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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 CBBPavia CBB
CBB DirectorLaura
CBB DirectorSalvaneschi
Addressviale C.Golgi 19
Address27100
AddressPavia
Phone Number+39 0382 503086-3088
Websitepvcbbank@smatteo.pv.it
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/01/1997
Number of Public Cord Blood Units4,335
Planned Number of Public Cord Blood Units Stored in 2015150
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationIBMDR (Italian Bone Marrow Donor Regsitry)
2. Cord Blood Units in Inventory
 

Current Processing MethodLiquid+ plasma only
Year Current Process Method Started2004
Percent of Units Plasma and RBC Reduced (manual)60
Percent of Units No Volume Reduction40
3. Accreditations, Licenses and Certifications
 

FACT-NetcordYes
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityNational Blood Center (CNS)/National Transplant Center (CNT)
Audited by National Stem Cell RegistryYes
ISOYes
OtherNMDP IND protocol
4. Cord Blood Collection
 

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

Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportOther (lower limit +1-35°C, higher limit +6-30°C)
6. Pre-Processing Evaluation
 

Completed Prior to Accepting a CBUMedical history, collection report, informed consent
Current Threshold for Accepting a CBUViability threshold CD45
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 InventoryNo processing
Pre Freeze Processing Methods- Unit in InventoryOther: Manual plasma depletion
Pre Freeze Processing Methods- CurrentOther: Plasma depletion manual
Additives Currently in UseNo additive
Current Cryopreservation MethodConventional CRF
Current Cryopreservation MethodOther: Liquid phase
Current Cryoprotectant AdditiveDMSO
Current CryobagSingle bag (one fraction)
Current Target Cryopreservation Volume (mL)50 or 100 ml
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
Current Packaging for StorageOther: 3 satellite cryovials containing NC(CB) stored with the unit
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 DNA
Extra Material Currently StoredMaternal plasma/serum
Current Post Processing Threshold for Accepting a CBU for Public Use
TNC
120
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU-GM
> or =1
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
> or = 1
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
70
9. Storage
 

Type of Storage Container UsedConventional tank liquid phase
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
Monitoring of StorageLid opening
Monitoring of StorageSystem default
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
IR
Current Level of HLA Typing at Time of Listing
HLA-DRB1
HR
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
7
Attached Segment Used for Confirmatory/ Verification TypingYes
Units Listed without Attached Segment and have not been Previously Typed on Attached SegmentYes
Percentage of CBUs that have an Attached Segmentbelow 50%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementNo
11. Reservation and Cancellation Policies
 

What Point is a CBU Reserved for a PatientReservation request
Length of Time a CBU can be Reserved
in days
Other
Length of Time a CBU can be Reserved
in days
30 days + 30 days
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
 

Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
40% / 60% NC recovery
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 TCProtective sleeve
Current Packaging for Shipment to TCTransport rack
Time Between Shipment Request and Sending CBUOther
Time to Prepare a Cord Blood Unit for Shipmentstandard procedure: 2 weeks, urgent procedure: 2 days
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 CompanyCBB
Who Selects Transport CompanyWorld Courier is selected by IBMDR. Excepted for couriers selected by FGM and ANT.
Shape of Transport ContainerMushroom
13. Adverse Events Reporting
 

Who are S(P)EARS Reported To
National Registry
Yes

14. Pictures of cord blood units in the inventory

 


15. Infectious Disease Marker (IDM) CURRENTLY performed.

View file
namepg_0030_WO-1366-IDM-response-141-2015.pdf
height250
 


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