Project details:
Project group: | Deliverable D6.1 (2018) | ||
Project group chair: | Paulien | ||
Project group members: | |||
| Project office supporter: | Lydia | ||
| Project description: | Questionnaire to collect regulatory information from EU Member States, to be used in 2019 | ||
| Product: | Websites, patents filling, etc. | ||
| Project status: | |||
| Start date: | 2018 | End date: |
|
Project progress:
Date | Description Action Task |
|---|---|
| August 21 |
|
Project outcome:
Date | Product |
|---|---|
CURRENT QUESTIONNAIRE
General information | |
|---|---|
| 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 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 |
PROPOSED QUESTIONNAIRE
Introduction
The EU has a common set of standards to ensure the quality and safety of:
- organs for transplantation, and
- tissues and cells for human use, including reproductive cells
For EU registries to import cells into a EU Member State the EU Member States must be able to ensure that cells imported under their licences meet the quality and safety requirements set out in the EU tissues and cells Directive 2004/23/EC and its implementing Directives, including 2006/17/EC and 2006/86/EC.
Instructions for completion
General information | |
|---|---|
| Organisation name | |
| ION of the organisation | |
| Country | |
| Year the registry started operations | |
| Products | |
| This organisation provides HPC, Marrow | |
| This organisation provides HPC, Apheresis | |
| This organisation provides HPC, Cord Blood | |
| This organisation provides MNC, Apheresis | |
| This organisation provides NC, Whole Blood | |
| This organisation provides Other products | |
| Please specify, other products provided: | |
| Number of national HPC products provided in 2017: | |
| Number of HPC products exported internationally in 2017: | |
| Licences and accreditations | |
| Organisation is licensed/accredited by the Competent Authority: | |
| 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: | |
| Is the registry WMDA Qualified or WMDA Accredited? | |
| Is the registry accredited by any other organisation? | |
| Affiliated centre information | |
| How many affiliated donor centres does the registry work with? | |
| How many affiliated collection centres does the registry work with? | |
| How many affiliated cord blood banks does the registry work with? | |
| How many affiliated transplant centres does the registry work with? | |
| How many affiliated IDM Testing Laboratories does the registry work with? | |
| How many affiliated HLA/other DNA markers testing laboratories does the registry work with? | |
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 | |
| Are the Cord Blood Banks FACT-NetCord accredited? If yes, which cord blood bank(s)? | |
| 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: | |
| We have requirements for affiliated centres in addition to WMDA Standards and applicable national regulations: | |
| If yes, please specify these requirements: | |
| How often does the registry audit affiliated centres? SPLITSEN | |
| Donor policy | |
| Are all donors unpaid volunteers? | |
| Are all donors informed about donation process and associated risks? | |
| Do donors sign a valid informed consent to donate in the presence of a medical practitioner? | |
| Does your registry have systems in place to protect and control access to donor/patient records: | |
| Does the registry maintain donor anonymity? | |
| Does the registry have detailed donor evaluation and exclusion criteria in place? | |
| Does the registry have donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines? | |
| IDM Testing at donor workup (please fill in Yes, On Request, No) | |
ALT/AST is tested at donor workup: | |
| Chagas is tested at donor workup: IgM and IgG antibody testing against Trypanosoma cruzi | |
| CMV IgG is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgG | |
| CMV IgM is tested at donor workup: Cytomegalovirus (CMV) Antibody testing IgM | |
| CMV Total is tested at donor workup: | |
| EBV IgG is tested at donor workup: Epstein-Barr Virus Antibody testing IgG | |
| EBV IgM is tested at donor workup: Epstein-Barr Virus Antibody testing IgM | |
HAV (NAT) is tested at donor workup: | |
| HBV (NAT) is tested at donor workup: Hepatitis B nucleic acid testing | |
| HBc Ab is tested at donor workup: Hepatitis B core antibody testing | |
| HBs Ag is tested at donor workup: Hepatitis B Surface antigen testing | |
| HCV (NAT) is tested at donor workup: Hepatitis C nucleic acid testing | |
| HCV Ab is tested at donor workup: Hepatitis C antibody testing | |
| HEV (NAT) is tested at donor workup: Hepatitis E nucleic acid testing | |
| HIV (NAT) is tested at donor workup: Human Immunodeficiency Virus nucleic acid testing | |
| HIV p24 Ag is tested at donor workup: Human Immunodeficiency Virus p24 antigen testing | |
| HTLV-I is tested at donor workup: Human T-Lymphotropic Virus type I testing | |
| HTLV-II is tested at donor workup: Human T-Lymphotropic Virus type II testing | |
| Malaria is tested at donor workup: Testing against Plasmodium (P): P. malariae, P. falciparum, P. vivax, P. ovale and P. knowlesi | |
| HSV is tested at donor workup: Herpes Simplex Virus IgG type 1 and IgG type 2 testing | |
| STS (Serological) is tested at donor workup: Serological tests for syphilis | |
| STS FTA-ABS (verification test) is tested at donor workup: Serological test for syphilis | |
Toxoplasmosis is tested at donor workup: | |
| VZV is tested at donor workup: Varicella Zoster Virus (HHV-3 - Human Herpes Virus type 3) testing | |
| WNV-NAT is tested at donor workup: West Nile Virus nucleic acid testing | |
| Other tests performed: | |
| Testing | |
Is the physical and medical exam at donor work up performed by a medical practitioner? | |
| All donor testing (at work up) 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: | |
| 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: |