Quality and safety in anaesthesia

Quality in healthcare is hard to define. One approach is based around six goals: safety; effectiveness; patient focus; timeliness; efficiency; and equity ( Table 18.1 ). Although errors and incidents are commonly discussed in relation to safety, the same fundamental principles apply to all aspects of healthcare quality.

Table 18.1

Aims of a high-quality healthcare system

1. Safe	Prevention of injuries to patients from the care that is intended to help them.
2. Effective	Provision of services based on scientific knowledge to all who could benefit, and refraining from providing services to those not likely to benefit.
3. Patient-centred	Providing care that is respectful of and responsive to individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions.
4. Timely	Reducing waits and sometimes harmful delays for both those who receive care and those who give it.
5. Efficient	Avoiding waste, including waste of equipment, supplies, ideas and energy.
6. Equitable	Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location and socioeconomic status.

Culture of quality and safety

Understanding generation of errors: systems approach

The cause of preventable deaths in healthcare systems is not usually incompetent or careless people but bad systems ( Box 18.1 ). A safety incident should be seen in an organisational framework of latent failures – the conditions that produce error and violation – and active failures. Some active failures (such as simple mistakes, slips or lapses) have only a local context and can be explained by factors related to individual performance and/or the task at hand. Major incidents usually evolve over time and involve many factors.

Box 18.1

Taxonomy of error

L atent failures are factors that exist within an organisation or process and which increase the risk of another error causing an incident. They are separated in time and often in place from the occurrence of the incident. Reason described these as organisational influences, unsafe supervision and preconditions for unsafe acts.

Organisational influences may include aspects such as training budgets and curricula and organisational safety culture.

Unsafe supervision might be reflected by a trainee anaesthetising a complex case near the limits of their competence without adequate consultant supervision.

Preconditions for unsafe acts include lack of robust checking procedures, near-identical drug ampoules and inadequate rest breaks for staff.

Active errors are unsafe acts which cause (or could cause) an incident. They may be errors of commission (doing the wrong thing) or omission (not doing the right thing). Various categories of active error are often described.

Execution failures occur when the knowledge and the intent are appropriate, but for a variety of reasons the correct actions do not ensue. These are often referred to as slips (observable actions, related to attention) and lapses (internal events, related to memory failures). They may be failures of recognition, attention, memory and selection . These are exemplified by drug errors in anaesthesia: every anaesthetist will be able to recall events where each of these failures has happened in their own practice.

Mistakes mean that the action proceeds as intended, but the wrong course has been chosen. These may be:

Rule based: Prior knowledge, intuition or a protocol is available for this situation (e.g. failed tracheal intubation) but is wrongly applied. This may be by omission, too late or by applying the wrong rule.

Knowledge based: An unfamiliar or novel situation requires the calculation of a solution based on the (usually incomplete) evidence. These require thought and are particularly prone to confirmation bias – evidence which supports the current model is sought, and contrary evidence is ignored.

Violations: These are deliberate choices to deviate from agreed practice (formal standing operating procedures (SOPs) or informal custom and practice). Again, these can be subdivided:

Routine violations: Corners are routinely cut. This may be at an individual or departmental level. ‘Normalisation of deviance’ may occur, where unacceptable practice becomes accepted practice over time. The risk is that practice becomes further and further away from good practice gradually, such that it is not noticed or dealt with until too late.

Self-serving violations: Breaking the rules for personal gratification.

Situational violations: Breaking the rules because (correctly) the situation demands it. There will always be circumstances when rules and procedures do not fit. A safety-conscious organisation seeks to learn from these incidents.

Organisational factors create latent failures, which result from management decisions, organisational strategy and/or planning. Latent failures then permeate through departmental pathways to the workplace, creating conditions that allow violations and commission of errors. The errors generated in the workplace environment may be prevented by a front-end clinician (near-miss). This concept of the trajectory of error is often referred to using Reason's Swiss cheese model. There are multiple layers of defence, each containing holes: organisational, supervisory, preconditions (such as an unfamiliar team, IT failures) and specific acts (slips, lapses; see Box 18.1 ). When these holes line up, a hazard can lead to a failure (incident).

To facilitate a quality and safety culture, several aspects are required:

Healthcare organisations must accept that system failure has a major role in all errors and accidents.
Openness and transparency must be reflected in organisational policies and procedures.
The organisation's response to an incident must be just and usually non-punitive for the individual involved.
Mechanisms are needed that promote learning and feed this in a sustainable way into practice.

