Patient Safety level 1

Study guide
Patient Safety level 1
Patient Safety Culture and Human Factors
CQC Outcome 12

A patient’s story

Rod was looking forward to a happy retirement but following a botched operation in
2007, he has spent the last ten years suffering follow-up operations, constant pain and
stress. Rod had been suffering from chronic pain which had proved resistant to
treatment, so his local hospital referred him to a neurosurgeon for a dorsal column
stimulator implant. This involves placing a device under the skin to produce mild
electrical pulses that are sent to the spinal cord. These pulses can mask pain and the
level of stimulation can be adjusted as required. The operation appeared to go well and a
week later, the stimulator was switched on. It was immediately clear that the electrodes
had been placed to stimulate his left side, not the right side where he had the pain. Rod
was offered corrective surgery which he accepted and which took place in May 2008.
But yet again, when the stimulator was turned on it was not working in the right place –
on the right side this time but still not at the site of the pain. With no improvement in his
pain, Rod had the stimulator removed in October 2008, followed by further operations in
2009 and 2011 to remove a remaining lead. In addition, pieces of electrode were found
to have been glued to his spine and could not be removed for fear of paralysis. Rod was
left with his original pain, compounded by additional pain, scarring and distress following
this series of major operations and has been unable to work since. He has suffered bouts
of depression, as well as the loss of his life savings as he battles for answers. Cases like
Rod’s affect more than just the patient. His wife has been suffering from stress-related
illness as a result of their ordeal.

“I have been let down by the NHS and if I had known then what a state I would be in now,
I would never have had the surgery.”

Rod’s surgery demonstrates the lifelong impact of NHS staff not ensuring the safety of a patient.
Spending two minutes more during this operation could have saved Rod years of pain, his life savings
and saved the NHS from a long court case. We don’t know the exact circumstances around what
happened during Rod’s operation but we do know what factors contribute to patient safety errors.

Read on to gain a better understanding of how circumstances and environment have a direct influence on
the care we give our patients.
Aims & Objectives of this document:
To define what is meant by patient safety & safety culture
To outline Safety I & Safety II models
To describe human factors & their relationship to safety & error
To describe a framework of non-technical skills & consider how developing this skill set can improve
patient safety & experience & staff performance

What is patient safety?

The NHS Patient Safety Strategy defines safety as: “Patient safety is about maximising the things that go
right and minimising the things that go wrong for people experiencing healthcare”. The WHO definition is:
“Patient safety is the absence of preventable harm to a patient during the process of health care and
reduction of risk of unnecessary harm associated with health care to an acceptable minimum. An
acceptable minimum refers to the collective notions of given current knowledge, resources available and
the context in which care was delivered weighed against the risk of non-treatment or other treatment.”
The scope of patient safety is huge and can be a daunting area to contemplate, but standard definitions
ensure we are at least using the same language and some basic knowledge helps us to understand why
things happen the way they do.

What is safety culture?

Organisations that have a healthy attitude towards safety culture adopt five key attributes:

1) ALL workers accept responsibility for the safety of themselves, their co-workers, patients, and
visitors.
2) Safety is prioritized above financial and operational goals.
3) Identification, communication, and resolution of safety issues are encouraged and rewarded.
4) Organizational learning from accidents is provided for and encouraged.
5) Appropriate resources, structure, and accountability are provided to maintain effective safety
systems.

Safety I and Safety II

The more traditional understanding of safety in health care is the Safety I model. Safety is defined as a
state where as few things as possible go wrong. Things go wrong due to technical, human and
organisational failures and detailed reports are produced to work backwards from events to determine the
cause. Things go right because the system functions as it should and people behave and work as they are
supposed or imagined to and as they have been trained to do. Safety I approaches are usually reactive,
and include incident reporting, investigations, guidelines and targets. Individuals may be viewed as
responsible, solutions often involve warnings or sanctions against individuals and education takes place
after the event. If the number of incidents then goes down, the system is considered safe.

Safety I does not explain why human performance almost always goes right; when something goes wrong,
we should begin by understanding how it otherwise usually goes right. This definition of safety, the Safety
II model changes our perspective from “avoiding something that goes wrong” to “ensuring that everything
goes right”. We cannot make things go right just by preventing them going wrong; we need to know how
things go right, as a basis for understanding why things occasionally go wrong.
Safety II looks at “work as done” rather than “work as imagined”. Work as done may differ significantly
from work as imagined, as it reflects the reality that people have to deal with. A certain degree of
adaptability, flexibility and variability are both normal and necessary for the system to work. Incidents are
usually as a result of unexpected combinations of every day variability. Safety II seeks to understand the
ability of healthcare professionals to adapt to problems and pressures and to strengthen their ability to
succeed under varying conditions and prevent problems before they occur.

