Billy Timmins
Question:69 Mr. Timmins asked the Minister for Health and Children the steps, if any, taken by him to date to implement the recommendations of the Finlay report relating to the Blood Transfusion Service Board. [19828/97]
Written Answers. - Blood Transfusion Service Board.
Alan Shatter
Question:123 Mr. Shatter asked the Minister for Health and Children the steps, if any, taken by him to date to implement the recommendations of the Finlay report relating to the Blood Transfusion Service Board. [19964/97]
I propose to take Questions Nos. 69 and 123 together.
The report of the Tribunal of Inquiry into the Blood Transfusion Service Board, which was published in March 1997, made six key recommendations and the following is the current position in relation to their implementation:
1. BTSB's Development Plan
The BTBS's development plan details a major renewal, reorganisation and investment programme over the coming years. Implementation of the key elements of the plan are progressing as a matter of priority.
As regards the construction of new national headquarters at St. James's Hospital, Dublin, I understand that a detailed sketch design has been agreed with the board and an application for full planning permission was submitted to Dublin Corporation on 30 October 1997. It is expected that the building contract will be placed for tender in November. The cost projection is £25 million. In respect of the Cork centre, an investment programme will involve upgrading or replacing existing buildings.
A new information technology department has been established at the BTSB and it expects to complete contract negotiations for a new software system shortly with a leading international supplier. My Department will be making available approximately £2 million to support the accelerated implementation of this new IT system. Significant new appointments have been made recently in the medical scientific and technical, and Quality Assurance areas. My Department will continue to work closely with the board to provide support and rapid decision making in relation to the implementation of the plan.
2/3. Monitoring of the BTSB by the Irish Medicines Board and the reporting of abnormal reactions
Arrangements have already been put in place to conduct more regular inspections at the BTSB as recommended by the tribunal. In relation to the separate annual report to be prepared by the Irish Medicines Board, I understand that a report will be submitted to me by the end of this year concerning the outcome of these inspections and any report of abnormal reactions or blood product transfusion. The Irish Medicines Board and my Department will have consultations with regard to the appropriate format of this annual report which I will publish.
In addition, the BTSB and my Department are developing proposals to establish on a pilot basis a haemovigilance programme to build on the current reporting of serious adverse reports by effective, timely and reliable co-ordination and evaluation of reports from hospitals. Discussions have already taken place with the Irish Medicines Board on the most effective implemention of such a haemovigilance system. The Irish Medicines Board already has in place a pharmacovigilance system for monitoring adverse reactions to medicinal products.
4. Blood Service Consumers Council
I will shortly be establishing a standing committee on transfusion medicine to support the development of best transfusion practice in hospitals. This committee will include consultants from major surgery specialties and will develop blood utilisation guidelines and key indicators of quality in clinical transfusion practice as well as having a role in understanding and informing patients' attitudes and concerns about transfusion. The tribunal report recommended that a major contribution to the maintenance of public confidence in the supply of blood products could be made by the establishment of a Blood Service Consumers Council. In that regard my Department is currently preparing proposals on the role and function of this advisory council which will complement the separate roles and functions of the Irish Medicines Board, the consultative council on hepatitis C and the standing committee on transfusion medicine.
5. Product Recall
In relation to the recommendation concerning procedures for the recall of products, the BTSB has in place standard operating procedures for recall of products and these are reviewed regularly by the Irish Medicines Board. As an additional support to hospitals, the BTSB will shortly issue a revised protocol for use by hospitals to assist in the tracing of products to a named patient.
6. Replacement of Blood or Blood Products
The BTSB has arrangements in place, should the need arise, for the immediate replacement of blood components such as red cells, platelets and plasma. As regards other blood products, the BTSB and the Irish medicines board are finalising arrangements for the alternate supplies of licensed blood products. In addition, my Department is currently preparing legislation to provide a statutory framework for the supply and use of unlicensed products where such use is considered necessary by clinicians to meet the particular needs of individual patients in special circumstances.