Martin Mansergh (Tipperary South, Fianna Fail)

I am replying to this matter on behalf of the Minister for Health and Children. All incidents of this kind are serious and are treated as such. They are distressing to the women and families involved and I express my sincerest sympathies to all those affected.

On 7 August 2009, solicitors for the couple concerned wrote to Our Lady of Lourdes Hospital, Drogheda, seeking certain assurances about the woman's care and other actions to be carried out by the hospital. On the same day, the solicitors wrote a short letter to the Minister for Health and Children enclosing a copy of that letter. This was also copied to the CEO of the HSE and to the State Claims Agency. The case was handled by the Department of Health and Children in line with the patient safety protocol adopted in September 2008, which deals with correspondence on issues of patient safety from patients, doctors, health service staff and solicitors. In view of the fact that a medical assessment of any potential patient safety issue is required, this is managed by the chief medical officer on behalf of the Minister for Health and Children.

Within one week the HSE responded to the solicitors, and a further letter was sent on 24 August. The Minister for Health and Children was copied on both these letters. The case was placed on the patient safety register and was reviewed regularly. In line with the protocol, the Department of Health and Children followed up with the HSE by telephone and letter to determine whether any risk issues had arisen 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 such an error being repeated were minimised. The Department requested further details, which were received in April 2010.

The 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 in a suitable manner and that a patient safety risk for other users of the service did not arise. It was determined that follow-up actions to enhance patient safety had been put in place at the hospital, and the chief medical officer was satisfied that the case had been dealt with appropriately.

I must point out that there has been no other case of this type on the patient safety protocol register since its inception in October 2008; neither was it indicated to the Department that any other such cases had been identified. However, as a result of media coverage in recent days a number of other cases were brought to the attention of the Minister for Health and Children.

As a result, a number of actions have been agreed by the HSE in conjunction with the Department of Health and Children to ensure the safe management of early pregnancy loss across the country, as follows. The HSE is in the process of initiating a review of cases over the past five years to determine the number of patients who were recommended drug or surgical treatment when the diagnosis of miscarriage was made in error, and where subsequent information demonstrated that the pregnancy was viable. The terms for the conduct of the review are being finalised at present and the HSE hopes to make them public in a matter of days. A joint letter from the Department's chief medical officer and the HSE's national director for quality and clinical care has been issued to all public and private obstetrics facilities advising them to put in place immediate measures to ensure the decision to use drugs or surgical intervention in women who have had a miscarriage diagnosed must be approved by a consultant obstetrician.

In addition, a clinical programme for obstetric care has been established by Dr. Barry White, the HSE's national director of quality and clinical care. The obstetrics programme will define standardised care for early pregnancy loss and other aspects of obstetric care. This programme is led by Professor Michael Turner of the Coombe Women's Hospital, who was appointed last month and will develop a guidance document for the management of early pregnancy loss in conjunction with the Institute of Obstetrics and Gynaecology.

Any objective look at the initiatives the Minister for Health and Children has taken and is taking demonstrate a determination and an earnestness to improve the safety and quality of care for all patients across the broad spectrum of health services activity. Under her stewardship key steps in this regard include statutory establishment of the Health Information and Quality Authority; the introduction of competence assurance for clinicians; the establishment of the commission on patient safety and quality assurance to set the agenda for change to improve the experience and outcomes of service users; the enactment of legislative provisions for protected disclosures by employees in the public health services who have concerns about safety of patients; preparation of legislative proposals to support open disclosure, adverse event reporting and clinical audit, which will be included in the Health Information Bill published this year; and legislative proposals for standards-based licensing of public and private health care providers, which are to be the subject to public consultation early next year.

I assure the Deputy careful attention will be given by the Department of Health and Children and the HSE to promoting learning from these incidents in order to improve patient experiences and outcomes.

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