John Freedman St Michael’s Hospital Professor Emeritus, Medicine &

1. John Freedman St Michael’s Hospital Professor Emeritus, Medicine & Laboratory Medicine & Pathobiology University of Toronto The Canadian Blood Transfusion system -- vive le differénce The Ontario and the Nova Scotia experience

2. Conflict of interest disclosure: John Freedman, MD, FRCPC Has no real or apparent conflicts of interest to report

3. As King Henry VIII of England said to each of his six wives I won’t keep you long---- • Objectives: • 1) The Canadian Blood System • The Ontario provincial Transfusion Coordinators (ONTraC) program in PBM • Description of the program • Results • Lessons learned • 3) The Nova Scotia experience in PBM

4. . . 90 percent of the population lives within 100 miles of the US border Canada Population: 35 million Ontario: 13 million Nova Scotia: 1 million Ontario is 2.6 X size of California (similar size population) Nova Scotia: second most densely populated province in Canada

5. Canada: • Universal health care • Blood is “gratis” (makes PBM more difficult) Two blood systems: • Canadian Blood Services (CBS) The CBS is basically one national system for all provinces & territories with the exception of Quebec -- serves population of 28 million • Héma-Québec –8 million population

6. CBS replaced the Canadian Red Cross Blood Program in 1998 in response to the inquiry led by Justice Krever into the tainted blood tragedy (longest & most expensive federal commission in Canada). CBS: not-for-profit organization operating at arm's length from govt. Its sole mission is to manage the blood supply for Canadians -- mandate for a national blood supply system that assures access to a safe, secure & affordable supply of blood & blood products. Canada is self-sufficient in blood & is working to be self-reliant in plasma. CBS is the only publicly funded provider of a health care service operating on a pan-Canadian (except Quebec) basis; all other health services are provincial.

7. The management structure of CBS balances need for ministerial responsibility and accountability, with the necessary autonomy to ensure a safe, secure & effective blood supply. The arm’s length relationship with Provincial/Territorial & Federal governments enables the CBS to operate within a business plan with reliable funding. CBS has established effective relationships with its stakeholders & helps hospitals improve blood utilization & surveillance, educates consumers/donors/physicians, and works with consumer groups to address strategic issues while monitoring the environment and key indicators to enable anticipation of changes.

8. Being a national, cost-shared, large bulk purchaser, and ensuring multiple sources, means stability of supply and significant leverage in getting access & good pricing (distributes > 30 biological agents to treat a variety of disorders e.g. hemophilia & rare immune disorders) Overall CBS budget about 1 billion $, ≈half of which for fractionated products – the CBS produces ≈ 900,000 units of red cells/yr. Provinces pay the CBS based on their provincial usage (Ontario blood budget ≈ $480 million/yr).

9. The CBS: • has created national patient registries & is working with govern-ments and stakeholders on a national strategy for organ and tissue donation and transplantation (OTDT). • is also developing Canada’s first national public cord blood bank. • maintains an active research program in Transfusion Science (both its own and in conjunction with the CIHR).

10. Composition of Board of Directors • Canadian Blood Services is governed by a Board of thirteen Directors: • four regional representatives • - Atlantic provinces of Newfoundland & Labrador, PEI, Nova Scotia and New Brunswick; • - Alberta, Saskatchewan, Manitoba, Northwest Territories and Nunavut; • - Ontario; • - BC and Yukon. • two consumer group/general public representatives • six medical, scientific, technical, business & public health representatives • Board of Directorsis responsible for the: • Overall direction of CBS' affairs • Appointment/dismissal of the Chief Executive Officer • Alignment of blood system operations with the organization's Business Plan • Development/implementation of organizational standards to supplement regulatory standards • Development of corporate/operational policies consistent with statutory requirements • The Board invites individuals or groups to make presentations at its Board meetings • National Liaison Committee

11. Health Canada: Regulatory role (similar to FDA) National Advisory Committee (NAC): Advisory to Provincial/Territor- ial committee of Deputy Ministers of Health Provincial Blood Offices: Advisory to the Provincial Ministries of Health and implementation of initiatives • Provincial Ministers of Health: • Are responsible for the overall expenditure of public funds by CBS in delivering the blood program & for selecting the Board of Directors • Approve CBS funding requirements. • Are responsible for recommendations to the Minister of Health of Canada regarding any proposed changes to CBS legislation. • Do not have the power to direct operational decisions of the Board of Directors or CBS staff.

