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General

The information has been reviewed in year :
Organisation name:DKMS gemeinnützige GmbH
Organisation ION:ION-4596
Country:Germany
Year the registry started operations:2014

Products

comment
Do you provide HPC, Marrow? yes Only ION-1574
Do you provide HPC, Apheresis? yes Both ION-1574 and ION-9935
Do you provide HPC, Cord Blood? no
Do you provide MNC, Apheresis? yes Both ION-1574 and ION-9935
Do you provide NC, Whole Blood? no

Product quantity

Data valid for year 2018
Number of products NationalInternational
HPC, Marrow products: 7 3
HPC, Apheresis: 4 7
HPC, Cord: 0 0

License

Organisation is licensed/accredited by the Competent Authority:no
Comment:
Name of Competent Authority:
Date of last inspection:
Link to website of Competent Authority:
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?
Is your registry WMDA Certified, WMDA Qualified or WMDA Accredited?Not WMDA Qualified/Accredited
The registry is accredited by any other organisation:no
If yes, by which organisation?

Affiliation

The registry works with the following number of affiliated donor centres:2
The registry audits its donor centres:Yes
The registry works with the following numer of affiliated collection centres:See ION-1574 and ION-9935
Ther registry audits its collection centres:See ION-1574 and ION-9935
The registry works with the following number of affiliated Cord Blood Banks:not applicable
The registry audits its Cord Blood Banks:not applicable
The registry works with the following number of affiliated transplant centres:> 50
The registry audits its transplant centres:Paper based evaluation according to WMDA criteria.
The registry works with the following number of affiliated IDM Testing Laboratories:See ION-1574 and ION-9935
The registry audits its IDM Testing Laboratories:See ION-1574 and ION-9935
The registry works with the following number of affiliated HLA/other DNA markers testing laboratories:1
The registry audits its HLA/other DNA markers testing laboratories:HLA laboratory is accredited by EFI and ASHI.
The registry would be able to provide a full list of name/addresses of each affiliated and their licence/accreditation status, on request: yes
The Cord Blood Banks are FACT-NetCord accredited:
If yes, the following Cord Blood Bank(s) are accredited:
The registry is able to provide a copy of all the certificates: yes
Affiliated centres comply with WMDA Standards and applicable national regulations: yes
The registry has requirements for affiliated centres in addition to WMDA Standards and applicable national regulations:no
If yes, what are these requirements?

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 -See ION-1574 and ION-9935See ION-1574 and ION-9935
ChagasChagas, T. cruzi -See ION-1574 and ION-9935See ION-1574 and ION-9935
CMV IgGCytomegalovirus (CMV) Antibody testing IgG -See ION-1574 and ION-9935See ION-1574 and ION-9935
CMV IgMCytomegalovirus (CMV) Antibody testing IgM -See ION-1574 and ION-9935See ION-1574 and ION-9935
CMV TotalCytomegalovirus Total -See ION-1574 and ION-9935See ION-1574 and ION-9935
EBV IgGEpstein-Barr Virus Antibody testing IgG -See ION-1574 and ION-9935See ION-1574 and ION-9935
EBV IgMEpstein-Barr Virus Antibody testing IgM -See ION-1574 and ION-9935See ION-1574 and ION-9935
HAV (NAT)Anti-hepatitis A virus nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HBV (NAT)Hepatitis B nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HBc AbHepatitis B core antibody testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HBs AgHepatitis B Surface antigen testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HCV (NAT)Hepatitis C nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HCV AbHepatitis C antibody testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HEV (NAT)Hepatitis E Virus nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HIV p24Human Immunodeficiency Virus p24 antigen testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HTLV-IHuman T-Lymphotropic Virus type I testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
HTLV-IIHuman T-Lymphotropic Virus type II testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
MalariaMalaria -See ION-1574 and ION-9935See ION-1574 and ION-9935
HSVHerpes Simplex Virus -See ION-1574 and ION-9935See ION-1574 and ION-9935
STSSerological tests for syphilis -See ION-1574 and ION-9935See ION-1574 and ION-9935
STS FTA-ABSSerological test for syphilis -See ION-1574 and ION-9935See ION-1574 and ION-9935
ToxoplasmosisToxoplasmosis -See ION-1574 and ION-9935See ION-1574 and ION-9935
VZVVaricella Zoster Virus -See ION-1574 and ION-9935See ION-1574 and ION-9935
WNV-NATWest Nile Virus nucleic acid testing -See ION-1574 and ION-9935See ION-1574 and ION-9935
Other tests performed -See ION-1574 and ION-9935See ION-1574 and ION-9935

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, to import cell products into the organisation country? If yes, please specify:See ION-1574 and ION-9935
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:See ION-1574 and ION-9935
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:See ION-1574 and ION-9935
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:See ION-1574 and ION-9935

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 Schemeno
- 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:See ION-1574 and ION-9935

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