Operational information
This data is publicly available. Parent page : $content.getParent().getTitle()
Operational data for Ezer Mizion BMDR - ION-4987 | |
|---|---|
| Organisation Overview | |
| The information has been reviewed in year : | |
| Issuing organisation Number (ION) | ION-4987 The Issuing Organisation Number of a organisation, this is globally unique number, as issued by the ICCBBA. |
| Time zone | Asia/Jerusalem (GMT+02:00) The timezone in which this organisation operates. |
| Business hours | 08:00-17:00 The daily hours in which this organisation operates. |
| Work schedule | Sunday - Thursday The normal work week in which this organisation operates. |
| Organisation closures | For all organisation closures, please see the WMDA Calendar. |
| Donor ID example | GRID 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, IR - A, B, C, DR, DP, DQ 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 | 90 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 | Up to 90 days after receiving CT results upon request of the registry/TC |
| Sibling Typing | |
| Registry is willing to arrange sibling typings | Yes |
| If yes, procedure to apply for sibling typings | Contact the registry for further information |
| Workup Request | |
| Product dosage limit | 20ml/Kg (BM) ; CD34: 5x10^6/Pt Kg (PBSC) 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 | patient physician needs to provide patient report on status and treatment plan 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 | If yes, the example can be found on the Documents Page. |
| Post-Transplant | |
| Subsequent donation policy | Yes, Please see Ezer Mizion Operation Manual |
| Anonymous contact allowed | Yes, immediately after transplant |
| Direct contact allowed | Allowed at least one year post transplant if patient and donor agree and sign consent |
| Gift exchange allowed | Yes, immediately after transplant. Gift must not be substantial or monetary value |
| Cord blood contact allowed | N/A |
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.
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: | Ezer Mizion Bone Marrow Donor Registry |
| Organisation ION: | ION-4987 |
| Country: | Israel |
| Year the registry started operations: | 1998 |
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: | 10 | 20 |
| HPC, Apheresis: | 133 | 291 |
| HPC, Cord: | N/A | N/A |
License | |
|---|---|
| Organisation is licensed/accredited by the Competent Authority: | yes |
| Comment: | |
| Name of Competent Authority: | Israeli Ministry of Health |
| Date of last inspection: | 11/05/2021 |
| Link to website of Competent Authority: | http://www.health.gov.il/English/Pages/HomePage.aspx |
| 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: | yes |
| If yes, by which organisation? | ISO27001:2013 And ISO27799:2008 |
Affiliation | |
|---|---|
| The registry works with the following number of affiliated donor centres: | None. The registry operates as registry and donor center |
| The registry audits its donor centres: | N/A |
| The registry works with the following numer of affiliated collection centres: | The majority of collections are facilitated at Ezer Mizion Collection Center. The registry is affiliated with an additional 1 Collection Center. |
| Ther registry audits its collection centres: | Paper audit every year and visit audit every 3 years if JACIE accreditation is not available |
| The registry works with the following number of affiliated Cord Blood Banks: | 0 |
| The registry audits its Cord Blood Banks: | N/A |
| The registry works with the following number of affiliated transplant centres: | 8 |
| The registry audits its transplant centres: | Paper audit every 3 years if TC is not JACIE accredited |
| The registry works with the following number of affiliated IDM Testing Laboratories: | 1 |
| The registry audits its IDM Testing Laboratories: | Collect valid accreditation certificates every year |
| 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: | Collect valid accreditation certificates every year |
| 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: | 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: | 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 |
IDM
IDM
Tested Method
Days between test
and sampling/workup
ALT/ASTALT/AST ratio, De-Ritis-Quotient
Yes ChagasChagas, T. cruzi
