Reassurance given on immediate safety issues but hospital asked to improve monitoring of care

Children’s heart surgery at Leeds General Infirmary can begin a phased restart on Wednesday, NHS England said today (Monday).

It follows completion of the first-stage of a review by a multi-disciplinary independent clinical team, which has been working to establish the immediate safety of the unit.

NHS England has accepted the Trust’s recommendation, supported by independent experts, that surgery should resume gradually over the next month, starting with lower-risk cases.

The second stage of the review will now begin looking at other areas where improvement may be necessary.  This will comprise:

• a review of the way complaints from patients are handled, including the issues raised by the Children’s Heart Federation;
• completion of a review of patients’ case notes over the last three years.

In addition, NHS England will further explore issues that have been raised about referral practices to ensure they are clinically appropriate.

During the first stage of the review, NHS England received assurances from independent experts about the quality of surgery and staffing levels that were sufficient to allow the phased resumption of operations.

However, it has asked for significant improvements to the way the unit monitors the quality of care so it can be compared with similar services.  The review found that the Trust’s data for monitoring surgical results was uniquely poor, triggering concerns about death rates and gaps in information.

The decision follows a risk summit that drew together the Trust, NHS England, the Care Quality Commission and the NHS Trust Development Authority.

Sir Bruce Keogh, the Medical Director of NHS England, said:  “The information that came to light about Leeds raised some really serious questions and action had to be taken.  The Trust agreed to pause surgery until these questions were investigated.

“If we have learned anything from public inquiries such as Bristol and Mid Staffordshire it is that patients were harmed while organisations argued about the veracity of data used to measure clinical results, rather than addressing the underlying issues. We would not have been forgiven if a child had died or suffered unnecessary harm while we sat on our hands.

“I am pleased that we have now been given assurances by independent assessors that the immediate safety concerns, which were bubbling up from a variety of sources, have been addressed and that the unit can recommence surgery.

“We now need to explore some of the wider issues around how the unit operates as a whole.  I hope we will soon be able to give the unit a full clean bill of health beyond this immediate reassurance of safety.”

He added: “I want to be clear that NHS England will do everything in its power to make sure that measuring clinical outcomes will be given priority in the new NHS.  Organisations cannot know they are providing effective or safe care unless they are measuring and monitoring their services.”

NHS England originally raised concerns about Leeds General Infirmary because of preliminary data suggesting high mortality, concerns about staffing levels, whistleblowing information from clinicians, and complaints from patients.

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