The Joint Committee met at 2.35 p.m.

MEMBERS PRESENT:

DEPUTY B. O'KEEFFE IN THE CHAIR

Dr. Barker: Thank you very much for the invitation. We are aware that the Committee had a delegation already from the medical practitioners in Cork. As Chairperson of the board, I will put the discussion topic, the centralisation of PCR testing in Dublin, into context. I commenced as Chairperson of this board in May last year. I am a relatively short time in the job. When I came into the organisation it was very clear that it was hugely damaged by the absolutely appalling events about which we all know. In many ways the organisation and staff still feel damaged by those awful events. Through my own association with it, I still feel some hurt and damage even though I had nothing to do with it and my colleagues were not with the organisation at the time.

The board is trying to move through a period of incredible change. We have had management recommendations and recommendations from the Finlay Report on how to change the organisation. The organisation is damaged, staff feel very hurt and we feel subject to enormous scrutiny and suspicion on all fronts and in everything we do. We all feel very defensive about it. I hope I do not come across as too defensive in this afternoon's presentation.

I would like the Committee to get a feel for the kind of enormous change we are having to go through in a society where all organisations are experiencing very fast change. Members of the staff of organisations everywhere subject to that kind of change, not just the BSTB, feel threatened and find it difficult to cope with change. In the BTSB, we are moving through a process of change. One can see from the papers before the Members the problems with which we have to deal include undue compartmentalisation of management, fragmentation of responsibility, significant communication problems and weakness in responding to the need for change. They are all the sort of problems identified for our organisation that we are now trying to address, and all of them together.

Our main concern is the quality and quantity of blood. Our strategy as a board is to aim for the best - a world-class organisation from being an organisation which was not efficient. It is clear from the Finlay Report that we were a poorly managed, poorly organised organisation and we are now trying to become a world class organisation. Members can probably understand that in terms of centralisation, part of what we are trying to do is create a national service. We are therefore looking at centralisation of our entire range of activities from personnel to information technology, a national computing service, the management of donor services, purchasing and finance. PCR testing has to be seen in the context of this change to a truly national organisation with common standards in Cork and Dublin. That is the context in which the board was trying to operate when I took over.

Dr. Murphy and Mr. Hynes were requested to present a report on the centralisation of testing. It is important to say that I represent all members of the board whose decision was unanimous and who included at the time the decision was made Professor Shaun McCann, consultant haematologist, St. James's Hospital; Professor Ian Temperley, professor of haematology, Trinity College Dublin; Professor Derry Shanley, director of the Dental Hospital; Dr. Rosemary Hone, consultant microbiologist, Mater Hospital, and Dr. Rosemary Bootman, medical officer, Department of Health and Children. The decision therefore was not made by general medical staff but by experts in the field of blood transfusion medicine, haematology. It is important that members of the committee clearly understand that it was not being done from a management perspective alone but with the advise of some of the best haematologists in the country. The report was prepared by Dr. Murphy, consultant haematologist, in consultation with his fellow consultants in the BTSB. We are therefore looking at a decision based on best quality blood for a national service.

In trying to effect this change it is important that I acknowledge the huge work done in the BTSB in the difficult circumstances outlined. Staff are available at 8 a.m., 9 p.m. and weekends to effect this change. We need the support of the structures of the State and all those with expertise and influence to understand the process of change and the objective to which we are working with the co-operation of the Irish Medicines Board. It would be unfair not to acknowledge the support we received prior to his departure from Deputy Cowen and his colleagues in the Department of Health and Children who understand what we are doing and keep themselves fully informed. At all stages they have offered us their support and expert advice.

Mr. Hynes: I forwarded to the committee on 29 February a copy of a report on the medical and technological factors that will impact on the way the Blood Transfusion Service Board performs its functions in the short to medium term which was considered by the board at a meeting in March 1999 following which Dr. Murphy and I were asked to prepare a report, a copy of which I have circulated, on the implications of developing a single site for donation testing.

Blood transfusion is an essential part of modern health care. It is expensive and uses a scarce human resource but as Dr. Barker indicated everything we do in the BTSB is based on the provision of adequate supplies of safe blood to hospitals. There are a number of key steps in transfusion. We collect blood from voluntary non-remunerated donors from low risk population in respect of which screening and testing is an essential part. Equally important is the effective clinical use of blood at hospital level.

Safe transfusion is assured only by close collaboration between the BTSB and hospitals. Our remit is to provide blood and blood products which are safe, accessible at reasonable cost and adequate to meet national needs. Regular blood donors are the foundation of our service. Quality assurance and good laboratory practice are essential in all areas of blood screening and processing.

The risks associated with transfusion became very clear in the 1980s when it was recognised that contaminated blood was responsible for the transmission of HIV and the screening of blood became more important than ever before. It was also realised that testing alone could not prevent the transmission of HIV and other infectious agents. Other factors such as poor donor selection practices and the unnecessary use of blood products were also recognised. It was recognised that safe supplies could not be assured without the development of comprehensive national blood transfusion policies. In common with many other countries, this has been included as an objective in the national health strategy.

While all transfusion services worldwide were dealing with these issues, the tragedy of the hepatitis C crisis and what happened afterwards has meant that in Ireland there is an expectation that the BTSB will be to the forefront in developing the safest and most effective possible blood transfusion strategy. The hepatitis C crisis was a tragedy for all those involved, the State and the BTSB. We are still dealing with the legacy and fallout and will continue to do so for many years to come.

Blood transfusion services worldwide are facing ever increasing demands to ensure quality standards in order to prevent harm. As a consequence the preparation of blood products for therapeutic use has undergone a huge change from being very much a laboratory-medicine based service to a pharmaceutical grade operation. This brings with it new demands of skill and financial resources. We are now required to provide buildings of a higher standard and to provide for huge increases in staffing in quality assurance and control departments.

On links with hospitals, there is a need for an integrated service. A national policy on the clinical use of blood is an essential component of a strategy to ensure blood and blood products are transfused only to treat conditions that may lead to significant morbidity or mortality and which cannot be prevented or treated effectively by other means. This requires the promotion of evidence based practice, including the use of alternatives to transfusion and devices to minimise the need for transfusion, where appropriate. A little over one year ago the Minister established a blood users group to provide advice and information on the clinical use of blood. We expect to receive reports from the group later this year. The establishment of hospital transfusion committees and the education and training of all staff involved in blood transfusion are critical. We have also established a national haemovigilance office as a focal point for the monitoring of adverse reactions to transfusions. The emphasis will be on prevention and training.

The Comhairle na nOspideal report on haematology services was published recently. I have included as an appendix to my submission the summary of its findings. It followed the Hederman-O'Brien report of 1995. One of the terms of reference for the Comhairle report was to examine existing consultant level haematology services throughout the country. It recommended the appointment of 22 additional haematologists in health boards and hospitals and four additional consultants in the BTSB.

Dr. Murphy: It is important that the proposal that testing be centralised is seen in the context of how the BTSB and blood transfusion services everywhere will do their job in the future. There are major changes coming and it is our job to ensure we are in a position to implement those changes as soon as they become practicable and applicable. For example, we have introduced the haemovigilance and universal leucodepletion programmes - one clinical, the other laboratory - in the last two years. We are in the process of introducing PCR testing. Over the next couple of years we will have to extend the range of PCR testing and introduce a new test for variant CJD which is, we believe, currently the major threat to the blood transfusion supply. At the same time we will almost certainly have to introduce new processing steps and techniques into blood component manufacture.

Both we and the blood product liaison group have the same objective, patient care. The biggest change that patients and hospitals will see is how patients are managed in hospitals. Many patients who now routinely get blood transfusion will not need blood transfusion in the future. This approach is already in place in many centres. Patients who undergo, for example, routine joint surgery, gynaecological surgery or even cardiopulmonary bypass surgery should be in a position, even now, not to expect to get a blood transfusion during that surgery. They might need to get it but it should not be routine. There are alternative techniques available which we should be in the process of developing and applying now.

The introduction of new techniques, particularly blood substitutes, in the not too distant future and developments in the way we use currently available pharmaceuticals will make this even more applicable. However, patients in hospital should and will see a major change in the way blood transfusion and blood transfusion service is delivered. Chairman, this is an important point. There is still a residual risk to blood transfusion. This risk exists everywhere, here and in every other country. Of the residual risk that exists, 95% - that is, 19 out of every 20 - of adverse events that patients experience in relation to blood transfusion is due to events occurring in the hospital itself, not in the blood transfusion service. It is not in the processing, manufacture, collection and distribution of the blood but in its administration or in patient specific problems at the bedside.

