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From public outrage to public trust

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Overcoming a Risk Disaster: Lessons Learned at Canadian Blood Services Ian Mumford Chief Operating Officer Canadian Blood Services To the Regulatory Craft in Nova ... – PowerPoint PPT presentation

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Title: From public outrage to public trust


1
From public outrage to public trust
Overcoming a Risk Disaster Lessons Learned at
Canadian Blood Services
Ian Mumford Chief Operating Officer Canadian
Blood Services To the Regulatory Craft in Nova
Scotia Conference Halifax, September 30, 2008
2
Public trust bedrock of the blood system
  • Blood products are ubiquitous life-saving
    commodities
  • Blood and blood components are freely donated,
    relying solely on public generosity and goodwill
  • Some products have a shelf life of just a few
    days
  • There are no effective substitutes for human
    blood
  • Product safety and security of supply are the
    foundations of public trust in the system
  • Any serious compromise to these foundations has
    dire, long-term consequences

3
The truths of trust
  • Trust is never a goal unto itself
  • Trust is earned by consistently meeting but
    preferably exceeding the expectations of
    customers, stakeholders and the Canadian public
  • Focus on safe, secure, cost-effective, affordable
    and accessible supply of quality blood and blood
    products and trust will automatically follow
  • A trusted individual or group is typically taken
    for granted

4
Canadian Blood Services Public trust model
Points of influence(External)
Points of change(Internal)
Influence leverages trust
Effective, visible change leverages influence
5
Public trust in the blood system is strong
Percentage of Canadians expressing trust in the
blood system managed by CBS (7 on a 10 point
scale) from third-party polling data
6
Overview
  • An overview of Canadian Blood Services
  • Starting afresh vision for change
  • Canadian Blood Services today a transformation
    realized
  • A glimpse into the future
  • Risk management foundation of quality
  • How Canadian Blood Services manages risk

7
CBS at a glance
MANUFACTURING
COLLECTIONS
DISTRIBUTION
ProductionTestingInventoryRDEducation
Serve732 Healthcare Facilities
415,000ActiveDonors
  • 872,506 whole blood donations (freq 2.18)
  • 51,770 apheresis plasma donations (freq 8.67)
  • 36,179 apheresis platelet donations (freq 5.15)
  • Est. 600,000 patient transfusions a year
  • 4,700 employees
  • 17,000 volunteers, 250,000 hours
  • 40 permanent collection sites
  • 19,000 mobile collection clinics
  • 12 manufacturing centres
  • 3 blood-testing centres

Fiscal 2007/08
8
Canadian Blood Services provides a broad range
of blood-related services
  • Blood operations
  • Recruit donors, collect blood, manufacture
    components, test, distribute to hospitals
  • Plasma program
  • Collect plasma, custom fractionation, acquire
    plasma derivatives, recombinant proteins and
    synthetic equivalents
  • Related Programs
  • Education, research development, clinical
    consultation
  • OneMatch Stem Cell and Marrow Network
  • Linked to 51 other registries worldwide
  • Diagnostic laboratories
  • Insurance Captives
  • Two wholly owned subsidiary companies to
    underwrite catastrophic loss
  • Canadian Blood Services Fundraising Office
  • To support and extend the mission of Canadian
    Blood Services

9
Basic blood facts
  • Only 3 1/2 of eligible Canadians donate blood.
  • Most common type O Rh-Pos (31)
  • Rarest type AB Rh-Neg (0.7)
  • Highest demandsA and O
  • Aligning supply and demands is a key issue
    because of limited shelf life of some products
  • Red blood cells up to 42 days
  • Platelets 5 days
  • Fresh frozen plasma for transfusion 1 year
  • Source plasma for fractionation 10 years

10
Born in an environment of failure and scandal
11
Who is Canadian Blood Services?
  • Founded in 1998 as the successor organization to
    the Canadian Red Cross
  • For over 50 years, Canadian Red Cross operated
    Canadas blood supply system
  • Early 1980s to mid 1990s
  • tainted blood scandal
  • largest public health crisis in the history of
    Canada
  • Culminated in the Krever Commission of Inquiry on
    the Blood System in Canada

