Published 4 November 2008, doi:10.1136/bmj.a2370
Cite this as: BMJ 2008;337:a2370

Feature

Patient safety

Cutting out human error

¹ London

Worldwide millions of people experience avoidable complications from surgery every year. Jane Feinmann looks at steps being taken to make it safer

Why do surgeons seem reluctant to adopt a simple safety procedure that outsiders would regard as second nature? The question was recently posed by Sir Ian Kennedy, chair of the Healthcare Commission and best known for the inquiry he led into the deaths of 29 babies in the paediatric cardiac surgery unit at Bristol Royal Infirmary. That report, published in 2000, found that systematic failure and a culture of arrogance among doctors were the leading causes. His recent comments suggest that he doesn’t think much has changed.

"It comes as a shock that a group of professionals should be prepared to wait until something disastrous occurs before they agree to change their behaviour. It’s rather like a dangerous pilot being told: wait until you have your first crash," he said.

Sir Ian’s comments at the first annual meeting of the Clinical Human Factors Group—an independent group of experts on factors that affect human performance from both inside and outside the healthcare professions (www.chfg.org)—in Harrogate in October are timely for once again the safety record of surgery is under scrutiny.

Last week, the health select committee began to question senior doctors and managers as part of its inquiry into patient safety. The investigation focuses on the issues identified by Kennedy: human error, poor clinical judgment, and systems failures rather than the better known problem of hospital infection.

The World Health Organization is also turning its attention to safety in the operating theatre. In June it warned of the growing risks of surgery in both the developing and developed world. Around 230 million operations are carried out every year—one for every 25 people in the world—giving rise to a million deaths and 7 million complications every year. "And that is because the quality and safety of surgery is dismayingly variable in every part of the world," said Atul Gawande, surgeon and professor at Harvard School of Public Health and now the WHO lead for a new initiative, Safe Surgery Saves Lives (www.who.int/patientsafety/safesurgery/en). The global project is based on use of a basic safety check similar to the one that has been mandatory in aviation for 20 years (box). The checklist has now been widely tested, and the results are expected imminently.

Safe Surgery Saves Lives checklist WHO recommends that a single "checklist coordinator" take responsibility for confirming that each member of the surgical team has completed his or her required tasks before the operation can begin. The checklist is divided into three stages, and the issues covered include: Sign in (before anaesthesia) The patient’s identity and exact surgical site The procedure to be performed Known patient allergies Antibiotics have been administered within 60 minutes of the operation Time out (before incision) Confirm team members have introduced themselves and their roles Team members verbally confirm the patient’s identity, site, and procedure Sign out (after the operation) All instruments, sponges, and needles are accounted for Labelling of specimens Plans for postoperative care What can we learn?

Breaking the chain

A further focus on surgery is the launch of The Journey, the first human factor training DVD. The film is produced by the Alliance for the Safety of Patients, a multidisciplinary group dedicated to improvement of the safety of patients, and was previewed at the Clinical Human Factors Group meeting. It shows a dramatic reconstruction of real events that led to a skilled team in a modern operating theatre allowing a patient to bleed to death during what should have been straightforward surgery for the removal of tumour.

What killed the patient, according to Tony Giddings, a former member of the council of the Royal College of Surgeons of England and now chair of the alliance, is "the latent conditions that reside in all of us as fallible human beings—unseen bugs that can be just as lethal as the micro-organisms that we scrub away before surgery."

The Journey describes "an extraordinary cascade of ordinary events": the surgeon’s favourite retractor going missing, the sucker failing to work; no preparation of platelets or cross matching of the patient’s blood despite the fact that he had been receiving anticoagulant treatment.

The surgeon, as leader, claims full responsibility and expects years of disabling guilt. But the DVD’s message is that this was a team failure: "Everyone was acting as an individual and no-one asked any questions before they began," said Mr Giddings.

