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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 CBBSt.Eugenio Hospital
CBB DirectorItalo
CBB DirectorDe Meis
Addresspiazzale dell'Umanesimo 10
Address00144
AddressRome
Phone Number0039 06 51002259
Websitecordbloodbank@aslrmc.it
Date CBB Started Collecting Cord Blood Units
(month/day/year)
03/01/1995
Number of Public Cord Blood Units846
Planned Number of Public Cord Blood Units Stored in 201570
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationITALIAN BONE MARROW DONOR REGISTRY IBMDR
2. Cord Blood Units in Inventory 
Current Processing MethodLiquid+ plasma only
Year Current Process Method Started2010
Percent of Units Plasma and RBC Reduced (manual)30
Percent of Units No Volume Reduction70
3. Accreditations, Licenses and Certifications 
FACT-NetcordNo
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityCentro Nazionale Sangue-Centro Nazionale Trapianti
Audited by National Stem Cell RegistryNo
ISOYes
4. Cord Blood Collection 
Current Collection Practice
Is the collection In/Ex -Utero or both?
Both
Current AntisepticBetadine
Collection BagDouble needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB 
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsUnqualified transporter
Transport ConditionsActive refrigeration system
Transport ConditionsPassive refrigeration system
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
Completed Prior to Accepting a CBUTransport report
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 InventoryOptipress
Pre Freeze Processing Methods- Unit in InventoryOther: Volume reduction manual
Pre Freeze Processing Methods- CurrentOther: Volume reduction manual
Additives Currently in UseNo additive
Current Cryopreservation MethodConventional CRF
Current Cryoprotectant AdditiveDMSO
Current CryobagSingle bag (one fraction)
Current CryobagOther: Two bags 50:50
Current Target Cryopreservation Volume (mL)130.0
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
Current Packaging for StorageAdditional separate segments
8. Testing 
PCR Performed on IgM+ ResultCMV
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
120
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
Viability
80
9. Storage 
Type of Storage Container UsedConventional tank liquid phase
Monitoring of StorageAlarm on individual tanks only
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
Monitoring of StorageLid opening
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
9
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 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
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
12. Release and Shipment 
Hemoglobinopathy Screening Performed Prior to ReleaseYes
Criteria to Ship a CBU
Viability and Cell Count
>40% / >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
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 ContainerOther
Shape of Transport Containercylindrical in the cubic container
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

14. Pictures of cord blood units in the inventory

 

15. Infectious Disease Marker (IDM) CURRENTLY performed.

Attachments

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View file
nameWO-1360-IDM-2015.pdf
height250

 

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