Willie Penrose
Ceist:46 Mr. Penrose asked the Minister for Health and Children if he will report on the progress to date on the implementation of the Finlay report. [10246/98]
Written Answers. - Blood Transfusion Board Report.
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.
Recommendation No. 1. — BTSB Development Plan
The BTSB'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, detailed design plans were submitted to Dublin Corporation for planning permission which has now been granted. Arrangements are now being made to commence site clearance and construction work. In respect of the Cork centre, a capital investment programme is also being implemented. A new information technology department has been established at the BTSB and a new software system is currently being implemented. The Department is making approximately £2 million available 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, and a quality assurance plan, together with an IT plan, have recently been submitted to the Department.
Recommendation Nos. 2 and 3 — Monitoring of the BTSB by the Irish Medicines Board and the Reporting of Abnormal Reactions
The Finlay tribunal report recommended that the Irish Medicines Board, IMB, should carry out more regular inspections of the BTSB and these arrangements have been put in place. The report also recommended that the IMB would prepare an annual report for submission to me in relation to its inspections of the BTSB. I received the first annual report on 8 April 1998. A number of operational deficiencies were identified by the IMB during its inspections and these either have been or are currently being addressed by the BTSB as a matter of priority.
In addition, proposals to establish a national 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 are almost completed. I will shortly be establishing the National Blood User's Group, comprising a number of specialists with a particular interest in blood utilisation, to support the development of best transfusion practice in hospitals.
Recommendation No. 4 — Blood Service Consumers' Council
The tribunal report recommended that a major contribution to the maintenance of public confidence in the supply of blood and blood products could be made by the establishment of a blood service consumers' council. My Department is currently finalising proposals on the role and function of this council having regard to the separate roles and functions of the Irish Medicines Board, the consultative council on hepatitis C and the proposed blood users' group.
Recommendation No. 5 — Product Recall
In relation to the recommendation concerning procedures for the recall of products, the BTSB has recently issued revised operating procedures to all hospitals covering the receipting, recall and tracing procedures for blood and blood products. The revised procedures were developed in consultation with the Irish Medicines Board.
The revised procedures are necessary to ensure that, should an occasion arise where the immediate withdrawal of a product is indicated, the hospitals concerned are in a position to locate all existing supplies of the product, and to establish which patients, if any, have received the products. The procedures require,inter alia, that each hospital designates one person and a nominated deputy to be responsible for the recall of blood components and blood products within his or her particular hospital.
Recommendation No. 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 IMB are finalising arrangements for alternative 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.