1.1 The development of the Red Book - Introduction

The 'Guidelines for the Blood Transfusion Services in the United Kingdom' were first published in 1990 by Her Majesty's Stationery Office (HMSO). They was compiled by experts from the then Regional Transfusion Centres and the National Institute for Biological Standards and Control (NIBSC). The aim was to define guidelines for all materials produced by the UK Blood and Tissue Services (UKBTS) for both therapeutic and diagnostic use.

The driving force for this joint initiative, which started in 1987, was the imminent European Union (EU) Directive which would bind member states to introduce product liability by July 1988. It was understood that human blood and substances derived from it would be defined as 'products' in terms of this Directive, and guidelines against which manufacturers could be inspected would be required.

Since 1990, eight editions of the Red Book (as the guidelines became known) have been published. They are now compiled by a group of experts both from within the UKBTS and from the wider NHS and universities. This group is the Joint Professional Advisory Committee to the UK Blood Transfusion and Tissue Transplantation Services (JPAC).

The Red Book contains guidelines reflecting best practice, sets standards to be met by the products, describes technical details of the processes involved, and states the legally binding requirements introduced in 2005 under the Blood Safety and Quality Regulations, Statutory Instrument 2005. More detailed information about the regulatory environment relating to blood and tissues in the UK can be found in chapter 2.

The JPAC guidelines reflect best practice and are developed by professionals in the field. JPAC consists of subject matter experts in blood transfusion and tissue transplantation. The Red Book reflects their work as it is implemented in the UK and focuses on the products rather than their use.

The JPAC guidelines are not legally binding but, as they reflect consensus best practice, may be taken into account by the UK judiciary. The guidelines take into account EU Directives, which have to be transposed into UK law, and these are legally binding.

The work of JPAC is conducted through it specialist Standing Advisory Committees (SACs):

SACBC

Blood Components

SACCSD

Care and Selection of Donors

SACCTP

Cellular Therapy Products

SACIH

Immunohaematology

SACIT

Information Technology

SACT

Tissues

SACTTI

Transfusion Transmitted Infection

JPAC, through its SACs, undertakes regular reviews of the guidelines in the light of developments in the field, both scientific and regulatory. The overall aim is to ensure, as far as possible, the safety of blood transfusion and tissue transplantation for both donors and recipients in the UK. Changes to the JPAC guidelines are therefore likely to occur frequently. These changes are reflected on the JPAC website, where an up-to-date version of the guidelines can always be found.