It is important that the health services address a large amount of energy and effort to solving that residual risk. That is what this is about. It is about having the resources and the ability to address major problems as they currently exist and major developments we will have to face and implement. We feel that we must consolidate where we can so we can go to the patients' bedsides and to hospitals throughout the country where we can.

There is another item which is also important. There will be more technological demands on blood transfusion services in the future. I can give an example. It is now becoming more widely accepted that the best treatment for extensive burn injury, particularly in children, is to tissue engineer the patient's own skin. One takes a tiny sample of the patient's skin and expands it in a tissue culture laboratory service. One grows the patient's skin cells. This leads to a more rapid, secure and better cosmetic result in the long term. It decreases morbidity and mortality and produces a better long-term result. That is just one application of the way tissue and cell engineering will go in the future. At its most dramatic, people will generate new blood vessels from the patient's pre-existing blood vessels for coronary artery disease. It could be used in the treatment of haemophilia and it will be used in the treatment of diabetes. This is all in the future.

We strongly believe that the blood transfusion service needs to ensure that the expertise to facilitate that technology as it becomes available should be available to patients in Irish hospitals. As our business is and has been the taking of cells from people, manipulating them in sterile or good manufacturing practice pharmaceutical grade conditions, it is appropriate that we would consider developing that technology in the initial stages and, perhaps, go on to provide it as a routine service in the future.

My last point is most important. We are not closing the Cork centre. That has never been on the table. We are talking about consolidating in one site the testing that currently goes on in two sites. That will free up resources, our energies and our ability to deliver new services and to continue to attempt to achieve the highest possible level of quality in what we do. There are over 100 staff currently employed in the Cork centre. When this is finished there will still be the same number of staff or more employed there.

I alluded to new blood component processing that will be required to deal with residual infectious agents in blood that we cannot test out or get rid off. That will have to be introduced in the Cork centre. There will have to be an expansion of apheresis technologies where donors will donate on a machine rather than into a plastic bag so we end up with a processed blood component at the end of the donation process.

We will bring forward a proposal to site the tissue engineering facility in the Cork centre. This is about consolidation and partitioning out around the country the tasks we need to do as best we can.

Mr. Hynes: A safe blood supply also means an adequate blood supply. An adequate blood supply is critical. We have 100,000 donors who donate regularly. Blood cannot be bought and cannot be stored so there is always a delicate balance between supply and demand. In the mid 1990s the BTSB suffered a reduction in public confidence as a result of the hepatitis C tragedy. There was a drop in the number of blood donors and low staff morale. There was high turnover of senior management. Against that background we have succeeded in creating a good operational environment and we have ceased to import blood, as we did up to 1998.

More recently we have been able to focus on longer term strategies and the implementation of recommendations made in previous expert reports and plans. I have a number of them with me. These reports were prepared, adopted as board policy and endorsed by successive Ministers. The recommendation to move to single site testing was one of a number of recommendations in the Baine report. This report was adopted as board policy and was endorsed by the Minister.

The current management and board examined how best to provide a transfusion service in light of the rapidly changing environment and transfusion medicine. We had to take account of hospitals' and customers' concerns regarding increased costs and consider how best to provide a service that is safe, efficient and effective.

The full implementation of the recommendations of previous expert reports and plans will ensure that Ireland is to the forefront in transfusion services. We need to implement change when change is required. We cannot operate by remaining rooted at a particular point in history or in a particular way of doing things. Our business demands that we be flexible, open to change at all times and that we continually learn from experience. We cannot needlessly replicate or duplicate scarce resources. We will not take our donors for granted and we will ensure that patients will have the safest product possible.

We cannot and will not dilute our services and we cannot operate by the standards of the past. Dr. Barker referred to the staff of the board. They deserve our praise and our thanks. I joined the board in July 1998. Many of the people who were there before me and who are still there worked very hard to maintain services in difficult times.

We thank the Chairman and members of the committee for affording us the opportunity to update the committee on the current blood transfusion service. It is a critical lynchpin in the hospital care system. The restructuring and rebuilding of the BTSB is an extremely onerous task and I ask for the committee's support in our ongoing endeavours.

Chairman: When were you appointed, Dr. Murphy? I am aware the chairman was appointed in May 1999 and the CEO was appointed in July 1998.

Dr. Murphy: I was appointed on 25 November, 1996. It was around the opening of the Finlay tribunal.

Chairman: Chairman, you raised an issue regarding the Hynes and Murphy report. To put this in historical context, we recall the Finlay tribunal of inquiry and the difficulties outlined in that inquiry relating to the renewal of the premises in Cork. That was in March 1997. The Irish Medicines Board, in October 1997, indicated that it had a difficulty with the premises in Cork and pointed to the need to upgrade them. In November 1997, the Minister for Health and Children stated that he would make funding available to the centre in Cork and in January 1998 it was to be put to tender. In that month, too, the IMB annual report contained confirmation that a new centre was to be built in Cork and in April 1998 we received the Ernst and Young report. It spoke about closing the existing location and transferring to a new premises. Everything appeared to be rosy in the garden in Cork. However, from April 1998 to July 1999 there was a transformation whereby all testing was being removed from the Cork centre.

A number of things are odd. The first is that Dr. Murphy's appointment was in November 1996 so he would have been part of any decision to have the two centres, Dublin and Cork, operating. Mr. Hynes was appointed in July 1998 which coincided with the Murphy and Hynes report.

Mr. Hynes, before the Hynes and Murphy report was initiated, is it a fact that you visited Cork and indicated that there would be one centre for testing? If that is the case, is it not extraordinary that a committee would be set up by the BTSB which included you, Mr. Hynes, even though your indication that there was to be only one centre negated the prior commitment of Dr. Murphy and others? The board appointed you, who had given a clear indication of what the outcome would be, and the medical director, Dr. Murphy. What scientific evidence was available to you between April 1998 and November 1998 to suggest the result in the Murphy and Hynes report?

People in Cork say there was tunnel vision in the Hynes and Murphy report given that Mr. Hynes had already committed himself to one conclusion, that there would be only one test centre, before the report was initiated.

Mr. Hynes: I am not sure where you get that from, Chairman. I visited Cork on several occasions but I never said there would be only one testing centre. I was not on the board in April 1998. I never made that statement.

Chairman: It is extraordinary. This came to my attention without anybody from Cork bringing it to my notice. On the day you visited Cork, prior to the July report, you informed staff in the Cork office that testing was to be taken out of that centre. I and others protested about this to the Minister for Health and Children. We said it was outrageous that the Minister was committed to having a new centre but, without the benefit of any report, the new CEO had decided there was only to be one test centre. You can imagine how appalled we were at the prospect of the Murphy and Hynes report. I knew it would have only one conclusion. People in Cork were devastated that the board would appoint two people who had committed themselves to one centre before the report was initiated.

Mr. Hynes: You mentioned the July report. That report was presented and circulated on 7 July and was considered by the board on 14 July. Between those dates I did tell the staff in Cork that the recommendation was going to the board but that it was a board decision. That is the only time I recall discussing it with the body of staff in Cork. However, the report had been prepared at that time. It was reasonable that it would have been available and that the staff in the Cork centre would know about it before the board came to consider it.

Chairman: After your visit to Cork, staff members contacted a number of public representatives. They stated that a unilateral decision had been taken by the new CEO to transfer all testing to Dublin. A number of us visited the Minister for Health and Children to ask how to reverse such a decision. The Minister had given a commitment to proceed with new premises to continue testing in Cork but this decision had been taken out of his hands. Following that meeting, it is my understanding that it was then decided to carry out a report. It is also my understanding that your visit did not coincide with the Murphy Hynes report but that the report was initiated as a result of your visit to Cork during which you said that the transfer would take place.

Dr. Barker: May I address that question? The board requested that the CEO and the national medical director engage in research and find out what at the time was the best current international practice. We were aware that that would involve travel to other countries to find out the best medical practice. We asked them to research the literature and conduct a normal scientific medical study of what the best scientific practice was.

There are two things happening here. One is to do with the management of staff and communication of data to staff. The other is the decision. As far as the board was concerned, the decision was to be based primarily on medical and scientific data. We were anxious to ensure that we would never be in the same position we were in previously. The board wanted to have a testing system in place to provide a blood supply to the country that would be at the cutting edge of what was available internationally.

