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Dáil Éireann debate -
Tuesday, 17 Dec 1996

Vol. 473 No. 1

Written Answers. - HIV Infected Blood.

James McDaid

Question:

26 Dr. McDaid asked the Minister for Health if he will give an update on the current investigation regarding the tracing of patients in the recent HIV crisis; and his views on whether the hospitals concerned were adequately informed of the gravity of the situation by the Blood Transfusion Service Board. [24521/96]

Limerick East): 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 that 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 BTSB dispatch records for the period prior to 1986. Of the 31 issues from these seven donors, 15 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 HIV donor screening test in October 1985, no lookback 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 lookback procedure for newly presenting donors.

It was under this procedure that a lookback 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 lookback 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 where traced and none of the recipients tested positive.

Following the 1993 lookback on this particular donor, the then Chief Medical Consultant of the BTSB wrote to the CMO 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 lookback 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 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 their approach to the lookback in respect of the seven donors and 31 issues which gave rise to concern.
I intend to make this document available to Deputies; I am also, as requested, circulating a copy of the BTSB's letter of 25 September addressed to the hospitals and 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 lookback, 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 they planned to assess the results of that initiative in terms of the number of issues traced on 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 they 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 they did.
Over the last week, the BTSB, with the assistance of my Department, has intensified its efforts with hospitals in tracing recipient and I was informed earlier today that the position is as follows: 31 outstanding issues; 15 issues relate to pre-1981 donations and are not considered to be a potential source of infection; 16 issues of concern, of which six have now been traced; and ten issues of concern remain to be traced.
As I assured the House last week, I have given this matter very serious consideration. I am advised that 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.
The Deputies have asked me to make a statement on this matter. Since I replied to the special notice question on 10 December, there have been criticisms made on the boards'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 would share with me an appreciation of the enormous difficulties which face the board and its new management in undertaking a vast programme of re-organisation 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 HLTVI and II viral screening.
In addition to all 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 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 re-organisation process is such that it will require a further three to five years of intense work by the BTSB before the Job is completed. During this period the board and management of the BTSB needs and deserves the support of the Minister and of 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 mid stream, 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.
I think it is very important that neither myself, nor the House, should presume upon the willingness of any particular person to conduct a further inquiry into a different, though 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 of 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 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.
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