Dáil Éireann debate -
Tuesday, 15 Jun 1999

Vol. 506 No. 2

Adjournment Debate. - Blood Transfusion Service.

Mr. Allen

I regret the Minister, who accused me in November 1997 of political mischief-making when I raised this issue, is not in the House to answer my questions.

The proposal by the Blood Transfusion Service Board to abandon testing of blood products in the Cork BTSB unit – thereby effectively downgrading the unit – is a cause of concern, not only to the people of Munster and surrounding health board areas but also to the Southern Health Board members, consultants and other medical staff working within the service.

The Cork unit has served the country well as a back-up for the Dublin unit and has rescued it in times of blood shortage. It is respected and has good working relations with the medical community. Therefore, it is very difficult to understand why a unit that has been working so well should be downgraded. Is it a Dublin-Cork power game?

The arguments put forward in support of a centralised testing unit in Dublin are finance driven, not medical. They are flimsy, poorly thought out and appear, at best, spurious. Surely the lessons of the hepatitis C scandal in the Dublin unit should teach us the wisdom of retaining a second centre in the country for backup, cross-checks, balances and quality control.

At present, all blood donations are tested by a serologic method in Dublin and Cork for potential infectious contaminants. Centralisation of such testing was not thought necessary before. Why now? There is no valid reason the Munster unit cannot continue. The drive to downgrade the Cork unit cannot be justified financially when judged against the millions of pounds that the errors in the Dublin blood transfusion board have cost the taxpayer in the case of the hepatitis C scandal, not to mention the heartache and tragedy. The lesson we should learn from that tragic episode is that there is great merit in retaining a second backup testing centre.

Is the Cork unit to be sacrificed because the new blood transfusion service building in Dublin has run seriously over budget? Why has the Blood Transfusion Service Board not undertaken a rigorous cost/benefit analysis of retaining testing in Cork?

In March 1997 the Finlay tribunal report stated that the replacement of the premises in Cork should be immediately commenced. In October 1997 the Irish Medicines Board threatened to withdraw the licence of the Cork centre unless substantial improvements were made in that centre.

In November 1997 the Minister for Health and Children, Deputy Cowen, stated:

The Blood Transfusion Board, in conjunction with my Department, has decided that the Cork centre requires replacement. I have given my approval to this. As an interim measure, refurbishment will take place on the present centre to meet the standards required by the Irish Medicines Board and for both projects my Department will make available the necessary resources.

Of course, that was in the middle of an election campaign.

Also in November 1997, the Blood Transfusion Service Board stated:

We propose to replace the centre. Pending completion of a new centre, which will take two years, the board wishes to update the existing centre to meet the Irish Medicines Board's requirements.

The BTSB also stated in November 1997 that the schedule was to complete construction and equipment validation by November 1999.

The question now is what has happened to change that scenario at a time when the buildings housing the centre are in need of replacement to meet the standards set by the licensing body, the Irish Medicines Board? What has happened to the Minister's commitment to provide the necessary resourcing for this replacement building? Is the Minister bringing about a scenario whereby the requirements of the Irish Medicines Board will not be met and, as a result, the Cork centre will lose its licence and will only operate as a depot? Why should a centre, which is working well and has achieved a quality standard – ISO 90002 – be downgraded, which is in stark contrast to the stated policy of the Minister, the Government and the Department of rewarding good service, decentralising health services and protecting those working and living outside the capital? These serious questions have not been answered.

Only yesterday, for example, it was stated in Cork that the medical services will be unable to cope with major accidents and disasters if the country is left with just one blood transfusion centre. This warning has been issued by the medical profession, lay interest groups in Cork and, most recently, by IBEC and Cork Chamber of Commerce. An article in The Examiner of 14 June 1999 stated:

Interest groups state that the proposal to close the blood transfusion unit in Cork in favour of upgrading the Dublin centre would leave the medical services vulnerable in the event of a major accident at either of the two international airports, Cork and Shannon, or at any of the many chemical and power companies in the south west region.

County Cork has the only oil refinery, the only commercial off-shore natural gas well and the only oil storage facility in the country. In view of this, it is absolutely essential that Cork retains the ability to deal locally and speedily with any major accidents. Past experiences, such as the Buttevant rail disaster and the Whiddy oil disaster, have shown that the existence of the major accident plan in Cork was a key to reducing the number of casualties. In view of the facts, it is incomprehensible there is a proposal to centralise blood testing which will only make the situation worse, not better.

Minister of State at the Department of Health and Children (Dr. Moffatt)

I thank Deputy Allen for raising this issue on the Adjournment.

The Minister rejects any suggestion that there is a lack of investment in the Blood Transfusion Service Board. In fact, the board of the BTSB fully acknowledges the significant investment which the Minister has approved over the past two years. In 1998 a 6 per cent increase in the price of blood components made available by the BTSB was approved at a time when the general level of price inflation in the health services was approximately 2 per cent. In addition, a one-off grant of £3 million was made available in 1998 to cover the cost of a number of developments at the BTSB, including the additional costs of the board's blood safety programmes. In 1999, a 48 per cent increase in the price of blood components, tests and services was approved. A total of £6.8 million has been made available to health boards and voluntary hospitals to cover the costs of these increases. The income generated by these measures will allow the board to introduce enhanced blood safety measures, cover the additional costs of ensuring regulatory compliance and recruit additional technical and scientific staff.

