UK Regulations and European Directives
The UK Regulations and EU Directives seek to ensure the quality and safety of blood and blood products during the whole transfusion chain. They set standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood products. It is essential that a complete audit trail is available for all blood and blood products. There are various ways to achieve a complete audit trail encompassing both paper based and IT solutions.
Copies of the regulations can be accessed via UKBTS Document Library / EU Directives & Regulations
Each year hospital transfusion laboratories are required to complete a Blood Compliance Report (BCR). This is reviewed by the MHRA Inspectorate division and the review of these will determine which laboratories will be inspected "for cause" by the MHRA. A copy of the current year's compliance form is available from the MHRA website.
The European Union Operational Impact Group (EU OIG) have produced tools, guidance and information which will asist with information when planning annual education and induction programmes for staff in this area.
Click here to navigate to the OIG toolkit pages.
CPA (Clinical Pathology Accreditation)
Encompasses organisation, quality management, resources and evaluation and quality activities required to ensure that laboratory activities are conducted in such a manner that they meet the needs and requirements of the users. Compliance with CPA standards signifies the ability of a laboratory, by certification, to be found compliant with the Essential Criteria & International Standards:
- ISO15189:2003 Medical Laboratories - Particular requirements for Quality & Competence
- EC4 Essential Criteria
National Occupational Standards (NOS)
National Occupational Standards (NOS) define the competences which apply to job roles or occupations in the form of statements of performance, knowledge and the evidence required to confirm competence. Each NOS describes a discrete work activity with a defined purpose and context, delivered as a series of functional statements against which are set the common measures of competence. Each standard aims to capture the decision making process, the knowledge required and the judgement applied.
The NOS are a Department of Health project and apply to the whole healthcare science (HCS) workforce (which includes biomedical scientists). There are three main divisions of the HCS workforce:
- Life sciences
- Physiological sciences
- Engineering and physical sciences
Biomedical scientists are in the Life Sciences category and NOS have been developed for each of the individual disciplines. A summary and the full text of all 581 healthcare science National Occupational Standards are now available on the Skills for Health Website - www.skillsforhealth.org.uk
The aim of a professional portfolio is to provide evidence of your personal and professional development. It should facilitate critical evaluation and reflective practice, which may be assessed against existing or evolving standards to provide an objective measure of progress, and provide a mechanism for the maintaining and developing of professional knowledge and competence. A professional portfolio provides the opportunity to:
- define and develop skills in self-direction
- acquire knowledge from past and current experiences
- demonstrate application of theory to practice
- enhance self-motivation
- identify learning needs and select resources to facilitate this process
- demonstrate performance levels against standards
- collaborate with mentor and other colleagues
- demonstrate evidence of professional and expert practice in the context of benefits to patient care and future developments
- formally or informally validate progress and development against existing or evolving standards
National Pathology Alliance Benchmarking Review
The Clinical Management Unit at Keele University is the home of The National Pathology Alliance Benchmarking Review. This study is now in its seventh year. Areas studied are: Clinical Biochemistry, Haematology & Blood Transfusion, Histopathology & Cytology, Microbiology (including virology and serology) and Immunology.
Workload is measured in a fair and equitable way
Staffing data is collected in terms of Whole Time Equivalents to ensure fair comparisons within the clusters. One of the areas of work that generates most interest from participant Trusts is the workload to staffing ratio, which is produced for, amongst others, medical and biomedical scientist staff.
Equipment and how it is purchased, reporting times and the hours that the departments are open, and how the out of hours staff are paid.
The National Transfusion Laboratory Collaborative
In August 2006, a meeting was convened at the headquarters of the Institute of Biomedical Science (IBMS) to discuss how laboratory errors could be reduced. At this initial meeting, a collaborative approach to reducing laboratory errors was agreed and the National Transfusion Laboratory Collaborative (NTLC) was established. The collaborators for this work are IBMS, Serious Hazards of Transfusion (SHOT), Royal College of Pathologists, British Blood Transfusion Society and the National Blood Transfusion Committee in England. Stakeholders are UK NEQAS (National External Quality Assessment Scheme), the British Society for Haematology (BSH), and the Medicines and Healthcare Products Regulatory Agency (MHRA).
The aims of the collaborative are to:
- Obtain information on:
Make recommendations aimed at making the transfusion laboratory process safer
- staffing in blood transfusion laboratories
- the training undertaken in blood transfusion laboratories
- the qualifications possessed by staff working in blood transfusion laboratories
- workload in blood transfusion laboratories
A draft report has been circulated for consultation. The final report, when published, will be posted on this web page.
Laboratories must establish a procedure to control all documents, both internally generated and from external sources, to comply with national standards.
There are a number of systems available for this purpose.
For guidance: www.cpa-uk.co.uk
Further details are available from the UK Blood Services Better Blood Transfusion Teams.
Quality Assurance Systems
Essential for the provision of reliable and accurate results. All laboratories should apply Quality Assurance procedures as part of monitoring professional standards of service to support optimal patient care through the use of External Quality and Internal Quality Assessment. Existing schemes:
National External Quality Assessment Service (NEQAS) - www.ukneqas.org.uk
Welsh Assessment of Serological Proficiency Scheme (WASPS)
First introduced in 1989, the scheme has been designed to assist laboratories in monitoring and improving performance of red cell antibody detection during blood transfusion compatibility testing. The scheme is based on simulated compatibility testing in which 4 sera are tested against 3 cell samples. It is designed to be performed by individual members of staff using routine methods. Sufficient material is provided to participant laboratories to allow all staff to perform the exercise. This has been a major objective of the Scheme allowing quality assessment to be more widely applied in routine laboratories. Further information is available at www.waspsqa.org.uk
The NHSBT reagents department based at theLiverpool site produce Internal Proficiency exercises (IPEx) 6 times a year. Each exercise consists of up to 3 'patient' samples and a number of questions to be used as a CPD exercise. The Laboratory Head is provided with the expected serological results and model answers.
Contact details Mandy Hunt 0151 552 7157 email email@example.com.
UK Legislation and EU Directives 2002/98/EC
Adopted into national law 08/02/2005.
Implemented by 08/11/2005
Requires Blood Transfusion records to be kept for 30 years
Copies of these can accessed via UKBTS Document Library / EU Directives & Regulations
Guidelines for Blood Bank Computing
Details the requirements to ensure computers provide strict accountability of blood components
HC(84)7 Blood Transfusion: Record-keeping and Stock Control Arrangements
Details the requirements for record keeping. This document is available through the Hospital Liaison Office, NHSBT (email: firstname.lastname@example.org)
Royal College of Pathologists & Institute of Biomedical Science Guidance:
The Retention and Storage of Pathological Records and Archives,
3rd edition, 2005
Guidance for the Emergency Transfer of Blood and Components with Patients Between Hospitals
A guidance document, co-written by the NHSBT Appropriate Use of Blood Group, and the National Laboratory Managers’ Group of the CMO’s National Blood Transfusion Committee, can be found here.
NHSBT Hospitals and Science
The site hospital.blood.co.uk has been developed in England and North Wales to provide information for Clinical and Scientific professionals supporting Blood Transfusion in hospitals and the research community and includes information on safe and appropriate use of blood including clinical guidelines, clinical audits and publications.