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IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient Yes< 30 days
ChagasChagas, T. cruzi On request< 30 days
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yes< 30 days
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yes< 30 days
CMV TotalCytomegalovirus Total On request< 30 days
EBV IgGEpstein-Barr Virus Antibody testing IgG Yes< 30 days
EBV IgMEpstein-Barr Virus Antibody testing IgM Yes< 30 days
HAV (NAT)Anti-hepatitis A virus nucleic acid testing On request< 30 days
HBV (NAT)Hepatitis B nucleic acid testing Yes< 30 days
HBc AbHepatitis B core antibody testing Yes< 30 days
HBs AgHepatitis B Surface antigen testing Yes< 30 days
HCV (NAT)Hepatitis C nucleic acid testing Yes< 30 days
HCV AbHepatitis C antibody testing Yes< 30 days
HEV (NAT)Hepatitis E Virus nucleic acid testing On request< 30 days
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yes< 30 days
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yes< 30 days
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yes< 30 days
HIV p24Human Immunodeficiency Virus p24 antigen testing Yes< 30 days
HTLV-IHuman T-Lymphotropic Virus type I testing Yes< 30 days
HTLV-IIHuman T-Lymphotropic Virus type II testing Yes< 30 days
MalariaMalaria On request< 30 days
HSVHerpes Simplex Virus On request< 30 days
STSSerological tests for syphilis Yes< 30 days
STS FTA-ABSSerological test for syphilis On request< 30 days
ToxoplasmosisToxoplasmosis Yes< 30 days
VZVVaricella Zoster Virus On request< 30 days
WNV-NATWest Nile Virus nucleic acid testing On request< 30 days
Other tests performed On request< 30 days

Testing

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: yes
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 :
 Click to show the exclusion criteria...

The party providing the cell product must exclude donors when:

  • They are pregnant;
  • They are breastfeeding;
  • There is the potential for transmission of inherited conditions;
  • There is evidence of any other risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration Donor travel and exposure history and local infectious disease prevalence;
  • There is presence on the donor’s body of physical signs implying a risk of transmissible disease(s);
  • There is a history of a disease of unknown aetiology;
  • There is a risk of transmission of diseases caused by prions;
  • There is systemic infection which is not controlled at the time of donation, including bacterial diseases, systemic viral, fungal or parasitic infections, or significant local infection in the tissues and cells to be donated;
  • There is history of chronic, systemic autoimmune disease that could have a detrimental effect on the quality of the Cell Product;
  • There is recent history of vaccination with a live attenuated virus where a risk of transmission is considered to exist;
  • There is ingestion of, or exposure to, a substance (such as cyanide, lead, mercury, gold) that may be transmitted to recipients in a dose that could endanger their health.
yes

Customs regulations

Are there any customs regulations to follow, or customs paperwork required, to import cell products into the organisation country? If yes, please specify:Yes, National Regulations
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:Yes, National Regulations
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:Yes, National Regulations
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:Yes, National Regulations

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:
- Mandatory National Reporting Scheme yes
- Voluntary National Reporting Schemeno
- 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

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:on a permanent basis

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