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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:

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Chagas:
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CMV IgG:
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CMV IgM:
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CMV Total:
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EBV IgG:
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EBV IgM:
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HAV (NAT):

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HBV (NAT):
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HBc Ab:
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HBs Ag: 
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HCV (NAT):
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HCV Ab:
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HEV (NAT):
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HIV (NAT):
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HIV-1 Ab:
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HIV-2 Ab:
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HIV p24:
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HTLV-I: 
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HTLV-II:
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Malaria:
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HSV:
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STS:
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STS FTA-ABS:
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Toxoplasmosis:

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VZV:
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WNV-NAT:
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Other tests performed:
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Testing

Please indicate whether the following are completed on the donor during the medical examination:


Additional 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: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

Quality management


Additional comments
Do you maintain Standard Operating Procedures (SOPs) for your work?YES / NO

Would you be willing to provide these to WMDA or another registry upon request?

YES / NO
Retention policy

Would you 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
Donor records
relating to the medical exam and HPC collection
process are retained for: 
process?