JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

2.3: Other standards

There are a number of other standards that help define how a quality management system should be designed to meet the needs of a particular aspect of a Service’s work. Table 2.1 provides information on some key standards inspection, licensing, accreditation and certification.

They are all applicable within England. Some apply directly to the whole of the UK (e.g. the International Standards), others to England and Wales (e.g. the NHS Litigation Authority Risk management assessment programme). Where there is not a direct cross-reference the reader should investigate further to determine how the standards might apply.

All the primary sources cited here are places where sound advice on management systems to address the various requirements of a modern Blood Service can be found. These will support the design and establishment of a system that can be confidently subjected to an external inspection process. The list is not intended to be exhaustive and by the nature of change is only current at the time of publication. It is for this reason version numbering has not been applied to the available standards; they will be constantly updated.

Table 2.1 List of some key inspection/licensing/accreditation/certification standards

Key standards Applicable to Responsible body Website

Caldicott Report 1997, implementation 1998

Confidentiality of patient data

Department of Health

www.dh.gov.uk

Care Quality Commission Fundamental Standards 2014

Health and social care services in England

Care Quality Commission

www.cqc.org.uk

Health and Care Standards 2015

Healthcare in Wales

Healthcare Inspectorate Wales

www.hiw.org.uk

Health and Social Care Standards 2017

Care and treatment delivered by NHS Scotland

NHS Quality Improvement Scotland

www.nes.scot.nhs.uk

Quality standards for health and social care 2006

The availability and quality of health and social care services in Northern Ireland

The Regulation and Quality Improvement Authority, Department of Health, Northern Ireland

www.rqia.org.uk

European Foundation for Quality Management (EFQM) Self-Assessment

Measurement of the effectiveness and, over time, the improvement in a Blood Service’s management system. Helping understand where they are on the path to excellence

British Quality Foundation

www.bqf.org.uk

www.efqm.org

European Blood Inspection System (EuBIS)

The safety of blood transfusion in Europe

Institut für Transfusionsmedizin und Immunhämatologie

www.eubis-europe.eu

Standards for Histocompatibility & Immunogenetics Testing

Histocompatibility and Immunology (H&I) – reference and tissue typing

European Federation for Immunogenetics (EFI)

www.efiweb.eu

The Data Protection Act

UK General Data Protection

Protection regarding processing of personal data of UK residents Information Commissioner's Office www.ico.org.uk
General Data Protection Regulation Protection regarding processing of personal data of EU residents EU Commission www.eugdpr.org

Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture

Validation of computer systems

International Society for Pharmaceutical Engineering

www.ispe.org

Good Manufacturing Practice (GMP) guidelines

Pharmaceutical environments

The European Commission publishes this online as EudraLex Volume 4

https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

HTA Directions 011/2021 – the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007

HTA Codes of Practice

Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment

Human Tissue Authority

www.hta.gov.uk

International standards for unrelated haematopoietic stem cell donor registries

WMDA Accreditation Programme

Stem cell and donor registries

World Marrow Donor Association (WMDA)

www.worldmarrow.org

ISO 15189 Medical Laboratories - requirements for quality and competence Medical laboratories UKAS www.ukas.com

ISO 17799 Information Security Management

Information security

BSI British Standards

www.bsigroup.com

ISO 9000 2000 and ISO 9001 2008

Quality management system requirements

Quality management system

BSI British Standards

www.bsigroup.com

ISO 20000 IT Service Management Standard Service management BSI British Standards www.bsigroup.com
ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Management of medical devices BSI British Standards www.bsigroup.com

Joint Accreditation ICT Europe and EBMT (JACIE) assessment standard

Stem Cell Immunology – Human Progenitor Cells (SCI – HPC) collection, processing and storage

The Joint Accreditation Committee ISCT & EBMT (JACIE)

www.ebmt.org

NHSLA risk management assessment programme for NHS Trusts

Management of claims and litigation

National Health Service Litigation Authority

www.nhsla.com

PRINCE2

Project control

Cabinet Office

www.gov.uk/government/publications/best-management-practice-portfolio/

 

Last updated 13/03/2024