Erica Wood

Overview of international haemovigilance

Change in focus: Product safety to patient safety

• Historical focus: infectious safety of blood supply

• Recent focus: clinical governance and practice improvement – Oversight (e.g. hospital transfusion committee)

– Guidelines and standards, clinical audit

– Use of technology

– Patient involvement and patient-centred care

– Human factors/process errors, staff education and training

– Haemovigilance

Aims and benefits of haemovigilance

• Increase safety and clinical outcomes (individual, public health), understand and reduce risks

• Reduce harm and consequences, reduce unnecessary transfusions (links with PBM), reduce re-work & wastage

• Benefit patients, government (MoH), hospitals, medical professionals, donors, wider community

Photo: Thalassaemia Australia

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“A set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence.”

International Haemovigilance Network

Australia

New Zealand

Singapore

JapanS. Korea

India

Pakistan

Iran

Namibia

South Africa

Brazil

USA

Canada

Sri Lanka

Austria, Belgium, Croatia, Cyprus, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Serbia, (Slovakia), Slovenia, Spain, Switzerland, Sweden, UK

TurkeyChina

Taiwan(Saudi Arabia)(Qatar)

• No “correct” or “best” model

• Work in context of local/national health system

• All systems evolve over time

Different approaches to HV

Different approaches to HV

• Operating agency

• Model (voluntary/mandatory)

• Governance and operations

• Scope – Vein-to-vein or recipients only, biovigilance– Confirmed/all (reviewed, imputability)– Severity/all– ‘Near miss’

• Resources

• No “one size fits all”

Learn from others: Share ideas, materials, resources,

results, experiences

• Directed at MoH, hospitals, HV programmes

• Leadership, policy, organisation, coordination, resources

• Donors, products and patients

www.who.int/bloodsafety/en

www.who.int/bloodsafety/en

Opportunities to cooperate

Practical aspects:

–Content-related

• Definitions

• Case report forms, databases

• Training requirements and tools

–Process-related

• Managing data, analysis and reporting

• Roles of steering committees and expert review groups

www.shotuk.org

SHOT 2016 report

Deaths reported to SHOT

Human factors

Change in thinking about safety

www.shotuk.org

http://nib.gov.in

Serious Transfusion Incident Reporting (STIR) Blood Matters

regional practice improvement programme, Australia

• Practice improvement programme based in Melbourne, Victoria

• Partnership between Department of Health and Human Services Victoria (MoH), Australian Red Cross Blood Service, and participating public and private hospitals – and collaboration from Tasmania, Australian Capital Territory, Northern Territory

Blood Matters regional practice improvement programme

STIR regional haemovigilance programme

• Commenced with pilot in 2005-6

• Heavily influenced by UK SHOT programme

• Now participation from ~ 40 health services – public and private – in four states/territories

• Voluntary participation – except for sentinel events (ABO-incompatible HTR, other catastrophic events)

• Confidential – de-identified after initial report

• Central team provide coordination, IT, data support

• Expert case review by medical, nurses, scientists

• Practice improvement focus – not punitive

• Reporting back to health services and community

• Submit aggregate, deidentified data for national report

Developing and sharing materials

Examples of educational, technical and

reporting materials

WHO Notify Library

• Library collecting examples of well characterised cases of adverse events/reactions

• Medical products of human origin (MPHO)

• Organs, tissues and cells and now blood

• Patient, product and donor issues

• Examples of “what can go wrong” but also “risk of harm”where no harm occurred

• Complement not replace HV program data

notifylibrary.org

WHO NOTIFY library

www.notifylibrary.org

Data collection and analysis

We need better international haemovigilance data

• Comparable and comprehensive?

• Events, denominators, rates

• Severity

• Imputability

• Suitable for analysis

– Complete, validated, etc

• Outcome measures

Definitions

• Availability • Content/scope: Focus to date on short-term outcomes

• Currency: Understanding of pathophysiology

• Functionality: For different purposes

• Applicability/universality: Different healthcare settings

• Mechanisms to implement, evaluate and update

International collaborations for development of definitions

Examples of definition projects underway

Recipient definitions

•TACO: revision of reporting criteria in phase II validation, 26 standardised cases involving pulmonary reactions

•TACO definition consensus conference planned for October 2018

•TRALI: revision of reporting criteria – second round of questions (Delphi)

•Paediatric: early work to systematically classify and address reactions

Donor definitions

•Validation of 2014 definitions completed 2016, 56 intl participants

•Analysis underway: terms cover donor adverse events well, opportunities to make categories and definitions more objective and clearer

•Manuscript in preparation

ISTARE data, 2006-2015 from 30 countries

Data

Units issued 190,418,030 million (100%)

Data on units transfused 83,122,057 (44%)

Recipients

Total ARs 164,468

Incidence 1 : 1158 components issued

Serious ARs 40,143 (24% of total reports)

