You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 22 Next »

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:

  1. Just started
  2. In progress
  3. In review
  4. Closed

Start date:2018End date:

 


Project progress:

Date

Description Action Task

August 21
  • Survey ontwikkelen om te checken of regulatory information compleet is (naar EU registries)
  • Paulien afspreken of ze online questionnaire tool wil uitleggen


Project outcome:

Date

Product





CURRENT QUESTIONNAIRE


General information


organisation nameAustralian Bone Marrow Donor Registry
ION of the organisationION-7748
Products
This organisation provides HPC, MarrowYes
This organisation provides HPC, ApheresisYes
This organisation provides HPC, Cord BloodYes
This organisation provides MNC, ApheresisYes
This organisation provides NC, Whole BloodYes
This organisation provides Other productsNo
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 CentresYes
This organisation has affiliated Collection CentresYes
This organisation has affiliated Cord Blood BanksYes
This organisation has affiliated Transplant CentresYes
This organisation has affiliated IDM Testing LaboratoriesYes
This organisation has affiliated HLA/other DNA markers Testing LaboratoriesYes
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:
Organisation ION:
Country:
Year the registry started operations:
Products
This organisation provides HPC, Marrow:YES / NO
This organisation provides HPC, Apheresis:YES / NO
This organisation provides HPC, Cord Blood:YES / NO
This organisation provides MNC, Apheresis:YES / NO
This organisation provides NC, Whole Blood:YES / NO
This organisation provides other products:YES / NO
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: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: SPECIFY WHICH ONE?YES / NO

The registry is accredited by any other organisation:

If yes, which organisation?

YES / NO


Affiliated centre information
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:

The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:

If yes, please specify these requirements:

YES / NO



Donor policy
All donors are unpaid volunteers:YES / NO
All donors are informed about donation process and associated risks:YES / NO
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registy staff:YES / NO
The registry has systems in place to protect and control access to donor/patient records:YES / NO
The registry maintains donor anonymity:YES / NO
The registry has detailed donor evaluation and exclusion criteria in place:YES / NO
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines:YES / NO
IDM Testing at donor workup (please fill in Yes, On Request, No, Test method)YESOn requestNOTest method

Timeframe before stem cell donation date (for donors) or

Timeframe when the materials sample is taken for testing (for cords)

ALT/AST:

  •  
  •  
  •  


Chagas:
  •  
  •  
  •  


CMV IgG:
  •  
  •  
  •  


CMV IgM:
  •  
  •  
  •  


CMV Total:
  •  
  •  
  •  


EBV IgG:
  •  
  •  
  •  


EBV IgM:
  •  
  •  
  •  


HAV (NAT):

  •  
  •  
  •  


HBV (NAT):
  •  
  •  
  •  


HBc Ab:
  •  
  •  
  •  


HBs Ag: 
  •  
  •  
  •  


HCV (NAT):
  •  
  •  
  •  


HCV Ab:
  •  
  •  
  •  


HEV (NAT):
  •  
  •  
  •  


HIV (NAT):
  •  
  •  
  •  


HIV-1 Ab:
  •  
  •  
  •  


HIV-2 Ab:
  •  
  •  
  •  


HIV p24:
  •  
  •  
  •  


HTLV-I: 
  •  
  •  
  •  


HTLV-II:
  •  
  •  
  •  


Malaria:
  •  
  •  
  •  


HSV:
  •  
  •  
  •  


STS:
  •  
  •  
  •  


STS FTA-ABS:
  •  
  •  
  •  


Toxoplasmosis:

  •  
  •  
  •  


VZV:
  •  
  •  
  •  


WNV-NAT:
  •  
  •  
  •  


Other tests performed:
  •  
  •  
  •  



Testing

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

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:


Additional comments
Mandatory National Reporting SchemeYES / NO

Voluntary National Reporting Scheme

YES / NO

WMDA SEAR/SPEAR Reporting Scheme:

YES / NO
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 / NO
Retention policy
Donor records relating to the medical and HPC collection process are retained for: 


  • No labels