Private Notice Questions. - Infected Blood Transfusion.

asked the Minister for Health when his attention was drawn to the difficulty with batches of blood infected with HIV which were administered in transfusions; if he will initiate a national screening programme for those who received blood transfusions and could be at risk; and if he will make a statement on the matter.

asked the Minister for Health the circumstances of the infection of a nurse with HIV by an infected blood transfusion in 1985; when he or his Department became aware of the problem involving potentially HIV-infected blood donations at the Blood Bank; the steps, if any, taken between 1985 and 1994 to contact those who may have been infected with HIV from infected blood transfusions or products; and if he will make a statement on the matter.

Limerick East): I avail of this opportunity to convey my sincere sympathy to the health care worker in St. Luke's Hospital, Kilkenny, and her family. I know the House will join me in that expression of sympathy. Before addressing the specific issues raised by the Deputies I would like to give a background in regard to HIV infected blood. The Blood Transfusion Service Board — BTSB — is of the view that the earliest date of infection by HIV of blood in Ireland was probably 1981. No screening test was available until 1985 — that was introduced in October 1985. Since then all blood donated to the BTSB has been screened for HIV and all donations found to be positive are discarded. I have been informed by the BTSB that since October 1985 until the present date a total of 24 donors have been diagnosed as positive. However, eight of these were first time donors and, accordingly, no risk of HIV transmission to recipients was involved in these cases.

It would be helpful if, in regard to the 16 repeat donors, I were to give details of the years in which the infected donations were first screened as positive. They are: 1985, two; 1986, two; 1987, two; 1988, nil; 1989, one; 1990, one; 1991, one; 1992, two; 1993, three; 1994, two; 1995, nil and 1996 to date, nil, giving a total of 16. In the case of nine of the 16 donors, recipients of products regarded as being at risk were traced and none of the recipients tested positive. Eight of these donations were post-1989 and one was pre-1989.

A difficulty arose in regard to tracing the recipients of the products produced from the donations of the remaining seven donors. Dispatch records in the BTSB in Pelican House are not available in respect of the period prior to 1986. The BTSB has informed me that there were 31 possible infected issues prepared for recipients from these seven donations. Of these 31 issues, 15 were donated prior to 1980 and are, therefore, not regarded as a potential source of infection. One of the 16 issues was transfused to the health care worker identified this weekend in St. Luke's, Kilkenny. It would appear, therefore, that concern now arises in relation to a maximum of 15 recipients.

I would like to revert to what I understand happened subsequent to the introduction of the screening test in 1985. In the period between 1985 and 1989 no lookback was undertaken 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. From 1989 onwards the BTSB had a lookback procedure in place for newly presenting positive donors. There were a small number of people, however, for whom a normal lookback could not be carried out because their donations related to the period prior to 1986 in respect of which dispatch records were not available.

When the new management was appointed to the board of the BTSB in April 1995 it identified a considerable volume of problems which had to be addressed, including the maintenance of confidence in the blood supply, the work associated with the screening for hepatitis C, with the legal cases, particularly the McCole case, and with the restructuring of the organisation. It also identified the issue of conducting a full lookback in regard to HIV as one of the items which needed to be addressed. The issue was addressed in some detail by the scientific committee of the board in May 1996, legal advice with regard to the duty of care was obtained in August 1996 and in the absence of dispatch records 45 hospitals were contacted with details of the numbers of the batches which were regarded as potentially infected. Since then 14 hospitals have responded and three of the batches have been identified. All of these three related to donations prior to 1980 and therefore did not pose a threat. The board has now intensified its efforts to work with hospitals to identify the recipients of the remaining issues.