12. The CBS is a service provider national in scope, federally regulated, nationally managed, and provincially funded. The cost‐shared funding model promotes accountability, sustainability & equality, and access of service for patients no matter where in the country they live. Provincial jurisdictions maintain their autonomy while agreeing on fundamental policies and programs -- encourages collaboration and co-operation, whilst centred on patient outcomes. It succeeds because it allows the provincial & territorial jurisdictions to accomplish more together than they can achieve separately. As such, it is unparalleled within Canada’s health care arena, which is profoundly shaped by its decentralized (provincial) approach.

13. So, we would like to think that ... A system born out of a source of outrage has turned into a pan‐Canadian institution worthy of the trust of the public, donors & health care providers.

14. International RBC transfusion rates 2007 (Morgan S: bbt_7537_steve-morgan[1].pdf)

15. Patient blood management In 1997, the Krever Commission Report in Canada stated that ‘blood components and blood products will never be without risk. The best way to reduce that risk is to reduce their use’ Despite important advances to reduce transfusion risks, this statement remains true today. • Allogeneic transfusion avoidance • Transfusion reduction 1. Correct preoperative anemia 2. Minimize perioperative RBC loss 3. Use minimal Hb-based transfusion triggers

16. Ontario MOH 2002 A NETWORK of ONTARIO TRANSFUSION COORDINATORS Enhance transfusion practice outside of the Blood Bank * ‘clinical bridge’ between Transfusion Service & rest of hospital Interact with physicians, nurses & patients to promote blood conservation & alternatives to allogeneic transfusion Anticipated a 5 to 10% reduction in red cell use www.ontracprogram.com

17. 10 25 hospitals chosen based on blood utilization & geography These hospitals accounted for ≈70% of the blood used in the province (≈ 400,000 units red cells annually) Focused on knee, hip CABG, prostate, (AAA), surgeries

18. Pre-operative approach • assess at pre-admission clinic (3-5 weeks before surgery) • identify patients at risk of transfusion ahead of surgery • discuss informed consent and transfusion alternatives • investigate, diagnose and treat anemia • (with family doctor, surgeon, anesthetist, hematologist) • facilitate erythropoietin and / or iron; [predonation of autologous blood (with hematinics + EPO)]; cell salvage; etc • minimize blood taken for lab testing Freedman J, et al: Experience of a network of Transfusion Coordinators for blood conservation (Ontario Transfusion Coordinators; ONTraC). Transfusion, 48:237-250, 2008.

19. Aggr

20. Reduction in transfusion rates since onset

21. mean ‘Flattening’ P=0.0105 Teaching vs Community NS P=0.008 Reduction in transfusion rates since onset

22. Effect of pre-operative Hb level Pre-op HbPercent transfused KneeHipCABG • Hb < 13 g/dL 26.0% 31.5% 56.3% • Hb > 13 g/dL 6.1% 7.3% 16.5% • Hb > 14 g/dL 3.7% 3.7% 10.2% Pre-op Hb of 10 g/dL has a seven-fold higher likelihood of transfusion than Hb 13 g/dL

23. Effect of having a long lead time to optimize preoperative treatment of anemia (2012) Hare GM, Freedman J, Mazer CD: Risks of anemia and related management strategies: can perioperative blood management improve patient safety? Can J Anaesth, 60:168-175, 2013.

24. Blood conservation measures: effect

25. Effectiveness of multimodal BC (2012): knee (N=1296) hip (N=1216) % Txed(% in group) % Txed(% in group) Any BC X 0 16.1% ( 9.6) 18.9% (14.1) Any BC X 1 11.4% (53.6) 15.4% (49.0) Any BC X 2 7.3% (26.7) 6.6% (26.4) Any BC X >3 3.1% (10.0) 7.9% (10.6)

26. OUTCOMES: Transfusion, LOS, infections LOS (days; mean ± SD) ___ TransfusedNot transfused One knee 6.4 ± 4.4 4.3 ± 4.0 One hip 7.7 ± 5.5 4.2 ± 2.1 CABG 8.3 ± 4.9 6.6 ± 3.5 RP 4.1 ± 1.9 3.8 ± 9.4 Multivariate analysis: allogeneic transfusion is an independent predictor of LOS Impact of transfusion on infection rate TransfusedNot transfused Knee 1.7% 1.1% Hip 5.4% 1.9% CABG 10.5% 3.4% (Incision site & deep surgical wound infection, septicemia, pneumonia, urinary tract, bone & joint infections. All had fever, positive cultures & treated with antibiotics)

27. ONTraC Annual red cell use: Ontario vs rest of Canada Difference at 2006/07 = ≈ 28,000 units/yr (≈$13 m for product alone)

