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Dáil Éireann díospóireacht -
Wednesday, 24 Sep 2008

Vol. 661 No. 1

Private Notice Questions.

Cancer Screening Programme.

Some Deputies have tabled private notice questions for the Minister for Health and Children, Deputy Mary Harney, regarding recent misdiagnoses of breast cancer in Ennis General Hospital. I ask them to submit their questions to the Minister in the order in which they provided them to my office.

Jan O'Sullivan

Ceist:

Deputy Jan O’Sullivan asked the Minister for Health and Children if she will request the Health Information and Quality Authority, HIQA, to carry out a full inquiry into the circumstances of the deaths of Ann Moriarty and Edel Kelly, and into allegations that there was a failure to diagnose breast cancer, particularly in view of the fact that early diagnosis and treatment might have saved the lives of the two women. Will the Minister make a statement on the matter?

James Reilly

Ceist:

Deputy James Reilly asked the Minister for Health and Children if she will instigate an independent inquiry into the misdiagnoses of breast cancer in Ms Edel Kelly and Ms Ann Moriarty, which in both cases occurred in Ennis General Hospital. Furthermore, such an investigation should include the mammogram which was carried out at St James’s Hospital and the core biopsy that was carried out at Limerick General Hospital. In that way we can reassure the public that our health services are indeed safe and that any lessons we learn from this will result in the implementation of a proper system to ensure that human error does not impact negatively on patient care.

Pat Breen

Ceist:

Deputy Pat Breen asked the Minister for Health and Children the position regarding the recent misdiagnoses of breast cancer at Ennis General Hospital, including tests performed at St. James’s Hospital and Limerick Regional Hospital, and the need to establish an independent inquiry.

Michael Noonan

Ceist:

Deputy Michael Noonan asked the Minister for Health and Children if she will hold an inquiry into the misdiagnoses of breast cancer, including the misreading of smear tests, in the mid-west region, and if she will make a statement on the matter.

Timmy Dooley

Ceist:

Deputy Timmy Dooley asked the Minister for Health and Children what assurances she can give to other patients attending Ennis General Hospital in view of matters arising from recent cases, and if she might indicate what role HIQA could play in this process.

For the past few days I have been considering how best to address the serious issues that arise from the recent tragic deaths of Ann Moriarty and Edel Kelly following their treatment in Ennis General Hospital. I have met with the husband and the sister of Ann Moriarty and I intend to meet the family of the other woman next week. I wish to extend my sympathy to both families on their sad losses. Ann Moriarty and Edel Kelly were two young women, both mothers.

The expert clinical advice available to me is that a clinical review of other patients treated in Ennis General Hospital would not be warranted. I am also conscious that in the context of future lessons for cancer services, breast cancer services have now been transferred from that hospital to the designated specialist centre for the mid-west and Limerick.

Regarding the treatment of Ann Moriarty in St. James's Hospital, I am aware that she was diagnosed with breast cancer two years previously and that she continued to attend the follow-up clinic at the hospital. Ms Moriarty's most recent follow-up was in April 2007 and at that time a mammogram taken was reported as clear. Subsequently the hospital has not been able to locate this mammogram in order to have it reviewed.

Regarding Edel Kelly, both a biopsy taken at Ennis General Hospital in October 2006 and a histopathology report noted that no tumour was identified but read "clinical correlation recommended". This clinical correlation did not occur nor was there a multidisciplinary meeting to discuss Edel Kelly's health.

The key factor in Ann Moriarty's case was the failure of Ennis General Hospital to refer her to a designated cancer centre when it was known that she had a history of cancer. In the case of Edel Kelly, the absence of a multidisciplinary team approach resulted in her cancer not being diagnosed. Since we have now moved breast cancer services from Ennis General Hospital, I feel it is important to have a wider examination of the operation of the hospital that would examine the approach to issues relating to the diagnosis and treatment of patients. This includes arrangements for quality and safety and communications within the hospital and, in particular, with patients. I believe there are many lessons to be learned by Ennis General Hospital and by the wider acute hospital sector.

I am very conscious that the Health Service Executive has worked for some time to reconfigure services in the mid-west region. It has engaged with clinicians and other health professionals in the region to agree a practical, patient-centred plan for reorganising services between Limerick Regional Hospital, Ennis General Hospital, Nenagh Hospital and St. John's Hospital. Clinicians in the region have worked positively and have shown strong leadership towards this end. I am aware that the HSE has placed a particular emphasis on integrating accident and emergency services, with clear roles for all four hospitals, as part of a well-defined emergency care network. I am also aware that the Health Information and Quality Authority, HIQA, has reviewed documentation relating to the cases of Ann Moriarty and Edel Kelly. Last week representatives of the authority met Mr. Karl Henry, husband of the late Ann Moriarty, to establish whether a further investigation is necessary.

Notwithstanding this, I am now requesting the Health Information and Quality Authority, under section 9(2) of the Health Act 2007, to review the arrangements for providing services at Ennis General Hospital, with particular reference to the diagnosis and follow-up of patients and the communications systems in place in the hospital for patients and staff. The review, to be completed in three months, will include an explanation of how these arrangements work in the emergency department in particular. It would be particularly helpful if any of the conclusions or recommendations were applicable to the wider acute hospital sector.

