Patient Safety Workshop

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Standard Operating Procedures and Guidelines
Ensuring Valid and Up-to-Date Training
Medication Safety
Patient Engagement

“I am continually moved
by the accounts of
medical error that affect
the lives of real people.”

Patient Safety Workshop
After an error that has harmed a patient has
occurred, we often ask the question: how did
this happen?
It can be very tempting to apportion blame
to just one issue or person. But this is too
simple. It presupposes that it is possible or
right to implicate a single contributing factor.
Since the World Health Organization
launched the World Alliance for Patient
Safety in 2004, our experience has been that
this is rarely the case.
There is an urgent case to strengthen the
defences in the health-care system as a
whole. As much as possible, we need to do
this without blaming individual health-care
workers. That is not to say that individuals
should never be held accountable for their
actions. However, relying on the blame
approach alone is likely to drive problems
underground and impede an honest and
effective strategy to improve patient safety.
First, we need to understand the extent
of the problems that face health-care workers
and patients. Medical error rates have been
quoted to be in the region of 5-15% per
hospital admission in the developed world.
Information about the overall state of patient
safety in transitional and developing countries
is less well known, due to data shortage.
Second, we need reporting systems that are
easily accessible to all health-care workers and
which facilitate learning. We have learnt that it
is possible to get health-care workers to report
incidents, but converting the data collected
into real systems change is challenging.
Third, we need to have an accurate way of
classifying medical errors so that we can share
knowledge internationally and make sense of
information from different reporting systems.
Fourth, we need strategies to reduce harm
to patients. This means dedicated research
to identify the best mechanisms, effective
dissemination of new ideas and enthusiastic
adoption of them.
Making health care safer has to focus on
the patient. I am continually moved by the
accounts of medical error that affect the lives
of real people. The consequences are far-
reaching: they can destroy lives, affect human
relationships and threaten trust in the health-
care system as a whole. Patients are too often
the victims of unsafe care and their points of
view need to be heard within health care.
Ensuring safer care is an enormous challenge.
By running this workshop, you are helping
the international health-care community
make another step towards this ambitious
but essential goal.
Sir Liam Donaldson
Chair, World Alliance for Patient Safety
Chief Medical Officer for England
Foreword by Sir Liam Donaldson
Patient Safety and the World Health Organization

Purpose of the workshop
This workshop explores how multiple
weaknesses present within the hospital
system can lead to error. It aims to provide
all health-care workers and managers with
an insight into the underlying causes of such
events. Although the workshop materials
revolve around an error involving the
inappropriate administration of vincristine,
the underlying principles of why an error
occurs are universal.
Vincristine: what went wrong?
Vincristine, a widely used chemotherapeutic
agent, should only be administered
intravenously and never by any other route.
Many patients receiving intravenous vincristine
also receive other medication via a spinal
route as part of their treatment protocol.
This has led to errors where vincristine has
accidentally been administered via a spinal
route, which leads to death in almost every
case. Over the last 35 years, this error has been
reported approximately 55 times in a variety
of international settings. However, errors
related to the accidental administration of
vincristine via a spinal route continue to occur.

