Cord Blood Bank Technology Survey

Transcription

1 Cord Blood Bank Technology Survey

2 1. General data Name of the Cord Blood Bank: * Name of director of the Cord Blood Bank: First name: Last name: address of the director of the Cord Blood Bank: Ctact details of the Cord Blood Bank: Address: Address: Address: ZIP-code: City: Country: Telephe number: Fax number: Website Address: Name of the pers completing the survey: * First name: Last name: address of the pers completing the survey (copy of the survey will be sent to this address): *

3 2. When did your Cord Blood Bank start collecting cord units? Calendar 3. Type of cord units in the inventory of your Cord Blood Bank (please note the number of cord units stored December 31, 2014). Cord Blood Units in inventory for Unrelated Allogeneic. Cord Blood Units in inventory for Related Allogeneic (directed). Cord Blood Units in inventory for Autologous. 4. How many cord units do you plan to store for public use (unrelated patients) in 2015? 5. Does your Cord Blood Bank list units in BMDW ( 6. Is your Cord Blood Bank affiliated with a Natial Stem Cell Dor Registry? If yes, list the name of the registry., please list the name of the registry Cord Blood Units in Inventory

4 7. Plasma and RBC reduced (manual). If you currently do this, mark "CURRENT PRACTICE" regardless of previous. Current current, but previous Never With segments in liquid phase Current current, but previous Never With segments in vapour phase Current current, but previous Never Without segments in liquid phase Current current, but previous Never Without segments in vapour phase Current current, but previous Never 8. Plasma and RBC reduced (automatic). If you currently do this, mark "CURRENT PRACTICE" regardless of previous. Current current, but previous Never With segments in liquid phase Current current, but previous Never With segments in vapour phase Current current, but previous Never Without segments in liquid phase Current current, but previous Never Without segments in vapour phase Current current, but previous Never

5 9. Plasma reducti ly. If you currently do this, mark "CURRENT PRACTICE" regardless of previous. Current current, but previous Never With segments in liquid phase Current current, but previous Never With segments in vapour phase Current current, but previous Never Without segments in liquid phase Current current, but previous Never Without segments in vapour phase Current current, but previous Never 10. What year did your Cord Blood Bank start using your current processes?

6 11. Please state the percentage (use your best estimate) of cord units that were processed using each method below. Find here an example: - 10% of the whole inventory stored are plasma and RBC reduced units (manual), - 40% of the whole inventory are plasma and RBC reduced (automated), - 30% of the whole inventory stored are red cell reducti (RBC reduced), - 20% of the whole inventory no volume reducti). The total of the categories must equal 100%. You can scroll the butt. 0% 100% Plasma and RBC reduced (manual) Plasma and RBC reduced (automated) Red Blood Cell Reducti ly (RBC reduced) volume reducti 12. If possible, please upload a picture of cord units in your inventory for plasma and RBC reduced (manual). Browse... Choose File file selected Upload 13. If possible, please upload a picture of cord units in your inventory for plasma and RBC reduced (automated). Browse... Choose File file selected Upload

7 14. If possible, please upload a picture of cord units in your inventory for Red Blood Cell Reducti ly (RBC reduced). Browse... Choose File file selected Upload 15. If possible, please upload a picture of cord units in your inventory for no volume reducti. Browse... Choose File file selected Upload 16. Total Nucleated Cell Count (x10e7) of your cord units stored for Unrelated Patients (Public Use). Please specify the number of cord units per category. A cord unit is ly counted ce. 50 > > > > > > 199 Accreditatis-licenses-certificatis

8 17. FACT-Netcord accreditati Is your Cord Blood Bank FACT-Netcord accredited? In process of accreditati Year of last -site inspecti (FACT): State year of your first accreditati: 18. AABB accreditati Is your Cord Blood Bank AABB accredited? In the process of accreditati. Year of last site inspecti (AABB): State year of your first accreditati:

9 19. Competent Authority/Natial Health Authority (state-based). Is your Cord Blood Bank licensed by a (state-based) Competent Authority? Does the Competent Authority perform -site inspectis?, please specify year of the last inspecti. Year of last -site inspecti of your Competent Authority: Name of the instituti Competent Authority: Link to the license website of the instituti Competent Authority: 20. Please ly respd ly if you are listing your cord units through a Natial Stem Cell Dor Registry. Is your Cord Blood Bank audited by your Natial Stem Cell Dor Registry?