Safety behaviour and non-technical skills

In clinical practice, some personal attributes of healthcare workers naturally render them safer than other colleagues.

Conscientiousness . Being sensible and meticulous, checking the information/drugs/equipment themselves, ensuring that the job is done properly and being thorough.
Honesty . Accepting limitations, giving correct and complete information, accepting their own mistakes, compliance with procedures and protocols.
Humility . Thanking colleagues of any grade and profession for their help and contribution, taking and seeking advice from other members of the team.
Self-awareness . Knowing limitations, knowing when they are tired or preoccupied.
Confidence . Knowing capabilities and being confident about them, able to speak up if necessary.

Non-technical skills are defined as ‘the cognitive, social and personal resource skills that complement technical skills and contribute to safe and efficient task performance’. They are not new or mysterious skills but are essentially what the best practitioners do to achieve consistently high performance and what the rest of us do on a good day.

The underlying premises are that:

the operating theatre is a complex environment with complicated tasks;
many people come together to work in this environment;
there is heightened potential for accidents and disasters in operating theatres; and
every human has limitations.

These non-technical skills are learned and can be taught. In particular, for the operating theatre environment, the following skills are important:

Communication, sharing of information
Teamwork
Situational awareness
Anticipation and preparedness
Decision-making

Communication and teamwork

The ideal scenario would be when all members of the team know each other, have mutual trust, are able to discuss problems and issues openly, learn from each other, are well-led and work together for a common goal. In practice this ideal is difficult to accomplish. Therefore organisations must actively explore and implement tools and training programmes that allow employees to enhance their level of communication and teamworking. Pre-list briefings are an important component of this process. They are tools to foster good communication, planning and learning for the whole operating theatre team. Debriefings are a complement to the briefing process. Good practice is reinforced, and areas of improvement are discussed constructively. Information from debriefings should be shared with other team members, and necessary actions should be completed and fed back to the team.

Situational awareness

Situational awareness refers to the ability to appraise the overall picture, to acquire relevant information quickly by scanning the whole environment and to monitor the environment continuously, in particular for any change. This term implies a broader understanding of what is going on and how events may unfold, more than just paying attention to the task. The core elements of situational awareness include:

continuous information gathering;
anticipation of events which may unfold; and
processing current information to interpret the situation in view of anticipated events.

Under stress, individuals tend to develop task fixation and lose an overall perspective of the situation. Patients continue to be harmed because anaesthetists fixate on tracheal intubation at the expense of maintaining oxygenation (see Chapter 27 ).

Anticipation and preparedness

Anticipation is the key component of full situational awareness. It involves thinking ahead about all reasonably predictable hazards, such as ‘What if there is severe bleeding?’, ‘What if I am unable to see the larynx?’, ‘What if the blood pressure drops on tourniquet release?’, ‘What if there is a power failure?’ Having considered what can go wrong, it is useful to mentally try responses and then work out whether these responses would address the problem. These mental exercises allow the clinician to adjust or prepare the environment. The aim is to avoid the hazards and/or prepare to deal with the hazards if they were to arise in a calm, systematic manner.

Decision-making

Decisions are taken based on previous experience, knowledge, intuition and good prevailing sense at the time. Decision-making for an individual in a condition of uncertainty can be very challenging. However, the process of decision-making can be evolved and evaluated using crisis management scenarios in a simulated environment. Here there are no clinical consequences, and the evaluation can be non-threatening. Examples of training in such scenarios include rapid-sequence induction, failed tracheal intubation, unexpected severe hypotension, cardiac arrest, malignant hyperthermia and anaphylaxis. All anaesthesia departments should have working protocols to deal with crisis situations to help clinicians make logical, systematic decisions under stressful conditions (see Chapter 27 ). The scenarios should be practised regularly in teams, and the experience of training should be enhanced by debriefing on teamwork and individual decisions. Existing protocols will never cover all possible eventualities. Therefore decisions will still need to be made on individual choices and judgements. A culture of openness within the department should allow healthy discussion of decisions if alternative options are possible; the value of collective decision-making should be emphasised.