A comparison between Safety I & Safety II is illustrated below.

What people do in everyday work situations is usually a combination of Safety I and II, depending on
experience and the specific situation. Organisational resilience is a combination of both and thought to
involve four capacities:

Ability to respond safely to problems as they occur

Ability to learn from experience and share that experience
Ability to monitor how things are going so that the need to respond can be identified as soon as
possible
Ability to anticipate future needs

Near misses
Near misses are the “silent majority” of errors, those that do not cause harm but reflect faulty processes
and are early warning signs of potential system failures. Studying these might facilitate learning about the
recovery strategies people use in response to problems and is a useful tool for supporting patient safety,
as it gives a wider overview of the system. Focussing on events that happen frequently may produce small
but cumulative improvements in everyday performance.

Errors – individual or system problem?

Most people involved in incidents did not choose to make an error but did what they believed to be the
right thing at the time. Nearly all adverse events involve a combination of two sets of factors; “active
failures” are unsafe acts committed by the people in direct contact with the patient or system and “latent
conditions” which exist within the system.
The Swiss Cheese Model
James Reason’s “Swiss Cheese Model” graphically represents incidents as the result of accumulation of
multiple failures in defences that align to create an adverse event. The model has been used to focus
attention in accident investigations, and to help identify potential hazards (missing defences) before harm
happens. It encourages viewing actions as just one unsafe act in a chain of many, rather than as the only
cause. It illustrates the potential relationship between active failures and latent conditions, the latter only
become evident when they combine with other factors to breach system defences.
Human factors
Human Factors are organisational, individual, environmental, and job characteristics that influence
behaviour in ways that can impact safety; the study of human factors and their relationship to safety and
performance is recognised as a science in the majority of high risk industries. We display universal human
characteristics, which may influence our behaviour in certain circumstances. Humans are naturally risk
takers; being willing to take risks has been responsible for important innovation throughout history, but we
are also fallible and therefore taking risks may contribute to errors. Approximately 70% of errors made
within healthcare settings are attributable either partly or fully to human factors, rather than lack of clinical
or technical knowledge. We also know that humans demonstrate recurrent patterns in behaviour, which
often become apparent during difficult situations.

The Dirty Dozen

The “Dirty Dozen” refers to twelve of the most common elements that can influence people to make
mistakes. This concept was described by Gordon Dupont in 1993. (www.tc.gc.ca). This is not an
exhaustive list; but provides a useful introduction to human error in the workplace. The 12 elements are, in
no order of priority:

 Lack of communication  Pressure

 Distraction  Lack of awareness

 Lack of resources  Lack of knowledge

 Stress  Fatigue

 Complacency  Lack of assertiveness

 Lack of teamwork  Norms

Lack of or poor communication often appears at the top of contributing factors in error reports.
Instructions may be unclear or inaccessible; the receiver may make assumptions about their meaning, and
the transmitter may assume the message has been received and understood. It is common for only 30%
of verbal communication to be received and understood.

Distraction refers to anything which draws a person’s attention away from the task on which they are
employed. Some distractions are difficult to avoid, such as noise and day to day problems requiring
immediate solutions, while others can be avoided or delayed until a more appropriate time, such as
decisions regarding non–immediate work. Distraction is the most common reason for people forgetting
things; hence the need to avoid becoming distracted and avoid distracting others.

Resources include data, experience, knowledge, personnel, skill, support, time and tools. Lack of or
resources which are inadequate or of low quality can interfere with our ability to complete a task.
Stress may be acute or chronic. Acute stress results from immediate demands while chronic stress is
accumulated and results from long term demands, including those outside of work. When we suffer from
persistent or long term life events, our reaction to demands and pressure at work can change and we may
react inappropriately, too easily or too often. Signs of stress include errors of judgement, lack of
concentration and poor memory. HALT and IMSAFE are acronyms used to describe some of the
circumstances in which staff might become unsafe.

Hungry Illness
Angry Medication
Late Stress
Tired Alcohol
Fatigue
Emotions

Many tasks rely on teamwork; no single person can be responsible for a safe outcome of all tasks, but if
someone is not contributing to the team effort, this can lead to an unsafe outcome. Workers must rely on
others for support, as well as give others support.