The board requested Mr. Hynes and Dr. Murphy to compile a report which would be compiled in a scientific way. I am a researcher so I would never embark on a report where one would have a conclusion and work backwards from it. The instructions from the board were clear. They were to look at what was best available practice internationally. This is a small country but they were to examine the position in the United States, the United Kingdom and Europe and seek the best international practice. They were to report back to the board and make recommendations on what was the best thing for this country. They were the conditions under which the report was set up.

The other matter is consultation with staff - a different issue - and whether staff were engaged in an appropriate way. However, the primary issue as far as the board was concerned, and as far as I was concerned in chairing this report, was that both Mr. Hynes and Dr. Murphy would engage in proper research and base their report on what they found to be best international worldwide practice. In consultation with the IMB and the consultant staff in the BTSB and in discussion with international experts they were to put forward a system that would mean Ireland would be, beyond doubt, at the cutting edge of best practice. I am anxious to stress this. What we looked at was the best international practice. Dr. Murphy engaged in the type of travel necessary, searched the literature and engaged in discussion with international experts. The report you saw is the report the board considered.

Chairman: I have no doubt about what the board wished to do. It had the best interests of a proper service in mind. However, certain decisions were taken before the report was initiated and that outraged people in Cork. They had been told it was to be transferred and, as a result, a number of public representatives were contacted about the decision. We then made our own contacts. After that it was signalled that the Hynes Murphy report was initiated.

Dr. Barker: On a point of information, the decision was made by the board based on the evidence we received. Whatever had been said in advance of that-----

Chairman: Dr. Barker, it is difficult to tell people in the Cork region that they will get anything other than the conclusion which was conveyed by the CEO to the staff in Cork before the inquiry was initiated. They were not expecting a different decision from the inquiry, given that parameters had been set before the inquiry was initiated. Their feeling was that an outside agency should have been asked to do it. If there was an independent inquiry, these issues would not have arisen.

Dr. Murphy, can you explain how you, as medical director, had no difficulty in 1997 with there being two centres in Ireland and then in July 1999 suddenly everything had changed and you saw that centralisation was the answer to everything? What scientific basis did you have for taking that decision? Why did you take the decision in 1997?

Dr. Murphy: Chairman, I am wondering which decision you are querying because I did not have any difficulty from anybody when the board at that time came to a conclusion that there should be two testing centres. It is important to point out that, between the time I arrived in the end of 1996 and the time Mr. Martin Hynes arrived in the middle of 1998, I had four CEOs to work with. In the two years preceding that there had been two other medical directors. The Blood Transfusion Service Board had experienced a revolving door phenomenon of senior management, and decisions were made and pressures were dealt with in a fairly pragmatic way. Therefore, when the decision was taken to review the requirement for testing and the more long-term strategy in the light of things as they developed through 1996, 1997 and 1998, then that decision was revisited appropriately. Decisions cannot be taken for all time. Had the decision gone the other way, that is, had the decision been taken to have a single testing site in Cork, I would have no difficulty with that.

Chairman: If there was to be one centre, of course we in Cork would feel that would be much more appropriate given the validation which Cork had as against Dublin - with the ISO 9000 and the other validation.

Dr. Murphy: Chairman, the BTSB is a national organisation.

Chairman: Of course.

Dr. Murphy: It is not two regions bickering together. I am responsible for the medical care given to patients requiring blood transfusion throughout Ireland. It is not divisible like that and I do not think you are correct in attempting to do so. We must put disharmony behind us and we must go on.

Chairman: We will come to harmony at a later stage.

Deputy Shatter: I have a number of questions on this issue, but there are other issues which were addressed this afternoon which I wish to raise also. Maybe we should deal with this issue first and come back to the others. However, I want to give notice of them.

My concern is that there is the best possible service for patients nationally. I do not see any merit on one side or another in territorial claims as to where the services should be sited. Having said that, there are some reasonable queries which can be raised on the single site testing issue. There are other things being said about the issue which I want to put to the BTSB simply to give the board the opportunity to respond to them because they have been said to this committee. It is as well the BTSB knows these things were said and that it responds to them because it might help shed some light on the situation.

What are the merits of the single site testing proposal in the context of patient care and the safe provision of blood products? Why can the type of approach which will be taken in the context of the single site not apply to two sites, whether the second site is located in Cork, Donegal or another location? As somebody who is not a haematologist or a medical practitioner, I see some practical advantages in having two site testing in the context of having come out of an extraordinarily fraught period where there have been great question marks over the safety of blood products. If something unexpected goes seriously wrong where the one site testing is taking place, surely it is an important fail-safe in the interests of public health that there is another site, be it inevitably in Cork because that is the location of the other centre, carrying out similar functions. Why should that not be the case because common sense, as opposed to scientific data, would suggest that there is merit in having two sites doing the work? Is it a cost issue. Is it that it is not practical because of the duplication of processes and technology? Is it that the BTSB wants to ensure a certain level of supervision and checks at one particular site? If that is the case, it is difficult to understand why it cannot happen at a similar level on the second site also.

I want to throw into that what has been put to the committee. I emphasis that this has been put to the committee because I want the BTSB to respond to this. Effectively it has been suggested that the reason this is being done is to get revenge on Cork because it was the Cork centre which brought to public attention the appalling scandal and tragedy of the contaminated blood products. It has been suggested that this is not a scientific or medical decision but that it is, to use the Irish Independent phrase, "pay back time".

The second matter in the context of this is that it has been suggested to the committee that this is all part of a process to undermine the Cork centre which is doing very important work. In fairness the BTSB responded to that in its opening submission but it may want to elaborate on that response.

There were a series of issues raised but the more practical issue is that the liaison group in Cork has raised a number of concerns about single site testing relating to transportation and emergency services and, in the context of having two sites, that the Cork site in an emergency service need not service solely the Munster region and there are many advantages for the southern seaboard in having a duality of operations.

Those are some of the issues which I want to raise in the context of the plethora of issues which have come before the committee. There are important issues relating to blood products and blood supply, some of which have been touched on by the BTSB, which have been in the public arena and which are a matter of concern. In the context of new variant CJD and in the context generally of the exposure in the United Kingdom of people to this, it has been suggested in other European countries that blood donations will not be taken from people who were resident in the United Kingdom through a period of particular years. I could well understand that this would be a matter of huge difficulty for the BTSB in the context of the interaction between people living here who visited the United Kingdom and people who lived in the United Kingdom and then came back to live here again. Will our guests comment on that and indicate the current position? Will the indicate the extent to which we can be assured that the blood supplies we are now using will not create a substantial problem in 15 or 20 years time in the context of new variant CJD because the testing system is not sufficiently sophisticated or because the exclusion of persons who visited the United Kingdom from being blood donors could completely emasculate the donation system and make it non-functional? This is a particularly serious public health issue and has more long-term implications than the spat about Cork and Dublin. However, as already stated, questions remain to be answered in respect of that matter.

In the context of the issue that was raised by Dr. Murphy, there are growing concerns about the extent to which our hospitals are harbouring a variety of infections and the extent to which this is being dealt with in a national and comprehensive way, rather than by means of local ad hoc initiatives to tackle particular problems. I was concerned by his reference to the supply of blood and residual hospital risks. Will Dr. Murphy clarify whether those risks relate primarily to infections within our hospitals which are contracted by patients or whether that is a separate issue? Will he also indicate the extent to which that is an issue of concern to the BTSB? Does it pose any particular concerns in terms of blood transfusions?

There are two aspects to final issue I wish to raise. Given the way biotechnology is developing, we appear to be heading into a situation where not only will people be manufacturing tissue but they will also have the capability to reproduce replica blood from individual donors. Will we shortly be in a position where a person who expects to undergo major surgery - be it cardiovascular surgery or cancer surgery - in a number of weeks or months as opposed to undergoing an immediate emergency procedure will be able to supply a small donation of blood from which blood identical to theirs can be manufactured? In other words, will biotechnological developments lead to a situation where people will be supplied with blood which is identical to theirs when undergoing major surgical procedures?

To what extent does the BTSB receive research funding? To what extent could it make a substantial impact on research in the areas to which I refer which would prove of benefit not only to this country but also internationally? To what extent does the BTSB co-operate or liaise with other groups engaged in research in these areas?

Chairman: I will take questions from two further Members before Dr. Murphy replies. The purpose of this meeting is, by and large, to deal with the question of the two sites. Perhaps our guests will address the Deputy's important questions when we discuss that other issue in full.

