BLOOD MANAGEMENT
Experts from the Medicines and Healthcare Products Regulatory Agency (MHRA) explain more about its role in blood management.
F
rom a regulatory perspective, blood is treated in two ways:
1. When blood components (platelets, red cells etc) are used for transfusion it comes under the EU Blood Directive 2002/98/EC and its three associated directives. This was transposed into national legislation via the Blood Safety and Quality Regulations 2005 No. 50 and the Blood Safety and Qual- ity (Amendment) (No.2) Regulations 2005 No. 2898 became effective for the purposes of regulation in the United Kingdom (UK) on November 8, 2005. They apply to blood establishments, hospital blood banks and blood facilities.
2. When blood is ‘industrially’ processed (e.g. in the manufacture of plasma-derived o products such as albumin, clotting factors and immunoglobulins) it comes under med- icines legislation (Directive 2001/83/EC).
For both circumstances, MHRA is the Competent Authority in the UK.
When blood is used for transfusion purpos- es, the MHRA is responsible for: • Ensuring compliance with the EU Blood Directives, as transposed into UK legisla- tion. This assessment may be by site in- spection, or by remote assessment of com- pliance report submissions.
• Authorising Blood Establishments (or- ganisations who collect, process and per- form screening tests on blood donations).
• Operating the UK’s haemovigilance sys- tem (SABRE), which collates reports of serious adverse events and serious adverse reactions relating to blood transfusion.
The MHRA, along with its equivalent com- petent authorities from the other EU Mem- ber States, also has a role in representing the UK during drafting and amendment of European standards and technical texts as- sociated with the Blood Directives.
Trends in compliance
The UK Blood Services have been inspected since loss of Crown Immunity in 1992, and therefore have a number of years of expe- rience in implementing the principles of Good Practice. The UK Blood Safety and Quality Regulations extended these re- quirements to Hospital Blood Banks and Blood Facilities from November 2005.
Some of the Quality Management Systems elements of Good Practice (such as change control, validation and non-conformance investigation) were new to Hospital Blood Banks, and took some time to become in- tegrated within the operational procedures at these sites. The MHRA identified these problem areas during assessment of an- nual blood compliance report submissions, and ran a series of seminars across the UK during 2009 that focused on these issues in order to provide Good Practice training to blood bank staff. Inspection findings have subsequently noted a general improvement
In such cases, the detailed compliance concerns are reviewed by the MHRA’s In- spection Action Group (IAG), which makes recommendations for action based on risk to public health.
The IAG is a cross-agency group who follow a risk assessment process including consid- eration of risks arising from difficulties in obtaining blood for transfusion as a result of the regulatory action. Wherever possi- ble, MHRA works with the organisation in question to return to a state of compliance, rather than taking formal action to prevent some or all activities. This often involves a period of increased inspection surveillance. Referrals for consideration of regulatory action have been made in a limited num- ber of cases since the regulations came into force in November 2005.
Record keeping
The EU Blood Directives require that national health executive Sep/Oct 11 | 79
in compliance, as non-compliances gener- ally relate to weaknesses in elements of the quality system, rather than absence of these elements.
Enforcement action
Regulatory Action may be taken against blood establishments, hospital blood banks or blood facilities, in cases of serious non- compliance with the requirements of Good Practice or regulatory obligations.
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