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COMMITTEE of PUBLIC ACCOUNTS debate -
Thursday, 3 Jun 1999

Vol. 1 No. 9

The Blood Transfusion Service Board: Annual Financial Statements 1995 and 1996 (resumed), 1997 and General Report on the Health Sector 1995 (relevant section).

Mr. M. Hynes (Chief Executive Officer, Blood Transfusion Service Board) and Mr. J. O'Dwyer (Secretary General, Department of Health and Children) called and examined.

The Committee of Public Accounts is now in public session to deal with the Vote of the Blood Transfusion Service Board: Annual Financial Statements 1995 and 1996 (resumed), 1997 and the relevant section of the general report on the health sector. Relevant documentation regarding this matter has been circulated. The committee will also deal with the resumed Vote on the 1997 Annual Report of the Comptroller and Auditor General and Appropriation Accounts: Vote 41 - Department of Health and Children.

Witnesses should be made aware that they do not enjoy absolute privilege and they should be appraised as follows: Attention is drawn to the fact that as and from 2 August 1998, section 10 of the Committees of the Houses of the Oireachtas (Compellability, Privileges and Immunities of Witnesses) Act, 1997, grants certain rights to persons who are identified in the course of the committee's proceedings. These rights include the right to give evidence, the right to produce or send documents to the committee, the right to appear before the committee, either in person or through a representative, the right to make a written and oral submission, the right to request the committee to direct the attendance of witnesses and the production of documents and the right to cross examine witnesses. For the most part, these rights may be exercised only with the consent of the committee. I welcome Mr. Martin Hynes, Chief Executive Officer of the Blood Transfusion Service Board. It is your first time before the committee. I understand you have recently taken up your appointment.

Mr. Hynes

That is correct.

I wish you the best in your new post. Please introduce your accompanying officials.

Mr. Hynes

I am accompanied by Dr. Emer Lawlor, Deputy National Medical Director, Mr. David Burbridge, finance officer and Mr. James Mulholland management accountant.

You are all welcome. I also welcome the Secretary General of the Department of Health and Children, Mr. Jerry O'Dwyer. Please introduce your accompanying officials.

Mr. O’Dwyer

I am accompanied by Anna May Harkin from the planning and evaluation unit, Dermot Magan from the finance unit, Helen Minogue, accountant, and Jim Breslin from the finance unit.

You are all welcome. Also inattendance from the Department of Finance are Mr. Thompson and Mr. G. Kenny and from the Blood Transfusion Service Board, Mr. Barron and Mr. Coffey. You are welcome.

We are dealing with a resumed Vote. I call on Mr. Colm Dunne, Director of Audit, Office of the Comptroller and Auditor General, to reintroduce the Vote.

Mr. Dunne

In my audit report on the 1997 accounts of the Blood Transfusion Service Board, I draw attention, as I did in the 1995 and the 1996 reports, to note 2 of the financial statements which outlines the circumstances surrounding the potential liability of the board in respect of hepatitis C and HIV infection. As members are already aware, the board has admitted liability to infection through anti-D cases and a compensation tribunal was established in 1997 to determine amounts of compensation to be paid. Claimants still have the right to sue in the courts if they are dissatisfied with, or do not wish to have their cases dealt with by the compensation tribunal. Awards made by the tribunal are borne by the Exchequer, in accordance with the statute under which it was set up.

The Department of Health and Children has undertaken to bear the full costs, including legal and other costs, of any awards made outside the tribunal. In 1996 the Department also decided that future compensation awards against the board relating to blood products would be funded by the Exchequer in relation to any annual excess over £250,000. The financial risks to the board are greatly reduced by these measures.

In 1997 the board received from the Department of Health and Children, and spent, £3,941,858 in respect of hepatitis C. The total amount spent since the liability arose in 1994 is £12.4 million. This only relates to expenditure directly incurred by the board and does not include any expenses or settlements of the compensation tribunal and only includes the settlement of two cases. The amount received from the Department and spent in 1997 in respect of the HIV programme was £1,146,334, which again relates to expenditure directly incurred by the board, including the settlement of one case.

The 1997 financial statements reveal a further deterioration in the finances of the board as a deficit of £1,445,815 was incurred. From being in profit in 1994, the board's finances have deteriorated since 1995 and cumulative losses of £2.3 million have been recorded in the three years, 1995-97, despite legal compensation and other costs relating to hepatitis C and HIV having been funded in full by the Department of Health and Children.

The deterioration in the board's financial position is mainly attributed to reduced demand for blood products due to the adverse publicity associated with the hepatitis C infections and extra overhead costs due to additional controls introduced since 1994. As detailed in note 17 to the financial statements, further losses will accrue to the board after 1997 due to the necessity to withdraw certain products and the decision to discontinue using human plasma in the manufacture of factor 8.

The recovery by the board in 1998 of moneys from its insurers in relation to hepatitis C losses, which the Department of Health and Children has apparently agreed may be retained by the board, will greatly strengthen its financial position. Interim work on the 1998 audit has been completed and the final work is scheduled to be done in August 1999.

Mr. Hynes, when did you take up your position?

Mr. Hynes

1 July 1998.

Have you all the problems resolved?

Mr. Hynes

In fairness, before I took up my position a number of the problems had been fairly comprehensively dealt with, especially with regard to the issues that arose as far back as 1994. On the other hand many changes have occurred in blood transfusion services world-wide, with new and more sophisticated testing and new products being required to meet higher standards in medical care. These will take many years of work to address.

