international standards for unrelated hematopoietic stem cell donor by qingqing19771029

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									                                                                     Bone Marrow Transplantation (2004) 34, 103–110
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Special report
World Marrow Donor Association: international standards for unrelated
hematopoietic stem cell donor registries

CK Hurley1 and C Raffoux2,3, on behalf of the World Marrow Donor Association3
1
 Department of Oncology, Georgetown University Medical Center, Washington, DC, USA; 2France Greffe de Moelle, Hospital
Saint-Louis, Paris, France; and 3Europdonor Foundation, Leiden, The Netherlands


Summary:                                                             tions published previously6 and were developed with the
                                                                     input of international experts in transplantation, histocom-
World Marrow Donor Association standards are aimed at                patibility, and registry operations.
enhancing the quality of unrelated volunteer donor                   I.    OVERVIEW AND DEFINITIONS
hematopoietic stem cell registries assisting transplant              1.0 These standards are intended to provide the mini-
physicians in the international search for unrelated donors                mum criteria for obtaining WMDA accreditation.
for their patients. The standards cover: (1) general                       1.01. In the initial implementation of the accred-
organization of registries; (2) donor recruitment; (3)                             itation process by WMDA, specific ‘bench-
donor characterization; (4) information technology; (5)                            mark’ standards have been identified that
facilitation of search requests; (6) second/subsequent                             must be met by a registry seeking accredita-
donations; (7) collection/processing/transport of stem                             tion. These standards have been indicated in
cells; (8) follow-up of patient/donor; and (9) financial/                           bold. Other standards, not in bold, are not
legal responsibilities.                                                            required during the initial implementation
Bone Marrow Transplantation (2004) 34, 103–110.                                    process. Registries certified during the initial
doi:10.1038/sj.bmt.1704542                                                         implementation period will be granted a
Published online 31 May 2004                                                       ‘pilot’ accreditation status based on their
Keywords: registry; hematopoietic stem cell transplanta-                           commitment to adhere to the ‘benchmark’
tion                                                                               standards. The WMDA Board will establish
                                                                                   the length of the initial implementation
                                                                                   period. Following the initial implementation
Today, approximately one-third of unrelated transplanta-                           phase, requirements to meet specific standards
tions worldwide utilize hematopoietic stem cells from a                            will follow standard 1.02.
donor in another country.1 An international voluntary                      1.02 After the initial implementation period is
organization of registries worldwide, the World Marrow                             completed, the words ‘must’ and ‘shall’
Donor Association (WMDA),2 has published policies and                              indicate that deviations are not acceptable.
procedures for these international exchanges (http://                              There will be no difference between bolded
www.worldmarrow.org).3–5                                                           benchmark standards and nonbolded stan-
   The WMDA recently adopted standards and is begin-                               dards containing the words ‘must’ and ‘shall’.
ning an accreditation process; both of these are aimed at                          ‘Should’, ‘might’, and ‘may’ are used for
enhancing the quality of the international search and                              recommendations that are not mandatory.
procurement process. Accreditation of individual registries                1.03 If national laws and regulations differ from
by the WMDA will be an indication that these registries are                        the WMDA standards, the requirement to
committed to follow WMDA standards. These standards                                meet local legal standards will be accepted as
promote the quality of procedures necessary to obtain, in                          a valid cause for variation from WMDA
the shortest possible time, the appropriate quality and                            standards.
quantity of hematopoietic stem cells from the best                   2.0 Definitions
unrelated donor suitable for engrafting a patient while
protecting the anonymity, health, and well being of the                 WMDA: An international nonprofit organization that
volunteer donor. The standards are based on recommenda-              promotes the definition and standardization of ethical,
                                                                     technical, medical, and financial aspects of hematopoietic
                                                                     stem cell transplantation involving volunteer donors in one
                                                                     country who give hematopoietic stem cells to unrelated
Correspondence: Dr CK Hurley, E404 Research Building, Georgetown     patients in another country.
University Medical Center, 3970 Reservoir Road, NW, Washington, DC
20057, USA; E-mail: hurleyc@georgetown.edu
                                                                        WMDA Board: The board includes the President, Vice-
Received 19 November 2003; accepted 23 February 2004                 Presidents, Secretaries, Treasurer, Chief Operating Officer,
Published online 31 May 2004                                         and Chairs of the WMDA Working Groups.
