How we regulate blood

In this section... General How does a manufacturer comply with the requirements? Blood Compliance Reports – 2011 submission MHRA Guidance on Electronic Issue of Blood Components, May 2010 Questions and answers

General
The Blood Safety and Quality Regulations 2005 No. 50 (external link) and The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898 (external link), became effective for the purposes of regulation on 8 November 2005.  An explanatory memorandum including a  Regulatory Impact Assessment for the Amendment Regulations are available:

Explanatory memorandum to The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898 (64Kb)

These Regulations implement  the requirements of the following EU Directives:

• Directive 2002/98/EC – setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
  
• Directive 2004/33/EC – regarding certain technical requirements for blood and blood component.

Two further technical Directives were adopted by the European Commission on 30 September 2005. These are:

• Directive 2005/61/EC regarding traceability requirements and notification of serious adverse reactions and events
  
• Directive  2005/62/EC regarding Community standards and specifications relating to a quality system for blood establishments.

These Directives were transposed into UK legislation by the Blood Safety and Quality (Amendment) Regulations 2006 No. 2013 (external link), which came into force on 31 August 2006.

The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keeping requirements to “facilities” which may receive blood and blood components (care homes, independent clinics, hospitals and other NHS facilities and services, manufacturers of medicines and medical devices and biomedical research institutes).

The Blood Safety and Quality (Fees Amendments) Regulations 2010 SI 554 - SI 2010/554 (external link) came into force on 1 April 2010 and implemented fee amendments.


How does a manufacturer comply with the requirements?
As of 8 November 2005, blood establishments are required to:

• submit an application for a blood establishment authorisation
• maintain a quality system based on the principles of good practice
• notify the competent authority of any serious adverse events and serious adverse reactions  (haemovigilance /SABRE)
• ensure that all prospective donors of blood and blood components comply with the Regulations
• maintain records to ensure full traceability from donation to the point of delivery  for no less than 30 years
• be subject to an inspection from the competent authority at least once every two years.

Hospital blood banks are required to:

• if they collect autologous blood and blood components submit an application for a blood establishment authorisation
• if they perform secondary processing of blood component (for example, irradiation, washing, splitting etc.) submit an application for a blood establishment authorisation
• maintain a quality system based on the requirements of Directive 2005/62/EC
• notify the competent authority of any serious adverse events and serious adverse reactions  (haemovigilance /SABRE)
• confirm compliance with the requirements of the directives by submitting an annual compliance report to the competent authority
• maintain records to ensure full traceability from donation to the point of delivery for not less than 30 years.

Further guidance is available on the UK Blood Transfusion & Tissue Transplantation Services site (external link)

Application form and guidance notes for a blood establishment authorisation
Application form for a blood establishment authorisation (144Kb)
Guidance notes on the application form for a blood establishment authorisation (109Kb)

For details of the fees payable, please see our fees section:

Fees for blood banks and other blood establishments

Blood Compliance Reports – 2011 submission
All 2011 compliance reports are in Microsoft Excel format. Please read the relevant guidance notes in full before completing the compliance report submission.

Hospital Blood Bank Compliance Reports 2011
The MHRA has been made aware of a discrepancy in the text of the 2011 Hospital Blood Bank Compliance Report.

Section R, relating to Distribution of Blood Components, incorrectly lists question R1 as follows:

"Do you contract any compatibility testing or antibody identification to outside laboratories?".

Question R1 should state:

"Do you supply blood components or services to off site locations or other organisations (e.g. community hospitals, hospices and satellite units)?"

As many transfusion laboratories will have already started to enter their compliance report responses, it is not proposed to publish a revised template to correct the discrepancy. Transfusion Laboratories are requested to answer question R1 with regards to the revised text provided above.

The change in text for question R1 will not affect the assessment of other responses to Section R questions.

The Blood Facility compliance report is unaffected.

Transfusion Laboratory assistance in this matter is appreciated.

Hospital Blood Bank Compliance Report v6 (2011) (259Kb)

Hospital Blood Bank Compliance Report Guidance Notes for 2011 (1740Kb)

Blood Facility Compliance Reports 2011

Blood Facility Compliance Report v2 (2011) (141Kb)

Blood Facility Compliance Report Guidance Notes for 2011 (1402Kb)

Addendum page for additional external supplied sites (please refer to Guidance Notes)

Distribution sites addendum page (33Kb)

Declaration page – Hospital Blood Bank and Blood Facility Compliance Reports

BCR Declaration Page (665Kb)

MHRA Guidance on Electronic Issue of Blood Components, May 2010

MHRA Guidance on Electronic Issue (80Kb)

Questions and answers
The questions and answers from a series of MHRA blood seminars held in September/October 2005 are available below:

Questions and answers from the MHRA blood seminars (45Kb)