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Testing

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


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

Customs regulations


Comments

Are there any customs regulations to follow, or customs paperwork required, to import cell products to your country? If yes, please specify:

YES / NO

Are there any customs regulations to follow, or customs paperwork required, to export cell products from your country? If yes, please specify:

YES / NO

Are there any import regulations to follow, or paperwork required, to import cell products to your country? If yes, please specify:

YES / NO

Are there any export regulations to follow, or paperwork required, to export cell products from your country? If yes, please specify:

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:


Comments
Mandatory National Reporting SchemeYES / NO

Voluntary National Reporting Scheme

YES / NO

WMDA SEAR/SPEAR Reporting Scheme:

YES / NO
Will 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?YES / NO

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