Deirdre Clune (Cork South Central, Fine Gael)
Link to this: Individually | In context

Question 42: To ask the Minister for Health and Children the number of calls to the Health Service Executive helpline on the baby scan misdiagnosis; the number of calls received to the special helpline established at Our Lady of Lourdes Hospital, Drogheda, County Louth; and if she will make a statement on the matter. [25777/10]

Martin Ferris (Kerry North, Sinn Fein)
Link to this: Individually | In context

Question 48: To ask the Minister for Health and Children the measures she will take to help prevent misdiagnosis of miscarriages; and if she will make a statement on the matter. [25967/10]

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

Question 74: To ask the Minister for Health and Children the action she is taking in response to the widespread incidents of miscarriage misdiagnosis which have come to light; the date on which she was first made aware of this problem; and if she will make a statement on the matter. [25961/10]

James Bannon (Longford-Westmeath, Fine Gael)
Link to this: Individually | In context

Question 81: To ask the Minister for Health and Children if, in view of the miscarriage misdiagnosis, she will instruct Health Information and Quality Authority to conduct an review of antenatal services, including equipment, protocols and training of personnel; and if she will make a statement on the matter. [25762/10]

Jan O'Sullivan (Limerick East, Labour)
Link to this: Individually | In context

Question 167: To ask the Minister for Health and Children her views on the recent cases of misdiagnosis of miscarriage; if she has requested any reports or recommendations to be provided; if she will give assurances that any shortcomings in staff, equipment or practices that are identified will be rectified; and if she will make a statement on the matter. [26066/10]

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

I propose to answer Questions Nos. 42, 48, 74, 81 and 167 together.

Incidents of this kind are distressing to the women and families involved and I again express my sincerest sympathies to all of those who were affected. They are serious incidents and are treated as such.

The initial case which was the subject of media coverage over the past two weeks, was brought to my attention by way of letter received in my office on 12 August 2009. The solicitors for the couple concerned wrote to Our Lady of Lourdes Hospital, Drogheda, on 7 August 2009, seeking certain assurances about the care of, and other actions to be carried out by the hospital for, the woman concerned. On the same day, the solicitors wrote a short letter to me enclosing a copy of that letter. This was also copied to the CEO of the HSE, Professor Brendan Drumm and to the State Claims Agency.

The case was handled by my Department in line with the patient safety protocol which I put into place in the Department in September 2008. The protocol deals with correspondence relating to issues of patient safety from patients, doctors, health service staff and solicitors. It is managed by the chief medical officer on my behalf given that a medical assessment of any potential patient safety issue is required. Within one week the HSE responded to the solicitors and a further letter was sent on 24 August. I was copied on both these letters. The case was placed on the patient safety register and was reviewed regularly.

In line with the protocol, my Department followed up by telephone and by letter with the HSE to determine if there were risk issues arising from its investigation of the case. Following these contacts, the hospital's risk management unit advised the Department in January that a number of measures had been put in place to ensure that the chances of making an error of this kind again were minimised. My Department requested further detail which was subsequently received in April 2010.

My Department's patient safety protocol meeting of 6 May 2010, reviewed the hospital's action in the case and was satisfied that it had been dealt with appropriately and did not pose a patient safety risk for other users of that service. It was assessed that the review and follow-up actions for patient safety had been put in place at the hospital. The chief medical officer was satisfied that the case had been dealt with appropriately at all times.

I wish to point out that there was no other case of this type on the patient safety protocol register since its inception in October 2008 and neither was it indicated to my Department that any other such cases had been identified. As a result of media coverage in recent days, a number of other cases were brought to my attention. A number of actions were agreed by the HSE in conjunction with my Department to ensure the safe management of early pregnancy loss across the country.

The chief medical officer of my Department and the director of quality and clinical care in the HSE recently wrote to all obstetric units advising them to ensure that the decision to use drugs or surgical intervention in these circumstances must be approved by a consultant obstetrician.

The HSE has now announced details of a miscarriage misdiagnosis review team and its terms of reference. The review team is being chaired by an independent expert in obstetrics and gynaecology, Professor William Ledger, vice president of the Royal College of Obstetrics in the UK, who will be joined by Professor Michael Turner, national clinical lead of the HSE's obstetrics programme and a former master of the Coombe hospital; Ms. Sheila Sugrue, HSE national lead for midwifery. Service-user representation will be provided by Cathriona Molloy from Patient Focus. It is expected that the review will be completed within six months and the report will be published.

