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Seanad Éireann debate -
Wednesday, 21 Apr 1999

Vol. 159 No. 1

Cancer Screening Programme: Motion.

I move:

That Seanad Éireann, arising out of the events at the North Western Health Board where screening for cervical cancer showed up a number of false negatives, calls on the Minister for Health and Children immediately to commence the cervical cancer national screening programme and to set out a schedule commencement date for a national screening programme.

In 1992, the latest year for which I have statistics, cervical cancer was responsible for 72 deaths in Ireland. This is totally unacceptable because this form of cancer is preventible by treatment during its pre-invasive stage. For this reason, for many years, women have been urged to present for smear tests. Therefore, it is essential that an efficient system for screening women in the target age range be set up, in accordance with the recommendations of the December 1996 report of the Department of Health's cervical screening committee. I implore the Minister to implement the recommendations of this report immediately.

The North-Western Health Board, under extreme pressure and with a backlog of 14 weeks, subcontracted work to Claymon Laboratories in Dublin. The board did so, by its own admission, without seeing the premises or satisfying itself that the staff employed were qualified to read smears. Claymon Laboratories have now admitted that the work could not be carried out on their premises as they do not routinely carry out routine cervical smear testing. The work was, in turn, subcontracted to cytologists and histopathologists working in St. Vincent's Hospital, Dublin, and the Bon Secours Hospital, Cork.

It has come to light that this work was, at times, carried out in the homes of staff rather than in the scientific environment of a clinical research laboratory. This led to incorrect readings – described as false positives – and the entire sample of 2,000 smears were sent to Glasgow to be retested. Of a total of 2,000 smears, 68 were found to have been incorrectly read. This represents a margin of error of 3.4 per cent. The Royal College of Pathologists in the United Kingdom accepts a margin of error in clinical testing of 0.05 per cent.

This travesty is now being repeated in the North-Eastern Health Board. Other hospitals have used the same contract laboratory and are now, by the Minister's admission in the Dáil yesterday, rechecking these smears. Seven hospitals are now checking their results. I am glad the Minister has agreed to the rereading of 5,000 smears but there may be more.

The women of Ireland are worried. They deserve explanations, answers and to have their fears allayed. Sooner rather than later, they deserve an efficient screening system that provides accurate results as quickly as possible. How can we face the women of the country and tell them that the current debacle will be investigated on an ad hoc basis? That is not acceptable.

The Minister must establish an independent inquiry by two members of the Royal College of Pathologists. The United Kingdom is our nearest neighbour and pathologists there are aware of our health procedures as we are of theirs. This inquiry must commence without delay. The brief of the inquiry should be to investigate the operating conditions of Sligo General Hospital which allowed for the second time in a few years a backlog of 14 weeks to develop, and thoroughly to investigate Claymon Laboratories and the laboratory's code of practice.

The inquiry should be conducted immediately and once completed, the attention of the investigators should be directed to a thorough investigation of the policy of each health board with regard to the contracting out of routine smear tests and a thorough investigation of contract research houses.

There are serious deficiencies in all areas of cervical smear testing and we must ensure that the recommendations of the Department's report are implemented. The 1996 report made four recommendations: a national cervical screening programme based on an age/sex register to be examined; women aged between 25 and 60 should be screened every five years, although the British Medical Journal in March 1999 recommended testing every three years; all personnel involved in the delivery of the programme must be trained to a high standard and comprehensive quality control must be an integral part of the programme at every level.

The Mid-Western Health Board was chosen to run a pilot scheme for the screening programme at the instigation of the then Minister for Health, Deputyl Noonan. Two years later, the project has not yet begun. Dr. Marian O'Reilly confirms that the project team is in place but organisational difficulties are delaying its commencement. To date, Claymon Laboratories have not published a list of health boards which subcontracted work to them. This information must be supplied immediately.

In every health board area there are worried women who face the prospect that their smears have been incorrectly read. Worried medical personnel are concerned that they were not aware they should have treated these women further. The recent guidelines from the World Health Organisation and quoted recently in the British Medical Journal suggest that all sexually active women should have a routine smear every three years until the age of 65. The first smear should always be followed by a second one a year later and thereafter every three years. Once the slide has been processed, it should be read within four weeks and the results passed to the referring doctor so that further medical intervention can be given, if required. That is very specific as regards cervical cancer. As the Minister stated many times, it is a cancer which is not life threatening if addressed immediately. The smears should be sent to a reliable quality assured laboratory for examination. In Ireland, there are no regulations governing the protocols or codes of practice employed in such laboratories, either contract or hospital based, which is highly dangerous as we are now witnessing.

In the UK, the practices of laboratories and practitioners in clinical research are tightly controlled and are regulated by the Department of Health and the Home Office. Both the laboratory and the practitioner must be licensed and must comply with good laboratory and clinical practice. Three separate licences are required: project, personnel and procedural. The project licence is held by the company or laboratory and relates to a specific project. The personnel licence is held by an individual and is only awarded after sufficient experience has been gained while working under another licensee and an examination – written and practical – has been passed. The procedural licence can apply to both the company laboratory and the individual. A laboratory may be licensed and deemed competent to carry out haematological testing but not histological testing, for example. It is possible that an in-vitro researcher would be deemed capable of cell culture techniques and embryo testing but not be deemed qualified and, therefore, not licensed to carry out routine histological testing. Procedures are, however, very tight in the UK.

Under good clinical practice, medical records must be kept accurately and data entered in permanent ink and not altered with correcting fluid such that the original entry cannot be read. Medical samples must be held in appropriate conditions and analysed as quickly as possible in accordance with recommended guidelines. Samples and tests vary in terms of processing and reading. Routine histological slides – for example, smear test slides, are processed very quickly and there should not be a bar to reading them immediately.

That there is no regulatory authority to govern and audit the independent contract research house in Ireland is dangerous. By virtue of third level education and membership of the Association of Medical Laboratory Scientists, individual scientists are, in some way, accredited but the accreditation is too broad and specific accreditation on a procedural level is needed. I spelled this out in detail because those procedures are in place in the UK.

While it is regrettable that health boards require to contract out routine testing, if they do, then it is the responsibility of the Minister for Health and Children, Deputy Cowen, to oversee the setting up of regulatory powers. It is not good enough for the North Western Health Board to say it was given details of staff qualifications and the names of personnel involved in the testing. From what I gather, at no stage did a member of the North Western Health Board visit the company and inspect raw data, and it should have done that. It has no way of being sure who did the testing and where it was carried out. The Home Office in Britain inspects contract houses without prior warning and retains the right to do so.

Women are worried and their questions need immediate answers. They need immediate assurances. Their fears are enormous and must be allayed. They are asking if their smears were read correctly and if they should contact their doctors. A counselling service should be set up immediately in the North Western Health Board area for the women affected by the debacle. An advice helpline service should be immediately set up nation-wide so that women can access information and advice as they require it.

We had the unfortunate hepatitis C scandal which, ultimately, had to be investigated by a tribunal. This is potentially a problem of equal magnitude. We, therefore, demand four measures: an immediate independent inquiry; the immediate commencement of a reliable transparent screening service for cervical cancer conducted according to the recommendations of the cervical screening committee; the setting up of a regulatory body to oversee the practices of laboratories and practitioners and, ultimately, the provision of reliable professional accreditation and an external audit system for the entire health service needs to be implemented as discussed at the recent IMO conference in Killarney – I do not know if the Minister attended – and the Department can start with this speciality.

I had to go through a mammogram. My life flashed before me in the hours I waited for the result and I was relieved when it was negative. If this was an area specific to men's health – this is not a sexist comment but the reality – there would be more stringent checking procedures and delays would not be tolerated. I refer the Minister to the excellent system in place for the treatment of prostrate cancer. This motion should be supported, otherwise we cannot face women with any moral integrity. I appeal to the Minister and Members opposite to support our motion.

