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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 2018 Number of products National International HPC, Marrow products:
2 HPC, Apheresis:
9 HPC, Cord:
Organisation is licensed/accredited by the Competent Authority: yes Comment: The Registry is part of Gesundheit Oesterreich GmbH which was established by Act of Parliament. Owner of Gesundheit Österreich GmbH is the Federal Government, represented by the Ministry of Health. 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: no If yes, by which organisation?
The registry works with the following number of affiliated donor centres: 5 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: 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: The registry audits its IDM Testing Laboratories: The registry works with the following number of affiliated HLA/other DNA markers testing laboratories: The registry audits its HLA/other DNA markers testing laboratories: 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: The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: 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:
Days between test
ALT/ASTALT/AST ratio, De-Ritis-Quotient
- ChagasChagas, T. cruzi
- 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
- 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
- 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
- HSVHerpes Simplex Virus
- STSSerological tests for syphilis
Yes STS FTA-ABSSerological test for syphilis
- VZVVaricella Zoster Virus
- WNV-NATWest Nile Virus nucleic acid testing
Yes Other tests performed
|The physical and medical exam at donor workup is performed by a medical doctor:|
|All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:|
|HLA typing for patient specific request is performed in an appropriately accredited laboratory:|
|Sterility testing is performed on the adult donor product:|
|Sterility testing is performed on the cord blood product:|
|Screening questionnaire to exclude communicable disease:|
|Screening questionnaire to exclude donors with 'high risk' lifestyles:|
|Donor reliability identified by a medical doctor:|
|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 :
Click to show the exclusion criteria...
The party providing the cell product must exclude donors when:
|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|
|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:|
|The registry does maintain Standard Operating Procedures for your work:|
|The registry would be willing to provide these to WMDA or another registry upon request:|
|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:|