SNBTS Strategy NSS Board Update March 2010 Keith J Thompson National Director SNBTS

Agenda  Strategic Aims  Blood Safety Developments  Service Modernisation and Development  Enough Blood for Patients  National Centre and Manufacturing  Sustainable Tissues  Services for Patients  An organisation fit for the future  Risks  A Winters Tale  2010 Celebrations

Key Drivers of Blood Policy  Keeping blood safe & vCJD  Declining Donor Base  Blood and Tissues are Regulated increasingly like Pharmaceutical Products  Economic pressure

Escalating Costs HB s Ag (Oct ‘70) Anti-HIV (Oct ‘85) Anti-HCV (Sept ‘91) CPMP ban use of albumin as excipient 98 CSM bans use of UK plasma for fract May 98 SNBTS introduce MBT FFP May 98 Universal component leucodepletion Nov 98 HCV NAT, frozen components Jul 99 (SNBTS) HCV NAT cellular components Apr 00 (SNBTS) BacTAlert screening of platelets Dec 01 (SNBTS) anti HTLV screening Nov 02 (SNBTS) HIV NAT screening Nov 02 (SNBTS) Imported FFP - born after 31 Dec 1995 Jun 03 (SN BTS) Defer PTDs Apr 04; male FFP May 04 Defer “unsure”PTDs Aug 04, Blood Safety & Quality Regulations (Nov 2005) 80% Platelets by Apheresis Double Red Cells vCJD screening test Prion filtration Pathogen inactivation £ ?

The SNBTS Vision  SNBTS will deliver excellent transfusion healthcare for the people of Scotland by:  Transforming the donation experience to make it more accessible and more satisfying;  Modernising our manufacturing processes to achieve pharmaceutical standards;  Reshaping clinical services to develop national specialisation and support local provision to patients

Keeping Blood Safe SaBTO  Anticipated mandatory blood safety measures  Prion filtration  For Under 16s  Double Dose red cells for high blood users rescinded  Pathogen reduction  Not yet recommended  100% Aphereis platelets  80% recommended as staging post  Introduce vCJD test  Candidate test fails to detect clinical samples  Confirmatory test developed by SNBTS  Donor attitude research  Unanticipated  Import Fresh Frozen Pathogen Inactivated Plasma for all

Enough Blood For Patients

Enough Blood for Patients: Aims  To reverse the decline in Scotland’s donor base, ensuring enough blood for patients today and into the future by  Implementing an integrated marketing and publicity strategy to address this issue between Jan 08 and Mar 10  To plan for the potential impacts of a test for vCJD  To develop and evaluate options for redesign to improve customer service, access and opportunities to donate

Enough Blood for Patients  Modernisation delivers multiple incremental benefits  Evolution not Revolution

Enough Blood for Patients Modernisation Successes  Reaching out to New Donors  Sample only donation rolled out May 2009, 60% uptake  Improving Communications with Donors  On line appointment booking under development  Missing You letter issued to 18,500 donors who had not donated for 9 months – 17% increase in response rate  Text reminder service developed for apheresis donors  Transforming Donor Venues  Board Room pilots  First ever collection session in Orkney.

Enough Blood for Patients Modernisation Successes  Transforming the Donation Experience  Pilots of appointments and “slots” roll out  Home DSR pilot  ~75% of attendees bring completed DSR  On session deferrals ~10% vs 15-16%  First donor on bed 4 mins  Reduced queuing at front end of session  Hemocue Hb screening  2% fewer donor deferrals  Blood mixers being rolled out  Should reduce short packs by up to 1%

Improving Deferral Rates 16.7% 32.7% 31.7% 15.1% Projected 18.3% Projected 38.0%

38.6/1000 Decreased Red Cell Demand 39.5/1000

Enough Blood for Patients Number of Active Donors 181,050  New & Returning Donors 2% above target  New donors 4.2% up on last year and 16% up on 07/08 Reduced marketing spend

Inventory Status  stocks kept high for pandemic flu  high stocks drive waste and age of blood

