⚠Due to planned maintenance you will experience short (<30 min) downtime between 08:00 - 08:30 CET.
Testing | |
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The physical and medical exam at donor workup is performed by a medical doctor: | yes |
All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority: | 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 |
Sterility testing is performed on the cord blood product: | no |
Screening questionnaire to exclude communicable disease: | yes |
Screening questionnaire to exclude donors with 'high risk' lifestyles: | yes |
Donor reliability identified by a medical doctor: | yes |
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 |
Customs regulations | |
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Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify: | |
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify: | |
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify: | |
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify: |
Reporting of Serious Adverse Events | |
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Please indicate which of the following schemes for reporting Serious Adverse Events relating to either the Donor or the product the Registry participates in: | |
- Mandatory National Reporting Scheme | |
- Voluntary National Reporting Scheme | |
- WMDA SEAR/SPEAR Reporting Scheme | yes |
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 |
Quality management | |
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The registry does maintain Standard Operating Procedures for your work: | yes |
The registry would be willing to provide these to WMDA or another registry upon request: | yes |
The registry would be willing to provide WMDA or another registry, on request, with copies of any packaging the HPC product will arrive in: | yes |
Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained: | 30 years |