Memorandum by Action against Medical Accidents
This Memorandum sets out the views of the charity
Action against Medical Accidents (AvMA) in respect of the terms
of reference the Committee has set for its inquiry into Patient
Safety. In particular we would draw the Committee's attention
to our comments regarding:
urgent action to implement recommendation
12 of Safety First
to make "Being Open"
a reality (see paragraph 4.4),
consolidation of the National Patient
Safety Agency (NPSA) as the key central organisation focussed
purely on patient safety, and more "clout" to be given
to its alerts / guidance,
more priority/resources being deployed
to safety "solution" or intervention work on known issues
rather than making reporting systems more elaborate,
action to be taken to increase reporting
rates in primary careperhaps by making reporting compulsory,
development of the "avoidability
test" as an alternative test to the "Bolam test"
in deciding whether to award compensation for clinical negligence
and to make the NHS Redress Scheme fairer and more aligned with
patient safety objectives and culture,
review of the NHS Litigation Authority
and transfer of its responsibility for standards to a more appropriate
putting patients and the public themselves
at the centre of patient safety work by building upon the Patients
for Patient Safety project managed in partnership between
the NPSA and AvMA
2. ABOUT ACTION
Action against Medical Accidents (AvMA) is the
UK patients' charity which is specifically concerned with patient
safety and with justice, in the widest sense, for people affected
by medical accidents. Established for 25 years, AvMA was campaigning
for better patient safety well before the issue was appreciated
by Government and the NHS. AvMA has influenced the development
of the patient safety movement in the UK and the establishment
of agencies such as the National Patient Safety Agency and Healthcare
Commission. AvMA's Chief Executive, Peter Walsh, is the only patient
representative on the National Patient Safety Forum, chaired by
the chief medical officer and chief executive of the NHS. AvMA
provides advice and support to around 4,000 people a year who
have been affected by medical accidents, which provides it with
a unique insight to what goes wrong and the experience of patients
and families following a medical accident (or "adverse event").
AvMA also works closely with other patients' organisations and
is a partner of the National Patient Safety Agency (NPSA) in managing
the Patients for Patient Safety project. This project implements
recommendation 13 of Safety First by establishing a national
network of patient safety "champions". AvMA draws on
all of its experience and contacts in providing these comments.
3.1 AvMA believes that too much emphasis
is put on individual human error and poor clinical judgement as
opposed to systems failures. That is not to say that human errors
should not be identified or that they are acceptable, but rather
that there should be systems in place to reduce the risk of such
errors. Organisations should take corporate responsibility for
patient safety. When things go wrong, investigations should seek
to identify the root causes and missed opportunities for intervention
or prevention rather than simply identify individuals who are
"to blame" for the incident. However, this should not
be at the expense of personal accountability where appropriate.
This represents a significant need to change the culture in healthcare.
The development of phraseology such as "blame free"
or "no blame" culture as the desired "patient safety
culture" was unfortunate and unhelpful as it was taken by
some to condone a lack of personal accountability. We support
the concept of a "patient safety culture" being a "fair
blame" and "open and fair culture".
3.2 Unfortunately, a number of factors militate
against the development of a genuine patient safety culture. One
which we would like to highlight, and which features prominently
in any discussions with health professionals about patient safety
and incident reporting, is that of litigation. There is currently
a reliance on civil litigation being the only means by which patients
or families affected by clinical negligence can obtain the compensation
they need and deserve. The definition of negligence used by the
civil courts (the so-called "Bolam test") means that
the focus of attention when something goes wrong is almost always
centred on finding an individual who is "to blame" (where
personal negligence has led to the harm caused). This is unhelpful.
However, in the absence of an accepted alternative means of offering
fair compensation, it would be entirely wrong to seek to restrict
injured patients'/families' access to justice through this route.
3.3 The Chief Medical Officer called for
a radical reform of how compensation is provided for clinical
negligence in his report Making Amends.
Whilst some of his recommendations have been rejected by the Government,
the proposal for an NHS Redress Scheme was taken forward by the
NHS Redress Act 2006. This provides the legislative framework
for establishing an NHS compensation scheme for clinical negligence
cases which would avoid the necessity to take legal action for
some claimants. However, the legislation restricts the scheme
to cases which would be eligible for compensation in tort, ie
they will use the civil courts' definition of negligence. We believe
that this is a fundamental flaw and a missed opportunity to rise
to the challenge posed by the Chief Medical Officer and to find
a compensation system which is both fair and conducive to a patient
3.4 We believe that the concept of "avoidability"
should be central to work on patient safety and also offers a
suitable way forward with regard to clinical negligence compensation.