28. PBM reduces costs in cardiac surgery (Lapar et al. J Thorac Cardiovasc Surg, 145:769, 2013) ONTraC COST SAVINGS – 2012(for the 4 targeted procedures only) Savings for RBC purchase only (@ $450/unit) $ 11,521,450 Savings to health care system overall*$ 43,467,900 * Shander A, Best Pract Res Clin Anaesthesiol 21:271, 2007; Shander et al, Transfusion 50:753, 2010 Cost of program $ 3,257,000 (but program provides savings beyond the 4 procedures above) In addition to catering to many patients’ preferences, improving quality of care & patient safety, the program very cost-efficient & cost-effective

29. Lessons Learned Cardinal to success is a local champion - a well-respected physician who works closely with the Coordinator in developing new procedures/protocols & presenting them to the staff • Need to develop algorithms & pamphlets relevant for their institution; tailor to institutution realities as much as possible; not “one size fits all” • To change practice needs data on current transfusion rates & practices – get ‘buy-in’ by sharing comparative data - no-one likes to be worse !

30. Lessons Learned • To change practice needs an appreciation of the potential adverse effects of transfusion i.e. +++ education • Essential to keep focus on blood conservation/PBM; prevent co-opting of coordinator to other tasks; seen as a ‘freebie’; puts coordinator in a difficult position (not research; not a hemovigilance/safety officer) • Decision to transfuse is too complex & important to be guided by a single number. Base the decision on individual patient characteristics, age, cardiovasc-ular disease etc to estimate specific patient’s benefit/risk from transfusion • Despite difficulties, a focused Blood Conservation Coordinator and a focused program dedicated to the concept can result in more appropriate blood use.

31. Difficulties & Pitfalls Emphasis on shorter wait times for surgery Changing scientific evidence: EPO, Aprotinin, PAD, IV iron Costs and accessibility to some blood conservation measures Turnover of coordinators, physicians, administrators → reversal of gains Can be quite difficult to recruit physician & administrative champions Concept that blood is “free” in Canada !!! Major difficulty: Changing the “culture”. The old thinking is that not transfusing is harmful …. We now know that it is transfusing that is harmful … Vamvakas, Decision Making in Transfusion Medicine. AABB Press, 2011

32. Keys to success • A strong team who believe in the program’s goals -- focused on team-work, good communication & strong knowledge of blood conservation • Mutual support of each other; networking; g • Continuing education, continually evaluating program efficiency, revising materials • Treating pre-op anemia; see patients early ONTraC: Our Nurses Transfuse Cautiously www.ontracprogram.com

33. So why has adoption of Blood Conservation techniques been slow? • Pathways supporting BC are simple in design, labor costs relatively low, capital investments small, quality and outcomes gains high, savings for the organization large, and the greater public good is served (Shander A) • Physician training & ‘traditional’ practices: transfusion the default position • Belief that blood is safe - risks ↓ with improved HIV and hepatitis testing Traditional Concept: Blood products are an effective therapeutic intervention New Concept: Transfusion of blood products is an undesirable outcome

34. Transfusion rates are not patient dependent, but are institution (geography) dependent (Bennett-Guerrero et al. JAMA, 304:1568, 2010) • High transfusion hospital: 2-fold odds of receiving transfusion vs average transfusion hospital Low transfusion hospital: 50% lower odds of transfusion vs average transfusion hospital (Qian et al. Ann Surg, 257:266, 2013) • 30% of the variation surgeon dependent, 70% hospital specific (Jin et al. Ann ThoracSurg 95:1269, 2013) - So need to change ‘culture’ in hospitals

35. Blood transfusion is a lot like marriage. It should not be entered into lightly, unadvisedly or wantonly, or more often than is absolutely necessary. [Beal RW: Aust N Z J Surg 46:309, 1976] ↓ Transfusion ↓ Morbidity ↓ Mortality ↓ LOS ↓Costs Thank you

37. Health care in Canada is delivered through a publically funded health care system, which is mostly free at the point of use. The government does not participate in day-to-day care or collect any information about an individual's health, which remains confidential between a person and his/her physician. The provincially-based Medicare systems are cost-effective partly because of their administrative simplicity. In each province each doctor handles the insurance claim against the provincial insurer. There is no need for the person who accesses health care to be involved in billing and reclaim. Competitive practices e.g. advertising are kept to a minimum, thus maximizing the percentage of revenues that go directly towards care. In general, costs are paid through funding from income taxes. Depending on province, dental & vision care may not be covered but are often insured by employers through private companies. In some provinces, private supplemental plans available for private hospital rooms. Cosmetic surgery & some elective surgeries are not considered essential care and are generally not covered. Pharmaceutical medications are covered by public funds for the elderly or indigent, or through employment-based private insurance.

38. From: Organization for Economic Co-Operation and Development. 2010-09-28.