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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 CBBCord Blood Bank of Samara Regional Center of Family Planning and Reproduction
CBB DirectorOlga
CBB DirectorTyumina
Address159 Tashkentskaya St
Address443095
AddressSamara
Phone Number+7(846)9560511
Websitecordbank.ru
Date CBB Started Collecting Cord Blood Units
(month/day/year)
06/07/2004
Number of Public Cord Blood Units7,555
Planned Number of Public Cord Blood Units Stored in 2015400
Lists on BMDWYes
Affiliated with National Stem Cell Donor RegistryYes
Registry AffiliationHPC registry
2. Cord Blood Units in Inventory 
Current Processing MethodLiquid+ red manual
Current Processing MethodLiquid+ red auto
Year Current Process Method Started2004
Percent of Units Plasma and RBC Reduced (automated)100
3. Accreditations, Licenses and Certifications 
FACT-NetcordNo
AABBNo
Competent Authority/ National Health AuthorityYes
Name of Competent AuthorityMinistry of Healthcare of Samara Region
Audited by National Stem Cell RegistryYes
ISOYes
OtherEFI accreditted lab #05-RU-005.995
4. Cord Blood Collection 
Current Collection Practice
Is the collection In/Ex -Utero or both?
In-utero
Current AntisepticChlorhexidine
Current AntisepticAlcohol
Collection BagSingle needle
Agitation during CollectionManual
5. Conditioning/Transport from Collection Site to CBB 
Secondary Bag UsedYes
Transport ConditionsQualified transporter
Transport ConditionsPassive refrigeration system
Transport ConditionsElectronic temperature probe
Transport ConditionsGround transport
Temp. for Storage and TransportRoom temperature
6. Pre-Processing Evaluation 
Completed Prior to Accepting a CBUMedical history, collection report, informed consent
External Proficiency Testing for QC of FACS LabNo
Post Processing/ Pre Freeze CD34+ Cell CountYes
Time from Collection to Processingup to 36H
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 MethodBioArchive
Current Cryoprotectant AdditiveDMSO
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 StorageAdditional separate segments
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 material for DNA extraction
Extra Material Currently StoredMaternal plasma/serum
Current Post Processing Threshold for Accepting a CBU for Public Use
TNC
150
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Single Platform
1.60
Current Post Processing Threshold for Accepting a CBU for Public Use
CD34 (10^6) Double Platform
1.6
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
NA
Current Post Processing Threshold for Accepting a CBU for Public Use
Viability
NA
9. Storage 
Type of Storage Container UsedBioArchive
Monitoring of StorageCentralized alarm system local
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
IR
Current Level of HLA Typing at Time of Listing
HLA-B
IR
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
LR
Current Level of HLA Typing at Time of Listing
HLA-DPB1
LR
Accreditation of HLA LabEFI accredited lab
Average Turnaround Time for Extended HLA Typing Results
in days
5
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
What Point is a CBU Reserved for a PatientShipment request
Length of Time a CBU can be Reserved
in days
90
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 ReleaseNo
Criteria to Ship a CBU
Viability and Cell Count
NA
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 TCProtective sleeve
Current Packaging for Shipment to TCSeparate segment
Time Between Shipment Request and Sending CBU2-3 weeks
Fee for Shipment CancellationYes
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 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
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.

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View file

Attachments

nameWO-1341-IDM-2015.pdf
height250

 

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