What is the total amount paid so far in compensation?

Mr. Hynes

I do not have any information on that. The compensation tribunal is independent of the board and does not report to it, so we do not have information——

Do you not take an interest in it?

Mr. Hynes

——other than what we read in the newspapers. It has been established in such a way that we are not entitled to information. The compensation tribunal acts in a confidential manner so it does not give information back to the BTSB.

Mr. O'Dwyer, do you have a figure on what has been paid out so far in compensation? How many cases are involved and how many are outstanding?

Mr. O’Dwyer

The figures before me are applicable as at 28 May 1999. The number of applications to date is 1,918, the number of awards to date is 1,213 and the amount awarded to date is £174 million. Legal costs, which have been settled in 1,013 cases, amount to £23 million. The average award to date is £143,477 and the average legal costs in a case to date is £22,750.

I will recap on those figures. The total number of applications is 1,918. The total number of cases in which awards have been made is 1,213 and total amount awarded is £174 million. The average award is £143,477. Legal costs have been settled in 1,013 cases and amount to a total of £23 million and the average legal costs in a case is £23,750.

Mr. Dwyer

The cost of the reparation fund to date, which is 20 per cent of the awards to date, is £35 million. Will I give the rest of the information I have?

Mr. Dwyer

The estimated cost of outstanding claims is £703 million. Based on the amount of the average award to date, the estimated cost of the claims is £100.5 million.

What about the estimated legal costs?

Mr. Dwyer

The estimated legal costs amounts to £20.5 million and the reparation fund would be £20.1 million.

What grand total does that give?

Mr. Dwyer

Taking account of the overall estimated total costs of the compensation tribunal, the total amount awarded to date is £174 million.

I get a figure of £373 million.

Mr. Dwyer

The estimated cost of administration of £4 million is not included in that figure. The total figure is £377 million.

The estimated cost of administration is £4 million and the total figure is £377 million.

Mr. Dwyer

Yes. To recap on the figures, the cost of awards to date is £174 million, the cost of legal fees to date amount to £23 million, the cost of the reparation fund to date is £35 million, the estimated cost of awards in the remaining cases is £100.5 million, the estimated cost of legal fees in the remaining cases is £20.5 million, the estimated cost of the reparation fund is £20.1 million, and the estimated cost of administration is £4 million, making a grand total of £377.1 million.

That is an appallingly large bill, but the damage that has been done to so many women is even more appalling. This cost to the Exchequer is nothing compared to the damage that has been done to many families.

Mr. Hynes, the Committee will be anxious to hear what checks and safeguards now exist in the Blood Transfusion Service Board to ensure this crisis can never happen again.

Mr. Hynes

There are about eight stages in the process of dealing with blood. The first, and one of the most important in the process, is donor selection. People are selected to donate blood on the basis of being healthy and fit and a number of exclusion criteria apply. The standards that apply and to which we adhere are generally set by the World Health Organisation and the Council of Europe and, in addition to those, we also have our own standards.

The second stage is donor collection. At this stage care must be taken not only to protect the safety of donors but also to protect the safety of the product that will be ultimately used by patients who require transfusions.

The next stage, which is important, is testing and it is increasingly becoming more sophisticated. We have improved testing facilities. We have introduced a number of new and more sophisticated tests in the past year and we will continue to add to them.

The next stage is component processing, where the different products are used. With the potential threat or theoretical risk of the transmission of CJD, we are removing the white cells from blood by a process known as leucodepletion, a development in the processing area.

Another development in the transfusion area, is a tendency to transfuse only red cells rather than whole blood. Very little of the blood we collect is transfused in the same manner in which it is collected. Initially when blood was transfused, it was transfused directly from the arm of one person into the arm of a patient with very few tests carried out, but now there are a number of stages in the process.

The next stage is at hospital level where there are stockholding units and all the blood collected is cross-matched. Doctors have become more careful in terms of when they prescribe the giving of blood. A blood user group was set up recently by the Minister to recommend optimal and best practice in blood transfusion. In addition, we have established within the BTSB a haemoviligence unit where any adverse reactions to blood are analysed and processed so that we can ensure the safety of the donor and, perhaps, also take account of any problems with our own products.

A great deal of caution is exercised and there are many checks in place at all stages in the testing and processing of the blood. We have manual and electronic checks and equipment that checks and double checks all stages of the process. If there is any doubt about a potential virus or anything like that, a second check is carried out by the virus reference laboratory. That is primarily to ensure the safety of the donor as well the product. Therefore, there are significant checks in place.

The BTSB is also inspected on a twice yearly basis by the Irish Medicines Board. It reports to us and we take action on anything it identifies. The Irish Medicines Board also submits an annual report to the Minister for Health and Children on the operation of the BTSB.

Can you assure the Committee that the standards applied by the board now are on a par with best international standards?

Mr. Hynes

Yes, Chairman, the standards applied by the BTSB are on a par with the best international standards. In some instances, as in the case of leucodepletion, Ireland was to the forefront in implementing that policy and other European countries have since followed suit. In so far as the BTSB can give assurances, we are to the forefront of best practice.