Pressure is to be expected when working in a dynamic environment, but when pressure interferes with
our ability to complete tasks, it has become too much. One of the most common sources of pressure is
that which we put on ourselves, by taking on more than we can handle, including other peoples’ problems,
and making assumptions about what is expected of us.

Working in isolation, or only considering one’s own responsibilities can lead to tunnel vision, a partial view,
or lack of awareness of the effect of our actions on others and the wider task.

Complacency is a feeling of self-satisfaction, accompanied by loss of awareness of potential dangers.

Such a feeling often arises when conducting routine activities which have become habitual, and which
may be considered by an individual or the entire organisation to be “safe”. Vigilance is relaxed & important
cues, information and signals are missed; the individual only seeing what they expect to see. Too little
stress and pressure results in boredom, complacency and reduced human performance.

Lack of specific experience and knowledge can lead workers to view things simplistically, believe a
concept is easier to understand than it actually is and so miss-judge situations and make unsafe
decisions.

Fatigue is a natural physiological reaction to prolonged physical or mental stress. When we become
fatigued, our natural ability to concentrate, remember and make decisions becomes impaired. We tend to
underestimate our level of fatigue and overestimate our ability to cope with it.

If we lack the assertiveness to express our concerns, & do not allow others to express theirs, we create
ineffective communication and team working. Unassertive team members can be forced go with a majority
decision even when they believe it is wrong or dangerous to do so.
Workplace practices develop over time into “norms”, through experience, workplace culture, peer pressure
and habit. Not all norms represent best practice, and staff are often aware of this, but may not feel
sufficiently empowered to change. Norms eventually become invisible and accepted as “the way we do
things”, Most norms have not been designed to meet all circumstances and therefore are not adequately
tested against potential threats.

Non-technical skills
Human actions are almost always constrained by factors beyond individual control but we can focus
attention and resources on possible countermeasures to mitigate against humans making errors. One
such example is better shared understanding of non-technical skills, a skill set not directly related to
clinical or technical knowledge. Non technical skills are not explicitly addressed in all clinical training
programmes and are developed in an informal manner in some specialities and not at all in others.
Demonstration of effective non-technical skills requires a high level of mental activity; people do not
develop these sophisticated skills without deliberate training and support. Crisis Resource Management
(CRM) is a 15-point framework, which can be used by any group of people working together. The 15 Key
Points are listed in no order of importance below - some of the terms may be more familiar than others.

1. Know the environment

2. Anticipate & plan
3. Call for help early enough
4. Exercise leadership & followership
5. Distribute workload
6. Mobilize all available resources
7. Communicate effectively
8. Use all available information
9. Prevent & manage fixation errors
10. Cross/double check
11. Use cognitive aids
12. Re-evaluate repeatedly
13. Use good teamwork
14. Allocate attention wisely
15. Set priorities dynamically

How much do you think you know about each of these areas? How could you become more skilled as an
individual? Within your team? What could your department adapt or change within this list to work more
safely and effectively?

1. Know the environment

Health care is a safety critical occupation, high risk procedures, but low margin for error. We work in a
complex, dynamic, fragmented, unpredictable and high pressured environment.
Yet we often take our environment for granted and assume we are more familiar with it than we actually
are. We sometimes only discover this during an emergency. What does your “environment” include? How
familiar are you with your workplace? What should you check regularly? How can the environment be
adapted to suit local demand?
2. Anticipate & plan
The NHS tends to be a reactive organisation – we often work at the very boundaries of safety and respond
when something adverse happens. Pace of work leaves little opportunity to act strategically once a difficult
situation gets underway. Other high risk industries approach this differently and consider “What might
happen today?”, “What mistakes might we make today?”. In this way, adverse events might be prevented,
but those that can’t can be predicted, anticipated and prepared for. “Pre-loading” is the art of preparation
for future tasks when the current workload is lower and putting contingency strategies in place well ahead.
“Pre compiled responses” involve asking “What if …?” questions, thinking about potential outcomes and
mentally compiling responses well ahead. If the event does happen, the mental plan can be retrieved, and
action taken more quickly. Safety briefings and huddles are a good example of these skills in practice, as
staff have an opportunity to consider key questions about the work ahead: What is the plan? Who needs
to know about it? Is there a plan B (C, D …)? Can the plan change? Generic actions might buy time for
more definitive treatment; for example performing a rapid but comprehensive ABCDE patient assessment
and addressing immediate concerns, might help stabilize an emergency situation while waiting for more
senior help to arrive. Simulation training creates opportunities for rehearsing the appropriate actions and
behaviours for a variety of situations. Should the event or something similar actually happen, staff may
feel more prepared and act more effectively after taking part in a simulation exercise. Barts Health has
simulation facilities at Newham, the Royal London, St Bartholomews and Whipps Cross and experienced
faculty are available to facilitate training and debriefing at many levels of complexity, such as table top
exercises, low fidelity simulation using manikins or complex full scale scenarios, involving inter-
professional teams. The simulation teams regularly undertake “Distributive simulation”, where training is
delivered in the workplace itself