No CMV IgGCytomegalovirus (CMV) Antibody testing IgG
Yes CMIA (by Abbot) CMV IgMCytomegalovirus (CMV) Antibody testing IgM
Yes CMIA (by Abbot) CMV TotalCytomegalovirus Total
No EBV IgGEpstein-Barr Virus Antibody testing IgG
Yes CMIA (by Abbot) - Only if EBNA IgG is Neg EBV IgMEpstein-Barr Virus Antibody testing IgM
Yes CMIA (by Abbot) - Only if EBNA IgG is Neg HAV (NAT)Anti-hepatitis A virus nucleic acid testing
No HBV (NAT)Hepatitis B nucleic acid testing
Yes NAT Ultrio Elite, PANTHER by Procleix HBc AbHepatitis B core antibody testing
Yes CMIA (by Abbot) HBs AgHepatitis B Surface antigen testing
Yes CMIA (by Abbot) HCV (NAT)Hepatitis C nucleic acid testing
Yes NAT Ultrio Elite, PANTHER by Procleix HCV AbHepatitis C antibody testing
Yes CMIA (by Abbot) HEV (NAT)Hepatitis E Virus nucleic acid testing
No HIV (NAT)Human Immunodeficiency Virus nucleic acid testing
Yes NAT Ultrio Elite, PANTHER by Procleix HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing
Yes Combo, CMIA (by Abbot) HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing
Yes Combo, CMIA (by Abbot) HIV p24Human Immunodeficiency Virus p24 antigen testing
Yes HTLV-IHuman T-Lymphotropic Virus type I testing
Yes rHTLV-I/II CMIA (by Abbot) HTLV-IIHuman T-Lymphotropic Virus type II testing
Yes rHTLV-I/II CMIA (by Abbot) MalariaMalaria
No HSVHerpes Simplex Virus
No STSSerological tests for syphilis
Yes TP-HA by CMIA; RPR only if TP-HA pos STS FTA-ABSSerological test for syphilis
- ToxoplasmosisToxoplasmosis
Yes CMIA (by Abbot) VZVVaricella Zoster Virus
No WNV-NATWest Nile Virus nucleic acid testing
Yes Aptima Combo 2, PANTHER (Gen-Probe) Other tests performed
-
IDM
| IDM | Tested | Method | Days between test and sampling/workup |
|---|---|---|---|
| ALT/ASTALT/AST ratio, De-Ritis-Quotient | Yes | ||
| ChagasChagas, T. cruzi | No | ||
| CMV IgGCytomegalovirus (CMV) Antibody testing IgG | Yes | CMIA (by Abbot) | |
| CMV IgMCytomegalovirus (CMV) Antibody testing IgM | Yes | CMIA (by Abbot) | |
| CMV TotalCytomegalovirus Total | No | ||
| EBV IgGEpstein-Barr Virus Antibody testing IgG | Yes | CMIA (by Abbot) - Only if EBNA IgG is Neg | |
| EBV IgMEpstein-Barr Virus Antibody testing IgM | Yes | CMIA (by Abbot) - Only if EBNA IgG is Neg | |
| HAV (NAT)Anti-hepatitis A virus nucleic acid testing | No | ||
| HBV (NAT)Hepatitis B nucleic acid testing | Yes | NAT Ultrio Elite, PANTHER by Procleix | |
| HBc AbHepatitis B core antibody testing | Yes | CMIA (by Abbot) | |
| HBs AgHepatitis B Surface antigen testing | Yes | CMIA (by Abbot) | |
| HCV (NAT)Hepatitis C nucleic acid testing | Yes | NAT Ultrio Elite, PANTHER by Procleix | |
| HCV AbHepatitis C antibody testing | Yes | CMIA (by Abbot) | |
| HEV (NAT)Hepatitis E Virus nucleic acid testing | No | ||
| HIV (NAT)Human Immunodeficiency Virus nucleic acid testing | Yes | NAT Ultrio Elite, PANTHER by Procleix | |
| HIV-1 AbHuman Immunodeficiency Virus HIV-1 antibody testing | Yes | Combo, CMIA (by Abbot) | |
| HIV-2 AbHuman Immunodeficiency Virus HIV-2 antibody testing | Yes | Combo, CMIA (by Abbot) | |
| HIV p24Human Immunodeficiency Virus p24 antigen testing | Yes | ||
| HTLV-IHuman T-Lymphotropic Virus type I testing | Yes | rHTLV-I/II CMIA (by Abbot) | |
| HTLV-IIHuman T-Lymphotropic Virus type II testing | Yes | rHTLV-I/II CMIA (by Abbot) | |
| MalariaMalaria | No | ||
| HSVHerpes Simplex Virus | No | ||
| STSSerological tests for syphilis | Yes | TP-HA by CMIA; RPR only if TP-HA pos | |
| STS FTA-ABSSerological test for syphilis | - | ||
| ToxoplasmosisToxoplasmosis | Yes | CMIA (by Abbot) | |
| VZVVaricella Zoster Virus | No | ||
| WNV-NATWest Nile Virus nucleic acid testing | Yes | Aptima Combo 2, PANTHER (Gen-Probe) | |
| Other tests performed | - |
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 : | 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, Proforma Invoice Customs certificate issued by the Israeli Customs Authority |
| 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: | Yes, Courier letter Customs certificate issued by the Israeli Customs Authority |
| Are there any export regulations to follow, or paperwork required, to export cell products from the organisation country? If yes, please specify: | Yes, Courier letter Clear from the Israeli Airport Authority |
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: | 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: | at least 30 years |