The European Union is taking an increasing interest in blood safety and each of the Presidencies of the European Union have taken initiatives to further protect the safety of blood and blood products. There was a major initiative taken by the Irish Presidency at the Adare colloquium and subsequent Presidencies have moved on from that. A recent conference was held by the German Presidency. Under the Amsterdam Treaty, there is provision for the EU Presidency to take an even greater interest in the whole area of public health which, as I understand it, will include blood.

Has any other country experienced the scandal and lapse we witnessed? Was that phenomenon a purely Irish one?

Mr. Hynes

There are two separate issues here. The anti-D product was one issue and another was the blood supply in terms of the HIV virus and other issues. Many of those issues relating to the blood supply were experienced by other countries to a greater or lesser extent than they were here. The anti-D product was particular to Ireland because of the way in which it was manufactured. I understand a similar problem was experienced in some part of East Germany, but I do not know the scale of it. Anti-D was a product manufactured within the BTSB. Problems arose with blood in a number of countries before the HIV virus was diagnosed, hepatitis C was transmitted and tests became available.

One must remember that when a problem emerges the solution does not often emerge until some time later. While the HIV virus emerged in the 1980s, it took some time to devise a test to diagnose it and sometimes it takes even longer to adapt such a test for the purpose of screeningthe thousands of people who need it in a short period.

You used the term "haemoviligance". What is that?

Mr. Hynes

Haemovigilance is a system that deals with the adverse reactions to blood. It gets reports from hospitals or general practitioners where there is a side effect or untoward reaction to blood or blood products.

What is the incidence of this?

Mr. Hynes

At the moment, Ireland is part of a British system called SHOT, Serious Hazards of Transfusion. Irish hospitals have been reporting through that system for the past year or two and these reports have been published. Many instances occur at hospital level where, perhaps, a wrong sample is taken, a wrong transfusion is given or people are given more transfusions than they need. There are a number of technical instances that Dr. Lawlor might be in a better position to explain.

How often does this happen and in what percentage of cases does a hazard manifest itself?

There is a certain amount of literature available on this. For example, there is the possibility of circulatory overload, where one is given blood too quickly and the heart cannot cope with it. This happens in approximately 1 per cent of transfusions. Because of the safety of blood testing and donor selection, there are no viral risks. If one receives a blood transfusion nowadays, the risk of dying from receiving the wrong blood is higher than the risk of getting a virus.

The viral danger has been eliminated?

The viral danger has been virtually eliminated. The problem is that there are not any figures worldwide. This is what everyone is trying to ascertain, and a system is being put in place in Europe and in Ireland. We hope to start recording these figures from October. The problem with an adverse reaction is that we get the reports but do not know necessarily what the baseline was; we do not know how many transfusions occur in hospitals and we must receive that information and work out the figures. In my hospital we would say that minor reactions might occur in approximately 1 per cent of transfusions but this seems to be more common with plasma. However, we are working on this but we need to obtain much more information.

What is the volume of blood transfused per year?

The issues are approximately 150,000 units of blood.

What is a unit?

A unit is about 500 mls of blood. People do not now get transfused unless they need to. Much of the original work was not evidence based. A small number of patients might have been looked at and it was decided that the haemoglobin needed to be treated with blood transfusion. In fact, people's blood count can fall quite low before they need to be transfused. Given the risks associated with viral disease and problems with blood transfusions through getting the wrong blood, people are much more careful about transfusing.

Are there difficulties in meeting the demand for blood?

Mr. Hynes

There are some difficulties in meeting the demand. Obviously we have had a great deal of negative publicity in recent years. We have 100,000 quite loyal donors. Usually, during the summer months, leading up to bank holiday week-ends or over the Christmas period are our most critical times because we cannot store the blood. Blood has a maximum shelf life of 35 days and platelet lasts for five days. A long week-end when donors are on holidays creates difficulties. Added to that, when there is a great deal of negative publicity, people tend to vote with their feet by staying away.

Has there ever been an instance of a donor having adverse problems as a result of being a donor?

Mr. Hynes

On occasions donors suffer swollen arms or bruising.

Nothing more serious?

Mr. Hynes

Very rarely. There is something in the international literature where instances have arisen, but generally speaking it is a very safe procedure.

Unfortunately, many people tend to associate it with viruses and so on but it is extremely safe procedure for donors.

On donor selection and screening, to what extent does screening take place at present in addition to any screening previously in place?

Mr. Hynes

Given that this is a medical matter, Dr. Lawlor might give some details on the changes that have taken place.

The first element of donor selection starts with the donor interview. This is becoming increasingly more complex in that donors are asked very searching questions about their lifestyle and risk exposure. This is still an important element of donor selection because screening is extremely sensitive. The only time it can miss someone is if the person has been recently exposed to infection. For example, if a donor had a risk exposure to HIV, it is 22 days before the antibody, which is what we pick up, will prove positive. The selection interview at the beginning is designed to make sure that a donor at risk does not come forward and donate blood. To indicate how effective testing is, it is estimated that approximately one in 3.3 million units might go out which would have missed testing. The interview process is designed to pick up this aspect.

Every six months or so, we review what is happening internationally. We add extra questions to the donor questionnaire. We are at present considering introducing a donor interview for first time donors, because they are the riskiest, or donors who have not donated in the past two years. We will introduce this system towards the end of the summer.