So What?  Successful rebuild  Cannot modulate frequency  Lower deferrals  Lower demand  High blood stocks  Likely lower vCJD test impact  Good progress on modernisation  Required Resilience Achieved  Reset Target donor base target to 180,000  Scale back marketing and publicity to maintenance

The National Centre and Manufacturing Service Modernisation

Planning for the National Centre  Property Strategy approved at NSS Board Nov 2008  SNBTS Strategic Development Plan approved Mar 2009  Reviewed & Ruled out collaboration with NHS Scotland Unlicensed Medicines Unit Sept 2009  Initial Agreement approved NSS Board Nov 2009  SGHD approval 18 Dec 2009  Outline Business Case NSS Board & SGHD Oct 2010/Feb2011  Full Business Case NSS Board & SGHD Feb/July2011  Complete transfer of ops Summer 2014

Comparison to NHSBT  Bristol Blood Centre  10 collection teams ~ 240,000 donations pa  Filton  P&T for Bristol, Southampton, Plymouth, Oxford, Birmingham 630,000 donations per annum  Plus testing for all these and Brentwood 930,000 tests pa  Service 40 collection teams  Relocated Stem Cells, H&I, RCI, IBGRL, Regional Donor Office, QA, IT, Admin, Engineering, etc  Warehousing and transport off site - short distance away  Service through local hubs, drop off team supplies, blood stocks, pick up donated blood for processing & testing

Service Modernisation Progress in P&T Current  Syphilis ELISA procured, currently under validation  PRISM viral antibody analyser upgrade  Black box Nucleic Acid Testing Planned  BacTAlert testing improvements  HTLV pooling equipment  Validate and implement e-Progesa …..…..etc

Service Modernisation LEAN  Training of multidisciplinary staff in Process Mapping and “Lean”/ process improvement  14 strong “Processing” Team mapped ‘as is’ for 4 key processes and developed ‘to be’ recommendations  54 improvement recommendations made leading to:  Improved management information  Improved efficiency and productivity  Reduced waste  Reduced costs  Staff integral to the continuous improvement process

Services for Patients

Services for Patients Developments  Blood Banking  Traceline implementation complete  Plasma products transferred to pharmacies  Histocompatibility and Immunogenetics  Appointment of new Consultants  Improvements supporting blood donation & organ transplant  Clinical Apheresis & Stem Cells  Common donor / patient information sheets and consent forms  Cord Blood Bank to become fully operational in Glasgow

Sustainable Tissues

Tissues and Cells Directorate  New name to reflect emphasis on cellular therapy  Skin banking established with NHSBT  Stem cells and cord blood to go into Tissue Trace  Retrieval Teams under training

Cellular Therapy Suite  Pancreatic Islet Cell Programme  GMP facility to support islet cell processing and purification for patients with brittle diabetes for treatment in RIE  Opened by Shona Robison  Cellular Therapy Developments  Collaboration with Edinburgh University, NHS Lothian, Scottish Centre for Regenerative Medicine  Development projects accessing a GMP environment

SNBTS Support

Quality and Regulatory  MHRA  HTA  EFI and JACIE  Pre-Audits  Less requirement to correct fundamentals  More emphasis on demonstrating compliance  Over time less pre-audit work with system in continuous compliance and improvement  Completion of current MHRA /Inspections  All licences retained with only 2 Majors, i.e. 0.4 per Inspection.  Published data from the MHRA for 2008/9  786 inspections at home and abroad and found  359 majors and 33 critical, i.e. 2.2 per inspection

R&D Blood Component Focus  Components and vCJD  Prion filtered red cells in man (PRISM) and in vivo  Confirmatory (PMCA) assay for vCJD in blood  Trials -red cell use in ICU (Relieve study) and Hb increment in chronic transfusion  Transfusion Transmitted Infection  Progressing microarray platform for donation testing novel pathogens  Assessing prevalence of hepatitis E in Scotland