Measuring safety and quality

Safety culture

Safety culture is ‘the product of individual and group values, attitudes, competencies and patterns of behaviour that determine the commitment to, and the style and proficiency of, an organisation's health and safety programmes’. One can also think in terms of culture being ‘what happens when no-one is watching?’ A positive safety culture in an organisation is characterised by its individual members respecting and trusting each other, perceiving safety to be important and having confidence that the safety interventions would be effective. Safety climate refers to ‘surface features of safety culture from attitudes and perceptions of individuals at a given point in time’, or ‘measurable components of safety culture’. The two terms, safety culture and safety climate, can be differentiated by comparing the culture to an individual's personality, and climate to his or her mood.

The most common method of measuring safety culture and climate in healthcare involves using quantitative questionnaires and qualitative methods including observations, semistructured interviews and focus groups. Safety culture can be described in terms of five different levels of maturity:

1.
Pathological. ‘Who cares so long as we are not caught?’
2.
Reactive . ‘We do a lot of “safety” whenever we have an accident’.
3.
Calculative . ‘We have systems in place to manage all hazards’.
4.
Proactive. ‘We anticipate problems before they arise’.
5.
Generative . ‘Safety is how we do business around here’.

Measuring quality

A comprehensive measurement of quality would assess, and somehow measure, all the individual components of the quality matrix, such as safety, clinical effectiveness, patient experience, timeliness, efficiency and equity. Avedis Donabedian introduced a framework for assessing quality in healthcare ( Table 18.2 ). This framework is based on three core domains – structure, processes and outcomes. These domains of measuring quality are interdependent. Good processes depend upon good structures, and they often lead to good outcomes. Consequently, assessment of only one domain (e.g. outcome – mortality) cannot assess quality or serve to improve it. It becomes useful only when this assessment is combined with finding the gaps in structure (e.g. staff shortage) or processes (e.g. non-adherence to guidelines).

Table 18.2

Donabedian's framework for measuring quality

Domain	Description
Structure	Setup for providing care, including:
	Material resources
	Facilities
	Human resources
	Technology infrastructure
	Equipment
	Guidelines and implementation programmes
	Teaching programmes
	Rotas
Process	What happens around delivery of care, including:
	Patient pathway from evaluation through diagnosis to treatment
	Assessment before anaesthesia
	Optimisation of comorbidities
	Adherence to guidelines and teaching programmes
	Checklists
	Monitoring
	Incident reporting and actions
	Ongoing audits of different aspects of care delivery
	Quality improvement programmes
Outcome	The effects of care, including:
	Morbidity
	Mortality
	Patient satisfaction
	Other clinical outcomes as decided by the department

Clinical outcomes: real or surrogate

In anaesthesia there is a lot of reliance on real clinical outcomes to indicate quality of care, such as incidences of epidural haematoma, nerve damage, brain damage or death. Although apparently straightforward, the use of real outcomes has limitations:

The real outcomes may depend on many factors, including the patient's pre-existing condition, population dynamics, surgical factors and individual reactions (e.g. unknown allergies), which may not necessarily indicate quality of care per se.
Direct anaesthesia-related mortality is rare and serious morbidity infrequent. Consequently, measuring anaesthesia-related mortality and morbidity are very crude measures and may not provide enough data to monitor quality on a frequent basis.

Adverse events and near misses are often taken as surrogate clinical outcomes. By monitoring the surrogates, a comprehensive picture can be obtained of the workflow and processes. Overall, more than 100 outcome measures have been described, so departments and individuals will make their own choices about what to measure.

Selecting a good quality indicator

No single indicator is sufficient as a quality measure in anaesthesia. Recording only major morbidity and mortality has limitations. Surrogate measures give a better picture of workflow and processes and potential problems, but they do not replace real outcomes. Characteristics of a good indicator include the following:

Easy to define and record
Finite frequency of occurrence so that it can be monitored regularly
Rate of occurrence must be influenced by quality and also must indicate something important about the process

Quality improvement tools

Requirements for quality improvement

In addition to collecting all the data at an individual patient level, the challenge for a department is to analyse the data systematically, disseminate the findings as widely as possible and identify learning outcomes and areas for improvement. To improve quality, departments must develop interventions targeted at areas for improvement, implement them, and monitor progress and the impact of implementation on outcomes. Embedding a culture of incident reporting and learning is vital. Morbidity and mortality meetings and other network opportunities at which all quality issues can be aired and discussed without fear of a punitive outcome are absolutely essential for embedding quality consciousness. Barriers, facilitators and approaches in engaging staff into quality improvement are summarised in Table 18.3 .

