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1. General Information | |
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Name of CBB | Calabria Cord Blood Bank |
CBB Director | Giulia |
CBB Director | Pucci |
Address | Presidio Morelli |
Address | AO BMM |
Address | V.le Europa, sn |
Address | 89133 |
Address | Reggio Calabria |
Phone Number | +390965393723 |
Website | www.calabriacbb.com |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 01/14/2006 |
Number of Public Cord Blood Units | 835 |
Planned Number of Public Cord Blood Units Stored in 2015 | 100 |
Lists on BMDW | No |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | IBMDR |
2. Cord Blood Units in Inventory | |
Current Processing Method | Vapour+ red manual |
Previous Processing Method | Vapour+ red auto |
Year Current Process Method Started | 2013 |
Percent of Units Plasma and RBC Reduced (manual) | 70 |
Percent of Units Plasma and RBC Reduced (automated) | 30 |
3. Accreditations, Licenses and Certifications | |
FACT-Netcord | No |
AABB | No |
Competent Authority/ National Health Authority | Yes |
Name of Competent Authority | Centro Nazionale Sangue / Centro Nazionale Trapianti |
Audited by National Stem Cell Registry | Yes |
ISO | Yes |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | Ex-utero |
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 |
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 |
Method for CD34 Remuneration | ISHAGE guidelines |
External Proficiency Testing for QC of FACS Lab | No |
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: Manual (buffy coat) volume reduction with semiautomated processor |
Pre Freeze Processing Methods- Current | Other: Volum reduction with semiautomated processor |
Additives Currently in Use | Other: Isotonic salt solution NaCl at 0.9%, Human Albumin |
Current Cryopreservation Method | Other: Rubinstein |
Current Cryoprotectant Additive | DMSO |
Current Cryobag | Single bag (one fraction) |
Current Target Cryopreservation Volume (mL) | 100.0 |
Current Packaging for Storage | Overwrap |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
8. Testing | |
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 | 1 colony x10E4 |
Current Post Processing Threshold for Accepting a CBU for Public Use Viability | 80 |
9. Storage | |
Type of Storage Container Used | Conventional storage tank vapor phase |
Monitoring of Storage | Alarm on individual tanks only |
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 | 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 | |
Current Level of HLA Typing at Time of Listing HLA-DPB1 | |
Accreditation of HLA Lab | EFI accredited lab |
Average Turnaround Time for Extended HLA Typing Results in days | ?10 |
Attached Segment Used for Confirmatory/ Verification Typing | Yes |
Units Listed without Attached Segment and have not been Previously Typed on Attached Segment | No |
Percentage of CBUs that have an Attached Segment | 90-100% |
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 | 80% at processing;? 40 % at QC |
Criteria to Ship a CBU HLA Identity Testing | Yes |
Current Packaging for Shipment to TC | Metal canister |
Current Packaging for Shipment to TC | Overwrap |
Current Packaging for Shipment to TC | Separate segment |
Current Packaging for Shipment to TC | 3 or more segments |
Current Packaging for Shipment to TC | Transport rack |
Time Between Shipment Request and Sending CBU | 4 days-1 week |
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 | IBMDR selects companies. World Courier |
Shape of Transport Container | Other |
Shape of Transport Container | dry shipper is cilindric. it is shipped inside a parallelepiped container |
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. IDM
15. Images
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