Private Notice Questions. - Cervical Smear Testing.

Tuesday, 20 April 1999

Dáil Éireann Debate
Vol. 503 No. 3

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Ms Coughlan: Information on Mary Coughlan  Zoom on Mary Coughlan  asked the Minister for Health and Children the action, if any, he will take in view of the serious concerns among women in the Donegal, Sligo and Leitrim areas arising from the incorrect reporting of cervical smear tests between August and December 1997 to ensure this matter does not recur; the further action, if any, he will take against the laboratory involved; the reason it took until 13 April 1999 to notify the women involved; the additional resources, if any, he will make available to the North-Western Health Board to ensure no further delays in test analyses; the way in which he proposes to instil confidence in the testing procedure and encourage women to undertake regular cervical smear testing; and if he will make a statement on the matter.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  asked the Minister for Health and Children the health boards and hospitals which [440] commissioned Claymon Laboratories to undertake cervical screening tests; when, or to which hospital, technicians were subcontracted by Claymon Laboratories; the health boards and hospitals currently rechecking or auditing the results of these tests; the years and number of women affected; and the quality control mechanisms in place to ensure the accuracy of test results.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  asked the Minister for Health and Children the steps, if any, he will take to restore public confidence in smear testing procedures in view of recent revelations; the plans, if any, he has to publish the results of any inquiries he has initiated; the action, if any, his Department will take against companies which have sub-contracted work to public facilities; the additional funding, if any, he will provide to ensure this vital health programme is availed of by as many women as possible; and if he will make a statement on the matter.

Mr. Perry: Information on John Perry  Zoom on John Perry  asked the Minister for Health and Children the steps being taken arising from the recent revelation from the North-Western Health Board on the inaccurate results of the cervical smear testing which involves more than 2,000 women; and if he will make a statement on the matter.

Mr. McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  asked the Minister for Health and Children the action, if any, he is taking to ensure the integrity of the cervical screening programme given the shocking revelation that 68 women in the North-Western Health Board area have been given inaccurate results; the steps, if any, he is taking to reassure the integrity and quality control of these tests in future; and the service and support being made available to the women traumatised.

Minister for Health and Children (Mr. Cowen): Information on Brian Cowen  Zoom on Brian Cowen  I sympathise with the 68 women in the North-Western Health Board whose test results were incorrectly reported. I assure them that any services they require will be made available and I am advised that the delay in detecting the error will not compromise them medically. This has been explained to them by the North-Western Health Board and I add my sympathy and assurances to that of the board.

The possibility of a problem in the North-Western Health Board was identified as part of the routine quality control process. Two smears categorised as positive were reviewed. The women concerned had smears the previous year which were categorised as negative. These smears were screened by a private laboratory and it was considered an error had been made in its classification. A review of all 2,115 smears the private laboratory had undertaken was carried out and further cases with abnormal cervical cells were discovered. This review was carried out by an [441] independent accredited laboratory in the UK and was not completed until the week before last.

The main priority for the North-Western Health Board was the health and welfare of the women affected by the situation. The health board considered 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 results are available within the week.

For those women who need further investigation by colposcopy, the board considered it important that they 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 some appointments were arranged in Dublin where this was more convenient.

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

The health board has acknowledged the tremendous support given by general practitioners, area medical officers and other board staff to ensure the women 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 and help those affected.

The North-Western Health Board had contracted the private laboratory to read the backlog of 2,115 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 the laboratory did not live up to its claims to have internal and external quality control systems and independent quality assurance. These are issues being considered by the health board and it will take whatever action is necessary.

Having satisfied myself the health board responded in a satisfactory way to the women identified as having had an incorrect reading of their smears, it then fell to me to consider what further actions were necessary at national level. My first concern was to identify what other cervi[442] cal cytology work was carried out by Claymon Laboratories. No other health board sent cervical smear tests to the private laboratory concerned. A voluntary hospital in the North-Eastern Health Board area, Our Lady of Lourdes Hospital, Drogheda, 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 which will be completed this week. It is not aware of any problem. Likewise the 150 smear tests from the North-Eastern Health Board are being rechecked by a UK laboratory and this will be completed this week. If any discrepancies emerge in the course of these rechecks, immediate action will be taken by the North-Eastern Health Board and Beaumont.

