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)

http://ettc.lrhsd.org/archives/Pictures/panflu.jpg�

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