I would like to turn to the specific questions raised by the Deputy. I was aware of the reference to the introduction of HIV testing and the discovery that one of the plasma donors for the anti-D programme was HIV positive in paragraphs 3.12 and 4.15 of the Report of the Expert Group on the Blood Transfusion Service Board, published in April 1995. That report indicated that the problem which arose was fully investigated at the time and that all products prepared from the plasma donated by the donor concerned still in use were withdrawn when the observation was made. PCR analysis of the product was found to be negative and it was furthermore concluded that the production method was effective in removing the viral material. Subsequent to that, while I was generally aware, in the context of hepatitis C lookback programmes, of difficulties in the BTSB with regard to the absence of certain dispatch records, I was not made aware of specific difficulties in relation to batches of blood infected with HIV until Monday, 9 December when I was briefed in the context of the incident which occurred in St. Luke's Hospital, Kilkenny.

In so far as my Department is concerned, it has been aware of the general arrangements made by the BTSB in regard to the screening of donors since its introduction in 1985. In the context of the publication of the review group report in April 1995, correspondence took place between my Department and the BTSB which incorporated an outline of the protocol adopted by the BTSB for the prevention of HIV transmission by transfusion. The question of a comprehensive lookback was addressed by the scientific committee of the BTSB in May 1996 and the steps I have outlined were taken.

The Deputies have asked if I will initiate a national screening programme for those who receive blood transfusions and who could be at risk. I have already supported the BTSB in the introduction of a targeted lookback in regard to hepatitis C and also a national optional testing programme. I am not in a position to take a decision on whether it would be appropriate to introduce a programme as the Deputies suggest. I have asked the Blood Transfusion Service Board to let me have, as a matter of extreme urgency, an assessment of how successful it thinks it will be in tracing the recipients of the donations which are regarded as potentially infected, following its intensification of the search being undertaken by hospitals. In this case I have offered the full support and involvement of my Department so that the co-operation of hospitals is unstinting. On the basis of the board's assessment of the position and an examination of the residual risk, I hope to be in a position to make an informed decision with regard to an optional testing programme at an early date. If I believe it is correct to do so, I will not hesitate to have the necessary arrangements put in place.

I would like again to avail of this opportunity to put on record my sincere sympathy to the health care worker involved. I would also like to endorse the statement of support made by the chief executive officer of the South Eastern Health Board at yesterday evening's press conference. It is a matter of great regret to all of us that this incident has arisen and I assure the House I will do everything possible to reduce further risk arising from infected blood donated before it was possible to have it screened for infection.

I wish to put on record my party's sincere sympathy for the health care worker in St. Luke's Hospital, Kilkenny, who has been infected by a blood product from the Blood Transfusion Service Board, and to her family and relatives. Does the Minister find it extraordinary that he was not made aware of specific difficulties in regard to batches of blood with HIV infection until 9 December? When was the Department informed and why did it not start a national screening programme in 1994 for people who might have received HIV infected blood product? Such a programme was introduced for hepatitis C victims. If memory serves me right, the Minister told the House at the time that he sought the advice of the Attorney General, who recommended that that should be done. Is there a difference between the two infections or was the Attorney General's advice not sought on this occasion?

(Limerick East): As Deputies are aware, these are very sensitive issues. We are all familiar with the issue of hepatitis C and other hepatitis infections. We have residual memories of the difficulties with HIV-AIDS in the 1980s, which, thank God, are not present now. I am informed by my Department that the unfortunate health care worker in Kilkenny is the first person in Ireland infected with HIV as a result of infected blood. Over the years 1,600 HIV cases have been identified in this country and a blood transfusion was produced in only one instance as the primary risk factor. When traced, that transfusion had been administered abroad. I want to put this matter in context so that people are not scared about what is happening.

