In many ways the year 2000 was the start of the safety movement as we know it today. There are many safety scholars out there who will cite the work as far back as the late 1800s that helped our thinking in patient safety and the brilliance of our anaesthetic colleagues who were in fact the first people to coin the term ‘patient safety’ in the 1970s. However…the year 2000 heralded the seminal document published in the UK by the then Chief Medical Officer Sir Liam Donaldson, ‘an organisation with a memory’ after convening a group of safety experts, including James Reason, to understand what we needed to do to improve patient safety in the NHS.
Because things are changing again … those words ‘an organisation with a memory’ are hugely important. It is vital to remember the past and think about what we can learn from it . Hindsight is a wonderful way of looking back at the valuable lessons for the future.
In the UK, as a result of an organisation with a memory, a new organisation was set up to oversee the safety of patients in England and Wales, called the National Patient Safety Agency (NPSA). The NPSA was an organisation dedicated to improving patient safety with expertise from across healthcare and other high risk industries. The NPSA was launched in 2001 and in 2003 and I was employee number 53. We had the most amazing and unique opportunity to make a massive difference to the way safety was approached in the NHS.
In the early days we looked to experts in aviation and air traffic control and promoted the models that had been identified by an organisation with a memory such as incident reporting, root cause analysis and the use of checklists. We also looked to other countries and in particular the US healthcare system. They had set up a similar organisation called the National Patient Safety Foundation, which has now been merged with the institute for health care improvement (IHI). I recall attending one of their conferences in Washington in the early 2000s and being amazed at the conversations that were being held. They were talking about creating a culture of safety, they described solutions to medication error and importantly they talked about the human cost both to patients and the people who care for them. There were moving patient stories that left us with a burning passion to do all we can to prevent another story like the one we had heard.
One of the first things the NPSA tried to do was to promote an open and fair culture in hospitals and across the health service, which we would now refer to as a just culture, just and learning culture or restorative just culture. This sat alongside an approach called ‘being open‘ which was about improving our communication with patients, the public and staff.
Some of the most exciting work the NPSA did was look at the design of the physical environment, equipment and medications. A number of medications were and still are packaged in the same way. Liquids are often put in glass vials with similar labels, such as solutions for sodium chloride (relatively harmless) and potassium chloride (potentially lethal). Mix these two up and a patient could die. So, the Agency did what only national agencies can do, worked with the pharmaceutical industry to try to improve the drugs the naming and packaging of drugs. There were too many that sounded alike and too many that looked alike.
Seven Steps
In early 2003 when I joined the National Patient Safety Agency a group of us pulled together the latest thinking on safety and wrote national guidance for the NHS, titled Seven Steps to Patient Safety (2003).
During this time many nation organisations fell into the trap of disseminating guidance and expecting change to happen simply as a result. Our knowledge of implementation science was very limited. We have been forced to admit that unless you support implementation then guidance may not turn out as originally intended and planned.
A significant effort went into producing the guidance which was based on a combination of a systematic review of the research, assimilation of the international and national safety knowledge and understanding, together with personal experience and expertise. We consulted people on the frontline and we sought help in writing the guidance so that it was easy to understand and interpret. Seven Steps was launched at the NPSA’s annual conference in 2004 and a copy disseminated to every healthcare facility throughout the NHS by NPSA staff. The seven steps which were at the heart of the guidance were also used as the basis for training of over 8000 NHS staff in safety. Over the following five years Seven Steps was adapted for primary care and community care settings. It was adopted by countries as far as Hong Kong as a way to develop a safety framework.
I read it now and it makes me both smile and cringe. It was really great but would be written completely differently today with what we now know – which to me is an important reminder that we have learnt so very much over the last 25 years.
NRLS
The agency designed the national reporting and learning system (NRLS) and captured incidents from every area of healthcare, acute care, mental health, primary care, community and ambulance services. The NRLS as it was called is now morphing into the Learning from Patient Safety Events (LfPSE) as I write. From a technological perspective and a reporting perspective the NRLS was a success.
But…
The problem with our approach to incident reporting was that we tried to catch everything you can think of (Carl Macrae writes beautifully about this in the BMJ, 2016). The data is not always as good as it should be. The ‘easy to see’ incidents are usually the ones that get reported the most. This is tricky because in trying not to miss key safety information there is an attitude of if in doubt report it. This means there is far too much information. It also means that safety is viewed as an incident driven process. If too many events are being reported then they are unlikely to be reviewed appropriately.
