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Root Cause Analysis kit

1-RCA Tools
1-Getting Started
Glossary - Root Cause Analysis

National Patient Safety Agency - 2009

Glossary - Root Cause Analysis


Incidents
Patient Safety
Freedom for patients from unnecessary or potential harm arising from healthcare. WHO
Patient Safety Incident
Any unintended or unexpected incident which could have or did lead to harm for one or
more patients receiving NHS funded care.
Please note:

This includes all terms such as adverse incidents, adverse events and near misses.
Unintended includes known and unexpected complications of treatment or side effects of medication.

Unintended would NOT include harm where this is an inevitable effect of a treatment.
e.g. Transplant anti-rejection medication affecting the immune system.
Unexpected includes unexpected outcomes and unexpected deaths.
Local organisations should investigate these to determine if a PSI contributed to the
unexpected outcome or unexpected death. Organisations should not enter a harm grading
of severe or death on a PSI report unless they believe that permanent harm or death
actually resulted and was directly attributable to a PSI.
Incidents include both acts and omissions.
Could have extends to situations that could realistically lead to harm or cause significant
concern for patient safety.
This includes incidents that occurred but, through luck or intervention, led to no harm.
Harm includes mental or psychological harm as well as physical harm.
NHS funded healthcare includes healthcare that is partially or fully funded by the NHS,
regardless of the location in which it is provided.
Patient Safety Incidents should be reported whether currently considered preventable or not.
In addition to improving safety around preventable incidents, we aim to also identify incidents
currently considered unpreventable. With improvements in knowledge, practice, and /or
technology; together we can work to ensure that more of these become preventable too.
Judging preventability at the point of reporting or before investigation can be difficult but
PSI reports can be updated as this becomes clear.
There are incidents which have been either prevented or which occurred but no harm was
caused. These are defined as follows:

Prevented Patient Safety Incident


Any unexpected or unintended incident which was prevented so no harm occurred.
National Patient Safety Agency - 2009

No Harm Patient Safety Incident


Any unexpected or unintended incident which ran to completion but no harm occurred.
Harm
Harm is defined as injury, suffering, disability or death.
Homicide (mental health)
The killing of one human being by another human being.
In healthcare, homicide is considered to be death (infanticide, manslaughter or murder)
caused by a patient receiving mental health services who was subject to a care
programme approach (CPA) in the recent past.
The term homicide is broader in scope than murder. Murder is a form of criminal homicide;
other forms of homicide might not necessarily constitute criminal acts.
Typically, the circumstances surrounding a killing determine whether it is criminal. The
mental state of the person who committed the homicide will be critical in determining
whether he or she had the necessary intent or mental capacity to commit a criminal
homicide.

Levels of severity of Patient Safety Incidents


None
A situation where no harm occurred: either a Prevented Patient Safety Incident or a No
Harm Patient Safety Incident.
Low
Any unexpected or unintended incident which required extra observation or minor
treatment and caused minimal harm, to one or more persons.
Moderate
Any unexpected or unintended incident which resulted in further treatment, possible
surgical intervention, cancelling of treatment, or transfer to another area and which caused
short term harm, to one or more persons.
Severe
Any unexpected or unintended incident which caused permanent or long term harm, to
one or more persons.
Death
Any unexpected or unintended incident which caused the death of one or more persons.

