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Instructions for completion
General information | |
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Organisation Organisation name: | |
Organisation ION: | |
Country: | |
Year the registry started operations: |
Products | Comments | |
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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 | |
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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 | |
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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 |
Donor policy | |
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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/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 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) |
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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: |
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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? |
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