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 inspection/licensing/accreditation/certification standards.

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

BS 15000 IT Service Management Standard

Service management

BSI British Standards HQ, 389 Chiswick High Road, London W4 4AL, UK
+44 208 996 9000

BSI Online, Technical Indexes Limited, Willoughby Road, Bracknell RG12 8DW, UK
+44 1344 404429

www.bsigroup.com

Caldicott Report 1997, implementation 1998

Confidentiality of patient  data

Department of Health, Richmond House, 79 Whitehall, London SW1A 2NL, UK
+44 207 210 4850

www.dh.gov.uk

Care Quality Commission

To regulate and inspect health and social care services in England

Care Quality Commission National Correspondence, Citygate, Gallowgate, Newcastle upon Tyne
NE1 4PA, UK
+44 3000 616161

www.cqc.org.uk

or

Healthcare Inspectorate Wales

Healthcare Inspectorate Wales is the independent inspectorate and regulator of all healthcare in Wales

Healthcare Inspectorate Wales, Bevan House, Caerphilly Business Park, Van Road, Caerphilly CF83 3ED, UK
+44 29 2092 8850

 

or

NHS Quality Improvement Scotland

Improving the quality of care and treatment delivered by NHS Scotland

NHS Quality Improvement Scotland, Edinburgh Office, Elliott House, 8–10 Hillside Crescent, Edinburgh EH7 5EA, UK
+44 131 623 4300

 

or

The Regulation and Quality Improvement Authority

Northern Ireland Department of Health, Social Services and Public Safety

Responsible for monitoring and inspecting the availability and quality of health and social care services in Northern Ireland, and encouraging improvements in the quality of those services

Controls assurance standards

The Regulation and Quality Improvement Authority, 9th Floor, Riverside Tower, 5 Lanyon Place, Belfast
BT1 3BT, UK
+44 28 9051 7500

Central ALB Governance Unit, Department of Health, Social Services and Public Safety, Castle Buildings, Stormont Estate, Belfast
BT4 3SQ, UK
+44 28 9052 2792

 

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, 32–34 Great Peter Street, London SW1P 2QX, UK
+44 207 654 5000

www.bqf.org.uk

www.efqm.org

European Blood Inspection System (EuBIS)

European project addressing the safety of blood transfusion

Institut für Transfusionsmedizin und Immunhämatologie, DRK-Blutspendedienst, Klinikum der Johann Wolfgang Goethe Universität, Sandhofstrasse 1, D-60528 Frankfurt am Main, Germany

www.eubis-europe.eu

European Federation for Immunogenetics (EFI)

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

European Federation for Immunogenetics (EFI), EFI Central Office, c/o Department of Immunohematology and Blood Transfusion, Leiden University Medical Centre, Building 1 E3-Q, PO Box 9600, 2300 RC Leiden, The Netherlands

www.efiweb.eu

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

Validation of computer system

International Society for Pharmaceutical Engineering, European Office, 7 Ave des Gaulois, B-1040, Brussels, Belgium
+32 2 743 44 22

www.ispe.org

Good Manufacturing Practice (GMP) guidelines

Pharmaceutical environments

The European Commission publishes this online as EudraLex Volume 4

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

HTA Directions 003/2010 – the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007

HTA Codes of Practice

Tissue banking activity

Human Tissue Authority, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ, UK

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 Office, Europdonor Foundation, Plesmanlaan 1b, 2333 BZ Leiden, The Netherlands
Fax: +31 71 5210457

www.worldmarrow.org/

ISO 17799 Information Security Management

Information security

BSI British Standards HQ, 389 Chiswick High Road, London W4 4AL, UK
+44 208 996 9000

BSI Online, Technical Indexes Limited, Willoughby Road, Bracknell RG12 8DW, UK
+44 1344 404429

www.bsigroup.com

ISO 9000 2000 and ISO 9001 2008

Quality management system requirements

Quality management system

BSI British Standards HQ, 389 Chiswick High Road, London W4 4AL, UK
+44 208 996 9000

BSI Online, Technical Indexes Limited, Willoughby Road, Bracknell RG12 8DW, UK
+44 1344 404429

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 EBMT-EurolSHAGE (JACIE) Alvaro Urbano-Ispizua, JACIE Office, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain
Tel: +34 93 454 9543
Fax: +34 93 453 1263

www.jacie.org/standards/
interim-standards

NHSLA risk management assessment programme for NHS Trusts

Management of claims and litigation

National Health Service Litigation Authority, Napier House, 24 High Holborn, London WC1V 6AZ, UK
+44 207 430 8700

www.nhsla.com

PRINCE2

Project control

Cabinet Office, Service Desk, Rosebery Court, St Andrew’s Business Park, Norwich NR7 0HS, UK
+44 845 000 4999

www.best-management-practice.com

Standards for the Medical Laboratory

Medical laboratories

Clinical Pathology Accreditation (UK) Limited, 21–47 High Street, Feltham TW13 4UN, UK
Tel: +44 20 8917 8400
Fax: +44 20 8917 8500

www.cpa-uk.co.uk