Written Answers. - Blood Transfusion Service Board.

Máire Geoghegan-Quinn

Question:

120 Mrs. Geoghegan-Quinn asked the Minister for Health the number of recommendations made by the expert group on the Blood Transfusion Service Board which have been implemented; the recommendations that remain to be implemented and the schedule for their implementation; the number of recommendations of the Bain report that have been implemented; the recommendations of the Bain report that remain to be implemented and the schedule for their implementation; and if he will make a statement on the matter. [1716/96]

Limerick East): The report of the expert group on the BTSB was published in April last. The report of the consultancy project carried out by Bain and Company at the BTSB was published in May last. The recommendations of the report group on the organisation and management of the BTSB were complemented by the recommendations made in the Bain report.

The main objective of the board and the central direction of the recommendations in the two reports is the development of the BTSB as the national centre of excellence in transfusion medicine and laboratory science in line with best international practice. The achievement of this objective and the making available of blood and blood components to the highest standards of safety and efficacy is being pursued with diligence by the board. While the complete implementation of all the recommendations contained in both reports will take time, significant progress has already been made by the board over the last nine months. Strategically, the board is redefining its role, function and contribution to the development of health care services on the lines recommended in the two reports.
The report identified the management of the BTSB as the major priority requiring urgent and significant attention. In that regard the Government in April 1995 approved of the appointments of Mr. Liam Dunbar, Chief Executive Officer of St James's Hospital as Chief Executive Officer of the BTSB and Professor Shaun McCann, Professor of Haematology and head of bone marrow transplantation at St James's Hospital as the medical director of the BTSB. The implementation of the recommendations of both reports as they apply to the BTSB is being led by the chief executive officer and the medical director in close association with the board and its chairman.
The appointment of a chief executive officer as the sole executive head of the organisation addresses the most important management recommendation in the reports. The chief executive officer leads the organisation and in association with the medical director and senior managers has addressed many of the other critical management problems identified. Significant progress has been made in defining authority, improving reporting relationships, facilitating the input of staff into the decision making process and in improving communications with the entire organisation. To support further progress in these areas the following sub-committees have been reconstituted: medical committee; scientific committee; and finance committee. The participation of the chief executive officer in the medical and finance committees has ensured effective decision making at executive level and that the board is fully informed of emerging policy and procedural changes. A clearer focus is in place concerning the business and cost efficiency aspects of the board. Improvements have also been realised particularly in contract negotiations and the supplies function.
The medical director, as well as co-ordinating the consultant medical resources of the board, provides expert clinical advice to the board and to the organisation encompassing all clinical matters relevant to the operation of a transfusion centre and such clinical matters as referred to in both reports. An ongoing review of all aspects of the organisation's procedures and processes including donor and patient care, blood collections, laboratory processing and testing has been established and the following developments have taken place: the revision and introduction of guidelines for donor selection; negotiating formal arrangements with a major hospital for microbiological and virology support for the organisation; introduction of revised standard operating procedures for blood collection, processing and storage; introduction of new technology to improve temperature monitoring of all aspects of blood and blood component storage; introduction of bar coding of blood and blood components to log such products from collection to despatch; appointment of the medical consultants to sessional commitments at major hospitals; clinical roles and sub-speciality interests of the consultant medical staff are being agreed; the interface between medical consultants and the various functions of the BTSB has been redefined and will be further substantially improved when sub-speciality interests are finalised; the appointment of additional specialist consultants with particular interest in transfusion medicine is currently being pursued; the interface between hospital medical and laboratory staff and similar staff at the BTSB is improving and seminars are being organised in various aspects of transfusion medicine and two successful seminars have already taken place; the board is establishing a research and development fund, and proposals for research projects have been sought from professional interests and an inter-disciplinary group has been established to review the proposals; and, the board is represented on EU Export Committees on blood and blood products and is actively seeking participation on other relevant committees of the EU.
The development of the utilisation, capabilities and capacity of the IT function at the BTSB is a common theme in many of the recommendations in the Bain report. The implementation of these recommendations particularly in relation to management analysis, donor care services, collections efficiency and blood inventory and the achievement of efficiencies in financial management and control will rely heavily on effective and workable IT solutions. In association with my Department, the BTSB has recently completed the first phase of a review of its IT requirements. The second phase which is now under way will document the existing system, complete a requirements specification of the information needs of the organisation and put in place an internal IT department. My Department has made available considerable financial support to these initiatives which involve external consultants who have considerable expertise in the development of IT systems in a health care environment.
The Bain consultants provided detailed advice to the Chairman and chief executive officer as part of the development by the board of its plasma products strategy and the sourcing of plasma products. This advice has contributed significantly to the successful completion of the board's negotiations with a contract fractionator and the achievement of considerable cost savings. Effective working relationships have also been established with the Irish Medicines Board which will assist the board in devising a strategy to achieve self-sufficiency in plasma products. The Irish Medicines Board through regular inspections is enabling the BTSB to achieve its objective of retaining good manufacturing practice status.
My Department has been discussing with the BTSB the board's accommodation needs. A joint Department/ BTSB project team is being established to carry out the necessary option appraisal and complete the preparation of a planning brief to meet the board's future accommodation requirements.
The report of the expert group on the BTSB also made a number of recommendations in relation to the licensing of medicinal products, including blood products as follows; the National Drugs Advisory Board (NDAB) should become the licensing authority for all medical products for human consumption; the board and management of the NDAB should be strengthened so that it can discharge its functions in relation to medicinal products with sufficient speed and efficiency; a formal system for monitoring and enforcing licences issued for medicinal products, including blood products, should be introduced; the arrangements for importing and supplying medicinal products on a named patient basis should be placed on a formal footing and the circumstances in which products may be issued on that basis should be clearly specified. The Government, by means of the Irish Medicine Board Act, 1995, has replaced the NDAB with a new Irish Medicines Board which is to be the licensing authority for all medicinal products. The membership of the board has a management rather than technical orientation, and is supported by two advisory committees for human and veterinary medicines to provide the necessary technical input. A new chief executive is in place, and the organisation is being restructured in line with the recommendations of a major management consultancy exercise on its systems, staffing and operational procedures.
In addition to its licensing function, the board has been given the responsibility for monitoring all aspects of the law relating to the manufacture and distribution of medicines. It has also been given a specific responsibility under section 4 of the Act, for the inspection of the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives with a view to ensuring their safety and quality. As regards the arrangements for importing and supplying medicinal products on a named patient basis, regulations are at present being prepared to place the named patients systems on a formal basis. It is hoped to finalise this work in the near future.