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General information | |
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organisation name | Australian Bone Marrow Donor Registry |
ION of the organisation | ION-7748 |
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 |
Other Other products provided: | |
Number of adult donor products shipped in the last 3 years: | 431 |
Domestic shipments: | 303 |
International shipments: | 128 |
Licences and accreditations | |
organisation is licensed/accredited by a national regulatory body/accrediting agency: | Not applicable |
Name of Competent Authority/national regulatory body: | 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 |
Serious adverse events and reactions are reported and investigated: | No- Not reported externally |
Affiliated centres | |
This organisation has affiliated Donor Centres | Yes |
This organisation has affiliated Collection Centres | Yes |
This organisation has affiliated Cord Blood Banks | Yes |
This organisation has affiliated Transplant Centres | Yes |
This organisation has affiliated IDM Testing Laboratories | Yes |
This organisation has affiliated HLA/other DNA markers Testing Laboratories | Yes |
There is a full list of affiliated centres with their license / accreditation status available: | Yes: See location below |
The full list of affiliated centres list can be obtained: | https://share.wmda.info/display/WMDAREG/Documents+ION-7748 |
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 |
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 |
We audit affiliated centres for compliance with applicable standards, national regulations and your organisation’s requirements: | Yes |
If Yes, the frequency of audits is : | Yearly, with an onsite inspection every 2 years |
Donor policy | |
Volunteer donors are unpaid: | Yes |
Donors are informed about donation process and associated risks: | Yes |
Donors sign a valid informed consent to donate: | Yes |
We have systems in place to protect and control access to donor/patient records: | Yes |
Our organisation maintains donor anonymity: | Yes |
Detailed donor evaluation and exclusion criteria in place? | Yes |
Detailed donor evaluation and exclusion criteria meet the WMDA guidelines? | Yes |
IDM Testing | |
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 |
Retention policy | |
Donor records relating to the medical and HPC collection process are retained for: | At least 35 Years |
Collection procedure | |
Are procedures in place to minimize microbiological contamination during collection? | |
Are records kept of the critical reagents, equipment and personnel involved in collection? | |
Are instruments and devices sterile, validated or specifically certified and regularly maintained as appropriate? | |
PROPOSED QUESTIONNAIRE
Introduction
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Licences and accreditations | Comments | |
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Organisation Organisation is licensed/accredited by the Competent Authority: | YES / NO | |
Name of Competent Authority: | ||
Date of last inspection: | ||
Link to website of Competent Authority: | ||
Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry can be provided: | YES / NO | |
The registry is WMDA Qualified or WMDA Accredited: If yes, please specify: | YES / NO | |
The registry is accredited by any other organisation: If yes, please fill in the organisation: | YES / NO |
Affiliated Affiliated centre information | Comments | |
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How many affiliated donor centres does the registry work with? | ||
How often does the registry audit its donor centres? | ||
How many affiliated collection centres does the registry work with? | ||
How often does the registry audit its collection centres? | ||
How many affiliated cord blood banks does the registry work with? | ||
How often does the registry audit its cord blood banks? | ||
How many affiliated transplant centres does the registry work with? | ||
How often does the registry audit its transplant centres? | ||
How many affiliated IDM Testing Laboratories does the registry work with? | ||
How often does the registry audit its IDM Testing Laboratories? | ||
How many affiliated HLA/other DNA markers testing laboratories does the registry work with? | ||
How often does the registry audit 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: Tip: you can upload the full list here and make it available for the WMDA membership | YES / NO | |
The Cord Blood Banks are FACT-NetCord accredited: If yes, which cord blood bank(s)? | YES / NO | |
The registry is able to provide a copy of all the certificates: | YES / NO | |
Affiliated centres comply with WMDA Standards and applicable national regulations: | YES / NO | |
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: If yes, please specify these requirements: | YES / NO |
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Testing Please indicate whether the following are completed on the donor during the medical examination: | Comments | |
The physical and medical exam at donor work up is performed by a medical doctor: | YES / NO | |
All donor testing (at work up) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: | YES / NO | |
HLA typing for patient specific request is performed in an appropriately accredited laboratory: | YES / NO | |
Sterility testing is performed on the adult donor product: | YES / NO | |
Sterility testing is performed on the cord blood product: | YES / NO | |
Screening questionnaire to exclude communicable disease: | YES / NO | |
Screening questionnaire to exclude donors with 'high risk' lifestyles: | YES / NO | |
Donor reliability identified by a medical doctor: | YES / NO | |
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: The party providing the Cell Product must exclude Donors when:
| YES / NO |
Customs regulations | Comments | |
Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify: | YES / NO | |
Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify: | YES / NO | |
Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify: | YES / NO | |
Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify: | YES / NO |
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