National Patient Safety Agency
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Christine Clark reports from a meeting at which
participants were told that hospital trusts should take on the
challenge of designing for safety
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The conference, entitled “Patient safety
2004” was organised by the National Patient Safety Agency,
and took place in Birmingham on 24 and 25 February
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Experiences at the sharp end of risk
 Patient safety was put into sharp relief
by the personal experiences of two
individuals who set the scene for the conference.
Amanda Cale, managing director, Classy Glass and Awards Ltd, described
how her father, Charles Bootle, had died after a series of events arising
from methotrexate treatment for arthritis.
At the age of 71 he developed severe rheumatoid arthritis affecting most
of his joints. He was referred to a consultant but the waiting time was
considerable and so he sought private medical treatment. After blood
tests and a chest X-ray he was prescribed a weekly does of methotrexate.
Some time afterwards he became breathless with moderate exertion. Thinking
that this might be due to one of his medicines, he asked his wife to
draw up a chart listing them all and their side effects, using the information
leaflets in the packets. He concluded that the most likely cause was
methotrexate and consulted his GP, who decided that he needed oxygen
and referred him to the accident and emergency department of the local
hospital. After initial assessment he was admitted for a presumed chest
infection.
The weekend passed and it was noted that “the patient says methotrexate
is causing the problem”. The following week a bronchoscopy was
carried out and Mr Bootle’s breathing continued to deteriorate.
He was scheduled for transfer to the intensive care unit (ICU) but there
was no bed so he remained on the ward. A new type of oxygen mask was
available but nurses were not allowed to use it on general wards. At
this point steroid treatment was started and Mr Bootle was provide with
an airbed as he was becoming sore. One week after visiting his GP he
was transferred to the ICU, sedated and artificially ventilated. By this
time he was very sick and the family was told that there was little hope
of recovery.
Mrs Cale told the staff that she had looked up methotrexate on the internet
and was surprised when the doctors said they had been doing the same
thing. She noted that lung complications with methotrexate were rare.
Shortly afterwards Mr Bootle died.
Mention was made of a yellow card and in the discussion that followed
the doctors said that many drugs had nasty side effects and if patients
were told about all of them they would be worried. Asked where the main
weaknesses in the system lay, Mrs Cale said that they were lack of communication
and lack of knowledge (about methotrexate side effects and appropriate
treatment).
Carol Black, president, Royal College of Physicians, said that methotrexate
was a good drug when used correctly with appropriate monitoring. Failure
to do this was unsafe and “bad medicine”. Patients should
be given information and allowed time to consider it and discuss it with
their families, before embarking on treatment. It is important to be
honest with patients and provide information that they can comprehend,
Professor Black added. Overdose
A tenfold overdose given to a baby had turned out to be “a negative
learning exercise” for Suzette Woodward, assistant director of
patient safety, NPSA. At the time Ms Woodward was a senior staff nurse
in a paediatric intensive care unit. Most of the patients received a
minimum of five to six intravenous medicines and these were always assembled
by the bedside nurse. There were frequent interruptions.
One evening, when Ms Woodward was on night duty, she checked a series
of medicines that had been drawn up for a patient by another nurse in
the usual way. One of the medicines was a new product that was dosed
by body weight and given by infusion over 24 hours. During the ward round
later she noticed several of the staff looking at the infusion pump and
looking at her. The doctor turned off the pump and whispered “too
much fluid”. After the round it was explained that a tenfold overdose
had been made up and the patient had received the 24-hour dose in just
over two hours. The likely effects were abdominal pain and liver damage.
Ms Woodward said she felt physically sick as she turned over in her mind
what had happened. The other nurse refused to speak to her and blamed
her for the incident. She blamed herself and also the other nurse. “I
no longer felt proud to be me and I did not want anyone to know what
a dreadful nurse I was,” she said.
Her line manager told her that she should have known better and that
she had let them all down. She was most irritated that Ms Woodward could
not explain how it had happened. There was no investigation of the incident
and “there was no learning to be had” from it.
Fortunately, the patient recovered unharmed and afterwards Ms Woodward
double-checked everything she did. It was only much later that she learnt
that incidents do not “just happen” and formed the view that
she was “set up to fail”.
In the discussion that followed Ms Woodward said that the responsibility
of the organisation to support staff involved in incidents should be
emphasised and the use of the NPSA incident decision tree would help
with this. In addition, she made a plea for a new system of working that
does not require nurses to calculate complex paediatric doses.
Peter Homa, chief executive, St George’s Hospital Trust, added
that there should be better training for staff and that trusts should
take on the challenge of designing for safety.
Lessons to be learnt from other industries
It is natural to compare health care with other hazardous industries but
there are not always direct parallels, said James Reason, Emeritus Professor,
University
of Manchester. Health care is often compared with the air transport industry — indeed,
anaesthetists have described themselves as doing the take-offs and landings
while the surgeons are responsible for the in-flight entertainment.
There are two ways to look at human error. The “person approach” is
deeply rooted in our culture and it says that the reason for an incident lies
with an individual performance failure. Remedial measures, such as retraining
and “fear appeal” posters are directed at the individual and not
at the situation in which the incident occurred. Crucially, this approach divorces
people from the context in which the error was made, explained Professor Reason.