Over and above these investments, the Minister has also made available approximately £4 million to replace the board's existing IT system. The construction of a new national headquarters is nearing completion at a cost of £25 million, excluding equipping costs. By any standards, this level of investment is substantial and will improve blood safety nationally.

The main priority in relation to capital investment in the Blood Transfusion Service Board is to ensure regulatory compliance. The Irish Medicines Board, the regulatory authority for the BTSB, required the replacement of the area for processing donations at the Cork centre as a condition of its manufacturing licence which covers the period to 31 October 1999. In order to continue to meet regulatory requirements, the BTSB completed the provision of a new components processing laboratory at the Cork centre. The BTSB has advised that the new laboratory is now among the best of its kind in Europe, and that at a recent inspection by the IMB the level of compliance was in accordance with the EU guide to good manufacturing practice. In addition to the provision of a new components processing laboratory, the BTSB also completed a new compatibility testing laboratory, a new product storage area, an upgrade of the donor clinic and new office accommodation.

The total level of capital funding made available was £524,000, which included the purchase of equipment for the centre. Given the level of investment in the centre, and the scale of the refurbishment which has been carried out, it is necessary to ensure there is a satisfactory return on the public moneys that have been invested.

Further capital investment in the centre will be dictated by the requirements of the IMB and any additional resources necessary for this purpose will be made available. Furthermore, proposals submitted by the BTSB for capital investment which are over and above those necessary to ensure regulatory compliance will also be considered by the Department. As the Deputy is aware, responsibility for the organisation and management of the national blood transfusion service rests with the BTSB. Transfusion medicine is undergoing rapid change. New technologies and additional safety tests continue to emerge. The BTSB continually assesses these developments to ensure that its practices are in line with the highest international standards consistent with efficiency and effectiveness. One such development is PCR testing which is being introduced on the advice of the medical consultants at the board following an evaluation of international best practice.

In February 1998, the board of the BTSB decided that having regard to international practice, PCR testing at both the Dublin and Cork centres could not be justified. It was decided, therefore, that PCR testing of all donations would be carried out at the new national headquarters of the BTSB which is currently under construction. The implementation of this decision will involve testing blood samples from all donations in the country at the new national headquarters.

The proposal which is now being assessed by the BTSB is whether all serological testing and not just PCR testing should be performed at the national headquarters. The board of the BTSB has asked the chief executive officer and the national medical director to prepare a report on the practical implications for patient services of developing a single site for donation testing in Ireland.

An Leas-Cheann Comhairle

The Minister of State's five minutes is concluded but if the House is agreeable to allow the Minister to continue—

Mr. Allen

I had to cut my contribution on account of time, but I will let the Minister continue.

An Leas-Cheann Comhairle

Is that agreed? Agreed.

Dr. Moffatt

Among the issues being addressed are: how best to provide the transfusion service in the light of the rapidly changing environment in transfusion medicine; the application of accepted international standards of practice in leading centres and blood services; the achievement of the goal of the organisation in supplying 100 per cent of hospital blood components on time and without fail; how best to prepare for a substantial reduction in the use of blood components given the alternatives to blood transfusion which are currently available and being developed; the concerns of health boards and hospitals, including their concerns about the substantial increase in the costs of the BTSB products; and the achievement of a service that is efficient and effective.

As part of this process, the chief executive officer and the national medical director are consulting with international transfusion experts. Consultation is also taking place with BTSB staff, relevant hospitals and blood users. A meeting has already taken place with members of the staff of the Southern Health Board. The BTSB has particularly invited scientific and medical input from hospital consultants in Cork to inform its considerations. The newly appointed chairman of the BTSB has also invited the Southern Health Board to make a presentation, and arrangements for such a presentation are now being made. The board of the BTSB will consider the outcome of the current assessment at its meeting in July.

The House may be assured that the closure of the BTSB Cork centre is not on the agenda of the BTSB or the Department, in spite of what Deputy Allen has said.

Mr. Allen

There is no new building in spite of the promises made by the Minister.

Dr. Moffatt

Fan noméid agus éist. All that is being considered is a possible change in one aspect of the Cork operation. Many of the Deputy's facts tonight do not stand up to scrutiny.

Mr. Allen

They certainly do. The Minister promised a new building—

An Leas-Cheann Comhairle

Order, please. The Minister has gone well over his time and I ask him to conclude.

Dr. Moffatt

May I make a final comment? All that is being considered is a possible change in one aspect of the Cork operation. There is no suggestion of any change in relation to other scientific and technical services currently being carried out at the Cork centre, such as blood grouping, component processing, compatibility testing and ante-natal testing. The only change is the PCR testing.

An Leas-Cheann Comhairle

For the benefit of all Members, I request that Members and Ministers try to confine themselves to the five minutes allotted to them under Standing Orders.