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 email@example.com 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.
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.
Changes to a BEA
If your business or premises goes through any major change which will alter the named authorised activities or sites, you must apply for a variation to your authorisation before making the change. You can do this by submitting the BEA application form with the proposed changes and sending the form to firstname.lastname@example.org.
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.
There are some changes to how hospital blood banks and blood facilities should complete compliance reports and declaration forms in April 2015. 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.
Blood facilities do not need to complete a compliance report for 2015 but must complete the blood facility declaration form, which should be filled in by facility managers and sent to MHRA.
Blood bank managers must fill in the blood bank compliance report and declaration form and send it to MHRA.
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 email@example.com