Errors and causation

National Patient Safety Agency - 2009

The following definitions are listed in the order in which they might appear on the
Organisational Model of Accident causation (see Introduction to Theory and Terminology in
the Resource Centre and Module 2 of the e-learning package).
Latent Conditions
Arise from decisions made by management at all levels - they become endemic to the
organisation over time and may arise from unrecognised incorrect decisions or tolerance
of poor practice over time.
Latent Failure
Arise from well intentioned but (with hindsight) wrong management decisions that go
unrecognised, or are weaknesses known about and tolerated by all layers of
management . The presence, or recognition, of the residual problem(s) only come to light
once an incident has occurred and an investigation reveals their presence.
Contributory factors / Associated Factors
Contributory Factors are those which affect the performance of individuals whose actions
may have an effect on the delivery of safe and effective care to patients and hence the
likelihood of Care Delivery Problems (CDP) or Service Delivery Problems (SDP) occurring.
Contributory factors may be considered to either influence the occurrence or outcome of
an incident, or to actually cause it. Generally speaking the removal of the influence may
not always prevent incident recurrence but will generally improve the safety of the care
system; whereas removal of causal factors or root causes will be expected to prevent or
significantly reduce the chances of recurrence.
Root Causes / Causal Factors
The prime reason(s) why an incident occurred. A root cause is a fundamental contributory
factor. Removal of these will either prevent, or reduce the chances of a similar type of
incident from happening in similar circumstances in the future.
Lessons Learned
Key safer practice issues identified during an investigation, but which did not materially
contribute to the incident.
Recommendation
A course of action that is recommended to address the problems identified and analysed
during the patient safety incident investigation.
Human Error
Human error occurs when the actions and decisions of individuals result in failures that
can immediately or directly impact patient safety. MERS-TM
Knowledge-based error
There are mistakes in which the individual encounters a novel situation for which his/ her
training does not provide some pre-learned rule based solution, The consequence is that
he / she has to use ad-hoc reasoning based upon experience to date. Due to this lack of
experience, he/ she will have an incomplete mental model of the problem leading to an
error. Reason (1993)

Rule-based Error

National Patient Safety Agency - 2009

Rule based error is when the individual encounters some relatively familiar problem, but
applies the wrong pre-packaged solution (either misapplication of a good rule or the
application of a bad rule. Reason (1993)
Skill-based Error
Involves the unintended deviation of actions from what may have been a perfectly good
plan. They normally occur when workers thought processes are functioning elsewhere and
not focused on the task in hand. Reason (1993)
Violations
Violations involve deliberate deviations from some regulated code of practice or
procedure. Reason (1993). They are deliberate actions, where someone has chosen to
deliberately break the rules. This can be for a variety of reasons.
Routine violations involve regularly performed short cuts between task-related points,
which are accepted locally, and sometimes by management.
Reasoned violations are occasional deliberate deviations from protocol or procedure,
where the violation is for a good reason. Taylor-Adams (2002)
Reckless violations are deliberate deviations. The reason is not good, but neither is actual
harm intended.
Malicious violations are deliberate deviations from the protocol and include acts of
sabotage.
Unsafe Act
An act or omission, which is taken outside policy or procedure, which increases the risks of
injury, failure or adverse outcomes.
Active Failure
Are unsafe acts or omissions committed by those at the "sharp end" of the system and
whose actions can have immediate adverse consequences. These unsafe acts are
influenced by contributory factors or performance-influencing factors, such as stress,
inadequate training and high workload.
Care Delivery Problem
Are problems relates to direct provision of care. They arise in the process of care, usually
actions or omissions by members of staff. They have two essential features a) care
deviated beyond safe limits of practice b) the deviation had at least a potential direct or
indirect on the eventual adverse outcome for the patient, member of staff or "general
public". Vincent et al (1999)
Service Delivery Problem
These are failures identified during the analysis of the patient safety incident, which are
associated with the way a service is delivered and the decisions, procedures and systems
that are part of the whole process of service delivery.
Barrier, defences and controls
A control measure that is designed to prevent harm to vulnerable or valuable persons,
organisations or objects. These measures may be physical, human action, administrative
or natural.
Note: The terms "barrier", "defence" and control" are used interchangeably throughout the
NPSA Root Cause Analysis Guide and Toolkit and in most instances, the word "barrier" is
used.
Responsible - Accountable for something within one's power, control, or management
National Patient Safety Agency - 2009