Since then we have captured millions of incidents and struggled to analyse them as effectively as we would like. A more purposeful system would have served us better. There are ways to count things and incident reporting systems should not be used for that – incident reporting systems should be about alerting us to potential hot spot areas or types of incidents that need action in order to minimise them in the future.
One of the strategies in the early days was to send out the message that an increase in reporting demonstrated a good safety culture. This message was shared across the system including the regulatory and commissioning system who then took the message and ran with it. We encouraged doctors and other staff to report incidents and near misses. Doctors in particular because up until this point incident reporting systems were led by and used by predominantly nursing staff. It was made clear that the purpose of reporting was to enable healthcare providers to learn lessons from each other in order to improve safety, not to identify individuals or organisations to punish. We now know that some unintended consequences have happened along the way with sadly reporting, in particular never events, being used to ‘punish’ both individuals and organisations. For many years, now safety performance in healthcare has been measured in terms of the number of incidents reported.
Providers are measured on the number of incidents and an increase in number seen as a success. This is a very mixed message to staff, patients and the public. On the one hand it is good to have the information, on the other hand you expect learning to occur and the incidents therefore to decrease. What an increased number of reports could mean is a poor culture of learning. Also, reduced reports of a particular type might simply indicate that people became accustomed to something happening, grew tired of reporting or stopped noticing the problem in question. Thus, when reports decline, incident data on their own cannot distinguish between a reassuring improvement in safety or a concerning organisational blind spot. Conversely, because hospitals are judged in relation to the number of incidents reported, staff are fearful of reporting. They want to avoid being the person that compromised the organisations performance record. This attitude to incidents is disempowering the very people who can provide the knowledge on how to adapt and protect patients.
Incident reporting should not be used as a way of measuring safety in an organisation. This is because:
- Incident reporting systems have never captured all the things that go wrong on a day-to-day basis and never will
- Incident reporting systems do not reflect what actually goes ok as this is not counted at all
- The data is skewed as people are biased towards reporting particular types of incidents but not others
- Incident reporting systems are used to capture problems better suited to other strategies, e.g., they are used as an ‘information system to talk to management’; a way of airing grievances about resources or staffing levels
- Very few doctors report safety incidents (still). Instead, incident reporting is largely undertaken by nurses, and incident reporting systems largely fall under their governance units within healthcare organisations
- Nursing staff in particular use the reporting systems to share their frustration at all sorts of administrative issues that are not particularly safety related. While these may impact on safety, they end up by drowning out the important information; truly hiding the proverbial needle in the haystack
- There is a lack of feedback regarding previously submitted reports together with a lack of solutions or answers that could prevent the incidents from happening again.
Campaigns
Over its short life span, the NPSA delivered nationwide training, set up annual conferences, launched numerous interventions such as Clean your hands, Matching Michigan, and Patient Safety First.
‘Clean your hands‘ was linked to a WHO global campaign on hand hygiene. While the evidence base for washing hands or using hand sanitiser before touching a patient was strong, compliance was weak. In fact, the last few years of a global pandemic has shifted the world’s attention towards the importance of hand washing in a way we could only have dreamt of. Clean your hands campaign was extremely successful in raising awareness of the importance of hand hygiene and improving practice. As a result of the campaign all healthcare settings placed hand sanitiser throughout their organisations.
Patient Safety First was a campaign that endeavoured to use lessons from the Institute for Healthcare Improvement (IHI) and its 100,000 Lives Campaign. IHI set a goal of saving 100,000 lives and called on healthcare organisations to implement six specific healthcare interventions; rapid response teams, medication reconciliation, immediate revascularisation for myocardial infarction, reducing central line infections, ventilator associated pneumonia and the use of perioperative antibiotics.
Patient safety first used lessons from the Clean your hands Campaign (NPSA), the Safer Patients Initiative (Health Foundation UK), Operation Life (Denmark), Safer Healthcare Now (Canada) and the World Health Organisation Global Safety Challenges.
In order to create a campaign that was both meaningful and measurable, Patient Safety First focused on five interventions that were deemed to have a significant impact on care.