None of these individual failings is even verging on criminal. The surgeon had a reputation for being demanding, arrived late, and got steadily more annoyed when nothing he shouted for was available until he was unable to see beyond these problems. The anaesthetist was from overseas, new to the hospital, and expecting the same system as had operated in her previous job. "I didn’t ask questions in case it looked as though I didn’t trust the rest of the team," she says.

The operating department practitioner didn’t check if cross-matched blood was available "because we don’t usually need it." And the scrub nurse made only one attempt to call for help when the patient developed a major venous bleed. When she was ignored, she shut up. "What I can tell you," she says, "is that a woman is often taken less seriously in a crisis."

The Journey goes on to show that the disaster would not have happened if the WHO checklist had been in place, enabling the healthcare professionals to work as a team, "sharing the plan, sharing the work, and sharing their experience." This is in line with early data from the global study showing that the initiative halves the likelihood of missing basic safety steps, greatly reducing potential complications and deaths.

"It’s a three step checklist that takes surgical teams around two minutes to complete—about the same time as the conversation that the surgeon and anaesthetist tend to have in the corridor before the operation," explained gastrointestinal surgeon, Krishna Moorthy, the project lead at Imperial College Healthcare NHS Trust, one of the eight sites that are evaluating the initiative.

"Yet the data so far show that that is time enough to put into practice established protocols on safe anaesthesia, preventable infection and bleeding, and good teamwork. We have also seen a significant improvement in the administration of prophylactic antibiotics within 60 minutes of the incision. The checklist reduces the chances that team members assume that someone else has administered the antibiotic," Mr Moorthy said.

Alongside the checklist, there is evidence that non-technical skills can be taught by using patient simulation manikins that produce real pathological responses to treatment. In one study at the Scottish Clinical Simulation Centre at Stirling Royal Infirmary, senior anaesthetic trainees took an average of four minutes to defibrillate a "patient" who developed ventricular fibrillation while having a hip replacement—a delay that reduces the survival rate by 20%.

"All the trainees knew that in a cardiac arrest scenario, defibrillation is the priority, but they muddled about for several minutes. That knowledge needs to be embedded for the doctor to have situational awareness and the leadership skills to get the right thing done in an unusual circumstance," said Nikki Maran, director of the centre. "The right place to embed that knowledge is the simulated theatre."

Putting safety into practice

So with pressure to act from both parliament and WHO and clarity on the way forward, will surgical teams routinely take on human factors training? Not necessarily, according to chair of the Clinical Human Factors Group, Martin Bromiley, a pilot and expert in human factors in aviation. He brought together the loose knit group of experts three years ago after the death of his wife during minor surgery.

"I believe there is a great will at the top of the NHS to make things happen. But the bureaucratic culture in the royal colleges creates an inertia that makes change difficult," he told the meeting in Harrogate.

Mr Moorthy was also cautious about the future of the WHO initiative. He warned that clinicians might demand a stronger evidence base. "At the moment we are focusing on outcomes—complications and deaths that are inevitably low in this day and age. We may need further local measures to bring everyone on board."

However, there are certain barriers to successful implementation of the checklist, he said. "After an extensive introduction to the checklist, 80% of teams used the checklist when researchers were present. That fell to only 40% when they were not. This probably reflects the fact that it may be essential for someone to be in the theatre in order to drive use of the checklist till teams are convinced of its importance," he added.

All of which leaves open the exact status of an evidence based Safe Surgery Saves Lives checklist. In the United States, use of the checklist looks set to become mandatory for all surgical teams—with the threat of the hospital losing its licence if it is not routinely used.

In the UK, the idea of the checklist being mandatory is controversial. But there is recognition that a handful of uncooperative senior staff could block progress. "There will always be 5-15% of mature professionals who won’t join in—including the surgeon that everybody has had to tiptoe around for years. Perhaps these people will need to move on," said Mr Giddings.

Cite this as: BMJ 2008;337:a2370

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Competing interests: None declared.

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