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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 CBBThe Swedish National Cord Blood Bank
CBB DirectorAnders
CBB DirectorFasth
AddressClinical Immunology and Transfusion Medicine
AddressSahlgrenska University Hospital
AddressVita Stråket 13
Address413 45
AddressGothenburg
Phone Number+46 31 342 78 62
Websitewww.sahlgrenska.se/sv/SU/Omraden/4/Verksamhetsomraden/Laboratoriemedicin/Klinisk-Immunologi-och-Transfusionsmedicin/Enheter/Immunologi-och-Transplantation/Nationella-navelstrangsblodbanken/
Date CBB Started Collecting Cord Blood Units
(month/day/year)
11/01/2006
Number of Public Cord Blood Units3,883
Planned Number of Public Cord Blood Units Stored in 2015300
Lists on BMDWNo
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationTobias Registry
2. Cord Blood Units in Inventory
 

Current Processing MethodLiquid+ red auto
Year Current Process Method Started2006
Percent of Units Plasma and RBC Reduced (manual)0
Percent of Units Plasma and RBC Reduced (automated)100
Percent of Units RBC Reduced Only0
Percent of Units No Volume Reduction0
3. Accreditations, Licenses and Certifications
 

FACT-NetcordYes
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityNarional Board of Health and Welfare
Audited by National Stem Cell RegistryNo
ISOYes
4. Cord Blood Collection
 

Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticChlorhexidine
Collection BagSingle needle
Agitation during CollectionAutomatic
5. Conditioning/Transport from Collection Site to CBB
 

Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsElectronic temperature probe
Transport ConditionsAir transport
Transport ConditionsGround transport
Temp. for Storage and TransportRoom temperature
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- CurrentSEPAX
Additives Currently in UseHES
Current Cryopreservation MethodBioArchive
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
 

Extra Material Currently StoredCord blood DNA
Extra Material Currently StoredCord blood material for DNA extraction
Extra Material Currently StoredPlasma/cord blood
Extra Material Currently StoredMaternal material for DNA extraction
Extra Material Currently StoredMaternal plasma/serum
Current Post Processing Threshold for Accepting a CBU for Public Use
TNC
120 (100 for non caucasian parents)
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
1.00
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
CFU-GM
1x10^5
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
>1x10^5
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
50% >50% if CFU-GM
9. Storage
 

Type of Storage Container UsedBioArchive
Monitoring of StorageCentralized alarm system local
Monitoring of StorageLN2 level
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
IR
Current Level of HLA Typing at Time of Listing
HLA-DRB1
IR
Current Level of HLA Typing at Time of Listing
HLA-DQB1
IR
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
2
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 PatientHLA typing request
Length of Time a CBU can be Reserved
in days
90
Reservation FeeYes
Reservation Cancellation Fee in Absence of Shipment RequestYes
Can Reservation be ExtendedYes
Is a Unit Report Provided on a Unit that is Reserved for Another PatientNo
Is TC Informed when CBU is ReleasedNo
12. Release and Shipment
 

Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
50% /NA
Criteria to Ship a CBU
HLA Identity Testing
Yes
Current Packaging for Shipment to TCOverwrap
Current Packaging for Shipment to TCProtective sleeve
Current Packaging for Shipment to TC2 attached segments
Time Between Shipment Request and Sending CBU2-3 weeks
Fee for Shipment CancellationNo
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 CompanyCBB
Who Selects Transport CompanyWorld Courier
Shape of Transport ContainerCubic
13. Adverse Events Reporting
 

Who are S(P)EARS Reported To
Competent Authority
Yes

14. Pictures of cord blood units in the inventory

RBC red aut

15. Infectious Disease Marker (IDM) CURRENTLY performed.

View file
nameWO-1342-IDM-2015.pdf
height250
 


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