⚠Due to planned maintenance you will experience short (<30 min) downtime between 08:00 - 08:30 CET.
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1. General Information | |
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Name of CBB | St.Eugenio Hospital |
CBB Director | Italo |
CBB Director | De Meis |
Address | piazzale dell'Umanesimo 10 |
Address | 00144 |
Address | Rome |
Phone Number | 0039 06 51002259 |
Website | cordbloodbank@aslrmc.it |
Date CBB Started Collecting Cord Blood Units (month/day/year) | 03/01/1995 |
Number of Public Cord Blood Units | 846 |
Planned Number of Public Cord Blood Units Stored in 2015 | 70 |
Lists on BMDW | Yes |
Affiliated with National Stem Cell Donor Registry | Yes |
Registry Affiliation | ITALIAN BONE MARROW DONOR REGISTRY IBMDR |
2. Cord Blood Units in Inventory | |
Current Processing Method | Liquid+ plasma only |
Year Current Process Method Started | 2010 |
Percent of Units Plasma and RBC Reduced (manual) | 30 |
Percent of Units No Volume Reduction | 70 |
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 | No |
ISO | Yes |
4. Cord Blood Collection | |
Current Collection Practice Is the collection In/Ex -Utero or both? | Both |
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 | Unqualified transporter |
Transport Conditions | Active refrigeration system |
Transport Conditions | Passive refrigeration system |
Transport Conditions | Electronic temperature probe |
Transport Conditions | Ground transport |
Temp. for Storage and Transport | Other (lower limit +1-35°C, higher limit +6-30°C) |
6. Pre-Processing Evaluation | |
Completed Prior to Accepting a CBU | Medical history, collection report, informed consent |
Completed Prior to Accepting a CBU | Transport report |
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 | No processing |
Pre Freeze Processing Methods- Unit in Inventory | Optipress |
Pre Freeze Processing Methods- Unit in Inventory | Other: Volume reduction manual |
Pre Freeze Processing Methods- Current | Other: Volume reduction manual |
Additives Currently in Use | No additive |
Current Cryopreservation Method | Conventional CRF |
Current Cryoprotectant Additive | DMSO |
Current Cryobag | Single bag (one fraction) |
Current Cryobag | Other: Two bags 50:50 |
Current Target Cryopreservation Volume (mL) | 130.0 |
Current Packaging for Storage | Overwrap |
Current Packaging for Storage | Canister |
Current Packaging for Storage | More than one segment |
Current Packaging for Storage | Additional separate segments |
8. Testing | |
PCR Performed on IgM+ Result | CMV |
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 DNA |
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 Viability | 80 |
9. Storage | |
Type of Storage Container Used | Conventional tank liquid phase |
Monitoring of Storage | Alarm on individual tanks only |
Monitoring of Storage | Centralized system remote monitoring |
Monitoring of Storage | LN2 level |
Monitoring of Storage | Lid opening |
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 | 9 |
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 | 30 |
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 |
12. Release and Shipment | |
Hemoglobinopathy Screening Performed Prior to Release | Yes |
Criteria to Ship a CBU Viability and Cell Count | >40% / >50% |
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 |
Current Packaging for Shipment to TC | Overwrap |
Current Packaging for Shipment to TC | Separate segment |
Time Between Shipment Request and Sending CBU | 1-2 weeks |
Fee for Shipment Cancellation | No |
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 | WORLD COURIER |
Shape of Transport Container | Other |
Shape of Transport Container | cylindrical in the cubic container |
13. Adverse Events Reporting | |
Who are S(P)EARS Reported To Competent Authority | 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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