                                                            Registry standards
                                                       CK Hurley and C Raffoux
104
             Note: The institutions providing hematopoietic stem cells              Blood Bank: A Blood Bank is a medical facility at which
          to a patient in another country vary in their organizational           blood intended for transfusion is drawn and stored.
          structures. The definitions below are aimed at defining the                 Confirmatory Typing: This typing includes the tests
          individual elements, which comprise this effort and are not            carried out on a specific donor at the request of a
          intended to indicate the requirement for a specific organiza-           Transplant Center to determine the appropriateness of
          tional structure.                                                      using hematopoietic stem cells from that donor for a
             Registry: A Registry is a national organization whose               specific patient.
          responsibility is to process requests for hematopoietic stem              WorkUp: At this stage, a volunteer has been identified as
          cells from donors originating from within the country and              a match for a patient, agrees to donate hematopoietic stem
          emanating from abroad. The Registry may coordinate the                 cells, and is medically evaluated for their fitness to donate
          activities of Donor, Collection, and Transplant Centers in             stem cells.
          the respective country.                                                II.     STANDARDS
             Donors: Donors are defined as (1) volunteer adult donors             1.0     General
          of hematopoietic stem cells or (2) umbilical cord blood                        1.01 A Registry that provides hematopoietic stem
          units collected after maternal permission.                                            cells obtained from an individual recruited by
             Donor Center: The Donor Center is the organization                                 that organization as a volunteer donor to a
          responsible for recruiting, consenting, counseling, and                               patient in another country and facilitates
          coordinating the testing of prospective donors. The Center                            exchanges on behalf of Transplant Centers in
          monitors the short- and long-term health of adult volunteer                           its country is eligible for accreditation by the
          donors who have provided hematopoietic stem cells. The                                WMDA.
          Donor Center maintains a register or database of donors,                              1.01.1 An organization that intends to
          which may be searched as appropriate.                                                          provide stem cells or intends to
             Cord Blood Bank: A Donor Center whose sole mission is                                       facilitate exchanges but has not yet
          to collect and maintain umbilical cord blood units is termed                                   done so is eligible for accreditation
          a Cord Blood Bank and may combine some or all of the                                           by the WMDA provided that the
          activities of both a Donor Center and a Collection Center.                                     organization can provide satisfac-
          For example, a Cord Blood Bank may be responsible for                                          tory documentation of their ability
          donor recruitment, cord blood collection, and storage, but                                     to provide stem cells to patients
          the database of donors might be maintained by a Registry.                                      within their own country following
          Alternatively, the Cord Blood Bank might include all of                                        WMDA standards.
          these activities and perform searches for Transplant                           1.02 If a Registry is accredited for international
          Centers.                                                                              exchange of hematopoietic stem cells by an
             Collection Center: The Collection Center is the medical                            international organization with standards
          facility at which hematopoietic stem cell collection from                             that meet or exceed WMDA standards, that
          selected donors actually takes place. This collection might                           Registry may be given WMDA accreditation
          include marrow aspiration or apheresis. The Collection                                following submission of material document-
          Center performs the medical workup of the donor and                                   ing that accreditation.
          provides the final approval of the donor for harvest. If                        1.03 If a Registry relies on other entities to
          umbilical cord blood is collected, the Center is responsible                          perform some of the duties described in these
          for processing and storage of the cord blood unit.                                    standards, it is the responsibility of the
             Transplant Center: The Transplant Center is the medical                            Registry to ensure that these entities comply
          facility at which a patient (recipient) receives a transplant                         with WMDA standards.
          (graft) with hematopoietic stem cells from an unrelated                               1.03.1 If a Registry relies on an independent
          donor or from an umbilical cord blood unit. The Center                                         Donor Center to recruit donors, the
          oversees the immediate medical treatment and provides                                          Registry must ensure that the Donor
          long-term follow-up of the recipient. The Search Unit                                          Center complies with WMDA stan-
          undertakes the search for an unrelated donor for specific                                       dards concerning donor recruitment
          patients. This entity may be contained within a Transplant                                     and characterization.