On screening, we screen for HIV 1 and 2, hepatitis C, hepatitis B, syphilis and a virus called HTLV 1 and 2. This virus is rare in this country but it can transmit a disease which in a small number of people could lead to leukaemia. This is not screened for in the UK. We also screen for cytomegalo virus. We have a wide range of tests which are in line with the tests carried out worldwide. These are antibody tests. We are now considering introducing a test for the virus for hepatitis C. For HIV the risk is about one to 3.3 million, for hepatitis C it is about one to 500,000. It is rare but it is more common than for HIV. The period before the antibody develops and the donor has been exposed is called the window period. To reduce that further, we are introducing testing for the hepatitis C virus. This will be done in association with Scotland and will take place in the middle to late summer.

How does your screening process and selection compare with that in Canada, Japan and other European countries?

They would be comparable and to the best standards.

As good as or better than?

As good as. Canada is now pretty good. They have learnt from their——

To what degree do you compare data with such countries on an ongoing basis and to what degree do you compare data with countries which have had difficulties in relation to blood products and the health thereof?

We look at this on an ongoing basis seeing how they differ from ours and talking to people, both informally and formally, about how they resolve their problems and what they are doing to sort them out. This is a continuing process and a very important one.

Dr. Lawlor gave a comprehensive reply as regards the manner and methods of screening to reduce the risk as much as possible, which I appreciate. Has it arisen that someone who was a donor for a number of years was subsequently identified by the BTSB as a risk donor and was struck off the donor's list?

Yes, that does happen.

What kind of virus or antibodies showed up in those case?. To what extent have those instances reoccurred? What action has been taken to identify such possibilities? I am talking about someone who has been a blood donor for perhaps ten or 15 years and suddenly has HIV antibodies or whatever. How does one identify those and, by the means and methodology which can be applied to do so, ensure public confidence is maintained in the system?

We are fortunate in this country that HIV is not a problem in the donor population. Last year, two donors were HIV positive.

Two from a total of how many?

Some 150,000 donations.

It is infinitesimal.

Yes, it is extremely small. For hepatitis C it is higher and for new donors the incidence would be about one in 2,000, whereas it is one in 34,000 repeat donors. When we get a donor who has donated - this happens more frequently with hepatitis C - we find out what donations they have made. We have samples of donations from 1994 so we can go back and test a sample if we have it. We can work out how far we need to go back - we usually go back a year after the last negative donation, on the basis that the window period for hepatitis C, making it wide, would be about a year.

Our protocol is based on those used in San Francisco's Irwin Memorial Hospital and we have adapted it somewhat. It is very tight and there are definite protocols as to how exactly we manage these donors. We find out from the hospital who got the blood and we contact the GP and arrange testing through him or her. It is an ongoing process. It does not happen that often but it does happen.

What tests are carried out as regards new donors?

Exactly the same tests as are done on a repeat donor. If the donor is found positive, obviously we do not have to worry about previous donations. However, we do have to worry about the donor. If we find him positive in one of the screening tests we send it to the virus reference laboratory who do further testing to confirm it. We interview the donor where possible to see what the risk factors were and to determine whether there is anything we can improve in our questionnaire - perhaps they did not see themselves as at risk or whatever. We then refer the donor to the relevant specialist unit in the hospital.

Is all that done before the donor gives blood?

No, the donor fills in the questionnaire. If he passes that he gives his unit of blood and the next day it is tested. At that stage, if the blood is found positive, a sample is sent to the virus reference laboratory. The blood is destroyed and the donor is counselled and sent on as appropriate.

What is the risk from blood donations from a person who has a virus or antibodies which have not yet shown up? Is there a risk in the valley period, so to speak, between contracting the virus and it showing up in a test?

Yes. That is the main risk. The tests are now automated and are carried out in a system that ensures all the reagents and samples are added so there are no mistakes. It is then dealt with by computer and validated. The IMB has inspected that and is happy with it. The risk is the valley or window period. For HIV the time of exposure to the time of developing antibodies is 22 days, which is extremely short. With the incidence in our donors, according to our statistical exercise based on an international model it would happen in only one in 3.3 million donations. For hepatitis C it is more frequent because that is more prevalent in the community and it would be about one in 500,000. Hepatitis B is more frequent in Ireland than people realise and is more difficult to estimate - it is probably one in 500,000 as well.

The incubation period is taken into account in each case.

Exactly.

The tests are stretched to overlap sufficiently.

Since those tests were introduced, have there been any instances of an infected product going through the system without being caught?

No. There was one ITD recipient who was exposed in 1993 and perhaps donated in 1994. However, there is no evidence there was any transmission there.

How would one know whether there was or was not transmission?

One of the problems is that because of the underlying disease for which patients are transfused, very often if one is coming back after two years, a number of recipients will have died and after ten years 50 per cent of recipients will have died from their underlying disease. Sometimes one cannot say absolutely whether it transmitted or not. That is one of the advantages of having what we call an archive sample from 1994 onwards.

To what extent does the BTSB compare with other blood banks throughout the world as regards incubation periods? To what extent do blood banks refer to each other particular conditions or risks which may arise in order to assure the highest possible standards are seen to prevail throughout the world?

That obviously depends on the prevalence in the community. For example, in America the comparable risk of a donor coming in in the window period would be higher than here. Sometimes one can do something about it but other times it is not very easy. We are fortunate HIV is not a problem in the donor population in Ireland so our risk is much lower. People discuss these matters and there are always meetings on how to reduce the risks to everyone from transfusion. It depends to a certain extent on the prevalence in the underlying community because that is from where one's donors are drawn.

