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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 CBBUniversity of Colorado Cord Blood Bank
CBB DirectorBrian
CBB DirectorFreed
Address12635 E. Montview Blvd
AddressSte. 300
Address80045
AddressAurora
Phone Number303-724-1306
Websitewww.clinimmune.org
Date CBB Started Collecting Cord Blood Units
(month/day/year)
11/12/1996
Number of Public Cord Blood Units8,092
Planned Number of Public Cord Blood Units Stored in 2015200
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationNMDP
2. Cord Blood Units in Inventory
Current Processing MethodVapour+ red manual
Current Processing MethodVapour+ red auto
Previous Processing MethodLiquid+ red manual
Previous Processing MethodLiquid- red manual
Previous Processing MethodLiquid+ red auto
Previous Processing MethodLiquid- red auto
Year Current Process Method Started2009
Percent of Units Plasma and RBC Reduced (manual)60
Percent of Units Plasma and RBC Reduced (automated)40
3. Accreditations, Licenses and Certifications
FACT-NetcordNo
AABBYes
Competent Authority/ National Health AuthorityNo
Audited by National Stem Cell RegistryYes
ISONo
OtherFDA Licensed #1855 FDA registered
4. Cord Blood Collection
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticChlorhexidine
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 +1-35Β°C, higher limit +6-30Β°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 LabCAP
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to ProcessingOther
Time from Collection to ProcessingMissing
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
Pre Freeze Processing Methods- CurrentVolume reduction with HES manual
Additives Currently in UseHES
Current Cryopreservation MethodConventional CRF
Current Cryoprotectant AdditiveReady for use DMSO-Dextran
Current Cryoprotectant AdditiveOther: DMSO Dextran compounded on site for each use
Current CryobagSingle bag (one fraction)
Current CryobagOther: Some units are too lsrge for one bag and must be frozen in two bags of equal volume
Current Target Cryopreservation Volume (mL)41.9
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageMore than one segment
Current Packaging for StorageOther: Three viable TNC at 0.5ml - two for post thaw QC - one for FDA reserve sample after release
8. Testing
Extra Material Currently StoredCord blood material for DNA extraction
Extra Material Currently StoredPlasma/cord blood
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
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
85
9. Storage
Type of Storage Container UsedConventional storage tank vapor phase
Monitoring of StorageCentralized system remote monitoring
Monitoring of StorageLN2 level
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
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 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 SegmentYes
Percentage of CBUs that have an Attached Segment75-90%
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release RequirementNo
11. Reservation and Cancellation Policies
What Point is a CBU Reserved for a PatientCBU report request
Length of Time a CBU can be Reserved
in days
Other
Length of Time a CBU can be Reserved
in days
until further notice
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
>= 70% post thaw viable cell aliquot
Criteria to Ship a CBU
HLA Identity Testing
Yes
Current Packaging for Shipment to TCMetal canister
Current Packaging for Shipment to TCOne attached segment
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 CompanyNetwork Global Logistics for Domestic; World or Quick for INT
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. Pictures of cord blood units in the inventory


15. Infectious Disease Marker (IDM) CURRENTLY performed.



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