Committee Reports > List of Committees > Joint > 2000 > Committee on Health and Children > Report - Report on the B.T.S.B., Single Site Testing of Blood Products

HOUSES OF THE OIREACHTAS

Joint Committee on Health and Children

Report on the B.T.S.B.

Single Site Testing of Blood Products

April 2000

CONTENTS

Introduction by the Chairman, Batt O’Keeffe T.D.

The Joint Committee on Health and Children was established in November 1997. Safety of blood products was included by the Committee as an item for consideration in its work programme for 2000.

During 1999, the Blood Transfusion Service Board made a decision to proceed to a single site testing centre in Dublin and terminate the testing of blood products in the Munster area. This decision has caused considerable concern among the medical profession in the Southern Health Board region. In the light of these concerns and the threat to the confidence of blood donors and patients alike, the Joint Committee decided that it would meet with the BTSB and the Blood Products Liaison Group of the General Hospitals Committee of the Southern Health Board.

Representatives of the Munster medical profession and the Southern Health Board addressed the Joint Committee when it met in public session on 17 February 2000. This was followed by a meeting with the BTSB on 14 March 2000.

The Joint Committee would like to thank both groups for their assistance in the Committees consideration of this matter. In particular, the Committee would like to thank the following individuals:

Chairman of the Southern Health Board, Councillor Michael Cahill

Members of the Blood Products Liaison Group, SHB

Dr. Catherine Molloy (Chairman)

Councillor Jackie Healy Rae T.D.

Councillor Vivian O’Callaghan

Councillor Paul O’Donoghue

Mr George Mullen, Consultant Orthopaedic Surgeon, CUH

Consultant Medical Staff, SHB

Dr. Stephen Cusack, Consultant Specialist in Accident and Emergency, CUH

Professor Fergus Shanahan, Professor of Medicine, CUH/UCC

Professor George Shorten, Professor of Anaesthesia, CUH

Professor Gerry O’Sullivan, Associate Professor of Surgery, Mercy Hospital

Chairman of ICGP (Cork City Branch), Dr. Edward O Sullivan

Chairman of the BTSB, Dr. Pat Barker

Mr. Martin Hynes, Chief Executive

Dr. William Murphy, National Medical Director

The draft report was considered by the Joint Committee at its meeting on 20 April 2000 The report, as amended, was agreed.

_________________________

Batt O’Keeffe T.D.

Chairman

20 April 2000

Chapter 1

Background

This report results from consideration by the Committee of the controversial proposal of the Irish Blood Transfusion Service Board to centralise all donor testing at the organisation’s new St. James’ Centre. Currently, approximately two-thirds of the country’s blood supply is collected by the Dublin centre through its Pelican House based facilities and tested at the same location. The remaining one-third of blood donations are obtained through the Cork centre and tested at their St. Finbarr’s Hospital based laboratory. The vast majority of the throughput of both centres is distributed to acute hospitals within their respective geographical catchment areas. However, a limited level of inter-centre transfer also takes place to cover periodic shortages or excess demand at either centre.

It is perhaps important to stress that the BTSB services are currently in the immediate aftermath of the discovery in 1994 of a major iatrogenic catastrophe at the Dublin centre which has resulted in the exposure of many thousand blood, and blood product recipients to the hepatitis C virus since 1977. While the majority of such cases involved female recipients of contaminated anti D vaccination, a substantial number of haemophiliacs and general blood product recipients were also affected. The consequences of this disaster in terms of mortality, and physical and psychological morbidity has been enormous. Estimates of the eventual fiscal cost to the State exceed £400 million.

While the optimally efficient operation of the services of the BTSB is absolutely essential at all times, the vital importance of the organisation regaining and retaining a position of widespread trust and respect is of particular importance in the aftermath of the 1994 discovery. This task is extremely onerous, and the Board has been given, and continues to receive, substantial funding from the State in order to reach an operational performance of the highest possible technical standard. It goes without saying that the BTSB must optimise its resources to the maximum possible degree, and that any hint of self-inflicted damage or trauma must be assiduously avoided.

Unfortunately, the proposal to remove donor testing from the Cork centre, and to centralise all such activities at the new Dublin headquarters of the BTSB has provoked a major controversy, particularly in the Munster area. It is absolutely imperative that the matter be resolved in a fair and rapid manner at the earliest possible time. This must be done in the interests of optimal patient care, and in accordance with best international practices.

So that the Committee might contribute most effectively to the resolution of this grave matter expeditiously, two extended meetings have taken place with the relevant parties. Initially, in February 2000, a representative body of the medical profession in Munster made a detailed presentation of their assessment of the proposal, and related issues. Subsequently, in March, the Chairperson, Chief Medical Officer and Chief Executive Officer of the BTSB appeared before the Committee to comment on the matter.

Chapter 2

Presentation by the Blood Transfusion Service Board Summary

The Committee met with a delegation from the Blood Transfusion Service Board on 14 March 2000. The BTSB were represented by the Chairperson, Dr. Pat Barker, the Chief Executive, Mr. Martin Hynes, and Dr. William Murphy, the National Medical Director.

At present, all blood donations are tested for potential infectious contaminants in the BTSB centres in Dublin and Cork using a serologic testing method. The Board of the BTSB have decided to centralise all testing in Dublin, using a more modern form of testing known as polymerase chain reaction, or PCR.

In their presentation to the Committee, the BTSB made the following points:

•The remit of the BTSB is to provide blood and blood products which are safe, accessible at reasonable cost and adequate to met the national needs. The strategy of the Board is to develop the BTSB into a world class organisation from one that was not efficient in meeting this remit.

•The BTSB is therefore moving through a process of restructuring and rebuilding to address problems within the organisation. These problems include undue compartmentalisation of management, fragmentation of responsibility, significant communication problems and weakness in responding to the need for change.

•The decision to centralise the testing of blood products must be viewed in the context of this process of change. The BTSB are examining the centralisation of not only the testing process, but also its entire range of activities, from personnel to information technology, purchasing and finance and management of donor services.

•The recommendation to move to a single site testing was one of a number of recommendations made in the Bain Report (1995), which was endorsed by the Minister for Health. In March 1999, the Board of the BTSB requested that the Chief Executive and the National Medical Advisor prepare a report on the implication of developing a single site for donation testing. This report, presented to the Board in July 1999 strongly recommended the move to single site testing. This recommendation was based on many factors, including:

▸International best practice

▸current and anticipated developments in transfusion medicine

▸the need for a high quality standardised approach

▸the capacity of the new laboratory facilities in Dublin

▸the escalation of testing and processing costs

▸the difficulty of replicating readily and economically at two centres the required expertise in virology, validation and quality assurance

▸the management of overall transfusion policy and services would be streamlined

▸the substantial cost of maintaining two centres into the future, at the expense of further developing other health care programmes

•Following the report of the Chief Executive and the National Medical Adviser, the Board of the BTSB was unanimous in its decision to centralise testing. At the time of the decision, the Board included some of the leading experts in blood transfusion medicine. The decision was not made from a management perspective alone but with a view to delivering the best quality blood for a national service.

•Blood transfusion is an essential part of modern health care. To meet the demands of modern health care, the BTSB must be flexible, open to change at all times and must learn from experience. Scarce resources cannot be needlessly duplicated. To ensure that patients will have the safest blood and blood products possible, the BTSB must not dilute its services or operate by the standards of the past.

The BTSB also provided the Committee with two documents:

(i)Medical and Technological Factors That Will Impact the Way the Blood Transfusion Service Board Performs its Functions in the Short to Medium Term.

(ii)Report on Developing A Single Site For Donation Testing.

Chapter 3

Presentation by the Blood Products Liaison Group Summary

The Joint Committee met with the Blood Products Liaison Group of the General Hospitals Committee of the Southern Health Board on 17 February 2000. This group is made up of members of the SHB and members of the medical profession in the Munster region. The delegation was led by the Chairperson of the Blood Products Liaison Group, Dr. Catherine Molloy and included Dr. Stephen Cusack, consultant in accident and emergency at Cork University Hospital; Professor Fergus Shanahan, professor of medicine at University College Cork and Cork University Hospital; Councillor Vivian O’Callaghan, member of the Southern Health Board and Cork County Council; Deputy Jackie Healy-Rae, member of the Southern Health Board, the Blood Products Liaison Group and Vice-Chairman of the General Hospitals Committee of the Southern Health Board; Councillor Paul O’Donoghue, member of Kerry County Council and the Blood Products liaison group; George Mullen, consultant orthopaedic surgeon in Cork University Hospital and a member of the Southern Health Board; Professor George Shorten, professor of anaesthesiology in Cork University Hospital and University College Cork; Professor Gerry O’Sullivan, professor of surgery in Mercy Hospital and University College Cork; Councillor Michael Cahill, Chairman of the Southern Health Board; Dr. Edward O’Sullivan, a general practitioner representing the ICGP and chairman of the Cork city branch, which represents approximately 120 GPs from Kerry, Cork and Limerick.

In their presentation to the Committee, the delegation presented the following views:

•The decision of the BTSB to terminate the testing of blood products has caused serious concern among the medical profession in the Southern Health Board area. The decision to centralise testing was taken without any prior consultation with the Munster medical profession. Despite these concerns and a detailed specialist report prepared by a representative group to justify the retention of testing, the BTSB failed to respond adequately. The concerns have grown as a consequence of this inadequate response. The groups experience of and interaction with the BTSB Board over recent months has been extremely unsatisfactory, and confidence in the Boards ability to carry out its duties has been severely damaged.

•In bringing their concerns before the Committee, the groups objectives were as follows:

•to ensure that patient care is maintained at the highest possible level in health care facilities throughout the country.

•to ensure that the application of the States resources throughout its various agencies is carried out in a manner that is of the highest standard in terms of efficiency, professionalism and justice.

•to ensure that there is no abuse of inter-regional differences and provincialism in the planning and implementation of health care policy.

The care and concerns of the patient are of paramount importance.

•The safe provision of a range of blood products and related services is an absolutely core element of present day acute and elective medical care. The service provided by the Cork centre of the BTSB has been exemplary, and the professionalism and commitment of the staff at the centre are major assets in the overall health care programme.

•Following the Hepatitis C scandal, the status of the BTSB was substantially diminished, and there has been a negative impact on the confidence of everyone involved in the health care system. In the aftermath of these difficulties, the BTSB has been going through a process of restructuring and rebuilding to address problems within the organisation. However, despite the outstanding track record of the Cork centre and its extremely high status among its large client base in the Munster area, there have been a number of alarming decisions and developments which have the potential to undermine one of the organisations most positive resources.

•there has been a failure to address major buildings problems at the Cork centre, despite the commitment of funds by the Minister, and the recommendations of the Finlay Report and the Irish Medicines Board.

•the decision to remove the testing facilities from the Cork centre and centralise testing in Dublin. This decision was made following an inadequate report from 2 Dublin based employees of the board, without either representation from the Cork centre or from independent experts.

•there has been a sustained process of marginalisation of the Cork centre, and negative engagement of the Blood Products Liaison Group.

•The Group has serious concerns about the report, prepared by Dr. Murphy and Mr. Hynes, which led to the decision of the BTSB Board to centralise the testing of blood products. These are

•the membership of the investigating team was inappropriate to the task

•the full range of options was not considered

•the consultative process was inadequate

•The Group brought their concerns about the move to a single testing centre to the attention of the BTSB Board. The Board accepted that substantial work and clarification was required in terms of

i.transportation issues

ii.crisis demand

iii.communication deficit in dealing with key users

iv.negative research connotations

v.negative training consequences

vi.serious morale damage to Cork staff

vii.risk augmentation due to the addition of an extra step to the process

viii.loss of backup with the closure of one testing facility

In the current difficult climate for the blood transfusion service in Ireland, the Group believe very strongly that issues of such magnitude should be decisively assessed before proceeding to any conclusion in terms of single site testing.

•The Blood Products Liaison Group believe that the BTSB must fully account for and explain

i.the decision not to proceed with the new building at the Cork centre in 1997-8, despite the availability of funding and the recommendations of Mr. Justice Finlay and the Irish Medicines Board.

ii.to explain each aspect of its decision to terminate testing at the Cork centre, including the selection of the study team, the consultation process, the grossly inadequate report and the use of the issue of PCR testing to justify single site testing.

iii.to fully account and explain the acceptance of the Murphy & Hynes report despite subsequently admitting a number of crucial concerns.

iv.to fully account for and explain the removal of a vital backup facility in the eventuality of a further substantial failure in the Dublin centre.

v.to fully account and explain supporting, or minimally tolerating, a climate which has progressively sapped the morale and confidence in the Cork unit.

vi.to explain its refusal to enter into meaningful engagement with the medical profession in Munster and jeopardising the potential for partnership at a critical time in the history of the Irish health services.

The Group also provided the Committee with a document entitled "The Proposal To Discontinue Blood Testing At The Munster Centre Of The Irish Blood Transfusion Service Board".

Chapter 4

Assessment of the Presentations

The Blood Products Liaison Group

The Blood Products Liaison Group from Munster consisted of a widely representative core of professional expertise from the Southern Health Board area. It included Professors of Medicine, Surgery and Anaesthesia; the Vice-Chairperson of the Health Board, and senior representatives of medical specialities, general practice, and the health authority. Their strongly held and energetically presented views on the matter might be summarised under two main headings, namely:-

(a)A strong rejection of the proposal to terminate blood testing at the Cork centre, and to centralise all such activities at the as yet unopened new Dublin centre at St. James’ Hospital. The group queried the origin of the proposal to centralise testing; the manner in which the issue was addressed by the Board in terms of selection of the Study Team; the quality of the consultative process undertaken by the review team; the value of the ensuing report; and the manner in which the Board accepted this report despite acknowledging a number of critical "work areas" which remained unresolved by the report. These included

(i)dealing with the implications of increased transportation times,

(ii)addressing crisis/emergency demands from one centre,

(iii)conveying to key so-called "stakeholders" the merits, if any, of moving towards a centralised mode of testing,

(iv)reducing the skills level at the Cork centre in terms of both blood processing and associated research,

(v)negative education and training consequences in terms of student placement,

(vi)negative impact on staff morale of downgrading of the Cork centre to essentially "depot" status,

(vii)increased risk of error, and

(viii)the lost of a backup service.

The Group were extremely dismissive of the suggestion that the introduction of PCR testing was in any way a compelling reason, or even a significant factor, which should influence a decision on the overall blood testing arrangements of the BTSB. They pointed out that PCR testing is already routinely carried out in this country.

(b)Equally, the Group expressed extreme concern regarding what was perceived as a sustained process of marginalisation and diminution of the Cork centre, particularly in the aftermath of the 1994 research findings from that Centre which have proven so traumatic for the Irish health care system. Key issues raised in this regard included

(i)the non-progression of a new building for the Cork centre despite the promised financial support of the Minister, assurances in this regard given to the Irish Medicines Board, and the specific recommendation of Justice Finlay

(ii)a long and unexplained delay in the provision of a second consultant haematologist position at the Cork centre, and

(iii)what was perceived by the Group as a disastrous state of relations between the BTSB executive and senior staff at the Cork centre. A number of specific examples were provided to illustrate both the nature and diversity of this schism. The unexplained exclusion of senior personnel at the Cork centre from a number of key national activities was stressed.

Blood Transfusion Service Board

The presentation of the BTSB representatives was quite different in both content and emphasis from that of the Blood Products Liaison Group. Acknowledging the disastrous lapse at the Dublin centre, they confirmed that the aftermath of the tragedy had indeed been extremely difficult for their organisation. It had caused much hurt and remained as a major influencing factor impacting on the Board’s planning and operational strategies. While the Chairperson expressed appreciation for the excellent and ongoing work of staff at the Cork centre, she stressed the overall unity of the BTSB’s vision of its facilities.

This theme of a single organisation with a dominant centralised headquarters and testing facility at the St. James’ Hospital/Trinity College complex emerged throughout the BTSB’s presentation. While the Chief Medical Officer accepted that he had changed his mind in relation to the Single Site Testing issue, he identified improvements in the organisation’s information technology facilities as a crucial factor in this regard. He stressed the central importance of ongoing changes in both processing technologies and demand patterns to the decision-making process of the BTSB. He anticipated a reduction in demand for clinical and non-clinical reasons. As new and more sophisticated testing processes became available, it would be more efficient and timely to introduce such technologies into one rather than two laboratories, e.g. testing for new variant CJD. While cost per se was not seen as a determining factor in relation to the wisdom of introducing Single Site Testing, the practice of having two teams rather than one team of specialist staff was considered inadvisable.

The BTSB’s representatives acknowledged the need for backup facilities in the eventuality of closure of the St. James’ Centre for reasons such as contamination and industrial problems. The provision of duplicate but independent equipment and laboratory facilities within the new Dublin complex was seen as at least a partial solution in this regard.

From the Board’s contribution, there seemed little apprehension in terms of the impact of the proposed changes on the well-being and effectiveness of the Cork centre. The tacit understanding seemed to be that new services would more than adequately compensate for any downgrading resulting from Single Site Testing. Similarly, the loss of the complementary and backup testing facilities at Cork was not seen as a cause for significant concern.

Chapter 5

Conclusions of the Committee

There were perhaps two quite positive observations possible from a consideration of this matter. First of all, there seems little doubt but that the Cork centre of the BTSB is a major resource for the organisation in the aftermath of the trauma of 1994, and that its value is fully recognised by key users in the region. Secondly, despite delays, the major new Dublin centre of the BTSB seems likely to become operational in the near future. It seems certain to prove an enormous asset to the National Blood Transfusion Service.

The decision, however, to close the testing facilities in Cork and to rely on Single Site Testing for the country has clearly directly and indirectly exposed major tensions within the BTSB organisation. Such tensions are totally contrary to the best interests of the health care system which has a critical dependence on the national blood transfusion service. Consequently, they must be fairly and effectively addressed as a matter of the utmost importance.

From a detailed assessment of the presentations of the two groups, and supporting material supplied, the current conflict seems to have resulted from two key factors namely:

(i)the many negative effects of the 1994 discovery of the hepatitis C tragedy and

(ii)the decision of the Board of the BTSB to move from an operational structure with two centres of equivalent status to a more centralised model.

The over-riding concern at this critical time in the history of the BTSB must, of course, be to take all possible steps to ensure structural provisions and operational standards of the highest possible level in all operations of the organisation. This can only be achieved through a judicious combination of maximising existing resources and introducing all feasible enhancing technologies. Taking these core requirements into account, and the critical need of re-building trust among recipients, and the country’s health care providers, the import of the two presentations to the Committee might be as follows:-

A. The security, backup and synergy provided through enhancing the present two Site Testing arrangements seems significantly superior to relying on a new and as yet unproved centre for all the country’s blood testing facilities.

B. Possibly as an unfortunate consequence of the 1994 hepatitis C catastrophe, a major and ongoing level of intolerable contention has developed between the two key centres of the national Blood Transfusion Sevice Board. It is imperative that this critical problem be addressed and resolved - comprehensively and fairly - as a matter of the gravest urgency. Only then can the overall organisation build on its strengths, and fully achieve its potential as a foundation component of the Irish Health Care system.

APPENDICES

Appendix 1

Minutes of Evidence

Minutes of Evidence

Meeting with the Blood Products Liaison Group

17 February 2000

Joint Committee on Health and Children

An Comhchoiste Um Shláinte Agus Leanaí

Déardaoin, 17 Feabhra 2000.

Thursday, 17 February 2000.

The Joint Committee met at 9.30 a.m.

MEMBERS PRESENT:

DEPUTY B. O’KEEFFE IN THE CHAIR

Presentation by Blood Product Liaison Group of the Southern Health Board.

Chairman: We have a presentation by the blood products liaison group of the Southern Health Board, which is a subcommittee of the health board’s general hospitals committee. I welcome my colleagues from Cork, the real capital of Ireland. I see a couple of people from the health board who are from the other real capital in Kerry, Deputy Healy-Rae and Councillor O’Donoghue, who is the brother of the Minister for Justice, Equality and Law Reform. They are very welcome.

We will have two or three short presentations of no longer than 15 minutes, followed by a question and answer session. Members have privilege but unfortunately that cannot be extended to those making presentations. I invite Dr. Molloy to introduce the delegation.

Dr. Catherine Molloy: I am accompanied by Dr. Stephen Cusack, consultant in accident and emergency at Cork University Hospital; Professor Fergus Shanahan, professor of medicine at University College Cork and Cork University Hospital; and Councillor Vivian O’Callaghan, member of the Southern Health Board and Cork County Council. I do not think I need to introduce Deputy Healy Rae, who is a member of the Southern Health Board, the blood product liaison committee and vice-chairman of our general hospitals committee for the Southern Health Board. There is also Councillor Paul O’Donoghue, who is a member of Kerry County Council and our blood product liaison group; George Mullen, consultant orthopaedic surgeon in Cork University Hospital and a member of the Southern Health Board; Professor George Shorten, professor of anaesthesiology in Cork University Hospital and University College Cork; Dr. Edward O’Sullivan, a general practitioner from Cork who is representing the ICGP and is chairman of the Cork city branch, which represents approximately 120 GPs and can speak broadly for Kerry, Cork and Limerick; Professor Gerry O’Sullivan, professor of surgery in Mercy Hospital and University College Cork; and Councillor Michael Cahill, chairman of the Southern Health Board.

I thank you, chairman, and the committee members on behalf of the deputation for hearing our case. Our Lord Mayor, Damien Wallace, sends his apologies. He would very much have liked to attend and had booked a flight but had to cancel this morning.

Our team is very broadly representative of medicine and health care policy in the Munster area. We include members of the health board and all the critical branches of medicine, including general practice, orthopaedics, traumatology and accident and emergency. We would like to put on record that we greatly regret we have had to impose upon the committee’s valuable time. However, this matter is of grave importance to us and the people of Munster. They deserve representation because they co-operate with us - it is a special relationship - by donating and they also receive blood transfusions.

Today we are representing 1.1 million people who will be affected by this BTSB decision to close testing at the Munster site in Cork. In all my experience of over 30 years of general practice, along with two years as chairman of the Southern Health Board - and I am now its vice-chairman - nothing has posed a more serious ethical dilemma than the decision of the BTSB to terminate testing in Cork. For 60 years people in the Munster area have had a blood transfusion service delivered from Cork. They are used to the highest standards of service and excellence, and all their blood products are well up to international standards. When blood supplies run short, people in Munster have always been extremely generous in coming to emergency clinics to present themselves for blood donations. Although they only account for a quarter of the entire population, the people of Munster provide over one third of the country’s blood supplies. It is an important point. Due to their generosity over the years, we have been able to supplement supplies to other parts of the country.

Sadly, the decision to centralise blood testing was taken without any prior consultation with us in Munster. Despite our efforts and a detailed specialist report by us to justify the retention of testing, the BTSB has failed to respond adequately to our queries and our attempts to engage with them constructively.

As a consequence of this inadequate response our concerns have grown. We have the support of the whole medical community in the Munster area, and the support of the public who to date have maintained a respectful silence while they await a decision. We feel that ethically, morally and professionally we are bound to stand by the people we represent, whose wishes and well-being are not being adequately addressed at the moment.

Over the last nine months we have carefully attempted to follow due process and, where possible, have avoided any confrontation with the BTSB. At all times we have tried to avoid causing any loss of public confidence in the BTSB, because we think that is very important. However, because of our fears and anxieties we are here today to ask for your support.

I would now like to ask Professor Fergus Shanahan, Professor Medicine at Cork University Hospital, to make a short presentation. Then Dr. Cusack, our A&E consultant, will make a further brief presentation.

Professor Shanahan: We are grateful to the committee for this opportunity to express our concern about a matter that we feel is of the gravest importance to the national health care service. Your attention to this matter will be vital in order to ensure a comprehensive assessment and rapid resolution to the problem. I will address three major areas of concern we have and which were alluded to by Dr. Molloy. I want to put the matter in context because we realise that members of the committee have varying degrees of background knowledge and we do not expect everything to be grasped in a short space of time.

Our main priority and duty is to ensure that patient care is maintained at the highest possible level in health care facilities throughout the country. We are concerned that the application of the State’s resources through its various agencies are carried out to the highest standards in terms of efficiency, professionalism and justice. There is no room for the mischievous use of provincialism in health care policy. In essence, patients’ welfare is of paramount importance and that is why we are here today. I will outline our specific concerns about the current operation of the blood transfusion service board. I would like to stress from the outset that we are totally committed to playing a positive role in the early resolution of this matter.

The safe provision of a range of blood products is a core element in present day acute and elective medical care. Munster has been fortunate in having an excellent resource in the BTSB’s Cork centre. Some committee members may recall that it was a team of researchers, headed by Dr. Joan Power in the Munster centre, who initially identified the inadvertent, widescale contamination of anti-D vaccination with hepatitis C virus, as a result of a major system failure at the Dublin centre of the BTSB in 1977-78. Even though Dr. Power’s identification of this major catastrophe was in itself an enormous contribution to the health care system, the revelation proved highly traumatic on a number of levels. First and foremost, over 1,000 people had to endure the agony of finding out that they had been exposed to a potentially dangerous virus. Their pain, and that of their families, has been immense. However, as a result of Dr. Power’s findings at the Cork unit, the families and patients have at least been able to address their medical situation with the full support of the State’s health care system, and to begin the recovery process. Their excellent support organisation, Positive Action, has made an enormous contribution in this regard.

The disaster has also been extremely traumatic for the overall healthcare system in other respects. With a financial cost estimated at sums as high as £400 million, the negative impact on the confidence of everyone involved in the healthcare system has been substantial. In particular, the status of the BTSB itself has been substantially diminished and much of its excellent work over the years has been overshadowed. Consequently in the shadow of the worst health care disaster to have affected Ireland in modern times - and, indeed, at any time - it was always going to require an extraordinary level of maturity and insight on the part of the BTSB if the organisation was to regain its status and position of trust within the health care system.

The key to recovery required co-operation of all involved in the use of healthcare products. While a number of agencies did indeed play an outstanding part in the recovery process - the political system, the Finlay investigation, the Hederman-O’Brien report, the country’s hospitals, the media and the affected patients’ excellent representation groups - it was absolutely vital that the board and executive of the BTSB would play a difficult but vital role based on two fundamental necessities. First, it was mandatory that an unequivocal admission of responsibility would be followed by a renewed focus on optimising the organisation’s strengths while minimising its weaknesses. Of equal importance it was absolutely vital to avoid even the vaguest hint of resentment or retribution towards those who initially made this shocking discovery.

It is with great regret that we are now bringing to the committee’s attention a range of developments which indicate a major failing of the BTSB in terms of magnanimously and professionally dealing with the aftermath of the 1994 findings. I will outline three major areas of concern.

Chairman: We have a very comprehensive report. Normally we try to restrict people to about five minutes. Perhaps you could give us a general overview rather than going through the full report. We will have an opportunity to do that ourselves. We find that the question and answer session is much more productive, if you would not mind doing that.

Prof. Shanahan: I will.

Chairman: Thank you.

Prof. Shanahan: The three major areas relate to, firstly, the failure to address the fundamental building needs at the Cork centre. They are outlined on page 3 of my report. I am giving you a brief chronology which is worth considering for a couple of seconds. To remind you, in March 1997, the Finlay tribunal of inquiry said, among other things, that "renewal of the premises in Cork...should also be commenced immediately".

The Irish Medicines Board reaffirmed that and indicated that, on the basis of the conditions of the buildings, such work was mandatory for the renewal of the licence.

In November 1997, the Minister for Health and Children, said "My Department will make available the necessary resources…".

In January 1998 the board’s tender indicated that the cost of rebuilding the Cork premises would be about £5.5 million.

The Irish Medicines Board in its annual report acknowledged this fact and was pleased to hear of it.

That is the relevant chronology. Yet, in July 1999, the Murphy & Hynes report stated that "If testing is to remain in Cork it is our view that a new centre would be required". The cost suddenly escalated to £12 million. There are several worrying features about this. The most important one, it seems to us, is that the Finlay recommendations have essentially been ignored in terms of the rapid response from the Department.

The second area of major concern we have has been this partisan approach to the single site testing issue. We looked at this from two perspectives. How adequate was the process used to examine that issue, and what was the quality of the report delivered by Murphy & Hynes on behalf of the BTSB? Specifically, was the membership of the investigative team that generated that report appropriate to the task? Was the full range of options considered? Did they argue from a premise to a conclusion, or did they decide on a conclusion and then backtrack to a premise, and try to rationalise the whole matter? Does the evidence confirm the essential fundamental requirements that the investigation worked systematically? In relation to the membership of the investigating team and the construction of the report, it would have been prudent if one had designed such a report to have included representation from both centres and with independent expert external advice. That was not done.

As regards the options, did they look at retaining both centres, or centralising in Dublin or Cork only? They only looked at one option. What was the quality of the consultative process? As Dr. Molloy indicated earlier, we are not happy that there has been any constructive consultation process. What was the quality of the report itself? The most damning aspect occurred on 14 July, when the board accepted this report. It issued a post-hoc response to 11 different concerns we had expressed to it at a meeting two days earlier. This is included in the information before members. For example, when we expressed concern about what would happen when there is a crisis demand ranging from a high number of operations requiring large volumes of blood to an emergency, either local or national, the board indicated that this was a genuine concern. In response to another point it said "this is a fair point and it should be a lesson to the Board", while it described a further point as "a valid concern".

The board acknowledged 11 different concerns we had. What does that say about the completeness and adequacy of the report? It went on to specifically acknowledge transportation issues, crisis demand, communication deficit, negative research connotations, negative training consequences, serious morale damage to Cork, risk augmentation and lack of a back-up in the eventuality of another scandal.

I have dealt with buildings delay, inadequate reports, an admission by the board that there are serious concerns, yet its acceptance of this report in the light of this and the failure to include independent external advice. I would now like to deal with the last issue, the marginalisation of the Cork centre. I have given several examples of where individuals in the Cork centre have been progressively marginalised from national initiatives by the BTSB which it has trumpeted but from which the Cork people have been excluded - these are the people who provide the blood for a quarter to a third of recipients of the national service.

I wish to reiterate our focus on patient care. That is our agenda - we have no other. In the aftermath of the hepatitis C tragedy the BTSB is in an extended period of probation. This issue should never have come to the table. The only thing we should be doing is strengthening the Cork unit, the Dublin unit and the synergy between the two. We should be engaging in a partnership with the medical profession, the political people, the people who care about patient welfare and the patients’ representative groups. We should not be engaged in conflict - this is not a time for that.

In this context we find the recent decision making of the BTSB to be highly unwise and totally unacceptable. We ask that the BTSB fully account for six different issues before this committee. First, to justify its decision not to proceed with the new building at the Cork centre in 1997-8, despite the availability of funding and the recommendations of Mr. Justice Finlay and the Irish Medicines Board. Second, to explain each aspect of its decision to terminate testing at the Cork centre, including the selection of a biased study team, a totally flawed consultation process, the grossly inadequate report and the absurd use of a pseudo issue, such as PCR testing to justify single site testing. Third, to fully account and explain the acceptance of the Murphy & Hynes report despite subsequently admitting a number of crucial concerns. Fourth, we ask it to fully account and explain allowing the removal of a vital backup facility - it served the country well in 1994 and alerted it to a problem and the health service is better off because of that - in the eventuality of a further substantial failure in the Dublin centre. Fifth, we ask it to fully account and explain supporting, or minimally tolerating, a climate which has progressively sapped the morale and confidence in the Cork unit. Sixth, to explain its refusal to enter into meaningful engagement with a united medical profession in Munster. It is sub-optimal and is not in the interests of international best practices. The board has gratuitously jeopardised the potential for partnership at a critical time in the history of our health services.

This issue has a potential solution. It requires full and immediate commitment to dealing with the buildings in Cork, putting aside the flawed decision on single site testing and, above all, engaging in a new dynamic and mutually beneficial partnership between the BTSB, the Cork centre and the medical profession.

Dr. Cusack: I am reflecting concerns of my colleagues in Munster. We are very concerned about this and about the fact that there has been very little transparency and very little accountability in terms of what the BTSB has been doing. It did not visit before it made a decision, nor did it carry out any audit. It appears to have had a premise and worked back from that. When a delegation visited us in July we asked for a good reason for this decision. Would it be safer? We did not get a clear answer. Would it be better? Would the standards improve? Cork has obtained an ISO industrial standard of quality while Dublin does not have one. We wanted to know would it be better? No answer to that. Would it be cheaper? No answer. Not a single costing, nor a smidgen of evidence that there would be an improvement in terms of the finances of the BTSB.

We have no confidence in the BTSB. It has managed to do what others have spent years trying to do but failing, that is, it has united the medical profession in Munster. We are united in a lack of confidence in the BTSB. We cannot have confidence in a group that engages in megaphone diplomacy and non-consultation. We have a complete lack of confidence in a group that has shown itself to be openly aggressive towards us and that has referred to us as liars in the media.

Chairman: Strong words. Thank you for the presentation. Dr. Cusack, you made a very strong statement to the effect that you have no confidence in the BTSB. Will you expand on that? Is it relative to the Cork centre or is it in general terms?

Dr. Cusack: Given the evidence presented to us in terms of its decision making process and given the record of BTSB members over the last few years, we cannot have confidence in it for the reasons I outlined earlier. At this stage we cannot have any confidence in the processes of decision making and the methods by which the BTSB has come to take the steps it is proposing.

The BTSB did not consult us. It approached us last July with a post-hoc decision made. As Professor Shanahan has pointed out, it then addressed our concerns on a point by point basis. Eleven times it said we were right to have these concerns. Having said so last July we are now approaching the end of February, yet not a single action has been taken by the BTSB to put in place a method whereby it would address even one of the 11 issues we raised. It is natural, therefore, that we have no confidence in it.

Professor Shanahan: From the point of view of patient care we have absolute confidence in the quality of the blood that is being provided to patients. The health service is safer today than ever before, as is the blood transfusion service. Some of the degree of that improvement has come from the identification by a hardworking Cork group of a hepatitis C scandal, which was created in the Dublin centre.

It is the decision making process to change what is working well that is at issue. As politicians you have heard consultants and doctors complain and whinge about lack of resources, supplies and services. This is unique in that a united medical profession is saying that the service in Cork is excellent.

It is not just a provincial issue about the quality of blood to people in Munster and Cork. What Cork achieved was the identification of a national problem. We have confidence in the service as it now stands. That is why we are wondering and questioning this flawed decision making process.

Chairman: What difference would it make to have the centre centralised in Dublin as opposed to having two centres? You say you want the highest level of health care facilities and the highest standards in terms of efficiency, professionalism and justice. What detrimental effects would follow from a decision to centralise in Dublin?

Professor Shanahan: When something is working very well those who want to change it should explain why. Had there been a central testing service in Dublin 1994 would we ever have known about the hepatitis C spill into the blood supply? Was there not sufficient complacence and arrogance in one centre that we needed a second centre to alert the nation that there was a problem? The outcome has been an enhanced blood service and a sensitisation to it. There is never grounds for complacence and arrogance in one centre.

Chairman: Deputy Clune requested this meeting. Deputy Clune, do you wish to pose a question?

Deputy Clune: I welcome Dr. Molloy and her colleagues who made a strong presentation. The proposed removal of the PCR testing to Dublin is at the centre of this controversy. How will that impact on a patient requiring blood products? Is the BTSB seeking the creation of one centre of excellence? If that centre was in Cork and not in Dublin, how would the delegation react? What happens in other European countries? I understand that other European countries have one testing centre for a similar population.

What are the implications of this? The 1997 commitment to provide funding to Cork has not materialised. Will more funding be needed to maintain the PCR testing service in Cork? How will that impact on the situation?

Professor Shanahan: Chairman, I will respond to some of those questions, but my colleague, Professor O’Sullivan, will answer some of those specific issues.

Professor O’Sullivan: The PCR is a technique which does not demand much in the way of high technology or expertise. It is performed in the second science course of every university or third level education facility and the principle of it will be taught for leaving certificate in the future. Therefore, it is not a difficult process.

We want to release blood products with a short shelf life such as platelets the day after which they have been taken or else they will go to waste. If one does not use a PCR or a rapid testing facility, these products must be released without being tested. Currently PCR testing is done in Scotland and that incurs a delay of four days. If one introduces a PCR facility within the laboratory, it means that one can test overnight and release the products the following morning when they are fresh and use them with guaranteed quality control. One cannot do that at present. If the PCR facility for Cork is based in Dublin, which involves the transportation of material overnight, it is unlikely that one will be able to use products which have a short shelf life with the same degree of efficiency and quality control.

On the economics, we do not require and no request has been made for additional facilities or staff in Cork to implement this. They can undertake bulk testing in lots of 300 to 400, identify with the very sensitive PCR test whether within that whole bulk there is a problem, and then isolate it and individualise. It is anticipated that they would only have to do individualised testing less that ten times per annum in Cork. It is a non-issue in the context of centralisation. It is a foolish issue which should never have been used.

Deputy Gormley: I thank the delegation for coming and making such a good presentation. I am not from Cork; I am a Dubliner.

Chairman: The Deputy is wearing the Cork colours this morning.

Deputy Gormley: I am fond of Cork. The letter to The Irish Times of 12 May asks could internal Dublin-Cork disharmony within the BTSB be the underlying motive. Does that refer to traditional rivalries between the capital and the real capital or is that letter more specific, identifying the reason as resentment in Dublin towards the good work done in Cork on the hepatitis C scandal? What is this underlying motive to which the letter refers?

Chairman: Matters which are internal to the operations of the BTSB are not a subject for discussion here.

Deputy Gormley: This is contained in the papers just received by members.

Chairman: The committee’s remit does not extend to examining the internal operations and workings of the BTSB. There is an issue before us. We certainly are not getting into any human relations issues within the BTSB.

Deputy Gormley: I am trying to find out what is this underlying motive. Let me be specific. I am not trying to be destructive. I am genuinely trying to find out what this is about. It is only when we discover the underlying motive, as referred to in this letter, that we can tackle the problem at source.

Professor Shanahan: I am not a Cork man either. I am actually a Dubliner. I am reminded of that every day in my work. The letter was an attempt - I will not deal with internal matters in any of the units - to cry halt and stop the nonsense. The letter was an attempt to show that the PCR is a non-issue; it is not central to this. The letter was an attempt to get them to start engaging in constructive dialogue. It was the first time I had written a letter to a newspaper. I do not engage in that type of thing, but this was the only thing to try and get attention and focus minds. There is no aspect of that letter which has ever been rebutted by the BTSB.

We should forget about motives, etc. As I said, patient care is the only thing that counts. It is about stopping the nonsense. Let us develop both centres and let us get them working well together. If Cork performed well in 1994, let us keep it so. Let us strengthen both of them and stop the provincialism. Let them work well together.

Deputy Gormley: Centralisation of any sort is not the way forward anyway. If a decentralised system is working, then let us keep it that way.

Deputy M. Ahern: I do not think I can add anything which will improve the presentation, and also the letters which have been written and all the information which has been put before the public on this issue over the past number of months. I am glad to see Professor O’Sullivan, my colleague on the board of the Mercy Hospital, and others from the Southern Health Board.

Chairman: Say hello to your constituents, Deputy.

Deputy M. Ahern: That shows the concern in the Cork, Kerry and Limerick region about this centralisation. My view and that of most of my colleagues is that the BTSB should listen to the views which are expressed by the profession in Cork and Kerry.

Deputy Dennehy: I had better declare my own interest. As a former chairman of the health board, I have a particular interest. I am glad that along with my four political colleagues there is such a wide range of medical opinion in favour of this.

Chairman, you ruled that personnel within the BTSB are not up for discussion today and I accept that ruling but, without naming individuals, does the delegation agree that the kernel of the problem is changes which took place in the recent past within that board? I have heard that there was an advertisement in February 1999 for a £5.5 million building for laboratories, test centres and a new donor clinic for the Blood Transfusion Service Board. That was placed in the local media at about the time a new CEO was appointed. The most relevant aspect of this discussion is that the BTSB was total consistent from the time the mistakes were found in Dublin, that it needed a new centre in Cork and it would build it. The Government supported that. It advertised for a £5.5 million building. A change of personnel took place.

In the same context I have the newspaper article, to which you referred, Chairman, where a group of medical personnel were described as liars. In 25 years of political life, this is unprecedented. That was done by the same person who was quoted in the Evening Echo of Monday, 17 January 2000, which is unprecedented. If the group was made up of 12 politicians we would accept such comments as part of the cut and thrust of political life, but, again, that underlines the personality clash between members of staff. Taken with the advertisement and the decision supported by the Minister for Health and Children in late 1997, it would indicate that there was a radical change of course by the BTSB. That coincided with a change in personnel, which was significant.

We will have an opportunity to discuss that matter later but when I put the question to the CEO of that board about the test centre, etc., I was informed that no decisions had been made. However, in March it was an open secret that the decision had been made so correct information was not given to the Committee of Public Accounts. We cannot avoid the personality clash because the same individual, who we would state has a closed mind, stated that "The BTSB cannot be deflected from doing what is right, irrespective of pressure from any source." I presume that is goes against what this committee, the Minister and the general public think and it shows that the person is not in favour of overturning the decision. As a Dáil committee acting for the good of the people, we cannot accept that.

I am glad the figures have been provided but I wish to ask again whether the figure of 1 million to which the Chairman referred is correct. When I raised that issue at the meeting in question I was cynically asked if I was suggesting there should be Cork blood for Cork people. That is what was put to me on that day and I cannot accept it. I am glad this delegation has been invited to appear today. I believe there was a personality clash within the BTSB and I am of the opinion that the correct thing must be done for the 1 million people directly involved. I look forward to discussing this matter-----

Chairman: We will have an opportunity to do so later

Mr. Dennehy: The members of the group will be able to offer varying opinions, not just those of Southern Health Board. It is critically important that we obtain a straightforward view on the technical aspects of this matter.

A final question on costing. Could I ask Professor O’Sullivan-----

Chairman: That is Deputy Dennehy’s first question now.

Mr. Dennehy: The Chairman and I will have the next 12 months to try to resolve this problem and have the decision reversed, so we will use this opportunity as best we can.

Professor O’Sullivan, the item that has been put forward is probably costing. People are being dazzled with this PCR costing. The suggestion is that it would be very costly to put in place the test facilities. Would I be correct in stating that most of these machines are rented out initially? Would I also be correct in stating that, almost by stealth, a support service is being provided in Dublin? Is there a second location in Dublin where this type of equipment is being put in place, quietly and calmly without any reference to the situation in Cork?

Chairman: Before Professor O’Sullivan answers, I know Deputy Shatter is obliged to be in the House for the Order of Business so perhaps he would like to table his questions.

Deputy Shatter: I am sure the House will survive without me, I am under no pressure to be in attendance.

Professor O’Sullivan: The technology for carrying out PCR testing is not very expensive. We would have between us several of these PCR type machines within our research laboratories. If you can afford them in a research laboratory environment, they are quite cheap. What would be required, for example, in the case of 300 samples bulked together in an overnight testing facility is probably five observations or five tests to be made. That is not very much in the context of a normally functioning laboratory. If they identify that there is a problem within that bulk - you would identify a problem because the PCR system amplifies foreign genes, which is its purpose. For example, it would amplify hepatitis C - then they would test individually, identify and isolate it. That can be done overnight at present. They have stated that they do not require any additional personnel to do that so it is not a big cost or economic issue.

It was stated that there may be a need for a back-up laboratory. One of the problems when PCR is being carried out is that contamination can enter the system and you can start amplifying genes and you get false positives. Therefore, you have to use a second laboratory. It would make good sense to have two experienced laboratories for the country because they would represent a national resource in the blood facility. It makes no sense to centralise laboratory testing because that will inevitably be closed down at certain times because of contamination.

Professor Shorten: In case that phrase "Cork blood for Cork people" gets bandied around again, that is incorrect. That is obviously not what this is about. During 1999 Cork transferred a total of 1,208 units of blood to Dublin and Dublin transferred 376 units to Cork. The purpose of that is not to say that the Munster centre is three times better or bails Dublin out three times more often than the other way around. That is not the purpose. The significance is that bailing out occurs; the existence of two centres is what is important.

Professor Shanahan: I want to return to the issue of cost. I do not believe the BTSB will try to make this argument on the basis of cost. It might imply that. It is the ultimate in arrogance to actually talk about costs from the point of view of safety when it has been responsible for a cost - up to £400 million at this stage - which, in terms of financial magnitude, is the greatest financial scandal in Europe.

On the specifics of costs, I know the board will not address that because it will be on a hiding to nothing on that point. The cost of PCR is not measured in terms of the machines and equipment, the companies will either rent or give them to you. The cost of PCR comes from the consumables, the things one uses up during the day. If you are using them up anyway for patient testing, it does not matter whether you use them up in Dublin or Cork or in both places.

On the specifics of doing PCR in terms of the expertise, we are doing PCR in Cork, we are measuring virus levels in patients’ blood in Cork.

Chairman: Is that in the acute hospitals?

Professor Shanahan: Yes, admittedly not perhaps on the scale that might be required in the next 20 years. It is only a matter of scaling up. If it is going to be scaled up in one location and if the cost is the same, it is a non-issue. PCR testing is a non-issue here, it is a red herring.

Dr. Molloy: Some points of clarification for Deputy Dennehy. In terms of colleagues representing Munster, I have spoken to all the hospitals and they have been very supportive. That includes Tralee, Bantry, Cashel, Clonmel, Waterford, all the Cork hospitals and the Bons Secours in Tralee. It also includes the Lord Mayor of Limerick, Jack Burke, who is chairman of both the Association of Health Boards and the Mid-Western Health Board. I have also spoken to the CEO and chairman of the South Eastern Health Board and they are all highly supportive of Munster blood being processed in Cork.

The other point I would like to raise - it was adverted to earlier - involves the consultations we have had with the BTSB. We met its representatives in March and July 1999. The general hospitals committee of the Southern Health Board actually invited them to come in March 1999 because we had heard the rumour that the board was going to centralise testing. The further meeting, which took place two days before the board’s report, which had already been prepared, was issued, in July 1999 took place at my invitation as chairman of the Southern Health Board to the board’s chairman. We had been asking for a meeting from June onwards because we felt we were getting closer and closer to the publication of the board’s decision. We asked the board’s representatives to attend in Cork University Hospital and two days before they handed out their papers we met them and they, again, gave that list of 11 concerns which deals with the matter inadequately in our opinion.

Deputy Dennehy: With regard to my point about costing, the Committee of Public Accounts is responsible for considering value for money issues and this matter was raised in the context of the substantial costs that would be incurred. The technical term for PCR was used at that meeting and it frightened the life out of most Members. That was the initial thrust of the argument and I am glad that there has been confirmation that there will not be a huge cost to the public. We will take that on board.

Deputy Shatter: I begin with two premises. I expect every politician in Munster to be supportive of the group on a regional basis and I do not regard that as a health reason for supporting its case. I appreciate that the group is making its point with such support but in the real world of politics I would be astonished if it did not have it. From the health perspective there is an important fail safe in having two centres carry out testing. That is the groups strongest argument, not listing Members, councillors and mayors who support it. It is difficult to understand why the BTSB has approached this issue in the manner it has. This is not the first time that this issue has been dealt with by the Houses of the Oireachtas. However, it is the first time we have had an opportunity to discuss it at this committee.

As Fine Gael health spokesperson I raised this issue in parliamentary questions which I tabled to Deputy Cowen, the former Minister for Health and Children, and it seemed that he was prepared to go along with whatever the BTSB was recommending. That is the realpolitik of this. I do not know whether a change of personnel with a regional focus will change the political perception. Has the group been successful in its request for a formal meeting with the new Minister for Health and Children? If so, on what date will the meeting be held?

I wonder whether by travelling on a different track the BTSB is beginning to develop a different perception because the BTSB in the context of the shortfall in blood supply has recognised the need for greater regionalisation. It seems that in the context of the remaining inadequacies in our transport and road systems there is a good deal of sense in maintaining and enhancing the service in Cork as technology improves and different processes become available. Is the approach taken in Cork at variance with what appears to be a different approach articulated by the BTSB given the need for greater regional focus by the board in its own activities?

Substantial changes to the building programme were recommended in the Finlay report and the Government failed to deliver on that. I also tabled a parliamentary question on this issue to the Minister last autumn and the reply was that there was no need to proceed to provide an entirely new centre because of the substantial sum of money that was invested in renovating the board’s current buildings. It seemed that the proposal for a new purpose built centre had been taken off the agenda by the Government. What is the group’ reaction to the Minister’s statement that the financial input into renovation and other works in Cork no longer makes the provision of a new centre necessary?

This service should be provided and there should be a greater regional focus but I will be devil’s advocate. It is also argued that Ireland is a relatively small country with a population of 3.5 million while Manchester is bigger. If one centre deals with certain counties in England that have a greater population than Ireland why is there a need to duplicate here? The failsafe argument is one argument against that. Are there are other responses to that proposition? If one assumes that standards within the BTSB in Dublin are maintained, the mistakes of the past are not repeated and guidelines are in place that will be rigidly adhered to, does it matter if this is only done in one centre?

Dr. Molloy: I will respond to some questions. We had asked the previous Minister to meet on a number of occasions but it seemed inappropriate because another report was about to be produced. We have written to Deputy Martin and he has responded-----

Deputy Shatter: Did the Minister refuse to meet or did the group decide, having requested the meeting, that one should not be held?

Dr. Molloy: He reasonably responded that we were about to produce our expert report. Since Deputy Martin took up office, we have written again from the Southern Health Board asking that he receive a deputation. He has written back to give us possible dates in the next three weeks. Deputy Shatter referred to speaking to other politicians about this issue. When I referred to the various locations, I was referring to concerned colleagues rather than casting disrespect on the politicians that have come with us.

Deputy Shatter: I did not want to either. This issue ultimately will be determined by health considerations as opposed to pressure from one political side or another.

Dr. Molloy: The reason we mentioned ethics is that we feel that we are here because of the patients. There is no other reason for this particular group to attend.

Professor Cusack: On the issue of size and population, Holland is smaller than Munster and it has more than one centre. The experience in Manchester was mentioned by Deputy Shatter. The centre in Liverpool was shut and moved to Manchester. Frank Dobson was Secretary of State at the Department of Health and he had to stand up in Parliament and say the entire episode was a matter of deep regret.

The argument is made that this is best practice and quotations will be made about Finland and Portugal. This is not best practice. For every example of best practice in Portugal or Azerbaijan we can bring forward best practice currently in Ireland and other European countries. We do not accept the argument that this is established international best practice.

Mr. Mullan: Deputy Shatter raised concerns about the Irish Medicines Board, which has a dual role in this situation. It is the licence holder and is also involved in GMP, good manufacturing practices. It has visited Cork since 1994 as part of its statutory responsibility. Its reports have pointed out the gross deficiencies in the fabric and structure of the Cork blood transfusion centre. Its 1997 report indicated the immediate necessity to update the components laboratory and £450,000 was secured and invested in a new laboratory. At the same time it indicated the immediate need for capital investment in the structure in St. Finbarr’s Hospital. The BTSB failed to follow through and did not take down the moneys available to it from the Department of Health. Therefore, the capital investment in the existing buildings at St. Finbarr’s never took place. If this does not take place and the GMP fails to come up to standard, the IMB, not the BTSB, could close down the facility in Cork because of lack of structural investment.

Deputy Shatter: I mentioned Finlay but I should also have mentioned the IMB. In a reply to a Dáil question in, I think, December 1999, the Minister stated the IMB found the Cork facility satisfactory which was another reason for not putting in the major capital investment.

Mr. Mullan: The IMB indicated it was satisfied with the components laboratory and that the GMP came up to standard. I have the written answer from the Minister and he indicated there was concern about the standard of the buildings in Cork. He indicated that it was hoped a project team would be established to deal with capital investment.

Deputy Shatter: One could infer from the reply that there was not a great sense of urgency or need in the Department.

Prof. Shorten: We are all agreed on the absolutely essential nature of the service we are talking about. Addressing it today are those responsible for its delivery and those who care for the patients. Deputy Shatter referred to the deputation from the regions and it becoming a political issue. It became a political issue because there was no due process for the medical profession in Munster. The nature in which the issue was handled made it political. To quote Shakespeare, "There is something rotten in the state of Denmark", when it comes to this service and the decisions made.

Professor Shanahan: Deputy Shatter raised a number of issues, all of which are constructive, and we are grateful to him for his kind comments. On the issue of playing the devil’s advocate, obviously that is the right thing to do. I do not doubt the BTSB can scramble some arguments for doing this - the likely one will be the international comparison and so-called best practice. However, that has to be defined - we are united in believing we have good practice. When has anyone heard people say in unison that something is working very well? It is a huge issue. It would be different if we were talking about constructing a huge structure in Cork - we are actually talking about maintaining a system which is working. On the international issue, one must compare apples with oranges. The small size of Holland was mentioned, as was Frank Dobson regretting the decision. However, it must be kept in mind that there is a big difference - in financial terms, Ireland had the largest medical scandal in the history of Europe. The women who suffered, and, by extension, their families, do not need to told that the system is going to be changed to one which seems to work well in some other countries and that the very thing that truncated their suffering and enabled them to identify their symptoms will be removed to improve the blood transfusion service. This should not be an issue. The strengthening of the two units is important. Those women need much more than an international comparison.

Deputy Shatter: I thank the delegation for its constructive response. I look forward to our meeting with the BTSB.

Chairman: It will be far more constructive on that day.

Deputy Shatter: Whatever international comparisons we make, I assume there will no decision made at the end of this meeting that we need visit Azerbaijan. We should concentrate on the needs of Ireland rather than worrying about what is best practice in Azerbaijan as Dr. Cusack invited us to consider.

Mr. Dennehy: I wish to point out that given its size, Holland still has four test centres.

Deputy Cooper-Flynn: My question related to how we compare with other European countries so it has already been answered.

Chairman: Regarding costs, a new centre was to be built on a greenfield site in Cork. What is the overrun on costs incurred in the refurbishment of the Dublin centre?

Professor Shanahan: That is not really within our remit. We welcome the development and strengthening of the Dublin unit. I understand it was initially budgeted in the low ’teens and has now increased to a figure in the order of £30 million. I do not claim to be an expert on that. However, it needs to be asked if over-capacity was considered in the planning of that centre. If over-capacity was planned and an enormous structure was built at the outset, what does that say about the integrity of the process? If they already planned this and reached a conclusion about what they wanted to do at the outset, the delay regarding the Cork buildings and the appointment of a second consultant haematologist and the ruse about the PCR non-issue testing are all a sham. This says something about the integrity of the process. That is the question, not a cost overrun on the Dublin centre. Was over-capacity built in at the outset?

Chairman: The intention of the BTSB under its acting CEO was to build in Cork. A different CEO took over and there was a change of policy to centralisation. Was the reason for this about-turn in BTSB strategy ever established?

Professor Shanahan: No. As Dr. O’Sullivan, we have been unable to engage in due process because we have not been granted that courtesy. Instead, where there should be collegiality, we have had controversy; where there should be partnership, we have had antipathy; and where there should be trust we have been accused of being liars.

Chairman: I thank the delegation and I am delighted all of them could attend. As always, this has been a constructive discussion. We all learned a great deal and my colleagues who are not from the Cork area have benefited from the expertise of the delegation and the knowledge they imparted. We intend to ask the BTSB to attend at the earliest possible opportunity. We will put many of the questions posed by the delegation to it. By and large, this committee is supportive of retaining a centre in Cork which has displayed its excellence over the years.

The Joint Committee adjourned at 10.50 a.m.

Minutes of Evidence

Meeting with the Blood Transfusion Service Board

14 March 2000

Joint Committee on Health and Children

An Comhchoiste Um Shláinte Agus Leanaí

Dé Máirt, 14 Márta 2000.

Tuesday, 14 March 2000.

The Committee met at 2.35 p.m.

MEMBERS PRESENT:

DEPUTY B. O’KEEFFE in the Chair.

Presentation by the Blood Transfusion Service Board

Chairman: I welcome the delegation from the Blood Transfusion Service Board: Dr. Pat Barker, Chairperson, Mr. Martin Hynes, Chief Executive and Dr. William Murphy, the National Medical Director. The delegation has been invited to make a presentation regarding the decision of the BTSB to terminate the testing of blood products in the Munster area and to move to a single site testing centre in Dublin. Copies of documentation received from the BTSB on this issue have been circulated to Members with the agenda for this meeting. Before we commence the presentation, I remind the delegation that Members of this Committee are covered by privilege. Unfortunately, those appearing before the Committee are not. I now invite Dr. Barker to lead. We would prefer a short presentation followed by questions and answers.

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.

Appendix 2

Submission to the Joint Committee

by

The Blood Products Liaison Group

Appendix 3

Submission to the Joint Committee

by

The Blood Transfusion Service Board

Appendix 4

Members of the Joint Committee

Members of the Joint Committee on Health and Children

Appendix 5

Orders of Reference of the Joint Committee

Joint Committee on Health and Children

ORDERS OF REFERENCE

Dáil Éireann

13th November, 1997, (** 28th April, 1998),

Ordered:

(1) (a)That a Select Committee, which shall be called the Select Committee on Health and Children, consisting of 14 members of Dáil Éireann (of whom 4 shall constitute a quorum), be appointed to consider such—

(i)Bills the statute law in respect of which is dealt with by the Department of Health and Children, and

(ii)Estimates for Public Services within the aegis of that Department,

as shall be referred to it by Dáil Éireann from time to time.

(b)For the purpose of its consideration of Bills under paragraph (1)(a)(i), the Select Committee shall have the powers defined in Standing Order 78A(1), (2) and (3).

(c)For the avoidance of doubt, by virtue of his or her ex officio membership of the Select Committee in accordance with Standing Order 84(1), the Minister for Health and Children (or a Minister or Minister of State nominated in his or her stead) shall be entitled to vote.

(2) (a)The Select Committee shall be joined with a Select Committee to be appointed by Seanad Éireann to form the Joint Committee on Health and Children to consider—

(i)such public affairs administered by the Department of Health and Children as it may select, including bodies under the aegis of that Department in respect of Government policy,

(ii)such matters of policy for which the Minister in charge of that Department is officially responsible as it may select,

(iii)the strategy statement laid before each House of the Oireachtas by the Minister in charge of that Department pursuant to section 5(2) of the Public Service Management Act, 1997, and shall be authorised for the purposes of section 10 of that Act, and

** (iv)such Annual Reports or Annual Reports and Accounts, required by law and laid before either or both Houses of the Oireachtas, of bodies under the aegis of the Department(s) specified in paragraph 2(a)(i), and the overall operational results, statements of strategy and corporate plans of these bodies, as it may select.

Provided that the Joint Committee shall not, at any time, consider any matter relating to such a body which is, which has been, or which is, at that time, proposed to be considered by the Committee of Public Accounts pursuant to the Orders of Reference of that Committee and/or the Comptroller and Auditor General (Amendment) Act, 1993.

Provided further that the Joint Committee shall refrain from inquiring into in public session, or publishing confidential information regarding, any such matter if so requested either by the body or by the Minister in charge of that Department; and

(v)such other matters as may be jointly referred to it from time to time by both Houses of the Oireachtas,

and shall report thereon to both Houses of the Oireachtas.

(b)The quorum of the Joint Committee shall be 5, of whom at least 1 shall be a member of Dáil Éireann and 1 a member of Seanad Éireann.

(c)The Joint Committee shall have the powers defined in Standing Order 78A(1) to (9) inclusive.

(3)The Chairman of the Joint Committee, who shall be a member of Dáil Éireann, shall also be Chairman of the Select Committee.

Seanad Éireann

19 November 1997

Ordered

(1) (a)That a Select Committee consisting of 5 members of Seanad Éireann shall be appointed to be joined with a Select Committee of Dáil Éireann to form the Joint Committee on Health and Children to consider—

(i)such public affairs administered by the Department of Health and Children as it may select, including bodies under the aegis of that Department in respect of Government policy,

(ii)such matters of policy for which the Minister in charge of that Department is officially responsible as it may select,

(iii)the strategy statement laid before each House of the Oireachtas by the Minister in charge of that Department pursuant to section 5 (2) of the Public Service Management Act, 1997, and shall be authorised for the purposes of section 10 of that Act, and

(iv)such other matters as may be jointly referred to it from time to time by both Houses of the Oireachtas,

and shall report thereon to both Houses of the Oireachtas.

(b)The quorum of the Joint Committee shall be 5, of whom at least 1 shall be a member of Dáil Éireann and 1 a member of Seanad Éireann.

(c)The Joint Committee shall have the powers defined in Standing Order 62A(1) to (9) inclusive.

(2)The Chairman of the Joint Committee who shall be a member of Dáil Éireann.

Appendix 6

Proceedings of the Joint Committee

AN COMHCHOISTE UM SHLÁINTE AGUS LEANAÍ

THE JOINT COMMITTEE ON HEALTH AND CHILDREN

Imeachtaí An Chomhchoiste

Proceedings of the Joint Committee

Dé Deardaoin, 20 Aibreán, 2000

1.The Joint Committee met at 10 a.m. in Room G24, Kildare House.

2.MEMBERS PRESENT.

The following members were present:

Deputies Batt O’Keeffe (in the chair), Michael Ahern, Paul Bradford, Deirdre Clune, Beverley Cooper-Flynn, John Dennehy, John Gormley, Cecilia Keaveney, Brendan Kenneally, Liz McManus and Dan Neville.

Senators Camillus Glynn, Mary Jackman and Pat Moylan.

3.DRAFT REPORT ON THE BTSB: SINGLE SITE TESTING OF BLOOD PRODUCTS

The Chairman brought forward a report entitled "REPORT ON THE BTSB: SINGLE SITE TESTING OF BLOOD PRODUCTS". The Report was read and agreed.

Ordered: To report accordingly.

4.ADJOURNMENT

The Committee adjourned at 10.15 a.m.

¹ Senator Kathleen O’Meara was appointed in place of Senator Pat Gallagher on 4 November, 1999

² Deputy Liz McManus was appointed in place of Deputy Róisín Shortall on 24 February, 1999