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
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
2
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
3
Canadian Blood Services’ Public trust model
Points of change
Points of influence
(Internal)
(External)
Effective,
visible change
leverages
influence
Influence
leverages
trust
4
Public trust in the blood system is strong
Jul 2001
Public trust in
1998, had
fallen to about
50%
Apr 2002
Dec 2002
Aug 2003
Aug 2004
Aug 2005
Sept 2006
Sept 2007
Mar 2008
79%
0%
20%
40%
60%
80%
Percentage of Canadians expressing trust in the blood system managed
by CBS (7+ on a 10 point scale) from third-party polling data
5
100%
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
6
CBS at a glance
COLLECTIONS
MANUFACTURING
DISTRIBUTION
~415,000
Active
Donors
Production
Testing
Inventory
R&D
Education
Serve
732
Healthcare
Facilities
• 872,506 whole
blood donations
(freq = 2.18)
• 51,770 apheresis
plasma donations
(freq = 8.67)
• 36,179 apheresis
platelet donations
(freq = 5.15)
• 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
7
• Est. 600,000 patient
transfusions a year
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
8
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 demands:A 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
9
Born in an environment of failure and scandal
10
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
Canada’s 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
11
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 R&D
12
…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
13
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
14
Legacy – Krever Commission of Inquiry
29 - 45: The Regulator – The Health Protection Branch
Health Canada’s regulatory oversight over
CBS has improved substantially:
A series of recommendations aimed at the
Federal regulator, arguing for:
Attempts to make regulatory framework active and
risk-based
Active, risk-based regulation (intelligibly written)
Commitment to adhere to its own performance
standards for review (however resources
constraints negatively impact CBS)
Independent decision making that is accessible
and open to public
Permitting manufacturer to exceed standards
Willingness to examine more streamlined
approaches to review and approval
Post-market surveillance (hemovigilance)
Frequent and thorough inspections
Over zealous inspection process, still very task
focused rather than process oriented
Adequate resources
Limited evidence of openness of decision making
International harmonization
Active hemovigilance program developing
15
Blood safety: A broadly shared responsibility
FEDERAL (HEALTH CANADA)
• Regulation (Food and Drugs Act)
• Establishment Licensure
• Compliance and enforcement
• National Disease Surveillance
PROVINCES/
TERRITORIES
• Funding of Blood Operators
• Regulate Health Professions
• Medical practice (hospitals)
• Public Health
SAFETY
OPERATORS (CBS/HQ)
• Donor recruitment
• Product collection, manufacture
and testing
• Acquisition, distribution of
derivatives
• One Match Registry
OTHERS
• Donors & Recipients
• Non-governmental organizations
• Advocacy groups
• Health professionals
16
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
17
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
18
Canadian Blood Services: A new organization
with a new governance model…
Arm’s 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 ≈ C$915 million
19
A clear sense of mission…
Mission statement
Canadian Blood Services operates
Canada’s 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
20
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)
21
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 servicedelivery 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 Canada’s blood system take place amid a businessas-usual environment in meeting the nation’s blood needs
22
Since 1998, Canadian Blood Services has been
transforming, strategically and continuously
Phase 1
Phase 2
Phase 3
(1998 to 2003)
(2002 to 2007)
(2007 to 2012)
Crisis Management
• Restore trust
• Restore safety
• Rebuild core
operations
• Stabilize
facilities
• Manage crises
• Tactical
management
Strategic Management
• Become model for
health care
delivery
• From blood
manufacturers to
“stewards” of the
blood system
• Embed strategy
across
organization
23
Realtime Integrated System
• Real-time demand
forecasting
• Seamlessly
integrated from
hospital to donor
• Widely deploy
collection technology
• Advance customerservice culture
Strategic change
Transition
Stabilize
Transform
Canadian Red
Cross Society to
Canadian Blood
Services
Gain
understanding of
major issues
Determine
requirements for
change
Re-engineer the
system
Regain trust and
confidence in the
blood supply
April – Sept. 1998
Approximately 18
months
24
3 – 5 years
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
25
Changing the service delivery model
Disconnected “Centres” eroded by cost, time and circumstances into
islands of duplication
26
Traits of the silo model
14 disconnected “silos”
across Canada
No consistent operational
look and feel
No coherent strategic
approach to the business
Major management skilldeficits
No big picture of problems
and solutions
Process and structural
duplication
Obsolete IT infrastructure
Lack of operating metrics
Error-prone manual systems
Many inconsistencies
27
Changing the service delivery model
Silo model
Integrated national model
Context: quality and and risk management
28
Today’s effective, efficient and interconnected
national service-delivery model
29
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
30
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
31
Corporate Strategy Map
Canadian Blood Services operates Canada's blood supply 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.