3. Call for help early enough

Lack of experience or knowledge can lead staff to misjudge situations and consequently make unsafe
decisions. Asking for help or information when you need it demonstrates a sense of responsibility and
respect towards your patients, work colleagues and yourself and is not a sign of weakness. Help may be
required for varied reasons – expertise, pairs of hands, seniority, support, a fresh pair of eyes. Think what
help you need, why you need it and how urgently you need it. If requesting help by telephone, think what
you need to say and how you will say it, write down key information and questions, and use the SBAR
tool. SBAR is structured way to communicate concisely and helps develop critical thinking, as the user
needs to define and describe a situation.

S – Situation - name, patient name, location, headline the concern

B – Background relevant to the call
A – Assessment – ABCDE, actions, trends
R – Recommendations and questions

While waiting for help to arrive, what can you do? Could you prepare equipment they might need? What
do you want them to do when they arrive? Who will handover key information? If help is not immediately
available, what alternative resources exist?

People are sometimes reluctant to call for help, but know your limitations and if in doubt, ask. Heroes are
dangerous!
4. Exercise leadership & followership
Challenging situations or emergencies usually require someone to fulfil a leadership or coordinator role.
Not all staff are comfortable with being a leader, but everyone can develop and improve key “leadership
skills”. Effective leadership is assertive, inclusive, fair, responsible and encourages a supportive
atmosphere in which team members feel able to contribute and voice concerns, opinions and thoughts.
Leadership which is disrespectful, dictatorial or hostile is less likely to promote such open communication
within the team. Followership receives less attention that leadership in training programmes, but if a team
member is not the leader in a given situation, they need to demonstrate good followership, a role of equal
importance in the success of the task. A follower does not passively accept whatever is going on, but
assumes responsibility for their allocated role, and offers feedback and support to the leader.

Assertiveness is a style of behaviour and communication that allows us to express concerns, needs and
opinions in a positive and productive manner. When we are assertive we also invite others to assert
themselves without feeling threatened or undermined. Assertive communication is appropriate, direct,
honest and respectful, but without being aggressive or compromising standards. The authority gradient
describes a situation where the challenger is more junior than the person being challenged and requires
both the junior to speak up and the senior to listen down. PACE is a technique used to raise and escalate
concerns. “It’s what is right, not who is right”.

P—Probe: Get attention, raise discomfort

A—Assert: Repeat with increased volume
C—Challenge: Use direct language, words such as “must” and “should”
E—Emergency: Direct eye contact or intervention

5. Distribute workload
No individual can do everything. Most staff are familiar with the “helicopter “ or “hands off” model of
leadership demonstrated by an effective team leader during an emergency. The team leader stands away
from the patient, in a position where he/she can see everything and direct team activity without becoming
involved in tasks. Effective delegation maximizes the abilities, capacities, experience, expertise, skills and
strengths of each team member. Think - is anyone overloaded? When is the task load unworkable?

6. Mobilize all available resources

What is a resource?

- People
- Expertise
- Equipment
- Information
- Space
- Time

Before requesting more resources, it might be sensible to consider how we use those we already have as
a first step.

7. Communicate effectively
Here we can only consider a few examples of good and less effective communication styles and
techniques. We may not think we are naturally a very good communicator, but small changes make a big
difference. Think what you want to say, how it may be received and consider changing a word or tone to
make the message more succinct.

We make assumptions about communication; that we say what we mean to say, what we say is heard,
what is heard is understood, what is heard and understood actually gets done. Communication can break
down at any of these stages. Work may be accompanied by unnecessary conversation, comments and
noise. If you need to make yourself heard, ask for silence. Staff assume they know what each other is
thinking; so much is left unsaid that should be said. State the obvious – just because something seems
obvious to you, does not mean it is obvious to everybody else. Declaring the situation with appropriate
urgency and without panic focuses collective attention on what needs to be done. Opportunities for asking
questions should be both given and taken.
Good communication involves listening just as much as talking. There is a reason why we were given two
ears but only one mouth! Examples of active listening include paying attention, making appropriate eye
contact, appropriate body posture, concentrating on what is being said, not interrupting and clarifying the
message.