10 21. ISO-certificati Is your Cord Blood Bank ISO-certified? Year of last site inspecti (ISO): State year of your first certificati: 22. Please describe other accreditatis, licenses, or certificatis your Cord Blood Bank might have. Cord Blood Collecti 23. What is your current for collecting cord? In-utero Ex-utero Both

11 24. Current antiseptic. Chlorhexidine Betadine Alcohol Other, please describe 25. Collecti bag Single needle Double needle Other, please describe 26. Agitati during collecti Automatic Manual Ne Cditiing and transport from Collecti Centre to Cord Blood Bank. 27. Do you use a secdary bag?

12 28. Transport cditis What describes your transport cditis best? Check all that apply. Qualified transporter Unqualified transporter Insulating transport ctainer Active refrigerati system Passive refrigerati system (gel, blocks) N-electric temperature probe Electric temperature probe Air transport Ground transport Other, please describe 29. Specify temperature range for storage and transportati of fresh product. N defined Room temperature Defined (above +8 C) Temperature between +2 to +8 C Other, please describe Evaluati

13 30. Does your Cord Blood Bank perform post processing/pre-freeze CD34 cell count? 31. Pre-processing Evaluati (see also the next two questis) Please specify your current threshold for accepting a cord unit for public use in your Cord Blood Bank. Please write NA if it is not taken into csiderati. Net weight (in grams) (excluding bag and anticoagulant) TNC (10E7) before processing CD34 (10E6) before processing Please specify threshold Please specify threshold Please specify threshold Please specify threshold Please provide additial comments Please provide additial comments Please provide additial comments Please provide additial comments 32. Pre Processing Evaluati Please mark the criteria that are completed before accepting a cord unit for public use in your Cord Blood Bank. Check all applicable optis. Medical History Collecti Report Informed Csent Other, please describe:

14 33. Pre Processing Evaluati Please specify your current threshold for accepting a cord unit for public use in your Cord Blood Bank. Please write NA if it is not taken into csiderati. Methods that are used are: 7-Amino- Actinomycin D, Propidium Iodide, Annexin, Trypan Blue. Viability, CD45 positive cells (%) Viability, CD34 positive cells (%) Please specify current threshold Please specify current threshold Please specify current threshold Please specify current method Please specify current method Please specify current method 34. Which method is used for CD34 remunerati? ISHAGE guidelines Other, please describe. 35. Do you use external proficiency testing for QC of your FACS lab?, please specify (e.g. UKNEQAS)

15 36. Acceptable time from collecti to processing. Specify your current time range in hours. 0-12H 12-24H 24-48H Over 48H Other, please specify Processing-Packaging 37. This questi applies to the cord units in your inventory. What are the existing prefreeze processing methods in inventory? Check all applicable optis. AXP processing Optipress SEPAX Volume reducti with HES-Manual Other, please describe

16 38. This questi applies to the method you are using today. What are your current pre-freeze processing methods? AXP processing Optipress SEPAX Volume reducti with HES-Manual Other, please describe 39. Please specify additives currently in use. additive HES Other, please describe 40. Please specify cryopreservati method currently in use. BioArchive Other, please describe Cvential CRF

17 41. Please specify cryoprotectant additives currently in use. Check all applicable optis. DMSO Ready for use DMSO-Dextran DMSO with other reagent(s), please describe 42. Please specify cryobag currently in use. Check all applicable optis. Single bag (e fracti) Single bag 80:20 Multiple bags Other, please describe 43. Please specify current target cryopreservati volume in ml (including cryoprotectant). 44. Please specify current packaging for storage. Check all applicable optis. Overwrap Metal canister One attached segment More than e attached segment Separate segments ''detached from the bag'' but stored with the cord unit Other, please describe

