Understanding and Managing Risk – Australia’s Response to a Shortage of Blood
Stephanie Gunn, Deputy General Manager
The Fong Nien – an Ode of Thanksgiving for a Plentiful Year
“Abundant is the year with much millet and much rice and we have our high granaries, with myriads, and hundreds and thousands and millions of measures in them. For spirits and sweet spirits, to present to our forefathers, male and female. And to supply all our ceremonies. These blessings sent down on us are of every kind”.
(from The Shih King - Book of ancient poems taken from “Living Thoughts of Confucius, by Doeblin)
So – Why is this stuff so important?
What We Get From Blood
Recombinant Clotting Factors
Immunoglobulins (inc IVIg)
Clotting Factors(inc pVIII)
Albumin
Overseas Manufacture
Platelets
Plasma
Red Cells
Whole Blood
Local manufacture
How Blood is Used
Supply/Demand Risks
Recombinant Clotting Factors
Immunoglobulins (inc IVIg)
Clotting Factors(inc pVIII)
AlbuminManufacture
Platelets
Inadequate donors Ineligible donors
Whole Blood
Inadequate blood collected
↑↑ Burns patients
Inadequate collections (expiry)
ContaminationManufacturing fault
Plant failure (few global sites)
Reaches regulatory standard
Risk Mitigation Options
Recombinant Clotting Factors
Immunoglobulins (inc IVIg)
Clotting Factors(inc pVIII)
AlbuminManufacture
Platelets
Whole Blood
Donation promotion
Multiple suppliersContract requirements
ImportationManage Demand
Product Reserves
ImportationAuthorisation of use
Clinical guidelines
Multiple suppliersIn country reserves
Approach - Authority
NBA Act (Part 2, Section 8 (1)), the NBA has responsibilty to: – Ensure that there is a sufficient supply of blood products and services– Enter and manage contracts/ arrangements for the collection, production
and distribution to ensure sufficient supply of blood products and services– Carry out safety measures, quality measures, contingency measures and
risk mitigation measures for the supply of blood products and services.
Agreement (Subsection 25(i)) - establishing and managing contingency/risk mitigation measures for national blood supplyRisk Analysis (SRRMP project) – recommended contingency plan be developedProject endorsed by JBC
Approach - Scope
Purpose:– provide a national framework for a rapid/coordinated response by the NBA,
and other responsible agencies, to manage the consequences of a demand surge or supply failure
– Support NBA's supply and demand planning role.
Goals:– Preparation and mitigation planning– Create awareness of NBSCP & blood products as a national resource– Facilitate national decisions:
• for an appropriate response during a supply and demand crisis,• through clear communication and provision of information and data • equity of access
– Integrate with broader health sector emergency management planning
The NBA
Civic, Canberra,
40 staff
– (0.75 FTE on risk)
09/10 Annual Operating Budget $10m
09/10 will spend just under $1b on blood products
NBA’s Risk Policy Development
Modification of ‘best practice’ example based on AS/NZS 4360:2004
Challenge was to:
– Create framework suitable for small agency– Understand our risks
• What implications did our unique governance have?
– Understand sector risks• Limited knowledge, skills or experience in
the subject manner– Embed risk assessment in our culture
• Not just policy, not just programs but real doing
VERY REAL RISKS
Approach – Risk Based Methodology
All based on a ‘risk approach’ reflecting NBA overarching Risk management policy and key business processes
Risk Management Principles 2003
Analyse
Plan
Implement
Communicate
Monitor
Review
Practical Outputs Then
Key Business Processes #1 Risk
Blood sector Crisis Management Plan
Plasma and recombinant product contingency plan
Interim Emergency Blood Management Plan
Business Continuity Plan
National Blood Supply Contingency Plan
Impact
Notifications of Influenza - 2007
Month of Notification
Jan Feb March April May June July August September October November December
Labo
rato
ry c
onfir
med
cas
es o
f Inf
luen
za
0
1000
2000
3000
4000
5000
6000
Australia Queensland
Red CellsImported into Queensland
2007 Flu Season
MonthMay Jun Jul Aug Sep Oct
Notifi
catio
ns o
f Inf
luenz
a
0
200
400
600
800
Impo
rted
Red
cell U
nits
0
200
400
600
800
1000
Movement of Red Cells to Queensland by State/Territory (May-Sept)
Sydney 195
Hobart 300
Darwin 327
Canberra 460
Melbourne 495
Perth 1153
Adelaide 3394
0500
100015002000250030003500
Sydney
Hobart
Darw
in
Canberra
Melbourne
Perth
Adelaide
Approach – Development
Context assessment/Research– Project Planning /Risk management (project Risks) – Relevant documents collected and reviewed (e.g. supplier risk plans) – Assessment of other government initiatives (e.g. HIAAG, EMA Role, NIR)
Risk Identification and Assessment (semi-quantitative):– Impact of demand and supply scenarios– Likelihood of Scenarios– Availability of alternative products
Approach – Development
Risk Evaluation– Development of triggers– Identification of Phases– Drafting of Plan
Consultation with Stakeholders– Governments (via JBC /AHPC/ HIAAG/ EMA/ TGA) – Suppliers – Clinical Community (e.g. private hospitals associations, public hospitals,
state based clinical forums, public and private pathology, ANZSBT, key Colleges / Societies,)
Approach - Development
Formal simulation
Difficulties in getting an endorsed plan/framework:– Different views on an acceptable level of risks– Varying degrees of product usage, therefore:
• Different local institutional arrangements required• Level of guidance sought varied
– Private sector saw different impacts of mitigation strategies
Implementation – Activation 2008
Weekly Red cell supply trends, by blood type between 27/03/2008 and 9/10/2008
0.00
2.00
4.00
6.00
8.00
10.00
12.00
27/0
3/20
08
3/04
/200
8
10/0
4/20
08
17/0
4/20
08
24/0
4/20
08
1/05
/200
8
8/05
/200
8
15/0
5/20
08
22/0
5/20
08
29/0
5/20
08
5/06
/200
8
12/0
6/20
08
19/0
6/20
08
26/0
6/20
08
3/07
/200
8
10/0
7/20
08
17/0
7/20
08
24/0
7/20
08
31/0
7/20
08
7/08
/200
8
14/0
8/20
08
21/0
8/20
08
28/0
8/20
08
4/09
/200
8
11/0
9/20
08
18/0
9/20
08
25/0
9/20
08
2/10
/200
8
9/10
/200
8
O PosO NegA Pos
ARCBS/ AHP
inventory holdings
IPM
Implementation
Phase 1:WHITE ALERT
Phase 2:Yellow Activate
Phase 3:Red Activate
Implementation – Promulgation
Evaluation/Debrief Donor Fatigue
SUPPLY CRISIS
What caused it and did the Plan work ?
