Child cardiac unit may restart operations if outstanding concerns about data and governance are resolved over the weekend
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guardian.co.uk, Friday 5 April 2013 12.04 BST
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The child cardiac unit at Leeds General Infirmary was closed last week for what the NHS medical director Sir Bruce Keogh called a 'constellation' of reasons. Photograph: Anna Gowthorpe/PA
Children's heart surgery at Leeds General Infirmary may resume next week if the hospital can provide data over the weekend to show that it is safe.
Supporters of the children's cardiac unit, where surgery was suspended last week, celebrated the announcement following a risk summit called by NHS England on Thursday, but it is understood that there are still questions to answer.
The outstanding issues are missing data on 18 operations and questions over governance. NHS England and the Care Quality Commission (CQC) are concerned that surgeons and other staff were not collecting full outcomes data on all the operations carried out on children, which is vital if doctors are to be certain they are doing their job as well as others in their field.
"Following a productive multi-agency meeting to review the decision to suspend children's cardiac surgery at Leeds General Infirmary, agreement was reached to work together to restart surgery on the site early next week subject to independent assurance of concerns raised," a statement from NHS England, Leeds Teaching Hospitals NHS trust, the NHS Trust Development Authority and the CQC said.
"Over the course of the weekend all agencies will work together to provide sufficient assurance to all interested parties that this service is safe and can therefore reopen next week."
The hospital is convinced that there are no underlying problems. Maggie Boyle, the chief executive of the trust, said: "I am extremely confident that this service is safe and effective and should recommence at the earliest opportunity. I want partner organisations to be as confident in the service as I am."
NHS England sounded a more cautious note. "The risk summit today has been extremely useful in moving a difficult situation forward constructively," said Mike Bewick, the organisation's deputy medical director. "We will play our full part in supporting the safe reopening of the service at the earliest opportunity."
Sharon Cheng of Save Our Surgery, the campaign to keep the unit open, said it welcomed the announcement. "The last week's investigations and discussions have indicated that standards at the unit are safe. We now wait for the final independent assurance so that we can move ahead," she said.
"We are asking that surgery be resumed as early as possible next week so that patients and families, who have been so worried through this suspension period, can be reassured that the unit is operating safely and that planned treatments will be able to proceed. Many children are reliant on the Leeds unit for urgent or ongoing treatment, so the sooner normal service can be resumed, the better."
Leeds may argue that the data on child deaths, which shows that the unit's rate has been unacceptably high, does not predict its future performance.
One of its surgeons has voluntarily withdrawn from operating because of questions over his ability. The hospital has been investigating.
But the immediate resumption of surgery that the hospital hoped for has not happened. There are still concerns over the failure of the unit to monitor its own performance. The data that the NHS medical director, Sir Bruce Keogh, saw in the week before Easter, which led him to travel to Leeds and advise that the trust suspend surgery, was of concern but it was not complete. In 130 cases, details of the child's weight, which are critical to assessing the likelihood of survival, were not submitted. In a further 18 cases, no details were submitted at all.
Since the Bristol babies disaster in the late 1990s, there has been great pressure on heart surgeons to collect proper data about their patients' state of health before the operation, the procedures carried out in the operating theatre and how many survived and how many suffered long-term damage.
Heart surgeons who operate on adults took up the challenge through the Society for Cardiothoracic Surgeons, and now have a comprehensive database which shows all surgeons' individual mortality rates, as well as those of their units. Keogh, himself a former heart surgeon, was a major player in making this happen.
Ironically, given that the Bristol scandal concerned poor data collection in children's heart surgery, paediatric cardiac units have not moved with the same speed. A model for calculating the likelihood of children dying in heart surgery that incorporates important factors such as other health issues, weight and the complexity of the operation, has only recently been devised, 12 years on from the Bristol inquiry. Pilot studies were published this week in the journal Heart.
Data from children's heart surgery is supposed to be submitted to the central cardiac audit database, which is chaired by Dr John Gibbs, who is himself a former Leeds General cardiologist. He protested at Keogh's intervention on the basis of the figures, saying it was too early to draw conclusions. In an email leaked to the BBC, he said: "We have not even got the data statistically analysed yet. It is not fair to the public [or researchers] to leak provisional data."