With the work already done by the Blood Transfusion Service Board, it has established that we are talking about a maximum of 15 recipients. I stress a maximum of 15 recipients because, as Deputies will be aware, people who go to hospital can get more than one issue of blood. Those issues could come from different batches but there is a possibility that we are talking about 15 issues rather than 15 people. Furthermore, all the infected blood we are discussing was infected prior to 1985 because screening was introduced in 1985. If a donor was screened out, say, in 1987, it does not follow that when his blood was used in 1983 it was infected because the HIV could have occurred between the two donations. That is what we must examine. In attempting to track this maximum of 15 persons we have to go through the hospital system, but if we are unable to identify persons with potential infection through an examination of the hospital records, I will again consider the type of national voluntary screening programme that I brought in successfully in respect of hepatitis C. While I have not yet had time to consult the Attorney General I will do so and I will be surprised if his advice will be other than that which I received in the previous instance in terms of our duty of care.

The Minister did not reply to the question posed by me in my Private Notice Question, namely, when were the Minister and the Department first made aware of this problem in relation to a potential HIV infected blood product in the blood bank? We know from the Minister's statement today that it was only on 9 December he was briefed in relation to this risk of HIV infection through transfusions. Why has it taken 11 years for this matter to come into the public arena and for the BTSB to disclose the fact that it knew in 1985 there was a problem in relation to the presence of HIV infection in the blood bank? Could it be that the same level of reckless incompetence was shown in relation to this matter as is now unfolding in the tribunal of inquiry?

(Limerick East): I regard this as a serious issue. I am simply explaining that the level of risk in terms of numbers is very significantly lower than the risk in terms of numbers in respect of hepatitis C. There are a maximum of 15 persons and one can qualify that subsequently but in a downward way. In terms of being directly aware of an incidence of HIV in blood, it came to my attention arising from the Miriam Hederman-O'Brien report which referred to one particular donor whose plasma was shown to have HIV but the manufactured product from his plasma, anti-D, was tested for HIV and found to be negative. Of course, like every person, both here and internationally, who has a passing knowledge of this problem, I knew there was a possibility when testing was introduced in 1985 that there was infected blood in the system prior to 1985. That is not a revelation; everybody knows that and that is the reason testing was introduced here and elsewhere. Such a possibility always existed. In regard to the problem with records from 1985 to 1989 and the potentially traceable transfusions in the system prior to 1985, I did not know that until 9 December.

The Minister stated, as did the Blood Transfusion Service Board in its press release, that dispatch records could not be located and therefore people could not be traced in the normal way. Will the Minister agree there was an obligation on the Blood Transfusion Service Board to set up a programme to identify those who had been placed at risk, particularly given the nature of HIV? The Minister told us in August that 45 hospitals were contacted by the Blood Transfusion Service Board but only 14 of those hospitals had responded. Does the Minister not think that in that four month period alarm bells should have rung in the Blood Transfusion Service Board, particularly in view of the saga that has unfolded over two years with the BTSB in respect of a related blood contamination? Will the Minister agree it is not sufficient for a Minister of Health to be told that a public statement is about to be made by a health board to the effect that such a difficulty arises in the Blood Transfusion Service Board in relation to blood contamination? What does the Minister intend to do about that?

(Limerick East): This is a problem from which a number of questions arise but while, at a level of principle, it is as serious as the hepatitis C issue, the numbers at risk are quite small. The new people who went in to run the Blood Transfusion Service Board concentrated first on reorganising the board, ensuring there was confidence in the blood supply and that everything was being done to best practice. They then concentrated on the hepatitis C case and the legal issues arising from that. They informed me that they knew there was a residual problem and they began to address that in May and have continued to address it since then. The Deputy asked me what I intended to do. I have asked the people in the Blood Transfusion Service Board for an even fuller report. I will give them my full support to ensure that hospitals comply with the requests being made. If there is a residual difficulty, I will consider again setting up an optional testing programme for persons deemed to be at risk. We must not scare people when the best information currently available to me indicates that while the risk is real, it applies to a very small number of people.

