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General information | ||
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Organisation name | Australian Bone Marrow Donor Registry | |
ION of the organisation | ION-7748 | |
Country | ||
Year the registry started operations | ||
Products | ||
This organisation provides HPC, Marrow | Yes | |
This organisation provides HPC, Apheresis | Yes | |
This organisation provides HPC, Cord Blood | Yes | |
This organisation provides MNC, Apheresis | Yes | |
This organisation provides NC, Whole Blood | Yes | |
This organisation provides Other products | No | |
Please specify, other products provided: | ||
Number of domestic national HPC products provided in 2017: | 303 | |
Number of HPC products exported internationally in 2017: | 128 | |
Licences and accreditations | ||
Organisation is licensed/accredited by a National Regulatory body | YES/NO | |
Name of Competent Authority/ National Regulatory body Authority: | N/A | |
Date of last inspection: | N/A | |
Link to website of competent authority/national regulatory body: | ||
Legal documentation from the national government that your organisation is allowed to operate as a registry can be provided: | Not applicable | |
Is the registry WMDA Qualified or WMDA Accredited? | No/WMDA Qualified/WMDA Accredited | |
Is the registry accredited by any other organisation? | YES/NO | |
Is your registry or cord blood bank an approved NMDP IND supplier? | ||
No- Not reported externally | ||
Affiliated centre information | ||
How many affiliated donor centres does the registry work with? | Yes | |
How many affiliated collection centres does the registry work with? | Yes | |
How many affiliated cord blood banks does the registry work with? | Yes | |
How many affiliated transplant centres does the registry work with? | Yes | |
How many affiliated IDM Testing Laboratories does the registry work with? | Yes | |
How many affiliated HLA/other DNA markers testing laboratories does the registry work with? | Yes | |
Yes: See location below | ||
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 | |
Yes | ||
Are the Cord Blood Banks FACT-NetCord accredited? If yes, which one? | ||
Are the collection centres FACT-JACIE accredited? | ||
Is the Registry able to provide a copy of all the certificates? | ||
Affiliated centres comply with WMDA Standards and applicable national regulations: | Yes | |
We have requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: | Yes | |
YesIf yes, please specify these requirements: | ||
How often does the registry audit affiliated centres? | Yearly, with an onsite inspection every 2 years | |
Donor policy | ||
Are all donors unpaid volunteers? | Yes | |
Are all donors informed about donation process and associated risks? | Yes | |
Do donors sign a valid informed consent to donate in the presence of a medical practitioner? | Yes | |
Does your registry have systems in place to protect and control access to donor/patient records: | Yes | |
Does the registry maintain donor anonymity? | Yes | |
Does the registry have detailed donor evaluation and exclusion criteria in place? | Yes | |
Does the registry have donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines? | Yes | |
IDM Testing at donor workup (please fill in Yes, On Request, No) | ||
CMV IgG is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgG | Yes | |
CMV IgM is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgM | On Request | |
CMV Total is tested at donor workup: | Yes | |
EBV IgG is tested at donor workup: Epstein-Barr Virus Antibody testing IgG | On Request | |
EBV IgM is tested at donor workup: Epstein-Barr Virus Antibody testing IgM | On Request | |
HBV (NAT) is tested at donor workup: Hepatitis B nucleic acid testing | Yes | |
HBc Ab is tested at donor workup: Hepatitis B core antibody testing | Yes | |
HBs Ag is tested at donor workup: Hepatitis B Surface antigen testing | Yes | |
HCV (NAT) is tested at donor workup: Hepatitis C nucleic acid testing | Yes | |
HCV Ab is tested at donor workup: Hepatitis C antibody testing | Yes | |
HIV–1 Ab is tested at donor workup: Human Immunodeficiency Virus HIV-1 antibody testing | Yes | |
HIV–2 Ab is tested at donor workup: Human Immunodeficiency Virus HIV-2 antibody testing | Yes | |
HIV (NAT) is tested at donor workup: Human Immunodeficiency Virus nucleic acid testing | Yes | |
HIV p24 Ag is tested at donor workup: Human Immunodeficiency Virus p24 antigen testing | Yes | |
HTLV-I is tested at donor workup: Human T-Lymphotropic Virus type I testing | Yes | |
HTLV-II is tested at donor workup: Human T-Lymphotropic Virus type II testing | Yes | |
STS (Serological) is tested at donor workup: Serological tests for syphilis | Yes | |
STS FTA-ABS (verification test) is tested at donor workup: Serological test for syphilis | On Request | |
WNV-NAT is tested at donor workup: West Nile Virus nucleic acid testing | No | |
Other tests performed: | Malaria (If required) | |
Testing | ||
Full donor screening for infectious disease risk is performed at the following stage: | Verification Typing | |
Physical exam and relevant donor testing is performed at the following stage: | Workup | |
Infectious disease testing is performed at the following stage: | Verification Typing | |
A sample for additional donor testing can be provided upon request: | Yes | |
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a national regulatory agency: | Yes | |
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 | |
HLA typing for patient specific request is performed in an appropriately accredited laboratory: | Yes | |
Sterility testing is performed on the adult donor product: | Yes | |
Reporting of Serious Adverse Events | ||
Mandatory National Reporting Scheme | ||
Voluntary National Reporting Scheme | ||
WMDA SEAR/SPEAR Reporting Scheme | ||
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? | ||
Retention policy | ||
Donor records relating to the medical and HPC collection process are retained for: | At least 35 Years |
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