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General information
organisation nameOssium Health
ION of the organisationION-8941
Products
This organisation provides HPC, Marrow
This organisation provides HPC, Apheresis
This organisation provides HPC, Cord Blood
This organisation provides MNC, Apheresis
This organisation provides NC, Whole Blood
This organisation provides Other products
Other products provided:
Number of adult donor products shipped in the last 3 years:
Domestic shipments:
International shipments:
Licences and accreditations
organisation is licensed/accredited by a national regulatory body/accrediting agency:
Name of Competent Authority/national regulatory body:
Date of last inspection:
Link to website of competent authority/national regulatory body:
Legal documentation from the national government
that your organisation is allowed to operate as a registry can be provided:
Serious adverse events and reactions are reported and investigated:
Affiliated centres
This organisation has affiliated Donor Centres
This organisation has affiliated Collection Centres
This organisation has affiliated Cord Blood Banks
This organisation has affiliated Transplant Centres
This organisation has affiliated IDM Testing Laboratories
This organisation has affiliated HLA/other DNA markers Testing Laboratories
There is a full list of affiliated centres with their license / accreditation status available:
The full list of affiliated centres list can be obtained:
Affiliated centres are required to be licensed by a national
regulatory body and/or have an internationally recognised accreditation (e.g. European Federation of Immunogentics (EFI), NetCord-FACT, JACIE)
Affiliated centres comply with WMDA standards and applicable national regulations:
We have requirements for affiliated centres in addition to
WMDA Standards and applicable national regulations:
We audit affiliated centres for compliance with applicable standards,
national regulations and your organisation’s requirements:
If Yes, the frequency of audits is :
Donor policy
Volunteer donors are unpaid:
Donors are informed about donation process and associated risks:
Donors sign a valid informed consent to donate:
We have systems in place to protect and control access to donor/patient records:
Our organisation maintains donor anonymity:
Detailed donor evaluation and exclusion criteria in place?
Detailed donor evaluation and exclusion criteria meet the WMDA guidelines?
IDM Testing
CMV IgG is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgG
CMV IgM is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgM
CMV Total is tested at donor workup:
EBV IgG is tested at donor workup:
Epstein-Barr Virus Antibody testing IgG
EBV IgM is tested at donor workup:
Epstein-Barr Virus Antibody testing IgM
HBV (NAT) is tested at donor workup:
Hepatitis B nucleic acid testing
HBc Ab is tested at donor workup:
Hepatitis B core antibody testing
HBs Ag is tested at donor workup:
Hepatitis B Surface antigen testing
HCV (NAT) is tested at donor workup:
Hepatitis C nucleic acid testing
HCV Ab is tested at donor workup:
Hepatitis C antibody testing
HIV–1 Ab is tested at donor workup:
Human Immunodeficiency Virus HIV-1 antibody testing
HIV–2 Ab is tested at donor workup:
Human Immunodeficiency Virus HIV-2 antibody testing
HIV (NAT) is tested at donor workup:
Human Immunodeficiency Virus nucleic acid testing
HIV p24 Ag is tested at donor workup:
Human Immunodeficiency Virus p24 antigen testing
HTLV-I is tested at donor workup:
Human T-Lymphotropic Virus type I testing
HTLV-II is tested at donor workup:
Human T-Lymphotropic Virus type II testing
STS (Serological) is tested at donor workup:
Serological tests for syphilis
STS FTA-ABS (verification test) is tested at donor workup:
Serological test for syphilis
WNV-NAT is tested at donor workup:
West Nile Virus nucleic acid testing
Other tests performed:
Testing
Full donor screening for infectious disease risk is performed at the following stage:
Physical exam and relevant donor testing is performed at the following stage:
Infectious disease testing is performed at the following stage:
A sample for additional donor testing can be provided upon request:
All donor testing (at work up) for infectious disease is performed
in a laboratory certified/licensed by a national regulatory agency:
The kits used for donor testing (at work up) for infectious disease are licensed/approved
for use on donors by the national regulatory agency?
HLA typing for patient specific request is performed in an appropriately accredited laboratory:
Sterility testing is performed on the adult donor product:
Retention policy
Donor records relating to the medical and HPC collection process
are retained for:


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