Accountable - Subject to the obligation to report, explain, or justify something (answerable)


Culpable - Deserving blame or censure; blameworthy.
Censure - An official reprimand, as by a legislative body of one of its members.
Liable - Deserving official reprimand, as by a legislative body of one of its members.
Liability - Debts owed; or pecuniary (monetary) obligations

Root Cause Analysis


Investigation
Investigation is a careful search or examination in order to discover facts. Collins English
dictionary
Root Cause Analysis (RCA)
A structured investigation that aims to identify the true cause of a problem, and the actions
necessary to eliminate it. Anderson B, Fagerhaug T (2000)
A systematic investigation technique that looks beyond the individuals concerned and
seeks to understand the underlying causes and environmental context in which the
incident happened. RCA Toolkit. www.npsa.nhs.uk
An interdisciplinary, impartial process (involving experts from frontline services and those
who are most familiar with the situation) that identifies changes that need to be made to
systems. It involves continually digging deeper by asking why, why, why at each level of
cause and effect. VA
Root cause analysis is not a single, sharply-defined methodology; there are many different
tools, processes, and RCA philosophies in existence. RCA is a collection of problem
solving methods aimed at identifying the root causes of problems or events.
The practice of RCA is predicated on the belief that problems are best solved by
attempting to correct or eliminate root causes, as opposed to merely addressing the
immediately obvious symptoms. By directing corrective measures at root causes, it is
hoped that the likelihood of problem recurrence will be minimised. Wikipeadia
Facilitator
The person who is designated to manage the root cause analysis process. This involves
setting up an investigation team and guiding them through the process of data gathering
and identification of problems and issues. It also involves facilitating a multi-professional
review to analyse these identified problems and to generate effective solutions.
Failsafe (from the term Fail to safe)
Relates to inherent strengths and weaknesses of control measures and safety
improvements. The objective is to put in place control measure(s) whose strengths are
dominant and therefore provide an optimum level of "guarantee" that intrinsically guards
against failure.
Preventative Action Plan / Improvement Plan
An improvement or Preventative Action Plan is an agreed plan of action targeted at
improving the health, safety and well being of the affected patient(s), the staff and the

National Patient Safety Agency - 2009

organisation with the express aim of significantly reducing the risk of such circumstances
coming together to cause harm in the future.
Significant Event Audit (SEA)
An effective quality assurance method in general practice. It enables primary care teams
to learn from patient safety incidents and near misses, with the aim of improving patients
experience, care and outcomes, and to identify changes that might improve future care.
SEA Toolkit. www.npsa.nhs.uk
Significant Event
A Significant Event is any event thought by anyone in the team to be significant in the care
of patients or the conduct of the practice.
Examples could range from a serious patient safety incident (e.g. a medication error
leading to death), to a moderate level error (e.g. failure to act on laboratory findings
resulting in a 4-week delay in diagnosis) to an event which demonstrates excellent care
provision (e.g. rapid diagnosis of unexpected malignancy in a fit young man) to one of a
seemingly trivial nature which has subsequent administrative consequences (failing to
change a recorded message on a Bank Holiday weekend).
SEA Toolkit. www.npsa.nhs.uk
Audit
Audit is a thorough assessment or review, or an evaluation of a person, organization,
system, process, project or product. Audits are performed to ascertain the validity and
reliability of information, and also provide an assessment of a system's internal control.
An audit is based on random sampling and is not an assurance that audit statements are
free from error. However the goal is to minimize any error, hence making information valid
and reliable. Wikipeadia
Independent Investigation (mental health services)
The commissioning and investigation of a healthcare incident by person(s) entirely
independent of the providers of care of the service under investigation. For serious
incidents requiring independent investigation, Foundation Trusts and PCTs should make
arrangements with SHAs.

