Chapter 20

Hospital blood banks: impact of EU Blood Directives and Better Blood Transfusion

Introduction

The safety of blood transfusion as a medical intervention depends not only on the safety of the product, but also on the safety of the clinical transfusion process and appropriate indications for transfusion. Hospital blood banks link the blood establishments (responsible for the product), the clinicians (responsible for the transfusion), and the patient who receives the blood.

The Better Blood Transfusion⁽¹⁾ initiatives emphasise the importance of hospital blood banks in promoting better blood transfusion and ensuring the safety of the clinical transfusion process. The 'Red Book' deals with the safety of the products; the Handbook of Transfusion Medicine deals with the indications for transfusion and the safety of the clinical transfusion process.

The European Union, whilst not having a competence in 2005 to influence clinical practice, has nevertheless included aspects of the work of hospital blood banks in the 'Blood Directives' in recognition of their key role in the safety of blood transfusion. It draws a clear distinction between blood establishments (the four national blood/transfusion services and the centres from which they operate) and hospital blood banks whose role it is to provide compatible blood components to clinicians for individual patients.

This chapter summarizes the regulatory impact of these Directives, transposed into UK law as the Blood Safety and Quality Regulations 2005,⁽²⁾ on hospital blood banks.

The printed Seventh Edition of the 'Red Book' reflects the situation in April 2005. Future changes will be described on the website www.transfusionguidelines.org.uk and, where appropriate, in Change Notifications issued by JPAC.