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The EU Blood directive and its impact on UK hospital blood banks

Joan Jones
Operational Impact Group
Welsh Blood Service

Tony Coates
Blood Bank
NE Wales NHS Trust

Ann Benton
Consultant Haematologist
Swansea NHS Trust

The 8 November 2005 was a momentous day for hospital transfusion laboratories (HTLs) when the transposed EU directive 2002-98-EC finally came into force as the Blood Safety and Quality Regulations (BSQR). Trepidation, confusion and hearsay had been rife in the transfusion fraternity for at least two years leading up to this day, fuelled by uncertainty and ignorance of exactly what implications  the final requirements would have for hospital-based transfusion practice. The delay in interpretation, legal transposition and eventual parliamentary ratification provoked varying responses from HTLs. Initial inertia and denial moved gradually into awareness as the regulations were published. Fear and panic then took over as the timing allowed little scope for sensible planning or allocation of resources required for the necessary changes prior to the implementation date. Ongoing uncertainty around the exact nature and remit of the UK’s competent authority, the Medicines and Healthcare Products Regulatory Authority (MHRA), and the precise requirements on HTLs meant that 8 November 2005 arrived not as the finishing post but as the starting point for a detailed process of change for most.

Interpretation and impact
A particular problem for the UK with the interpretation of the directive relates to the level and type of activity undertaken by hospital laboratories, most of which perform in-house compatibility testing and have responsibility for issuing blood components. Some also perform tasks, such as autologous donation, granulocyte collection and irradiation, that are categorised as “processing” in the BSQR, which had to define the technical distinctions between hospital laboratories and blood establishments. All of these issues highlighted the need for a self-help group to provide guidance and support for HTLs. An Operational Impact Group (OIG) was convened to provide sound practical advice. The potential of this group was recognised and adopted as an official advisory body to the UK’s Department of Health (DH). They undertook a year’s serious work to address the issues that arose and support HTLs as they worked towards compliance with the BSQR, identifying key areas, sharing best practice and maintaining the focus on the essential aspects to be addressed. Groups were assigned to review the four main requirements: traceability, quality systems, education and training, and serious adverse event (SAE) and serious adverse reaction (SAR) reporting. Information from the working groups is available in the OIG report and has been widely circulated throughout the UK.(1) The ongoing effort of the OIG provides a major conduit for discussion between the MHRA and HTLs, and continues to deliver information on the inspection process as it becomes established.

To continue with “processing activities”, HTLs had to apply for a licence to operate as a blood establishment (BE) or to stop these activities and register as a hospital blood bank. Several took the plunge, registered as blood establishments and awaited inspection. The majority of these registrations were to allow them to continue to irradiate components and in one instance to continue undertaking autologous donations. Most were successful and obtained BE status, but all found the inspections taxing and required action plans to address their “noncompliances”.

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Regulation 9(1)(e) requires hospital transfusion laboratories “to maintain, for not less than 30 years, the data needed to ensure full traceability of blood and blood components, from the point of receipt of the blood or blood component by the hospital blood bank.”

Traceability is an issue that has taken hospitals much time and effort to address. It was soon apparent that “issue does not guarantee receipt” and the BSQR require unambiguous evidence of traceability. While all agree that the ideal would be to implement a total blood tracking system from laboratory to the final bedside check, this is currently a “step too far” for many due to resource constraints. Bedside tracking systems facilitate compliance with the BSQR and address Serious Hazards of Transfusion (SHOT) recommendations, but cost and training issues are major stumbling blocks. In the meantime, hospitals have taken on simple paperchasing solutions based on “bag and tag” systems, return of the compatibility form and the transfusion record, and in some instances use of the patient’s notes to retain the traceability for the required 30 years. It would appear from speaking to hospitals that these systems are working, but the time required by staff to chase up “nonreturns” or “incomplete returns” is significant. Once these paper returns have been received in the hospital laboratory the information is then entered into the Laboratory Information System (LIS). Providing the procedure is documented and validated there is then no requirement to keep the paper trail. What will be necessary in all cases where the LIS is the repository of unambiguous traceability is to ensure data is kept and remains accessible when new IT systems are installed.

Quality systems
Regulation 9(1)(b) requires hospital transfusion laboratories “to establish and maintain a quality system for the hospital blood bank which is based on the principles of good practice.” Implementation of a comprehensive Quality Management System (QMS) is essential to deliver compliance with the BSQR. The provision of appropriate resources to achieve this is an issue for many HTLs. The OIG has developed various documents to help HTLs, especially in areas that may be unfamiliar such as managing the cold chain requirements and relationships with other organisations.(2) The increased scope and stringency of quality management required for the regulations in relation to storage and distribution of blood components and cold chain management is placing significant strain on HTLs. Gaining an understanding and delivering on these more stringent quality issues continues to be a major area of concern in relation to compliance. The transition towards full good manufacturing practice cannot occur overnight and hopefully will remain an iterative process over the next few years.

Education and training
Regulation 9(1)(a) requires hospitals to ensure the provision of specific, regularly updated training to staff involved in the testing, storage and distribution of blood omponents. Unfortunately, the BSQR only require the provision of training for laboratory staff and those involved in distribution (ie, those collecting components from the issue fridges). However, the OIG recommends that relevant training should be provided for all staff involved in the transfusion process to ensure compliance with traceability and serious adverse event and reaction reporting. The area of training and competency assessment for laboratory staff involves time and effort on the part of all staff, is an enormous undertaking, needs to be performed on a regular basis and should include locum and agency staff. Although many of the requirements will previously have been met to some degree, the formalisation and extent of the process now required imposes an additional burden on already overstretched staffing levels. The minimum requirement must be to establish a system to address these training issues,allowing implementation to follow as the process develops.

SAE and SAR reporting
The BSQR introduce a legal requirement for SAR and SAE occurring within EU Member States to be reported to a relevant competent authority. The MHRA has developed a new online reporting system for this purpose, which allows mandatory reporting through the Serious Adverse Blood Reaction and Event (SABRE) site, and also allows SHOT-only reports to be undertaken from the same site.

Hospital blood bank inspections have started and the feedback will be used by the OIG to provide more specific information to other HTLs. The MHRA has put in place a Blood Consultative Committee, and it is envisaged that this group will provide regulatory information, discuss updates to regulations and be used as a means of communication to the wider transfusion population. Representatives on the group include consultant haematologists, blood bank managers, SHOT, the OIG, the Blood Services, Clinical Pathology Accreditation staff, quality personnel and representatives from all four UK countries. This group will take over from the OIG and hopefully provide appropriate support and advice to HTLs as they continue to strive for full compliance. SHOT, which collects reports from clinical as well as laboratory areas, will continue to make recommendations to, and work together with, the MHRA and will inform the ongoing quality and safety agenda for blood transfusion.


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