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 CBBSt. Louis Cord Blood Bank
CBB DirectorDonna
CBB DirectorRegan
Address3662 Park Avenue
Address63110
AddressSaint Louis, Missouri
Phone Number314 268 2787
Websiteslcbb.org
Date CBB Started Collecting Cord Blood Units
(month/day/year)
01/26/1996
Number of Public Cord Blood Units25,673
Planned Number of Public Cord Blood Units Stored in 20151,300
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationNMDP
2. Cord Blood Units in Inventory
Current Processing MethodLiquid+ red manual
Current Processing MethodVapour+ red manual
Year Current Process Method Started2009
Percent of Units Plasma and RBC Reduced (manual)100
3. Accreditations, Licenses and Certifications
FACT-NetcordNo
AABBYes
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityUS FDA
Audited by National Stem Cell RegistryYes
ISONo
OtherFDA License # 1873 College of American Pathologists (granted 'deemed status' by CLIA for CMS)
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
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsInsulating transport container
Transport ConditionsNon-electronic 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 LabCAP
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to Processingup to 48H
7. Processing and Packaging
Pre Freeze Processing Methods- Unit in InventoryOther: RBC/plasma reduction with HES (1996-2009); PrepaCyte-CB (Cord Blood) Processing System (2009-present)
Pre Freeze Processing Methods- CurrentOther: PrepaCyte
Additives Currently in UseOther: PrepaCyte
Current Cryopreservation MethodConventional CRF
Current Cryopreservation MethodOther: Custom biogenic systems 2100 series controlled rate freezing system
Current Cryoprotectant AdditiveReady for use DMSO-Dextran
Current CryobagSingle bag (one fraction)
Current Target Cryopreservation Volume (mL)30.0
Current Packaging for StorageOverwrap
Current Packaging for StorageCanister
Current Packaging for StorageOne attached segment
Current Packaging for StorageOther: Older units were stored with fewer segments, all of which may have been used to perform confirmatory or quality testing. Units processed after 2009 are to retain one segment for the TC.
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
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
CFU
CFU/TNC ratio >2 per 10,000
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
85
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 StorageLN2 level
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
IR
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 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 PatientHLA typing request
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
minimum 6 weeks
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
segment CFU >25% of post-proc CFU
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 CBU0-3 days
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 CompanyNMDP or transplant center
Shape of Transport ContainerMushroom
13. Adverse Events Reporting
Who are S(P)EARS Reported To
Competent Authority
Yes

14. Pictures of cord blood units in the inventory

RBC red manRBC red manRBC red man

15. Infectious Disease Marker (IDM) CURRENTLY performed.



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