Table 18.3

Barriers, facilitators and approaches to engage staff in quality improvement

Barriers	Top-heavy approach
	Lack of involvement at the beginning
	Punitive actions
	Lack of evidence
	Lack of assurance
	Lack of control
Facilitators	Role models
	Peer pressure
	Evidence
	Common sense
	Good outcomes
	Enhancement of professional position
	Rewards
Approaches	Science approach
	Safety research
	Research into causes of errors Research into prevention of errors
	Research into systems
	Educational approach
	Curriculum
	Training
	Courses
	Cross-learning modules
	Faculty
	Management approach
	Vision
	Strategy
	Organisational change
	Risk management
	Implementation
	Professional leadership
	Networking

Checklists

Although they existed earlier, the modern era of the safety checklist is generally attributed to the crash of the newly designed Model 299 Boeing bomber in 1935. The cause of the crash was straightforward – the elevator lock had been left on. However, two extremely important facts emerged from the investigation. First, the pilot was extremely experienced and competent. Second, taking the elevator lock off was not an unusual requirement. The pilot would do this normally, but on this occasion, presumably because of distraction by other things, he forgot. The response of pilots was to create a process which ensured that simple things did not get missed, regardless of the situation.

The introduction of the WHO checklist as a strongly encouraged or mandated part of theatre practice has refocussed attention on the potential benefits and risks of checklists in healthcare, and particularly perioperative care. Checklists are not new in anaesthesia; various national bodies produced anaesthetic machine checklists in the 1980s and 1990s. This was in response to the emerging data that demonstrated a significant number of patient safety incidents could have been avoided by proper checking of equipment.

The term checklist is used for documents which may have a variety of purposes. Conceptually they can be thought of as:

cognitive aids for crisis situations;
checking;
briefing; and
planning.

Most checklists are tabulations or summaries of accepted best practice. We would hope that anaesthetists would recognise the need to undertake these actions regardless of whether a checklist exists. Their role is, therefore, about ensuring that these actions take place for every patient, every time. The human memory is fallible and, regardless of professional status, cannot be relied upon to remember more than about seven items.

Anaesthetists are not particularly good at completing all the necessary checks. This applies to the anaesthesia machine, drug checking and WHO checklist. The reasons for this are multifactorial and relate to all aspects of safety and quality discussed in this chapter. Specific barriers to full engagement with checklist processes include the following:

Perceived importance. The rate of incidents related to the items on the checklists is very low and therefore the overwhelming likelihood is that there will be nothing amiss. The anaesthetist may, therefore, choose (consciously or subconsciously) to prioritise another activity.
Organisational culture. Perceptions of organisational prioritisation of efficiency over safety may encourage an individual to save time by shortening or omitting checklists. Conversely, an organisation that fails to monitor compliance with checklists or hold individuals to account when appropriate sends a message that it does not value them either.
Resistance to standardisation. Anaesthetists are highly trained individuals with a large amount of professional autonomy. Checklists, by definition, standardise and consequently restrict practice and may therefore be resisted. This may manifest itself in academic arguments about the validity of evidence in favour of specific checklists.
Professional behaviour and stereotypes. As a result of the three previous aspects, senior medical staff may view the checklist process as beneath them and something to be delegated to more junior staff. This may in turn promote a culture of non-importance.
Checklist design . Undoubtedly some checklists are badly worded and designed. There may be too many questions, questions asked at the wrong time in the process or questions that encourage yes/no answers without true engagement. The evolution of the Association of Anaesthetists' anaesthetic machine checklist demonstrates improvements in layout and wording to encourage full compliance.
Human fallibility . However well designed the checklist process, humans make mistakes. Most commonly reported are automatic responses – answering yes when the checks have not actually been done and performing checklists by rote.

Well-designed cognitive aids assist performance in crisis periods, especially when they have been used in training or drill rehearsal. Anaesthetists are strongly encouraged to use them (see Chapter 27 ).

WHO checklist

The WHO checklist is a hybrid checklist. It involves elements of planning, briefing and checking ( Table 18.4 ).