On the question of the absence of records, I knew there was a difficulty with records in the context of the hepatitis C look back programmes; we have had that conversation in this House on several occasions. The difficulty arises in the dispatch record. While there is a batch number on the blood transfusions sent to hospitals, there is an absence of information on the hospital to which the transfusion was sent. There are records — very good in some hospitals, not so good in others, particularly some of the Dublin hospitals — for the 1980s but it is the record indicating the destination of the blood, which goes with the dispatch record, which causes the problem. That is the reason all hospitals had to be contacted with a list of batch numbers. They have been asked to go through their records to see if they can match them up and identify the persons involved.

May I ask the Minister when this intensification started? The batch numbers were sent to the various hospitals to see if they could be traced but why did it take 11 years for those batch numbers to be sent to hospitals when the BTSB knew about this problem since 1985? I ask the Minister for a third time when he or his Department were made aware of this problem in relation to HIV infected blood.

(Limerick East): I cannot explain the reason nothing happened between 1985 and 1989 or whether it was due to the absence of records. The Blood Transfusion Service Board introduced testing in 1985, the same time it was introduced internationally; there is no discrepancy in that regard. It was only in 1989 that they began to look back under the screening programme on donors who proved to be infected. There is a residual problem now which amounts to a maximum of 15 people but, when the qualifications are brought into that figure of 15, the actual risk is significantly less than that. I was informed yesterday, 9 December of the detail of this, and I am told by my officials that the Department of Health was informed on 8 December about this case.

How long does the Minister think it acceptable for 31 hospitals not to respond to a serious request from the Blood Transfusion Service Board in relation to HIV-infected blood? How can the Blood Transfusion Service Board justify its claim that most of those who received potentially infected blood transfusions before 1985 would have died from their underlying illness? That sounds like a repeat of what we heard in relation to hepatitis C. Is the Minister seriously asking us to believe that the Blood Transfusion Service Board did not, at any time since 1985, advise the Department of Health that there was such a problem?

(Limerick East): In respect of the notification of hospitals, my reaction was the same as the Deputy's when it came to my attention. The Blood Transfusion Service Board has contacted all hospitals by telephone, and an urgent search of the records is being carried out to see if the batch numbers can be matched.

I cannot vouch for what happened in the past. This only came up in the Hederman-O'Brien report in respect of one case where plasma was used for the manufacture of anti-D product. The general issue did not arise. The advice to me always was that we did not have a HIV problem in Ireland from blood. Approximately 1,600 people are infected with HIV. When they were tested, only one indicated that blood was a risk factor, and that person received the blood transfusion in another European country. The Kilkenny case is the first case of infection from blood. In my time as Minister for Health, in 1995 and 1996, no donor tested positive. I presume that if donors tested positive for HIV I would have been informed.

Will the Minister accept that if it had not been for the public-spirited actions of the nurse who has been tragically infected through no fault of her own but through the possible negligence of the State yet again, this matter would not have come into the public domain, and that the actions now being taken in an urgent fashion have only come about because of her action? Will the Minister comment on the BTSB statement last night in which it claimed that most of the people who received potentially infected blood transfusions before 1985 "would have died from their underlying illness"? How can the BTSB say that in relation to persons whom they have not yet been able to trace?

(Limerick East): It was the identification of the health worker in Kilkenny that brought this into the public domain. However, almost six months ago the BTSB had started the process of checking with hospitals arising from a meeting of their scientific committee in May last year. I do not know how far or how exact matching will be, but at the outside we are looking at 15 possible cases.

A number of Deputies asked why the BTSB spoke last night in terms of a number of these persons being dead. I understand there is a rule of thumb in hospitals and in the Blood Transfusion Service Board that five years after transfusion up to 50 per cent of recipients are dead. It was a statistic which the board used to indicate that people die from underlying causes. I am not using the statistic. I do not know whether or how many persons who received blood between 1980 and 1985 are dead, but it is a fact of hospital life that some would have died from underlying causes and not from any potential infection. I am giving the figures I have. At the outside there are 15 cases. The reference to persons having died from underlying causes, from surgery, etc., is not being put on the record by me. We will see what the tracking back reveals.