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.