          Center or may be separate from the Transplant Center. If                              1.03.2 The Registry must ensure that Trans-
          separate, the Search Unit may coordinate searches for one                                      plant Centers affiliated with the
          or several Transplant Centers. In the standards, reference                                     Registry and requesting a donor
          to a Transplant Center should be interpreted as a                                              from another country meet stan-
          Transplant Center and/or a Search Unit as appropriate.                                         dards designed to insure that dona-
          Transplant Centers/Search Units seeking an international                                       tion of hematopoietic stem cells will
          donor work through the Registry in their country.                                              only be requested for patients for
             Testing Laboratories: These laboratories perform the                                        whom transplantation is a medically
          histocompatibility, blood group, infectious disease, and                                       acceptable procedure.
          other testing of the prospective donors and patients. They                                     1.03.2.1     The Registry shall have
          may be under the direction of a Registry, Donor Center or                                                   established standards for
          Transplant Center or may be separate from these entities.                                                   Transplant Centers that
                                                                                                                      shall be public.

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             1.03.3   If a Registry relies on an indepen-                          required to perform international searches
                      dent Collection Center for the fol-                          within a time based on goals as recom-
                      low-up of donors or for collection of                        mended in WMDA procedures for unrelated
                      donor samples, for example, the                              donor search while maintaining the confi-
                      Registry must ensure that the Col-                           dentiality of patient and donor.
                      lection Center complies with                          2.08 The Registry must have a fixed physical
                      WMDA standards in these areas.                               location.
            1.03.4 These standards may be defined                                   2.08.1 The location must have sufficient
                      by the Registry or by an appropriate                                   space so that all work can be carried
                      national or international organiza-                                    out in an environment designed to
                      tion.                                                                  minimize errors and maintain con-
            1.03.5 The nature of these affiliations and                                       fidentiality.
                      the duties and responsibilities of                    2.09 The Registry must have sufficient communica-
                      each entity must be documented.                              tion links to facilitate searches.
      1.04 The Registry should abide by other WMDA                                 2.09.1 These links must include telephone,
            recommendations in further detail as far as                                      fax, and international telematic links
            they do not contradict national laws and                                         (email, internet).
            regulations.                                                    2.10 The Registry must maintain written policies
2.0   General organization of the Registry                                         and protocols for all procedures performed in
      2.01 The Registry must be a legal entity or be                               the Registry including staff training and
            contained within a legal entity operating within                       quality management.
            the laws of the country in which the Registry         3.0       Donor recruitment for the Registry and donors
            resides.                                                        selected for specific patients
      2.02 The Authorized Official of the legal entity is                    3.01 The recruitment of donors must be per-
            responsible for ensuring the Registry’s com-                           formed under the direction of individuals
            pliance with the WMDA standards and must                               who are experienced in recruitment of donors
            authorize all official documents related to                             and in management activities including edu-
            WMDA accreditation.                                                    cation, consenting, counseling, confidential-
      2.03 The Director or key Registry personnel must                             ity, and medical screening.
            have demonstrated experience in program                         3.02 The willingness to become a donor must be the
            administration in a health-care setting.                               individual choice of each adult donor, that is,
      2.04 The Director or key Registry personnel or                               donors must be volunteers. Donors must be
            consultants must have a sound knowledge of                             willing to donate on behalf of any patient being
            human histocompatibility and hematopoietic                             treated in any part of the world. Donors must
            stem cell transplantation. At least one of these                       not be paid for their donation but may be
            individuals must be a physician. These indivi-                         reimbursed for expenses incurred during the
            duals must possess a basic understanding of                            donation process, for example, time lost from
            diseases treatable by hematopoietic stem cell                          work or travel to the Collection Center.
            transplantation, comprehend alternative thera-                  3.03 The initial donation must be anonymous. The
            pies and donor search problems associated                              Registry must have a written policy listing the
            with these diseases, understand HLA specifi-                            conditions under which donors and recipients
            cities (serologic, cellular, and DNA-based) and                        might be informed of each other’s identity.
            haplotypes, and possess a knowledge of                          3.04 Adult donors must be informed regarding their
            Transplant Center, Donor Center, Collection                            potential role in the donation of hematopoietic
            Center, and Registry protocols in their own                            stem cells and the risks involved in the
            country and abroad.                                                    donation.