The systems approach says that people at the sharp end are inheritors of accidents
that are waiting to happen rather than instigators. Remedial measures involve
examining how the barriers in the system failed.
Both of these are extreme positions and what is needed is a sensible “person
approach” embedded in a sensible “systems approach”, suggested
Professor Reason.
One of the biggest differences between health care and aviation is that aviation
was predicated from the outset on the notion that errors would occur. Consequently,
there has always been a strong emphasis on the possibility of failure and
on training people to cope with it. In health care, practitioners go through
a
long and arduous training and there is an expectation that they will then
get things right. This has led to the development of an organisational culture
in which discussion of errors and near misses has not been the norm.
Another difference is that there have been huge wake-up calls in aviation
after major incidents.
The system view of incidents inevitably demands to know which of the defences
failed and how. Although some events are triggered by an unsafe act by an
individual set against background of latent problems, some occur with no
contribution
from individuals. The King’s Cross underground disaster in 1989 is
an example of such an incident.
In other areas, similar situations recreate and reinforce the same kinds
of bad events. In health care, some of these are simple, for example similar-looking
labels; others may be considered as an insidious accumulation of fault lines,
such as the repeated accidental intrathecal administration of vincristine.
Fatal accidents occur in aviation at a frequency of less than one per million
miles flown. It is less well-known that aviation has a higher rate of “lost-time
injuries” (for example, due to back injuries in baggage handlers) than
most other industries — even higher than logging. It is clear that different
standards apply in different parts of the industry, and Professor Reason wondered
whether there were also subcultures in health care.
Another difference between health care and aviation or the nuclear power
industry is that in the latter two the job is “standard” whereas in health
care it is complex and diverse. Jobs could be broken down into three components,
he said: maintaining control under routine conditions, maintaining equipment
and handling emergency conditions. The latter two provided most opportunity
for error. Health care work was more like the aircraft maintenance engineer’s
work than the airline pilot’s job, he
concluded.
There were numerous other factors that made health care different, including
the vulnerability of patients and the fact that healthcare is delivered by
one to one or by few to one whereas nuclear power for example is delivered
by few to many. In addition healthcare staff are often prepared to “go
the extra mile” to provide a service.
What is needed is a balance between the person and systems models, he argued.
Excessive reliance on the system models leads to “learned helplessness,” he
said, and has also been described as “a bungler’s charter”,
because it encourages individuals to disclaim responsibility. Moreover, professionals
at the sharp end need to be able to identify error-prone situations and take
the appropriate action. Many professionals acquire this kind of ability over
time but could be helped to develop it earlier. Three bucket model
Professor Reason put forward the idea of the “three bucket model” to
help to identify potentially risky situations. This says that three factors
contribute to the likelihood of an error — the individual, the context
and the task itself. If each of the three is represented by a bucket, there
can be a certain amount of “bad stuff” in each bucket. For example,
in the first “self” bucket, the individual can be stressed, tired
or emotional, in the context bucket there can be noise and interruptions and
in the task bucket there can be complex calculations or operations.
In any situation the likelihood of an error is a function of the amount of
bad stuff in all three buckets. Full buckets do not guarantee an error and
neither do empty buckets guarantee total safety but they
provide a forewarning and prompt for extra vigilance.
Benefits of openness and transparency
Dr Hammett: patients need an apology and an explanation |
Patients in Australia had called for openness when things went wrong and
this had given rise to the “open disclosure” initiative,
explained Rohan Hammett, director, Healthcare Improvement Projects, New
South Wales Institute for Clinical Excellence.
Patients involved in an adverse event — defined in Australia as any event
that results in unintentional patient harm — need an apology, an explanation
of what happened, necessary treatment, action to prevent recurrence and ongoing
support. An open culture involves ongoing activity that meets the needs of
patients and staff involved in adverse events; it is not a “one-off” activity.
Patients may require ongoing support for as long as two years after the
event, said Dr Hammett. The clinicians involved can find the effects catastrophic
and often need support and advice. They also need recognition of the systems
nature of events and for the peers not to see them as substandard practitioners.
In Dr Hammett’s experience, open communications increased trust between
all parties, decreased anger, increased safety, permitted quicker investigations
and possibly decreased litigation. “People sue because of anger, lack
of acknowledgment and a desire to find out what happened,” he added.
The Australian open disclosure programme has involved wide consultation and
painstaking development of standards on which all stakeholders agree. (See
the Australian Council for Safety and Quality in Healthcare website www.safetyandquality.org.) The biggest challenge in implementing the scheme is the readiness of
institutions.
“As long as you continue to jail clinicians [in the UK] you will have difficulty
getting them to co-operate with open disclosure initiatives,” said
Dr Hammett.
Global patient safety challenge
Talking about the global patient safety challenge, Sir Liam Donaldson, Chief
Medical Officer, said we should be hard on ourselves and expect the public
to be hard on us if we fail to learn and let the some incidents occur again
and again.
Package design
Talking drug packs that would say the name of the product when opened was
one of the options considered by Phoenix Pharma when it came to redesign its
packaging,
according to Steve Watkin, managing director, Phoenix Pharma. Radio frequency
identity chips and EAN 128 barcodes were also considered but innovative use
of colour and label design was eventually chosen. |
The
Pharmaceutical Journal