Limerick East): I propose to take Questions Nos. 9 and 11 together.
As I informed the House on Tuesday, 10 December 1996 in reply to Private Notice Questions, I was made aware of the residual problem relating to HIV infected blood on Monday, 9 December when I was briefed by my Department on the incident at St. Luke's Hospital, Kilkenny.
The BTSB has confirmed it did not inform my Department until 8 December 1996 of the residual problem relating to potentially infected HIV blood. The residual problem can be stated as follows. It has not been possible to date to trace all the recipients of the 16 issues derived from potentially infected blood donations made prior to 1985 from the blood of seven donors who have tested positive for HIV since HIV testing of blood donors commenced in October 1985.
As I informed the House on Tuesday, 10 December, 24 blood donors have tested positive in the 11 years of testing. Eight of these donors were first time donors and, accordingly, no risk of HIV transmission to recipients was involved. In the case of nine of the remaining 16 donors, recipients of issues regarded as being at risk were traced and none of the recipients tested positive.
The tracing of recipients of the issues from the remaining seven donors has been rendered very difficult by the absence of the BTSB dispatch records for the period prior to 1986. Of the 31 issues from these seven donors, 17 were donated prior to 1981 and are not regarded as a potential source of infection. As I have already stated, the residual problem relates to tracing the recipients of the balance of 16 issues derived from potentially infected blood donations made prior to 1985.
As I informed the House on 10 December, I understand that following the introduction of the HIV donor screening test in October 1985, no look-back was undertaken in the period between 1985 and 1989 in respect of earlier donations made by donors who now screened positive. However, their donations were not used and they were advised to contact their general practitioner for further assessment and counselling. I also informed the House on 10 December that the BTSB had, from 1989 onwards, a look-back procedure for newly presenting donors.
It was under this procedure that a look-back on previous donations took place in respect of a donor who tested HIV positive in March 1993. This particular donor had donated previously in November 1989 and May 1990. The 1990 donation was traced and tested negative. The BTSB, therefore, considered it unnecessary to undertake a look-back on the 1989 donation. I should emphasise that this 1993 donor is one of the nine donors whom I have already mentioned where recipients of issues regarded as being at risk were traced and none of the recipients tested positive. I indicated that last Tuesday in reply to the Private Notice Question.
Following the 1993 look-back on this particular donor, the then chief medical consultant of the BTSB wrote to the chief medical officer of my Department on 16 April 1993 outlining the action taken following the identification of this donor. The letter was at that stage brought to the attention of the other relevant senior officers in the Department by the CMO. This letter was brought to my attention by officials of my Department on Friday last, 13 December.
Following receipt of this letter of 16 April 1993, I understand that at the next meeting of the board of the BTSB, held on 21 April 1993, the chief medical consultant reported to the board meeting on the recent look-back and was requested by the board to prepare an updated Protocol for the handling of such cases in the future. I understand that a revised Protocol was submitted and accepted in principle by the board of the BTSB at its next meeting on 26 May 1993.
Since my statement to the House on 10 December 1996, I have met with Mr. Liam Dunbar, chief executive officer of the BTSB, and officials of my Department have also met senior management of the board on a number of occasions. I sought an explanation as to why the board did not inform me or my Department until last week of the residual problem which exists in relation to untraced donations.
The BTSB has provided me with a detailed document setting out its approach to the look-back in respect of the seven donors and 31 issues which gave rise to concern. I do not want to read a long report into the record of the House because I would probably be accused of attempting a filibuster. However, I intend, a Cheann Comhairle, to make the report I got from the BTSB on this issue available to Deputies. I am also, as requested, circulating a copy of the BTSB's letter of 25 September addressed to the hospitals. In addition, I am circulating full details of the main features of the work programme undertaken by the new management of the BTSB since April 1995.
As Deputies will note from a reading of the document dealing with the look-back, it was decided by the BTSB to avail of the mechanism of the tracing programme for hepatitis C undertaken by the hospitals to determine the possibility of tracing the small number of potential HIV infected individuals. Then it planned to assess the results of that initiative in terms of the number of issues traced or untraced. When the outcome of this was known, it was intended to inform the Department of Health with a full assessment and recommendations for action at that stage.
