Quality in blood and tissue establishments and hospital blood banks
Introduction
The quality environment
The previous format of this chapter was designed in the late 1980s to support the United Kingdom Blood/Blood Transfusion Services in meeting the challenge of complying with UK Medicines Licensing requirements for the first time. It meant that Blood Services had to interpret the requirements of the European Community Good Pharmaceutical Manufacturing Practice (ECGPMP), and formally apply them to their collection, testing, processing and distribution services for the first time. The chapter was written to support Blood Services by demonstrating through an adaptation of BS 5750 'Quality Systems' how they could create a working quality management system that would support that licensing requirement. At that time, whilst the UK Guidelines covered other aspects of a blood service's activity, there was little requirement for those activities to be specifically regulated or accredited.
Whilst the UK Guidelines for Blood Transfusion Services in the United Kingdom continue to provide support for the majority of work of the blood establishments, these are complemented by a number of other legislative and/or accreditation requirements.
Taking all this into account the authors of this chapter feel it inappropriate to continue using the original format that was extended to cover the development of ISO 9001, which replaced BS 5750 Part 1. It was still dedicated to describing a quality management system for the collection of blood together with the subsequent testing, processing and distribution of blood and blood components. We also feel that trying to rewrite ISO 9000: 2000 and try to make this fit every aspect of a blood establishment's work would be inappropriate. For example, a blood establishment may wish to manufacture and distribute reagents. This requires the organization to be registered with a Notified Body and be awarded, following audit, the ability to apply the CE Mark to its products. To achieve this there are a number of routes from so called 'Full Quality Assurance' to independent batch testing of reagents before release by the Notified Body. The decision as to which route to take is individual to each organization and will be based on considerations such as: the categorization of the reagent; the scope of their operation; how much they wish to do to comply with the legislation; and how much they would wish to award to a third party.
To try and write a 'Quality' chapter that described a 'one size fits all' quality system would be inappropriate for this reason. It also seems inappropriate because of the huge leap in quality management skills within the blood establishments; providing a detailed description of how to install a quality system now seems redundant.
What the authors did want to do, was provide readers with the bigger picture. To describe how thinking on quality has developed within the Health Services of the United Kingdom into a holistic approach to assure stakeholders that donors, patients and staff meet their statutory duty of quality.
To that end, the following are described:
how, through the Health Services Governance initiatives, the Guidelines for the Blood Transfusion Services of the United Kingdom help meet our statutory duty of quality
key initiatives that are designed to improve the use of blood and blood components
key European initiatives that have an impact on the work of the blood establishments and blood banks
key principles that need to be considered when implementing a quality system
key standards and guidelines that need to be considered during the development and implementation of a quality management system.
This chapter is considered to be a primer in developing an understanding of how quality principles can be used to support the work of 21st century blood establishments and blood banks. We hope they will encourage an open and informed dialogue with 'quality' professionals, which will help ensure that the blood and tissue establishments and hospital blood banks implement, and more importantly use their quality management systems to measure and improve on the quality of donor and patient care.
Governance
The fundamental purpose of governance/quality is to provide 'assurance' to stakeholders. Blood establishments and blood banks deliver care to donors and patients through a range of products and services. The convergence of clinical and corporate governance has emphasized an increasing understanding that assurance is imperative, in respect of these products and services.
NHS bodies are required to provide assurance particularly that risks are being managed effectively through an annual 'Statement on Internal Control' that encompasses the statutory duty of quality. Licensing and accreditation systems are an integral part of a blood and tissue establishment's and hospital blood bank's assurance framework and should be seen and utilized as such.
The Chief Medical Officers' 'Better Blood Transfusion' initiatives
The first initiative, in 1998, resulted from concerns regarding the sufficiency and increasing cost of blood, and concerns regarding safety arising from successive SHOT (Serious Hazards of Transfusion) reports and awareness of the possibility of vCJD transmission. It was recognized that the development of a blood safety strategy must involve clinical users as well as the blood services. The second initiative, in 2001, was aimed at setting the agenda for NHS transfusion services for the next three years and focused on:
providing better information to patients
avoiding unnecessary transfusion
making transfusion safer.
This helped ensure that 'Better Blood Transfusion' was an integral part of NHS care. These objectives were further defined in Health Service Circulars in the four countries.
The UK blood establishments have a central part to play in the delivery of these objectives not only by ensuring optimum safety of blood components but also by working with users to develop comprehensive strategies for blood conservation.
Duty of care to patients and donors
Guidelines on the care and selection of donors are aimed at minimizing clinical risks to both the patient who receives the blood or tissue and the donor who gives it. This requires that the principles of clinical governance be in place as follows:
clear lines of accountability for the overall quality of clinical care
a comprehensive programme of quality improvement activities
clear policies aimed at managing risks
procedures for all professional groups to identify and remedy poor performance.
There is therefore a requirement for donation to be conducted in an appropriate environment, with adequate staffing levels, including suitably trained and competent health care professionals working to agreed clinical standards.
Appropriate safeguards must be in place to govern access to and storage of confidential patient and donor information as recommended in the Caldicott Report on the Review of Patient Identifiable Information. The quality of clinical care, including record keeping, should be monitored by clinical audit and adverse incidents affecting patients and donors must be reported and reviewed in order that lessons may be learned from them.