Learning objectives
By the end of this workshop, participants
1. Be introduced to an understanding of
why errors occur
2. Begin to understand which actions can
be taken to improve patient safety
3. Be able to describe why there should
be greater emphasis on patient safety
in hospitals
4. Identify local policies and procedures to
improve the safety of care to patients
Who should be invited to participate
in this workshop?
A multidisciplinary approach is recommended,
but this may be adapted as required. This
patient safety workshop is designed to be
suitable for health-care workers (e.g. nurses,
doctors, midwives, pharmacists), health-care
workers in training (e.g. nursing students,
medical students, residents), health-care
managers or administrators, patient safety
officers, and any other groups involved in
delivering health care.
Who should facilitate the workshop?
This booklet should enable any health-care
worker to facilitate a workshop. You may
find it helpful to consult a health-care worker
familiar with error prevention and root
cause analysis techniques. However, this is
not essential.
How should the workshop be organised?
The two sessions of the workshop can be
delivered on separate days, or together with
a short break in between. A schedule is
suggested but can be adapted to fit the
time available.
Session One: root cause analysis
After watching the drama on the DVD,
a trainer could briefly review the concept
of learning from error using techniques such
as root cause analysis and then divide the
workshop into small groups. Blank fishbone
templates (Copy Sheet One) are provided
and can be photocopied and distributed
to the groups to help guide analysis of the
patient safety incident seen on the DVD.
Each group could then present their findings
to the workshop. Trainers are provided with
a fishbone analysis diagram with a few
suggestions under each heading to prompt
discussion, if needed.
Session Two: five factors in system errors
The second part of the DVD analyses the
drama in the light of five factors that can
reduce error in health care. After watching
this, a facilitator can distribute photocopies
of questions to consider (Copy Sheet Two)
and divide the workshop into small groups.
The questions to consider are designed to
provide a structure for participants to discuss
their own experience of delivering health
care, and to identify factors in their own
organization which could potentially be
changed to reduce the risk of error. It may be
easier for each group to consider one area of
analysis than for each group to attempt to
consider all areas. Groups can then feed back,
in the plenary session, to the workshop as
a whole, to stimulate wider discussion.
At the end of the workshop, there should be
a debriefing session to identify key learning
points and to discuss how participants will
apply these to their work to improve patient
safety. Finally, participants should also complete
an evaluation of the workshop (Copy Sheet
Three). The WHO World Alliance for Patient
Safety would be pleased to receive these, to
improve future workshops and to share key
learning points relating to patient safety.
Patient Safety Workshop

Suggested Schedule
Running Content
Workshop tools
for the Participant
for the Trainer
Advance preparation
• Workshop booklet:
Learning from error
• Guidance for
Facilitator outlines workshop
course organisers
aims and schedule.
Each participant gives their name, role,
and learning expectations.
DVD: Learning from error.
• DVD: “Learning
All watch 20 minute DVD drama
from Error” (Part I)
depicting vincristine error.
Theory: root cause analysis.
• Root cause
Facilitator reviews concepts of root cause
analysis and answers questions.
Small groups: fishbone technique
• Fishbone template:
• Fishbone analysis:
Facilitator describes fishbone technique.
Copy Sheet One
discussion prompt
Groups apply technique to DVD drama.
Plenary feedback.
Each group gives feedback on their
main conclusions. Plenary discussion.
BREAK 10 mins (optional)
DVD: Analyzing error.
• DVD: “Learning
All watch DVD analysis of error
from Error” (Part II)
according to five key factors.
Small groups: Five factors in system
• Questions to consider: • Questions to consider
errors. Discuss the experience of
Copy Sheet Two
participants in their organizations,
using the questions as prompts.
Plenary feedback.
Each group gives feedback on their main
conclusions, plenary discussion and
brainstorming session on how errors can
be prevented in their own organization.
Wrap-up and evaluation.
• Evaluation form:
Roundtable where each participant
Copy Sheet Three
says what they learned and what
they will change in their practice.
Complete evaluation forms.

Identifying common factors which contribute
to error is critical to the development
of viable solutions aimed at making health
care safer. This should take account of
fundamental flaws and design faults in the
system as well as unusual and one-off events.
Sadly, organizational responses to address
these contributing factors have been slow
to occur in health care.
In this training package, we have focused
on five ways in which errors can be reduced.
These are:
• standard operating procedures and
• ensuring valid and up-to-date training;
• effective communication;
• medication safety; and
• patient engagement.
Understanding and classifying contributing
factors can be a complex task. Making sense
of the wide variety of inputs that lead to
the final error needs to be made accessible,
not just to experts but to all health-care
workers. Our experience indicates that the
most successful high-risk organizations are
obsessed with error and the possibility of
future error. They accept that errors can
and will occur, so have internal systems that
are ready to deal with errors, know when
to request outside assistance, promote a
culture that does not accept error and also
realise that the first impression in any error
is often misleading.
1. Reason J. Beyond the organisational accident:
the need for “error wisdom” on the frontline.
Qual Saf Health Care 2004;13(Suppl II): ii28-33.
2. Reason J. Human error: models and management.
BMJ 2000; 320: 768-770.
Factors Contributing to Error
Patient Safety Workshop

