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1. General Information | |
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Name of CBB | Florence Cord Blood Bank |
CBB Director | Riccardo |
CBB Director | Saccardi |
Address | Largo Brambilla, 3 |
Address | 50134 |
Address | Florence |
Phone Number | +39-0557947672 |
Website | www.cbbtoscana.it / www.aou-careggi.toscana.it/internet/index.php?option=com_content&view=article&id=477&Itemid=951&lang=it |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 06/22/1994 |
Number of Public Cord Blood Units | 2,148 |
Planned Number of Public Cord Blood Units Stored in 2015 | 120 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | IBMDR |
2. Cord Blood Units in Inventory | |
Current Processing Method | Liquid+ red auto |
Current Processing Method | Vapour+ red auto |
Previous Processing Method | Liquid+ red manual |
Previous Processing Method | Vapour+ red manual |
Previous Processing Method | Liquid+ plasma only |
Previous Processing Method | Vapour+ plasma only |
Year Current Process Method Started | 2008 |
Percent of Units Plasma and RBC Reduced (manual) | 24 |
Percent of Units Plasma and RBC Reduced (automated) | 74 |
Percent of Units No Volume Reduction | 2 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | No |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | CNT/CNS |
Audited by National Stem Cell Registry | Yes |
ISO | Yes |
Other | IND Qualification, FDA listed |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
Current Antiseptic | Chlorhexidine |
Current Antiseptic | Betadine |
Collection Bag | Double needle |
Agitation during Collection | Manual |
5. Conditioning/Transport from Collection Site to CBB | |
Secondary Bag Used | Yes |
Transport Conditions | Qualified transporter |
Transport Conditions | Insulating transport container |
Transport Conditions | Passive refrigeration system |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Ground transport |
Temp. for Storage and Transport | Other (lower limit +1-35Β°C, higher limit +6-30Β°C) |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
Current Threshold for Accepting a CBU | Viability threshold CD45 |
Method for CD34 Remuneration | ISHAGE guidelines |
External Proficiency Testing for QC of FACS Lab | UKNEQAS |
Post Processing/ Pre Freeze CD34+ Cell Count | Yes |
Time from Collection to Processing | up to 48H |
7. Processing and Packaging | |
Pre Freeze Processing Methods- Unit in Inventory | SEPAX |
Pre Freeze Processing Methods- Unit in Inventory | Other: Volume reduction without HES |
Pre Freeze Processing Methods- Current | SEPAX |
Additives Currently in Use | HES |
Current Cryopreservation Method | Conventional CRF |
Current Cryoprotectant Additive | Ready for use DMSO-Dextran |
Current Cryobag | Single bag 80:20 |
Current Target Cryopreservation Volume (mL) | 26.0 |
Current Packaging for Storage | Overwrap |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
8. Testing | |
PCR Performed on IgM+ Result | CMV |
PCR Performed on IgM+ Result | Toxoplasmosis |
PCR Performed on IgM+ Result | EBV |
Extra Material Currently Stored | Cord blood DNA |
Extra Material Currently Stored | Cord blood material for DNA extraction |
Extra Material Currently Stored | Plasma/cord blood |
Extra Material Currently Stored | Maternal material for DNA extraction |
Extra Material Currently Stored | Maternal 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 CFU | presence of growth |
Current Post Processing Threshold for Accepting a CBU for Public Use Viability | 90 |
9. Storage | |
Type of Storage Container Used | Conventional storage tank vapor phase |
Type of Storage Container Used | Conventional tank liquid phase |
Monitoring of Storage | Centralized alarm system local |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | Temperature monitoring |
10. HLA Typing | |
Current Level of HLA Typing at Time of Listing HLA-A | HR |
Current Level of HLA Typing at Time of Listing HLA-B | HR |
Current Level of HLA Typing at Time of Listing HLA-C | HR |
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 Lab | EFI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | 8 |
Attached Segment Used for Confirmatory/ Verification Typing | Yes |
Units Listed without Attached Segment and have not been Previously Typed on Attached Segment | Yes |
Percentage of CBUs that have an Attached Segment | below 50% |
Confirmatory/ Verification Typing on an Attached Segment is Pre-Release Requirement | Yes |
11. Reservation and Cancellation Policies | |
What Point is a CBU Reserved for a Patient | Reservation request |
Length of Time a CBU can be Reserved in days | 60 |
Reservation Fee | No |
Reservation Cancellation Fee in Absence of Shipment Request | No |
Can Reservation be Extended | Yes |
Is a Unit Report Provided on a Unit that is Reserved for Another Patient | No |
Is TC Informed when CBU is Released | Yes |
12. Release and Shipment | |
Hemoglobinopathy Screening Performed Prior to Release | Yes |
Criteria to Ship a CBU Viability and Cell Count | 40 |
Criteria to Ship a CBU HLA Identity Testing | Yes |
Current Packaging for Shipment to TC | Metal canister |
Current Packaging for Shipment to TC | One attached segment |
Time Between Shipment Request and Sending CBU | 1-2 weeks |
Fee for Shipment Cancellation | Yes |
Dry Shippers Validated to Maintain Temperature of at least -150 for 48 hours Beyond Expected Arrival | Yes |
Electronic Temperature Data Logger on All Dry Shippers | Yes |
Who Selects Transport Company | CBB |
Who Selects Transport Company | The transport company (currently World Courier) is selected by IBMDR; some Transplantation Centers select the transport company for DNA. |
Shape of Transport Container | Mushroom |
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.
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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
Team Calendars | ||
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