Fulfill our
Mission
to
ensure
we
Customer
Service
Excellence
Safety
Operational Excellence
Plan for Tomorrow
C1. “CBS provides us with
safe products and services”
C2. “CBS manages an effective,
efficient and trusted blood system for
Canadians”
C3. “CBS helps us meet future
needs”
which
drive
the
Strategic
Actions
enable
us to
execute
S5. Deliver the right
product, at the right
place, at the right time
S2. Protect
against risks
S1. Monitor known and
emerging hazards
S4. Optimize donor
recruitment and
retention
Developing strategic assets
E1. Develop
our skills,
talent and
knowledge
+
E2. Support the
business through
information
technology
+
E3. Develop the
quality system
and culture
S6. Deliver
efficiency
and productivity
gains
S3. Promote the
optimal utilization of
product
S8. Create, develop or adopt new
knowledge, products and services
S7. Anticipate long term changes
in future needs for products and
services
Developing strategic assets
E1. Develop
our skills,
talent and
knowledge
+
E2. Support the
business through
information
technology
+
E3. Develop the
quality system
and culture
Developing strategic assets
E1. Develop
our skills,
talent and
knowledge
+
E2. Support the
business through
information
technology
Our
Enabling
Resources
R2. Build and sustain facilities that support our
business requirements
R1. Ensure a healthy financial
structure
CBS Values
32
+
E3. Develop the
quality system
and culture
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
33
Results amid change: the new model in action
Year-over-year Change in Funding
25%
20%
CBS Core
Revenue
15%
10%
5%
Canadian
Health Care
(excluding
Quebec)
0%
2001
2002
2003
2004
2005
2006
Performance
1,000,000
215.0
210.0
950,000
205.0
900,000
200.0
Total Units Collected
(WB, Platelets,
Plasma)
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
195.0
850,000
190.0
Units Collected Per
Employee
800,000
185.0
180.0
750,000
175.0
700,000
170.0
2000
2001
2002
2003
2004
2005
2006
34
Trending upward
89%
80%
75%
56%
Safe to
Receive
blood
Safe to
Donate
blood
1998
2007
Public trust in the blood system restored by emphasizing risk
management, product quality and safety, operational transparency
and accountability, and customer service
35
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
36
39
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:
From
To
• Activity focused
• Process oriented
• Regulatory compliance
• Good business practice
• Passive senior management
• Active process ownership
• An obstacle and burdensome
to day-to-day activities
• Management tool that enables
change & improvement
37
46
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
38
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
39
Risk management framework
40
Risks in blood and plasma systems
Freedom from transmissible
harmful agents (THAs)
Adequacy of supply
Control of the system
41
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
42
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
43
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)
44
48
Transforming Canadian Blood Services, a
continuing process
Phase 1
Phase 2
Phase 3
(1998 to 2003)
(2002 to 2007)
(2006 to 2012)
Crisis Management
• Restore trust
• Restore safety
• Rebuild core
operations
• Stabilize
facilities
• Manage crises
• Tactical
management
Strategic Management
• Become model for
health care delivery
• From blood
manufacturers to
“stewards” of the
blood system
• Embed strategy
across
organization
45
Realtime Integrated System
• Real-time demand
forecasting
• Seamlessly
integrated from
hospital to donor
• Widely deploy
collection tech
• Full customerservice
culture
Looming challenge: the boomer bubble
Impact of Aging Population
 Donor base faces rapid decline
 Product demand is escalating
 Both trends are intensifying and
long-term
46
Collision course: demand-supply issues
Demand
Supply
• Aging population
• Increasing morbidity
• Increasing medical
procedures
• Changing product mix
• Population growth
• Ethnicity
• Expanding role of the blood
business
• Global competition for plasma
and fractionated products
• Aging population
• Health-cost containment
• Creating new donors
• New pathogens
• Increasing deferrals
• Regulatory issues
• System capacity, flexibility,
scalability
• Technology deficit
• Skills deficit
• Supply management
• Blood’s competitive brand and
profile
47
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
48
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
49
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