A standard operating procedure (SOP)
is a protocol which details how a certain
procedure should be carried out every time
it is performed. SOPs are a daily feature
of many high-risk industries. Often, there
has been resistance to the adoption of SOPs
and their uptake in medicine has been
disappointingly slow. Barriers to SOP use
include the fear that clinical autonomy will
be reduced, lack of familiarity with guidelines,
not believing that they will actually help,
and lack of motivation to change practice.
Yet, SOPs provide a real opportunity to
make care significantly safer.
Professor Archie Cochrane battled for most
of his life to ensure effective health care was
free at the point of access and that evidence-
based medicine was the normative practice
of every health-care worker. An extension
of his groundbreaking work is to standardise
best practice. This relies on evidence-based
treatments and procedures being consistently
performed by every health-care worker.
Clinical decision-making
A common criticism of SOPs has been that
they reduce clinical decision-making. SOPs
are not designed to turn health care into
a production line. Instead, SOPs provide
a stable basis, particularly suited to high-risk
areas and practices, on which clinical
excellence can flourish.
Recently, a study in New Zealand
demonstrated the importance of SOPs.
It observed the responses of 20 anaesthetists
in a simulated operation and tested their
response to the oxygen supply being cut off
for 15 minutes. All anaesthetists maintained
ventilation throughout the lack of oxygen
supply period and turned on the back-up
cylinder, but 70% had not realised this was
empty preoperatively. Interestingly, none of
them tested the composition of the gas when
normal oxygen supply returned, a simple test
that would be included in every SOP related
to handling this type of incident.
Standard Operating Procedures and Guidelines
“ SOPs provide
a stable basis,
suited to
high-risk areas
and practices,
on which clinical
can flourish. ”

In a similar study during eight simulated
paediatric arrests, the number and type of
drug errors was recorded. Results showed the
potential for serious error: in 17% of cases,
the exact dose was not specified; in 59% the
route of administration was not specified; in
16% of syringes, there was a deviation of at
least 20% from the expected dose.
These situations illustrate the importance of
SOPs. They indicate that if adhered to on every
occasion, they have the potential to reduce
serious harm. Some are simple to implement,
like the correct procedure for ensuring the
accurate dose of a drug in a syringe, others
require more training, like the complex and
detailed procedures for advanced life support.
Improving learning
Within the aviation industry, airline pilots
almost unanimously agree that SOPs make
flying safer. It has been demonstrated that
not following SOPs is strongly linked to error.
Understanding SOPs can help health-care
workers learn across different institutions and
even national boundaries. A lumbar puncture
kit varies across the world. However, the
safest position for the patient and the sites
for needle insertion do not vary. A checklist
of events helps health-care workers memorise
and safely perform clinical duties in addition
to providing a framework of safe practice upon
which to build further skills. SOPs can also be
developed locally to produce best practices
appropriate to the resources available.
Harm caused by committing the wrong action
or omitting to perform the necessary action
can be reduced by the presence of SOPs.
SOPs give patients the opportunity to
identify with their care pathways and to
play a part in areas such as medication safety.
SOPs aid learning and contribute to the daily
functioning of a high quality health-care
system. Good leadership and the development
of systems to support SOPs are needed to
aid their implementation.
Selected references
1. Gray JAM. How to get better value health care.
Offox Press, Oxford, 2007. ISBN 978-1-904202-01-1.
2. Hopper J. Left, Right, Left…’Forward March’
towards standard operating procedures?
Knee 2003; 10(4): 309-10.
3. Kozer E, Seto W, Verjee Z, Parshuram C, Khatatk S,
Koren G, Jarvis DA. Prospective observational study
on the incidence of medication errors during
simulated resuscitation in a paediatric emergency
department. BMJ 2004; 329: 1321.
4. Rozich JD, Howard RJ, Justeson JM, Macken PD,
Lindsay ME, Resar RK. Standardization as a
mechanism to improve safety in health care.
Jt Comm J Qual Saf. 2004; 30(1): 5-14.
5. Donaldson L. On the state of Public Health:
Annual report of the Chief Medical Officer 2005.
Department of Health, London, 2006.
6. Weller J, Merry A, Warman G, Robinson B.
Anaesthetists’ management of oxygen pipeline
failure: room for improvement. Anaesthesia 2007;
62(2): 122-126
7. Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH,
Abboud PA, Rubin HR. Why don’t physicians follow
clinical practice guidelines? A framework for
improvement. JAMA 1999; 282(15): 1458-1465.
Patient Safety Workshop

