Blood Work

2005-10-18

Standards are commonly thought of as applying to mechanical devices, plumbing fixtures and electrical appliances. But do they really have a place in people’s veins?

In a way, yes.

In the 35 years since the inception of the Standards Council of Canada (SCC), standards have reached into aspects of our lives previously unexplored. Into our forests and farms. Computers and telecommunications equipment. Matters of privacy. Issues of climate change. And even, human blood.

The National Standards System, overseen by the SCC, has enabled industry, government, consumers and the standards community to work collaboratively on a wide range of practical solutions to the challenges of the day.

The safety of Canada’s blood supply is one such example. In 1993, the Krever Inquiry was called to investigate the operation of Canada’s blood system, including the HIV and Hepatitis C infections that occurred in the late 1970s and early 1980s. One of its recommendations was the implementation of a national blood standard.

At the request of Health Canada, a technical committee of the Canadian Standards Association (CSA) undertook the serious task of addressing the issues of quality and safety in Canada’s blood system. Building on the work of a Health Canada Expert Working Group, the technical committee completed the first comprehensive standard to encompass Canada’s blood system. CAN/CSA-Z902-04, Blood and Blood Components provides a consistent national management framework for use by medical institutions throughout Canada. It was published and accepted by the SCC as a national standard of Canada in 2004.

Although guidelines and standards for blood management had been developed before, the CAN/CSA-Z902-04 committee created something unique for Canada, and indeed for the world: a comprehensive national standard covering all aspects of blood collection, processing, storage and use.

The standard also exemplifies the positive outcomes the standards community can achieve through close collaboration with stakeholders, a rigorous and consensus-driven process and an outward focus on societal needs.

The heart of the issue

While blood has been regulated and closely monitored at a federal level, the Food and Drugs Act (and associated documents) covers the collection, preparation and storage of blood components, but not transfusion. Meanwhile, the Canadian Society for Transfusion Medicine had the only major blood standard in Canada, but it covered only the hospital side of blood management and transfusion. Matters of patient safety have generally come under the purview of provincial and territorial hospital acts.

In the wake of HIV and Hepatitis C infections, the Krever Report documented the importance of national standards for the handling of blood and blood components. One of its recommendations referred to the importance of national standards in ensuring that "all persons in Canada needing blood components or blood products have access to products of uniform quality." Another recommendation was the setting and enforcement of standards. And a third stated, "the regulator must set minimum standards for all phases of the collection, processing and storage of blood and blood plasma, [and] enforce compliance with the standards." As the regulator of Canada’s blood system, Health Canada commissioned CSA to develop this standard.

Collaboration and consensus

What ensued was the kind of close collaboration among experts for which Canada’s National Standards System is renowned.

As a neutral third party, CSA provided the structure and forum for a committee of expert volunteers and stakeholders to develop the standard, using the "balanced matrix" approach that capitalizes on the combined strengths and expertise of members from various areas – with no singlegroup dominating. Members were drawn from professional associations, governments, patient groups and blood centres, and included representatives of the Canadian Blood Services, Héma-Québec, the Canadian Hemophilia Society and the Canadian Society for Transfusion Medicine.

The rigour with which standards are developed in Canada is essential to their acceptance in the marketplace. CAN/CSA-Z902 was developed through close consultation with a variety of stakeholders, and extensive research into best practices around the world. While CSA’s blood standard is voluntary unless referenced in law, its adoption is made more likely by the inclusive nature of its development. As one indication of uptake, the Ministry of Health and Social Services in Quebec is requiring all hospital transfusion services to be enrolled in a recognized audit program based on the standard by December 31, 2005. Other regulatory authorities, having been involved in the process, are likely to mandate use of the standard too.

A living standard

CAN/CSA-Z902-04 does not replace detailed specifications and operating procedures. It is a management standard that provides flexibility for addressing emerging issues in the constantly changing health care field. The standard directs testing labs to perform any additional screening tests required by Health Canada. In this way, testing for new health threats can begin as soon as Health Canada has approved the test method. The standard also provides consistency. With a national management framework for medical institutions, participants throughout the blood system understand their responsibilities and can act appropriately and efficiently.

Today’s health care issues demand solutions such as these ones — that combine flexibility with consistency and predictability, ones that accommodate new technologies and new practices while helping to ensure safety. What’s most satisfying is that this standard has the power to influence perceptions and affect behaviour in positive ways. In a recent poll by Leger Marketing, 20 per cent of Canadians polled said they would be more likely to give blood knowing that a national standard was in place covering

Canada’s blood system from collection to transfusion. Given that only about 3.5 per cent of us currently give blood, CAN/CSA-Z902-04 will help reinforce in Canadians’ minds that the blood system is safe. What’s more, it could have a significant impact on the quality of Canada’s blood supply.

Prepared by Pat Keindel

Pat Keindel is President, Standards, Canadian Standards Association (CSA), one of four SCC-accredited standards development organizations (SDOs). CSA has developed hundreds of standards that are playing an important role in protecting and preserving the health and safety of Canadians.

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