In addition, a clinical programme for obstetric care has been established by the HSE's national director of quality and clinical care which will define standardised care for early pregnancy loss and other aspects of obstetric care. It is important to understand that the use of scans and other technology must be guided by expert clinical opinion based on careful clinical history and examination. Scans will not always be necessary or appropriate.

The HSE has advised it has been working with all maternity facilities nation-wide to ensure that women with concerns about their care or treatment have access to information, support and reassurance. The number of calls to these facilities between Wednesday 9 June 2010 and midday on Friday last, has totalled 295. Of these calls, 95 were made to the maternity unit at Our Lady of Lourdes Hospital, Drogheda.

The HSE advised my Department that it has consulted HIQA in relation to the terms of reference of the miscarriage misdiagnosis review. I am satisfied with the course of action being taken by the HSE on this issue to date and I consider it appropriate to await the outcome of the HSE review. I see no necessity at this time to ask HIQA to conduct a parallel review.

It is important to put this case in context. Ireland has, by international standards, a very high-quality maternity service. Maternal mortality, perinatal mortality and infant mortality are all low by comparison to other jurisdictions. Women can be satisfied and confident as they come to use this service.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

I hope I will be allowed time to address all those statements because, to be frank, the HSE might be happy and the Minister might be happy, patients are not happy, I am not happy and neither are the people on this side of the House.

Terence Flanagan (Dublin North East, Fine Gael)
Link to this: Individually | In context

Hear, hear.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

Scans are not always appropriate but by God, they are appropriate if a pregnancy is going to be terminated by doing a D and C, then one better bloody well have a scan. Second, why are people not afforded the opportunity to have a second scan in those situations? Expecting a woman and her partner, having just been devastated by the news that they have lost their unborn baby, to have the composure and the strength to demand a second opinion, is not fair. This should be an automatic decision. Nothing should be done to endanger the life of the unborn until such time as it is proven to be no longer viable and this has not been the case in the past. I do not understand how the Minister can say she does not believe that HIQA needs to do a report. I believe it certainly does need to do so. She also says that the chief medical officer is happy with the internal review carried out in Drogheda and that it would not happen again. This is utter nonsense. The hospital still does not have a scenographer and it took six months to get rid of the machine that was fatigued and not fit for purpose. I really do not understand how the Minister can defy logic in her reply.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

These tragic circumstances unfortunately occur and as the Deputy will know well, medical errors can occur. We need national standardised practice in so far as these matters are concerned. The appropriate people to introduce that standard practice are clinicians with expertise in this area. In particular, there is a strong role for the college of obstetrics and gynaecology.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

The Minister should give them the resources.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

It is not just a case of resources. Everything is not down to resources. It is the case in many hospitals in the country - and it should be the case - that a second opinion is sought in these circumstances. However, as I said in my response, it is not just simply a matter of machinery because there are a wider number of issues. We need to await the outcome of the review. The important fact is we have a person of the level of Professor Turner and I think the Deputy will agree he is highly respected in this field. He is a lead clinician in this area. He was appointed in May before this matter came into the public domain and for a different reason. He was asked to look at obstetric practice in Ireland and to make appropriate recommendations to ensure we have standard procedures right around the country.

I was in Mullingar hospital yesterday. It has always had a practice of a second opinion in operation, I am happy to say. We need a standardised approach to all these issues. In particular, we need to ensure we have obstetric cover to be able to give advice, examination and guidance to women in these circumstances.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

I welcome the terms of reference and the establishment of the review team in this case. However, a number of very serious questions remain. Why did the Minister, the Department and the HSE have to wait until after Melissa Redmond's story went into the public arena, when it was known from last August 2009? Did not the Minister, the Department or the HSE consider the implications of what was brought to their attention then, not only with regard to Melissa Redmond's story but for other women presenting at Our Lady of Lourdes Hospital, Drogheda and for women who would present, perhaps in similar circumstances, at other maternity units across the State? Why is it always that the Minister can only respond when the spotlight of public attention is placed on an issue? Has the Minister or the HSE taken the opportunity to try to establish from the records of maternity units across the State, the noted and acknowledged numbers of misdiagnoses that resulted in the loss of a child unnecessarily?

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

It is not the case that we waited until this case came into the public domain. From the time this came to the attention of the HSE, of my Department and, in fairness, of the hospital, action was taken swiftly to establish what had happened in this case.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

What about the implications?