As regards public confidence and the financial position of the board at present, what actions has it taken, other than those which are obviously necessary, to improve standards and limit something going wrong to the greatest possible extent? For example, to what extent have the board's premises and the quality of the work environment for staff improved? All of these factors can affect the quality of the product and perhaps the health of the community as a result. To what extent have those issues been addressed?

Mr. Hynes

All those issues are being comprehensively addressed. Deputy Durkan mentioned premises with which I will deal first. With the capital grant from the Department of Health and Children we are currently erecting a new premises at St. James's Hospital. There is a great deal of investment there. The building work is to be completed some time this month. The fitting out and the remainder of the work, such as equipping it, is expected to be finished on 24 October 1999. We will have a new premises with the most up to date equipment.

It is state of the art.

Mr. Hynes

It is a state of the art facility. More important are the things just mentioned by Dr. Lawlor, such as improved tests and donor selection criteria. In terms of exchanging information with other transfusion services, last year countries such as ourselves, which have a national blood donation service made up of voluntary non-remunerated donors, established a European blood alliance which enables us to share information with such countries. That takes place all the time and will improve as time goes by.

We are also investing in a new computer system which will track the donation from the point at which the donor is recruited to the point at which the unit is dispatched to the hospitals. That system has been installed in a number of other European countries and also in New Zealand and Australia. It is due to be finally installed on 4 October 1999. These two additional major capital investments will help us in terms of premises and equipment, in addition to our existing tests.

It will take more time to restore donor confidence. Obviously, there is a great deal of hurt due to what happened. We must take responsibility for bringing the organisation forward into the next century. However, it is important to remember that many people in hospital would die without blood transfusions. There is a balance. It is difficult to get across the message that we have changed. As Dr. Lawlor said, since we introduced these changes there have not been adverse reactions.

There will always be new challenges as new diseases might emerge from a foreign country which we do not know about yet but which will require testing. We are always conscious that the work is not finished yet as there may be more transmissible illnesses and viruses which medical technology and science do not know about yet or have answers to.

However, in terms of restoring public confidence as much as possible, we are endeavouring to put as much information into the public arena as we can. We believe that full disclosure of all the information to the public is the best way to go about this. We have begun a series of regular bulletins for people who use blood in hospitals. We are also preparing regular newsletters for donors to make them aware. We published an annual report last year - one had not been published for a few years because of the other constraints - in which we provided information. The 1998 annual report will be published on Friday this week. Much more information is being given to the public. All we can do is make people fully aware of what we are doing and endeavour to make them aware of the changes we have brought about, which is the critical part. Given the other issues which take place off stage, it is difficult for us to do that.

Mr. Dunne identified earlier in his report the increasing cost to the board of recruiting donors. We have had to spend more money on advertising and communicating with donors. However, in fairness, the response has always been great if we advertise for donors or make an appeal. There is an underlying generosity among the Irish community if they are aware of the need.

We are also required to be self-sufficient. Unfortunately, we had to import blood last year and in previous years. We discontinued that last August and have managed to meet hospital orders since then. We are having reasonable success, although we are regularly concerned that we might not be able to meet hospital demands at holiday periods or if there were an upsurge in demand.

We believe that confidence is being restored at the moment. We have greater communication with hospital clinicians and the people who prescribe and use blood. The vigilance system will increase our communications with hospital clinicians. We are also increasing our communications with donors.

There are state of the art facilities in the headquarters, but what sort of facilities are there for collecting donations and transporting them between the various locations around the country and headquarters? To what extent will those be upgraded in order to maintain the standards set by the national headquarters?

Mr. Hynes

We go to 290 locations throughout the country to collect blood. We must use whatever facilities are available in the local community. Sometimes it is a school hall, a parish hall, community centre or a local hotel. Standards vary, although we have set out minimum standards which must be there. However, generally speaking, the standard of facility needed in a local hall is not particularly onerous because the blood is taken directly from the person's vein into a sealed bag. There is no risk of anything happening between the person's vein and the bag. However, we like people to be comfortable in the halls. and heat, light and power points are essential requirements.

We have refrigerated transport equipment. The blood is brought back at particular temperatures. We have vans which can transport it back to the centre.

Within what period?

Mr. Hynes

If we finish a clinic at 9 p.m. the blood is immediately taken back to the centre that night.

From anywhere in the country?

Mr. Hynes

From anywhere in the country. We have two fixed centres - one in Pelican House in Dublin and one in Cork. It is intended to retain a clinic in the vicinity of Pelican House. We are not moving the donor clinic to the new headquarters, which will be just for processing and the laboratories. There will be a platelet Rhesus clinic but there will not be a major blood donor clinic, which will remain in the vicinity of Mespil Road.

It is said that every operation is as good as its weakest link. Has Mr. Hynes identified the weakest link in the chain he commands? To what extent can he reassure the public about his ability to address what he perceives as the weakest link in that chain?

Mr. Hynes

As I said, there are eight separate processes, all of which are equally important. I would not identify any particular weak link at the moment. We need to integrate them better. It is critical that we improve links with the hospitals in terms of ensuring we get more information out and more information back from the hospitals. The haemovigilance unit we are establishing will deal with that. That is probably the most important task yet to be undertaken. The donor selections, testing facilities and processing facilities are being brought up to a very high standard. The next stage is to improve links with the hospitals. The blood users group, which has been established by the Minister, will also add to the system by providing guidelines and advice to clinicians who prescribe blood.