Deputy Shatter: I appreciate that. Perhaps we can deal with the single site issue and obtain a response in that regard.

Deputy Clune: There has been a strong outcry from members of the medical profession in the Southern Health Board region. Our guests will be aware that a group representing these people appeared before the committee a number of weeks ago. Its members stressed that their primary concern involves the care of patients and they consistently indicated that they believe patients will be put at risk by putting in place a single testing facility in Dublin. I am concerned about that.

I am not a medical expert or a haematologist and, therefore, it is difficult to come to terms with the medical information placed before us. However, given that members of the medical profession in the Southern Health Board region have come out strongly against the advent of a single testing facility, we must take note of their concerns.

Deputy Shatter asked that our guests address the implications a single facility in terms of PCR testing. A PCR testing facility in the UK was contaminated in September 1999 and the system had to be closed down for four days. Will our guests address that matter when replying?

With regard to the Hynes-Murphy report, will Dr. Barker indicate why the board did not request that independent external experts should be consulted during the production of that report? If the board is determined to make changes in its blood testing services, it strikes me that it should seek independent expert advice.

Deputy Dennehy: Mr. Hynes and I discussed this matter at a meeting of the Committee of Public Accounts last year. I was not satisfied with the responses he offered at that stage and I remain unsatisfied. I have served as chairperson of the Southern Health Board in the past 20 years and I kept in close touch with the transfusion service and matters related to it. During our previous discussion on this subject I emphasised that it was not a case of merely wanting a testing service to be based in Cork for the sake of it, we are concerned about the welfare of over 1 million people.

On the last occasion I quoted Dr. Murphy's letter and I wish to do so again. Dr. Murphy stated that, in his medical opinion, this country needs two fully operational centres, including full testing facilities. Therefore, it was not a question of keeping an open mind. I do not have the letter in my possession today but I am sure Dr. Murphy can indicate whether he made that assertion. Will he indicate what happened to change his mind in the intervening period?

Dr. Barker referred to the international situation. She also referred to the fact that the big hitters in the medical profession are all based in the Dublin area. I am not saying that they would be biased towards Dublin but everyone knows that if they were asked to choose between Cork or Dublin they would choose the latter. I do not believe there were too many southern based members of the medical profession on the board. Will Dr. Barker indicate if any such people served on the board when she replies?

Reference has consistently been made to the term "best practice" with which I have no difficulty. Since the issue of single site testing arose, I tried to carry out a number of surveys on what constitutes best practice. In my opinion best practice does not equate with single site testing. I discovered during my research that there are ten centres in France, five in Holland - a country the size of Munster - Edinburgh and Glasgow, which are 60 miles apart, both have centres and in the UK as a whole there are nine centres, three of which are capable of PCR testing. I sought to discover whether the number of centres in operation in these countries related to geographical, demographic or financial considerations but I could not identify a trend which suggested that we should centralise our service.

I presume our guests are aware of the history of the £400 million worth of damage, particularly in medical terms, that was done in the past. I hope they will ensure that everything is done to avoid a recurrence of that. If they put all their eggs in one basket and gamble on a single site, they could be in danger of repeating that awful tragedy.

On the point Deputy Shatter made at length, what is the working relationship with the Cork centre and its personnel and regional director? Was the regional director promoted, rewarded or recognised in any way for discovering this awful occurrence in the 1980s? I presume the person was promoted. I would like to know the relationship and how it is being dealt with. It may be an internal matter and I might be told to mind my own business, but I would like to know if a case is being taken by that person against the board, a portion of it or personnel employed by it. What has been the slippage of senior staff in Dublin? Has there been a high turnover or a loss of senior personnel or has there been a rise in morale and are more people being employed?

Is there a proposal to terminate the hepatitis C unit in Cork and to centralise its work in Dublin? Obviously we would proud that that unit discovered this horrendous incident which might have otherwise gone unnoticed by Dublin. Does the board believe that this might be in direct conflict with the Government's stated commitment to decentralisation and to caring for the regions? Each Department has been issued with clear instructions to decentralise. There will probably be a denial of this but does the board see the move to take testing from Cork and to make it merely a collection centre for blood as a downgrading of the centre? Would it describe the decision to direct the regional director in Cork to report to Dublin in future as a downgrading, considering that Cork functioned for 60 years before it recentralised with Dublin?

The next question would be directed to Mr. Hynes because, at the meeting of the Committee of Public Accounts in June of last year, Mr. Hynes said he would welcome the voice of medical people in the southern region on this issue and that he had not heard much from them until then. He said he had sought information but that there had not been much reaction. That was the way Mr. Hynes put it at the time in June of last year. He said he would welcome their views - a medical and scientific voice - on the issues, and that he would be open to listening to hospitals and clinicians on best practice and what should be done. Some 22 of the most eminent people in the region signed a letter immediately after that which was published in all the national newspapers, and I understand each of the hospitals wrote formally to Mr. O'Dwyer, the then Secretary-General at the Department of Health and Children, and to the Minister. A few more hospitals have since followed on to the point where every person who has a major medical responsibility in the southern region has responded saying that they are extremely concerned. These are people who would not allow themselves to be biased by regional or local views. Some of them may be from Dublin.

The only response from the board to date has been to describe those people publicly as liars. That was the only response received from the board and that was in the media. Mr. Hynes conveyed his wish to me at the meeting and I conveyed that further to all these people. The liaison group in Cork is 90% composed of medical people with one or two politicians on it, such as the Lord Mayor who is an ex officio member or the county chairman of the Southern Health Board. That was the only response. Mr. Hynes asked me for and said he would welcome the viewpoints of the medical professionals which he said he would take into consideration more so than those of politicians.

I cannot help feeling that this is a programme of retribution and that people are being put in their place. As a result, there has been a downgrading of the role of the regional director and of the centre. More importantly for us, we believe there could be a potential danger to the one million people we serve. That is the medical advice and not politicians making their case. I would like to hear some responses to that before we go further because, as long as I am a public representative in Dáil Éireann, I will not tolerate any repetition of the previous record of the Blood Transfusion Service Board if I can help it. Things seem to have changed radically since April, May or June of 1998 and I want to know why.

Chairman: There is a mouthful.

Dr. Murphy: I will deal with the most important issue, which is whether patients' lives will be put at risk by this manoeuvre. If the answer is yes, then the job of Deputies is clear and we can all go home. That concern is the major one. If we cannot solve it, we cannot solve anything and there is no point in discussing this. This also relates to the involvement of an external expert and how such advice is to be obtained. We are clear that patients' lives will not be put at risk by this. Our premise, which is an honest one and is my professional view shared by colleagues in other countries, is that patients' lives will be put at risk if we do not consolidate and direct our energies where we can and if we do not work in an efficient way. On the contrary, patients' lives are more likely to be put at risk if we do not have the opportunity to manage this business with an eye to the real needs and future.

The liaison group of Cork clinicians did not take up this point and move it forward in the report prepared by it. Although there was a dispute about this with the accident and emergency consultant, Dr. Cusack, on Morning Ireland, I understand the group has moved from this point and has been convinced that the argument that patients' lives will be put at risk is not tenable. What will happen is that the blood taken, stored, processed and distributed in the Cork centre will stay in Cork. We will not move that. What will happen is that the sample, which is normally stored overnight and tested the next day in the Cork centre, will be shipped to a testing centre in Dublin and tested the next day, which is as it would be only it will take place in Dublin. There is not a problem from that point of view.

Regarding shortages and emergencies, such as a repeat of the Buttevant rail disaster or the Omagh bombing, and the testing of new donations which need to be collected to deal with that emergency, obviously that is a prime problem. It is worth pointing out that, in the Omagh disaster where hundreds of people needed immediate blood transfusions, not one unit of blood transfused was collected that day. All the blood transfused was available in the country at the time, some of it in the Republic, and the logistics do not exist to bleed, test and process blood in the time required for a major emergency. Similarly in the Oklahoma bombing in the United States blood was shipped in from nearby hospitals initially and progressively from those further away. That blood can be made available within hours. To collect blood from donors, to process it and to test it would take eight hours or more. There are thousands of units of blood in this country at any one time. There is more blood available now than there could be surgeons, nurses and physicians to transfuse it in any one hospital in 24 hours. In that scenario, we have plenty of time to replenish our stocks. That is what happens in major emergencies so, in that setting it is not a problem.

