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Section 1 General Info
Question
|
CBB answer
|
|---|
| Name of the cord blood bank: |
|
| Number of cord blood units the cord blood bank plans to store for public use (unrelated patients): |
|
Section 2 Cord Blood Units in Inventory
Question | CBB answer |
|---|
| Current processing method(s): |
| Plasma and RBC reduced (automatic) | ☐ |
| Plasma reduction only | ☐ |
| Plasma and RBC reduced (manual) | ☐ |
| RBC reduction only | ☐ |
| Total Nucleated Cell Count (x10E7) of your cord blood units stored for Unrelated Patients (Public Use). |
| < 125 : |
|
| 125 - 149 : |
|
| 150 - 199 : |
|
| 200 - 250 : |
|
| > 250 : |
|
Section 3 Cord Blood Collection
Question
|
CBB answer
|
|---|
| Current practice for collecting cord blood: |
|
| Current antiseptic: |
|
| Collection bag: |
|
| Agitation during collection: |
|
Section 4 Conditioning and transport from Collection Centre to cord blood bank
Question | CBB answer |
|---|
| Secondary bag used by the cord blood bank (sealed, plastic bag or similar to avoid any leakage): |
|
| Transport conditions: |
| Insulating transport container | ☐ |
| Active refrigeration system | ☐ |
| Passive refrigeration system (gel, blocks) | ☐ |
| Electronic temperature probe | ☐ |
| Non-electronic temperature probe | ☐ |
| Qualified transporter | ☐ |
| Unqualified transporter | ☐ |
| Air transport | ☐ |
| Ground transport | ☐ |
| Other, | ☐ |
| Temperature range for storage and transportation of fresh product: |
|
Section 5 Evaluation
Question | CBB answer |
|---|
Pre-processing Evaluation:
Current threshold for accepting a cord blood unit for public use in the cord blood bank: |
| Net weight in grams (excluding bag and anticoagulant) before processing |
|
| TNC (10E7) before processing |
|
| Viability CD45 positive cells (%) |
|
| Viability CD45 positive cells (method) |
|
| Viability CD34 positive cells (%) |
|
| Viability CD34 positive cells (method) |
|
| Criteria that are completed before accepting a cord blood unit for public use in the cord blood bank: |
| Medical History | ☐ |
| Collection Report | ☐ |
| Informed Consent | ☐ |
| Maternal IDM results | ☐ |
| Temperature and integrity of the bag | ☐ |
| Other, | ☐ |
| Used method for CD34 enumeration: |
|
| The cord blood banks uses external proficiency testing for QC of the cord blood banks FACS lab: |
|
| The cord blood bank performs post processing/pre-freeze CD34 cell count: |
|
| Acceptable time from collection to processing: |
|
Section 6 Processing-Packaging
Question | CBB answer |
|---|
| The pre-freeze processing method(s) cord blood bank uses at any stage in time: |
| AXP | ☐ |
| SEPAX | ☐ |
| Optipress | ☐ |
| Prepacyte | ☐ |
| Manual- plasma and red cell reduction | ☐ |
| RBC/plasma reduction with HES | ☐ |
| Ficoll sedimentation | ☐ |
| Centrifugation and volume reduction | ☐ |
| No processing | ☐ |
| Manual- plasma reduction only | ☐ |
| Other, | ☐ |
| The current pre-freeze processing method(s): |
| AXP | ☐ |
| SEPAX | ☐ |
| Optipress | ☐ |
| Prepacyte | ☐ |
| Manual- plasma and red cell reduction | ☐ |
| RBC/plasma reduction with HES | ☐ |
| Ficoll sedimentation | ☐ |
| Centrifugation and volume reduction | ☐ |
| No processing | ☐ |
| Manual- plasma reduction only | ☐ |
| Other, | ☐ |
| Additives currently in use in addition to anticoagulants and DMSO during processing: |
| HES | ☐ |
| Prepacyte | ☐ |
| Plasmalyte | ☐ |
| Albumin | ☐ |
| Isotonic salt solution NaCl (saline) | ☐ |
| No additive | ☐ |
| Other, | ☐ |
| Cryoprotectant additives currently in use: |
|
| Cryopreservation method currently in use: |
| BioArchive | ☐ |
| MVE 1850 Vapor freezer | ☐ |
| Programmed cryopreservation with Air Liquid program (FREEZAL) | ☐ |
| Programmed freezer | ☐ |
| Two-step (equilibrium) freezing | ☐ |
| Cryobag currently in use: |
|
| Currently used packaging when a unit is stored: |
|
| Segments currently stored with the unit by the cord blood bank: |
| One attached segment | ☐ |
| Two or more attached segments | ☐ |
| Separate segments detached from the bag, but stored with the CBU | ☐ |
| Other samples | ☐ |
| None | ☐ |
Section 7 Testing
Question | CBB answer |
|---|
| Does your cord blood bank currently store extra material? |
| Cord blood DNA | ☐ |
| Cord blood material for DNA extraction | ☐ |
| Plasma/cord blood | ☐ |
| Maternal DNA | ☐ |
| Maternal material for DNA extraction | ☐ |
| Maternal plasma/serum | ☐ |
| HLA typing at time of listing: |
| HLA-A |
|
| HLA-B |
|
| HLA-C |
|
| HLA-DRB1 |
|
| HLA-DRB2 |
|
| HLA-DPB1 |
|
Section 8 Storage
Question | CBB answer |
|---|
| The following type(s) of storage container is currently used by the cord blood bank: |
| BioArchive tank | ☐ |
| Conventional storage tank-Vapor phase | ☐ |
| Conventional tank-Liquid phase | ☐ |
| Double walled liquid Nitrogen | ☐ |
| Type following type(s) of storage monitoring is currently by the cord blood bank: |
| Alarm on individual tanks only | ☐ |
| Centralized system-local | ☐ |
| Centralized system-remote monitoring | ☐ |
| LN2 level | ☐ |
| Lid opening | ☐ |
| System default | ☐ |
| Temperature monitoring | ☐ |
| No temperature monitoring | ☐ |
Section 9 Adverse Events Reporting
Question | CBB answer |
|---|
| Adverse Event Reporting used by the cord blood bank: |
| Competent authority | ☐ |
| Internal report | ☐ |
| National registry | ☐ |
| Transplant centre | ☐ |
| WMDA | ☐ |