Brendan Howlin (Wexford, Labour)
Link to this: Individually | In context

Please allow the Minister.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

Furthermore, this case was seen by the chief medical officer and his team as an isolated case. It was not regarded as something that affected other areas. To put this in context, I refer to the Port Laoise issue in September 2008. As a result of the patient safety implications that arose, I set up new protocols in the Department for dealing with patient safety issues, because I frequently get letters from Members, doctors, health care professionals, patients and lawyers suggesting patient safety is at risk. I am not competent to deal with those issues and neither are the administrative people in the Department. The people competent to deal with the issue are medics and that is why this is being overseen by the chief medical officer. The protocols are working very well. At any one time, there could be a significant number of issues and currently there are up to 120. Many of these are resource issues, but others are situations where misdiagnosis has been alleged. These must all be properly investigated.

In May 2010, prior to any of this coming into the public domain, it was decided that an elite clinician in the field of obstetrics would be appointed by the HSE to have appropriate clinical pathways, just as we are doing with heart failure and stroke -----

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

The Minister has already told us that. This was not an isolated case.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

This relates to all these issues. We now have new clinical leadership emerging where clinicians will be involved in rolling out clinical pathways in this and other areas. It is only when we have this standardised approach from the college of obstetrics and gynaecology that we can be assured, whether in the public or private sector, of a standardised approach throughout the country.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

Has the number of cases in question been established?

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

There is no way of establishing that. The review will do that. As I mentioned, up to last Friday approximately 295 calls had been made since the helpline was opened. I understand that 95% of those calls were made to Our Lady of Lourdes Hospital. I do not suggest all of those calls are cases, but obviously they were from people who had a miscarriage. To put the numbers in context, we have 14,000 miscarriages a year and 70,000 births. We do not suggest that all the calls relate to cases similar to the unfortunate Redmond case, but 295 is the number of calls made.

Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

I warrant there is information to confirm misdiagnosis in some cases.

Jan O'Sullivan (Limerick East, Labour)
Link to this: Individually | In context

The Minister said medical errors will occur. I agree, but they are much less likely to take place if we do not have outdated equipment and if proper protocols are in place. Is the Minister now sure that we no longer have equipment that is too old for the job in the case of these life and death issues? She said that we can be assured now that any decision regarding terminating a pregnancy and taking away the life of a viable child will not happen unless it is signed off by a clinical obstetrician. However, she has not assured us that there will be a second opinion. While a second opinion is standard practice in many obstetric units throughout the country, this is not the case in all of them. Will the Minister assure us that she will demand there be a second opinion before any intervention is made in a pregnancy?

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

The clinical advice I have received from Professor Turner and others is that it should be signed off by an obstetrician. It would be difficult if we required a signing off by two obstetricians in every case because we have some very small hospitals where there are only two or three obstetricians. The machine in question was not old. The lifespan of these machines is seven years and the one in question was only six years old.

Jan O'Sullivan (Limerick East, Labour)
Link to this: Individually | In context

Is the Minister saying the report was wrong?

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

No, the point I am making is that it was not a machine that had passed its sell-by date. It was within the seven-year timeframe.

Jan O'Sullivan (Limerick East, Labour)
Link to this: Individually | In context

We were told it was an old machine.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

Yes, but the scan was not outside the seven-year timeframe but within it.

Jan O'Sullivan (Limerick East, Labour)
Link to this: Individually | In context

It did not work properly.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

We need to put forward a recommendation of clinical examination.

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

The Minister, like everyone else, understands motor cars. A two year old car with 300,000 miles on it is clapped out. The machine in question had a huge workload on it. The Minister cannot answer the question because she has not carried out an audit of these ultra sound machines, as she was asked to do. Will the Minister's new investigation address the issue of protocols, training and workload of both machines and staff? If a doctor's bleep goes off three times during the course of an examination, how in the name of God can one say that is a proper working environment in which a proper decision can be made about a patient?

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

When we seek to do things in the interest of patient safety, such as the cancer programme, the Deputy opposes us. He cannot have it every way

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

That is not an answer to the question. The Minister should deal with the issue.

Mary Harney (Dublin Mid West, Independent)
Link to this: Individually | In context

The person who will roll out the protocol will be Professor Turner who is the lead clinician in this area. He is the appropriate person to deal with the college of obstetrics and gynaecology which has the national expertise and will be centrally involved. Written answers follow Adjournment Debate.