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Policies and regulations

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

We are accountable to the Department of Health for the standard of our products and services. The quality of our products and services is crucial, and we have established robust processes to ensure regulatory compliance and offer the highest level of care.

Clinical regulation

We are regulated by a number of external regulatory agencies. These include the Care Quality Commission (CQC), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA).

The CQC monitors, inspects and regulates our services to make sure they meet fundamental standards of quality and care. The MHRA is responsible for the regulation of medical devices and medicines used in healthcare and also the regulation of blood establishments. The HTA regulate the removal, storage and use of tissue, including organs, for transplantation.

Quality and regulatory compliance

Our Quality Assurance Department supports all our functions and provides advice on regulatory compliance to employees across the organisation. This helps us continually improve efficiency; and the quality of our products and services, ensuring the finest care for donors and best outcomes for patients.

We operate a single Quality Management System to ensure we meet all our regulatory requirements. We are regularly inspected by the CQC, MHRA and HTA, and hold Blood Establishment Authorisation and a Procurement License for organ transplantation. The MHRA also licence us for the manufacture of Medicinal products such as "Specials" and Investigational Medicinal Products. Our 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).

Framework agreement

This document outlines how the Department of Health and NHSBT will work together, setting out roles, responsibilities, governance and accountability arrangements. It also briefly defines the relationship between the other UK Health Departments and NHSBT for functions carried out in the rest of the UK.

View the Framework Agreement document

View the Framework Agreement Annex



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