Quality and Regulatory Compliance

All the activities we carry out to save and improve patients lives are subject to strict regulations.

For blood donation and component manufacture we hold a Blood Establishment Authorisation and are regularly inspected by the Medicines Healthcare products Regulatory Agency (MHRA) to verify compliance with the Blood Safety and Quality regulations.

For Tissues we are licensed by the Human Tissue Authority (HTA) and as such comply with the Tissue Quality and Safety Regulations.

The blood and tissue products we make must conform to the specifications outlined in the Guidelines for the Blood Transfusion Transfusion Services in the United Kingdom (current edition).

For Organs we hold a Procurement License and are inspected regularly by the HTA under the Quality and Safety of Organs intended for Transplantation Regulations.

The MHRA also licence us for the manufacture of Medicinal products such as "Specials" and Investigational Medicinal Products.

NHSBT's laboratories are accredited and subject to audit from professional bodies such as the Clinical Pathology Accreditation scheme and the Joint Accreditation Committee - ISCT & EBMT (JACIE).

To enable us to manage and comply with these requirements we operate a single Quality Management System. NHSBT has a Quality Assurance Department which supports all our functions and provides advice on regulatory compliance to staff in all areas of the organisation.

NHSBT promotes a culture of continuous improvement so taking every opportunity to improve our efficiency; and the quality of our products and services.

By working in this way we ensure that blood, tissues and organs meet the highest quality and safety standards to ensure the best care for our donors and best outcomes for patients.

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