- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Blood regulation and safety
- 18 December 2014
- Last updated:
- 4 August 2017, see all updates
Licences and regulations for organisations that handle human blood or blood products and reporting adverse incidents with blood through SABRE.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the controls and authorisations that apply to blood establishments (BE) and controls that apply to hospital blood banks (HBB) and sites that collect, test and supply human blood or blood components intended for transfusion.
If the blood is intended for transfusion you need to comply with the UK’s Blood Safety and Quality Regulations.
You are a BE and need to hold a blood establishment authorisation (BEA) if you:
- collect blood
- conduct donor tests
- process blood
- store or distribute blood
You will also need a BEA if you:
- carry out secondary processing of blood components, including
- cell washing
- pack splitting
- collect blood or blood components for pre-deposit autologous transfusion (where the donor and recipient is the same person)
- import blood from a non-EU country (known as a ‘third country’)
You are a HBB and need to submit an annual blood compliance report if you are a unit within a hospital which:
- stores and distributes blood
- performs compatibility tests on blood and blood components exclusively for use in hospital facilities, including hospital-based transfusion activities
If you receive blood from a HBB for transfusion purposes but do not perform compatibility tests on site you are a ‘facility’. Facilities do not have to submit a blood compliance report as long as there is service level agreement, or similar document, in place which clearly show that the HBB that supplies you is responsible for these functions.
If you’re not sure which one you are contact MHRA by emailing firstname.lastname@example.org or calling 020 3080 6000.
Blood establishments (BEs)
To operate as a blood establishment you must:
- have a BEA
- be inspected by MHRA at least once every 2 years
- have a system for reporting any serious adverse blood reactions or events to MHRA (haemovigilance/SABRE)
- pay authorisation and haemovigilance fees each year and a further fee following an inspection
You will be inspected by MHRA when you first apply for your BEA.
After each inspection you will get a follow up letter describing the areas that need correction to get or keep your authorisation.
Complete a BE compliance report
You will have to complete a BE compliance report before an before an inspection unless it is a triggered inspection, which are only notified at short notice.
Read the Compliance report guidance (PDF, 1.79MB, 15 pages)
For significant changes between inspections an Interim Compliance report (MS Word Document, 381KB) is required to be submitted.
You should send your completed Pre-inspection compliance report (MS Word Document, 418KB) to the email address given by the inspector. Hard copies of compliance reports will not be accepted.
Apply for a BEA
The applicant at the blood establishment needs to sign the form.
The application will trigger an inspection. If you pass the inspection you will be authorised to hold a BEA and you should receive your authorisation within 90 days of your application.
To maintain your authorisation you will be inspected at least once every 2 years to ensure that you remain in compliance with the requirements of the legislation.
Make a change to a BEA (variation)
If your business or premises goes through any major change which will alter the authorised activities, sites or personnel, you must apply for a variation to your authorisation before making the change.
Hospital blood banks (HBBs) and facilities
To operate as a HBB or facility you must:
- have a system for reporting any serious adverse blood reactions or events to MHRA (haemovigilance/ SABRE)
- submit an annual compliance report and pay a compliance fee (only applied to HBB)
- pay a haemovigilance fee (unless you are a facility)
MHRA will inspect your organisation periodically depending on your organisation’s level of risk, which is based on information in your compliance reports.
Blood compliance reports
HBBs must send a blood compliance report to MHRA every year. This provides details about the activities you carry out, together with specific information relating to:
The compliance report is used to assess your organisation for risk. The higher your risk rating the more likely your organisation is to be inspected.
Hospital blood banks must complete the compliance report and the declaration form. The majority of questions that need free-text responses have been removed, some sections are not available and some question numbers do not seem to be in order in some sections.
Some questions in the 2017 Hospital Bank Compliance Report have been updated. The 2017 Hospital Blood Bank Compliance Report Guidance Notes have been revised to reflect the changes.
Please read the guidance notes before completing the BCR.
The person responsible for signing the “Compliance Report completed by” section on the BCR Declaration Form must ensure:
- all the questions are completed on the BCR
- the completed answers are true and accurate
Blood facilities do not need to complete a compliance report for 2017 but must complete the blood facility declaration form, which should be filled in by facility managers and sent to email@example.com.
Deadline for submission of reports is 30 April 2017
Report a serious adverse event or reaction related to blood
As a BE, HBB or facility you must report all serious adverse event and reactions related to blood to MHRA using SABRE. You will need to register with SABRE before you can report. SABRE does not replace your local reporting arrangements.
If you have questions about SABRE email firstname.lastname@example.org
Reducing the risk of Transfusion-transmitted Hepatitis E Virus infections in patients undergoing Solid Organ Transplantation and Haematopoietic Stem Cell Transplantation
The Department of Health (DH), in conjunction with MHRA, Serious Hazards of Transfusion (SHOT) and UK Blood Transfusion Services, have agreed an approach to the implementation of “Reducing the risk of Transfusion-transmitted Hepatitis E Virus infections in patients undergoing Solid Organ Transplantation and Haematopoietic Stem Cell Transplantation”. These are The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO)/ The British Society of Blood and Marrow Transplantation (BSBMT) Recommendations on the use of Hepatitis E Virus (HEV)-screened blood components.
The recommendations are expected to be implemented by hospitals using strategies similar to those for providing other patient ‘special requirements’ (e.g. Cytomegalovirus (CMV) negative components and washed cells). Expectations for review during MHRA inspections will follow this approach, and will assess each situation on its own merits with regard to the effectiveness of procedural controls and overall risk to the patient.
Haemovigilance reporting to Serious Adverse Blood Reactions and Events (SABRE) and SHOT will be required following failure to provide a blood component which meets patient ‘special requirements’ if these special requirements are known to the laboratory. This may be from a current or previous blood component request. Cases where clinical staff have failed to order HEV-negative components (rather than laboratory failure to provide) are also SHOT reportable.
Hospital transfusion laboratories should request HEV negative blood components only for those patients referred to in the SaBTO/BSBMT recommendations.
Legislation and guidance
Published: 18 December 2014
Updated: 4 August 2017
- New link to SHOT added to the page.
- Blood Compliance Report information for 2017 added
- Added section about new blood safety regulations - “Reducing the risk of Transfusion-transmitted Hepatitis E Virus infections in patients undergoing Solid Organ Transplantation and Haematopoietic Stem Cell Transplantation”
- New forms added
- Changes to reporting needs
- First published.