      2.05 The Registry must have at least one physi-                              3.04.1 Fully informed written consent must
            cian to assist the Registry with making                                          be obtained from all adult volunteer
            unbiased decisions, for example, when deter-                                     donors at the time of workup.
            mining the appropriateness of a second                                 3.04.2 Written consent must be obtained
            donation or evaluating a donation by a                                           initially at the time of recruitment.
            donor with health problems.                                            3.04.3 Written consent may be obtained at
            2.05.1 A review panel should be available                                        other stages of the matching and
                      as needed for complicated or con-                                      donation process.
                      troversial situations.                                       3.04.4 A donor must be free to withdraw at
      2.06 The Registry should have direct daily access to                                   any time.
            expert consultants in the areas pertinent to the                       3.04.5 Consent must be obtained if donor
            operation of the registry to assist the registry in                              blood or other biological material or
            establishing policies and procedures.                                            information is stored and/or used for
      2.07 The Registry must retain a staff large enough                                     the purpose of an ethically approved
            to assume the volume and variety of services                                     research project.

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                         3.04.6  Consent documents signed by volun-                                                   used to define antigens in
                                 teer donors must be available for                                                    the population tested
                                 review by individuals designated by                                                  that    are    frequently
                                 the Registry or national authorities to                                              missed    and/or      mis-
                                 evaluate the Registry.                                                               assigned.
                  3.05 Requirements for donor health affecting the                              4.04.4 DNA-based testing is required for
                       eligibility of donors must be established.                                        HLA-DRB1.
                       3.05.1 An initial health screening may be                                4.04.5 Registries must have established
                                 performed at the time of recruit-                                       approaches to monitor and ensure
                                 ment.                                                                   the quality of HLA types listed in
                       3.05.2 A health screening must be per-                                            the donor database.
                                 formed at the time of confirmatory                      4.05 Infectious disease testing of donors selected for
                                 typing.                                                        specific patients must include testing for
                       3.05.3 A medical examination must be per-                                diseases thought to be important to consider
                                 formed at the time of workup.                                  in hematopoietic stem cell transplantation.
                  3.06 Prospective unrelated adult volunteer donors                             Testing must monitor infection with human
                       selected for hematopoietic stem cell harvest                             immunodeficiency virus (HIV), hepatitis B
                       must have passed a minimum age established                               virus, hepatitis C virus, cytomegalovirus
                       by national regulations or their 18th birthday                           (CMV), and Treponema pallidum (syphilis).
                       if no regulations exist and an upper age-limit                           4.05.1 Selected donors should also be
                       for donation must be stipulated after which                                       tested for locally important diseases
                       donors will be removed from the Registry.                                         that are important to consider in
                       3.06.1 That upper age limit should not                                            transplantation.
                                 exceed 60 years.                                               4.05.2 Volunteer donors may be screened
          4.0     Donor characterization                                                                 for some infectious diseases before
                  4.01 Characterization of donors for blood group                                        listing the donor on the Registry.
                       markers, for the presence of infectious                                  4.05.3 Registries must also have the cap-
                       diseases and for any other markers considered                                     ability of shipping donor blood
                       important in transplantation must be per-                                         samples to the appropriate Trans-
                       formed.                                                                           plant Center in the event the Trans-
                  4.02 Testing must be carried out by laboratories,                                      plant Center requires additional
                       which meet national guidelines for perform-                                       infectious disease testing.
                       ing these services.                                              4.06 The blood group testing of adult volunteer
                       4.02.1 The HLA typing laboratory must                                    donors selected for a specific patient must
                                 be accredited by the European Fed-                             include identification of ABO blood group and
                                 eration for Immunogenetics (EFI),                              Rh factor at the confirmatory typing stage.
                                 the American Society for Histocom-                             4.06.1 Blood cell counts of donors selected
                                 patibility   and     Immunogenetics                                     for specific patients must be per-
                                 (ASHI), Australasian and South                                          formed at the workup stage.
