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Organisation name: Australian Bone Marrow Donor Registry Organisation ION: ION-7748 Country: Australia Year the registry started operations: 1991
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:
6 HPC, Apheresis:
14 HPC, Cord:
Organisation is licensed/accredited by the Competent Authority: yes Comment: Name of Competent Authority: The Australian Charities and Not-for-profits Commission Date of last inspection: N/A Link to website of Competent Authority: https://www.acnc.gov.au/charity/aa0bd7d2f2f85f8717705efc45587ce9 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 Accredited 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 The registry audits its donor centres: Yes The registry works with the following numer of affiliated collection centres: 12 Ther registry audits its collection centres: Paper audit only The registry works with the following number of affiliated Cord Blood Banks: 3 The registry audits its Cord Blood Banks: Yes The registry works with the following number of affiliated transplant centres: 15 The registry audits its transplant centres: Paper audit only The registry works with the following number of affiliated IDM Testing Laboratories: 5 The registry audits its IDM Testing Laboratories: Paper audit only The registry works with the following number of affiliated HLA/other DNA markers testing laboratories: 6 The registry audits its HLA/other DNA markers testing laboratories: Paper audit only 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: yes If yes, the following Cord Blood Bank(s) are accredited: Sydney CBB, Queensland CBB, BMDI CBB Melbourne The registry is able to provide a copy of all the certificates: yes 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: yes
Days between test
ALT/ASTALT/AST ratio, De-Ritis-Quotient
No ChagasChagas, T. cruzi
No CMV IgGCytomegalovirus (CMV) Antibody testing IgG
Yes Combined/total IgG/IgM 5 working days CMV IgMCytomegalovirus (CMV) Antibody testing IgM
Yes Combined/total IgG/IgM 5 working days CMV TotalCytomegalovirus Total
Yes Combined/total IgG/IgM 5 working days EBV IgGEpstein-Barr Virus Antibody testing IgG
On request Combined/total IgG/IgM 5 working days EBV IgMEpstein-Barr Virus Antibody testing IgM
On request Combined/total IgG/IgM 5 working days 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 4th Gen serology HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing
Yes 4th Gen serology HIV p24Human Immunodeficiency Virus p24 antigen testing
Yes 4th Gen serology HTLV-IHuman T-Lymphotropic Virus type I testing
Yes Anti HTLV serology only HTLV-IIHuman T-Lymphotropic Virus type II testing
Yes Anti HTLV serology only MalariaMalaria
Yes Antibodies only HSVHerpes Simplex Virus
On request Anti HSV serology only STSSerological tests for syphilis
Yes Treponemal STS FTA-ABSSerological test for syphilis
On request Serological antibody VZVVaricella Zoster Virus
On request Serological antibody WNV-NATWest Nile Virus nucleic acid testing
No 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: Yes Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify: Yes Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify: Yes Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify: Yes
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 yes - Voluntary National Reporting Scheme no - 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: yes Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained: 99 years
The party providing the cell product must exclude donors when: