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Section 1 General Info
Question | CBB answer |
|---|
| The information has been reviewed in year : | |
| Name of the cord blood bank: | Versiti Michigan |
| Number of cord blood units the cord blood bank plans to store for public use (unrelated patients): | 3786 |
Section 2 Cord Blood Units in Inventory
Question | CBB answer |
|---|
| Current processing method(s): |
| Plasma and RBC reduced (automatic) | checktrue |
| Plasma reduction only | checkfalse |
| Plasma and RBC reduced (manual) | checkfalse |
| RBC reduction only | checkfalse |
| Total Nucleated Cell Count (x10E7) of your cord blood units stored for Unrelated Patients (Public Use). |
| < 125 : | 2357 |
| 125 - 149 : | 718 |
| 150 - 199 : | 595 |
| 200 - 250 : | 103 |
| > 250 : | 13 |
Section 3 Cord Blood Collection
Question | CBB answer |
|---|
| Current practice for collecting cord blood: | In-utero and ex-utero |
| Current antiseptic: | Other povidone-Iodine |
| Collection bag: | Single needle |
| Agitation during collection: | Manual |
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): | yes |
| Transport conditions: |
| Insulating transport container | checktrue |
| Active refrigeration system | checkfalse |
| Passive refrigeration system (gel, blocks) | checktrue |
| Electronic temperature probe | checkfalse |
| Non-electronic temperature probe | checkfalse |
| Qualified transporter | checktrue |
| Unqualified transporter | checkfalse |
| Air transport | checkfalse |
| Ground transport | checktrue |
| Other, Validated 2-8 C transport box | checkfalse |
| Temperature range for storage and transportation of fresh product: | Temperature between +2 to +8°C |
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 | 70 - 79.99 grams |
| TNC (10E7) before processing | 125 - 149 |
| Viability CD45 positive cells (%) | NA- not evaluated pre-processing |
| Viability CD45 positive cells (method) | 7AAD |
| Viability CD34 positive cells (%) | NA- not evaluated pre-processing |
| Viability CD34 positive cells (method) | 7AAD |
| Criteria that are completed before accepting a cord blood unit for public use in the cord blood bank: |
| Medical History | checktrue |
| Collection Report | checktrue |
| Informed Consent | checktrue |
| Maternal IDM results | checkfalse |
| Temperature and integrity of the bag | checktrue |
| Other, | checkfalse |
| Used method for CD34 enumeration: | BD Stem Cell Enumeration Kit and software |
| The cord blood banks uses external proficiency testing for QC of the cord blood banks FACS lab: | yes |
| The cord blood bank performs post processing/pre-freeze CD34 cell count: | yes |
| Acceptable time from collection to processing: | 24-48H Collection up to 48 hrs |
Section 6 Processing-Packaging
Question | CBB answer |
|---|
| The pre-freeze processing method(s) cord blood bank uses at any stage in time: |
| AXP | checkfalse |
| SEPAX | checktrue |
| Optipress | checkfalse |
| Prepacyte | checkfalse |
| Manual- plasma and red cell reduction | checktrue |
| RBC/plasma reduction with HES | checkfalse |
| Ficoll sedimentation | checkfalse |
| Centrifugation and volume reduction | checkfalse |
| No processing | checkfalse |
| Manual- plasma reduction only | checkfalse |
| Other, | checkfalse |
| The current pre-freeze processing method(s): |
| AXP | checkfalse |
| SEPAX | checktrue |
| Optipress | checkfalse |
| Prepacyte | checkfalse |
| Manual- plasma and red cell reduction | checktrue |
| RBC/plasma reduction with HES | checkfalse |
| Ficoll sedimentation | checkfalse |
| Centrifugation and volume reduction | checkfalse |
| No processing | checkfalse |
| Manual- plasma reduction only | checkfalse |
| Other, | checkfalse |
| Additives currently in use in addition to anticoagulants and DMSO during processing: |
| HES | checktrue |
| Prepacyte | checkfalse |
| Plasmalyte | checkfalse |
| Albumin | checkfalse |
| Isotonic salt solution NaCl (saline) | checkfalse |
| No additive | checkfalse |
| Other, | checkfalse |
| Cryoprotectant additives currently in use: | DMSO- Dextran |
| Cryopreservation method currently in use: |
| BioArchive | checkfalse |
| MVE 1850 Vapor freezer | checkfalse |
| Programmed cryopreservation with Air Liquid program (FREEZAL) | checkfalse |
| Programmed freezer | checktrue |
| Two-step (equilibrium) freezing | checkfalse |
| Cryobag currently in use: | Single bag (two fractions) |
| Currently used packaging when a unit is stored: | Metal canister and overwrap |
| Segments currently stored with the unit by the cord blood bank: |
| One attached segment | checkfalse |
| Two or more attached segments | checktrue |
| Separate segments detached from the bag, but stored with the CBU | checkfalse |
| Other samples | checkfalse |
| None | checkfalse |
Section 7 Testing
Question | CBB answer |
|---|
| Does your cord blood bank currently store extra material? |
| Cord blood DNA | checkfalse |
| Cord blood material for DNA extraction | checkfalse |
| Plasma/cord blood | checktrue |
| Maternal DNA | checktrue |
| Maternal material for DNA extraction | checktrue |
| Maternal plasma/serum | checktrue |
| HLA typing at time of listing: |
| HLA-A | High Resolution |
| HLA-B | High Resolution |
| HLA-C | High Resolution |
| HLA-DRB1 | High Resolution |
| HLA-DRB2 | High Resolution |
| HLA-DPB1 | High Resolution |
Section 8 Storage
Question | CBB answer |
|---|
| The following type(s) of storage container is currently used by the cord blood bank: |
| BioArchive tank | checkfalse |
| Conventional storage tank-Vapor phase | checktrue |
| Conventional tank-Liquid phase | checkfalse |
| Double walled liquid Nitrogen | checkfalse |
| Type following type(s) of storage monitoring is currently by the cord blood bank: |
| Alarm on individual tanks only | checktrue |
| Centralized system-local | checkfalse |
| Centralized system-remote monitoring | checktrue |
| LN2 level | checktrue |
| Lid opening | checktrue |
| System default | checkfalse |
| Temperature monitoring | checktrue |
| No temperature monitoring | checkfalse |
Section 9 Adverse Events Reporting
Question | CBB answer |
|---|
| Adverse Event Reporting used by the cord blood bank: |
| Competent authority | checktrue |
| Internal report | checktrue |
| National registry | checktrue |
| Transplant centre | checkfalse |
| WMDA | checkfalse |