I have also requested that the laboratory provide my Department with a list of any other private clients who might have used its services for cervical screening. The laboratory has advised it may not disclose the names of its private clients until they are advised that their names will be given to the Department of Health and Children. The laboratory has confirmed it is in contact with its private clients on this matter. I hope to get this information in the next few days and I will then initiate any action 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 and reported on by professionals in Dublin and Cork. The Bon Secours Hospital in Cork has confirmed its involvement on behalf of Claymon Laboratories. In Dublin, St. Vincent's Hospital has assured me it did not carry out work for the private laboratory. Such work was done in a private capacity by hospital staff. Preliminary screening was not carried out at the hospital but at home. The staff concerned also had attachments with St. Vincent's, Elm Park; Mount Carmel, St. Michael's, Dún Laoghaire; and the Bon Secours Hospital, Glasnevin.

While I am not aware of any problems in these hospitals, given what happened in the North-Western Health Board, to allay public concerns and as a precautionary measure, I have asked the hospitals concerned in Dublin and Cork where the professionals were employed to review their cervical cytology work in these hospitals and to let me have an early report on the matter. This review is to cover the period 1994 to 1998 and involves approximately 5,000 smears.

I do not want this issue to be hyped up out of all proportion. It is important to keep it in perspective. I do not want to see 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 [443] 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. Given the experience in the North-Western Health Board, these reviews are necessary to deal with any doubts, to allay the fears of women and to maintain confidence in cervical screening. The problem identified relates to a period in 1997 and to a small number of individuals and is being dealt with in a comprehensive way.

I regret the concern this issue is causing women. It is essential they 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 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 some ten to 15 years for cervical cancer to develop. That is why 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, nor does an abnormal smear result mean a 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. Over 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.

A further concern which had to be addressed was what other work Claymon Laboratory carried out for the health services. My Department has obtained the details and has written to all the hospitals and health boards involved asking them to take steps to satisfy themselves the results were satisfactory and to inform the Department of the position.

Having satisfied myself that everything possible was being done with screening services, I then turned my attention to the national cervical screening programme. I am committed to the development of this programme for women aged 25 to 60 years of age. 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.

The Mid-Western Health Board area was chosen for phase one. A sum of £300,000 was [444] made available in 1998 to the Mid-Western Health Board for the recruitment 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 which 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 that 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 also instructed senior officials from my Department to meet with senior staff from the Mid-Western Health Board to ensure that the pilot programme commences as soon as possible.

The current waiting period for reporting 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 reporting cervical smear test results. Since then about £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 Royal College of Surgeons in Ireland to process some 20,000 smear tests. The waiting period for results in laboratories is one to seven weeks. Any smear test marked urgent is, of course, examined immediately.

There are difficulties in recruiting trained cytotechnicians. 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. While overall the capacity of our laboratories would appear to be sufficient for an organised programme along the lines recommended in the report of my Department'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 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 [445] operate efficiently and effectively and errors avoided.

The report of my Department's cervical screening committee, which was 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 re-screening of normal smears or 30 second screening of all smears and selected re-screening.

Since 1997 the Irish Association for Clinical Cytology, the IACC, has also developed guidelines and these have been circulated to all laboratories. I have met with the chairman of the expert advisory committee on cervical screening, whose terms of reference include advising my Department on the piloting of the programme and on best practice, including quality assurance and new technologies. A sub-group of the expert committee has almost completed its work on quality assurance. I have requested that this work be finalised this week. This 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 re-screening of all smears by another cytotechnician and double screening of abnormal screens. I wish to emphasise again that the problem which has been identified relates to a period in 1997 and to a small number of individuals. I also wish to reassure women who are currently using the cervical screening service that they have no need to be worried.