Risk Management
Risk
The chance of something happening or a hazard being realised that will have an impact
upon objectives. It is measured in terms of consequences and likelihood
Standards Australia (1999)
Risk in healthcare
The likelihood of harm that somebody or something will be harmed by a hazard, multiplied by
the severity of the potential harm. DOH (2000) An Organisation with a Memory.
Risk Assessment
The overall process of risk analysis and risk evaluation Standards Australia (1999) Risk
Management
Risk Management
The culture, processes and structures that are directed towards the effective management
of potential opportunities and adverse effects Standards Australia (1999) Risk
Management.

National Patient Safety Agency - 2009

Risk Management in healthcare


Clinical and administrative activities undertaken to identify, evaluate and reduce risk of
injury to patients, staff and visitors and the risk of loss of the organisation itself. Joint
Commission on Accreditation of Healthcare Organisations (2000)
Safety Vulnerable Organisations
Have introduced Policy, planning and audit without considering contextual information
such as human factors and organisational culture.
Safety Reliable Organisations
Have a dependable Safety Management System, yielding the same or compatible results in
different circumstances. They expect every function and individual to perform in a predictable
and therefore controllable way. There is no room for ambiguity, flexibility or human fallibility.
Compliance with standards and procedural documents is paramount. Everything therefore
must be defined, analysed, documented and audited.There are a number of difficulties with a
high reliability system for healthcare. Reliable organisations need to be wary that patient
safety is taken seriously; and that the organisation and its workforce are vigilant and on the
lookout for the unexpected, and that bad news can be told, accepted and acted upon without
blame or punishment. A high reliable system is not necessarily safe and a highly safe system
is not necessarily reliable. In fact increasing reliability may decrease safety.
Safety Resilient Organisations
Whilst reliability is somewhat dependent upon predictability of risks, resilience is the ability
to manage situations when there is uncertainty, change and little control, In healthcare,
judgement is at the heart of decision making; often there is no right or wrong answer. The
most likely outcome changes all the time in response to new evidence either from the
patient themselves or the healthcare community.
A resilient safety management system is flexible in its approach to risks, understands the
levels of tolerance of risk balanced with compliance with rules and regulations. The
strength of this system is the ability to recover quickly from or adjust easily to change or
misfortune. There are trade-offs between efficiency and thoroughness, between costs and
benefits, behind every decision. This system utilises commitment of senior management
to balance acute pressures (activity and finance) with chronic pressures (risks and safety
management)

References
MERS-TM Medical Event Reporting System Transfusion Medicine
NPSA NRLS National Patient Safety Agency National Reporting and Learning System
Anderson B, Fagerhaug T., RCA: simplified tools & techniques. (ASQ Quality Press, Milwaukee, 2000)
Centre for Chemical Process Safety of the American Institute of Chemical Engineers Guidelines for Investigating Chemical Process
Incidents, (New York, 1992)
Standards Association of Australia, Risk Management. (AS/NZS 4360: Strathfield,1999) p3
Report of an Expert Group of Learning From Adverse Events in the NHS Chaired by the Chief Medical Officer. DOH An Organisation
with a Memory. (The Stationery Office. London, 2000)
Taylor-Adams S et al (2002) Long Version of the CRU/ALARM Protocol: Successful Systems Event Analysis (In print, 2002)
Vincent CA, Adams S, Hewett D, Chapman J et al. A Protocol for Investigation and Analysis of Clinical Incidents. (Royal Society of
Medicine Press Ltd., London, 1999)
Reason. J.T. 'The Human Factor in Medical Accidents', in Vincent CA (ed). Medical Accidents. (Oxford Medical Publications, 1993)
Rasmussen, J. (1983). Skills, Rules and Knowledge: signals, signs and symbols and other distinctions in human performance
models. (IEEE Transactions: Systems, Man and Cybernetics. SMC-13, 1983) pp 257-267.
Dineen M (2002) Six Steps to Root Cause Analysis Consequence (Oxford, 2002 ISBN 0-9544328-0

National Patient Safety Agency - 2009