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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 CBBPUGLIA CORD BLOOD BANK
CBB DirectorLAZZARO
CBB DirectorDI MAURO
AddressPUGLIA CORB BLOOD BANK
AddressVIALE PADRE PIO, 1
Address71013
AddressSAN GIOVANNI ROTONDO
Phone Number+ 39 0882 416206
Websitewww.operapadrepio.it/it/content/view/1343/1010/
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/31/2008
Number of Public Cord Blood Units1,601
Planned Number of Public Cord Blood Units Stored in 2015100
Lists on BMDWNo
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationIBMDR
2. Cord Blood Units in Inventory
Current Processing MethodLiquid+ red manual
Current Processing MethodVapour+ red manual
Previous Processing MethodLiquid+ red auto
Previous Processing MethodVapour+ red auto
Previous Processing MethodLiquid+ plasma only
Previous Processing MethodVapour+ plasma only
Year Current Process Method Started2009
Percent of Units Plasma and RBC Reduced (manual)91
Percent of Units Plasma and RBC Reduced (automated)3
Percent of Units RBC Reduced Only3
Percent of Units No Volume Reduction3
3. Accreditations, Licenses and Certifications
FACT-NetcordNo
AABBNo
Competent Authority/ National Health AuthorityNo
Audited by National Stem Cell RegistryYes
ISOYes
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticBetadine
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 ConditionsActive refrigeration system
Transport ConditionsPassive refrigeration system
Temp. for Storage and TransportTemperature between +2 to +8Β°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 InventoryVolume reduction with HES-Manual
Pre Freeze Processing Methods- Unit in InventoryOther: Manual plasma and RBC reduction
Pre Freeze Processing Methods- CurrentOther:Manual plasma and RBC reduction
Additives Currently in UseOther: Albumin
Current Cryopreservation MethodConventional CRF
Current Cryoprotectant AdditiveDMSO
Current CryobagSingle bag (one fraction)
Current Target Cryopreservation Volume (mL)110.0
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageOne attached segment
Current Packaging for StorageAdditional separate segments
8. Testing
PCR Performed on IgM+ ResultCMV
PCR Performed on IgM+ ResultToxoplasmosis
PCR Performed on IgM+ ResultEBV
Extra Material Currently StoredCord blood DNA
Extra Material Currently StoredCord blood material for DNA extraction
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
120
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
1
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
1
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
60
9. Storage
Type of Storage Container UsedConventional storage tank vapor phase
Type of Storage Container UsedConventional tank liquid phase
Monitoring of StorageCentralized alarm system local
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
LR
Current Level of HLA Typing at Time of Listing
HLA-B
LR
Current Level of HLA Typing at Time of Listing
HLA-C
LR
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
4
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
Length of Time a CBU can be Reserved
in days
60
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 ReleasedNo
12. Release and Shipment
Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
50
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 TCOverwrap
Current Packaging for Shipment to TCSeparate segment
Current Packaging for Shipment to TCTransport rack
Time Between Shipment Request and Sending CBU1-2 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
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


15. Infectious Disease Marker (IDM) CURRENTLY performed.



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