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CBB Survey 2015

These data are submitted by the cord blood bank to the WMDA in February 2015. The WMDA makes no representations or express or implied warranties regarding any information on this site or obtained through these links; expressly disclaims all legal liability and responsibility for the accuracy, completeness, currency, suitability, validity, or usefulness of such information; and is not and will not be liable for any statements, errors, or omissions in posted information, or for any losses, injuries, or damages that arise or are alleged to arise from such information. Use of any information provided on this site does not and is not intended to create a contractual or other relationship. All information is on an as-is basis. The data cannot be updated.


1. General Information
Name of CBBBedomaich Chayi CBB
CBB DirectorGideon
CBB DirectorBach
Address5 HaMarpe St.
AddressP.O.B. 50220
Address91056
AddressJerusalem
Phone Number+972-2-6499899
Websitewww.cordblood.org.il
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/01/2006
Number of Public Cord Blood Units4,784
Planned Number of Public Cord Blood Units Stored in 2015600
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationHadassah Bone Marrow and CB registry, Jerusalem, Israel
2. Cord Blood Units in Inventory
Current Processing MethodVapour+ red manual
Current Processing MethodVapour+ red auto
Year Current Process Method Started2006
Percent of Units Plasma and RBC Reduced (manual)85
Percent of Units Plasma and RBC Reduced (automated)15
3. Accreditations, Licenses and Certifications
FACT-NetcordNo
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityIsraeli ministry of health
Audited by National Stem Cell RegistryYes
ISONo
OtherGMP Certificate by the Institute for the Standardization and Control of Pharmaceuticals, Ministry of Health, Jerusalem, Israel
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticChlorhexidine
Current AntisepticAlcohol
Collection BagSingle needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsPassive refrigeration system
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportOther (lower limit +1-35Β°C, higher limit +6-30Β°C)
6. Pre-Processing Evaluation
Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Method for CD34 RemunerationISHAGE guidelines
External Proficiency Testing for QC of FACS LabUKNEQAS
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to Processingup to 48H
7. Processing and Packaging
Pre Freeze Processing Methods- Unit in InventorySEPAX
Pre Freeze Processing Methods- Unit in InventoryVolume reduction with HES-Manual
Pre Freeze Processing Methods- CurrentSEPAX
Pre Freeze Processing Methods- CurrentVolume reduction with HES manual
Additives Currently in UseHES
Current Cryopreservation MethodConventional CRF
Current Cryoprotectant AdditiveReady for use DMSO-Dextran
Current CryobagSingle bag 80:20
Current Target Cryopreservation Volume (mL)25.0
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
8. Testing
PCR Performed on IgM+ ResultCMV
PCR Performed on IgM+ ResultEBV
Extra Material Currently StoredCord blood material for DNA extraction
Extra Material Currently StoredPlasma/cord blood
Extra Material Currently StoredMaternal plasma/serum
Current Post Processing Threshold for Accepting a CBU for Public Use
TNC
100
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
1.50
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Double Platform
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
80
9. Storage
Type of Storage Container UsedConventional storage tank vapor phase
Monitoring of StorageCentralized alarm system local
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
Monitoring of StorageTemperature monitoring
10. HLA Typing
Current Level of HLA Typing at Time of Listing
HLA-A
IR
Current Level of HLA Typing at Time of Listing
HLA-B
IR
Current Level of HLA Typing at Time of Listing
HLA-C

Current Level of HLA Typing at Time of Listing
HLA-DRB1
IR
Current Level of HLA Typing at Time of Listing
HLA-DQB1

Current Level of HLA Typing at Time of Listing
HLA-DPB1

Accreditation of HLA LabEFI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
3
Attached Segment Used for Confirmatory/ Verification TypingYes
Units Listed without Attached Segment and have not been Previously Typed on Attached SegmentNo
Percentage of CBUs that have an Attached Segment90-100%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementYes
11. Reservation and Cancellation Policies
What Point is a CBU Reserved for a PatientReservation request
What Point is a CBU Reserved for a PatientShipment request
Length of Time a CBU can be Reserved
in days
Other
Length of Time a CBU can be Reserved
in days
reservation can be extended by request. a fee is charged for extending the reservation and it is discounted from the CBU release fee
Reservation FeeNo
Reservation Cancellation Fee in Absence of Shipment RequestNo
Can Reservation be ExtendedYes
Is a Unit Report Provided on a Unit that is Reserved for Another PatientNo
12. Release and Shipment
Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
Minimum 60% TNC recovery and 60% Viability
Criteria to Ship a CBU
HLA Identity Testing
Yes
Current Packaging for Shipment to TCMetal canister
Current Packaging for Shipment to TCOne attached segment
Current Packaging for Shipment to TCTransport rack
Time Between Shipment Request and Sending CBUOther
Time to Prepare a Cord Blood Unit for ShipmentCBUs can be shipped within 3-4 days. it is recommended to request a CBU at least 14 days in advance for completing a CFU assay on a frozen sample from the attached segment
Fee for Shipment CancellationYes
Dry Shippers Validated to Maintain Temperature of at least -150 for 48 hours Beyond Expected ArrivalYes
Electronic Temperature Data Logger on All Dry ShippersYes
Who Selects Transport CompanyRequesting transplant centre
Shape of Transport ContainerMushroom
13. Adverse Events Reporting
Who are S(P)EARS Reported To
Competent Authority
Yes
Who are S(P)EARS Reported To
Internal Report
Yes
Who are S(P)EARS Reported To
National Registry
Yes
Who are S(P)EARS Reported To
Transplant Center
Yes
Who are S(P)EARS Reported To
WMDA
Yes

14. Pictures of cord blood units in the inventory

RBC red manRBC red manRBC red aut

15. Infectious Disease Marker (IDM) CURRENTLY performed.



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