Operational information

This data is publicly available. Parent page : ION-7813

Operational data for Spanish Bone Marrow Donor Registry - ION-7813

Organisation Overview
The information has been reviewed in year :2023
Issuing organisation Number (ION)ION-7813
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneEurope/Minsk (GMT+02:00)
The timezone in which this organisation operates.
Business hoursfrom 8:00 to 18:00
The daily hours in which this organisation operates.
Work scheduleMonday to Thursday from 8:00 to 18:00 - Friday from 8:00 to 15:00
The normal work week in which this organisation operates.
Organisation closures6 January, 15 and 18 April, 5 and 24 June, 15 August, 26 September, 12 October, 1 November, 6, 8, 26 Desember
For all organisation closures, please see the WMDA Calendar.
Donor ID example7813000000000000000
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, LR - A, B, C, DR, DQ, DP
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 request60 days
Verification Typing
Maximum blood volume allowed50 ml.
Requires organisation specific typing request formNo
If yes, form required can be found on the Documents Page.
IDM testing performed at verificationYes
Number of days donor is reserved for a patient after a request60 days
Sibling Typing
Registry is willing to arrange sibling typingsYes
If yes, procedure to apply for sibling typings The procedure that applies is exactly the same (cost included) than the one for unrelated donors.
Workup Request
Product dosage limit8X10E6 CD34+/Kg recipient
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collectionYes
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collectionDonor-patient match should be at least 7/8 identities. Diagnosis and transplant indications should be according to EBMT guidelines.
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 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 availableYes
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policySubsequent donations are in principle accepted. However each one is evaluated individually by our Medical Direction.
Anonymous contact allowedA single anonymous contact is allowed. No specific time post-transplant
Direct contact allowedNo
Gift exchange allowedA small gift is also allowed at the same time of the anonymous contact
Cord blood contact allowedThese communications are not sent to the donor's mother themselves but to the cord blood banks and they publish them in their website as a recognition for all mothers who have donated their CBU.

IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient Yes< 30 days
ChagasChagas, T. cruzi On request< 30 days
CMV IgGCytomegalovirus (CMV) Antibody testing IgG Yes< 30 days
CMV IgMCytomegalovirus (CMV) Antibody testing IgM Yes< 30 days
CMV TotalCytomegalovirus Total On request< 30 days
EBV IgGEpstein-Barr Virus Antibody testing IgG Yes< 30 days
EBV IgMEpstein-Barr Virus Antibody testing IgM Yes< 30 days
HAV (NAT)Anti-hepatitis A virus nucleic acid testing On request< 30 days
HBV (NAT)Hepatitis B nucleic acid testing Yes< 30 days
HBc AbHepatitis B core antibody testing Yes< 30 days
HBs AgHepatitis B Surface antigen testing Yes< 30 days
HCV (NAT)Hepatitis C nucleic acid testing Yes< 30 days
HCV AbHepatitis C antibody testing Yes< 30 days
HEV (NAT)Hepatitis E Virus nucleic acid testing On request< 30 days
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing Yes< 30 days
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing Yes< 30 days
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing Yes< 30 days
HIV p24Human Immunodeficiency Virus p24 antigen testing Yes< 30 days
HTLV-IHuman T-Lymphotropic Virus type I testing Yes< 30 days
HTLV-IIHuman T-Lymphotropic Virus type II testing Yes< 30 days
MalariaMalaria On request< 30 days
HSVHerpes Simplex Virus On request< 30 days
STSSerological tests for syphilis Yes< 30 days
STS FTA-ABSSerological test for syphilis On request< 30 days
ToxoplasmosisToxoplasmosis Yes< 30 days
VZVVaricella Zoster Virus On request< 30 days
WNV-NATWest Nile Virus nucleic acid testing On request< 30 days
Other tests performed On request< 30 days


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 :
Organisation name:Spanish Bone Marrow Donor Registry (REDMO)
Organisation ION:ION-7813
Country:Spain
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? yes
Do you provide MNC, Apheresis? yes
Do you provide NC, Whole Blood? yes

Product quantity

Data valid for year2023
Number of products NationalInternational
HPC, Marrow products: 9 13
HPC, Apheresis: 164 182
HPC, Cord: 7 74

License

Organisation is licensed/accredited by the Competent Authority: yes
Comment:
Name of Competent Authority:Health Department - Servei Català de la Salut
Date of last inspection:2020/11/26
Link to website of Competent Authority: http://trasplantaments.gencat.cat/en/ocatt/guia_de_centres
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 Qualified
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:17
The registry audits its donor centres:Every 4 years (sooner if needed according to our Audit plan)
The registry works with the following numer of affiliated collection centres:29
Ther registry audits its collection centres:Every 4 years (sooner if needed according to our Audit plan)
The registry works with the following number of affiliated Cord Blood Banks:7
The registry audits its Cord Blood Banks:Every 4 years (sooner if needed according to our Audit plan)
The registry works with the following number of affiliated transplant centres:34
The registry audits its transplant centres:Every 4 years (sooner if needed according to our Audit plan)
The registry works with the following number of affiliated IDM Testing Laboratories:22 (affiated to DC)
The registry audits its IDM Testing Laboratories:Every 4 years (sooner if needed according to our Audit plan)
The registry works with the following number of affiliated HLA/other DNA markers testing laboratories:17 (affiated to DC)
The registry audits its HLA/other DNA markers testing laboratories:Every 4 years (sooner if needed according to our Audit plan)
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: yes
If yes, the following Cord Blood Bank(s) are accredited:Andalucia CBB, Barcelona CBB, IVIDA
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: yes
If yes, what are these requirements?National Regulations/Laws

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

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 yes
- 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:on a permanent basis


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