Operational information

This data is publicly available. Parent page : ION-8941

Operational data for Ossium Health - ION-8941

Organisation Overview
The information has been reviewed in year :2024
Issuing organisation Number (ION)ION-8941
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneAmerica/Los_Angeles (GMT-08:00)
The timezone in which this organisation operates.
Business hours9:00 am - 5:00 pm
The daily hours in which this organisation operates.
Work scheduleMonday - Friday
The normal work week in which this organisation operates.
Organisation closuresLabor Day (September 2, 2024), Thanksgiving Day (November 28, 2024), Day After Thanksgiving (November 29, 2024), Christmas Eve (December 24, 2024), Christmas Day (December 25, 2024), New Year's Day (January 1, 2025), Martin Luther King Day (January 20, 2025), Presidents Day (February 17, 2025), Memorial Day (May 26, 2025), Juneteenth (June 19, 2025), Independence Day (July 4, 2025)
For all organisation closures, please see the WMDA Calendar.
Donor ID example8941 2024 000 00552 134
ID to be expected on paperwork, samples, and products.
Preliminary Search
Requires preliminary search request formNo
If yes, form required can be found on the Documents Page.
Extended Typing
Typing options available for requestHR-A, B, C, DRB1 performed on all donors
Please note special requirements listed
Requires organisation specific typing request formNo
If yes, form required can be found on the Documents Page.
Number of days donor is reserved for a patient after a request30 days
Verification Typing
Maximum blood volume allowedNot applicable
Requires organisation specific typing request formNo
If yes, form required can be found on the Documents Page.
IDM testing performed at verificationNot applicable
Number of days donor is reserved for a patient after a requestNot applicable
Sibling Typing
Registry is willing to arrange sibling typingsNot applicable
If yes, procedure to apply for sibling typings Not applicable
Workup Request
Product dosage limitProduct dosage determined by physician
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collectionNot applicable
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collectionNot applicable
Must provide additional information to organisation.
Requires organisation specific work up forms Not applicable
If yes, form(s) required can be found on the Documents Page.
Workup IDM completed 30 days prior to collectionYes
Donor IDM results must be performed within 30 days of collection date to be valid and allow the collection to proceed.
Medical Health Questionnaire example availableNot applicable
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policyNot applicable
Anonymous contact allowedNot applicable
Direct contact allowedNot applicable
Gift exchange allowedNot applicable
Cord blood contact allowedNot applicable


Regulatory information

This data is publicly available. Parent page : ION-8941
General information
organisation nameOssium Health
ION of the organisationION-8941
Products
This organisation provides HPC, MarrowYes
This organisation provides HPC, ApheresisNo
This organisation provides HPC, Cord BloodNo
This organisation provides MNC, ApheresisNo
This organisation provides NC, Whole BloodNo
This organisation provides Other productsNo
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:Yes
Name of Competent Authority/national regulatory body:US FDA
Date of last inspection:May 20, 2024
Link to website of competent authority/national regulatory body:https://www.fda.gov/
Legal documentation from the national government
that your organisation is allowed to operate as a registry can be provided:
Not applicable
Serious adverse events and reactions are reported and investigated:
Affiliated centres
This organisation has affiliated Donor CentresNot applicable
This organisation has affiliated Collection CentresNot applicable
This organisation has affiliated Cord Blood BanksNot applicable
This organisation has affiliated Transplant CentresNot applicable
This organisation has affiliated IDM Testing LaboratoriesNot applicable
This organisation has affiliated HLA/other DNA markers Testing LaboratoriesYes
There is a full list of affiliated centres with their license / accreditation status available: Not 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)
Not applicable
Affiliated centres comply with WMDA standards and applicable national regulations:Not applicable
We have requirements for affiliated centres in addition to
WMDA Standards and applicable national regulations:
Not applicable
We audit affiliated centres for compliance with applicable standards,
national regulations and your organisation’s requirements:
Not applicable
If Yes, the frequency of audits is :
Donor policy
Volunteer donors are unpaid:Yes
Donors are informed about donation process and associated risks:Yes
Donors sign a valid informed consent to donate:Yes
We have systems in place to protect and control access to donor/patient records:Yes
Our organisation maintains donor anonymity:Yes
Detailed donor evaluation and exclusion criteria in place?Yes
Detailed donor evaluation and exclusion criteria meet the WMDA guidelines?Yes
IDM Testing
CMV IgG is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgG
Yes
CMV IgM is tested at donor workup:
Cytomegalovirus (CMV) Antibody testing IgM
Yes
CMV Total is tested at donor workup:Yes
EBV IgG is tested at donor workup:
Epstein-Barr Virus Antibody testing IgG
Yes
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
Yes
HBc Ab is tested at donor workup:
Hepatitis B core antibody testing
Yes
HBs Ag is tested at donor workup:
Hepatitis B Surface antigen testing
Yes
HCV (NAT) is tested at donor workup:
Hepatitis C nucleic acid testing
Yes
HCV Ab is tested at donor workup:
Hepatitis C antibody testing
Yes
HIV–1 Ab is tested at donor workup:
Human Immunodeficiency Virus HIV-1 antibody testing
Yes
HIV–2 Ab is tested at donor workup:
Human Immunodeficiency Virus HIV-2 antibody testing
Yes
HIV (NAT) is tested at donor workup:
Human Immunodeficiency Virus nucleic acid testing
Yes
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
Yes
HTLV-II is tested at donor workup:
Human T-Lymphotropic Virus type II testing
Yes
STS (Serological) is tested at donor workup:
Serological tests for syphilis
Yes
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
Yes
Other tests performed:Trypanosoma cruzi (Chagas), Toxoplasmosis (Toxo)
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:
Yes
The kits used for donor testing (at work up) for infectious disease are licensed/approved
for use on donors by the national regulatory agency?
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
Retention policy
Donor records relating to the medical and HPC collection process
are retained for:
Indefinitely


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