                                 East Asian Tissue Typing Associa-                      4.07 Information on donor age and gender must be
                                 tion (ASEATTA), or an agency                                   collected at the time of recruitment.
                                 with similar standards and accred-                     4.08 Information on donor parity and history of
                                 itation process.                                               other prior sensitizing events such as transfu-
                  4.03 Testing must be carried out in a manner to                               sion should be obtained during the confir-
                       ensure the accuracy of the data.                                         matory typing stage.
                  4.04 The histocompatibility testing of donors must                    4.09 Female donors of childbearing years must have
                       include identification of HLA loci considered                             a pregnancy test performed during the workup
                       essential for transplant success.                                        stage.
                       4.04.1 A minimum of HLA-A, -B, -DRB1                             4.10 To ensure confidentiality, the identity of
                                 should be defined at serologic split                            donors must be protected. Approaches to
                                 or low resolution prior to listing the                         ensure donor confidentiality must be estab-
                                 donor on the Registry.                                         lished.
                       4.04.2 A minimum of HLA-A, -B, -DRB1                             4.11 Other appropriate information on the donor
                                 must be defined at serologic split or                           such as racial/ethnic group might be collected
                                 low resolution prior to donation for                           subject to national legislation.
                                 a specific patient.                               5.0   Information technology including the database or
                       4.04.3 DNA-based testing is recommended                          register of donors
                                 for HLA-A, -B.                                         5.01 The Registry must have a documented plan for
                                 4.04.3.1    If serology is used for                            data entry and storage to ensure the main-
                                             HLA-A, -B, a DNA-                                  tenance of accurate records, that is, validation
                                             based method must be                               of data integrity.

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      5.02    All patient and donor communications and                              6.05.1   Counseling for donors selected for
              records must be stored to ensure confidenti-                                    specific patients must include anon-
              ality.                                                                         ymity of the donor and patient,
      5.03 Records must be preserved and protected from                                      requirement for further blood sam-
              accidental or unauthorized access, destruction,                                ples before donation, requirement
              or modification.                                                                for infectious disease and other
              5.03.1 Records should be maintained for                                        testing, risk of donation, possible
                       an appropriate period of time as                                      duration of loss of time from normal
                       dictated by national standards.                                       activities, location of the harvest,
              5.03.2 The ongoing backup and data                                             requirement for collection of auto-
                       restoration procedures must be                                        logous blood, donor’s right to with-
                       appropriate, validated, and docu-                                     draw and consequences for the
                       mented.                                                               patient, details of insurance cover-
      5.04 Procedures for systems development, mainte-                                       age, possible subsequent donations
              nance, and operations must be validated.                                       of hematopoietic stem cells or blood
              Documentation of systems development,                                          products, alternative collection
              maintenance, and operations including poli-                                    methods and whether blood is re-
              cies and procedures must be complete and in                                    served for research purposes.
              an appropriate language. Modifications to                              6.05.2 The adult volunteer donor should be
              the computer system must be authorized and                                     informed if the donation involves an
              documented.                                                                    experimental procedure performed
      5.05 Search algorithms must allow reliable                                             for a patient.
              searches, which can be completed in a time                  6.06      The Donor Center and the donor must be
              frame consistent with WMDA recommenda-                                informed of the proposed date(s) of transplant
              tions.                                                                at the time a specific donor is requested for
      5.06 Each printed report must be dated. Quality                               stem cell donation on behalf of a specific
              assurance procedures should include dating                            patient. The Transplant Center must specify
              each step in the search process in order to                           the latest date by which the Donor Center
              evaluate the time required for each stage of                          must approve the eligibility of a donor for
              the search process.                                                   donation of hematopoietic stem cells for a
6.0   Facilitation of search requests                                               specific patient (ie provide donor clearance).