Demand Predictions
Capacity to Increase Red Cell
Production
Demand Models and Predictive Capacity
Data on Usage
Pressure for Apheresis Products
Need for New Donors
Changing Life and Work Priorities
Impact of Other
Government Priorities
Inventory Practices
Hospitals ARCBS
Increased Demand for Red
Cells
Inadequate Data on High
Variability and High Volume
Use
Management of a “free good”
Increasing Demand
Relating to Demographics
Increased Funding for
Elective Surgery
Prescribing Behaviours
Donor Retention
Capacity to Recycle Red
Cells
TGA Requirements
Evaluation/Debrief
De-Brief:– Involved JBC/TGA/OHP/ARCBS– Utilised SWOT analysis– Feedback from Clinical Community
Future Improvements– Refine the trigger points
• Multi factorial risk assessment – Improve equity of impact– Data - in normal and crisis
Short Term Benefits
National inventory report
Framework provided National approach
Transparent processes for managing stock
Consistent and controlled communication
No reports of adverse patient outcomes.
A collaborative approach between governments and ARCBS.
Increased awareness and need for “stewardship” of blood products
Long Term Benefits – Risk Management
Integration and consistency with OHP/NIR– Dengue outbreak 2008/09 – Victorian bushfires 2009, – Ashmore reef disaster 2009, – H1N1 Outbreak 2009, and – Samoa 2009
Continuous improvement – supply management/planning:– Developing Intensive Product Management framework for fresh
components.– Exploring strategies to minimize demand for product going forward, and – Understanding broader health policy impact on supply.
Specific jurisdictional policy directives requiring development of capabilities consistent with roles and responsibilities in the NBSCP
Long Term Benefits – Organisational Priorities
Improved communication with JBC (GovDex Portal ) Mechanism for continual review of supply risksContract Management:
– Improved relationship and communications with ARCBSClinician awareness of supply challengesGovernance arrangements for institutions in a range of other projects underway within the NBA and jurisdictions.Clinical Community engaged – working on other NBA projects
So what have we learned ?
Evolution of our Risk Principles
In the beginning: -
Analyse / Plan / Implement / Commu
NOW
Leadership
Credibility
Engagement
Communication
Reform
nicate / Monitor / Review
Practical Outputs Now
Key Business Process on Risk - V4
Business Continuity Plan - V3
Blood Sector wide contingency plans
Engagement in health sector contingency planning
1. Understand and Utilise Context
An excellent document which deals with the normal blood sector arrangements; blood and blood product management; crisis planning; preparation for and mitigation of a crisis; and response at all levels”, the “plan is well worth reading”1
2. Ensure Shared Understanding of Risks
3. Understand Limitations of each Stakeholder
“In the event of an emergency, apart from a high level policy decision such as to enforce cancellation of elective surgery, governments cannot and should not pre-determine the treatment regime of individual patients. The patient requirements for blood and blood products will need to be assessed by the treating physician, with their care and treatment to be determined in the context of these needs and the capacity of the facility to provide that treatment.”
4. Agree to Clear Roles and Responsibilities
Don’t change fundamental normal roles
Build on current expertise
Support to fill gaps
Provide guidance and structure
– 1 x Commonwealth (NBA and Health)– 8 x States / Territories– 2000 hospitals that use blood
5. Think Outside Your Square
6. Communicate and Communicate Again
Publish and disseminate
– Make space for other roles
Newsletters
Keep people informed of current thinking
– Eg current pan flu responses
7. Use it, learn from it, build on it
De-brief
– Work with stakeholders to address weaknesses• Not just risk based• Develop broader capabilities to PREVENT risk events• Integrate into other processes
Review
– Learn from domestic, global, sector changes
8. Acknowledge
Engage and listen to stakeholders
Work collaboratively
Be flexible
Respect knowledge
Be knowledgeable
No blame - collaborative / partnership / advocacy
Acknowledge
– All States / Territories/ DoHA / suppliers