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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.

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1. General Information
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Name of CBBFinnish Cord Blood Bank
CBB DirectorMatti
CBB DirectorKorhonen
AddressKivihaantie 7
Address00310
AddressHelsinki
Phone Number+358 29 300 1010
Websitewww.bloodservice.fi
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/01/1998
Number of Public Cord Blood Units3,358
Planned Number of Public Cord Blood Units Stored in 20150
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationFinnish Stem Cell Registry
2. Cord Blood Units in Inventory
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Current Processing MethodLiquid+ red auto
Previous Processing MethodLiquid+ red manual
Year Current Process Method Started2004
Percent of Units Plasma and RBC Reduced (manual)15
Percent of Units Plasma and RBC Reduced (automated)85
3. Accreditations, Licenses and Certifications
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FACT-NetcordIn process of accreditation
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityFinnish Medicines Agency
Audited by National Stem Cell RegistryYes
ISONo
4. Cord Blood Collection
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Current Collection Practice
Is the collection In/Ex -Utero or both?
Ex-utero
Current AntisepticAlcohol
Collection BagDouble needle
Agitation during CollectionNone
5. Conditioning/Transport from Collection Site to CBB
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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 TransportRoom temperature
6. Pre-Processing Evaluation
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Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Completed Prior to Accepting a CBUInfectious Disease Markers (must be negative/non-reactive)
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
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Pre Freeze Processing Methods- Unit in InventorySEPAX
Pre Freeze Processing Methods- Unit in InventoryVolume reduction with HES-Manual
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
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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 DNA
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
150
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
NA
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
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
90
9. Storage
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Type of Storage Container UsedBioArchive
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
10. HLA Typing
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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
HR
Current Level of HLA Typing at Time of Listing
HLA-DQB1
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Current Level of HLA Typing at Time of Listing
HLA-DPB1
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Accreditation of HLA LabEFI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
6
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
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What Point is a CBU Reserved for a PatientHLA typing request
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
30
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
Is TC Informed when CBU is ReleasedYes
12. Release and Shipment
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Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
90
Criteria to Ship a CBU
HLA Identity Testing
Yes
Current Packaging for Shipment to TCMetal canister
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 CBU4 days-1 week
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 CompanyWe suggest transport company and the requesting transplant centre must approve. We use World Courier.
Shape of Transport ContainerMushroom
13. Adverse Events Reporting
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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

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15. Infectious Disease Marker (IDM) CURRENTLY performed.

View file
nameWO-1348-IDM-2015.pdf
height250

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