With regard to the general issues of quality assurance in pathology, each sub-speciality operates to its own professional standards and guidelines. For example, in cytology, as already indicated, the Irish Association of Clinical Cytology 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 and they are represented by a joint working group comprised of representatives of the Faculty of Pathology RCPI, the Academy of Medical Laboratory Science and the Association of Clinical Biochemists. The objective of these [446] discussions is to develop and implement a formal accreditation system for pathology laboratories.

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

Ms Coughlan: Information on Mary Coughlan  Zoom on Mary Coughlan  I thank the Minister for his reply. Is he aware that the notification made available to the women concerned was not satisfactory in that some were not notified prior to notification to the media, even though the North-Western Health Board was aware of concerns and problems since last January? Will he introduce some form of regulation nationally to ensure this never happens again?

Will the further screening and medical intervention be made freely available to the women involved? Will the laboratory in question have a financial penalty imposed upon it? With regard to accreditation, to which the Minister adverted, can he advise us when there will be a national accreditation scheme in the country?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  Following the review conducted by the North-Western Health Board, the quality assurance review and the pro-active approach of the board it advised that all 2,115 smears should be re-tested by an independent laboratory in Scotland. I am sorry to hear the Deputy indicate that information may have become public prior to people being advised personally because the purpose of awaiting the outcome of these procedures was to enable the board to deal with matters as it would have wished, which would have been for GPs to notify the persons concerned. I would be pleased to have the details of any specific cases in which this occurred of which the Deputy is aware and to make inquiries into how it could have happened. The board was anxious from the time the results came back to do everything to ensure that people were notified in the way it had planned. I am not aware how this could have arisen in any other instance.

The North-Western Health Board is taking advice on action that might be taken against the laboratory concerned or against anyone involved in this matter. I have indicated that based on the facts available to me – I am bringing the Dáil up to date on the matter – it would appear that the internal and external quality assurance criteria for which the board contracted were not adhered to in this case. In view of this, it must take advice on the matter because the contract was between the board and the laboratory concerned.

With regard to the accreditation system and the accreditation of private laboratories generally, we have made a submission to the joint working group since 9 March setting out some accreditation models which we believe the group would work to and agree upon. We have asked the group to make an immediate response to this to enable us to proceed on that basis.

[447] On the question of the quality assurance, professional bodies have set out the guidelines on opportunistic screening and these are available to the laboratories. The clinical work is the responsibility of the pathologist supervising and working from the cytotechnicians in the laboratories. Those would be the responses to the questions which have been raised.

Ms Coughlan: Information on Mary Coughlan  Zoom on Mary Coughlan  What about payment for any further tests, analysis or medical intervention for the women whose tests have proved negative?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  Obviously it would be a matter for the board to deal with that issue. I do not expect people who have got an inaccurate test to have to pay a second time.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  Would the Minister accept as a basic principle that women should be the beneficiaries and not the casualties of the health service? Would he acknowledge that the report of the cervical screening committee of the Department of Health and Children recommended that comprehensive quality control must be an integral part of a cervical screening programme at every level? Why did it take this particular health scandal to motivate the Minister to meet the chairman of the expert advisory committee and only in the past week or so to request that standards for quality assurance be furnished to him? Will he acknowledge that it is more than two years since that report was published and that by now we should have in place national quality assurance controls and systems and guidelines to apply to laboratories to ensure the accuracy of test results? Will he acknowledge that if other EU countries have been able to put in place an accreditation system for laboratories, we should also have in place such a system? Will he assure the House that no woman who has had a smear test in the past 12 months need have any worries or doubts about the accuracy of the results furnished?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  To take the final question first, the Deputy will be aware that there are quality assurance criteria involved in the present smear testing programme. It was as a result of the exercise of that quality assurance by the North-Western Health Board in Sligo General Hospital that this issue was investigated. This issue arose because of the proactive quality assurance measures which are already in place.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  If they were working, we would not have had this difficulty in the first place.