To what extent do the board and the Department of Health and Children keep in regular contact?

Mr. Hynes

The Department of Health and Children has two representatives on our board, so there is contact at that level. Apart from that, issues are reported to the Department if necessary. Department officials are here today, which is an indication of the close relationship. It has funded our capital development and there are Department officials on that project team. The Department is also funding the IT project and it is also represented on that project team. There are regular contacts with different sections of the Department, in terms of what we are doing and the projects it is funding. It has been very supportive of our efforts over the past number of years to bring about improvements and changes.

Does Mr. Hynes believe that procedures are now in place to avert, as far as possible, the possible recurrence of a likely cost to the Exchequer of almost £400 million in compensation and £40 million or £50 million in legal fees, plus the other administrative costs about which we heard?

Mr. Hynes

The short answer is yes. We will need to move into our new headquarters and put in our new computer system before we are absolutely sure. However, the steps to do that are being taken and will be in place by the end of this year. The testing and so on has already been put in place.

The state of the art equipment and facilities will be made available quickly. I presume, Mr. O'Dwyer, that the financial facilities required to support such ventures will be available on tap, no pun intended.

Mr. O’Dwyer

The best predictor of the future is what happened in the past. Over the past few years, as Mr. Hynes said, there has been unequivocal technical and financial support from the Department. There are two driving forces, one being the perceived and actual needs of the Blood Transfusion Service Board, which is the specialist agency ultimately responsible for quality assurance and, parallel to that, the Irish Medicines Board, which is the independent guarantor ensuring the BTSB acts to best standards. The board and management of the BTSB set out to benchmark it against the best in terms of facilities, practice and, in due course, productivity. That approach is supported by the Department and I do not anticipate any difficulty, given the policy and practice now being developed and moved forward. However as the director stated, the board is faced with the reality that while overall use of blood is reducing, the unit cost is increasing. These factors are unlikely to change in the foreseeable future. When fully geared up, the board faces the challenge of finding the way to be most productive. At this stage no questions have been raised in this regard.

Is there no possibility of a financial hiccup or shortfall as happened in the case of Tallaght Hospital?

Mr. O’Dwyer

First, I do not accept there was a shortfall in relation to Tallaght Hospital but we can talk about that separately. Second, anything requested from the capital or the revenue side in relation to the BTSB, the Irish Medicines Board or any related issues has been readily forthcoming.

I have no more questions.

We have dealt with this previously but the figures quoted of £377 million in costs do not tell the story of this episode and the pain, suffering, horror and trauma faced by over 2,000 people. That is the real story. I am worried we may be moving backwards to the bad old days. When we were in the thick of this and they could not get many volunteers to take over staff positions, my colleague from Cork, Mr. Tom O'Dwyer, came and tried to resuscitate the board. At that time people appeared before the committee and painted a future of what was needed, prescribed and would be done. A letter dated 20 November 1997 from the Minister for Health and Children, Deputy Brian Cowen states:

With regard to the Cork Centre itself, the Board in conjunction with my Department has decided that the Centre requires replacement. I am pleased to inform you that I have given my approval to the development.

An inquiry from Anne Marie Mannion, biotechnology inspector, which sought a reply in February 1999 states:

A timetable relating to a new Centre [in Cork] was attached to the letter. This included commencement of Construction Works on the 28/7/1998 [in Cork]. At the time of this inspection, construction has not commenced.

I ask Mr. Hynes the present status of the 1997 decision.

Mr. Hynes

The first thing that happened was a very big investment in the components and laboratory area in Cork. More than £500,000 was spent on the building itself and an additional £60,000 was spent on equipment. A substantial investment was made to bring the facilities required for blood processing up to the required standards. The Cork unit is now deemed one of the best in Europe in terms of the building and equipment.

Some additional building work is required. We have to decide exactly what is to take place in the building and what is required. The main requirements are a donor collection suite and storage and office accommodation for the facility. The collection of blood is being more and more decentralised and the Cork unit processes blood taken from Limerick. We have a team based in Limerick which deals with only the collection of blood and the blood is sent directly to Cork for processing.

The £500,000 investment took place in conjunction with, not prior to, the decision to build a new centre. Why did the building project stop in July 1998? From where did the directive come? I also put that question to Mr. O'Dwyer in the context of his mentioning the unequivocal support of the Department. Obviously there is a link. Who made the decision to stop the work? It was taken in conjunction with the investment of £500,000.

Mr. Hynes

It is fair to say the upgrading work carried out was well in excess of what was originally envisaged. Originally a short-term or stop-gap solution until a newer premises was built was envisaged. However, the investment made was in excess of that. It is difficult to reinvest immediately in a unit now deemed to be one of the best in Europe. We have to decide what exactly is to take place in the building in Cork and we will come back to the board of the BTSB in July with a recommendation and proposal. After that we will work out exactly what is required in terms of building.

What is Mr. Hynes's personal view on the total centralisation of testing services? If he is in favour of it, should it be located in Dublin or Cork?