12
Krever recommendations set change agenda
  • More openness and transparency
  • Clear accountability
  • Informed decision-making
  • A national system under a single operator
  • Sufficient funding and contingencies to eliminate
    risks from financial compromise
  • Improved regulation and regulatory framework
  • Better transfusion practices
  • More RD

13
all to ensure that blood safety is paramount
  • Krever Commission report emphasized the Canadian
    blood supply should be governed by five basic
    principles
  • Blood is a public resource
  • Donors of blood and plasma should not be paid for
    their donations
  • Whole blood, plasma and platelets must be
    collected in sufficient quantities in Canada to
    meet domestic needs
  • Canadians should have free and universal access
    to blood components and products
  • Safety of the blood supply is paramount

14
The Commission of Inquiry on the Blood System in
Canada
  • Federal government determines need for a
    commission of inquiry
  • Justice Horace Krever, appointed by Order in
    Council, October 4th 1993
  • to review and report on the mandate,
    organization, management, operations, financing
    and regulation of all activities of the blood
    system in Canada
  • Justice Krever tables an Interim Report
  • February 15th 1995
  • 43 recommendations focused on operational,
    technical and clinical
    aspects of blood system at the time
  • Work on final report continues
  • 247 days of hearings from 474 individuals
  • phase I input from those infected with HIV or
    HCV
  • phase II national issues concerning historical
    actions and relationships
  • phase III organization of the blood system at
    the time
  • appeals under Section 13 of the Inquiries Act
    caused significant delays
  • final report released November 26th, 1997

15
Legacy Krever Commission of Inquiry
29 - 45 The Regulator The Health Protection
Branch
Health Canadas regulatory oversight over CBS
has improved substantially Attempts to make
regulatory framework active and
risk-based Commitment to adhere to its own
performance standards for review (however
resources constraints negatively impact
CBS) Willingness to examine more streamlined
approaches to review and approval Over zealous
inspection process, still very task focused
rather than process oriented Limited evidence of
openness of decision making Active hemovigilance
program developing
A series of recommendations aimed at the Federal
regulator, arguing for Active, risk-based
regulation (intelligibly written) Independent
decision making that is accessible and open to
public Permitting manufacturer to exceed
standards Post-market surveillance
(hemovigilance) Frequent and thorough
inspections Adequate resources International
harmonization
16
Blood safety A broadly shared responsibility
17
Tragic and costly lesson
  • Investment in blood safety is increasingly
    resource intensive
  • Failure to invest in safety interventions costs
    far more than the interventions themselves
  • cost of loss of trust
  • cost of loss of supply
  • cost of compensation programs for injured

18
Picking up the pieces
  • Collections had seriously declined
  • Public confidence in blood was low and sinking
  • Totally demoralized staff
  • Operations consisted of 14 disconnected silos
    across Canada
  • Decayed infrastructure and technology
  • Inadequate quality systems

19
Canadian Blood Services A new organization with
a new governance model
  • Arms length, not-for-profit agency independent
    of government
  • Regulator Health Canada (Blood is classified as
    a drug under Schedule D of the Food and Drugs
    Act)
  • Exclusively serve 9 provinces and 3 territories
  • Funded by Provinces and Territories (except QC)
  • Global budget no charge to hospitals
  • Operating budget FY2008-09 C915 million

20
A clear sense of mission
  • Mission statement
  • Canadian Blood Services operates Canadas blood
    supply system in a manner that gains the trust,
    commitment and confidence of all Canadians by
    providing a safe, secure, cost-effective,
    affordable and accessible supply of quality
    blood, blood products and their alternatives

21
A clear mandate
  • Rebuild the blood system in Canada
  • Regain the trust of Canadians in their blood
    supply
  • Create risk management programs aimed at
    preventing future catastrophes
  • (Province of Quebec established an independent
    agency in 1998, Héma-Québec)