      6.01 Critical communications between Registries or                  6.07      The adult volunteer donor must be medically
              between a Registry and a Transplant Center                            examined to ascertain fitness to donate. This
              must be in writing.                                                   examination must be performed by a physician
              6.01.1 These communications should con-                               who is not a member of a team who has cared
                       tain a signature of authorization and                        for the patient.
                       be sent by fax or email.                                     6.07.1 Policies for testing of the donor must
      6.02 Registries must respond to search requests and                                    be established.
              to requests for additional information and/or                         6.07.2 Infectious disease markers must be
              an aliquot of donor sample within a time                                       measured within 30 days of the
              period consistent with WMDA recommenda-                                        hematopoietic stem cell harvest and
              tions and in a defined manner.                                                  the results must be provided to the
              6.02.1 The policy of the Registry regard-                                      Transplant Center before commence-
                       ing repetition of the database search                                 ment of patient conditioning.
                       for a specific patient should be                                       6.07.2.1     Markers that must be
                       defined.                                                                            tested include, at a mini-
      6.03 Donor and patient identity must remain                                                         mum, HIV, hepatitis B
              confidential during the search process so that                                               virus, hepatitis C virus,
              only appropriate Registry personnel have                                                    Treponema pallidum (sy-
              access to these data.                                                                       philis), and cytomegalo-
      6.04 A donor selected for a specific patient must                                                    virus.
              be placed on a ‘reserved’ status from the time                        6.07.3 Policies for counseling the donor in
              of confirmatory typing until the transplanta-                                   the case of positive identification of
              tion date is reached.                                                          donor health risk such as the pre-
              6.04.1 A maximum time limit and the                                            sence of an infectious disease should
                       procedures for granting exceptions                                    be established.
                       for this status should be set in                             6.07.4 The Registry must make their policy
                       writing.                                                              for the minimum criteria needed to
      6.05 Adult volunteer donors must be counseled                                          allow a specific donor to be available
              when selected for further tests and when                                       for a specific patient available to
              selected as a donor for a specific patient.                                     the public.

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                                  6.07.4.1     This policy might include                8.03  Written policies and procedures must be in
                                               a minimum level of HLA                         place to ensure the quality and quantity of the
                                               match, guidelines for pa-                      collected cells. These must include policies
                                               tient-specific     criteria                     for communication between the Transplant
                                               such as specific diseases                       Center and Collection Center regarding the
                                               or disease stages for                          number of cells required.
                                               which transplantation is                       8.03.1 This may include the collection of
                                               not considered appropri-                                such information from the Trans-
                                               ate, the optimal amount                                 plant Center receiving the donated
                                               of marrow aspirated                                     stem cells.
                                               based on the weight of                   8.04 Written documentation of the characteristics
                                               the donor, or require-                         of the collected product important in facilitat-
                                               ments for Transplant                           ing the transplant must be provided with the
                                               Center credentials.                            cells according to applicable guidelines. At a
          7.0     Second and subsequent donations of hematopoietic                            minimum, this information must include in-
                  stem cells and/or blood products for the same                               formation on the number of cells collected, the
                  patient                                                                     donor’s unique identification code, donor ABO
                  7.01 Adult volunteer donors must be fully informed                          group, identification of the patient, date and
                          in advance of the original donation regarding                       time of collection, and name and contact
                          the possibility of and possible procedures                          information of the Transplant Center.
                          involved with a subsequent donation of                        8.05 Cells must be transported in a timely and
                          hematopoietic stem cells or blood products                          reliable manner to ensure the quality of the cell
                          intended for therapeutic use for the same                           product as it reaches the Transplant Center.
                          patient and the risks involved in the second                        Policies and procedures documenting the
                          donation.                                                           transport process must be stipulated.
                          7.01.1 The Registry must have a process for                         8.05.1 These policies may include criteria
                                   communicating the donor’s willing-                                  for the designated courier, describe
                                   ness to participate in a subsequent                                 information and resources available
                                   donation to the appropriate Trans-                                  to the courier, plans to address
                                   plant Center, although the donor                                    disruption of travel, transport
                                   must be free to decline a subsequent                                temperature, communication pro-
                                   donation at the time that it is                                     cedures used to contact the Trans-
                                   requested.                                                          plant Center, to ensure receipt by the
                  7.02 The Registry must have a written policy                                         Transplant Center, procedures to
                          regarding the process to be followed upon a                                  avoid damage of the cells, and
                          request by a Transplant Center for a subse-                                  procedures to maintain anonymity
                          quent donation.                                                              of patient and donor.