Table 18.4

Examples of different purposes of checklists

Checklist	Purpose	Example	Notes
Anaesthesia machine	Checking	Check that the anaesthetic apparatus is connected to a supply of oxygen and that an adequate reserve supply of oxygen is available from a spare cylinder.	Printed cards attached to machine Long-list
Advanced life support (4 Hs and 4 Ts)	Checking	Potential causes or aggravating factors for which specific treatment exists must be sought during any cardiac arrest. For ease of memory, these are divided into two groups of four, based upon their initial letter, either H or T (see Chapter 28 ).	Memorisation encouraged Time-critical
WHO Checklist	Multiple/hybrid		No explicit differentiation between checking, briefing and planning
WHO Checklist	Checking	Is the anaesthesia machine and medication check complete? (Sign-in) Have the specimens been labelled (including patient name)? (Sign-out)	Refers to another process/SOP
WHO Checklist	Briefing	Are there any critical or unexpected steps you want the team to know about? (Time-out)	A ‘stop–go’ moment, but mainly a confirmation of adequate staff briefing
WHO Checklist	Planning	Are there any specific equipment requirements or special investigations? (Time-out)	Really a planning question May be too late to solve the problem

SOP, Standard operating procedure.

There are three phases to the checklist:

1.
Sign-in: Is it safe to start anaesthesia?
2.
Time-out: Is it safe to start surgery?
3.
Sign-out: Has surgery been completed safely? Is it safe to hand over to the next phase of care?

Local adaptation is encouraged, both to match local circumstances and to ensure the appropriate questions are asked. For instance, cataract surgery under local anaesthesia is ill-served by questions related to airway management but may have specific issues around preoperative biometry. There are other surgical checklists, notably the SURPASS system pioneered in the Netherlands. The basic principles are the same.

There is reasonable evidence that implementation of the WHO checklist is associated with improvement in outcomes after surgery. The degree of compliance with perioperative checklists appears to be associated with both intraoperative teamwork and postoperative outcomes. In other words, doing it well is as important as doing it at all. As with all checklists, lack of engagement, overfamiliarity and tick-boxing are significant risks from its continued use. Efficacy of the WHO checklist is enhanced by processes such as briefings and debriefings, which promote wider team communication and allow problems to be identified and addressed without the pressure of having a patient present.

Designing problems out of the system

Human error is inevitable. A key approach to minimising error is therefore to limit the possibility for human error. The example of drug errors in anaesthesia is discussed in Box 18.2 .

Box 18.2

Drug errors in anaesthesia

Drug errors in anaesthesia are common. They are estimated to occur in around 1 in 300 drug administrations.

Errors can be classified at each of the steps of safe drug management:

Diagnosis
Prescription
Selection
Preparation
Labelling
Syringe swaps
Administration
Dosage
Documentation

Reason's taxonomy of human errors can be applied to each of these steps (see Box 18.1 ).

No single approach can eliminate these errors. Taking the Swiss cheese analogy, every barrier to error has its own holes.

Strategies to reduce drug errors include the following:

Protocols and policies for prescription (e.g. antiemetics, analgesics, antibiotics)
Limiting availability of drugs (e.g. neat potassium chloride is not kept in a routine anaesthetic cupboard)
Facilitating rapid access to drugs required in high-workload periods (e.g. resuscitation drugs, sugammadex) using ‘grab boxes’, preprepared syringes etc.
Clear labelling
Colour coding to facilitate initial drug class selection
Deliberate drug separation within drug cupboards and the workspace (e.g. keeping local anaesthetics separate) ( Fig. 18.1 )
Bar-coding and automated readout technology
Formal reading out loud of drug labels (alone or with an independent member of the team)
Formal training and assessment of safe drug preparation/administration practices
Adoption of sterile cockpit principles such that drug preparation is treated as a mission-critical activity that should not be disturbed by non-essential conversation

Safety by design

The anaesthetic machine is a device designed to deliver a safe mixture of gases to a patient. Over the years, almost every method of failing to do this has happened, often with tragic consequences. It is now difficult to deliver hypoxic mixtures regardless of human interaction. Specific design features include non-interchangeable screw threads and valves on gas supplies, hypoxic guards and linkages on flowmeters, and standardised connections for breathing systems. The same approach can be taken with presetting of infusion protocols for intravenous and epidural infusions.

Organisational design

There are theoretical safety (and financial) advantages to limiting the variation in drugs and equipment available to anaesthetists. There is often scant evidence to suggest that one drug or device is better than another, but by limiting choices, individuals are more likely to be familiar with what is available and possibly less likely to confuse one for another. This approach can be seen in the rationalisation of anaesthetic drug cupboards to have the same core drugs, laid out in the same way. ‘Dangerous’ drugs that are used rarely but with potentially catastrophic consequences (e.g. neat potassium chloride) are kept out of standard anaesthetic drug cupboards.

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