I second the motion. I welcome the Minister to the House for this important debate. I agree with everything Senator Jackman said. I, like other Members, regularly hold clinics and hear of issues about which people are concerned. Senator Jackman's last comment was probably one of the most important. The value the system places on women's health issues is not adequate. We need to pay more attention to issues which seriously affect and impact on women's lives.

I understand that in the North Eastern Health Board region cervical smear testing is done in Our Lady of Lourdes Hospital. Having heard complaints about the length of time people had to wait for smear testing to be done, I raised the issue some months ago with the North Eastern Health Board. To my amazement I found there was a backlog in excess of three months for most of those routinely tested. If the doctor or consultant indicated there may be a difficulty with a particular slide, it was taken out of sequence and dealt with more quickly.

Strangely, there was a lady in Drogheda who was fully and professionally qualified to do smear testing but the hospital could not get clearance for a position to be created to employ that person permanently to do that work. I believe the health board was being charged £10 per slide to send it to other allegedly competent bodies about which we are now wondering. That was a disgraceful situation. The health board has since made arrangements to employ that competent local person to do the work. We are not giving adequate and proper care to women's health issues.

Last Saturday I met a lady who suffered grievously from physical violence. She had a barring order to keep her partner away from her premises. When she came to me she was in fear of her life and said that if she went back to her house, she would be battered to death despite the barring order. This morning I heard on the radio about a report on that issue. In many cases, where barring orders are broken a penalty is not imposed by the courts. This is not a criticism of judges as such but of the system. This is another area at which we need to look again.

We need to pay more attention to women's issues which affect the health of the community, which is also concerned about them. Cervical smear testing must be done professionally, effectively and quickly. As Senator Jackman said, if these smears were being done for males, there would not be a delay of three to five months – they would be done straight away. We must tackle this issue.

There are other issues which concern families. I am concerned about the delays for those awaiting speech therapy. Children with speech problems in County Louth must wait 12 months to get an appointment with a speech therapist and that is utterly disgraceful. There is a great deal of concern about orthodontic treatment waiting lists. Some children have serious dental problems, such as facial disfiguration, which upset them greatly because other children laugh and sneer at them. They will never receive treatment if they are in category C. Money is not put into areas of the health service where it is most needed.

I look forward to the Minister's comments on cervical smear testing. We must get our act together, stand up as a community, insist that women are treated properly and that their fundamental right to proper, safe and adequate smear testing is dealt with immediately and adequately. There can be no hiding behind health board waiting lists. I do not blame the Minister for this because health boards are under pressure and have their own agendas. However, they must give cervical smear testing an absolute priority and the best way to prioritise it, and to move away from private companies which do not carry out adequate testing, is to do it themselves. They should employ an adequate number of proper professional people who are qualified to do the work in their hospitals. I could not believe it when I heard that some testing was carried out in the private homes of individuals.

This issue should be given the priority it deserves and dealt with properly, safely and adequately. Women deserve no less than that and the Minister must insist that health boards carry out this testing by the book.

I move amendment No. 1:

To delete all words after "That" and substitute the following:

"Seanad Éireann notes the public concern at the events in the North Western Health Board region where a number of false negatives were discovered in cervical screening test reports; and notes with approval the rapid and effective action which the Minister for Health and Children took to deal with the situation and the advanced arrangements which he has in place to commence a cervical screening pilot programme".

I welcome the Minister to the House; he has not been afraid to come here to address issues. I sympathise with those who received abnormal smears. At the best of times going to a doctor is an unnerving and unsettling experience but if the doctor decides testing in whatever form is needed the patient must wait for results for a number weeks. This further unsettles the patient and is a cause of grave anxiety for many. I sympathise with the women caught up in these events.

The Minster has taken certain steps to deal with this problem and the North Western Health Board should be congratulated on the steps it has taken quickly, efficiently and effectively to deal with the women who have been affected. It is probably the first time in the history of Irish medicine that a problem such as this was not only detected but followed up quickly to allay whatever fears the patients may have had. The health board and the Department of Health and Children cannot be blamed for the actions they took.

However, other issues arise. Is there an effective audit of people engaged in the technical side of medicine, such as technicians and pathologists – those engaged in a field of medicine where the facts speak for themselves? I am not referring to clinical medical, where clinical decisions are often made on the basis of subjective perceptions, but to chemistry, pathology, biochemistry, etc., where facts stand up. One can carry out a test, the results come back, a decision can be taken and there can be no argument unless there has been a mistake in the technical process.

The nub of problem in this case is that there was a defect in the technical process of examining the smears and reporting on them. Health boards and the Department face problems dealing with smears. Every abnormal or unusual cell that shows up in a smear does not mean that the patient has cancer. However, if the cell is unusual or has an abnormal coloration or disfiguration, one checks it again.

Senator Jackman touched on the fact that an independent audit organisation is needed which will oversee the accreditation of laboratories, the training of technicians and also further and continuous education and assessment of technicians. The day is fast approaching when people in the medical profession – doctors, nurses, pathologists, psychologists – can no longer qualify and never have their standards re-evaluated. I do not say that they should be examined frequently but it should be a requirement that an individual's licence to practise should be renewed on a regular basis once he or she has provided proof of having partaken in further medical education schemes. Such an arrangement should be examined and introduced.

Given the pace of change in medical technology and education, what was good enough yesterday is not good enough today because standards change all the time. The activities of a doctor or a pathologist will be judged on the standards that pertain today and not those that pertained four years ago. This must be looked at. The Irish Medical Organisation and the General Medical Council have been slow to embrace this concept.

I empathise with Senator Jackman. Anxiety was created but she must acknowledge that the North Western Health Board and the Department moved quickly and effectively to allay the fears of those involved.

Like Senator Fitzpatrick, I take a broad view on this. I congratulate those working for the North Western Health Board who, despite the fact that the board does not have adequate staff, are efficient in carrying out routine quality control processes. The Minister said in the Dáil that they first picked up the mistakes when two results which were described as "positive" were "negative" the year before following their own examination. They quickly reviewed them, realised mistakes had been made and immediately began to ascertain the status of the other slides.

It is very hard on the women involved. It is nerve-wracking enough for them to have to wait for the results of such tests without then finding out that mistakes made in laboratories may have related to them. I hope that everything possible is done to reassure them. If a person on clinical examination has what looks like a carcinoma it is important that these slides are fast tracked. I hope that any women who are waiting anxiously to go to Altnagelvin or Sligo hospitals to have further smears taken do not think that they have had cancer for months. That is most unlikely to be the case because clinical cases are treated quickly and screening tests pick up abnormal cells.

One problem is that it is hard to get cytotechnicians. I do not know whether the reason is a lack of money or the tedious nature of the work. The technician spends hour after hour, day after day looking at slides on which a small abnormality of the cell must be noted. This is why I am horrified that tests were being done in private homes, presumably after work hours. As the Minister knows, I complain continually about the long hours which doctors and technicians must work and I have praised Commissioner Pádraig Flynn for proposing a 52 hour week for non-consultant hospital doctors. Going home from work to look down a microscope is not the same as going for a walk or playing a round of golf and if one is tired coming home from a laboratory one will be extremely tired looking at slides later in the evening. It is an extraordinary development in the health service that laboratories are farming out work for people to do after coming home from their jobs. This is one of the most shocking aspects of the matter.

Like many medical practitioners, if I suffered from ill-health I would go to one of the big teaching hospitals. I do not cast aspersions on the private health system but the care in the teaching hospitals is excellent, and what worries me about this is how much work is being farmed out from these hospitals. The Minister has asked other hospitals what they do when they are unable to handle certain tests and whether they send them to private laboratories.

As other speakers pointed out, we have no accreditation system for private laboratories and this case points up the urgent need to tackle this. I realise that discussions on the issue are ongoing with the Royal College of Surgeons in Ireland but we should at least ask private laboratories to give their names to the Department on a voluntary basis, because we will have no assurance about quality control in these laboratories if we do not know they exist. I had never heard of the laboratory in this case before and I do not know who runs it or who it asks to do the tests. I was astonished to discover that the testers used by the laboratory seem to be employed by every hospital in South County Dublin, and that these hospitals did not know their staff members were undertaking this work.

The Minister asked hospitals to inform him about tests they may have sent to this laboratory, but what about private practitioners who may have sent slides? A considerable number of tests are carried out by general practitioners. The Minister should also ask them to check the results they received, because they are as likely to have received false negatives on their tests. That would be well worth doing and I hope the Minister asks the Department to alert general practitioners who may have sent slides to this laboratory to its lack of proper quality control practices.

All screening tests can be criticised from some viewpoint – there will be false negatives and positives – but the aim of those programmes is to prevent early death from these conditions. We should go ahead with tests which have been proven reputable internationally. I was at the launch of the breast screening programme and heard the Minister's remarks. That programme is worthwhile because, while such programmes were criticised by an epidemiological survey in Stockholm, that paper has itself been criticised. We are right to go ahead with the programme because a number of such programmes have been under way for some time and are considered satisfactory.

Running a screening programme is tedious and expensive and the Minister will have to employ more staff, both for breast cancer and for cervical cancer screening. Premature death from cervical cancer can be completely avoided so I support what the Minister is doing because it is essential.

It is a great pity that sexual education programmes do not point out the problems caused by sexually transmitted diseases. The human papilloma virus is constantly implicated in cancer of the cervix. Perhaps the Minister will encourage his colleague in the Department of Education and Science to include more information in schools' sexual education programmes.

Breast screening is under way and we hope to have cervical screening also. A columnist in The Irish Times has suggested we think only of women's health but this is not true. Prostate screening will be brought forward but it is not as satisfactory as we had hoped. Blood tests for prostate specific antibodies have not been found to be as reliable as one would like, but the test is available for men. On the other hand, screening for bowel and rectal cancer seems quite hopeful. A recent article in The New England Journal of Medicine stated that, at a cost of $1,000 to $1,500, a person can be spared the further extension of bowel cancer purely by sigmoidoscomy and examination of faeces for occult blood. A huge number of cases are discovered in this way, and this cancer is one of the major causes of death in this country. I always seem to raise issues like this when Senator Dardis is in the Chair and awaiting a meal.

It is a pure coincidence.

In the interest of being gender-sympathetic, perhaps we could consider introducing that as our next screening programme and providing it on a male only basis for the first ten years.

I sympathise fully with the women in the North Western Health Board area whose test results were incorrectly reported. I assure them that any services which they may require will be made available and I am advised that the delay in detecting the error will not compromise them medically. I know all this has been explained to them by the North Western Health Board's staff but I would like to add my personal sympathy and assurances to that of the board.

When the possibility of a problem in the North-Western Health Board was identified as part of the routine quality control process, two smears which were categorised as positive were reviewed. The women concerned had smears the previous year which had been categorised as negative. These smears had been screened by a private laboratory and it was considered that an error had been made in their classification. A total review of all 2,115 smears which the private laboratory had undertaken was carried out and further cases with abnormal cervical cells were discovered. This review was carried out by an independent accredited laboratory in the UK and was not completed until the week before last. The result of this process was that the cases of 68 women required to be followed up.

The main priority for the North-Western Health Board was the health and welfare of the women directly affected by the situation. The health board considered that, in the first instance, the most appropriate means of contacting these women was through their general practitioners. An information pack was prepared, but only as an adjunct to the general practitioners' approach. It was arranged with general practitioners that women who needed a repeat smear would be offered this as soon as possible. A taxi service was contracted to transport the slides directly to the laboratory. A fast track service within the laboratory will ensure that results are available within the week. For those women who need further investigation by colposcopy, the board considered it important that they should have a choice as to where and when this would be carried out. Three clinics have been organised, one in Sligo and two in Derry, and, in addition, some appointments were arranged in Dublin where this was more convenient.

Telephone support lines were established, staffed by trained nursing and medical staff. Over 90 calls were received during the four days that they were in operation. Some women required and received follow-up telephone calls from the support staff. Further counselling will be made available for women whose general practitioners request it. In partnership with their general practitioners, the board will continue to provide ongoing care and support to all the women into the future.

The health board has acknowledged the tremendous support given by general practitioners, area medical officers and other health board staff to ensure that the women directly involved received the best possible service. The board has also acknowledged the support received from Altnagelvin Hospital and consultants at Holles Street Hospital. The health board will take any and all further steps to support people affected in any way.

The North-Western Health Board contracted the private laboratory in 1997 to read the backlog of 2115 smears on the basis that the laboratory would adhere to accepted clinical practice which means that after all smears have been read by a cytotechnician they are reviewed by a second cytotechnician. In addition any abnormal smears above borderline are reviewed by a consultant pathologist.

The North-Western Health Board is carrying out its own investigation into what happened and has not ruled out legal action against the laboratory involved. It is clear based on the facts before me, that the laboratory did not live up to its claims to have internal and external quality control systems and independent quality assurance. These issues are being considered by the health board and it will take whatever action is necessary.

Having satisfied myself that the health board has responded in a satisfactory way to the women who were identified as having had an incorrect reading of their smear it then fell to me to consider what further actions were necessary at national level.

My first concern was to identify what other cervical cytology work was carried out by Claymon Laboratories. I can confirm, at this stage, that no other health board sent cervical smear tests to the private laboratory. A voluntary hospital in the North Eastern Health Board, that is Our Lady of Lourdes Hospital Drogheda, which is now in the ownership of the health board, and Beaumont Hospital Dublin both used the private laboratory in 1997 to report a total of 350 smear tests.

I have instructed Beaumont Hospital to carry out a recheck on the 200 smears reported on by the private laboratory. I am advised this will be completed this week. As of now it is not aware of any problem. Likewise the 150 smear tests from the North Eastern Health Board are being re-checked by a UK laboratory and this will, I am advised, be completed this week. If any discrepancy emerges in the course of these rechecks immediate action will be taken by the North Eastern Health Board and Beaumont Hospital.

I have also requested that the laboratory provide my Department with a list of any other private clients who might have used their services for cervical screening. This covers the point raised by Senator Henry. The laboratory has advised that it may not disclose the names of its private clients until these clients are advised that their names will be given to the Department. The laboratory has confirmed that it is in contact with its private clients on this. I hope to get this information in the next few days and I will then initiate any action which I think appropriate and necessary. Where other clients used this laboratory a review of the cervical smear test results will be required as will appropriate action to follow up any missed abnormalities.

The next step was to identify the individuals who carried out the screening for Claymon Laboratories. The cervical smear tests were examined by and reported on by professionals in Dublin and Cork. The Bon Secour Hospital in Cork has confirmed its involvement on behalf of Claymon Laboratories.

In relation to Dublin, St. Vincent's Hospital has assured me that it did not carry out any work for the private laboratory. The work was done in a private capacity by staff from St. Vincent's Hospital. Preliminary screening was not carried out at the hospital but at home. It is interesting to note the level of discrepancy was less in the home service than in Cork. The staff concerned also had attachments with St. Vincent's, Elm Park, Mount Carmel, St. Michael's, Dún Laoghaire and the Bon Secour Hospital, Glasnevin.

I am not aware of any problems in these hospitals. However, in view of what has happened in the North-Western Health Board, to allay public concerns and purely as a precautionary measure, I have asked the hospitals to review their cervical cytology work in these hospitals and to let me have an early report on the situation. This review is to cover the period 1994 to 1998 and involves approximately 5,000 smears.

It is important to keep this issue in perspective, as some Senators have already mentioned. I do not want the confidence of women in cervical cytology undermined. Neither do I want to undermine the confidence of staff working in cervical cytology. I am aware of how difficult cervical screening is. It is subjective and completely dependent on the human eye. The screener has to review slides with some 50,000 cells and abnormalities can be missed. Professionals do not agree on borderline or mild abnormalities and some professionals tend to over-report these.

In view of the experience in the North-Western Health Board these reviews are necessary to deal with any doubts, allay the fears of women and to maintain confidence in cervical screening. The problem which has been identified relates to a period in 1997 and to a small number of individuals and is being dealt with in a comprehensive way.

I very much regret the concern which this issue is causing women. It is however, essential that women understand that the purpose of screening is not to detect cancer as it is not a diagnostic test, but to identify changes in the cells of the cervix which can be treated before a cancer develops. The likelihood of a negative result is about 93 per cent.

As with any screening tests there is a chance that some abnormalities may not be detected. In addition, it takes ten to 15 years for cervical cancer to develop. That is why regular cervical smears are recommended at minimum intervals of five years. A single smear is not a guarantee of being free from cancer or its precursors. I repeat an abnormal smear result does not mean the woman has cancer.

Cervical screening is one of the few areas of the health services where the technology for automation is not yet available. Clinical trials are taking place and I hope automated screening, which has been tried and tested, will become a reality in the next few years. This will enable us to improve accuracy, quality and throughput in our laboratories. However, more than 170,000 smear tests were examined in 1998 in our laboratories and there is no reason to doubt the accuracy of the results apart from the ones at issue here. The inaccuracies arose as a result of the quality assurance techniques involved in the review procedures in the North-Western Health Board.

A further concern which had to be addressed was what other work did Claymon Laboratories do for the health services. My Department has obtained the details and all of the hospitals and health boards involved have been written to by my Department and asked to take steps to satisfy themselves that the results were satisfactory and to inform the Department of the position.

Having satisfied myself that everything possible was being done in relation to the screening services, I went on to look at the national cervical screening programme. I am fully committed to the development of this programme for women aged 25 to 60 years. The introduction of an organised screening programme is a formidable task and must be done properly. It must be well managed, have high uptake levels, be fully computerised, and include comprehensive quality control as an integral part of the programme at every level.

For these reasons it was considered that the screening programme should be introduced on a phased basis to identify and resolve any difficulties which might arise and the Mid-Western Health Board area was chosen for phase one. A sum of £300,000 was made available in 1998 to the Mid-Western Health Board for the recruit ment of additional staff who will be responsible for the development, introduction, management and evaluation of the project. The population register is being developed, the software system has been selected and the paperwork is being developed. Subject to a satisfactory outcome of negotiations with the IMO it is envisaged that the pilot screening programme will be launched early next year.

The aim of phase one is to develop a cervical screening programme which runs successfully in the mid-west and can then be implemented throughout the rest of the country. Following the evaluation of the first phase in the mid-west the programme will then be rolled out to the rest of the country. While I am determined the national programme will be introduced at the earliest possible date it can only be done when management, quality control and other appropriate issues have been addressed and put in place. I have instructed senior officials from my Department to meet senior staff from the Mid-Western Health Board to ensure the pilot programme commences as soon as possible.

The current waiting period for the reporting of cervical smear test results in the North-Western Health Board is four to six weeks. It is important to remember that the use of the private laboratory took place in 1997 when many laboratories had backlogs in the reporting of cervical smear test results. Since then £2 million has been invested in cervical cytology to improve the laboratory service and for the recruitment of three consultants, 15 cytotechnicians and four clerical or laboratory aids. In addition, arrangements were made with the RCSI to process some 20,000 smears. The waiting period for results in laboratories is currently one to seven weeks. Any smear test marked urgent is of course examined immediately.

There are difficulties in recruiting trained cytotechnicians, as Senator Henry remarked. Medical laboratory technicians are not attracted to working in cervical cytology. In any case where they are recruited it takes up to two years before they are fully proficient in screening and can work unsupervised. Then they have to be maintained in that type of employment. There are also concerns about the recruitment of medical laboratory technicians in general. My Department met the joint committee for medical laboratory sciences on 23 March last about the anticipated shortfall in numbers of medical laboratory technicians. The committee is in the process of preparing a submission which will deal with the number of extra places needed over the short to medium term to address the anticipated shortfall, the additional costs involved and the capacity of colleges to take on these additional students. On receipt of this submission, officials of my Department will enter into discussions with both the Departments of Education and Science and Finance to further progress the matter.

While overall the capacity of our laboratories would appear to be sufficient for an organised programme along the lines recommended in the report of the Department of Health and Children's cervical screening committee the problem is that opportunistic screening is taking place more frequently than the recommended five yearly interval. It is essential that the laboratories are used effectively and efficiently for the women for whom cervical cytology is indicated, particularly in the preparation and integration of the current opportunistic screening into the proposed forthcoming national screening programme. It is important to repeat here that the recommended interval for cervical screening is five years. Laboratories and smear takers should be advising a five yearly screening interval where routine repeat cytology is indicated if laboratories are to operate efficiently and effectively and errors avoided. We must also ensure that the widest possible target group undertakes smear tests.

The report of the Department's cervical screening committee issued in 1997 contains many recommendations on quality assurance regarding the introduction of a national screening programme. The report recommended that each laboratory should have written guidelines for all aspects of the cytopathology service including quality control, from the time of receipt of the specimen to the discharge of the report. The report also recommended double screening of all abnormal smears, proportional rescreening of normal smears or 30 second screening of all smears and selected rescreening. Since 1997 the Irish Association for Clinical Cytology has also developed guidelines and these have been circulated to all laboratories.

I met the chairman of the Expert Advisory Committee on Cervical Screening, Dr. Michael Darling, former master of the Rotunda hospital. The committee has overseen the introduction of phase 1 of the cervical screening programme in the mid-western region. It has also been developing guidelines on quality assurance. I have requested that this work be finalised this week.

With regard to quality assurance in the laboratory, the document will make detailed recommendations on the reception of slides; laboratory preparation; reporting practice; management of smear results; assessment of adequacy of smears; staffing, training and continuing professional development; laboratory equipment and environment; quality control of smear reporting; accuracy; retention of slides and cytopathology laboratory process. This document will deal with quality assurance in all areas of cervical screening. It will provide the standard for quality assurance in all areas of cervical screening and its implementation will commence immediately.

Laboratories are staffed by qualified personnel and ultimate responsibility for the quality of the work lies with the consultant pathologist. Quality control procedures currently in place include primary screening by trained cytotechnicians, rapid rescreening of all smears by another cytotechnician and double screening of abnormal smears.

I emphasise again that the problem which has been identified relates to a period in 1997 and to a small number of individuals. I can reassure women currently using the cervical screening service that they do not need to be worried.

In relation to the general issue of quality assurance in pathology, the situation is that each sub-speciality operates to its own professional standards and guidelines. For example, in cytology, as already indicated, the IACC has produced guidelines for cytology testing which would be available to all pathology laboratories. Quality assurance arrangements are in place in pathology laboratories, designed to monitor and evaluate the operational procedures and outcomes in relation to each laboratory.

In common with other EU member states, Ireland is currently developing a formal laboratory accreditation scheme in consultation with the relevant professional interests. These are clinical pathologists, medical laboratory technicians and biochemists. They are represented by a joint working group comprised of representatives from the Faculty of Pathology of the RCPI, the Academy of Medical Laboratory Science and the Association of Clinical Biochemists. The objective of these discussions is to develop and implement a formal accreditation system for pathology laboratories.

On 9 March the Department of Health and Children proposed a number of accreditation models to the joint working group and a response is awaited. The Department is anxious to conclude these discussions and has asked the joint working group to respond to the proposals as a matter of urgency.

In relation to the specific issues that have arisen, the North-Western Health Board, from the internal quality assurance process, had the ability to note the fact that national norms were not applying in relation to results that came from this laboratory. It arranged for independent reassessment of those smears and ensured they were all tested. It also made arrangements for a professional and sensitive approach to those who had abnormal smears evaluated improperly. It ensured there was no change in the health outcome despite the fact that smears had been tested inaccurately.

As I have said, we are carrying out a comprehensive overview. We checked where Claymon Laboratories carried out other cervical tests and they have been re-evaluated. We checked who carried out the tests. Their work is also being rechecked. The five year rechecking period is the proposed period of time recommended by the expert committee as being the period during which cervical smears should be re-examined.

With regard to any work carried out by Claymon Laboratories for private clients, we are awaiting information subject to it notifying those clients that such information is being brought to the Department. With regard to whatever appropriate action needs to be taken on the re-examination of those smears we will adopt the same con sistent approach as in relation to the issues that have arisen so far.

That is the up to date position. On the wider accreditation issues, it is clear from the response in this case that it is wrong to suggest it is only as a result of this issue arising that the accreditation issue is being addressed. The expert group set up for the national screening programme – which is the best way to go – has carried out a lot of work. It is in the process of finalising the protocols, as outlined in my presentation. That wide range of issues will ensure quality control criteria are maintained from the beginning to the end of the process for cervical screening.

With regard to the accreditation of private laboratories and laboratories in general, we have submitted accreditation models to the joint working group since 9 March. We await their response so that we can deal with those wider implications as well.

I congratulate the North-Western Health Board personnel for the manner in which they dealt with this matter. Deputy Coughlan indicated to me in a in the Dáil yesterday some concern about a prior notification being available to the public before some individuals were notified. I do not know how that could happen and I asked for details. It was not intended to happen. The North-Western Health Board dealt with this matter on a confidential basis in so far as that is possible while meeting their public interest obligations by addressing the issue in a comprehensive press conference during the week. As soon as the scientific results were available, which was the week before last, and we were notified we immediately identified the wider implications involved. Within a few days we were able to ring-fence the size of the problem and identify where the issues might have arisen. It is unfortunate to discover that a contracting out of services for cervical screening involved some of them being conducted at home. That indicates that the quality control criteria was not being observed because a second cytotechnician was not involved.

The level of discrepancy was lower for the 1,615 home screenings than for the 500 tests carried out in the Bon Secours hospital, Cork, in percentage terms. Regardless of that, home tests were not part of the contractual arrangements the North-Western Health Board had with Claymon Laboratories. The health board is taking the necessary legal advice on this issue.

Some of the problems of the past are being dealt with. There has been an investment. There were historical backlogs. At present there is a four to six week waiting time at Sligo General hospital and throughout the North-Western Health Board region. The national average waiting time is one to seven weeks. That is a great improvement on past waiting lists. The £2 million investment made since 1997, subsequent to the issues that have arisen in the public domain during the past few weeks, is indicative of the Department's response to resourcing this area better. We must also bear in mind the difficulty in recruiting people for this type of work because of its repetitive nature and the amount of microscope work required for such a subjective test.

Therefore, while Members can express their views of this matter, it is important to maintain public confidence in a system that is working well. There is no reason to suggest there are any inaccuracies over and above those known publicly because internal quality control measures exist in our laboratories. I commend the level of work and the systematic professionalism of those who work in our public hospital laboratories. We have every reason to be confident that the work is being carried out consistently efficiently.

We are moving from an opportunistic screening programme to a national screening programme. The problem with opportunistic screening is that it appears only certain numbers of women are having the smear tests. These women have smear tests more frequently than is recommended but we would like other woman to avail of the programme. The purpose of the national programme is to introduce a screening programme which will allow women between the ages of 25 to 65 years to have one free test every five years. Presumably, anyone who has a smear test on a more regular basis will have to pay for it.

I believe that the provision of a national screening programme will be welcomed. I accept the criticism that it may take longer than expected but we must get the procedures right and ensure there is confidence in the new programme from the beginning. I do not believe the delay is unduly long. The programme is on target and many discussions with professionals are taking place. It is hoped to commence phase one of the programme at the beginning of the new year.

Members will be aware that we have started phase one of the breast screening programme. Everyone who attended the launch was satisfied that the time given to the preparation of the programme prior to its launch was time well spent. This has given people confidence that the programme will be successful. It is vitally important that national screening be introduced and that there be a high uptake of the service. We must ensure the fullest possible participation in the service and it is only by beginning on a professional footing that we can ensure this happens. I thank Senators for their contributions.

I welcome the Minister nd compliment him for responding quickly and satisfactorily to the concerns expressed. When news of this episode reached the media and women realised the system appeared to have broken down, many recalled what happened in the BTSB. It is unfortunate that we must live with the legacy of what happened in the BTSB, particularly in relation to women's health. One can understand women's fears being heightened in relation to issues such as this because of that bad experience. Therefore, it is important to recognise the vigilance of the North-Western Health Board and the fact that its quality system worked and also the vigilance and response of the Minister in reassuring women.

We must sympathise with these women whose test results were incorrectly reported. I am sure it was a frightening time for them until they were reassured and the various mechanisms were put in place. Unfortunately, this matter got into the public domain. I must declare an interest here because I am chairperson of the Well Woman Centre. Part of the service we provide is smear testing. It is indicative of the feelings of so many women that there were many phone calls to our clinics. This prompted us to put up notices reassuring women about the standards of the smear testing procedures carried out by the RCSI. The Minister has addressed comprehensively many of these fears. However, it is important to outline the facts.

We know that the controls over the operation and management of laboratory testing left a lot to be desired. The Minister referred to the protocols that will be implemented and stressed the difficulties of employing technicians and so on. In the UK there is a ceiling on the numbers of smears examined by a technician on a given day. The object is to reduce the rate of human error and this should be part of the controls of laboratory testing. This is indicative of how difficult the procedure is.

There is a difficulty regarding the training of technicians in Ireland. Some hold the view that this has not been standardised and that some technicians pass borderline smears to supervisors for a second opinion. Generally technicians have a masters degree in cytology. However, to date, there has not been a requirement for a suitable minimum qualification for testers and this has led to quality being assumed rather than guaranteed.

A number of speakers alluded to the fact that, notwithstanding the fact that standards seem to have been better in testers' homes than in other locations, there is no legislation to prohibit testers examining slides at home on a piecework basis. I find this extraordinary, given that the home cannot be a laboratory sterile environment and, therefore, there is the prospect of contaminating, corrupting or altering a sample and obtaining a different result. This is not suitable as a cottage industry – it is not like farming or knitting – and must be eradicated quickly. The UK has legislation to cover such an eventuality.

The Minister referred to the difficulty in obtaining cytologists. This puts a pressure on the testing system and affects the turn around of results. I hope the Minister's initiative will lead to a quicker response. We need standards and reassurance about standards for the audit, operation and quality assurance of laboratories in ensuring that human error is reduced to the lowest level possible. No system will ever be infallible but the public must be reassured. I am content with theMinister's reassurances and look forward to a national screening programme.

I take on board the Minister's statement that it is important to get this programme right. This episode has highlighted how important it is to have our procedures right and to have the proper protocols in place. Unfortunately, there were gaps in the system but, fortunately, they were observed in this case and acted upon swiftly.

This is a timely debate and I am glad Senator Jackman tabled the motion because it provides another opportunity to reassure women. As previous speakers said, it is important that women have regular cervical smear tests. We know that cervical cancer is preventable and it is important that women should be encouraged to have smear tests on a reasonably frequent basis. Women should be reassured by the steps that have been taken. The Minister has given genuine reassurances and I encourage women to continue to have cervical smear tests in order to ensure that people do not die needlessly because they were afraid to have a test carried out.

Everyone has read newspaper articles or seen or listened to various television and radio reports on this issue. I read the Minister's speech and I noted his statement that 170,000 smear tests were examined in 1998. In that context, I acknowledge that there is always a possibility that errors will occur and I do not believe we can lay the blame at the Minister's door or that of anyone else.

In my opinion women have gained an increased awareness of how the testing can prevent illness and there is a huge take-up in screening tests which were not available in the past for every part of the body. However, because of the nature of growth in that regard, the monitoring systems were not in existence or failed outright. Like Senator Keogh, I cannot believe that EU standards prevent people from baking brown bread in their kitchens and putting it on sale , yet similar standards could not be applied to the testing system for this potentially serious illness. I am surprised that testing was carried out in such an ad hoc manner.

The Minister referred to several hospitals in the Dublin area and indicated the centres to which their smear tests were sent. However, I do not believe he made reference to St. James's Hospital. I have a particular interest in that regard because a young man with whom I am acquainted lost his 34 year old wife last October as a result of cervical cancer. His wife was screened twice and informed that there was no problem. I do not wish to say anything other than that about the case because it is a matter to be resolved by the man and the hospital involved.

The Minister said that tests from 1994 would be screened. Will tests carried out on people who have since died of cervical cancer during that period also be screened? If errors were made, we should acknowledge that, in some cases, they may have been fatal. In the case to which I refer, I believe the error was probably fatal. However, I cannot offer proof in that regard because I am not a member of the medical profession and I do not have access to any information other than the fact that the woman was reassured twice before dying of the disease.

I acknowledge the difficulties that have arisen for the Minister in terms of reminding people that they should not be of the view that testing should be discontinued. However, sound reassurances must be given. A woman pointed out to me today that it costs her £25 for an annual smear test and she is now wondering if she is wasting her time and money, particularly if the test ends up on someone's draining board and is mixed with foreign substances. I accept that the Minister must address a difficult problem. However, I would like him to reply to my question in respect of tests dating back to 1994.

I support any monitoring systems he proposes to introduce. It is impossible to prepare for such terrible mishaps. However, we must take action immediately to prevent further occurrences. I accept the Minister's statement that we should not move too hastily and that a better job might be done if time for reflection is taken. However, women require a high level of reassurance.

I have had smear tests and on one occasion I was asked to return to the hospital for a second test. I was petrified but happily, as in most cases, the second test was clear. Women are terrified about this because it involves unknown factors. We had thought that having a smear test was safe, wise and sensible and we should continue to do so, but we require reassurance. I look forward to the Minister's response. If it is proven that there was neglect which resulted in unnecessary deaths, it should be exposed.

I will be brief because most of the points I wanted to make have already been made by other speakers and it would be a waste of time to repeat them. I acknowledge the alacrity with which the Minister responded to this problem when it arose and I believe that no blame whatsoever should attach to the North-Western Health Board.

My thoughts and those of every Member go to the 68 women who were called in for further tests as a result of these mistakes. It is important to note that, while it is not an exact science, cervical smear test technology is nevertheless an important aid to diagnosis, particularly that of cervical carcinoma. The Minister and others made the point that it is difficult to recruit cytotechnicans because it takes approximately two years to train them to a level where they can work unsupervised. Therefore, only small numbers of people are interested in pursuing a career in that particular branch of laboratory science.

The Minister also said that there are difficulties involved in introducing an automated screening system. However, I hope we will be able to welcome the advent of such a system in the not too distant future. It is reasonable to assume that, in light of continuing advances in technology, it will become a reality.

It is important to state that the problem under discussion arose when a private company, which was not fully accredited for this work, misled the North-Western Health Board in respect of its ability to examine smear tests. I am married with two daughters and I can imagine that I would be worried to death if any of my family was recalled for cervical screening. The people to whom it happened must have gone through a living hell. I was delighted by the alacrity with which the Minister and the North-Western Health Board responded to this crisis. The Minister outlined the range of measures the health board has already put in place.

It is imperative that the confidence of the general public in the health boards and the cervical screening process should be maintained. The Minister referred in great detail to the measures that have been introduced and I am satisfied with his explanation and reassurances in that regard.

I am delighted we have been given the opportunity to speak on this issue and I wish to comment on Senator Ridge's remarks. She is correct that it is important to ascertain the number of people, whether alive or not, affected by this crisis because the statistics themselves are important. The whole concept of cervical cancer diagnosis is linked directly to cervical screening. I am delighted that appropriate action has been taken, and that the Minister has signalled clearly what will happen in the near future.

It is my duty to speak on this as I have several constituents who have suffered in this situation and I remember the hepatitis C case. Women in general are concerned and in particular those who have been affected by the incorrect reporting of the tests, which happened between August and September 1997, although it was 13 April before many of them were contacted by the health board. I have not spoken to the health board yet so I can only give one side of the story. I welcome the statement by the Minister and other Members that the North Western Health Board did everything in their power and investigated the matter as quickly as possible when they thought something was wrong.

I know that many of the inadequacies in 1997 have since been corrected but the health of the people affected is of the utmost importance. While the tests and future tests may not cause any difficulties for them, at present they are going through a traumatic experience. They have to be given support and in some cases they do not feel they have been given that. The Minister has assured us that everything possible is being done. I know he will look into the individual cases and try to give whatever reassurance is possible. Those affected feel there is a lack of communication and information. All they have been offered are telephone lines manned by trained staff but the best thing would have been personal contact with somebody qualified from the health board.

In one case the woman had a test in 1992, was tested again in 1997 and two years elapsed until she has been told this. She is half way through the fifteen-year period that has been mentioned. While nothing may arise she is in a very difficult situation, yet she feels she is not getting the proper support from the health board. I hope the board will speak to these individuals; so far it has been left to their family doctors. Due to the nature of the test a lot of the women would have gone to a female doctor, who would not be their family doctor. In one case, the woman had received nothing until the news broke in the media and then she was told of the problem by letter. I accept that everything possible may be done but the nature of what has happened may have a more profound mental effect than the final result. I know the Minister is doing everything possible and hopes to bring in the national screening programme as soon as possible.

Mr. Ryan

We are all terrified of this sort of issue, men in particular, who deal with it by ignoring it completely. There is considerable evidence that if men took care of their own physical health, the mortality rate from testicular cancer could be spectacularly reduced. If the insane 30 per cent of the population that insist on smoking were to desist, another huge incidence of cancer would be reduced. Women are more willing to address the questions of their own health and are better than men in facing and dealing with these issues. There is evidence that women are prepared to use whatever resources are available and this is why this is so tragic. Women were more prepared than men in a similar situation to use and trust a service which offered them a reasonable reassurance that a particularly threatening form of cancer could be identified and averted. It is not an issue for political conflict though there are constructive suggestions to be made about what could be learnt from it.

I am not clear about the procedures that the North-Western Health Board used to assure itself of the bona fides of this laboratory. One should not base one's judgment on the bona fides because they tell you they do it properly. Presumably the health board did not know that this laboratory which was very good at marketing its services was in fact subcontracting this work further. The degree to which this issue is the responsibility of a hospital which tends to boast about its services inordinately in Cork and which is regarded by many of the citizens there as the ultimate in health care is a separate issue. I do not think any laboratory should be able to carry out these practices if it does not meet acceptable standards of quality assurance. There is a need to make sure that any clinic or pathology laboratory operates to the highest standard, whether it be private or public. People should be assured that standards are met. I accept that the North Western Health Board detected these problems by a process of quality assurance but quality assurance which only remains in one sector of a chain of services is not really quality assurance. It would not get you ISO9000 if you were in business. A computer manufacturer, for instance, relying on ISO9000 must assure itself that every one of its sub-suppliers meets equivalent standards. Did the North-Western Health Board assure itself of the standards that it would expect and implement in its own laboratories or did it simply accept a sales pitch from a body that claimed to have a greater reputation than it deserved? That is the crux of the matter. I do not want to point a finger at the North-Western Health Board. If we want to be assured of the accuracy of tests in this and other areas, as the possibilities for screening for many other potentially fatal illnesses arise, we will need equivalent quality assurance programmes in all these areas. The need for quality assurance in this area has often been mentioned. Those who work in clinical pathology laboratories have told me that the best a skilled person could be expected to do is about 28 of these tests in a day. That is the limit beyond which human error begins to creep in.

We need to ensure there is a system of accreditation in this category. While we are attempting to develop a system of accreditation, clinical pathology accreditation already exists in the United Kingdom. One laboratory in this State, the blood transfusion laboratory in Cork, has CPA. It is a peculiar irony that the Department of Health and Children and the Southern Health Board are attempting to close that laboratory. I wish they were not trying to do that. While this point is not directly related this matter, that laboratory has achieved that level of accreditation and it ought to be used as a model for other pathology laboratories.

As a stopgap measure, we could require bodies that purported to sub-contract services to the State to meet CPA standards and to seek CPA accreditation from the UK. We could inform them that if they want to provide sub-contracted services to the State service, they must meet CPA or some equivalent standard.

I know we are working on an improved system, but it was disingenuous of the Minister to say that in common with our EU partners we are seeking something. Some of our EU partners already have national accreditation standards and we have been slow to achieve those standards. In the meantime the Minister should consider at least at ad hoc standards of accreditation before he sets up a full national accreditation system for clinical pathology laboratories, which presumably would be legislatively based. He should require ad hoc adherence to the standards required by such an accreditation system and, if necessary, he should set up an independent group to ensure that happens.

If the interval of five years between tests, which the Minister and the experts recommend, had been adhered to in the North Western Health Board, the contradiction between the two tests, which were found to be negative one year and positive the following year, would not have been identified. We have been lucky in this case.

There is an internal review.

Mr. Ryan

The women concerned had smears the previous year, which were categorised as negative. One year they were categorised as positive and another they were categorised as negative. I am glad they did it, but it seems a little of happenstance that women are having these tests more often than is recommended, which the Minister said is causing the backlog. I am glad we were lucky and I am glad the women involved were lucky.

The Minister should inform anybody who wants to subcontract work from a State pathology laboratory that he or she must have some international accreditation or else those laboratories should get the work done by laboratories outside the State, which have that accreditation.

A question arises about whether all GPs have been adequately trained in the taking of smear tests. This can result in errors. Do we have the resources and the skills to provide this service? There is a major gap in that area. Medical laboratory science is one of the extremely high demand areas in the third level sector, partly because of the small numbers involved. If we want to extend the quantity and the quality of our clinical pathology services, we will have to expand substantially the number of people being trained to provide them. That has a considerable resource implication.

I welcome the Minister to the House and congratulate him on the job he is doing as Minister for Health and Children. It never was and never will be an easy portfolio. The Minister has it well sussed out. He has all the facts and he has been excellent in looking after the medical needs of those in his care. Regardless of what others may say, I believe he is one of the best Ministers for Health we have had for a long time.

I was a member of the North Western Health Board for more than 20 years. I was always proud of its work and I am even more proud of it today. Were it not for its internal audit and vigilance, the discrepancy between the tests would not have been detected. People can rest assured that they are in safe hands when they are in the care of the North-Western Health Board and that no chances will be taken.

It is worrying that so many professionals are negligent about their work. It was not bogmen or country lads or lassies who did this work. We have had the BTSB and the hepatitis C scandal. Who did that work? Doctors who were all professionals, with letters after their names. They did not do their jobs conscientiously, as they should have done them. That cost the country millions of pounds and caused heartbreak to many people and their families.

In this case professionals were entrusted with this work. The company to which the health board subcontracted this work did not tell it they would hand out it to cowboys without horses. These professionals brought this work home with them and did it in their kitchens. That is scandalous and those people should be called to book. It is high time a system was put in place in this regard.

Many in high society are being hauled over the coals over simple matters, but people can do what they like in some of our health services and get away with it. I ask the Minister to investigate why those professionals did what they did. It was highly incompetent of them. They are the cause of this problem. I appeal to all professionals in future to be more conscientious. People trust them with their health. It fearr an sláinte na an táinse – health is better than wealth. It cannot be bought. When people entrust their medical care to professionals, they should act in a conscientious and honest way and not take shortcuts. They should not be seen to act as cowboys. That is what they did.

I pay tribute to the North-Western Health Board. Were it not for its efficiency, the way it carries out its internal audits and checks results, this discrepancy would never have come to light and we might have faced a far more serious problem in the future. I congratulate the Minister on the excellent job he is doing. The North-Western Health Board is also doing an excellent job. I sympathise with the victims in this case. As an ex-member of that health board, I can assure them that it will look after their interests and do everything in its power to ensure that their minds are set at ease.

I compliment the Minister on the swift action he took when this problem came to light. Swift action is the key to solving any problem. Unfortunately, when something like this happens, the alarm bells ring. It brings to mind the cases of the BTSB and the hepatitis C scandal. Public confidence in our health service has been damaged to a certain extent. We are trying to encourage people to look after their health. I welcome the recent launch of the national breast screening programme, which is taking place in my health board area. We must try to instil public confidence. It would be wrong to hype out of all proportion. I sympathise wholeheartedly with those who have been involved. We must continue to bring people in for cervical screening. The Minister said it was understood that a large number of people do not come forward for screening. I have worked in maternity hospitals where people have undergone cervical screening programmes. One cannot describe the emotional and psychological trauma involved for an individual in coming to hospital to have that test carried out. It is probably very difficult for men to understand it, but it is extremely difficult for any woman to go through that test and to be obliged to repeat it is so unfair.

I have seen cases where tests can be positive in one instance and negative the next time. One can sometimes get the wrong impression from the media. I stand to be corrected, but at various times, be it following infection or at various stages of a woman's life cycle, cells can be altered. When people have the test carried out it is explained to them that a second test may be necessary.

Women must have confidence in the system. If one has an abnormal test it does not necessarily mean that cancer is present. That is explained time and again when individuals go for screening. However, reading the reports over the last couple of days, it would not encourage people to come forward. From my experience of working in this field, it is possible that tests can be positive on one occasion and negative on another. In an environment where doctors and other medical staff are working effectively, such problems can be overcome and people can be re-tested.

It is important that the laboratory in question is seen to have to pay a penalty because what occurred was inconsiderate, insensitive and amounts to carelessness on the part of those who have been carrying out the tests. As Senator Farrell said, these people were not taken in off the street to carry out the tests. If they are being paid to do the job they should carry it out 100 per cent. In a case like this there is no room for complacency.

I am delighted to see that the Minister has taken action so swiftly. I am particularly delighted to see the whole screening programme is taking off at long last. I hope that in the coming years, as we are trying to establish nationwide testing, there will be no restriction in funding both for cervical and breast screening. Prevention is better than cure.

I welcome the Minister's swift action in relation to this case. It would be wrong if public confidence were damaged by the continual hype. People should realise it is more advisable to come forward for screening.

I listened with interest to what the Minister had to say but I am disappointed that he has not found it necessary to have an independent inquiry, which I feel is essential. I reiterate that the United Kingdom's Royal College of Pathologists should re-examine the north western area, including Sligo General Hospital, to discover why for the second time in a few years a testing backlog of 14 weeks was allowed to develop. Another college of pathology could do so, but the Royal College of Pathologists is the nearest to us and, to a degree, they have the same culture.

As importantly, they should thoroughly investigate Claymon Laboratories and the code of practice. We cannot just leave them aside. Surely the Minister must be happy that a correct code of practice is employed. Is it the policy of the health boards to contract out routine smear tests? The contract research houses should be investigated. If the backlog cannot be met within hospitals one has a vicious circle of contracting out to Claymon who in turn subcontract further. Most of the testing is not done in hospitals but at home.

The Minister said he will work to ensure that all women who present themselves for screening will be dealt with immediately. How will he ensure that their smear tests are analysed quickly if the procedures are not in place? This matter has not been addressed at all.

They are in place.

No. I am talking about the procedures in place if we have to rule out Claymon or any other laboratory following an independent inquiry. If it was necessary to contract out to these houses, who will undertake the work?

Since 1997 the position in Sligo General Hospital has been corrected. There has been a £2 million investment, with the extra staff that I outlined in my address, which has dealt with that situation. The backlog was as the result of a lack of resources at that time. Without making a political point, it was under the previous Administration. We have put in more resources and people are now in a position to do screening within their own resources. Only two other hospitals, Our Lady of Lourdes in Drogheda and Beaumont in Dublin, contracted out that particular type of screening to Claymon. That is the size of the problem.

The reason we do not have to worry about it being contracted out again is that they have brought in extra staff and now have a better throughput in their laboratory system. Therefore, we do not need an inquiry as to whether there will be delays again because we have corrected that problem.

That applies to the North Western Health Board, but I am asking about all the other health boards. Do we know whether or not they contracted out tests? Are we happy that they have not? Is the Minister assuring us that any woman who presents herself to any health board will be dealt with and that there will be no further backlog?

Do we know that, considering that the national screening programme is not in place?

We know that no other health boards or voluntary hospital has contracted out cervical screening to Claymon, except the ones mentioned in my speech, so that is covered.

We have sought information in relation to any other contracted out work Claymon has done. If the laboratory did cervical screening for private clients we will get that information as soon as they have notified those clients that they are giving us the information. Whatever the situation is, we will obviously apply the same consistent approach to those tests as to the ones we have identified thus far.

The investigation has not been finalised. That is my point.

Exactly. I am bringing the up to date situation to the House. For example, we do not yet have the results from Drogheda or Beaumont, but we expect to have them this week. There may be no change in the situation. I can only bring the up to date situation to the House.

I understand that. The motion is general because the situation changes from day to day. I am not happy with it. Hopefully nothing will be wrong with the 350 smear tests from Drogheda and the 200 from Beaumont. Following the two that were pinpointed by the North Western Health Board, the full audit found 68. That is an error of 3.4 per cent, while the acceptable margin of error is half of one hundredth of 1 per cent. There is a very big difference between both figures and it is quite frightening. I hope, as I know the Minister does, that there will be no further fallout in relation to the other tests.

I find the matter of accountability quite extraordinary. I find it strange that staff, who were within the responsibility of the health board and the Department of Health and Children were carrying out work at home. Who allowed them to carry out the tests at home? This is a question of accountability. Was it Claymon, the health board or the Department of Health and Children? Many Members stated that the tests were not carried out in a clinically sterile environment. Nobody is questioning the strange practice of going home to carry out these tests. I would like accountability in this area.

On a point of clarification, there are two contracts. One is between the North Western Health Board and Claymon Laboratories based on the quality assurances received from Claymon Laboratories. Senator Ryan's criticism may be valid and the board may have accepted, based on the fact that this was an accredited laboratory, that they were being provided with professional standards. There was also a sub-contract between Claymon Laboratories and the individuals concerned, so Claymon Laboratories would probably now claim that the work was not carried out on a sub-contractual basis and on the basis it understood the individuals concerned to be doing this work.

As St. Vincent's Hospital pointed out, it had no contact with Claymon Laboratories. Individuals in that hospital who carried out the work did so in a private capacity and the hospital is not in a position to dictate to people what they do outside their normal working hours. That does not excuse the fact that the North Western Health Board was not provided with the level of service it understood it had contracted from Claymon Laboratories. Those are issues on which they are taking legal advice.

I hope that this practice of what may be called "nixers" will be cut out.

How long will phase one last? It will have to be completed before the mid-west region, my area, enters the national cancer screening programme? There seems to be a problem with the IMO. Will there be another delay? This matter seems to have lasted since 1996.

On a point of clarification—

We should not have a question and answer session.

The important point is to clarify the matter.

Acting Chairman

It is unusual but I will allow it.

I apologise for not having clarified this in my speech. Phase one of the national screening programme was to begin early in the new year. There are issues to be addressed, such as some staffing matters. We do not anticipate problems with the IMO but there will have to be some negotiations with that body in relation to the participation of general practitioners in taking smears. Those matters will have to be included in the timescale but everyone involved, including the expert committee, expects that phase one will start at the beginning of the new year.

Full evaluation of phase one will take 18 months, but that will not preclude the possibility of rolling out the screening programme to other areas once we are satisfied the preparatory work will be of the same quality as that prepared for phase one in the mid-west.

The crucial factor is that the surest way of undermining the national screening programme, bearing in mind that we want maximum participation from the target group, would be through inaccuracies because we implemented this in a fashion that was not absolutely foolproof from the outset. Testing is subjective. It is not automated and will not be brought on stream for two or three years after clinical trials. However, just as we are doing with the breast cancer screening programme, we must insist that every possible issue is covered so that public confidence is not damaged as it has been in this case.

We agree with the Minister – that is what everyone wants. However, the time element concerns me. For instance, the expert advisory committee has been developing guidelines on quality assurance, which is essential. The Minister made no reference to regulatory power to oversee all this, which is also essential.

The question of quality assurance criteria from technical assessment to providing reports, including the way in which the laboratory operates, will be finalised this week as a result of months of discussion at expert level between medical and other staff. Those discussions did not arise as a result of this matter coming to the fore in the past few weeks. It has been ongoing since the expert group was set up almost two years ago.

On the wider accreditation issue, we are trying to get people from various disciplines to come together to agree on an accreditation model. I outlined examples of possible models to the three specialties as far back as 9 March. It does not allow them a very long time for their consideration, but in view of what has happened and the wider implications of the North Western Health Board episode, we would like to have their considered replies as a matter of urgency and I have indicated as much to the joint working group.

The confidence of women has been shattered and there is no point pretending that is a result of media hype.

I do not agree that it has been shattered.

It is important that women understand that the purpose of screening is not to detect cancer but to identify changes in the cells of the cervix which can be treated before cancer develops. I refer the Senator to paragraph 112, page 11 of the report of the Department of Health's cervical screening committee. She will get an explanation there for the negative smears. It can happen that there may be a genuine progression from a normal cervix to invasive carcinoma in a short period.

People have been described as being unwilling to take up positions in cytology. Will funding be made available?

Acting Chairman

The Senator's last point is provoking an answer.

It is a rhetorical question. Where can people go if these positions are not filled? I ask the Minister to prioritise this so it is not ignored until another crisis arises. It is essential that the Minister works on this matter, because a commitment has been given to women's health and to improvements in that area. I appeal to the Minister not to let this rest until it has been thoroughly investigated and women are reassured about the treatment of all cancers, not just the treatment of cervical cancer. That must be a priority for the Minister.

I give the Senator that assurance.

Amendment put.

Bohan, Eddie.Bonner, Enda.Callanan, Peter.Cassidy, Donie.Chambers, Frank.Cox, Margaret.Cregan, JohnDardis, John.Farrell, Willie.Finneran, Michael.Fitzgerald, Liam.Fitzgerald, Tom.Fitzpatrick, Dermot.Gibbons, Jim.

Glynn, Camillus.Keogh, Helen.Kett, Tony.Kiely, Rory.Leonard, Ann.Lydon, Don.Mooney, Paschal.Moylan, Pat.O'Brien, Francis.O'Donovan, Denis.Ó Murchú, Labhrás.Ormonde, Ann.Quill, Máirín.Walsh, Jim.


Burke, Paddy.Caffrey, Ernie.Coghlan, Paul.Coogan, Fintan.Costello, Joe.Cregan, Denis (Dino).Gallagher, Pat.Hayes, Tom.

Henry, Mary.Jackman, Mary.Manning, Maurice.McDonagh, Jarlath.O'Dowd, Fergus.O'Toole, Joe.Ridge, Thérèse.Ryan, Brendan.Taylor-Quinn, Madeleine.

Tellers: Tá, Senators T. Fitzgerald and Keogh; Níl, Senators Burke and Ridge.
Amendment declared carried.
Motion, as amended, agreed to.