A question then arises about platelets which are slightly different. They have a shorter shelf life and there is less in the country. However, even in a situation where there is a major demand for platelets, the time taken to call in, process, test and get the platelets ready is such that it does not matter where one tests, one has plenty of time to ship the sample to a remote site for testing and have the result back before the platelets are ready for transfusion. One would still pull on platelets from stores in other hospitals to meet an immediate shortfall.

It is clear that patients' lives are not being put at risk.

Chairman: Are you suggesting that if it is left in Cork, they would be? What about a fail-safe system? In terms of the Dublin centralised system, additional equipment will have to be purchased as back-up and additional staff will have to be recruited even though they are already available in Cork.

Dr. Murphy: We will have to purchase additional equipment to run a single site. There is little saving in capital equipment. The saving is in the skill and expertise required to run one centre. If one needs to do that in two centres, one requires the same level of expertise at the other centre. There is no reason why one would not do that in Cork. That expertise could be made available without difficulty. One does not need that level of skill for that particular process on two sites. We have a huge job to do and we need to divide the tasks where we can.

Chairman: Will you answer my question? Will patients' lives be at risk if there are two centres?

Dr. Murphy: They could be put at risk, not now, but in the future. If a new method of testing is required for variant CJD, we will have to get it up to a high level quickly before we start using it. Doing that twice is more difficult - it is not twice as slow but it is considerably more difficult than doing it once. Doing it once and well on one site, we would get there more quickly - not just for variant CJD but for the ones after that. Blood transfusion services are completely different from what they were 20 years ago. In the next five, ten and 15 years they will be completely different from now. We will also have to develop services such as that referred to by Deputy Shatter. That is my honest opinion.

Deputy Dennehy: Omagh was mentioned previously and it is still clear in everyone's minds. Is there a shortage of blood at different times every year? Is it correct that the stocks in hospitals are not adequate or suitable for all patients at all times? This is why appeals for blood donations have to be made. The position is different in Northern Ireland. Hospital stocks back-up do not cover a situation where product from one centre is withdrawn, as happened in January 1996 at Pelican House. The hospital stock was unusable and Cork was needed to immediately replace stocks. It is not much good saying that Omagh was well-handled. It was a once-off and is an unfair and emotive example to use.

Terms such as "it is a fair point", "there should be a lesson for the board in future", "there should be proposed changes where the board did not consult with people", "it is a genuine concern", "the board must satisfy itself" and "this is acknowledged as a valid concern" etc. are used in answer to the seven or eight expressed concerns. Does Dr. Murphy accept that after the report, substantial clarification was required regarding transportation issues, crisis demands, the communication deficit in dealing with key users, negative research connotations, negative training consequences, serious morale damage to Cork staff and loss of back-up with the closure of one testing facility? This is difficult to tolerate and accept. It was a fait accompli. I was able to tell Mr. Hynes what the report would contain before it was published. It was not telepathy.

Dr. Barker: The Deputy fairly quoted the report. The board decided to move to centralised testing in principle. It was not a detailed decision - no logistics were worked out. It was a decision made in principle last summer because we needed to know how to configure the new building for centralised testing which is almost completed at St. James' Hospital. Consequently, the plans which are still going ahead for the rebuilding plan in Cork could also be configured appropriately. The decision was scientifically and medically based and cost was a secondary concern.

I went to Cork with members of the board to hear the concerns of medical consultants. There was no scientific or medical concerns in contravention to the decision we had made in principle. The concerns we had, which the Deputy quoted and which were listed in dealing with the board's response, related to the development of the logistical details regarding the implementation of this decision in principle. For example, we were asked how transportation would be dealt with. There was no concern that there would be problems with the principle decision but we needed detailed contingency planning, for example, what would we do if there were leaves on the railway, fog at the airport etc.

In terms of what the Deputy quoted, the board acknowledged that these concerns should and would be addressed by the board when looking at the detailed planning, including the contingency planning regarding PCR. There are 290 donation centres around the country. Blood is transported regularly - PCR testing is currently being done in Scotland. All that data is being collected to form a database on which to base contingency and detailed logistical planning of the movement of PCR tests. It must be remembered that we are talking about small test samples, not bags of blood, all of which will remain in Cork.

Our response to the clinicians in Cork were, as the Deputy said, detailed. We took on board all of their concerns which will be addressed. We have not forgotten about them - they will be addressed when we come to the detailed contingency and back-up plan regarding PCR testing. We were honest - the board and I did not try to fudge the issue. We did say that the concerns were legitimate and we will address them.

Deputy Dennehy: One would expect these issues would be examined in any organisation in the lead up to a decision on centralising or otherwise? These issues should have been decided. Was the reason for centralising purely cost-based?

Dr. Barker: No, it is important to say that was not the case. The decision was based on safety and supply. Cost was a secondary concern. It is not appropriate to address detailed logistical decisions in coming to a decision in principle on whether it is medically and ethically correct to have a centralised testing system. The detailed logistical planning takes place once the decision in principle is made. Any organisation would do this in terms of planning for a new product, a new process or whatever.

Deputy Shatter: In the context of the questions to which Dr. Murphy was responding regarding whether there should be two centres as a fail-safe system and the problems that may or may not arise in relation to technology, he did not respond to one issue. That relates to a concern none of us may contemplate currently whereby in the Dublin centre in three years' time there is just one site testing and there is a contamination problem. A difficulty of that nature might arise if someone does something wrong. Human beings do things wrong on occasions that none of us anticipate. Is there a possibility this could take the centre out of commission for some days in doing this type of testing and is there not a public health benefit in duplicating, albeit that may require staff in both centres with the same level of skills, even to do the newer issues I touched on?

Dr. Murphy: Clearly, this is an extremely important question and one which we must be satisfied about. Our considered view is that we must have a back-up system in place which works. We would back that up by having dual processes in place. In the PCR system, a contaminated laboratory should not have to be closed for some time - it is four days in the UK - overnight would be more usual where this happens. What one does in PCR testing is one amplifies a gene. This is the most sensitive test available for biological contaminants. For example, this system is so sensitive that if one dropped a sugar lump into Lake Michigan, the PCR test would pick it up. That is the level of sensitivity at which we are looking. It is extraordinarily sensitive. However, this brings its own problems. It relies on the natural capacity of DNA to replicate itself under certain circumstances. It puts it through cycles of replication so that one gets billionfold amplification of the signal. If one drops a phial of that in the laboratory, one will have more bits of hepatitis C - not full viruses - floating around the laboratory than ever existed in the planet in the natural state. To way to get round that level of contamination is to close down the laboratory, flood it with UV light and clean it out. If this happens, the laboratory is closed and is out of commission for a time. It might take just a few hours to clean it up. However, to make sure it is clean, we must run several samples through because if bits of hepatitis C fall into every sample, one will get false positives. This is a better scenario than getting false negatives but it is nevertheless a major problem. One must run through a few runs. What happens is that there is a laboratory next door, staffed by the same staff, using the same processes and that is used, perhaps with a different shift of staff. Therefore, one is up and running the next day or within hours. That is the provision which exists in most places to deal with this problem.

The argument has been made on several occasions that PCR is straightforward, that it will be on the leaving certificate syllabus. This is true. In my previous job, I was head of a research and development facility in the Edinburgh Transfusion Service where three groups of scientists used the PCR system. It was run-of-the-mill routine technology. However, that is very different from doing 800 samples per day or 150,000 samples per year, regularly, on time, ascribing every result correctly to the donation it has to be ascribed to. If it is as simple as just a laptop basic technology, then it is difficult to understand why the American Red Cross, which serves 100 million people with something like 4.5 million donations per year, has just one site in the whole of the US. All the samples of the American Red Cross are shipped to one site in the US. There is another blood transfusion service in the United States which uses several more sites. However, each site serves many millions of people.

There are four sites in Holland but each site serves approximately 3.5 million people. The Dutch bleed at a higher rate than we do so the minimum throughput for most planning is about 200,000 units per year, which is still larger than we would have if we did all of them in one site. The Australians will have just five sites, widely separated. The UK will have three sites, even though it serves a population of 55 million to 58 million. There is one PCR site in Scotland which serves a population of 5.5 million. I am trying to make the point that this is routine technology but, done at the scale and with the degree of accuracy and control required in a pharmaceutical grade operation, it is not routine technology, far from it, the opposite is the case.

Chairman: What is the cost of putting in place in Dublin the fail-safe system?

Dr. Murphy: In relation to the fail-safe system, there is a possibility that something catastrophic could happen and the whole laboratory would close, not just PCR, but everything else. It is extremely important to address this and to have a robust system in place. We would go outside the country. We are talking about shipping a box with all the samples for testing. We already have in place a testing agreement with the Scottish Blood Transfusion Service. They do the PCR testing on all our donations at the moment. We would maintain that contractual link. We are talking about a delay of approximately one day, no more. Red cells last approximately 35 days; they have a five week shelf life. Although there are shortages from time to time, we are in a position of shortage while there are approximately 200,000 units in the country. Therefore, we are not in an emergency, back-to-the-wall, situation at that stage, so to speak. The worst that happens is that people are asked to cancel elective surgery while we try to build up the stocks. From the red cell point of view, we would certainly have a day to put in place a back-up fail-safe mechanism. This is not a trivial event, we are talking about a major catastrophic collapse of the service at that stage. We are talking about an earthquake or a jumbo jet hitting the building at that stage, so to speak.

Chairman: What is the cost of the back-up system in Dublin and will there be redundancy of equipment in Cork as a result of the removal of testing?

Mr. Hynes: The capacity for PCR testing is built into the new facility. In other words, space has been provided for that but we have not got to the point of costing what is going into it because there are a very limited number of suppliers of PCR testing. This is not yet a very developed system. Very few countries use the system at the moment. We have tendered for suppliers for which the closing date is early next month. While the tender process is in place, it would be inappropriate to say what we expect to pay for this system. We must allow the two suppliers in the market at the moment to bid for the service.

Chairman: It seems extraordinary that a board with budgetary responsibility is putting in place a fail-system without having a clue of the cost. The attitude seems to be, we will see what it costs and take it from there. We will see what it costs and take it from there. We will ask what redundancies there will be in Cork as result of moving PCR testing to Dublin.

Mr. Hynes: We are not removing PCR testing, there is no PCR testing in this country. That is the message which is being overlooked. Testing is carried out in Scotland. We will source the equipment, staff and training. There is much work to be done before this is introduced. Our contract with the Scots will last for two years. We will not be up and running for at least 12 months. It would be premature to give definitive answers to specific questions. It is an expensive test but we cannot be precise about cost. Given the scale of the operation, the need to modify the building and install equipment, we cannot be clear. I wish we could be clearer.

Dr. Barker: Deputy Clune asked why we did not use independent external experts. As a board of directors, we had confidence in the CEO and the national medical director. The national medical director is the NMD of the Blood Transfusion Service. His expertise is in this area. On the board there were experts in haematology. We had no reason to doubt that there would be an objective report of the highest quality.

Chairman: Mr. Hynes indicated before the report was initiated that there would be centralised testing.

Dr. Barker: I was aware that there had been several reports and that, arising from the Finlay report, independent experts recommended that there should be centralised PCR testing. The Chairman asked what had changed to make us pause. At the time it was felt the computer system was not appropriate and that, before we could centralise testing, we would need to install a state of the art IT system. That system, PROGESA, is now in the final stages of installation. I am aware that the external recommendation was to centralise and create a national service. I was also aware that it was not possible to do that when the recommendation was made because our IT systems were incapable of supporting it. I was also aware that the PROGESA system was to be installed. That is capable of supporting a high quality system.

Deputy Clune: I also asked about the fail-safe mechanism with regard to Britain.

Dr. Barker: Deputy Dennehy asked if board members are based in Cork or Dublin. I discussed this with the Minister recently and, as an independent chairman of a board of directors with a simple objective - the quality and efficiency of the product we offer - I have no agenda for ensuring that the people on the board represent particular geographic areas or political parties. My only agenda is that they be competent. I have given the Minister a lists of the competencies I wish to see on the board. If this is to be a highly efficient system, it cannot be based on a person's political allegiance or geographical background. We are a national service and I am looking for competence in areas such as haematology, virology, finance and pensions. I want medical competence. I stress that I do not know where people are from. I do not ask them.

Chairman: I hope the consumer has not been forgotten.

Dr. Barker: I have included the consumer as one of the requisite competencies on the list.

Deputy Dennehy: Dr. Barker jumped in quickly to say that she could not have it said that cost would be an issue. I cannot have it said that I suggested that people might vote in any particular way. I referred to medical personnel. I did not even know there were non-medical members of the board. I ask the witness to withdraw her remarks because I never mentioned political interests, I mentioned the geographical location of medical personnel. I do not care what politics they have.

Dr. Barker: I told the committee what I told the Minister about the required competencies and that was the context in which I spoke.

Deputy Shatter: We are going around in circles. We should get back to the issues.

Deputy M. Ahern: In October 1987, Dr. Murphy stated he was in favour of two sites. He has since changed his opinion. What caused that change?

Dr. Barker stated that the board's aim is to set up an efficient and effective system. Does that imply that the Cork site was not efficient and effective?

Dr. Murphy: The first question is difficult to answer. I was a member of a group in the Scottish blood transfusion service several years earlier. I worked in the medicine department in Edinburgh University for nine years and my salary was paid by the blood transfusion service. In 1992 I worked on the future of the Scottish service. Ironically, I visited the Irish blood transfusion service to look at its lay out. I also visited other countries. We came up with a recommendation at that time for a single testing and processing site for all Scotland. That is now being implemented. Currently there are two sites but the plan is to reduce to one in due course. At that stage I was of one view which suited the circumstances facing the Scottish transfusion service.

The main idea behind the introduction of PCR, which has come a long way in two years, was to enable, within a reasonable length of time, black box, single sample testing for PCR. We thought the technology for a sample being analysed by a machine was on the way. That has not materialised. The technology which looked so promising has ebbed away and may not be developed for another five years. That helped to change my mind. Large scale PCR testing has not got any easier.

There have been strides forward in the development of blood substitutes and demand for alternatives to transfusion. The haemovigilance programme has also been established. This has raised new areas where we have to devote resources. What has become apparent is the need for tissue engineering and perhaps even the development of patient specific gene therapy. There was also a managerial and team issue in relation to how the blood transfusion service could be made work in Ireland in 1987. The BSTB was an extraordinary bruised organisation, and still is, even though PCR testing looked as if it was going to become simpler, without the knowledge of the advances in the intervening years in blood substitutes and alternative blood transfusion technologies and services and tissue engineering. At that stage, we could not keep a CEO for very long. I felt that the decision which I had favoured and promoted in Scotland was actually not appropriate at that time. With the change in the development of PCR testing and haemovigilance, I feel that our best chance of providing better patient care and hospital service is by consolidating.

Dr. Baker: Deputy Ahern asked if it could be inferred from what I said that the people in Cork were not offering an efficient and effective service. I do not view Cork and Dublin but the national service. I have been to Cork on a number of occasions and have nothing but praise for the people and the service they offer. I have no question mark at all over the people in Cork and the service. They do not do PCR testing so I cannot say whether they are more or less efficient. From the point of view of the national service, it is more efficient and effective to have the PCR testing in Dublin and a laboratory facility in Cork where there is a national centre for tissue engineering or research in a different area, so that we do not have both services provided in each centre but separate centres of national excellence. We are a small country. We do not have the staff or resources to duplicate. It is more efficient for Dublin and Cork to work in different areas so that they can develop a national expertise.

Chairman: Does Mr. Hynes wish to respond?

Mr. Hynes: I would like to respond to a number of questions asked by Deputy Shatter.

Chairman: Mr. Hynes, I do not get involved in internal politics but I am aware there is a perception that there is a difficulty in the interpersonal relationships that exist within the board in Cork. The committee is aware that a case was taken regarding harassment at a very senior level and was heard by the board of the BSTB. I do not know or want to know the outcome of that. Last Friday the CEO and Mr. Murphy indicated to the director in Cork that his staff report should directly to Dublin from Friday, 10 March. This has created a dilemma in the interpersonal relationships between the two test centres and is not going to resolve the conflicts within the board. We are very concerned about the approach being taken to the staff in Cork. I find it ironic to hear you say how well the staff in Cork have worked and how confident you are in their approach in the knowledge that last Friday the Director in Cork was overwritten and her staff were asked to report directly to Dublin. That does not smack of confidence in the staff but of vindictiveness rather than co-operation between top management and people in Cork. It would need to be looked at very seriously.

Mr. Hynes: It is very clear from the reports of the BTSB carried out by Bain, Hederman O'Brien and the board's re-organisation plan that there were ineffective work relationships between Dublin and Cork. They put a number of structures in place to deal with that. It was decided that a number of functions within the board would be national functions. Finance and personnel matters were centralised functions. The donor services management and the management of the national blood supply would be the function of a single officer at national level. Quality assurance was to be a national function. As Dr. Murphy pointed out, there were a number of vacancies in the senior management positions for quite some time, so it was not possible to move on to the implementation of the recommendations contained in the 1996 report. We are now in a position, because we have staff at national level, to take on these responsibilities. We are giving effect to the plans that have been in place since 1996 which were also endorsed by the Finlay tribunal. We were mandated by the Finlay tribunal to have all these things done by the end of 1999. People have known for quite some time that all of these changes were to happen. We have been a little late in doing it but we are now actually implementing what has been long standing board policy since before I joined and perhaps since Dr. Murphy joined the board.

Any suggestion of vindictiveness does not arise. I do not understand where this idea comes from or why it has been repeated here on a couple of occasions. What is here is a national organisation with policies and plans set out by independent experts. We were asked why there were not independent experts involved. Mr. Bain reviewed testing and many of the services of the board. His report was presented in 1995 and was accepted unanimously by the board and the Minister of the day.

Over the last two years we have created a stable operational environment and put in place all the plans and recommendations of the previous expert committees. Unfortunately all of this brings change in the working environment but that is the job the board has to undertake. All of the deficiencies and problems identified in previous reports have to be corrected.

Deputy Dennehy: Mr. Hynes, are you aware that Bain's company was out of business 12 months after publishing that report because of the mess they made in England? I would not be in the habit of criticising any company except if you are dependent on them for the judgment. Mr. Murphy referred to how well the blood transfusion board bonded together after difficulties. Mr. Hynes, I genuinely do not believe that you are in touch with the difficulties among the staff in Cork.

The staff have been there from day one. Morale among the staff is very low and it is not just a question of change and staff feeling neglected.

All of the reports pointed to deficiencies in Dublin. The reports pointed to the need for a new building in Cork providing test facilities costing in the region of £5.5 million which was advertised in October 1995 by the board.

I want to revert back to the issue of costs. At the Committee of Public Accounts everybody accepted that one cannot waste public money in replication and that was a valid argument. Dr. Murphy is now telling the committee that there will be replication. There will be two sets of grouping machines - I think that is what they are called - which will be in separate buildings or offices next to one another. There is an acceptance that there must be a complete back-up system of equipment. This involves replication.

On the staffing issue, Mr. Hynes told me once that there was a need for validation engineers, validation managers, quality assurance and other support services. If one of the two Dublin offices or laboratories was moved to Cork, will Dr. Barker tell the committee what personnel shortages exist the Cork in terms of the provision of testing? Is Dr. Murphy aware of a United Kingdom centre which has more than one of these grouping machines? Do any of them provide the back-up which the BTSB intends providing in Dublin? I say this because one of the initial arguments was that the BTSB wanted to save public money but now the BTSB will replicate the equipment. The two facilities will be provided in order that there will be back-up. Therefore, that nullifies the argument about expensive equipment. How many staff are needed in Cork to provide the back-up in Cork rather than next door to the Dublin centre?

Dr. Murphy: The only reason for not having two fully operational PCR laboratories in Ireland is that there is no need for them. If the argument is that the BTSB should have them for other reasons, that is fair enough. One would have to employ and maintain two sets of highly skilled staff doing the same job when there is no need for them.

Deputy Dennehy: Approximately how many would be needed?

Dr. Murphy: Eight.

Deputy Dennehy: Is it correct to say that none of those people exist in Cork?

Dr. Murphy: No. Of course one can find the staff in Cork to do this.

Deputy Dennehy: How many extra personnel, other than the present complement in Cork, would be needed?

Dr. Murphy: Eight.

Deputy Dennehy: Is it that the Cork centre has none of them?

Dr. Murphy: Correct. They would be new staff.

Deputy Dennehy: Could the Cork centre train any of the eight?

Dr. Murphy: But the Cork staff would remain doing what they do currently. PCR is a new test; it is not replacing previous tests.

Deputy Dennehy: Did the BTSB not tell the committee that it was shifting all of the tests from Cork?

Dr. Murphy: Yes, but if one maintains the current tests and PCR-----

Deputy Dennehy: One minute Dr. Murphy is stating that the BTSB is keeping the tests. Is it that the BTSB does not need the people who are doing the testing at present?

Dr. Murphy: Correct.

Deputy Dennehy: Therefore, all that is needed is for the new equipment to be transferred to Cork and let them use it there.

Dr. Murphy: But one would still need another eight staff to do the PCR testing, if one is doing testing on two sites.

Deputy Dennehy: Could one do PCR testing on one site and all of the other testing on the second?

Dr. Murphy: Yes, but why would one do so? One must ship the samples to the single site anyway. The capacity is there to do both at the same time. One must link the results from the testing in one site and the other site before one can release the blood in one site. One could do so and there is no reason for not doing so, but I cannot see why one would do so.

Deputy Dennehy: I am fascinated, Chairman. One of the key points in the committee's recommendations will be that all of the equipment is being replicated. I was not aware that there was to be a complete second back-up laboratory. There was a fear among people about contamination, shut down and break down on the basis of previous experience, but Dr. Murphy is telling the committee that there will be total replication of the equipment.

Dr. Murphy: There will be a replication of a large part of it, yes, but testing consists of putting a sample into a large machine, running it through the machine and getting the results by computer. A large part of the skill involved is the maintaining of the machines and the quality assurance of the day's run and of the processes.

Deputy Dennehy: I presume that the Cork people have been successful in managing that for 30 or 40 years or for the 60 years before there was one organisation and since then. I do not think that there have been any black marks against them to my knowledge to date.

Dr. Murphy: Absolutely not, of course not.

Deputy Shatter: This is an important issue. I am glad that we have had the opportunity to make these exchanges, but the committee has a national function also. Irrespective of the discussions we may have later and the message which will emanate from the committee, the way these matters should be dealt with is one which guarantees the best possible patient care and safety of blood products. That is the central issue. The other extremely important issue is that there is a fail-safe system in place which works and will deal with all eventualities wherever it is located. That is an important second issue. I am not sure the way the committee should approach this issue is from the perspective of Dublin versus Cork or vice versa. The issues which need to be addressed are quite clear, but internal relationships within the BTSB are such that it is important that any difficulties, which may now exist as a consequence of the changes in administrative and testing practices which are being put in place, are dealt with in a manner which ensures that the Cork centre, as part of the BTSB, functions in a manner which is in the national interest. There must be a move away from a period where, having given birth to a national tragedy, the BTSB does not find itself locked into internal wrangling and internecine warfare between the medical profession in different parts of the country. I am not sure we should stoke the flames, Chairman.

Chairman: Dr. Barker, if the committee was seeking documentation as a result of hearing both sides, would it be possible that that documentation could be made available to us? I am sure most of it would be available under the Freedom of Information Act, 1997

Dr. Barker: Yes, the Freedom of Information Act, 1997, means that most documentation would be available. I cannot think of any documentation which would not be available apart from individual human resource files, which I would not concede to making available to anybody.

Chairman: That would not be at issue.

Dr. Barker: The BTSB would certainly be willing to consider favourably any requests for information other than HR files.

Chairman: Rather than using the sledgehammer approach in terms of interpersonal relationships within the board and in the long-term interests of the board, as Deputy Shatter mentioned, one would certainly want to have a look at how one approaches ones staff and how one deals with them.

Mr. Hynes wanted to address some of the questions raised by Deputy Shatter.

Mr. Hynes: There were three or four questions raised but the group is getting quite small and maybe we have lost our audience.

Deputy Dennehy: Mr. Hynes will note, in fairness, that the Cork back line is still solid.

Mr. Hynes: There are perhaps a few important issues which have been raised. In terms of decentralisation, the BTSB is in the process of decentralising. The BTSB is centralising the collection of blood and proposes to establish a centre in Carlow to deal with the south-east and one in Ardee to deal with the north-east. The BTSB is, therefore, very much in line with policy in so far as is possible.

There are other issues which I am not sure are for today. The question of what the BTSB was doing about CJD was raised.

Deputy Shatter: That is an important issue.

Mr. Hynes: That is an important issue because it is, as Dr. Murphy pointed out, one of the big issues which the BTSB must face.

