The Ezer Mizion Bone Marrow Donor Registry Rules of Operation for International Patients
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1 The Ezer Mizion Bone Marrow Donor Registry Rules of Operation for International Patients Table of Contents 1. Purpose and Scope Introduction Starting and Terminating a Search Typing Requests Confirmatory Typing Sample Procurement Infectious Disease Markers Work Up Post Transplant Finance EMDIS implementation level... 6 Page 1 of 7 Sep 2018 Version no: 3
2 1. Purpose and Scope This document gives the basic information to international registries or transplant centers outside Israel on how to access Israeli donors through the Ezer Mizion (EM) Bone Marrow Donor Registry. This document is not intended to provide comprehensive or detailed insight into registry activities. More specific information on requirements of our registry can be found in the Ezer Mizion Operation Manual ( 2. Introduction The Ezer Mizion Registry (EM) was established in 1998 and works directly with most established registries in the world and maintains relations with some transplant centers in countries where no established registry exists. EM operates both as bone marrow donor registry and as donor center. It is responsible for the recruitment and maintenance of a current panel of donors, maintains contact with and providing information to donors, collections centers and to the search coordinators units in the national transplant centers. EM provides suitably matched unrelated voluntary donors for national and international patients in need of transplantation. Contact information: Ezer Mizion Bone Marrow Donor Registry Oranit Center, 40 Kaplan Street, Petach-Tikva, 49210, Israel. Tel: (+972) / 2/ 4/ 5/ 6/ 8 Fax: (+972) or Emergency telephone number: (+972) address: or niras@bmdr.org.il Web page: (Eng); (Heb) EMDIS HUB: IL Platform: Prometheus and in-house system ECS software: ESTER Page 2 of 7 Sep 2018 Version no: 3
3 3. Starting and Terminating a Search Preliminary Search: Preliminary searches can routinely be initiated from outside of Israel by registries that are operating according to WMDA standards on behalf of cooperating TCs in their country or by TCs from countries without an established registry. TCs seeking a direct cooperation with Ezer Mizion should provide specific details (FRM_S22, available upon request) which may be subject to approval by the Medical Director. Requests can be submitted by EMDIS or fax/ by using EM forms, WMDA forms or similar. In addition to patient name and HLA data, birth date, diagnosis and gender of the patient are required before starting a search. We require serological or molecular data for at least HLA-A, -B and -DR(B1); Mismatch: It is possible to ask for mismatch. Activation: Patients can be activated via EMDIS and repeated searches are performed every night. Search requests by fax are not activated. A repeat search will only be performed on request. Termination: Search request should be cancelled either by EMDIS or by /fax. There is no need to cancel a search that has never become active. For activated searches, Ezer Mizion expects a formal cancellation of the donor search. This is usually performed when a suitable donor has been identified and/or the patient proceeds to transplant, when the patient is no longer interested in or eligible for a transplant or when the requesting center loses contact with the patient. 4. Typing Requests Requests can be submitted by EMDIS or fax/ by using EM forms, WMDA forms or similar. Typing is performed by molecular methods in EFI/ASHI accredited laboratory. In most cases extended HLA typing is performed on stored samples. The results will be send about 14 days after request, otherwise an explanation for the delay will be sent. Page 3 of 7 Sep 2018 Version no: 3
