Mary Harney (Dublin Mid West, Independent)

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.

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