                          7.02.1 This document might include the                  9.0   Follow-up of patient and donor
                                   specific details that should be                       9.01 The Registry must have policies and proce-
                                   provided      by    the   Transplant                       dures for the short-term follow-up and care of
                                   Center to document the need for a                          adult volunteer donors for conditions related to
                                   subsequent donation, identifica-                            the hematopoietic stem cell donation. Short
                                   tion of any medical review                                 term is defined as within the first year
                                   committee, and details regarding                           following donation.
                                   the time frame of the process                        9.02 The Registry must have policies for the long-
                                   and the planned conditioning regi-                         term follow-up and care of adult volunteer
                                   men.                                                       donors for conditions related to the hemato-
                          7.02.2 The policy should be available to the                        poietic stem cell donation. Long term is
                                   public.                                                    defined as the time period following the first
          8.0     Collection, processing and transport of hematopoie-                         year after donation and extending for at least
                  tic stem cells                                                              four years.
                  8.01 Collection of hematopoietic stem cells and any                   9.03 Donor health issues potentially affecting the
                          other collected cell products intended for                          health of a patient receiving a hematopoietic
                          therapeutic use must be performed at a                              stem cell donation from that donor must be
                          Collection Center that fulfills national and/or                      reported to the Transplant Center.
                          regional and/or international guidelines for                  9.04 Adverse events affecting donors undergoing
                          such a facility.                                                    harvest of hematopoietic stem cells and occur-
                  8.02 Autologous donor blood must be collected at a                          ring long term as a consequence of the donation
                          blood collection center that fulfills national                       must be defined and must be recorded.
                          and/or regional and/or international guidelines                     9.04.1 Reports of adverse events should be
                          for such a facility.                                                         submitted to the Registry involved

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                      in the transplantation if the event                      10.04.2 A Registry must have adequate ad-
                      might affect a subsequent donation.                               ministrative structures and financial
             9.04.2 Reports of adverse events should be                                 resources to guarantee the settlement
                      submitted to a WMDA sponsored                                     of all invoices in due course.
                      international centralized database of                    10.04.3 It is the responsibility of the request-
                      such events.                                                      ing Registry to collect funds from
       9.05 Cells or DNA from donor and recipient                                       any person or institution ultimately
             should be preserved for research purposes by                               covering these expenses.
             the Registry if approved by national legisla-               10.05 Legal liability
             tion in the countries of the patient and                          10.05.1 The Registry must assume responsi-
             donor.                                                                     bility and establish procedures for all
             9.05.1 Consent for preservation and re-                                    donor medical expenses including the
                      search use must be obtained from                                  pre-collection physical, the collection
                      individuals      providing    research                            procedure and all post-collection med-
                      material.                                                         ical expenses that are directly related
       9.06 The Registry should collect data on the                                     to the donation.
             status of the patient post transplant.                                     10.05.1.1 Registry should offer dis-
10.0   Financial and legal liabilities                                                               ability and death benefits
       10.01 Responsibilities                                                                        to all stem cell donors.
             10.01.1 The Registry must keep complete and                                             These benefits might be
                      correct accounts for all services pro-                                         provided through insur-
                      vided and requested according to                                               ance coverage.
                      national laws and regulations as well                    10.05.2 The Registry should maintain liabi-
                      as international standards.                                       lity insurance.
             10.01.2 The Registry must have sufficient
                      staff dedicated to perform all
                      accounting duties.
       10.02 Fee structure                                     Conclusions
             10.02.1 The overall charges of HLA testing,
                      infectious disease marker testing,       These standards set forth only the minimum guidelines
                      harvest and other related services       for registries working through the WMDA to facilitate
                      should be readily available on a fee     hematopoietic stem cell transplants. The standards do
                      schedule.                                not set forth all that may be required of the registry to
             10.02.2 Any cost not standardized or, for         conform to country or state or regional laws or regulations
                      any reason, not accessible through       or the standard here prevailing in the relevant community.