R&D Clinical Focus  Immunohaematology  Peptide Tolerisation, RhD and HPA-1 response – complete model studies and clinical studies planned  Mimotopes: peptides that substitute for cells for detection blood group antibodies  Genotyping foetal Rh type using maternal blood so only mums with Rh+ve foetus receive anti-D  Cellular Therapies  Bloodpharma project to develop clinical grade red cells from embryonic stem cells

Risks  Supply Failuregreen  Safetygreen  Regulatory licencesgreen  Modernisation  Competing prioritiesgreen  Integration with National Centregreen/amber  Benefits realisation Manufacturinggreen  Benefits realisation Donor servicesgreen  Benefits realisation Tissuesamber  Benefits realisation Clinicalamber  National Centre  Financegreen/amber  Resource conflictgreen/amber  Programme integrationamber  HR supportred  Penroseamber  Fiscal constraint amber  Stakeholder Support green

2010 Celebrations

 Why celebrate?  80 years ago, in 1930, the first volunteer blood donor panel in Scotland was founded  70 years ago the Scottish National Blood Transfusion Association was established

2010 Celebrations  2010 will be a celebration of:  The committed, selfless individuals who freely give their blood and tissues  The courage of our patients  The innovative and motivated team of professionals who deliver this service

2010 Celebrations  Celebrations will include:  The Scottish Parliament  Garden lobby reception  Enhanced donor awards ceremonies  Bigger and Better Scotblood 2010  celebration dinner at Stirling Castle

A Winters Tale

CHALLENGES  weather continued to deteriorate in the run up to Xmas  Disruption to sessions, deliveries (and public)  A number of patients being treated as a complication of suspected anthrax – took multiple components (including O Neg), also ECMO treatments  Difficult journeys, especially for transport team

CHALLENGES  Deterioration on 22 Dec with very heavy snow fall  Commenced daily co-ordinating conference call  Collection sessions lost/ shortened opening  Emergency request for Stornoway 22 Dec – air ambulance arranged but redirected 11 th hour - alternative flight arranged ex Aberdeen

CHALLENGES  Analysis of likely cancellations and corrective actions  Blood Donor 24 activated eg on 23 Dec, 34% attends in Lauriston Place – O Neg  Additional platelet collection packs issued, pooled platelet production increased (set aside for 7 day)  Arctic conditions took hold  In run up to New Year, 1,500 attends lost  MDC in Edinburgh, out of service (frozen pods)  Fixed site donor centres saved the day along with the commitment and resourcefulness of staff

CHALLENGES  Extended opening hours in donor centres  Xmas eve, rbc & platelet stocks good  29 th Dec, Perth session at Dewars Ice Rink  Staff cleared an access route to the venue  Carried all the equipment up icy steps  No heating in the hall – 222 attends  Blood Collection Nurse in rural Aberdeen  Walked across snow covered fields to next farm got a lift to the main road to get a bus to work

CHALLENGES  Weather unlikely to improve  Age profile of Supply Chain stock  Lack of knowledge on age profile of Hospital stock (did ascertain for SNBTS)  Weekend approaching  Requested 250 O Pos and 150 A Pos from NHSBT (arrived Friday 08 th Jan) BLOOD STOCK POSITION THURSDAY 07 JAN 2010

CHALLENGES  05 Jan, Dingwall closed early, 06 Jan Golspie cancelled – called donors to centre  07 Jan, Aberchirder cancelled (110), new replacement venue in Union Square shopping centre  07 Jan, West Calder cancelled (150), donors called to extended opening in donor centre – 260 attends  09 Jan, flood in the plant room, Gartnavel  10 Jan, Mintlaw cancelled (185) replaced with Union Square shopping centre and new Centre session (103 and 68)  Real problem was lack of snow clearing etc, KJT letter to Council CEOs made a difference

Summary  An exceptionally challenging period  Blood supply maintained throughout  Fantastic commitment from our donors, esp platelets  Excellent Team Working across SNBTS  Fantastic commitment and resourcefulness from staff MEETING THE TRANSFUSION NEEDS OF PATIENTS IN SCOTLAND