Key requirements for blood establishments and hospital transfusion laboratories are defined within the Blood Safety and Quality Regulations (Statutory Instrument 2005 No.50) and are enforced by the Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA operate an inspection process designed to achieve continual quality improvement across the entire transfusion pathway, and include donation, processing, testing, collection, handling and storage, administration and traceability.
This regulator along with various other patient safety organisations and accreditation services listed within this section each play a pivotal role in the safe delivery of a blood transfusion. Requirements for tissues and cells are defined in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (Statutory Instrument 2007 No. 1523), and are enforced by the Human Tissue Authority (HTA) and are also included within this section.