Deputy Shatter: It is relevant to the issues which we have been talking about.

Mr. Hynes: It is, because it is relevant to testing and at some stage the BTSB anticipates a test for that.

Chairman: The serious issues raised by Deputy Shatter should be the subject of a full hearing of the committee. Deputy Shatter, is it possible that the committee would invite the BTSB back to address some of those issue?

Deputy Shatter: Chairman, the issue of new variant CJD is important. It might be an issue on which the committee might get a preliminary view and then come back to it. There is genuine public interest in this. In addition, it is not a million miles removed from the other issue, which is a location issue as opposed to a purely medical issue. Having dealt with a location issue for two and half hours, this is a major health issue and I would be interested in getting a response to it.

Chairman: It was not on the agenda today, but I recognise that it is an important issue.

Deputy Shatter: Other issues were raised in the presentation today.

Chairman: The board should come back at a future time to discuss other issues.

Dr. Barker: Would it help if we made a preliminary written submission in response?

Chairman: Perhaps the delegation would deal in deference to Deputy Shatter. He has been very patient on this issue. Perhaps the delegation would give us a preliminary look at this issue.

Dr. Murphy: I would be delighted to. Variant CJD could represent a very serious risk to the blood supply and is something we have taken very seriously and has to be taken very seriously. We are very close to the UK where almost all of the 62 cases that have now arisen have been. I will go through this step by step. There is no evidence as yet that Variant CJD, the new form of BSE in humans, can be transmitted between humans but it might be possible. We must act as if that was the case. There is no evidence that humans who are incubating the disease can spread it to another human by blood transfusion but they might be able to. We know that in blood transfusions a large part of the infectious agent is on the white cells and we have known that for some time. Therefore, to address that, all platelets for transfusion in this country have all the while cells removed. We have taken that measure in line with France and the UK. Australia, Japan, Canada, America, the Netherlands and Belgium are following that route.

We know that some countries, which have been alluded to, such as the US, Canada, Australia and Japan, now Austria and recently Germany, are excluding people who have spent six months or more in the UK between 1980 and 1996, which was the major infectious period. We have examined what that would mean to us. They have taken this as a precautionary measure and they have looked at the number of donors that they have whom they could exclude and what their loss would be to the donor population. It is about 2% in all of those countries or less. An extremely important part of that is their indigenous risk - the risk from eating contaminated food stuffs in those countries is almost zero, whereas none of those involved in the cases in France, which had three cases of CJD, ever set foot in Britain. They contracted it through an indigenous ingestion of contaminated foodstuffs, whether from French cattle or imported cattle, we do not know.

We have examined our situation. A total of 13% of our donors have spent six months or more in the UK in the relevant time periods. The sudden loss of 13% or more of our donors would be very serious. We would and could work through it but in the interim, many operations would be cancelled for some time. We do not know whether that would make a difference to the risk to people in this country from CJD because we do not know the risk from eating contaminated foodstuffs in the indigenous population. It could be as high as 20% of the population. Whether they will develop the disease or not remains to be seen and hopefully nobody will.

There is a very large issue of the risk of Variant CJD in this country to which blood transfusion may well contribute. At this stage there are two actions we can take and have taken. We have referred the matter to the Irish Medicines Board and this matter is dealt with by regulatory authorities throughout Europe very actively. It is a main focus of activity of the Commission in what used to be DG XXV or de santé commission at the moment. They are actively considering whether people should defer people who have been in the UK. When that decision is reached, it is likely to be that no decision will be reached because of the number of imponderables.

The CJD Advisory Committee advises the Minister. We have members on that committee and are in constant discussion and consultation with that group. We are in constant consultation with experts in the UK and in the US as the biology of this disease becomes apparent and as we understand more of the natural history of the disease. One of the matters which needs to be developed and which we are working on developing is that people who need blood transfusion in this country should now be transfused only when it is clear that there is a considerable benefit to them to be achieved by that transfusion. There needs to be a major shift in the way people regard blood transfusion.

If one has leukaemia and one's bone marrow does not work, one will die without blood transfusion so a theoretical risk of Variant CJD does not figure very strongly in that equation. If a person has a Caesarean Section and their haemoglobin count is nine, they have to go home to five kids and they are feeling awful because their blood is low, nine times out of ten that woman would receive a blood transfusion to increase her sense of well-being in the short term. That woman should not now be transfused. She should be helped through that situation with medicine, rest and support rather than transfusion. That shift in thinking has to be put across to people.

There will come a time which may come fairly soon when we have to admit that people who have lived in the UK for a greater or lesser period have a higher risk of transmitting this disease and therefore, they should be excluded. and we would take that on the chin.

Deputy Shatter: How close are we to a test?

Dr. Murphy: Two years is the best guess.

Mr. Hynes: This is a subject...

Dr. Murphy: The test will have a major impact on the blood supply because we will have a test for a disease or for an infectious agent in people's blood and because of the phenomenally long incubation period of this disease which is nine or 11 years or even longer in some people, we will then ask people to take a test. We will give them the result that may indicate they are incubating a disease which they may or may not develop because we will not know the consequence of a positive test. People will find it very difficult to donate in that situation. Many people will feel under great pressure not to donate and not to have the result of that test. We will not even know if one can transmit the disease through co-habitation or sexually to one's partner or to one's children. The test will have huge implications when it becomes available. We may have to tell a donor that they have this infectious agent in their blood and that we do not know whether they will develop this disease. They will have to live with it for nine or ten years of worry. That will have a major impact on the blood supply so we have to address that.

Deputy Shatter: Nevertheless, in the context of the lack of knowledge of incubation and the extent to which it is predictable, and that someone will develop Variant CJD in full type, we will still need to do the test when it becomes available.

Dr. Murphy: Of course, no question about that. We will do the test immediately.

Deputy Shatter: There is no way out of that in the context of the state of knowledge available.

Dr. Murphy: That is true. The point is that doing that will have a major impact on the blood supply and on the job we have to do.

Mr. Hynes: There are one or two other questions relevant to testing, one of which is a question that was raised about replica blood or blood substitutes or haemoglobin solutions. They are on the horizon as well. Many companies are doing research on them. If they come they will take away a substantial proportion of the work we now do because there will be alternatives to blood. As an organisation we must plan for the future and issues such as that must be taken into account.

Deputy Shatter: Provided it is the right type it does not matter whether it is self donated or how it is derived.

Mr. Hynes: Maybe Dr. Murphy will comment on the different options in that regard as well because we have referred to it in the report. If one looks at the text of the report, some of these misuses are there.

Deputy Shatter: It refers to developments on the way in the context of ---

Mr. Hynes: The haemoglobin solutions and the alternatives to that. Again they will impact on what we do and on the volume of blood we are required to test and issue to hospitals.

Deputy Shatter: It could change the whole profile of the actions of the BTSB.

Mr. Hynes: Very quickly.

Dr. Murphy: Very much so.,

Mr. Hynes: It is in the documentation.

Deputy Shatter: The other issue is the extent to which the board can involve themselves in research or the extent to which it is reliant on research from others.

Mr. Hynes: There is a small amount of research going on and we have some funding. Consultants in the BTSB do much research. Historically some people did very good research, others are still doing research and it will continue. Research is being carried out into blood usage because we do not have good information on blood usage in this country. Dr. Riordan, one our consultants, did a good exercise in that. There are other studies going on at the moment. Maybe Dr. Murphy would comment on the technical details.

Dr. Murphy: There are two aspects of research particularly in biotechnology in the area of developing products and safety. One is coming up with the drug and bringing it forward to be ready for clinical use. We are not involved in that. One really needs to work with a pharmaceutical company or with a large academic group to move that forward. What we will become involved in more and more is developmental research to introduce developing techniques and approaches to the clinic. This is extremely important; otherwise we would fall well behind and be slow to make emerging technologies available to Irish patients.

Chairman: I thank you for appearing before the committee. Your appearance has given us an opportunity to engage in straight talking. We all share a common objective, the provision of a safe blood supply in the best interests of patients. We will give this issue further consideration having heard both sides of the argument. Did you read the report in the Irish Independent on Saturday which appeared to indicate that the Minister may be about to overturn your decision on testing given the significant funding to be invested in the Cork centre?

Dr. Barker: The Minister has indicated that he has an interest in the development of a research centre in Cork. I am delighted that he is seriously thinking about this. He would have my support.

The Joint Committee adjourned at 5.03 p.m.