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1. General Information
Name of CBBLifeCord/LifeSouth Community Blood Centers
CBB DirectorYesi
CBB DirectorSevilla
Address4039 Newberry Road
Address32607
AddressGainesville
Phone Number1 352 224-1600
Websitewww.lifesouthcord.org
Date CBB Started Collecting Cord Blood Units
(month/day/year)
06/01/1998
Number of Public Cord Blood Units6,216
Planned Number of Public Cord Blood Units Stored in 20151,000
Lists on BMDWNo
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationNational Marrow Donor Program (NMDP)
2. Cord Blood Units in Inventory
Current Processing MethodLiquid+ red auto
Previous Processing MethodVapour+ red manual
Previous Processing MethodVapour+ plasma only
Year Current Process Method Started2012
Percent of Units Plasma and RBC Reduced (manual)5
Percent of Units Plasma and RBC Reduced (automated)28
Percent of Units RBC Reduced Only67
Percent of Units No Volume Reduction0
3. Accreditations, Licenses and Certifications
FACT-NetcordYes
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityFDA
Audited by National Stem Cell RegistryYes
ISONo
OtherQC Lab - CLIA
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Collection BagSingle needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsPassive refrigeration system
Transport ConditionsElectronic temperature probe
Transport ConditionsAir transport
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 CBULabeling criteria
Current Threshold for Accepting a CBUViability threshold CD45
Method for CD34 RemunerationISHAGE guidelines
External Proficiency Testing for QC of FACS LabStem cell technology, CAP
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- 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)29.0
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageOne attached segment
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 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
50
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
1.25
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
Growth
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
Growth
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
85
9. Storage
Type of Storage Container UsedBioArchive
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 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
HR
Current Level of HLA Typing at Time of Listing
HLA-DPB1
HR
Accreditation of HLA LabASHI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
?10
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 Segment75-90%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementYes
11. Reservation and Cancellation Policies
What Point is a CBU Reserved for a PatientShipment request
Length of Time a CBU can be Reserved
in days
Other
Length of Time a CBU can be Reserved
in days
30 days prior to shipment date and 30 days post shipment date
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
85%
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 TCProtective sleeve
Current Packaging for Shipment to TC3 or more segments
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 CompanyRequesting transplant centre
Shape of Transport ContainerMushroom
13. Adverse Events Reporting
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

14.

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Pictures of cord blood units in the inventory

15. Infectious Disease Marker (IDM) CURRENTLY performed.

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Attachments

Attachments

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Holiday Calendar

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