22
Multi-step action plan to get from there to here
  • Phase 1 Transfer of legacy operations
  • Phase 2 Fully transform Canadian Blood Services
    into a truly national integrated service-delivery
    organization focused on quality and service
    excellence
  • Phase 3 Evolve to a full-integrated national
    system based on real-time demand forecasting and
    advanced collections technology

NOTE All changes to Canadas blood system take
place amid a business-as-usual environment in
meeting the nations blood needs
23
Since 1998, Canadian Blood Services has been
transforming, strategically and continuously
24
Strategic change
Transform Re-engineer the system Regain trust
and confidence in the blood supply 3 5 years
Stabilize Gain understanding of major
issues Determine requirements for
change Approximately 18 months
Transition Canadian Red Cross Society
to Canadian Blood Services April Sept. 1998
25
Phase 1 to Phase 2 Transformation
  • Canadian Blood Services is a business in a state
    of profound change
  • Successful transition from the previous operator
    and stabilization of major risks
  • Comprehensive re-engineering of entire operation
  • Transformation of
  • service delivery model
  • support services
  • business strategy
  • corporate culture

26
Changing the service delivery model
Disconnected Centres eroded by cost, time and
circumstances into islands of duplication
27
Traits of the silo model
  • 14 disconnected silos across Canada
  • No coherent strategic approach to the business
  • No big picture of problems and solutions
  • Obsolete IT infrastructure
  • Error-prone manual systems
  • No consistent operational look and feel
  • Major management skill-deficits
  • Process and structural duplication
  • Lack of operating metrics
  • Many inconsistencies

28
Changing the service delivery model
Integrated national model
Silo model
Context quality and and risk management
29
Todays effective, efficient and interconnected
national service-delivery model
30
Features of the new service-delivery model
  • Fully integrated national network of
  • collections, testing, production, labeling,
    distribution
  • Comprehensive metrics, process improvement
  • Single national inventory
  • improved supply-demand alignment
  • Upgraded planning, budgeting and financial
    controls
  • Comprehensive use of information technology to
    improve safety and accountability
  • e.g. MAK Progesa, advanced modular testing
  • Fully integrated donor management to improve
    supply
  • national marketing and communications,
    national/local branding, advertising, media
    relations, proactive National Contact Centre,
    intensified donor development with a strong
    community focus
  • Improved hospital relations

31
Getting the right things done
  • To ensure successful execution of the ambitious
    change agenda, Canadian Blood Services has
    adopted the Balance Scorecard
  • Rigorous methodology that promotes efficient and
    effective strategy development, strategy
    communication, corporate alignment, priority
    setting and strategy execution
  • Balanced Scorecards developed at all levels of
    governance
  • Board of Directors, CEO, Corporate level, Senior
    Executives and all Divisions
  • designed to increase likelihood of successful
    execution of the strategy

32
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33
We have accomplished a lot
Safety NAT, WNV, bacterial testing
Security of supply Increased collections and improved ability to meet hospital demand
Consolidation and standardization Testing, production, tele-recruitment
Automation MAK, PRISM, SAP,
Employee satisfaction Improved communications, benefits enhancements
Infrastructure New and renovated facilities
Relationship management All key stakeholders
Public involvement National Liaison Committee, Regional Liaison Committees, advisory committees
34
Results amid change the new model in action
  • CBS year-over-year increases in core funding have
    declined below the general Health Care rate yet
    we have delivered increased value to Canadians
  • CBS has increased operational effectiveness.
    Collections have grown more than 20 since 2000
  • CBS has delivered major operational efficiencies.
    Collections per employee have grown more than 14
    since 2000

35
Trending upward
Safe to Receive blood
Safe to Donate blood
Public trust in the blood system restored by
emphasizing risk management, product quality and
safety, operational transparency and
accountability, and customer service
36
Risk management the foundation of quality
  • Premise of Transformation is to create a high
    quality organization, delivering safe products
    and services in the most efficient manner
    possible
  • This is about much more than quality assurance,
    quality control, quality compliance or quality
    policies
  • Quality is to be a core competency of Canadian
    Blood Services and central to the culture of the
    organization
  • compliance is simply the cost of entry into the
    business
  • quality simply makes good business sense
  • Objective is to become the Toyota of blood
    manufacturers worldwide

