Operational information

This data is publicly available. Parent page : ION-5315

Operational data for C.W. Bill Young Department of Defense Marrow Donor Program/Georgetown University - 5315

Organisation Overview
The information has been reviewed in year :
Issuing organisation Number (ION)5315
The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA.
Time zone
The timezone in which this organisation operates.
Business hours
The daily hours in which this organisation operates.
Work schedule
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 form
If yes, form required can be found on the Documents Page.
Extended Typing
Typing options available for request
Please note special requirements listed
Requires organisation specific typing request form
If yes, form required can be found on the Documents Page.
Number of days donor is reserved for a patient after a request
Verification Typing
Maximum blood volume allowed
Requires organisation specific typing request form
If yes, form required can be found on the Documents Page.
IDM testing performed at verification
Number of days donor is reserved for a patient after a request
Sibling Typing
Registry is willing to arrange sibling typings
If yes, procedure to apply for sibling typings
Workup Request
Product dosage limit
Number of donor cells allowed based on recipient weight.
Requires patient to meet certain standards in order to proceed with collection
Organisation may or may not allow donor collections for some patients.
Patient physician must report the following in order to proceed with collection
Must provide additional information to organisation.
Requires organisation specific work up forms
If yes, form(s) required can be found on the Documents Page.
Workup IDM completed 30 days prior to collection
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
If yes, the example can be found on the Documents Page.
Post-Transplant
Subsequent donation policy
Anonymous contact allowed
Direct contact allowed
Gift exchange allowed
Cord blood contact allowed

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:C.W. Bill Young Department of Defense Marrow Donor Program/Georgetown University
Organisation ION:ION-5315
Country:United States of America
Year the registry started operations:

Products

comment
Do you provide HPC, Marrow?
Do you provide HPC, Apheresis?
Do you provide HPC, Cord Blood?
Do you provide MNC, Apheresis?
Do you provide NC, Whole Blood?

Product quantity

Data valid for year
Number of products NationalInternational
HPC, Marrow products:
HPC, Apheresis:
HPC, Cord:

License

Organisation is licensed/accredited by the Health Authority:
Comment:
Name of Health Authority:
Date of last inspection:
Link to website of Health Authority:
Can you provide the Legal documentation from the Competent Authority that your organisation is allowed to operate as a registry ?
The registry is accredited by any other organisation:
If yes, by which organisation?

Donor policy

All donors are unpaid volunteers:
All donors are informed about donation process and associated risks:
Donors sign a valid informed consent to donate in the presence of a medical doctor/health care personnel/registry staff:
The registry has systems in place to protect and control access to donor/patient records:
The registry maintains donor anonymity:
The registry has detailed donor evaluation and exclusion criteria in place:
The registry has donor evaluation and exclusion criteria that do meet or exceed the WMDA guidelines:

IDM

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

Regulatory information section 2

Relevant documents will be uploaded by the organisation to the documents page.

Testing

The physical and medical exam at donor workup is performed by a medical doctor:
All donor testing (at workup) for infectious disease is performed in a laboratory certified/licensed by a Competent Authority:
HLA typing for patient specific request is performed in an appropriately accredited laboratory:
Sterility testing is performed on the adult donor product:
Sterility testing is performed on the cord blood product:
Screening questionnaire to exclude communicable disease:
Screening questionnaire to exclude donors with 'high risk' lifestyles:
Donor reliability identified by a medical doctor:
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 needed to import cell products into the country of the affiliated transplant centres?
Are there any customs regulations to follow or customs paperwork required needed to export cell products from the country of the affiliated organisation?
Are there any import national regulations to follow or paperwork required needed to import the cell products into the country of the affiliated transplant centre?
Are there any export regulations to follow or paperwork required needed to export cell products from the country of the affiliated organisation?

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
- Voluntary National Reporting Scheme
- WMDA SEAR/SPEAR Reporting Scheme
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 organisation does maintain Standard Operating Procedures for its work:
Please indicate if your organisation/country has any specific requirements that should be communicated in advance to the requesting entity (e.g., financial sanctions, specific regulatory forms, etc.) :
Donor records relating to the medical exam and cell product collection process are the following number(s) of year(s) retained:

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