4 Locus Low Intermediat High A B C DRB1 DQB1 DQA1 DRB3, DPB1* DPA1* *t routinely performed, but can be performed in request. Time to result can vary. 5. Confirmatory Typing Sample Procurement Requests can be submitted by EMDIS or fax/ by using EM forms, WMDA forms or similar. The total quantity of blood samples for confirmatory typing must not exceed 50mL per donor. We cannot guarantee that blood samples are provided exactly as requested. This may refer to the number and volume of tubes and in rare cases to minor variations concerning the anticoagulant. A standard set of infectious disease markers is performed at the time a CT sample is collected. part of these samples must be used for research. A message is sent by EMDIS notifying the transplant centre of the CT arrival date, which is set to two days after the appointment date. When CT is requested on a donor that has not yet been typed for HLA-DRB1 IR/HR HLA-DRB1 typing must be requested before and performed. Once confirmatory typing results are received, one donor can be Held for workup for 3 months until a definitive collection and transplant date is confirmed. A CT request may be cancelled at any time. If processing cannot be stopped with any reasonable effort, an invoice will still be issued and must be paid. This is typically assumed if a typing or IDM result can be delivered within 14 days after cancellation. Search cancellation automatically cancels all pending requests except work-up. Page 4 of 7 Sep 2018 Version no: 3
5 6. Infectious Disease Markers A screening for Infectious disease markers (IDM) is always performed when requesting a blood sample. The results are sent about 1 week after blood drawing. IDM includes HBs antigen, antibodies against CMV, HIV-1+2/p24 Ag (combo test), HTLV, HBc, HCV and also includes the testing of the ABO and Rh blood group. 7. Work Up Workup requests cannot be received via EMDIS. Workup requests must be send by fax or using the applicable Ezer Mizion forms (available at Ezer Mizion website) or any other WMDA compliant forms. A confirmation of receipt will be returned by the same day or the day after receipt of workup. A confirmation on donor availability will be send within 7 days after receipt of work-up. In case of urgency CT and work-up may be requested concurrently, but the result of the CT must be submitted before the donor clearance can be obtained. The requesting registry/tc must have submitted confirmatory typing results at least for the loci HLA-A, -B, -C, -DRB1 and -DQB1 demonstrating at least a 9/10 match at high resolution level. Lower than 9/10 high resolution matches are subject to review. 8. Post Transplant Donor follow-up after stem cell donation is the responsibility of the donor centers. Patient follow-up is the responsibility of the transplant centers and has to be performed according to national and applicable international standards. Ezer Mizion expect to receive upon request information about the recipient s condition six months and one year post transplant. Donor-Recipient Contact: Anonymous patient-donor contact is permitted after the transplantation. Generally, personal contact is possible beginning at least one year after the transplant if the patient and the donor agree and sign a declaration of consent to release personal information. Page 5 of 7 Sep 2018 Version no: 3
6 9. Finance The current Schedule of Fees is routinely distributed to the cooperating registries by thirty days prior to implementation. A Preliminary search and activation of the search process are free of charge. The price for the confirmatory typing sample includes testing for infectious disease markers. The procurement fee for marrow or peripheral stem cells does not include the courier costs, a separately shipped pre-collection and/or IDM sample. Provision of the courier by the transplant center is encouraged. Cancellation: Every effort is made to cancel a test but if tissue typing has commenced an invoice is issued on receipt of the results and has to be paid. For provision of blood samples, if an appointment date (blood draw date) has passed and the samples shipped an invoice for the sample collection and freight is raised. If the shipment can be stopped in time, freight is not charged. Terms of Payment: 1. The total amount is due within 30 days. 2. Payment must be made by a check or a bank draft direct to our business bank, expressed in USD, for the full amount invoiced free of bank charges, drawn to the corresponding business bank, payee Ezer Mizion. 3. Our invoice numbers should be noted on the document. 10. EMDIS implementation level Message ALM_REQ ALM_RES CBR_REQ DONOR_CB IDM_REQ IDM_RES MARR_STAT MATCH_SUM Incoming Outgoing Page 6 of 7 Sep 2018 Version no: 3
7 MSG_ACK MSG_DEN NEW_RES NO_RES PAT_STAT PAT_UPD PHEN_LIST REQ_CAN RES_REM RSV_REQ RSV_RES SMP_ARR SMP_REQ SMP_RES TT_MSG TYP_REQ TYP_RES WORNING WORK_REQ Page 7 of 7 Sep 2018 Version no: 3
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