Mr. Hynes

At this stage I do not have a fixed view on one or two testing centres although I point out the board has already made a decision that PCR testing - a new test mentioned earlier by Dr. Lawlor - will be carried out at only one centre. As we are not in a position to initiate it at this time, as an interim measure we have entered into a contract with the Scottish National Blood Transfusion Service so samples must be sent to Scotland. We will commence this in the coming month. In the longer term this test will be centralised in Dublin. We must now consider whether, in light of us testing one sample in Dublin, we should bring all samples to Dublin. That decision must take into account whether it is the best interests of the total organisation.

This is a national organisation. There was a time when the Cork service was independent of the national service. It was assimilated in 1976. The Limerick service remained independent until 1991 and only became part of the BTSB in 1991. We are now dealing with one national service. We have new standards to meet and different criteria. As speakers have said, the Irish Medicines Board has also referred to that. We are now talking about a facility which produces up to pharmaceutical industry standard which is higher and different to that traditionally adhered to by blood transfusion centres.

The question arises of whether we need or ought to replicate these services. It is not only the physical buildings for testing. There must also be validation engineers, validation managers, quality assurance and many other support services. The question of whether these should be replicated arises. We are looking at best practice worldwide and in Europe particularly and we will present a report to the board of the BTSB in July. After that a final decision will be made on the functional content of the building in Cork and what exactly is required there.

Is Mr. Hynes aware the national medical director in October 1997 expressed his view that "in his medical opinion this country needs two fully operational transfusion centres including full testing facilities"? Also is he aware of any changes in that kind of thinking?

Mr. Hynes

In even the past two years there have been significant changes in testing and requirements of regulatory authorities, not only in Ireland, but particularly from the European dimension. There have been changes in thinking, not only in Ireland but elsewhere. We must consider what is in the best interests of the whole service throughout the country. We supply 67 hospitals throughout the country 365 days a year and we must have products available to meet that. We have staff on duty throughout the year to meet the needs of hospitals. At any stage we can receive a request from hospitals. However, the type of testing, specification of buildings and equipment and the staffing required to operate them are substantially different to what we had five or ten years ago.

We have produced a medical manpower plan to recruit a consultant virologist. The consultant virologist will be intimately involved with the testing of samples, dealing with abnormal samples and linking them. Our proposal is that the post will be jointly shared with the virus reference laboratory which will improve both our operations to the benefit of both donors and recipients of blood.

With regard to PCR, is it not correct to say that the testing service will be provided on a rental basis?

Mr. O’Dwyer

That would not be the situation, Mr. Chairman.

May I ask Mr. O'Dwyer how many of the 69 hospitals would be trauma 1 hospitals?

Mr. O’Dwyer

I would not be able to answer that. The people in the BTSB would have a better idea of the relative demands from the different levels of hospitals.

Perhaps Mr. Hynes is aware of that, but I thought it would be the other way around.

Mr. Hynes

Trauma 1 is not a term that is used widely in this country, obviously many hospitals throughout the country have accident and emergency departments. It is only a guess, but if we exclude the maternity hospitals, which are separate and major customers of ours, at least 80 per cent of hospitals would have accident and emergency departments and would for the locality they serve be the major centres for accident and emergency services.

How many are major accident and emergency hospitals? In the national plan a certain number of hospitals have been designated major centres for accident and emergency services. As far as I know there are only three or four hospitals designated as major accident and emergency centres.

Mr. Hynes

Perhaps we are talking about different things but clearly there are hospitals which for their local community are the accident and emergency service. There are tertiary referral centres but different hospitals have responsibility for different aspects, for example, people with head injuries will go either to Cork or Beaumont and skin grafts will go to St. James's Hospital. In the first instance most trauma cases will go to the nearest accident and emergency department and generally they are stabilised and then transferred to a specialist hospital if that is needed. I imagine that seven or eight hospitals would take referrals from other hospitals. Obviously the regional hospitals function in that way, in the west University College Hospital, Galway, will be the referral centre for the hospitals in Castlebar, Ballinasloe and Roscommon.

In Mr. Hynes's absence I questioned the reason for centralising testing facilities and Mr. O'Dwyer explained that all European countries are rationalising transfusion services and I got the impression that they were centralising testing. May I ask Mr. Hynes if that is accurate?

Mr. Hynes

As the chairman said earlier, I joined this business in the middle of last year and all the countries I am familiar with in Europe and further away are reviewing everything to do with transfusion services not just testing. In the BTSB, our approach is to decentralise a number of our functions, for example, the collection service which we operate out of Dublin, the board have already made a decision to establish a collection team in the south-east. It is not that we are centralising everything. There are already centralised services, for example, our finance and personnel departments are centralised.

Testing is the kernel of the service. There are five such centres in Holland, ten in France, Edinburgh and Glasgow, neighbouring cities in Scotland both have testing centres and in the UK there are nine testing centres, three with PCR testing. Does Mr. Hynes accept those figures?

Mr. Hynes

I accept this is the current position in those countries, but all countries are looking at what they should have currently. I have not expressed a view whether Ireland should have one or two as that ultimately is a matter for the board. My responsibility is to present a report to the board with the national medical director and that is what I will do. It would be wrong to say the decision is already made. We have asked for and have sought medical and scientific evidence in support of best practice and we have not got a lot by way of response from the medical community in terms of medical and scientific advice on the issue which we would welcome and we are open to hearing from hospitals and clinicians on best practice and what we should do.