Incidence 1 : 4743 blood components issued

Courtesy Prof Constantina Politis

ISTARE data, 2006-2015 from 30 countries

Courtesy Prof Constantina Politis

Recipients

Deaths 583 (0.35% all ARs)

Incidence 1 : 326,618 components issued

TACO n=143, TRALI n=95, TAD n=81 Total n=319 = 55% of total fatal ARs

TTIs n=25 (4,3%) including bacterial n=20 (3,4%)

Allergic n=77 (13.2%)

ISTARE data, 2006-2015 from 30 countries

Donors

Total donor complications 594,477

Incidence 660 / 100,000 donations

Severity 2.9% severe

Courtesy Prof Constantina Politis

1716151413121110090807060504030201

1000

800

600

400

200

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Country code

Rate

Local complications among donors:rate per 100,000 donations by country in 2012

Sharing experiences

Opportunities

Global information sharing:

–Rare and emerging complications

–Understand clinical and economic consequences

– Lessons learned

–Benchmarking

–More efficient and effective HV systems

Example: How to encourage hospitals and blood centres to participate?

• Show the potential benefits: To improve safety and quality

– Achieve excellence

– Reduce risks and negative publicity, improve patient experience

– Save money (reduce re-work, and blood wastage, insurance/legal)

– Comply with regulations, standards

– Professional society/MoH expectation

– Opportunities for research

• Include them in the process– Find some “champions” to advocate in the hospital/province

– Participate in system development and pilot project

– Expert review group and/or provincial, national committees

• Provide resources: Electronic, personnel (France HV officers)

• Share results: with hospitals, with MoH

Reporting

• Open and transparent – aim is practice improvement, not punishment

• Careful analysis and interpretation of results, including participation

• Timeliness

• Audience/language

• Recommendations

(Implementation!)

• Permissions to publish

• Awareness/access www.health.vic.gov.au/bloodmatters/stir

www.blood.gov.au/haemovigilance-reporting

Reporting

• Open and transparent – aim is practice improvement, not punishment

• Careful analysis and interpretation of results, including participation

• Timeliness

• Audience/language

• Recommendations (Implementation!)

• Permissions to publish

• Awareness/access

Australia: STIR recommendations

www.health.vic.gov.au/bloodmatters/stir

Australia: national recommendations

www.blood.gov.au/haemovigilance-reporting

Australia: national recommendations

www.blood.gov.au/haemovigilance-reporting

www.shotuk.org

http://www.jrc.or.jp/mr/english/pdf/Haemovigilance2016_en_JRCS.pdf

Initial report

Expert review

Final determination

http://www.jrc.or.jp/mr/english/pdf/Haemovigilance2016_en_JRCS.pdf

http://news.nationalpost.com/2012/08/06/errors-mislabelled-samples-pose-staggering-cost-to-canadas-blood-banks

Need to anticipate results and prepare to manage interest and concerns: •Reporting and communications strategy•“No surprises” rule!

Haemovigilance does work

www.shotuk.org

www.shotuk.org

Haemovigilance does work

Getting involved

• At your hospital or blood centre

• Provincial and national activities

• International activities

– China membership of IHN –welcome!!!

– Join ISBT HV working party

– Share experience, provide data

– Participate in scientific meetings

– Present and publish findings

• Collaboration, sharing experience

• International database (ISTARE)

• Definitions (with ISBT, AABB)

• Seminars

• Education/materials

• Award and medal

www.ihn-org.com

IHN supports HV systems worldwide

Changsha, China Nov 2016

Riyadh, Saudi Arabia, 2017

Taichung, Taiwan 2017

Daegu, Korea, 2017Photo: SY Kwon

Guadalajara Mexico, 2017

Cologne, Germany2017

Great support from our French colleagues

Scientific presentations and debate

IHN Seminar 2016

International focus

IHN medal: Dr Peter Tomasulo IHN award: Dr Luc Noel

IHN Seminar 2018

Chair: Dr Kevin Land, USA

•Individual members of ISBT interested in HV

•Donor and recipient haemovigilance

•Definitions

•Share experiences, data, project ideas

ISBT working party on haemovigilance

www.isbtweb.org/working-parties/haemovigilance

Key points

• International best practice: HV is important tool to improve blood safety

• Closely linked with broader transfusion practice improvement activities e.g. PBM and minimising wastage

• Different models, but all focus on practice improvement, with non-punitive approach

• Expert case review valuable

• Important benefits from sharing experiences and data

• Essential role of MoH, public health authorities, professionals, patients

• Make and implement recommendations

Many thanks to:•Monash Health transfusion team•Blood Matters/STIR•National Blood Authority Australia

•Paula Bolton-Maggs, SHOT•Jo Wiersum, TRIP•Akanksha Bisht, HVPI India•Masahiro Satake, Japan

•ISBT•IHN•WHO

Thank you for inviting me to China!