- Leadership for safety —a compulsory action for all trusts signing up to the campaign was to implement the leadership intervention. It focused on getting Boards fully engaged with safety by demonstrating that it is their highest priority
- Reducing harm from deterioration —by reducing in-hospital cardiac arrest and mortality through early recognition and treatment of the deteriorating patient
- Reducing harm in critical care —by reducing central line infections and ventilator associated pneumonia
- Reducing harm in perioperative care —by reducing surgical site infections and implementation of the World Health Organisation’s Surgical Safety Checklist
- Reducing harm from high-risk medicines —by reducing harm associated with anticoagulants, injectable sedatives, opiates, and insulin.
All trusts were asked to participate in the leadership intervention to help Boards become more engaged with safety. They could then choose anything from one to all of the four clinical interventions. The interventions were chosen because of their importance in terms of prevalence for high risk and harm.
The implementation principle was to support existing activity and not add new initiatives to the system where possible. Messaging and action were aligned with other safety work across the NHS including the NPSA alerts and solutions, Department of Health Guidance and training programmes across the NHS.
Throughout, the campaign emphasised the simple approach that could be taken to change practice. Providing purposefully simple audit tools, or monitoring tools to focus on one aspect of care such as recording observations to make change easier. This was further emphasised during Patient Safety First Week with a strapline of ‘one new step’ and the subsequent focus weeks with their single aims for those weeks. Focusing on just five interventions with practical ‘How to’ guides was instrumental in helping demonstrate how changes in safety could be made simply and easily.
A campaign should be thought of as a coordinated set of activities designed to motivate people to take action to achieve a common purpose. If a campaign is to ‘win the hearts and minds’ of front-line staff, it must be designed clearly with this as a central focus. This approach was considered quite empowering. We found a lot of members of staff felt quite empowered because they had the freedom to experiment, rather than being told exactly what to do. Clinicians were engaged in a number of different ways through:
- Regular, simple targeted communication
- Presentations from champions, local leaders to inspire
- Expert webinars and workshops
- Targeted mini-campaigns to inspire them to take part
- Engaging their professional bodies or networks
- Providing practical tips
While the campaign had its successes, it engaged and motivated nearly 98% of the NHS in England, but it was still an approach that centred on finding the problem and fixing it. We were missing the opportunity to study the good practice and sharing the learning from what we do well.
Where are we now?
Just 10 short years after being set up the NPSA and a number of national organisations were sadly stopped in their tracks as the agency was abolished in yet another reorganisation of the NHS as set out by the 2012 Health and Social Care Act.
Many have stated that the NPSA was abolished for reasons entirely unrelated to its performance or value. As Lucian Leape says in Making Healthcare Safe (2021):
The chaos of an NHS reorganization that its CEO said was so big that “It could be seen from space” made patient safety an “also ran” in NHS priorities. Under Donaldson’s leadership, the UK was one of the few countries to make a meaningful national commitment to safety and back it up with structural changes and funding. His strong commitment gave safety visibility and stature. This was lost with the abolition of the NPSA and the redesign of the CMO post to no longer have responsibility for quality and patient safety in the NHS.
Even from the earliest days, the NPSA was under intense scrutiny. After just three years it was audited to assess its performance and aspects such as ‘Seven Steps to Patient safety’, which had only just been disseminated, was ‘found to be ineffective’. It takes on average over a decade to get guidance embedded into new practice, yet the audit office thought it would assess this within one year of publication. In fact, the vast majority of what the NPSA had done in its 3 years of existence was criticised. This criticism stuck and in a way the organisation never quite got over that criticism, with its demise constantly being considered.
In 2023 the Imperial College patient safety report of that year stated that sadly we have yet to achieve a positive and just safety culture in the NHS.
Being open has been replaced by a legal requirement called the ‘duty of candour’ which in many instances has simply become a tick box exercise.
There is very little effort put into the design of the environment, improving the conditions in which people work to enable them to be as safe as possible and all kinds of other system factors that should have been continued over the last decade.
The approaches we have taken to date in the field of safety have stayed the same while our knowledge and the world has changed.
I am completely biased but I think we were only just finding our feet when the rug was dramatically pulled from under us, and my view is that the NPSA can be credited for being the driving force for the safety movement in the UK. It increased awareness and knowledge across the NHS and laid the foundations for the future. And that future has shown some progress since 2012 with interventions such as the patient safety incident response framework, the patient safety specialists, patient safety strategy, syllabus and plans. Also campaigns such as Sign up to Safety and global challenges from the WHO.
I hope that the coming reorganisation remembers the need to learn from the past and where we have been, what has worked well, what we could have done differently and be inspired to move forward with that knowledge.
PATIENT SAFETY NOW 