The HSE is also putting arrangements in place for those patients who attended hospital breast clinics throughout the country in the past two years and who do not have a diagnosis of cancer but have concerns in light of recent events. A specified referral arrangement for these patients is being put in place and any woman with concerns should contact her general practitioner who will be able to refer her to a specialist breast clinic.

There is every reason to believe that the vast majority of women have received the correct and appropriate assessment but I believe it is important to offer patients the option of a specialised referral service, following discussions with a general practitioner.

I will now call on the Deputies to table supplementary questions in the order in which they submitted questions to my office.

I welcome the fact that the Minister has awoken to the need for her to show leadership on this issue. She took a long time to do this but I am happy that she is announcing an inquiry today. However, from listening to the Minister, it appears to me that the inquiry is more about the agenda of downgrading Ennis General Hospital, Nenagh Hospital and St. John's Hospital than about finding out what happened to these two unfortunate women and their families. Can the Minister clarify whether this investigation will examine what went wrong in the cases of Ann Moriarty and Edel Kelly? Will the inquiry study those cases specifically?

The Minister said that consultation with clinicians in the mid-west is ongoing but when will she engage with patients and the public in the region? When will the Teamwork report be published? This is all going on behind closed doors and the public is not supposed to know about it. We received one leaked document from Nenagh Hospital but we have no idea what is happening in the mid-west. As I said, I welcome the fact that there is to be an inquiry, but why did the Minister wait so long? Why did she not immediately ask HIQA to undertake an examination of what went wrong in the two cases concerned? Can the Minister clarify whether this inquiry will address the concerns of the two stricken families or whether it is about an agenda she holds, along with the HSE, regarding hospitals in the mid-west?

My agenda is to ensure that the services we provide are as quality assured as possible. This is why, with regard to the cancer control programme, we are putting in place eight designated centres. Notwithstanding that expert advice from Ireland and overseas recommends this, there is considerable opposition to it in this House and around the country. Only last week I met a group of people from the north west who strongly oppose the service being moved from their local hospital. With regard to breast cancer, all of the evidence from cancer experts in Ireland and elsewhere shows that unless a centre has at least 150 new cases per year, two specialist breast surgeons, two specialist pathologists and two specialist radiologists, a quality-assured service, which improves outcomes for women by up to 25%, cannot be provided. This means that while five out of five women may survive in a specialist centre only four out of five will survive in a non-specialist centre.

We know the facts in the case of Edel Kelly. A clinical correlation was recommended but did not happen and there was no multidisciplinary approach to her case.

We do not know why this did not happen nor whether it applies to other cases.

It did not happen because hospitals like Ennis General Hospital do not have the capacity to provide such a service.

Of course they do.

We do not have specialist breast surgeons and pathologists specialising in breasts in small hospitals. It would not be possible. Until recently more than 30 hospitals in this country were involved in breast surgery. Between 2005 and 2007 there were 17 breast procedures in Ennis General Hospital. It is not possible to have skilled expertise with volumes as low as that.

They could have dealt with the request for a clinical correlation.

Regarding the two cases in question, HIQA is considering whether there is a need to assemble a new set of facts. I told the sister, whom I met last week, and the husband of the late Ann Moriarty, that we will leave no stone unturned to ensure they get the information required in whatever way it can be assembled. A considerable amount of information has already been assembled as there were three different inquiries into that case. Mr. Henry and his family still have questions and they are entitled to answers. HIQA, an independent body, is examining the issues relating to the two specific cases.

There are wider issues relating to Ennis General Hospital that concern me because Ann Moriarty presented as an accident and emergency department case. People present every day at accident and emergency departments and I want to ensure that when we provide hospital services we provide quality-assured, safe services to patients, to the best of our capacity as a country.

This is not about downgrading anything but is about upgrading patient care and safety. The Deputy asked why there is not patient buy-in, but patients look to the clinical community on these issues, as do I. I have taken advice from Professor Arnie Hill, head of the Royal College of Surgeons and one of our leading breast surgeons, who is involved with Professor Tom Keane in implementing the new cancer control programme. I have listened to Professor Keane, a breast radiation oncologist of international repute, and my own medical team at the Department. This is the advice I must listen to as I am not a clinician. Even if I were a clinician, it is important to listen to the advice of experts. I take that advice when it comes to clinical matters.

We cannot have inquiries into every misdiagnosis that occurs. Long before I became Minister for Health and Children, in the 30 years I have been in this House, I dealt with constituents who have experienced misdiagnoses and families that have lost a loved one. This is the reality as even in the best health system in the world errors may occur. We have had a number of inquiries and will continue to have them when necessary. However, we cannot tie up the best clinicians in the country in constant inquiries at the expense of services. This is why so much focus must now be on putting in place the new programme.

By March 2009, breast surgery will take place in the eight designated centres. Nineteen hospitals already have ceased performing breast surgery and at that point, one will be able to state that Ireland is providing the best possible service to breast cancer patients which is on a par with the best that is on offer throughout the world.

I also welcome the inquiry. However, from the Minister's remarks, I am unclear whether this inquiry will include the two specific cases mentioned, those of Ms Moriarty and Ms Kelly. From her remarks I understand it will encompass services of a broader nature at Ennis General Hospital. Like my Labour Party colleague, I must say, "better late than never". However, it is upsetting and disappointing to be obliged to wait for so long and that the leadership took so long to be seen, as well as to move, act and represent the public interest. The families were obliged to go through the trauma of public glare to get what was rightfully theirs, namely, justice and transparency for their loved ones. I refer to the damage done to the credibility of the HSE, as one professional after another was rolled out to pour cold water on the need for an independent inquiry. The Minister mentioned the gentlemen concerned and I would be the first to acknowledge their expertise, which lies in breast cancer and not in public disquiet or in meeting the concerns of the public. Such expertise lies within this House, to which Members were elected to represent the people.

I also am concerned there has been no mention of the disappearance of the mammogram at St. James's Hospital as being part of this inquiry because I believe it is extremely serious. For instance, is it known whether a digital machine performed this procedure? If so, is there not a record of it on the hard drive and, if not, why not or how not? This must be investigated. I accept the biopsy might have been taken in Ennis General Hospital and examined in Limerick Regional Hospital. As a clinician, clinical correlation to me means asking whether this fits with what one has seen as a clinician. That is all it means and if the biopsy is negative, the ultrasound is clear and the mammogram shows nothing to worry about, one must ask the reason the patient was not brought back to have a further review if the lump was still present in a month's time or whatever. This must be examined and we must find out what went wrong.

The Minister's is absolutely correct regarding her further questions on Ennis General Hospital. We must find out the reason blood markers were not followed up, what happened in the accident and emergency unit and the reason, the patient having been there for four days, it occurred to no one this could be a recurrence of cancer. In so doing, we must help and support those who were involved in this case in order that they do not make the same mistakes again and to fix the system that allowed this to obtain. Has this anything to do with the lack of investment in Ennis General Hospital, which my good colleague, Deputy Breen, has informed me has been promised yearly for many years?

The Minister also made a statement which I do not accept, that one cannot investigate every incident throughout Ireland. Had we an identifiable patient safety authority, to which people could go with their concerns without being obliged either to resort to publicity and the associated glare and upset it causes for families or to go to the courts, such matters could be dealt with. Fine Gael has asked for this in the past and while one could be accused of creating another quango, this would not be the case as it could be brought under the remit of the Health Information and Quality Authority, HIQA, or vice versa. The point is that Irish people are entitled to know they and their loved ones are being looked after properly. I frequently have been on record as stating that while human error always will be with us, a good system will minimise the impact of such human error on the patient. When human error takes place and has a negative impact, people should not be obliged to go through the trauma through which Mr. Henry and Mr. and Mrs. Kelly were obliged to go.

The Minister mentioned the movement to the eight centres. It does not matter what these centres are called, be they centres of excellence, specialist centres or whatever, unless they are funded and resourced appropriately to carry out the job they must do, we will have more of the same. I specifically refer to Waterford Regional Hospital, which originally was due to take all breast cancer cases in the south east by November 2009. Last week, it was informed that the process must be completed by the end of next month. There is no confidence there that it has the theatres, staff or resources to deal with the influx of patients with which it will be obliged to deal. There is a sense there of being set up to fail, rather like Portlaoise hospital, which also was a designated centre.

I would be grateful were the Minister to respond to my concerns. I will finish by again welcoming the independent inquiry. I hope it will be expeditious and does not transpire to be like the inquiry on the north east, on which one still waits, despite it having been promised last July.

Many questions have been raised by the Deputy. First, the terms of reference will mandate that the inquiry be concluded within three months because speed is important. It is important for confidence in Ennis General Hospital, for the patients who attend there and for everyone else who is involved. Second, the mammogram in St. James's Hospital was analogue and not digital. However, I understand it is now digital. The mammogram was taken in the private hospital, which at the time was not part of the PACS system and was of the other breast. Unlike Deputy Reilly, I am not a clinician but the report of the mammogram states it was clear. Doctors have told me it is highly likely that the cancer does not spread to the other breast but to other parts of the body. I understand this was metastatic cancer. However, in the dialogue HIQA has had with Mr. Henry, the issue of the missing mammogram in St. James's Hospital has been part of their consideration.

As for the issue of expertise, the expertise in respect of whether we have clinical look-backs rests more with people such as Professor Hill and Professor Keane than with anyone in this House. I reject the suggestion, which places a question over their professionalism, that people on their level with reputations such as theirs would be rolled out or used by anyone. Certainly there is no question of me asking anyone, not least someone at that level, to perform a function they do not wish to do. If they are invited by the media to participate in programmes and agree to so do, they give their honest views on matters as they perceive them.

As a general practitioner, the Deputy will acknowledge that the speed of the transformation in breast cancer services in recent months has been incredible. It has happened with incredible speed, which is impressing clinicians. Only last night I spoke to a clinician from Galway who, as a doctor, was really inspired by the speed at which the reforms have been put in place. I welcome this and that is the reason the target date for the completion of the transition of breast services from the smaller hospitals to the eight centres has been brought forward. It is precisely because women themselves wished to attend such centres and did not wish to attend hospitals that were not designated centres.

Professor Keane sought and received resources for the transition last year. He has sought resources for next year for prostate and lung cancer in particular and will receive those resources, notwithstanding the changed economic circumstances. He has made the point that we spend considerable resources in the area of cancer. Successive Ministers for Health and Children, including Deputy Noonan, who is present, invested considerable resources in cancer. However, when such investment is fragmented, the same benefit does not accrue from those resources as would be the case were the resources and expertise brought together. This is what is taking place and much of the additional resources involves transferring the resource from the local hospital to the centre. For example, Mr. Barry in Mayo will move to Galway from Castlebar hospital for two days a week to perform breast surgery. The same also will apply to other breast surgeons. I understand one already has moved from Kilkenny to Waterford and so on.

As for the two individual cases and what other facts must emerge, we know a lot about what went wrong in both cases. Although Ann Moriarty should have been referred back to St. James's Hospital, where she had been treated for breast cancer, that did not happen. As for Edel Kelly, while the Deputy knows more about this than do I, the HIQA report in respect of Rebecca O'Malley made recommendations about fine needle biopsies. As I understand it, one does not simply go in with a needle, take a sample and send it for a biopsy. Instead, I understand one also uses ultrasound to guide one as to which tissue to remove. I understand that did not happen. Therefore, I presume the tissue that was subject to the pathology examination in Limerick Regional Hospital probably was fine. I understand the issue is whether the appropriate tissue was examined.

HIQA is a patient safety authority. Its job is to set and enforce standards in the health care system. Such standards are set and enforced with a view to improving services for patients. We have had the report of the patient safety commission and, among others things, we must introduce a licensing or accreditation system. The reality is that we do not have particular standards of care and criteria for the opening and functioning of hospitals. That, in particular, is very unsatisfactory from a patient safety perspective. I will bring the recommendations of the commission to Cabinet very shortly with a recommendation for their implementation.

With regard to the comments about me not acting speedily, I met Mr. Henry last week. I became aware of the Edel Kelly case late last week. I am always interested in meeting patients and I meet a number every week. Many cases never get into the public domain and many patients are satisfied with how their complaint has been resolved at a local level. The Deputy would know that. Many people feel they are listened to and supported while others feel their complaint was not taken seriously or dealt with as sensitively or speedily as they would have wished.

I met Mr. Henry and the late Ann Moriarty's sister. I will meet the Kelly family next week. I emphasise that every time we have a misdiagnosis or error — we have them every day and even when we have the eight centres of excellence I am advised by experts there will be an approximate 1% error rate — we cannot continue to have inquiries which tie up the best experts we have in the country. As there has been a second case in addition to that of Edel Kelly, it is important for the hospital that people can have confidence in the services. The cancer services have closed but other services continue to be provided. I understand many telephone calls have been made to the hospital and others in the region, with people worried not just about cancer, but about other services in the hospital.

We owe it to the hospital, patients and staff to ensure we clinically review what is happening there with a view to ensuring that anything which needs to be put right is done as quickly as possible.

I welcome that the Minister has called HIQA in to look at the services in Ennis General Hospital, as we have a serious situation in County Clare.

I take the Minister back to last May, when she said she acted speedily. I do not believe this. At that time, the Minister told the Oireachtas Members from Clare, three of whom are present today, along with the mayors of Clare, that she would be down in Clare within two weeks to compliment staff on the way they treated the C. difficile crisis that emerged in the hospital at that time. She stated she would probably include Ennis in the capital programme for 2008, which was what we all expected. We did not see the Minister then and still have not seen her.

A very serious issue has emerged with those two cases. When the Minister responded to the recommendations of the Portlaoise and Barrington cases reports, she said patients' interests come first. This has not been the case regarding what the Minister has said this afternoon, that an investigation cannot take place with everybody. Every case is important.

I visited the Kelly family yesterday morning. They were on local radio and the girls in my office cried upon hearing what they said. I was touched by these people, who just want answers and not publicity. We need to know what happened and why. In the case of Ann Moriarty, we must know why the suspect blood was put on the shelf and why the X-ray was not read properly. X-rays are taken every day outside of cancer services in Ennis General Hospital and blood samples are also taken daily. We must know why the problem happened and if it was a resource or staffing problem. We need answers quickly.

The Minister's announcement this afternoon of an investigation by HIQA will help but there are other issues. I want to know why the Minister has not put funding for the development plan in place. She promised she would visit the area.

The issue of mammograms is related to what we are talking about. Why is it that a patient with a family history of cancer but without symptoms is not being given a mammogram currently? Why has BreastCheck not been rolled out in the mid-west region? Women are extremely worried about themselves following the incidents in Ennis General Hospital. When will the roll-out happen? It is an important action but only people with symptoms are being referred for mammograms currently. There are many worried women in County Clare now, particularly public patients, who cannot go for mammograms as a result.

I have two other questions. A CAT scanner was announced by the Minister at the May meeting but I have never heard of a CAT scanner working for just five days a week, which is the Minister's proposal. People do not get sick only between 8 a.m. and 8 p.m. but rather on a 24 hours a day basis. Car accidents can happen at any time. A CAT scanner is a necessary piece of equipment in a hospital but the Minister is only putting it in place for five days a week. What is stopping a technician being appointed, with the film being sent to the Limerick centre of excellence for a report?

Is the Minister aware of any other cases of misdiagnosis in Ennis General Hospital aside from the third case we know of from last night? Are there other cases and has the Minister been in touch with the HSE in this regard? We must know this information.

When will the Minister come to the hospital to give assurances to the Clare people and the staff, whose morale is very low? She should assure these people that investment is going into the hospital as we cannot put it on the long finger any more. The Minister does not act speedily but rather very slowly.

I regret some of the comments made by the Deputy as I have met him on many occasions with regard to Clare matters. I stated that I was planning a private visit to Clare and would call into the hospital. I did not make the private visit, as it happened — I was going to attend a private family event and circumstances dictated I could not attend. I would be more than happy if in Clare to visit Ennis General Hospital but I am not into PR stunts.

We do not want PR stunts; we want action.

I do not make a significant number of hospital visits because I am quite busy working in the office as much as I can. I meet people from Ennis and I have met with the Deputy on many occasions, as he knows.

The Minister is not delivering.

With regard to capital investment, I gave a commitment that provision will be made in the 2008 capital plan for capital works at Ennis. That is a fact and there are parliamentary questions down today where I have answered that issue. The capital works must be compatible with the developments taking place at the hospital. As I stated in my earlier reply, significant work has been under way between the four hospitals in the region, all of which have accident and emergency departments.

Many Members may have heard Professor Drumm say this morning something he has said on many occasions, that we have many hospitals in the country where we have four times more doctors employed than admissions per day. Deputies do not need me to tell them that in such an environment, quality care is not possible. It is not a good use of resources.

The whole reform effort aims to get clinical buy-in to the change and listen to the clinical experts on the ground and nationally. For 30 years this country has sought to reform its health service but has always fallen down because of a failure to achieve clinical buy-in, which is the key to success. This is particularly true of the cancer programme, where there is significant buy-in from the clinical community in Ireland to what we are doing.

With regard to mammograms, BreastCheck has been rolled out to the mid-west, although it has not yet been rolled out in Clare. There are approximately five or six counties left to roll out BreastCheck, which is happening as we speak.

It is not happening.

One of the issues arising for BreastCheck is the recruitment of specialist radiographers. As a result of difficulties in seeking to recruit these specialist radiographers, arrangements have been put in place with the NHS in Britain and it may be possible to second radiographers for a short period to BreastCheck in order to facilitate the roll-out to those counties where this has not happened.

When does the Minister expect it to happen in County Clare?

I cannot give a precise date and have never done so. I do not know. We have provided the resources for the roll-out nationally and the centres have been constructed and are operational in Cork and Galway. The mobile units are in place in many counties around the country. It is regrettable that take-up in some areas, for example, County Mayo, is disappointing. We all need to apply our collective efforts to encouraging women to come forward for a mammogram because we know early detection is essential.

The Deputy asked about two specific cases. HIQA, which is examining the facts of the cases as it knows them, may conclude a review of the cases, over and beyond the information we have, is warranted. Mr. Henry wants other questions answered, particularly on clinical care and contact made between a clinician and Mr. Henry's family concerning how the complaint was handled. I hope these outstanding issues can be addressed to his satisfaction. We have a considerable amount of information about what went wrong in the cases of Ms Edel Kelly and from the three reports into the death of Ann Moriarty.

I wish to sympathise with the bereaved families. The loss of a wife and mother is very difficult for a family, even more so when the events which caused the death could have been avoided, as appears to be the case here. I welcome the inquiry. In my question I asked the Minister to include in its remit the issue of misreading of smear tests. However, she failed to answer that part of the question. I made this request because I have not yet received replies to a letter I wrote several weeks ago to both the Minister and Professor Drumm in which I provided documentary evidence showing there had been a misreading of several smear tests and that two false negatives had been issued from a laboratory in Galway, as was proven to be the case when archival samples were retested.

The woman involved in the case in question is now very seriously ill. I did not want to raise the case publicly because the woman and her family want to maintain their anonymity. However, I have forced into a position in which I must raise the issue because I am unable to obtain a reply from the Minister or Professor Drumm. Although the former acknowledged the correspondence, I expected I would have received a substantive reply by now given that I wrote to her almost three weeks ago. When I wrote to Professor Drumm I received the usual, ludicrous answer with which Deputies are familiar, namely, that the matter was being referred to the parliamentary affairs section of the Health Service Executive. For the HSE to refer to its parliamentary affairs section a letter about a person who is seriously ill with cancer following the misreading of a smear test as if it were a routine inquiry by a Deputy makes one wonder what is going on in that organisation. While I presume the matter has been brought to the Minister's attention, failing that I ask her to seek out the information.

A woman whom I know quite well is extremely ill with cancer. The circumstances of the case are that a general practitioner took a smear test for cervical cancer in 2006. The test was sent to Galway and the result was negative. However, when inquiries took place earlier in the summer, it was found that a smear test had also been sent for analysis in 2001. When the 2006 archival sample was retested, it showed clearly that the indicators of cancer were present in the sample. The 2001 sample, taken five years previously, also showed that pre-cancerous cells were present. At a minimum, precautions should have been taken at that stage and the woman in question made the subject of observation.

Did the Minister's officials show her my correspondence? I did not make an allegation or send a routine letter but provided her with the results of the archival laboratory tests to show that the family who raised the matter with me are speaking the absolute and simple truth and are supported by their clinicians. Did the Minister have a conversation with Professor Drumm? It seemed from something he said this morning that he may have been made aware of the case last night because he referred to a third case. I am not certain he was referring to the woman in question.

I am constrained by the fact that the family in question do not want publicity about the case and while I will not name names today, I regard this as an extremely serious issue which has been very badly handled. There may be reasons for this. Perhaps matters are being inquired into in the Department or a substantive reply is on its way to me. However, in view of the gravity of the case and the serious condition in which the woman in question finds herself, I would have expected to have been contacted by the Department and Professor Drumm.

The focus of the questions is Ennis General Hospital and the tragic deaths of two individuals. I am, however, familiar with the Deputy's correspondence which was received in my Department on 28 or 29 August. He also tabled a parliamentary question which I cleared last night. In my reply to the question, I indicated that the matters raised are being fully examined, that I have asked the Health Service Executive for a report and that I will communicate with the Deputy by the end of this week as the report is almost complete.

I included in this question a request to inquire into this matter. Will the Minister agree to do so?

I have done so already. My office brought the matter to my attention and the Department is aware of the Deputy's correspondence. All patient safety issues are now referred to the chief medical officer in the Department. A new medical officer who will be appointed some time in October — a recruitment campaign is under way — will head up a new patient safety division in the Department for the first time. Obviously, we must get the facts before we can respond. However, the Department sent the Deputy an acknowledgement.

Earlier this month, when we were rolling out the new cervical screening programme, our main priority when sourcing cytology was to ensure it was quality assured. Without quality assured cytology services, a screening programme is not of great value. Considerable controversy arose about this issue.

One cannot do without kits.

Errors also occur in a quality assured service. I regret very much the circumstances and state of health of the woman to whom the Deputy referred. I hope to have all the facts of the case and to be in a position to communicate with the Deputy by Friday. If the facts, as suggested by the Deputy, are borne out, we will have had a cytology failing in one of our hospitals. I would regret that very much.

Did it not occur to anyone in the Department to telephone me to inform me the information had been received and would be dealt with confidentially, as I wished?

That happens all the time.

It clearly did not happen in this case.

The Deputy could have telephoned me.

I thank the Minister for the frank manner in which she has dealt with this matter which is a serious issue both for the two families concerned and all those who are worried at this time. I also welcome the review she announced, which will help to restore confidence in Ennis General Hospital and assist patients who have an ongoing relationship with the hospital. Having met both the families in question, I am hopeful the review will go a long way in addressing their individual concerns. As the Minister noted, however, it may not fully address the concerns of one of the families, although I hope the involvement of HIQA will help to do so.

When does the Minister expect the specialised referral service to be up and running? This service will be critical to restoring confidence among patients of the hospital, particularly those who had dealings with its breast-related cancer services before they were transferred to the centre in Limerick.

I compliment the Minister on the manner in which she has dealt with the families in question. I am aware she has met the family of one patient and intends to meet others. Her approach shows that she cares and helps to build confidence in the health service and political system.

On the terms of reference of the review, will it be possible to examine the culture of dealing with mistakes, specifically the possibility of introducing a process or protocol for communicating with patients or, in the case of patients who are deceased, with their families when mistakes are identified? I am aware there is always a difficulty in the context of accepting liability and responsibility but such an acceptance is important to families and those affected by matters of this nature. Will the Minister indicate whether it might be possible to put in place a process of arbitration or mediation which would allow those who are seriously ill or their families to avoid the necessity of seeking redress through the courts? Anything that would prevent people from being obliged to take the legal route would be of assistance. Perhaps the review might extend to providing some guidance in respect of future cases of this nature.

I thank the Deputy for his comments. A process relating to referrals for women who have concerns is, in effect, up and running. I understand the HSE is in contact with general practitioners in order to make available to them information relating to the precise referral arrangements in each region. This matter relates to hospitals other than that in Ennis. The idea is that there will be a person in each region whom general practitioners can contact. Referral appointments can be made after women have contacted their GPs.

There is a culture of denial, embarrassment and, perhaps, guilt that takes hold when mistakes occur. The medical community here is probably no different than those in other countries. I have attended many patient safety seminars in Ireland and elsewhere since I became Minister for Health and Children and the pattern often appears to be the same. One would hope, particularly in light of enterprise liability, it would be somewhat easier to come to terms with errors. We have a great deal to do in the context of changing the culture relating to how we respond to patients or their loved ones when an error has occurred. It will take some time to achieve this because changing a culture is one of the most difficult things to do in any walk of life, not least in the area of medicine.

We recently appointed a new medical council, the majority of the members of which are lay persons. The purpose of that was to bring a wider dimension to the regulation, training and education of medics in this country. Some doctors who are on the council and who were reluctant for a majority of its members to be lay persons are of the view, even after only a few meetings, that this is a worthwhile development.

I am strongly of the view that when it is clear that an error has occurred, people should not be forced to have recourse to the courts in order — I do not know if this is the appropriate language to use — that they might be compensated. An arbitration system is far more compassionate and responsive. I have already spoken to the HSE in respect of this matter, not only in respect of these cases but also regarding others where errors occurred. Too often in the past we forced people to litigate and they were obliged to cope with all of the trauma associated therewith. One mother who lost her son ten or 12 years ago informed me that the need to pursue litigation compounded the trauma of the original error and that in many ways it made matters worse.

As already stated, there is much to do in the context of changing the culture. A huge effort is under way in the HSE in this regard. The Director of Consumer Affairs, Mary Culleton, her staff and many other people are extremely sensitive to the need to respond to patients. Many of the letters etc., I receive come from people who have good things to say regarding how complaints were dealt with. Equally, however, I receive communications which indicate the reverse. Particular individuals respond differently. However, one would hope that, over time, the response would be appropriate in every set of circumstances.

If a woman in County Clare has concerns, what procedure should she follow? If she had a test carried out during the period in question and is worried that the results may not have been accurate, should she contact her GP in order to obtain a referral?

The second matter I wish to raise relates to a question posed by Deputy Breen to which a reply was not given. I refer to the announcement by Professor Keane that routine mammograms would not be carried out at centres of excellence and that women would have to be referred by their GPs when it was established that symptoms were present. There are families in which there is a history of breast cancer. In the region in which I live, women cannot access mammography services of any kind unless symptoms are present. That is causing a great deal of distress in areas — I refer her to Clare and five or six other counties — where BreastCheck is not in operation.

Will the Minister request that the position in this regard be reviewed? I am aware of cases where three or four sisters in particular families died as a result of breast cancer and where a surviving sister who does not have symptoms wants to have a mammogram carried out in order that she might be reassured. It is cruel that such women cannot avail of routine mammograms. Even if one manages to scrape the money together, I understand that, since the closure of the Barrington's service, one cannot avail of a mammogram in the mid-west region.

That is true.

Even if they are in a position to pay, women in the region must travel to Galway or Kerry to have mammograms. The position must be re-examined.

Women in Clare or anywhere else who are concerned should go to their general practitioners who will be able to refer them to one of the eight centres of excellence. The idea is that the centres deal with those suffering from symptomatic cancer. However, they also deal with families that are in the high-risk category. Earlier this week I was visited in my office by a group from another part of the country. One of the women present was diagnosed with breast cancer as part of a routine follow up which resulted from her mother being diagnosed with the disease. There must be a misunderstanding regarding the matter to which the Deputy refers. It would not be the intention to prevent members of families in which there is a history of cancer to attend specialist clinics. If there is a particular issue in the mid-west region, I would like to speak to Professor Keane about it.

That is the impression that was given.

There are family history clinics at a number of locations, including the Mater Hospital, Drogheda and elsewhere. If there is an issue regarding the mid-west region, I will communicate with Professor Keane in respect of it.

It is not my intention to digress but the Minister referred to cervical screening, which commenced at the beginning of the month. I made a number of telephone calls last night and discovered that only one practice in north Dublin had received a kit. I made my feelings on that matter known in the past and was castigated for doing so. However, there is no point in announcing a service when it is not available. Prematurity only undermines the position.

I referred earlier to Waterford but the Minister did not respond. In what way will resources be provided in order to allow the authorities there to achieve in a month what was supposed to take one year? Will the Minister address the concerns of the people who work there?

Despite the fact that matter has been the subject of media reports for two to three weeks, I received a telephone message from a journalist earlier this afternoon to the effect that there is no advice on the HSE's website for people who were misdiagnosed. A telephone number has not been provided and there is no indication of what they should do. Perhaps the Minister will check the position and ensure this matter is resolved.

The Minister referred to the Commission on Patient Safety, which recommended in its report that a patient safety authority be established. She also referred to HIQA enforcing standards. How can HIQA do so when it is not in a position to censure hospitals? It can set standards and impose them on hospitals but when its officials return 12 months later, they will be informed by the powers that be that they did not get around to implementing them. Nothing can be done in such circumstances. In the case of a private facility, HIQA may be in a position to revoke the licence. In terms of enforcement, the authority lacks teeth.

As usual, the Minister engaged in one of her favourite tricks, namely, reframing the comments I made in respect of Professor Keane and others. I stated that public representatives are the best people to judge public concerns and that experts should be left to their areas of expertise. Their expert opinion in respect of a look-back goes a step further. I stated that HIQA should carry out an independent inquiry and that if, as a result of the latter, a full review is required, it should be carried out expeditiously. I am glad the Minister has taken my view on board in that regard.

Deputy Breen inquired if the Minister is aware of any further cases but she did not provide a reply. Will she indicate whether the biopsy from Limerick was reviewed?

I understand that the biopsy relating to Edel Kelly has been reviewed.

Yes, I believe that to be the case. As the Deputy is aware, there is a recommendation in the Rebecca O'Malley report regarding which tissue should be the subject of a fine needle aspiration. I understand that doctors should be guided by ultrasound scans in order to identify which tissue to take.

Professor Drumm stated that another case is being investigated. That is not the cytology case to which Deputy Noonan referred and I apologise for not responding to his earlier question. I do not believe any information has been assembled as to whether there was a possible delayed diagnosis. The case in question does not involve a death but there may have been someone whose diagnosis was delayed. The case relates to Ennis and not any of the other hospitals.

In regard to Waterford, the breast surgeon from Clonmel has gone there. Professor Keane does not transfer services from a hospital until he is certain the resources are in place. Interviews took place recently and ten cancer doctors are being recruited, one for each centre. Some of them are surgeons and many are specialist radiologists. I understand there was a high level of interest from many excellent doctors. Further interviews are to take place to recruit other specialists for the eight centres.

In regard to licensing and so on, we do not have a licensing regime here for the public or the private sector. That is a deficiency we must act on as quickly as possible. It requires legislation which will be drafted and forthcoming as quickly as possible. Until we have a licensing regime, it is not possible to establish an organisation to close things down if we allow people to open without any permit or authorisation. We must ensure that in the way we fund hospitals, we only fund those places which operate to the standards we deem necessary.

For example, in regard to breast cancer, I spoke to the insurers to ensure they do not fund through insurance activities in places which do not live up to the new national standards. I have got that assurance from the VHI and I believe it will be forthcoming from the other insurers as well.

I welcome that because I spoke to the Minister about it last year.

We spoke about two cases and possibly a third case of which the Minister said she is aware. Are there other cases? We spoke about misdiagnoses but much good work is done in the hospital. People must work in very difficult circumstances. Most days the accident and emergency department in Ennis is crowded. It is small and cramped and there are not enough beds. There are not even rooms in the hospital to give people privacy in the event of a loved one being seriously ill.

The Minister did not answer my question about the CAT scan. I urge her to put the development plan in place as soon as possible. We need to restore confidence in the hospital. As I said, staff are hardworking and I do not want the HSE to use these misdiagnoses as a means to downgrade the hospital. We want the hospital, particularly for the people of west Clare who must travel long distances.

The only other case in regard to Ennis of which I am aware is the one to which I referred. I understand the HSE is investigating whether a breast cancer diagnosis was delayed. However, as Minister and a representative for Dublin Mid-West, I am aware of many cases around the country where there were misdiagnoses.

To put this in context and to be fair, because it is not often understood by the public, errors are made in even the best hospitals in the world, including the most resourced, the best equipped and a hospital I visited last year, M. D. Anderson in Texas, that deals with 78,000 cancers per year, which is nearly four times more cancers than we have in this country. In the developed world where research has taken place, it is estimated that in approximately 10% of hospital experiences are adverse and that 1% of them can result in a fatality. What we are trying to do in the reorganisation of our services is not to eliminate error because, as everybody acknowledges, that is impossible but to minimise the capacity for error making.

In regard to the scanner and any other equipment put in place, there are 37 hospitals in this country with accident and emergency departments for a population of 4.3 million. People do not need me to tell them that one cannot resource to the standards which might be expected in 37 hospitals with all the modern equipment necessary. It is not financially sustainable or possible, nor is it possible to get the kind of clinical expertise with that type of dispersion. It is very difficult to get top doctors to work in an environment with small volumes. That is the case in many of our hospitals and that is why we are trying to work to bring a network of hospitals together so that they complement each other and the clinicians work as part of a team in the region, such as the mid-west region where there are four hospitals. That is the ideal scenario.

The hospital is only of use to the patients in its catchment area if it can provide high quality services. I have no doubt that is what patients want and that is what we will have in Ennis. That is why the review I have asked HIQA to do will ensure that can be guaranteed in the future.

Are there plans to appoint additional consultant oncologists in the mid-west region?

I understand one of the ten appointments now being made is a radiologist for Limerick. Limerick will have a minimum of two full-time breast surgeons, two radiologists with a specialist interest in breasts, two pathologists and additional medical oncologists. The recruitment process is under way and ten appointments have been made, or certainly people have been offered appointments. Further appointments will be made in the coming months.

Written Answers follow Adjournment Debate.

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