Operational information

This data is publicly available. Parent page : ION-4364

Operational data for Japan Marrow Donor Program - ION-4364

Organisation Overview
The information has been reviewed in year :
Issuing organisation Number (ION)ION-4364
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zoneAsia/Tokyo (GMT+09:00)
The timezone in which this organisation operates.
Business hours09:00-17:30
The daily hours in which this organisation operates.
Work scheduleMonday to Friday
The normal work week in which this organisation operates.
Organisation closures
For all organisation closures, please see the WMDA Calendar.
Donor ID example
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 requestNo
Please note special requirements listed
Requires organisation specific typing request formNot applicable
If yes, form required can be found on the Documents Page.
Number of days donor is reserved for a patient after a requestNot applicable
Verification Typing
Maximum blood volume allowed50mls
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 request40 days after confirmatory typing test
Sibling Typing
Registry is willing to arrange sibling typings
If yes, procedure to apply for sibling typings
Workup Request
Product dosage limitBM:Determined by the marrow volume, PBSC:(CD34)More than 2X10*6/kg per recipient. If less than, the second day collection will be performed.
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collectionNo
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collectionUnnecessary
Must provide additional information to organisation.
Requires organisation specific work up forms Yes
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 availableNo
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policyOnly DLI
Anonymous contact allowedNo, only letter exchange, two times within two years after transplant.
Direct contact allowedNo
Gift exchange allowedNo
Cord blood contact allowedNo



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:JMDP - Japan Marrow Donor Program
Organisation ION:ION-4364
Country:Japan
Year the registry started operations:12/18/1991

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? no

Product quantity

Data valid for year2023
Number of products NationalInternational
HPC, Marrow products: 787 4
HPC, Apheresis: 312 2
HPC, Cord: 0 0

License

Organisation is licensed/accredited by the Competent Authority: yes
Comment:
Name of Competent Authority:Ministry of Health, Labor and Welfare
Date of last inspection:3/18/2014
Link to website of Competent Authority:http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/kenkou/ishoku/index.html
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:7
The registry audits its donor centres:No, the DCs belong to JMDP
The registry works with the following numer of affiliated collection centres:PBSC:143 BM:200
Ther registry audits its collection centres:Yes
The registry works with the following number of affiliated Cord Blood Banks:0
The registry audits its Cord Blood Banks:No
The registry works with the following number of affiliated transplant centres:258
The registry audits its transplant centres:No
The registry works with the following number of affiliated IDM Testing Laboratories:1
The registry audits its IDM Testing Laboratories:No
The registry works with the following number of affiliated HLA/other DNA markers testing laboratories:2
The registry audits its HLA/other DNA markers testing laboratories:No
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:
If yes, what are these requirements?When a collection center has been certified as a JMDP collection center, that means they meet all the WMDA standards chapter 6-9. We will not include WMDA standards in future contracts with collection centers because of this. JMDP’s CC/AC must be defined by the Medical Care Act (Act No. 205 of 1948), which is from the Ministry of Health, Labor and Welfare. That means CC/AC clear very strict regulation.

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:no
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:
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.

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:No
Are there any customs regulations to follow, or customs paperwork required, to export cell products from the organisation country? If yes, please specify:No
Are there any import regulations to follow, or paperwork required, to import cell products into the organisation country? If yes, please specify:No
Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify:No

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 Scheme yes
- 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:

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:
Donor records relating to the medical exam and HPC collection process are the following number(s) of year(s) retained:35 years


IDM

IDM TestedMethod Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient YesJapan Society of Clinical Chemistry (JSCC) method
ChagasChagas, T. cruzi No
CMV IgGCytomegalovirus (CMV) Antibody testing IgG YesEIA
CMV IgMCytomegalovirus (CMV) Antibody testing IgM On requestEIA
CMV TotalCytomegalovirus Total YesEIA
EBV IgGEpstein-Barr Virus Antibody testing IgG On requestFA, EIA
EBV IgMEpstein-Barr Virus Antibody testing IgM On requestEIA
HAV (NAT)Anti-hepatitis A virus nucleic acid testing -
HBV (NAT)Hepatitis B nucleic acid testing On requestPCR
HBc AbHepatitis B core antibody testing YesPHA
HBs AgHepatitis B Surface antigen testing YesCLEIA
HCV (NAT)Hepatitis C nucleic acid testing On requestRT-PCR
HCV AbHepatitis C antibody testing YesCLEIA
HEV (NAT)Hepatitis E Virus nucleic acid testing -
HIV (NAT)Human Immunodeficiency Virus nucleic acid testing On requestRT-PCR
HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing YesCLEIA
HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing YesCLEIA
HIV p24Human Immunodeficiency Virus p24 antigen testing On request
HTLV-IHuman T-Lymphotropic Virus type I testing YesLIA
HTLV-IIHuman T-Lymphotropic Virus type II testing No
MalariaMalaria No
HSVHerpes Simplex Virus -
STSSerological tests for syphilis YesLA
STS FTA-ABSSerological test for syphilis On requestFA
ToxoplasmosisToxoplasmosis On requestELISA
VZVVaricella Zoster Virus On requestPCR
WNV-NATWest Nile Virus nucleic acid testing On request
Other tests performed -

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