18 45. Using the list below, indicate which Infectious Disease Marker (IDM) testing of the maternal dor and/or cord is CURRENTLY performed by your Cord Blood Bank. cord request maternal available by request cord Hepatitis B Surface Antigen cord request maternal request cord Hepatitis B core Antibody cord request maternal request cord HBV NAT cord request maternal request cord Hepatitis C Antibody cord request maternal request cord HCV NAT cord request maternal request cord HIV 1/2 Antibody cord request maternal request cord HIV 1 and Antibodies cord request maternal request cord

19 HIV p24 Antigen cord cord request request maternal maternal available by request request cord cord HIV NAT Antigen cord request maternal request cord HTLV I/II Antibodies cord request maternal request cord HTLV NAT cord request maternal request cord CMV Antibody - IgG cord request maternal request cord CMV Antibody - IgM cord request maternal request cord CMV Anitbody Total cord request maternal request cord Syphilis cord request maternal request cord West Nile Virus NAT cord request maternal request cord

20 West Nile Virus Antibody cord cord available request by maternal request maternal available by request available cord by request cord T. Cruzi Antibody (Chagas Disease) cord request maternal request cord EBV Antibody - IgG cord request maternal request cord EBV Antibody - IgM cord request maternal request cord EBV Antibody Total cord request maternal request cord Toxoplasmosis Antibody - IgG cord request maternal request cord Toxoplasmosis Antibody - IgM cord request maternal request cord Toxoplasmosis Antibody Total cord request maternal request cord

21 46. In case the Antibody - IgM is positive (for CMV, Toxoplasmosis or EBV) does your Cord Blood Bank perform a PCR? Please mark checkbox, when your Cord Blood Bank performs PCR testing. CMV Toxoplasmosis EBV 47. Does your Cord Blood Bank currently store extra material? Check all that apply. Cord DNA Cord material for DNA extracti Plasma/cord DNA material for DNA extracti plasma/serum

22 48. HLA typing time of listing. Please specify your current level of HLA typing at time of listing. Low Resoluti Intermediate Resoluti High Resoluti HLA-A Low Resoluti Intermediate Resoluti High Resoluti HLA-B Low Resoluti Intermediate Resoluti High Resoluti HLA-C Low Resoluti Intermediate Resoluti High Resoluti HLA-DRB1 Low Resoluti Intermediate Resoluti High Resoluti HLA-DQB1 Low Resoluti Intermediate Resoluti High Resoluti HLA-DPB1 Low Resoluti Intermediate Resoluti High Resoluti

23 49. Current threshold for accepti of a cord unit for public use (post processing) Please specify your current threshold for accepting a cord unit for public use in your Cord Blood Bank. Please write NA if it is not taken into csiderati. Methods that are used are: 7-Amino- Actinomycin D, Propidium Iodide, Annexin, Trypan Blue. Please specify threshold Please provide method Please p Minimum TNC (10E7) Minimum CD34 (10E6) single platform Minimum CD34 (10E6) double platform CFU-GM Please specify threshold Please provide method Please p Please specify threshold Please provide method Please p Please specify threshold Please provide method Please p Please specify threshold Please provide method Please p Total- CFU Please specify threshold Please provide method Please p Viability Please specify threshold Please provide method Please p Storage

24 50. Type of storage ctainer used in your Cord Blood Bank. This ccerns your whole inventory. Check all optis that apply. BioArchive Cvential storage tank-vapor phase Cvential tank-liquid phase Double walled liquid Nitrogen Other, please describe 51. Mitoring of storage. Check all that apply for current storage mitoring of cord units. temperature mitoring Alarm individual tanks ly Centralized alarm system-local Centralized system-remote mitoring LN2 level Lid opening System default Temperature mitoring Verificati/Extended HLA Typing

