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Organisation name: Austrian Bone Marrow Donor Registry Organisation ION: ION-2614 Country: Austria Year the registry started operations: 1989
comment Do you provide HPC, Marrow?
Do you provide HPC, Apheresis?
Do you provide HPC, Cord Blood?
Do you provide MNC, Apheresis?
Do you provide NC, Whole Blood?
Data valid for year 2021 Number of products National International HPC, Marrow products:
2 HPC, Apheresis:
37 HPC, Cord:
Organisation is licensed/accredited by the Competent Authority: yes Comment: The Registry is part of the Austrian National Public Health Institute / Gesundheit Oesterreich GmbH Name of Competent Authority: Date of last inspection: Link to website of Competent Authority: Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ? yes Is your registry WMDA Certified, WMDA Qualified or WMDA Accredited? WMDA Qualified The registry is accredited by any other organisation: yes If yes, by which organisation? TÜV Austria (ISO 9001 certified)
The registry works with the following number of affiliated donor centres: 6 affiliated donor centres The registry audits its donor centres: Audits will take place every two years. The registry works with the following numer of affiliated collection centres: 4 collection centres Ther registry audits its collection centres: Collection centers will be inspected and licensed by the Federal Office for Safety in Healthcare - Austrian Agency for Health and Food Safety. Licensed tissue establishments will be listed on the EU platform: https://webgate.ec.europa.eu/eucoding/reports/te/index.xhtm The registry works with the following number of affiliated Cord Blood Banks: 1 cord blood bank The registry audits its Cord Blood Banks: no The registry works with the following number of affiliated transplant centres: 5 transplant centres The registry audits its transplant centres: Permit required by the local government The registry works with the following number of affiliated IDM Testing Laboratories: not applicable The registry audits its IDM Testing Laboratories: not applicable The registry works with the following number of affiliated HLA/other DNA markers testing laboratories: not applicable The registry audits its HLA/other DNA markers testing laboratories: not applicable The registry would be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request: yes The Cord Blood Banks are FACT-NetCord accredited: no If yes, the following Cord Blood Bank(s) are accredited: The registry is able to provide a copy of all the certificates: Affiliated centres comply with WMDA Standards and applicable national regulations: yes The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: no If yes, what are these requirements?
All donors are unpaid volunteers: yes All donors are informed about donation process and associated risks: yes Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff: yes The registry has systems in place to protect and control access to donor/patient records: yes The registry maintains donor anonymity: yes The registry has detailed donor evaluation and exclusion criteria in place: yes The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines: no
Days between test
ALT/ASTALT/AST ratio, De-Ritis-Quotient
- ChagasChagas, T. cruzi
No CMV IgGCytomegalovirus (CMV) Antibody testing IgG
Yes CMV IgMCytomegalovirus (CMV) Antibody testing IgM
Yes CMV TotalCytomegalovirus Total
No EBV IgGEpstein-Barr Virus Antibody testing IgG
Yes EBV IgMEpstein-Barr Virus Antibody testing IgM
Yes HAV (NAT)Anti-hepatitis A virus nucleic acid testing
No HBV (NAT)Hepatitis B nucleic acid testing
Yes HBc AbHepatitis B core antibody testing
Yes HBs AgHepatitis B Surface antigen testing
Yes HCV (NAT)Hepatitis C nucleic acid testing
Yes HCV AbHepatitis C antibody testing
Yes HEV (NAT)Hepatitis E Virus nucleic acid testing
No HIV (NAT)Human Immunodeficiency Virus nucleic acid testing
Yes HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing
Yes HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing
Yes HIV p24Human Immunodeficiency Virus p24 antigen testing
On request HTLV-IHuman T-Lymphotropic Virus type I testing
On request HTLV-IIHuman T-Lymphotropic Virus type II testing
On request MalariaMalaria
No HSVHerpes Simplex Virus
No STSSerological tests for syphilis
Yes STS FTA-ABSSerological test for syphilis
On request VZVVaricella Zoster Virus
No WNV-NATWest Nile Virus nucleic acid testing
Yes Other tests performed
The party providing the cell product must exclude donors when:
The physical and medical exam at donor workup is performed by a medical doctor: yes All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: yes HLA typing for patient specific request is performed in an appropriately accredited laboratory: yes Sterility testing is performed on the adult donor product: yes Sterility testing is performed on the cord blood product: yes Screening questionnaire to exclude communicable disease: yes Screening questionnaire to exclude donors with 'high risk' lifestyles: yes Donor reliability identified by a medical doctor: yes Donor clearance to donate is confirmed by a medical doctor, following as a minimum the donor exclusion criteria in Annex 1 of EU Directive 2006/17/EC :
Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify: Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify: Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify: Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:
Reporting of Serious Adverse Events
Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in: - Mandatory National Reporting Scheme - Voluntary National Reporting Scheme - WMDA SEAR/SPEAR Reporting Scheme yes The registry will notify the receiving Registry within 24 hours of receiving information relating to any serious adverse event that could be considered to affect the patient receiving the product: yes
The registry does maintain Standard Operating Procedures for your work: yes The registry would be willing to provide these to WMDA or another registry upon request: yes The registry would be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in: Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained: 30
The party providing the cell product must exclude donors when: