Breen questions Health Minister on the position regarding the recent cases of cancer misdiagnosis

September 25th, 2008 - Pat Breen

Deputy Pat Breen: I ask 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.

   Deputy Pat Breen: 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.

 

   Minister for Health and Children (Deputy Mary Harney): 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 multi-disciplinary meeting to discuss Edel Kelly’s health.

 

[Deputy Mary Harney]

  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 multi-disciplinary 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, HSE, 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.

 

   Deputy Mary Harney: 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.

 

   Deputy Mary Harney: 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.

 

 

 

   Deputy Mary Harney: 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.

 

   Deputy Mary Harney: 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.

 

   Deputy Mary Harney: 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.

 

   Deputy Pat Breen: We do not want PR stunts; we want action.

 

   Deputy Mary Harney: 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.

 

   Deputy Pat Breen: The Minister is not delivering.

 

   Deputy Mary Harney: 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.

 

   Deputy Mary Harney: 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.

 

   Deputy Pat Breen: When does the Minister expect it to happen in County Clare?

 

   Deputy Mary Harney: 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.

 

   Deputy Pat Breen: 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. 

 

   Deputy Mary Harney: 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.