I accept that point. I believe the people in Munster may have been slow up to now but having received mail in the past week they will be making up for that shortfall and they are holding meetings to brief people on the dangers.

There has been a difficulty in meeting the demand for blood. I understand that, to meet the demand in Dublin, they had to go to Amsterdam for blood last year. Was there any problem with supply in Munster?

Mr. Hynes

We look at blood supply stocks as a national issue. We do not differentiate between Cork, Dublin and the rest of the country. Obviously from time to time there are shortages, for example, last week there was a shortage of blood type O in Cork and blood type A in Dublin so we sent blood type O from Dublin to Cork and blood type A from Cork to Dublin. There is a national management system for the blood stock levels and, as I said, our purpose is to supply all hospitals in the country. There is no point in having blood available in one part and not in another. If we have a national service, it must be available equally throughout the country. There are four blood groups which are further divided into Rhesus positive and Rhesus negative, in effect eight different types of blood, and it can be difficult from time to time to get the balance right. A number of hospitals act as stock holding units so if there is problem they can supply to the smaller hospitals in their area.

I will pass on Mr. Hynes's point about wishing to have the benefit of the wisdom of medical personnel. I know 22 of them have signed a public letter to him in the past week. The Mercy Hospital, Cork, has written to Mr. Hynes formally as well as to Mr. O'Dwyer and the Minister. The other hospitals will follow. It is only in the past two months that they have suddenly realised that the testing facility in Cork could be in danger. They presumed that political pressure would maintain the centre in Cork with full testing facilities and they may have been politically naive to believe the letter of 20 November 1997 meant their facility was safe. It was a grave warning and I do not think we should suggest that because they have not been to the forefront that they are not aware of it. They accept that the BTSB is an autonomous body but they presumed the Minister would speak with authority on it. They also thought that having the word of the national medical director would have meant something and that his wisdom would be taken into account.

Considering the record of the service in Dublin and the danger of putting all the eggs in one basket, it is logical to have a backup and I suggest that should be in Cork and not Edinburgh or Belfast. I suggest that internal disharmony, the Cork-Dublin split, may be the underlying motive. I suggest that being conscious of the history of the clashes, the makeup of the board and the influences that can be brought to bear. It is that sort of decision, not a medical decision. We will spend £400 million to rectify previous systems. We are going down a slippery slope with this. Do not lecture me about the safety of one centre. I will support the BTSB if it wants money for a second centre but it is my opinion that the decision has been presented as a fait accompli.

Why has the recommendation made by Mr. Justice Finlay for a law which obliges doctors to report adverse reactions to blood products not been implemented? Would the agency oppose that?

Mr. Hynes

We would not oppose it but experience in other countries has shown that a voluntary system works well. The concept of haemo-vigilance is new. Many countries, as Dr. Lawlor outlined, are establishing haemo-vigilance units. We are approaching this from the point of view of training and education to encourage people to identify and report. A voluntary system is likely to be effective. It is a matter for the Minister and the Department to legislate for this but we believe that the voluntary system can and will work well. In other countries experience suggests it is an effective system. We are satisfied with the level of co-operation we are getting from hospitals and are confident that will be the case.

People in Ireland are also contributing to the SHOT system - serious hazards of transfusion. They are doing this because they want to adhere to best practice and identify risks. We will keep it under review, as will the Department.

Are there any countries in which the mandatory approach is taken?

There is an obligation in America to report fatalities due to blood transfusions to the FDA within 24 hours. That is the only mandatory aspect of the haemo-vigilance system in the US. There is a mandatory system in Sweden but it gets very few reports. In France it is mandatory to report everything. That can cause difficulties. When there is a transfusion reaction in a patient, it can be difficult to work out if this is due to the underlying disease, the transfusion or the drugs. That means that many things which cannot be interpreted are reported.

The major factor in transfusion mortality is receiving the wrong blood, which would occur in 1 in 33,000 transfusions. Usually, because the groups may be the same or the patient does not react, nothing happens and it is not picked up. There is probably a fatality in 1 in 600,000 transfusions. We cannot wait for that. Our function is to educate, ensuring that blood transfusion is safe. That is the important part. We have two transfusion surveillance officers who are extremely experienced appointed to the board. The Department of Health and Children has made money available for transfusion surveillance officers, largely nurses, in the hospitals. We have already run a two day training course inconjunction with St. James's Hospital andTrinity College and we will run another in the autumn.

This is the way to go. If people are afraid to report reactions, because many are made by human error, and they are hidden, the situation is much worse.

Was the legal requirement as operated in Sweden studied?

No, but my understanding is that there is one report every five years. Obviously things happen more frequently than that.

The Committee will be heartened by the apparent progress made in the Blood Transfusion Service Board but we cannot forget that we are still feeling the after effects of the worst public scandal I can remember in my time in politics. This Committee deals with the costs of things but much greater than the cost has been the awful pain and suffering which resulted from official negligence. That must be the primary concern.

The group, Positive Action, which represents the women involved, is present in the gallery today. It deserves great credit for its constructive and energetic approach. Had it been listened to earlier, some of the humiliation and delays could have been avoided. We can only hope that those who suffered will find some comfort from this.

We will note the report on the Blood Transfusion Service Board and wish Mr. Hynes every success. We hope that there is eternal vigilance for high standards on that board.

The witnesses withdrew.

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