Part 1: Introduction

1.1
In this Part, we discuss:

• the purpose of our audit;
• the role of the Blood Service;
• how we carried out our audit; and
• what we did not audit.

The purpose of our audit

1.2
We carried out a performance audit to assess how well the Blood Service manages the safety and security of supply of blood products.

1.3
We assessed how well the Blood Service:

• ensures that it has enough volunteer blood donors to meet the country's needs (see Part 2);
• manages the safety of blood and blood products (see Part 3);
• supplies blood products and services in a cost-effective and timely way to meet needs (see Part 4); and
• ensures that its operations and practices are in line with international best practice (see Part 5).

The New Zealand Blood Service's role

1.4
The Blood Service, a Crown entity, is the only provider of blood products to the health sector. Blood products, which are made from donated blood, are vital life-saving medicines for many illnesses and injuries, such as cancer, burns, and bleeding disorders such as haemophilia.¹ Surgeons use blood products to treat trauma victims and in organ transplant operations. Therefore, it is essential that the Blood Service ensures that it collects enough blood and always has enough blood products to meet needs.

1.5
The Blood Service operates an integrated national "vein-to-vein" blood service, which means that it is responsible for all stages of blood transfusion, including:

• collecting blood from voluntary donors;
• testing donated blood and processing it into blood products;
• managing the storage of blood and blood products in their blood banks and providing advice and guidance to hospitals about storing blood products;
• selling and distributing blood products to hospitals; and
• giving specialist advice about blood transfusion to hospitals.

1.6
The Blood Service collects free donations from the New Zealand population. It then sells the blood products to district health boards (DHBs) to ensure that hospitals have appropriate and safe levels of these products. It sells the blood products to DHBs to cover its operating and manufacturing costs. Any financial surplus is returned to DHBs as a rebate or to offset price increases.

1.7
In the year ended 30 June 2011, the Blood Service had total expenses of $93.0 million and total income of $102.3 million, resulting in a net surplus for the year of $9.3 million.

1.8
Appendix 1 has more details about how the vein-to-vein service works and describes how the Blood Service collects, tests, and distributes blood and blood products.

1.9
Blood products for many life-saving medical needs are expensive to make. They have different expiry dates or "shelf lives", after which they are no longer safe to use. Depending on the type of blood product, these shelf lives range from five days to two years. Therefore, the Blood Service needs to ensure that it can supply blood products while minimising the discarding of expired blood products. Appendix 2 lists blood products, their main medical uses, and shelf lives.

1.10
As well as efficiently balancing supply and demand for blood products, the Blood Service must manage safety effectively at all stages of blood transfusion. The Blood Service has set "Safety is our cornerstone" as the core value for all that it does.

How we carried out our audit

1.11
We interviewed Blood Service staff who are responsible for managing the safety and security of supply of blood products, and officials in stakeholder entities responsible for the scrutiny and independent quality assurance of the Blood Service and its operations. These entities included the Ministry of Health (including Medsafe), and International Accreditation New Zealand (IANZ).²

1.12
We examined many documents relevant to the Blood Service's operations, including:

• policy manuals and standards;
• internal and external performance reports;
• quality assurance reports; and
• information about the safety and supply of blood products.

1.13
We visited the Blood Service's national headquarters and collection and manufacturing hub in Auckland to learn about and observe how the Blood Service collects, tests, processes, stores, and distributes blood products.

What we did not audit

1.14
The Blood Service helps the health sector match patients with donors before organ or tissue transplants, and provides tissue banking, products derived from bone, and stem cell services. We excluded these services from our audit because they do not directly relate to the safety and security of blood products.

1: The Medicines Act 1981 considers blood to be medicine. Medsafe, a business unit of the Ministry of Health, is responsible for regulating therapeutic products, including medicines. Therefore, blood processing comes under Medsafe's regulatory scrutiny.

2: IANZ is the authority responsible for accrediting testing and calibration laboratories. It is the accreditation body of the Testing Laboratory Registration Council, which is an autonomous Crown entity established by the Testing Laboratory Registration Council Act 1972.