Page History

...

Instructions for completion

General information
Organisation Organisation name:
Organisation ION:
Country:
Year the registry started operations:

Products		Comments
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 other products provided:
Number of national HPC products products provided in 2017:
Number of HPC products exported internationally in 2017:

Licences and accreditations		Comments
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 centre information	Comments
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

Donor policy
All donors are unpaid volunteers:	YES / NO
All

donors

donors are informed about donation process and associated risks:

YES / NO

Donors

Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry 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

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)	YES	On request	NO	Test 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:

...

Quality management		Comments
Do you the registry maintain Standard Operating Procedures (SOPs) for your work?	YES / NO
Would you the registry be willing to provide these to WMDA or another registry upon request?	YES / NO
Would you the registry be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in?	YES / NO
How many years are donor records retained relating to the medical exam and HPC collection process?

...