Association (WMDA) is to establish internationally acceptable recommendations, standards and procedures for the search for unrelated volunteer haematopoietic stem cell (HSC) donors, on behalf of patients in need of transplantation.1, 2, 3 Two of the WMDA's working groups, the Clinical and Quality Assurance Working Groups, collaborated in the development of these guidelines.

This document presents recommendations and eligibility criteria for the evaluation of volunteer donor health at recruitment and during the following donor selection procedures. The major goal of an unrelated donor registry is to create a file of well-informed and well-selected volunteers, with the greatest likelihood of being suitable donors if chosen for specific patients. The loss of a registered donor under consideration as a match for a searching patient, through medical deferral or by withdrawal for personal reasons, leads to a loss of precious time and money during the search process and, more importantly, can drastically impact on a patient's chances to receive a transplant. It is, therefore, of fundamental importance to focus efforts on the overall medical evaluation of the volunteer before recruitment into the registry as well as in the following selection phases.

The purpose of the WMDA recommendations is to provide Donor Centres responsible for the recruitment of potential donors, with general principles and minimum criteria for the registration and further evaluation of an individual who has volunteered as a potential stem cell donor. This document recognizes that the recommendations contained herein may be subject to variances in order to meet the legal requirements of individual countries. Nevertheless, the extent of international cooperation establishes sufficient common denominators for the recommendations to be widely adhered to in the interest of best practice.

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Donor evaluation

When an individual is recruited as a volunteer donor, the primary goal is to determine if the volunteer is in good health in order to (1) protect the volunteer from the risk of damage to his/her own health, and (2) protect the recipient from transmissible diseases. It is, therefore, an essential requirement that only individuals in good health, who meet specific eligibility criteria, should be registered as potential stem cell donors. The Donor Centre, in accordance with the Registry standards and national laws, must also comply with established age, height and weight criteria.

During HSC donation, infectious agents (hepatitis B and C viruses, human immunodeficiency virus, and so on), genetic defects or even disseminated malignancies can be transmitted. Assessing these risks of disease transmission and of donation requires that the examiner obtains a concise medical and life-style history and requests laboratory tests that have not always been done at time of first registration of volunteers. Screening questionnaires are helpful to obtain complete and relevant information on the donor's medical history and general health.

A pre-printed questionnaire should be completed at recruitment (a sample can be found in Appendix 1). A second questionnaire must be completed when a donor is being considered for a specific patient (for example requested for confirmatory typing). A sample questionnaire can be found in Appendix 2. The questionnaires should be designed to elicit information relevant to potential selection of that individual as a stem cell donor. The questionnaires should be also supplemented, where necessary, by direct questioning. Some specific questions asked of donors are designed to identify individuals who may be at a high risk of transmitting infectious diseases. A positive response to these questions will, in general, lead to a temporary or permanent deferral but in each case it must be considered on its own merits. Since questioning of the volunteers as to the country(ies) in which they were born, were brought up or have visited is essential for effective detection, every Donor Centre should have a map of the endemic zones and an alphabetical list of the countries concerned. All donors should be provided with accurate and updated information on specific infectious diseases including human immunodeficiency virus and hepatitis transmission so that those indulging in unsafe sex practices or other risk behaviour exposing them to potential infectious sources will refrain from donating. The information provided may vary between countries according to local epidemiological data. The questionnaire should be signed by the donor and the person who carries out the medical evaluation certifying that the relevant questions have been asked.

Based on the information obtained through the questionnaires, the guidelines provided in Tables 1, 2, 3, 4, 5 and 6 should be followed. Table 1 lists conditions that should lead to permanent deferral of the volunteer. Table 2 lists infectious diseases, some of which result in permanent deferral and Table 3 discusses volunteers who have had close contact with infected individuals. A list of temporary deferral conditions is provided in Table 4. Since it is unusual that a potential donor is asked to donate within a few months of his/her registration, volunteers with a condition with a deferral period of less than 6 months may be recruited onto the registry. This deferral period should be noted in the donor's record. Table 5 lists a variety of common immunizations and the deferral status of volunteers who have received them. As donors may present with a variety of medical problems, past or present, only some of the more common examples which require individual assessment by the Donor Centre are considered in Table 6.







The donor's medical history must be evaluated before approving a volunteer as a potential donor. Abnormal findings must be referred to the physician in charge, who makes the final decision on the eligibility of the volunteer to be listed on the Registry or to be considered as a potential donor. If the physician is in doubt, the volunteer should be deferred. The volunteer must be informed about the reason for deferral and, if appropriate, any consequences to his/her health.

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Summary

Donor assessment and testing are very important issues affecting quality and safety of donation. The international legislative frameworks (European directives for donor of tissue and cellular therapy products, US Food and Drug Administration, and so on) have detailed requirements on donor evaluation.

The WMDA has prepared these recommendations with the intent to provide Donor Centres with general eligibility criteria for the medical evaluation of unrelated haematopoietic stem cell donors. These donor screening tools reflect WMDA recommendations to ensure donor and recipient safety and to ensure the quality of the cellular product. As standards and regulatory requirements may vary in different countries, Donor Centres must also consider local requirements when designing their donor screening materials.

WMDA recommends that Donor Centres, or the organization established to carry out the unrelated donor eligibility assessment, follow these guidelines to offer the appropriate quality of product for engrafting the patient, while protecting the health and well being of the volunteer donor.

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References

  1. Goldman JM, for the Executive Committee of the World Marrow Donor Association. Special report: bone marrow transplants using volunteer donors—recommendations and requirements for a standardized practice throughout the world—1994 update. Blood 1994; 84: 2833–2839. | PubMed | ISI | ChemPort |
  2. Gahrton G. Goals and activities of the WMDA, World Marrow Donor Association. Int J Hematol 2002; 76 (Suppl 1): 384–385. | PubMed | ISI |
  3. Hurley CK, Raffoux C, World Marrow Donor Association. World Marrow Donor Association: international standards for unrelated haematopoietic stem cell donor registries. Bone Marrow Transplant 2004; 34: 103–110. | Article | PubMed | ISI | ChemPort |
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Appendices

Appendix 1

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Donor health questionnaire before the first registration

Appendix 2

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Donor health questionnaire at time of closer consideration for a certain patient (confirmatory typing or work up)

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Acknowledgements

We thank the WMDA members for their contributions and the WMDA Board for review of this paper.

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