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  On the question of the assurance the Deputy is seeking for people who have had tests – let us remember that there were 170,000 tests in 1998 – there is no evidence to suggest that tests, other than the ones which have come before us in respect of this matter, will be disputed in any way because there are internal qual[448] ity assurance controls in all of the laboratories. That is how this issue came up in the first place. It is important to make that point.

I agree with the Deputy that women are beneficiaries of the health service. That is why we introduced these developments in the first place. The review in 1997 to which the Deputy referred is the blueprint for the introduction of a national cervical screening programme. As has been said and as the Deputy stated in alluding to the recommendation, quality control must be an integral part of this service before we get it up and running. We do not want to repeat some of what happened in other jurisdictions where confidence was undermined in those programmes because of the number of inaccurate tests which arose as a result of not dealing with those matters before introducing the national screening programme. The expert working committee is conscious of that and has been making preparations as a result of moneys which it has only received in 1998 – it did not receive money to proceed in 1997. The money is for the training of staff; to provide a population register for women between 25 and 60 who are sexually active – the target group for the screening programme – and the need to have a proper computerised call back service. I understand the committee has been looking at models in New Zealand and Australia and it saw one in New South Wales which it believes would probably be best suited to Irish circumstances.

It is not correct to suggest that the expert working group has been sitting on its hands in relation to this matter.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  I suggest the Minister has been sitting on his hands as with other issues.

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  That is the Deputy's view. I ask him to let me address the issue. We have just begun to introduce a breast screening programme in two health board areas which we will evaluate and progress to other health board areas as we introduce a national breast screening programme. It was the plan of the previous Administration, with which I agreed, that we begin phase one of the cervical screening programme in the Mid-Western Health Board region on the basis of the necessary preparatory work being conducted. That is at an advanced stage.

On the need for accreditation and quality control, in addition to preparing for a national cervical screening programme the expert working group is at an advanced stage of bringing forward protocols to deal with that issue generally and hopes to have it finalised this week. Therefore, it is not as a result of this unfortunate incident having occurred in the past fortnight that suddenly this work is coming to finality. It is as a result of a process which has correctly taken time because of the membership of that board wanting to make sure they get everything right before they introduce the national screening programme.

The purpose of any national screening programme is not to undermine confidence. We have [449] identified the size of the problem in the North-Western Health Board where 68 wrong indications were given out of 2,115,and that has been dealt with. There are 350 further smear tests to be conducted in relation to what Claymon Laboratories did at Our Lady of Lourdes Hospital, Drogheda and at Beaumont Hospital. Having identified the people who did that work on its behalf on an agency basis outside public hospital facilities, we are now making sure that whatever work was done by that personnel in the system will be checked. The reason I am going back over a five year period is that is the period which the experts say is the period for routine screenings. As a precautionary measure, we are having the absolute maximum investigation which is prudent in the circumstances to meet the proper concern of this House about this matter while re-emphasising that confidence may be given to the screening programme generally in view of the quality assurance issues, which are dealt with on a daily basis and which highlighted this problem in the first instance.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  In the context of the 68 women who have been recalled for further checks, has it been identified yet whether the problems with their test results derived from the work done in the Bon Secours Hospital or the work done by the medical and technical staff attached to St. Vincent's Hospital who apparently did this work at home? Would the Minister agree it is an outrageous scandal that such testing was undertaken in the home or homes of one or more individuals?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  The contract which was drawn up between the North-Western Health Board and Claymon Laboratories referred to quality assurance criteria, normally available in the North-Western Health Board laboratories being made available by Claymon Laboratories. Otherwise the North-Western Health Board would not have in good faith subcontracted that work, which was a backlog of work which had arisen because of a lack of investment in cervical screening up to 1997. There has been a £2 million investment in it since. I outlined where that money has been spent in general terms on improved staff and expertise so that we are not in a similar situation now, and it is important to make that point.

If there was a breach of contract – on the face of it there appears to have been a serious breach of contract – that is a matter on which the North-Western Health Board must take appropriate advice.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  Does the Minister agree that because we do not have a national cervical cancer screening programme at present women's lives are being lost; it is a kind of screening which is immensely effective; and it is vital that it is put in place on a national basis if we are to protect women from cervical cancer? Does he also accept that, in this instance, the laboratory had international accreditation and this factor needs to be [450] considered by the Department? I accept the Minister does not want these events to undermine women's confidence in the screening programme. However, does he accept their confidence has been seriously undermined and that he must do more than simply review what has happened in the past, which is the essence of his reply? He must put the implementation of a national cervical screening programme on fast track, in line with the commitment given by his Department that this programme would be fully functioning this year. There is grave concern among those operating in the service about the lack of staffing and a lack of training for the staff required. Will the Minister outline how he is meeting that requirement?

Will the Minister comment on one of the gravest aspects of this series of events? Irish women between 25 and 60 years old, who are sexually active and are entitled to a service they can trust, have in the past week seen a service that in part at least has the hallmarks of a cottage industry. The idea of people setting up a laboratory of sorts in their kitchen or living room to assess smear tests is extraordinary. Does the Minister consider this domestic style of laboratory acceptable? Is he aware of whether it is extensive, whether it exists at all or whether it has been removed? If the system exists, who is partaking and at what standard? Does he approve of this kind of scientific analysis of something which is so vital to women's lives?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  There is no question that the methodology used in the screening of some of these smear tests is in any way acceptable. The manner in which these tests were conducted is not part of the system. The Deputy said that in some way this is a cottage industry; I ask her to accept this is not a typical situation as regards the screening of smear tests. We have been contacted by cytotechnicians and people in this field who are anxious that their professionalism is upheld. This is not recommended or accepted by anyone in the health service as an acceptable method of doing this work.

That is clearly not the case as there is a requirement for cytotechnicians to view a test and for a second cytotechnician to look at it again. In the instance of a borderline case, it is necessary for a consultant pathologist to sign off on it. That clearly did not apply in this situation. For that reason we are taking every possible step to ensure the work which may have been done by any member of staff as a result of this will be dealt with comprehensively over a five year period as a precautionary measure.

The introduction of a national cervical screening programme is online. It was not the objective of the committee to introduce a programme in 1999; the pilot was to have begun by 1999.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  Not in the Minister's strategy. He is wrong.

[451]Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  The Mid-Western Health Board was supposed to do that. There was no prospect of a cervical screening programme prior to providing some resources. There was an absence of resources until recently as regards the staffing of existing laboratories and the need to fund phase 1 of a national cervical screening programme.

I agree with Deputy McManus that a national cervical screening programme would benefit the public health of women generally. One of the main problems with the opportunistic screening programme is that I, along with many in the health sector, am not satisfied that those who should be screened are being screened. Many women are being screened more than once within the five year period while others are not being screened at all. The purpose of moving from an opportunistic screening programme, as is the case at present, to a national screening programme would be to ensure a wider public health benefit. Whether it is in relation to breast or cervical screening, these are the benefits to the female population.

It is important that when we introduce a national cervical screening programme, the present arrangements where women are tested more frequently than the five yearly interval will have to be dealt with by laboratories because it militates against the effective introduction of a national screening programme to test all of the women in the target group identified as requiring testing.

I do not accept Deputy McManus's contention that we are simply reviewing the matter as a result of this issue. As I said to Deputy Shatter, we have been proactive in this area, both as regards the introduction of phase 1 of the screening programme, which we hope will happen early next year and sooner if we can manage it, and the issue of accreditation. It is more than a month since we provided models to the joint working group to agree an accreditation model with those working in the sector concerned. Far from being complacent, we are anxious to deal with the matter generally, first as regards the accreditation of laboratories and second as regards moving ahead with phase 1 of the national screening programme as a matter of urgency, for which we have provided funds. As regards the specific issues which have arisen and the wider implications generally, we are comprehensively reviewing whatever needs to be reviewed so that public confidence in the system can be maintained.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  The Minister did not reply fully to my question. He said home testing should not be happening, with which I agree. However, he did not say it does not happen. Will the Minister guarantee that laboratories will operate at a capacity of more than 15,000 smears, which according to the working group is the requirement from now?

[452]Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  The protocol suggested is at least 10,000 smears annually.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  It is 15,000.

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  There is no reason to suggest the work being conducted in smaller laboratories in many hospitals has caused problems. The public health system comes out well in this matter, in view of the fact we have had no problems.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  What about home testing?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  I assure the Deputy I am not aware of any example, other than the one evidenced here, that home testing is taking place. If there is, they are in breach of contract.

Mr. Perry: Information on John Perry  Zoom on John Perry  Was the Minister aware that Sligo General Hospital had handed the task of clearing a backlog of tests to a private company? If he was so aware, and it is inconceivable that he was not, what measures, if any, did he take to ensure the Dublin based private company had quality control standards similar to those in operation at Sligo General Hospital? It is unacceptable that so soon after the appalling and sometimes fatal mistakes made in blood transfusion that almost 70 women have had the harrowing experience of being told the results of tests conducted 18 months ago and initially reported as normal are abnormal.

In his investigation, the Minister must reconcile the conflicting claims of the North-Western Health Board and the private Dublin based laboratory. On one hand, the North-Western Health Board stipulated that the Dublin based laboratory should use quality control standards similar to its own. On the other hand, the company has stated that it does not carry out smear tests and, therefore, it had to send a sample for examination by outside experts. Is such a confused approach acceptable in such a vital area for women?

Is the Minister aware that in the Republic of Ireland 80 women die every year from cervical cancer? Comprehensive screening programmes have been introduced in England and most other EU countries over the past 11 years for the very basic reason that international evidence has conclusively shown that screening significantly reduces the incidence of cervical cancer. Is the Minister aware that screening is voluntary in this country at present? It is up to women to present themselves for screening but when they do they get less than a satisfactory response, in light of what has happened with private laboratories.

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  I have already answered some of those questions. I explained the difference between opportunistic screening, which is the present system, and the benefits of bringing forward a national cervical screening programme.

The backlog arose because of the lack of resources being provided at that time for the laboratories to deal with the amount of work coming [453] through. This Administration has provided investment to deal with that backlog. We now have a far more satisfactory situation in relation to waiting times than was the case two and a half years ago. I know the Deputy was not a Member of the House at that time but he was probably a card carrying member.

Any dispute which exists between the North-Western Health Board and Claymon Laboratories may have to be resolved in a forum outside this House. However, based on the facts presented to me and the North-Western Health Board's position on this matter, it appears that there was a breach of contract and it is taking advice accordingly.

Mr. McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  Does the Minister agree that cervical smear testing should be a central element in the country's health programme for women? There is a great danger that the fiasco which occurred in the North-Western Health Board area will undermine national confidence in the integrity of these tests, which would make matters even worse. What steps does the Minister propose to take to assure women of the integrity of future tests and that they will be given proper and accurate results?

The Minister may have already admitted this, but the backlog of 2,000 cases is a result of inadequate resourcing in Sligo where they have the facilities to do this in credited laboratories. Can the Minister guarantee that all future tests will be carried out in credited laboratories with the highest quality control certification and that accurate test results will be delivered to those who have taken them?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  I agree with the Deputy it was unfortunate that the only option available to the North-Western Health Board in 1997 was to have this work done by contract because the then Administration had not provided adequate resources for the health board to do it. Since then, we have provided resources to ensure the North-Western Health Board does not have to again face the prospect of having to contract out 25 per cent of its smear testing because of lack of resources in its laboratories to deal with the backlog.

Mr. McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  Is there a backlog at present?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  I understand the waiting time in the North-Western Health Board is now between four and six weeks. We are dealing with a qualitatively different situation than that of two years ago; which one would expect, given the investment in laboratories and the recruitment of staff. However, there have been difficulties in recruiting staff because of the type of work involved, which is manual and will not be automated for another few years. Hospital and health board management have had problems in training up staff and in retaining them once they have been trained. That issue has been, and is being, addressed.

[454] While this is a most unfortunate occurrence and I greatly sympathise with the 68 women who must be revisited to allow clarification, I make the point, without reducing the importance of this to individuals, that smear testing does not denote the condition. There is a ten to 15 year period before the condition arises, which is why five yearly intervals are suggested by the national cervical screening committee. All the medical evidence available to me suggests there would not be a different medical outcome for the persons concerned, once the retesting takes place. That is of major consolation. However, errors have take place and we must learn from the failures which occurred. I am anxious to ensure we get a comprehensive review of whatever tests need to be reviewed as a result of the evidence that has emerged in this case and to deal with the issues in the way I described in my address to the House.

An Ceann Comhairle: Information on Séamus Pattison  Zoom on Séamus Pattison  We have spent 50 minutes on this subject and the House must deal with other matters today. However, I will allow a very brief supplementary question.

Mr. Shatter: Information on Alan Shatter  Zoom on Alan Shatter  Arising from the Minister's various replies, is he giving an undertaking to this House that quality assurance mechanisms and the new standards that are to apply will have national application within a matter of weeks and, if so, from what date? Will the Minister give that undertaking to the House?

Will the Minister clarify whether there is a timeframe for determining the criteria to apply to the accreditation of laboratories? Will he agree that, as it is well over two years since the report addressed these issues, both he and his Department have been extraordinarily slow in implementing these recommendations and recognising the urgent need to so do? Can he give an assurance that, as a consequence of the events we have learned of in recent days, there will be a greater sense of urgency from the Department of Health and Children and the Minister about the need to ensure the accuracy of all results and to ensure proper quality control assurance mechanisms are in place, in the interests of women who rely on cervical screening as a life saving mechanism and so that they can obtain treatment in good time where it is required?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  I confirm to the Deputy, as I set out in my up to date report to the House on this, that the expert working group is finalising the protocols for quality assurance issues in laboratories in these matters. That has been the result of a great deal of deliberation on its part. I understand one more meeting should result in the finalisation of those issues. I will then immediately seek to have those recommendations and protocols implemented as a matter of urgency, as a result of what we have seen here.

The current review will allow us to ensure that what happened here will not be repeated. Contracting work may not be a problem in itself, but [455] the manner in which this was subcontracted and dealt with is not acceptable and should not have occurred. We will have to ensure that there is every necessary mechanism in the system to prevent it recurring.

Ms McManus: Information on Liz McManus  Zoom on Liz McManus  Will the Minister give a commitment that he will publish all the findings of his review, including the letters he sent to the two hospitals? I am sure he would agree that his giving full and frank information would help to restore public confidence. However, I am also concerned that some of the statements he has made in the House may not stand up in terms of contractual obligations. While I am sure they were said in good faith, I am concerned that there may be binding contractual arrangements in regard to subcontracting which could be applied against the particular laboratory.

Will the Minister tell the House when the national cervical cancer screening programme will be fully implemented across the country? I am not talking about pilot schemes but about a proper national programme which was outlined in the national cancer strategy published by his Department. When does he intend the national programme to be fully operational?

Mr. Cowen: Information on Brian Cowen  Zoom on Brian Cowen  As regards publication, my job is to bring all the facts to the House either at the request of Deputies or on my own behalf. As regards correspondence with the hospitals, that matter will be dealt with between the Department and the hospitals. The Deputy can rest assured that all relevant facts in relation to this matter and the review of the 350 smear tests currently in the two voluntary hospitals and, as a result of my instruction to the hospitals, the wider review of the staff who handled these smear tests will be in the public domain as it is in the public interest to do so. The Deputy should have no fears about me discharging my duties in that regard.

As regards a target date for setting up the programme nationally, it is my intention to proceed with phase one of the national cervical screening programme as a matter of urgency based on the advice of the expert committee. In the same way as we have seen the benefits of starting the breast screening programme in recent weeks, the committee is the best way to proceed and to take the medical advice accordingly. The chairman is aware from my discussions with him that we are anxious to move on this as quickly as possible.

Written Answers follow Adjournment Debate.

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