25 52. Is extended/verificati typing performed at an ASHI, EFI or CAP accredited lab? ASHI accredited lab CAP accredited lab EFI accredited lab accredited lab 53. What is the average turnaround time for extended HLA typing results? The questi applies to typings organized by your Cord Blood Bank (not s sent to Transplant Centres). 1 Day 2 Days 3 Days 4 Days 5 Days 6 Days 7 Days 8 Days 9 Days 10 Days or more Cfirmatory/verificati typing. 54. Does your Cord Blood Bank use an attached (ctiguous) segment (if available) for cfirmatory/verificati HLA typing currently?

26 55. Does your Cord Blood Bank list cord units that do NOT have attached segments and have NOT previously been cfirmatory typed attached segments? 56. What is the percentage of cord units in your inventory that have an attached (ctiguous) segment that will remain attached and be sent to the transplant centre if the cord unit is requested for shipment? below 50% 50-75% 75-90% % 57. Is cfirmatory/verificati typing an attached segment a pre release requirement at your Cord Blood Bank currently? Reservati/cancellati policies

27 58. At what point is a cord unit reserved for a patient and not available for other patients? At time of cord unit report request At time of HLA typing request At time of reservati request At time of shipment request Other, please describe 59. What is the length of time a cord unit can be reserved? The time that a cord unit is not available for other patients when requested for by a transplant centre. 30 days 60 days 90 days Other, please describe 60. Is there a fee to reserve a cord unit? 61. Is there a fee to cancel the reservati for a cord unit in the absence of a subsequent request for shipment?

28 62. Do you allow for an extensi a reservati of a cord unit? 63. Will your Cord Blood Bank provide a cord unit report a cord unit that is already reserved for another patient (and thus not available) without specifying that the cord unit is already reserved? 64. If your Cord Blood Bank releases a cord unit from a patient s search (as opposed to the transplant centre indicating that the cord unit may be released), do you inform the transplant centre of the release? Release-Shipment 65. Does your Cord Blood Bank perform hemoglobinopathy screening before release?

29 66. Criteria to allow a cord unit to be shipped to transplant centre. Please list criteria and acceptable range of values (specify cord unit and method). Please write NA, if it is not taken into csiderati. Methods used for viability testing are: 7-Amino-Actinomycin D, Propidium Iodide, Annexin, Trypan Blue. Viability / cell count: Acceptable range of values Please provide method Please pr Acceptable range of values Please provide method Please pr 67. Criteria to allow a cord unit to be shipped to transplant centres. What do you perform at the time a cord unit is released to be shipped to a transplant centre? Check all applicable optis. Identity testing with HLA Other IDMs, please describe Other, please describe

30 68. Current packaging for shipment to transplant centre. Check all that apply. Metal Canister One attached segment Overwrap Protective sleeve Separate segments detached from the bag but stored with the cord unit Three or more attached segments Transport rack Two attached segments 69. What is the current average time to prepare a cord unit for shipment to transplant centre? Time between shipment request and sending to transplant centre. 0-3 days 4 days-1 week 1-2 weeks 2-3 weeks More than 3 weeks Other, please describe 70. Is there a fee for cancellati of shipment?

31 71. Does your Cord Blood Bank validate its dry shippers to ensure they maintain the temperature at -150 C at least 48 hours beyd the expected arrival time at the receiving facility? 72. Do all dry shippers used by your Cord Blood Bank ctain an electric temperature data logger? 73. Who selects the transport companies? Requesting transplant centre. Cord bank, please specify company 74. Please specify the shape of the transport ctainer you currently use. Cubic Mushroom Other, please describe Adverse Events Reporting

32 75. Adverse Event Reporting Who is your Cord Blood Bank reporting S(P)EARS to? Check all applicable optis. Competent authority Internal report Natial registry Transplant centre WMDA 76. Would your Cord Blood Bank ctribute to an internatial survey S(P)EARS in cnecti with cord?