The deaths of 10 patients in 10 months was the spur for the Commission for Health Improvement to launch its investigation into heart and lung transplantation at St George's Healthcare trust in London. But the recommendations from CHI have a far broader scope, and carry repercussions for the state of heart and lung services nationally and the arrangements in place to monitor them. CHI also calls for increased investment for heart and lung transplant services.
CHI's report highlights poor communication between clinicians and managers, and a lack of investment which left clinical facilities dilapidated, resulting in poor morale.
Although St George's carried out a relatively small number of heart and lung transplants - just 31 in the last financial year - between December 1999 and October 2000 there were 10 deaths which were 'very unlikely to have occurred purely as a statistical coincidence'.
According to CHI, this probably came down to the fact that candidates for transplants were inadequately selected for the operation.
St George's criteria for selection were found to be little different to those used in other units across the country.Yet in practice it deviated in a way that was 'idiosyncratic', which meant that several patients would not have been accepted for transplant elsewhere.
Other factors were the coordination of donor organ retrieval, infection control and uncertainty over the future of the service itself in the face of a national review on the future of heart and lung units.
The fact that facilities were not up to scratch was noted in an external report by the Royal College of Surgeons in March 1999. It said that they were 'far below presently acceptable standards' and were eroding morale and clinical effectiveness.
These conclusions were confirmed when CHI inspectors visited the unit after the deaths were first made public. CHI said 'the privacy and dignity of patients were compromised by the cramped and poor conditions'.
Staff at the unit had raised concerns with managers, but according to CHI they were told that the solution lay in the opening of a new cardiothoracic unit. Unfortunately that was, at the time, three years away. It produced, according to one staff member, a 'Dunkirk spirit among staff, patients and relatives'.
Investigators heard allegations of 'staggeringly poor' safety standards - including animal faeces in the corridor near the operating theatre, rat traps in operating theatres and water leaking from toilets.
For the trust the cost of tackling problems will have to be balanced against the fact that the site will soon be closed.
'Trust management should work with staff and patients on the cardiothoracic unit to identify those environmental improvements which are required immediately, ' it says.
'A balance will need to be struck between investing in the current unit, given the opening of the new unit in March 2003, and ensuring that government guidance and health and safety standards are adequately complied with.'
CHI found evidence of some good practice - in particular high-quality patient information and active self-reporting by senior clinical staff.
When the increased death rates were first noted, 'swift and responsible action' was taken during the first four months of 2000, according to CHI. Meetings were set up, the issues discussed and, although inadequately carried out, a review was undertaken.
The National Specialist Commissioning Advisory Group - responsible for monitoring heart and lung programmes - was also informed and an external review launched by consultant cardiothoracic surgeons from Manchester and Birmingham. But it was not until October 2000, six months after concerns had first been raised, that the medical director and the chief executive of the trust were told of what was going on - even though both had responsibility for clinical governance.
'The investigation concluded that internal monitoring arrangements were too informal and crucial information on patient care - specifically the increase in death rates - was not shared with trust management at an early stage.'
Recommendations include changes to management arrangements to ensure clinical governance procedures are understood and implemented by all trust staff.
CHI also wants to see the system co-ordinated to allow information and accountability from service delivery units to service centres to trust managers.
Although much of the spotlight is on the activities of St George's Hospital, agencies designed to spot when things go wrong do not escape criticism from CHI.
The investigation found there was no clear leadership of the performance-monitoring process, with no document defining which organisation was responsible for what.
Under the recommendations, the NCCAG is urged to organise a system of co-ordinated monitoring as well as the examination of a single agency for all aspects of performance monitoring, designation and finance allocation.
CHI said it will return to St George's within 12 months.
Room for improvement: CHI recommendations St George's
The cardiothoracic unit should audit the quality of patients'records.
A suitable IT system for infection control management should be installed.
Improvements should be made to the fabric of the cardiothoracic unit.
Managers should identify the available resources needed to implement fully clinical governance.
National A review of funding for heart and lung transplant programmes should start, based on the principle of levelling up.It should also take into account the entire patient pathway.
Heart and lung transplant programmes should ensure a 'solid and transparent approach'to selecting candidates for operations.
Changes in criteria should lead to amendments to their local transplant protocols and patients'booklets.
When units suffer increases in death rates, external statistical expertise should determine whether the rises are statistically significant.
Information on outcomes given to patients and relatives should be based on the most recent evidence available.