Cord Provision Advisory service. Graft Selection Strategy Workshop Irina Evseeva 24 th June 2016

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1 Cord Provision Advisory service Graft Selection Strategy Workshop Irina Evseeva 24 th June 2016

2 OBJECTIVES 1.To capture, analyse and present quality data of Cord Blood provisions facilitated by Anthony Nolan 2. To accumulate knowledge and expertise in practices, guidelines, standards of cord selection and provision worldwide to create a centre of consultancy and advice for operations staff and customers 3. To test a new service on CBU shortlisting with different types of customers

3 ANALYSIS OF CORD PROVISION DATA FOR UK PATIENTS What do we capture: All CBU provisions: UK-UK, UK-Int, Int-UK Patient information: age, diagnosis, weight CBU parameters: HLA match at low and high resolution levels, TNC dose/kg, CD34+ dose/kg, single or double UCBT CBB information: name, country, accreditation TC information: pre-infusion TNC and CD34+ dose (recovery)

4 ANALYSIS OF UK VERSUS INTERNATIONAL CBU PROVISION FOR UK PATIENTS 134 UK patients with UCBT in 2014/ UK and international CBUs 69% of the CBUs selected were international Availability of an alternative UK CBU was assessed based on current UK recommendations Reasons for selecting international CBU analysed separately for single and double UCBT Results: 19% no acceptable alternative suitable, but not considered 61% 20% inferior parameters Presentation: plan to present at BSHI-16

5 KNOWLEDGE AND EXPERTISE ON CBU PROVISION > 600,000 CBUs worldwide Hundreds of Cord Blood Banks in dozens of countries Different accreditation levels, processing methods, reservation policies, fee schedules, test timetables etc. Country Cord Bank FACT accredited Tests performed at reservation Israel MDS Yes No Further testing performed at reservation stage. VT is only performed on an attached segment after a formal signed shipment request is received. Charge for reservation? Period of reservation Information on Shipment request (Release) No 90 days CBU is automatically reserved upon any request for info. After a formal CBU request is received, it takes two weeks for results of 3 additional tests: 1. HLA-VT from a segment - low res HLA-A,B,DRB1 2. CFU from a segment (and Trypan Blue viability) 3. Haemoglobinopathies IDMs performed before release IDMs: HIV, HBsAg, HCV, T.pallidum, HTLV I-II and NAT (HIV, HBV, HCV) are tested on maternal samples prior to listing of unit. The bank do not perform these tests on CB samples Cancellation charges There is no charge for cancellation after a shipment request has been made - only for the confirmatory typing on the attached segment.

6 CBU Shortlisting Service: Pilot Aim to enhance registry service in cord search and provision in order to improve customer experience and increase use of CBUs for HSCT in the UK Scope National and international CBU search upon request CBU search results evaluation by the trained Cord Provision Advisor 10 best CBUs for the patient shortlisted based on published national guidelines Search information presented in the Summary Table: TAT 1 day CBU Reports information evaluated by the expert, checklist on quality and critical information filled Summary Table updated with CBU Report information: TAT 2 days Summary Table is ready to be used for advise of CSAP Added value Quick TAT in cord search and unit report delivery Critical information summarised in CSAP-format table Second opinion on CBU selection Quality reassurance through CBU Report checklists

7 CBU Summary Table (example) Date 16/06/2016 Clinical Contact Clinical contact Centre H&I Contact H&I contact Patient Details: Initials MA Anthony Nolan ID Age or DOB 00/01/1900 Weight (Kg) 5 PATIENT HLA Proposed Transplant Date Diagnosis Monosomy 7 A* A* B* B* C* C* DRB1* DRB1* DQB1* DQB1* HLA-Specific Antibodies not reported ABO & RhD B+ 03:XX 68:XX 52:XX 58:XX 03:XX 12:XX 03:01 15:01 02:01 06:02 Cord Blood Unit Details: Rank Bank *FACT accredited CBU ID TNC x10 7 Vol ml CD34 x10 6 TNC x10 7 /kg CD34 x10 5 /kg CFU x10 4 Viability % Year RBC ABO & RhD CBU HLA A* A* B* B* C* C* DRB1* DRB1* DQB1* DQB1* HLA Match Low High /6 /8 Barcelona* SPUCBAR :01 03:01 52:01 58:01:01 12:02 07:AAGAJ 15:01 03:01 02:01:01 06:02: India :XX 68:XX 52:XX 58:XX 03:XX 12:XX 15:XX 03:XX 02:XX 06:XX 5 7 India :XX 68:XX 52:XX 58:XX 03:XX 12:XX 03:XX 14:XX 02:XX 05:XX 4 6 USA# :HGFD 26:HGFW 52:DDVD 58:GREH 12:GPWH 03:02 15:02 03: USA# :03 68:01:02G 52:01 58:01 12:02 03:02 15:01 11:01 03:01 06: New York* NLCB :01 52:XX 40:XX 12:02 15:CVB 15:01 03:01 02:XX 06: USA# :01:01G 33:03 52:01 58:01 12:02 03:02 03:01 07:01 02:01 03: Canada CAC :20 32:01 52:AGJCA 58:AGMCN 03:AEKBU 12:AGNZG 15:AGFWH 03:AGGAZ 4 6 India :XX 68:XX 52:XX 58:XX 03:XX 12:XX 03:XX 14:XX 02:XX 05:XX 4 6 NHSBT* G K :01 33:03 52:01 58:01 03:02 12:02 03:01 04:03 02:01 03: Key: Bank FACT accreditation: * accredited, # info to follow Red blood cells: D=deplete, R=replete,?=information not provided HLA match (including predicted): Red = antigen and allele mismatch Blue = antigen match and allele mismatch Green = antigen and allele match Brown = unknown / difficult to predict Additional Information CBUs are presented in order of TNC dose; UK CBUs are indicated in bold. Please note that Indian CBB is not FACT accredited, but approved by FDA for units collected after 01/11/2014 CAC comes from not FACT accredited CBB NLCB is homogygous on A*68:01, so has additional match in HvG direction

8 CBU Report Quality Checklist

9 Pilot 1: Manchester H&I laboratory Duration: 3 months, completed Total number of patients: 5 (all paediatric) Number of searches cancelled: 2 (patient reasons) Number of cases analysed: 3 Results: No principal discrepancies in CBU selection for paediatric single CBT revealed. Certain TC-specific criteria influenced the choice Good feedback on logistics, TAT, level of communication No suggestions on service improvement Service can be beneficial to customers who have less experience with cord requests and want to have a second opinion

10 Pilot 2: Leeds Teaching Hospital, Jan-Jul/ No of patients requested for workup(cord) (so far) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% (so far) No of Int cords requested for work up No of UK cords requested for work-up CBUs requested for W-U not recommended by Service CBUs requested for W-U recommended by Service

11 Further steps Pilot 3 with GOSH Analysis of the results Business decision on service implementation Service development

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