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Instructions for completion
General information |
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| Organisation name |
Australian Bone Marrow Donor Registry | ION-7748 |
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| Country |
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| Year the registry started operations |
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| Products |
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| This organisation provides HPC, Marrow |
Yes |
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| This organisation provides HPC, Apheresis |
Yes |
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| This organisation provides HPC, Cord Blood |
Yes |
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| This organisation provides MNC, Apheresis |
Yes |
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| This organisation provides NC, Whole Blood |
Yes |
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| This organisation provides Other products |
No |
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| Please specify, other products provided: |
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Number of adult donor products shipped in the last 3 years: |
431 |
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| Number of national HPC products provided in 2017: |
303 |
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| Number of HPC products exported internationally in 2017: |
128 |
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| Licences and accreditations |
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| Organisation is licensed/accredited by a National Regulatory Authority: |
YES/NO |
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| Name of Competent National Regulatory Authority: |
N/AN/A |
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| Link to website of competent authority/national regulatory body: |
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Legal documentation from the national government
that your organisation is allowed to operate as a registry can be provided: |
Not applicable |
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| Is the registry WMDA Qualified or WMDA Accredited? |
No/WMDA Qualified/WMDA Accredited |
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| Is the registry accredited by any other organisation? |
YES/NO |
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| Is your registry or cord blood bank an approved NMDP IND supplier? |
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Serious adverse events and reactions are reported and investigated: |
No- Not reported externally |
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| Affiliated centre information |
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| How many affiliated donor centres does the registry work with? |
Yes |
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| How many affiliated collection centres does the registry work with? |
Yes |
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| How many affiliated cord blood banks does the registry work with? |
Yes |
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| How many affiliated transplant centres does the registry work with? |
Yes |
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| How many affiliated IDM Testing Laboratories does the registry work with? |
Yes |
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| How many affiliated HLA/other DNA markers testing laboratories does the registry work with? |
Yes |
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There is a full list of affiliated centres with their license / accreditation status available: |
Yes: See location below |
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Would the registry be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request?: Tip: you can upload the full list here and make it available for the WMDA membership |
https://share.wmda.info/display/WMDAREG/Documents+ION-7748 |
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Affiliated centres are required to be licensed by a national
regulatory body and/or have an internationally recognised accreditation (e.g. European Federation of Immunogentics (EFI), NetCord-FACT, JACIE) |
Yes |
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| Are the Cord Blood Banks FACT-NetCord accredited? If yes, which one? |
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| Are the collection centres FACT-JACIE accredited? |
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| Is the Registry able to provide a copy of all the certificates? |
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| Affiliated centres comply with WMDA Standards and applicable national regulations: |
Yes |
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We have requirements for affiliated centres in addition to
WMDA Standards and applicable national regulations: |
Yes |
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| If yes, please specify these requirements: |
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| How often does the registry audit affiliated centres? |
Yearly, with an onsite inspection every 2 years |
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| Donor policy |
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Are all donors unpaid volunteers? Volunteer donors are unpaid: |
Yes |
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| Are all donors informed about donation process and associated risks? |
Yes |
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| Do donors sign a valid informed consent to donate in the presence of a medical practitioner? |
Yes |
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| Does your registry have systems in place to protect and control access to donor/patient records: |
Yes |
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| Does the registry maintain donor anonymity? |
Yes |
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| Does the registry have detailed donor evaluation and exclusion criteria in place? |
Yes |
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| Does the registry have donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines? |
Yes |
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| IDM Testing at donor workup (please fill in Yes, On Request, No) |
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ALT/AST is tested at donor workup:
Alanine aminotransferease (ALT) and aspartate aminotransferase (AST) Enzyme testing |
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Chagas is tested at donor workup:
IgM and IgG antibody testing against Trypanosoma cruzi |
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CMV IgG is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgG |
Yes |
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CMV IgM is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgM |
On Request |
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| CMV Total is tested at donor workup: |
Yes |
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EBV IgG is tested at donor workup:
Epstein-Barr Virus Antibody testing IgG |
On Request |
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EBV IgM is tested at donor workup:
Epstein-Barr Virus Antibody testing IgM |
On Request |
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HAV (NAT) is tested at donor workup:
Hepatitis A nucleic acid testing |
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HBV (NAT) is tested at donor workup:
Hepatitis B nucleic acid testing |
Yes |
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HBc Ab is tested at donor workup:
Hepatitis B core antibody testing |
Yes |
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HBs Ag is tested at donor workup:
Hepatitis B Surface antigen testing |
Yes |
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HCV (NAT) is tested at donor workup:
Hepatitis C nucleic acid testing |
Yes |
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HCV Ab is tested at donor workup:
Hepatitis C antibody testing |
Yes |
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HEV (NAT) is tested at donor workup:
Hepatitis E nucleic acid testing |
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HIV (NAT) is tested at donor workup:
Human Immunodeficiency Virus nucleic acid testing |
Yes |
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HIV p24 Ag is tested at donor workup:
Human Immunodeficiency Virus p24 antigen testing |
Yes |
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HTLV-I is tested at donor workup:
Human T-Lymphotropic Virus type I testing |
Yes |
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HTLV-II is tested at donor workup:
Human T-Lymphotropic Virus type II testing |
Yes |
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Malaria is tested at donor workup:
Testing against Plasmodium (P): P. malariae, P. falciparum, P. vivax, P. ovale and P. knowlesi |
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HSV is tested at donor workup:
Herpes Simplex Virus IgG type 1 and IgG type 2 testing |
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STS (Serological) is tested at donor workup:
Serological tests for syphilis |
Yes |
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STS FTA-ABS (verification test) is tested at donor workup:
Serological test for syphilis |
On Request |
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Toxoplasmosis is tested at donor workup:
IgM and IgG antibody testing against Toxoplasma gondii |
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VZV is tested at donor workup:
Varicella Zoster Virus (HHV-3 - Human Herpes Virus type 3) testing |
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WNV-NAT is tested at donor workup:
West Nile Virus nucleic acid testing |
NoMalaria (If required) |
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| Testing |
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| Full donor screening for infectious disease risk is performed at the following stage: |
Verification Typing |
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| Physical exam and relevant donor testing is performed at the following stage: |
Workup |
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| Infectious disease testing is performed at the following stage: |
Verification Typing |
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| A sample for additional donor testing can be provided upon request: |
Yes |
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All donor testing (at work up) for infectious disease is performed
in a laboratory certified/licensed by a national regulatory agency: |
Yes |
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The kits used for donor testing (at work up) for infectious disease are licensed/approved
for use on donors by the national regulatory agency? |
Yes |
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| HLA typing for patient specific request is performed in an appropriately accredited laboratory: |
Yes |
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| Sterility testing is performed on the adult donor product: |
Yes |
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| Reporting of Serious Adverse Events |
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| Mandatory National Reporting Scheme |
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| Voluntary National Reporting Scheme |
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| WMDA SEAR/SPEAR Reporting Scheme |
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| Wil the Registry 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? |
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| Retention policy |
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Donor records relating to the medical and HPC collection process
are retained for: |
At least 35 Years
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