                      such a schedule (eg courier charges)     Each registry must determine and follow any additional
                      should be communicated in advance        laws, regulations, practices, and procedures that apply in
                      to the requesting Registry and/or the    their particular community. The WMDA disclaims all
                      Transplant Center.                       representations or warranties, expressed or implied, that
             10.02.3 If the harvest procedure is cancelled     compliance with the WMDA standards will fulfill the
                      after the final donor selection, the      requirements of all applicable country or local laws and
                      Collection Center and/or Donor           regulations or the standard of care prevailing in the
                      Center and/or Registry are entitled      relevant community.
                      to charge for services performed            These standards have been developed through discus-
                      prior to notice of cancellation.         sions with WMDA members and were based on a
       10.03 Billing                                           special report by Goldman in 1994.6 They have been
             10.03.1 The Registry providing a donor or         reviewed and approved by WMDA member registries.
                      any other service should bill to and     During the accreditation process, the WMDA will not
                      request payment from the Registry        visit a site but will instead review documentation sub-
                      requesting the donor or service.         mitted by the Registry. The entire accreditation
             10.03.2 Billing should occur within 60 days       procedure is described in a document on the WMDA
                      after the service has been completed.    web site (www.worldmarrow.org). The organization
       10.04 Payment                                           began accrediting registries in the fall of 2003 and registries
             10.04.1 A Registry requesting a service for a     that have been accredited will be listed on the WMDA
                      patient or forwarding such a request     web site.
                      from a Transplant Center guaran-            Together, the world’s hematopoietic stem cell registries
                      tees the payment of such service if      and cord blood banks include over 8 million volunteer
                      completed properly provided the          donors (http://bmdw.org). The increased demand for
                      search for the patient is still active   higher resolution HLA matched donors to optimize
                      or within 30 days after search           transplant outcome7,8 and the ability of registries to work
                      inactivation.                            together productively2 have resulted in over 1900 interna-

                                                                                                               Bone Marrow Transplantation
                                                              Registry standards
                                                         CK Hurley and C Raffoux
110
          tional donations in 2002. The WMDA standards and                             guidelines for hematopoietic stem cell transplantation using
          registry accreditation process will enhance the quality of the               volunteer donors. Hum Immunol 1999; 60: 347–360.
          management of international searches and donations for                   4   Cleaver SA, Warren P, Kern M et al. A special report: donor
          those patients in need of unrelated donors.                                  work-up and transport of bone marrow – recommendations and
                                                                                       requirements for a standardized practice throughout the world.
                                                                                       Bone Marrow Transplant 1997; 20: 621–629.
                                                                                   5   Rosenmayr A, Hartwell L, Egeland T. Informed consent –
          Acknowledgements                                                             suggested procedures for informed consent for unrelated
                                                                                       haematopoietic stem cell donors at various stages of recruit-
          We thank the WMDA members for their contributions to the                     ment, donor evaluation, and donor workup. Bone Marrow
          standards and the WMDA Board for review of this manuscript.                  Transplant 2003; 31: 539–545.
                                                                                   6   Goldman JM. A special report: bone marrow transplants using
                                                                                       volunteer donors – recommendations and requirements for a
          References                                                                   standardized practice throughout the world – 1994 update.
                                                                                       Blood 1994; 84: 2833–2839.
          1 Marry E, Oudshoorn M (eds). World Marrow Donor Associa-                7   Morishima Y, Sasazuki T, Inoki H et al. The clinical
            tion. Donor Registries Annual Report 2001, 5th edn, 2002                   significance of human leukocyte antigen (HLA) allele compat-
            WMDA: Minneapolis, USA.                                                    ibility in patients receiving a marrow transplant from serologi-
          2 Gahrton G. Goals and activities of the WMDA, World                         cally HLA-A, HLA-B, and HLA-DR matched unrelated
            Marrow Donor Association. Int J Hematol 2002; 76 (Suppl. 1):               donors. Blood 2002; 99: 4200–4206.
            384–385.                                                               8   Petersdorf EW, Anasetti C, Martin PJ, Hansen JA. Tissue
          3 Hurley CK, Wade JA, Oudshoorn M et al. Quality Assurance                   typing in support of unrelated hematopoietic cell transplanta-
            Donor Registries. A special report: histocompatibility testing             tion. Tissue Antigens 2003; 61: 1–11.




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