Less effective communication includes:

Hinting and hoping – we hint about something, hoping the listener will hear and understand the message.
Asking clearly and assertively promotes clearer understanding and expectations.

Making statements into the air – comments such as “Shall we start some fluids …” are unhelpful. The
request has not been directed towards an individual. Has the request been heard? Who is going to do the
task? Will anyone do it? Will more than one person do it? How do we know when it has been done?

8. Use all available information

Humans are cognitively lazy – we tend to seek for information which confirms what we already feel or
think about something. Deliberately seeking out information which does not fit helps to eliminate
assumption or artefact. Taking 10 seconds to pause, collect and consider available information may save
10 minutes later on.

9. Prevent & manage fixation errors

We commonly make three types of fixation errors.

“This & only this”: We interpret available information to fit around what we have decided is the problem; a
type of bias known as confirmation bias. We then miss the actual problem.

“Anything but this”: The feeling that “it can’t be” this. Take the example of an oxygen saturation probe
reading 85%. We find it easier to believe the probe is faulty rather than admit the patient is hypoxic. An
extensive search for more information, while not addressing the problem wastes time.

“Everything is OK” - denial!: Failure to realise a problem or declare an emergency means we do not ask
for or accept help when needed.

Many of the non-technical skills listed here help to reinforce behaviours which make fixation errors less
likely.

10. Cross/double check

Information can be checked in different ways; either the same information can be verified separately by
more than one person, or information from different sources can be checked against each other for
correlation, for example, do the blood results suggest similar a condition from the patients’ reported
symptoms?

People often see what they expect to see, so an example of good practice is medication checking
between two nurses, where a prescription is checked by one nurse, then independently checked by
another. By not checking the prescription simultaneously, each nurse is more likely to check the
information carefully and accurately.

Verifying data from different sources suggests the information is reliable and less likely to be caused by
artefact. An example in practice would be repeating a set of vital signs if uncertain or doing a more
thorough ABCDE patient assessment rather than jumping to conclusions from a single piece of
information.

11. Use cognitive aids

A cognitive aid enables us to retrieve information quickly when needed; examples are algorithms,
checklists, guidelines, mnemonics, monographs and protocols. Cognitive aids are usually clearly defined,
well established, standardised and simplified and present key actions in a logical, organised and
systematic approach. The amount of clinical knowledge currently available is beyond that which any
individual can memorize. Using cognitive aids and looking things up is a marker of responsibility and safe
practice, not inadequate knowledge.
12. Re-evaluate repeatedly
Situational awareness is a person’s perception and understanding of the current situation and being able
to predict likely future scenarios and possible impact of their actions. Situational awareness is created
from multiple sources of information, collated into a coherent picture. Situational awareness is used to
assess risk, make decisions, identify priorities, anticipate, plan and predict consequences and has three
stages – information gathering, understanding information and anticipation. Effective situational
awareness can be created by clear briefing, minimising distractions during critical tasks, regular review.
Questions to ask when re-evaluating are: Did the chosen action have any effect? Is the situation better,
worse or the same? Are there any side effects to the action? Are there any new problems I missed? Was
the initial assessment correct? Is there a mis-match between the current situation and what I expected to
happen?

13. Use good teamwork

Individuals make more rational decisions and fewer errors when working in teams that function effectively.
High functioning teams tend to have an assertive, open communication style and demonstrate an
atmosphere of empathy, respect, support and trust. Well functioning teams can be more cost effective -
good team decision making ensures increased output and better use of resources.

14. Allocate attention wisely

What things occupy your attention? We noted that boredom, complacency, distraction, overload and
routine may all degrade our ability to be vigilant. Humans naturally think ahead, so when returning to a
task following a distraction, we think we are further ahead than we actually are. Reducing distractions
involves good workspace design and creating safety zones around workers engaged in safety critical
tasks. A good illustration of this is the nurse in charge of a drug round wearing a “Medication Round: Do
not Disturb” tabard.

15. Set priorities dynamically

Patient condition or workload can change unpredictably and we need to be able to respond by balancing
risks, considering options and revising the agreed course of action in the light of new information. This is
not the same as indecisiveness!

MUST DO's

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Safety level 1 eAssessment.

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