39
37
Evolution to quality system maturity
  • Manage resistance to change
  • Priority given to quality system implementation
    versus other strategic initiatives
  • Ability to demonstrate benefits
  • Cultural shift

46
38
Risk Management
  • Seeks to assess and control the hazards that make
    up a risk domain
  • Relies on scientific risk assessment to estimate
    the probable harm to persons and environments
    resulting from specific types of substances and
    processes
  • Key activities
  • Hazard characterization
  • Exposure assessment
  • Benefits assessment
  • Uncertainty analysis
  • Options / decision analysis

39
Risk Issue Management
  • A response to a specific public controversy about
    the adequacy of risk management measures and
    approaches
  • Typically becomes the subject of a protracted
    battle among stakeholder interest groups
  • Competing visions as to where the optimal
    resolution lies
  • Key activities
  • Risk communication
  • Stakeholder relations

40
Risk management framework
41
Risks in blood and plasma systems
Freedom from transmissible harmful agents
(THAs) Adequacy of supply Control of the system
42
Safety measures intended to interdict HIV
  • Belts and suspenders approach to safety
  • Successive measures aimed at risk reduction are
    increasingly complex, expensive
  • Incremental risk reduction is increasingly small

43
Safety measures introduced to Canadian blood
supply since 1998
  • Viral testing using
  • state of the art, automated testing platforms
    (PRISM)
  • nucleic acid testing program (NAT) for HIV, HCV
  • West Nile virus testing
  • Universal prestorage leukoreduction
  • Deferral criteria for vCJD
  • Bacterial detection assays
  • State of the art information system to manage
    entire supply chain, from donor recruitment
    through to product shipment (MAK Progesa)
  • ensures complete product traceability
  • minimizes risk for error due to operator
    variability

44
Successful outcomes favour the prepared
  • Multiple aspects
  • business continuity planning
  • labour disruption
  • adverse weather conditions
  • loss of systems
  • disaster recovery planning
  • manmade (e.g. 9/11, Aug 2003 blackout)
  • natural
  • emergency preparedness
  • bioterrorism
  • emerging transmissible harmful agents (e.g. WNV)
  • public health threats (e.g. SARS, Pandemic
    influenza)

48
45
Transforming Canadian Blood Services, a
continuing process
Phase 1(1998 to 2003)
Phase 2(2002 to 2007)
Phase 3(2006 to 2012)
Crisis Management
Strategic Management
Realtime Integrated System
  • Become model for health care delivery
  • From blood manufacturers to stewards of the
    blood system
  • Embed strategy acrossorganization
  • Real-time demand forecasting
  • Seamlessly integrated from hospital to donor
  • Widely deploy collection tech
  • Full customer-service culture
  • Restore trust
  • Restore safety
  • Rebuild core operations
  • Stabilize facilities
  • Manage crises
  • Tactical management

46
Looming challenge the boomer bubble
47
Collision course demand-supply issues
48
The way forward A Blueprint for Excellence
  • New enhanced relationships with hospitals
  • Real-time demand forecasting
  • Optimized collection, production and distribution
    model
  • Hub-and-spoke production and distribution
  • More new technology for collections
  • Collect only what hospitals need
  • Achieve donor service excellence
  • Elevate public mindshare on the crucial
    importance of blood donations

49
Summary
  • Canadian Blood Services has come a very long way
    since its crisis driven inception
  • safety and integrity of products
  • adequacy of supply
  • control of the system
  • Well on the road to implementing a business
    strategy aimed at entrenching and sustaining a
    culture of safety, operational excellence and
    planning for tomorrow
  • Robust systems in place for mitigating risks,
    emergency preparedness and contingency planning
  • Continue to build on this foundation in growing
    the value of the blood system and earning the
    trust of Canadians

50
From public outrage to public trust
Overcoming a Risk Disaster Lessons Learned at
Canadian Blood Services
Ian Mumford Chief Operating Officer Canadian
Blood Services To the Regulatory Craft
Conference Halifax, September 30, 2008
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