Operational information

This data is publicly available. Parent page : $content.getParent().getTitle()

Operational data for Danish StemCellDonors West - ION-2015
Organisation Overview
The information has been reviewed in year :	2023
Issuing organisation Number (ION)	ION-2015 The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zone	Europe/Brussels (GMT+01:00) The timezone in which this organisation operates.
Business hours	8 am to 3 pm The daily hours in which this organisation operates.
Work schedule	Monday - Friday The normal work week in which this organisation operates.
Organisation closures	For all organisation closures, please see the WMDA Calendar.
Donor ID example	2015000000012345678 ID to be expected on paperwork, samples, and products.
Preliminary Search
Requires preliminary search request form	No If yes, form required can be found on the Documents Page.
Extended Typing
Typing options available for request	HR and LR Please note special requirements listed
Requires organisation specific typing request form	No If yes, form required can be found on the Documents Page.
Number of days donor is reserved for a patient after a request	30 days
Verification Typing
Maximum blood volume allowed	50 ml
Requires organisation specific typing request form	No If yes, form required can be found on the Documents Page.
IDM testing performed at verification	Yes
Number of days donor is reserved for a patient after a request	90 days
Sibling Typing
Registry is willing to arrange sibling typings	Yes
If yes, procedure to apply for sibling typings	Email: skejby.dbmdr@rm.dk
Workup Request
Product dosage limit	8 x 10¨6/kg Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collection	Yes Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collection	Yes, see guidelines for request for donation and subsequert donations on Documents Page. Must provide additional information to organisation.
Requires organisation specific work up forms	No If yes, form(s) required can be found on the Documents Page.
Workup IDM completed 30 days prior to collection	Yes 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 available	No If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policy	Yes, see guidelines for request for donation and subsequert donations on Documents Page.
Anonymous contact allowed	Yes
Direct contact allowed	Yes, after two years
Gift exchange allowed	Yes
Cord blood contact allowed	Yes

IDM

IDM Tested Method Days between test
and sampling/workup

ALT/ASTALT/AST ratio, De-Ritis-Quotient Yes 30

ChagasChagas, T. cruzi No

CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yes CLIA 30

CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yes CLIA 30

CMV TotalCytomegalovirus Total No

EBV IgGEpstein-Barr Virus Antibody testing IgG Yes CLIA 30

EBV IgMEpstein-Barr Virus Antibody testing IgM Yes CLIA 30

HAV (NAT)Anti-hepatitis A virus nucleic acid testing No

HBV (NAT)Hepatitis B nucleic acid testing Yes Procleix Ultrio Elite Assay 30

HBc AbHepatitis B core antibody testing Yes CMIA 30

HBs AgHepatitis B Surface antigen testing Yes CMIA 30

HCV (NAT)Hepatitis C nucleic acid testing Yes Procleix Ultrio Elite Assay 30

HCV AbHepatitis C antibody testing Yes CMIA 30

HEV (NAT)Hepatitis E Virus nucleic acid testing No

HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yes Procleix Ultrio Elite Assay 30

HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yes CMIA 30

HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yes CMIA 30

HIV p24Human Immunodeficiency Virus p24 antigen testing Yes CMIA 30

HTLV-IHuman T-Lymphotropic Virus type I testing Yes CMIA 30

HTLV-IIHuman T-Lymphotropic Virus type II testing Yes CMIA 30

MalariaMalaria No

HSVHerpes Simplex Virus On request CLIA 30

STSSerological tests for syphilis Yes CMIA 30

STS FTA-ABSSerological test for syphilis On request WR

ToxoplasmosisToxoplasmosis Yes ELFA 30

VZVVaricella Zoster Virus On request CLIA 30

WNV-NATWest Nile Virus nucleic acid testing No

Other tests performed -

Regulatory information

The data provided on this page is updated by the organisations.
The WMDA makes no representations or express or implied warranties regarding any information on this page.
Use of any information provided on this site does not and is not intended to create a contractual or other relationship.

General
The information has been reviewed in year :	2023
Organisation name:	Danish Stem Cell Donors - West
Organisation ION:	ION-2015
Country:	Denmark
Year the registry started operations:	1990

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?	yes

Product quantity
Data valid for year	2022
Number of products	National	International
HPC, Marrow products:	0	2
HPC, Apheresis:	1	18
HPC, Cord:	0	0

License
Organisation is licensed/accredited by the Competent Authority:	yes
Comment:
Name of Competent Authority:	Danish Patient Safety Authority
Date of last inspection:	September 2018
Link to website of Competent Authority:	https://en.stps.dk/en/
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?	yes
Is your registry WMDA Certified, WMDA Qualified or WMDA Accredited?	WMDA 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:	0
Ther registry audits its collection centres:	Yes
The registry works with the following number of affiliated Cord Blood Banks:	NA
The registry audits its Cord Blood Banks:	NA
The registry works with the following number of affiliated transplant centres:	2
The registry audits its transplant centres:	Yes
The registry works with the following number of affiliated IDM Testing Laboratories:	0
The registry audits its IDM Testing Laboratories:	Yes
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:	Yes
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:
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

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

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	no
- Voluntary National Reporting Scheme	no
- 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:	30

Space shortcuts

Page tree

Operational information

Operational data for Danish StemCellDonors West - ION-2015

IDM

Regulatory information

General

Products

Product quantity

License

Affiliation

Donor policy

Testing

Customs regulations

Reporting of Serious Adverse Events

Quality management

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

Space shortcuts

Page tree

Operations and Regulation ION-2015

Operational information

Operational data for Danish StemCellDonors West - ION-2015

IDM

Regulatory information

General

Products

Product quantity

License

Affiliation

Donor policy

Testing

Customs regulations

Reporting of Serious Adverse Events

Quality management