Risk management and the National Blood Supply Contingency Plan

The NBA maintains an integrated risk management program. We focus on managing issues that pose a risk to the Australian blood sector, especially to continuous supply security.

Our program ensures that responsibility and accountability lie with those who can best manage each risk. We also have structured measures to address risk where appropriate. These include:

• supply risk management measures
• National Blood Supply Contingency Plan
• National Managed Fund.

Managing supply risk

Our supply risk management measures help ensure our suppliers have appropriate risk management plans in place.

Supplier contracts

Suppliers must provide us with risk management plans as part of their supply contracts.

These plans show how suppliers will identify, avoid and mitigate risks when providing products and services. We discuss risk management with suppliers based on their plan.

We consider suppliers’ plans when we develop our own risk management plans for arrangements under each supply contract or suite of contracts.

Commercial contracts

We have developed a framework of risk management arrangements related to supply contracts. This provides robust risk management to ensure security of supply.

These arrangements include:

• notification and reporting processes to identify impending risks
• intensive product management mechanisms
• commitments from suppliers to give preferred customer status to supply for Australia
• requirements for products to have a specified minimum level of shelf life at the time of supply in Australia
• requirements to hold required levels of in-country reserves
• provision for supply of alternative products, if triggered by the NBA
• in some cases, multiple supplier arrangements
• a committed global stock requirement for products with a steady demand, where a supplier will specifically allocate product held in the normal global supply chain for supply to Australia
• contractual procedures for managing a product recall
• alternative minimum inventory requirements for products with low or highly variable demand, where it is difficult for suppliers to sustainably commit to the NBA’s normal in-country reserve requirements.

Fresh blood supply contract

Australian Red Cross Lifeblood(Opens in a new tab/window) (Lifeblood) is the only supplier of fresh blood products in Australia.

It is also the only organisation licensed by the Therapeutic Goods Administration (TGA)(Opens in a new tab/window) to collect blood for manufacturing blood and blood components.

For this reason, we ensure Lifeblood has appropriate strategies in place to address risks such as:

• financial risks
• unavailability of critical infrastructure
• a disrupted supply of blood and blood products or an unknown spike in demand
• incorrect clinical and product advice.
   

To address these risks, the following risk management strategies are in place:

• regular financial reporting
• output-based funding model agreed every 3 years
• insurance
• National Managed Fund
• contingency planning
• notifiable events reporting to the NBA that may impact on:
   
  • donor or recipient safety
  • the security or adequacy of supply
     
• funding from the NBA of major processing centre infrastructure
• regular supply and demand planning
• inventory management initiatives
• blood sector risk reviews
• audit rights by the NBA for compliance activities.

National Managed Fund

Governments established the National Managed Fund (NMF) to cover potential future claims made against Lifeblood in relation to the supply of blood and blood products in Australia.

The fund was set up as a discretionary managed fund with a finite scope. There is no contractual liability to agree to claims.

The Australian, state and territory governments and Lifeblood contributed to the NMF. Interest is earned on the balance.

National Blood Supply Contingency Plan

The National Blood Supply Contingency Plan (NBSCP) is a framework that specifies the arrangements for the management of a crisis affecting the supply of blood and blood products. It enables the NBA and key stakeholders to institute a rapid national response to supply threats.

The NBSCP complements supplier and government contingency plans across jurisdictions. This allows a joint approach to managing risks to the blood supply and potential impacts on the broader health sector.

About the NBSCP

The NBSCP main document outlines the risk management approach taken to mitigate a supply or demand crisis. This covers:

• risk identification
• governance arrangements
• roles and responsibilities
• overarching strategies.

The plan also aims to improve awareness and ensure appropriate planning is in place for dealing with the impact of a blood crisis in the health sector.

As well as the main document, the NBSCP has 4 annexes. These detail specific response plans:

• Annex A – Red Cell Response Plan
• Annex B – Plasma and Recombinant Products Response Plan
• Annex C – Platelets Response Plan
• Annex D – Transfusion Transmissible Infection (TTI)

The NBSCP response to activation has 3 levels of accountability in a crisis:

National level covers the roles of national government bodies in:

• gathering and communicating information between governments and suppliers
• being the link to broader government emergency management arrangements.

National bodies include:

• the NBA
• the Australian Health Protection Principal Committee
• the Office of Health Protection
• the TGA.

Operational level covers the role of suppliers in managing operational activities around:

• collection
• manufacture
• distribution
• interface with the clinical community.

Clinical level covers the role of clinicians and pathology providers in reducing demand through strong triage and vetting processes based on clinical needs.

The clinical community is vital to any activation of the NBSCP. Institutions should have arrangements in place to:

• support the clinical management of blood and blood products in a crisis
• assist clinicians to respond to patient needs effectively.

Review of the NBSCP

In 2019, the NBA reviewed the NBSCP. During the review we consulted suppliers and stakeholders. The review found the NBSCP is a well-established contingency plan in the Australian blood sector.

The review also found the NBSCP would benefit from:

• a structured testing and exercise program
• harnessing opportunities to work with other contingency planning arrangements across all jurisdictions and levels of government.

In 2020, the NBA formed a working group of key stakeholders to provide input into the NBA's recommendations for a testing and exercise program.

Findings from this process and observations from the COVID-19 pandemic will result in updates to the NBSCP. The working group has reconvened to progress the review.

Get in touch

If you have a query about risk management, please contact us.