We recommend that any NHS Redress Scheme should replace the legal
definition of negligence (the "Bolam test") with what
we describe as an "avoidability test".
AvMA propose that what we have called an "avoidability
test" is applied to determine eligibility for redress. In
essence, this would mean that in cases which are being considered
under the NHS Redress Scheme the first question to be asked would
be "Could the adverse outcome have been avoided if the
organisation responsible for the treatment had followed accepted
If it could be demonstrated that good practice
had been followed, there is no qualification for redress. If the
practice is not considered to be good/in accordance with standards
and guidelines in England, there would be a qualification for
redress, unless the NHS body could demonstrate, on the balance
of probabilities, that the adverse outcome was not caused by the
failure to follow good practice.
We believe this approach has significant advantages.
it moves away from the blame culture/focus
on pinning blame on individual health professionals which is considered
a hindrance to improving patient safety,
it focuses on root causes and systems
issues, meaning that one investigation should result in the answers
needed to help improve patient safety as well as to whether or
not someone deserves redress,
it is fairer. Most people would agree
that someone who has suffered harm as a result of sub-standard
treatment should be entitled to redress.
It would drive quality improvement
by making the acceptable standards "good" practice rather
than practice which is not so bad as to be categorised as "negligent".
3.5 We believe that society rightly places
great priority on the prevention of avoidable harm in healthcare,
ie "patient safety". We do not agree with the view expressed
by some health economists that a purely quantitative approach
to assessing the priority attached to any patient safety intentions/solutions
should be applied. Principles such as "fairness", "justice"
and "public confidence" (and some would say, "common
sense") must also be considered. Thus, whilst the prevention
of a small number of perfectly avoidable deaths as a result of
errors in administering intravenous injection of drugs is justifiable.
For example, even if an assessment of quality adjusted life years
(QALYs) against other potential uses of the resources would suggest
that the alternative use was more productive. This is because
we place higher priority on "moral weight" to addressing
problems which we know are perfectly avoidable and the consequence
of which are so serious. We therefore suggest that patient safety
is a special case and continues to deserve more resources to be
put towards it.
4.1 We believe that NHS Boards and Primary
Care practitioners in particular have a long way to go to establishing
a patient safety culture. With regard to NHS Boards we would point
to the apparent failure to take guidance such as Being Open
seriously (There has been very little take up of the training
offered by the NPSA). With regard to primary care practitioners
we would point to the scandalously low rates of reporting to the
NHS national reporting and learning system. Consideration should
be given to making the reporting of incidents which may have caused
harm mandatory in common with some other modern health services.
It seems perverse that it is against the law not to report a road
accident but the reporting of a medical accident remains voluntary.
4.2 We believe that the introduction of
further public/private mix in provision of NHS healthcare has
significant risks, and that the impact on patient safety should
be taken more into account in making decisions in this regard.
For example, we do not think that patient safety issues are examined
carefully enough in the rush to establish independent sector treatment
centres. We have seen some of the unfortunate consequences in
our casework. It seems obvious to us that it is a huge enough
challenge to develop a patient safety culture and consistent approaches
to patient safety in a large public institution such as the NHS.
Fragmenting the system and placing responsibility for provision
in a variety of different private organisations whose primary
motivation is profit can only make this more difficult.
4.3 We approve of Safety First as
the template for improving patient safety and the sense of urgency
which it sought to instil. This momentum must be continued until
we see well evidenced and sustained improvements. We believe that
significant achievements are being made in the implementation
of Safety First recommendations. However, we would like
to draw the Committee's attention to what we believe is more urgent
and robust action to address the needs identified in recommendation
4.4 Recommendation 12 of Safety First
recognises that "Communicating openly and honestly with patients
and their families when things go wrong is a vital part of patient
safety" and recommends action to make this a reality. We
welcome this, but regret the lack of action so far. The NPSA has
already published excellent guidance, training and a safety alert
on "Being Open". However, there appears to have been
little take up of the training and, given the number of "must
do's" that NHS Boards are faced with, they are unlikely to
make this guidance a priority. We think it is fundamentally wrong
that something so vital should be relegated to optional guidance.
