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General

The information has been reviewed in year :
Organisation name:DKMS
Organisation ION:ION-5525
Country:Deutschland
Year the registry started operations:1991

Products

comment
Do you provide HPC, Marrow? yes
Do you provide HPC, Apheresis? yes
Do you provide HPC, Cord Blood? no
Do you provide MNC, Apheresis? yes
Do you provide NC, Whole Blood? no

Product quantity

Data valid for year2019
Number of products NationalInternational
HPC, Marrow products: 160 771
HPC, Apheresis: 1211 3461
HPC, Cord:

License

Organisation is licensed/accredited by the Health Authority:
Comment:DKMS is a Donor Center
Name of Health Authority:
Date of last inspection:
Link to website of Health Authority:
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?
The registry is accredited by any other organisation: yes
If yes, by which organisation?ZKRD

Donor policy

All donors are unpaid volunteers: yes
All donors are informed about donation process and associated risks: yes
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff: yes
The registry has systems in place to protect and control access to donor/patient records: yes
The registry maintains donor anonymity: yes
The registry has detailed donor evaluation and exclusion criteria in place: yes
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines: yes

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient -
ChagasChagas, T. cruzi -
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yesmax. 30
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yesmax. 30
CMV TotalCytomegalovirus Total -
EBV IgGEpstein-Barr Virus Antibody testing IgG Yesmax. 30
EBV IgMEpstein-Barr Virus Antibody testing IgM Yesmax. 30
HAV (NAT)Anti-hepatitis A virus nucleic acid testing -
HBV (NAT)Hepatitis B nucleic acid testing Yesmax. 30
HBc AbHepatitis B core antibody testing Yesmax. 30
HBs AgHepatitis B Surface antigen testing Yesmax. 30
HCV (NAT)Hepatitis C nucleic acid testing Yesmax. 30
HCV AbHepatitis C antibody testing Yesmax. 30
HEV (NAT)Hepatitis E Virus nucleic acid testing Yesmax. 30
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yesmax. 30
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yesmax. 30
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yesmax. 30
HIV p24Human Immunodeficiency Virus p24 antigen testing On requestmax. 30
HTLV-IHuman T-Lymphotropic Virus type I testing Yesmax. 30
HTLV-IIHuman T-Lymphotropic Virus type II testing Yesmax. 30
MalariaMalaria No
HSVHerpes Simplex Virus No
STSSerological tests for syphilis Yesmax. 30
STS FTA-ABSSerological test for syphilis -
ToxoplasmosisToxoplasmosis On requestmax. 30
VZVVaricella Zoster Virus No
WNV-NATWest Nile Virus nucleic acid testing Yesdepending on season, travel history of the donor
Other tests performed -

Regulatory information section 2

Relevant documents will be uploaded by the organisation to the documents page.

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:
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 :

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 needed to import cell products into the country of the affiliated transplant centres? not applicable, only exporting
Are there any customs regulations to follow or customs paperwork required needed to export cell products from the country of the affiliated organisation?
Are there any import national regulations to follow or paperwork required needed to import the cell products into the country of the affiliated transplant centre? not applicable, only exporting
Are there any export regulations to follow or paperwork required needed to export cell products from the country of the affiliated organisation?

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
- Voluntary National Reporting Scheme
- WMDA SEAR/SPEAR Reporting Scheme
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:

Quality management

The organisation does maintain Standard Operating Procedures for its work:
Please indicate if your organisation/country has any specific requirements that should be communicated in advance to the requesting entity (e.g., financial sanctions, specific regulatory forms, etc.) :
Donor records relating to the medical exam and cell product collection process are the following number(s) of year(s) retained:

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