I feel that the BTSB should have informed me and my Department in advance of the arrangements which it intended to put in place to trace the recipients of the potentially infected blood issues. However, I accept that the management of the BTSB acted in good faith and saw valid reasons for proceeding in the manner in which it did.
During the past week the BTSB, with the assistance of my Department, has intensified its efforts with hospitals in tracing recipients and I was informed earlier today that the position is as follows. There are 31 outstanding issues, 15 of which relate to pre-1981 donations and are not considered to be a potential source of infection. There are 16 issues of concern, of which six have now been traced, leaving ten issues of concern which remain to be traced.
As I assured the House last week, I have given this matter very serious consideration. I am advised there can be no guarantee that all the remaining ten issues will ever be traced. I am also aware that some donors who may have been HIV positive prior to the introduction of the screening of donations in October 1985 have not come back to donate since 1985 and, therefore, cannot be identified.
I have, therefore, decided that there should be an optional HIV testing programme put in place for blood transfusion and blood product recipients between the beginning of 1981 and October 1985. I have instructed my Department to put in place the necessary arrangements with the BTSB and other health agencies so that the optional testing programme can commence in January 1997, aimed at the cohort of people who were recipients of blood or blood products during this period. Of course, the trace back will continue in parallel for the ten issues which have not been traced.
Deputies who tabled questions have asked me to make a statement on this matter. Since I replied to the Private Notice Question on 10 December, there have been criticisms made of the board's performance and, in one instance, a call made for its disbandment. I think it is essential to put the matters raised by the Deputies in context and to avoid creating further avoidable problems in what is an already difficult situation.
I would hope that the Deputies share with me an appreciation of the enormous difficulties which face the board and its new management in undertaking a vast programme of reorganisation and restructuring in one of the State's most vital health agencies. This is being undertaken against a background of unprecedented adverse circumstances which have their origins in events which occurred over a period of 20 years.
I have circulated to Deputies details of the 17 major initiatives undertaken by the new management team since April 1995. I would, in particular, like to highlight the significant steps which have been taken to improve quality assurance measures. These include improvements in donor screening; archiving of samples of all donations; improvements in the structure of the laboratories, including the construction of a specific hepatitis C laboratory; upgrading of the quality assurance function and the introduction of environmental monitoring; ensuring standard operational procedures manuals are in force in all areas of the BTSB; and the introduction of HLTV I and II viral screening.
In addition to this, the new management has had to cope with an unprecedented volume of litigation and the preparation of documentation for submission to the tribunal of inquiry. It has also managed to maintain the blood supply, the essential and primary purpose of its existence. It is my view that the scale of the renewal and reorganisation process is such that it will require a further number of years of intensive work before the BTSB's job is completed. During this period the board and management of the BTSB needs and deserves the support of the Minister and the House.
The issue of extending the current tribunal of inquiry to examine the questions which have arisen in relation to HIV infection has been raised. The current tribunal of inquiry in relation to hepatitis C has been conducted with widely acclaimed efficiency, expedition and care by Mr. Justice Finlay.
I am advised, and it is my own view, that it is not appropriate that the careful planning and scheduling of that inquiry should be disrupted in midstream, but rather that it should be allowed complete that work. Deputies will be aware that the terms of reference for that inquiry include provision for an interim report not later than the 20th day of oral hearings. I understand that the tribunal will adjourn this week for the Christmas break and I expect to receive the interim report during the Christmas recess.
It is very important that neither I nor the House should presume upon the willingness of any particular person to conduct a further inquiry into a different, although related, matter. Any new questions would involve the assembling of new documents and statements, steps which would involve further time and effort of unknown dimensions.
What I propose is exploring the feasibility of either extending the existing terms of reference or setting up an additional but related inquiry to deal with specific questions which are now being raised in relation to HIV infection and the way that that problem was handled by the Blood Transfusion Service Board. The success of the current tribunal is widely ascribed, among other things, to the specificity of the terms of reference and if there is to be an extension of this inquiry, or an associated inquiry in relation to HIV, then that example should be followed.
It is my hope that terms of reference which express specific questions can be drawn up with care and reasonable expedition and put before the Dáil at the end of January, at which stage the interim report will be to hand and it will hopefully have been possible to explore with the tribunal whether it, or some variant of it, could best undertake these further inquiries.