In order to make Being Open a reality and achieve a genuine
patient safety culture, we recommend that:
The Chief Medical Officer's recommendation
for a legal "duty of candour" (Making Amends, 2003)
The Healthcare Commission/new Care
Quality Commission actively monitor NHS bodies' implementation
of the Being Open guidance/safety alert and uptake of the training.
Resources are made available for
NHS bodies to take up training on "Being Open".
The principle of "Being Open"/patients'
and families' right to full and unfettered information and explanation
of what may have gone wrong with treatment and what will be done
to learn lessons, is enshrined in the NHS Constitution.
The NHS Litigation Authority withdraws
its circular on "apologies and explanations" (August
2007) and replaces it with more enlightened guidance. (See Comments
on NHS Litigation Authority below).
4.5 We believe that spending on patient
safety could be used more effectively. We have always felt that
it was a mistake to place so much emphasis on the development
of an elaborate reporting system at the expense of actual intervention/solution
work. There is ample evidence of the same sorts of errors being
reported already without going to extreme lengths to identify
new issues. We agree with having a reporting system, but would
like to see a re-alignment of resources with priority being given
to solution work. Some of the most useful work done by the NPSA
for example has been on patient safety problems which have been
known about for some time and have been crying out for action
(eg Wrong Site Surgery; Hospital Acquired Infections). There are
many more areas which are known about, which do not require the
reporting system to be identified.
4.6 We recommend that Safety Alerts and
other publications from the NPSA are given more "clout".
The public find it quite incomprehensible that safety alerts may
not be implemented by NHS bodies, with no comeback for them. If
the NPSA is not itself to be given more authority, there must
be a close marry-up with the new Care Quality Commission to ensure
that safety alerts and guidance from the NPSA are implemented
by NHS bodies and boards held to account if they are not.
4.7 We think it is a right that there is
a body such as the NPSA which is solely concerned with patient
safety, so as to give patient safety the prominence and priority
it deserves. The NPSA should be strengthened and be given the
confidence and stability it needs to fully develop its role. We
do not think that the notion of hiving off different aspects of
patient safety work (for example, "solution" work to
NICE) would be at all helpful.
4.8 We believe that the NHS Litigation Authority
should be reviewed and modernised. We see the existence of a body
such as the NHSLA as a major advantage. However, we perceive that
so far there has been a massive missed opportunity to learn lessons
from the clinical negligence claims which the NHSLA deals with.
We would like to see evidence in the future of tangible steps
which have been taken to learn lessons and implement improvements
as a result of clinical negligence claims. This will require closer
working with the NPSA.
4.9 We believe the NHSLA is the wrong body
to be responsible for developing and monitoring safety standards.
Currently, they are, in the form of their "risk management
standards". Whilst it is important that lessons from NHSLA's
work inform standards for improving safety, we believe it is wrong
to have responsibility for standards underpinning patient safety
with what is essentially an organisation with an insurance industry
approach. This work would more appropriately be handled by another
agency/agencies such as the NPSA and Care Quality Commission,
so that standards are informed by other areas of their work.
4.10 An example of how far the NHSLA is
from an understanding of patient safety culture came as recently
as August 2007 when it re-issued old guidance on "apologies
and explanations" to all trusts. This circular confused apologies
with mere "expressions of regret" or "sympathy"
and actually warned NHS bodies that care must be taken on the
dissemination of explanations so as to "avoid future litigation
risks"". Ironically, under the NHS Redress Act, the
NHSLA could be the body responsible for the NHS Redress Scheme
which relies on NHS bodies proactively telling patients/families
that they may have a potential claim which would be successful
THE NHS SHOULD
5.1 In addition to the points made above
and summarised in the executive summary (paragraph 1), we believe
that more effort should be made to involve patients and the public
in patient safety. It is due to the countless avoidable tragedies
and the perseverance of injured patients and their families that
it has become recognised that there is a need to improve patient
safety. They deserve to be at the centre of the movement to make
improvements. We recommend that the start that has been made in
increasing lay/patient involvement in improving patient safety
through the "NPSA/AvMA Patients for Patient Safety"
project is further developed. Whilst the recruitment and support
of a national network of "patient safety champions"
is a useful start and provides a focal point and resource to develop
more widespread patient involvement, it is not an end in itself.
A fully developed project would see more "champions"
recruited and supported, but also a wider ranging network, support
and training for other patients to actively engage in work on
patients safety, and also for staff to help them engage with patients
344 Safety First, Department of Health 2006. Back
Being Open, National Patient Safety Agency, 2004. Back
Making Amends, Department of Health 2003. Back