Patient safety as a topic is largely absent
from health-care education, demonstrating
the low priority given to safe patient care.
Safe care for patients can only be optimised
if health-care workers receive the right
training and are helped to keep up-to-date
with knowledge.
This situation represents a deeper system
failure which has two main components.
Firstly, a failure to address patient safety
education in training, and secondly a failure
to ensure the competence of health-care
workers through regular and up-to-date
training and assessment.
Patient safety education
Within other high-risk industries, rigorous
safety procedures and hundreds of hours of
training are put in place to prevent harm to
human life. In aviation, safety procedures are
ingrained and assessed during flight training
and throughout a pilot’s working life, through
regular assessment and appraisal. The same
is not true of health care. The development
and implementation of patient safety as
a core curricular topic, would contribute
to providing a framework for safe practice
during a clinician’s professional life.
At the University of Aberdeen, in Scotland,
a patient safety module has been integrated
into the latter stages of the medical school’s
undergraduate curriculum. It teaches students,
amongst other things, to: acknowledge human
fallibility; recognise medical errors; understand
the importance of clear documentation and
the reporting of errors; and learn about how
other high-risk industries approach risk.
Human factors
The field of human factors concerns the
interaction between humans and the system
in which they work. Training in non-technical
skills has been shown to be vital to reduce
errors in other industries. However, although
human factors training exists within medicine,
it is often not seen as a core part of daily
work. Topics such as task management,
multidisciplinary team working, risk
perception and prediction, decision making
and recognition of personal and technological
limitations all contribute to a deeper
understanding of error and have been shown
to prevent error. Nevertheless, these concepts
are still not taught with the same rigour
as more traditional educational topics.
Simulation has been shown to be useful at
both the undergraduate and postgraduate
levels. Students often find it difficult to acquire
the range of experience they need. Simulation
of procedures, ranging from venepuncture
to laparoscopic cholecystectomy, offers the
opportunity for turning standard operating
procedures into habits and allows practice
of manual skills without the risk of causing
harm to a real patient.
Simulation has also been successfully used in
the training of teams and in the familiarisation
of daily routines. For many years, the Advanced
Life Support courses have assessed trainees
in simulated scenarios, where practical skills,
teamwork and leadership are required to
ensure safe and high-quality outcomes.
Ensuring competence
Medical education has traditionally taken the
form of an apprenticeship. Students are often
encouraged to learn based on the principle
of see one, do one, teach one. This is rarely an
appropriate method of ensuring safe health
care. It also reinforces a culture in which
training is not prioritized.
Poorly trained health-care workers can be a
major contributing factor leading to adverse
events. Staff may not be well placed to judge
their own level of competence; they may also
be overconfident as a consequence of their
own limited experience.
Ensuring Valid and Up-to-Date Training

National bodies and individual institutions
need to ensure they have the systems in place
for validating health-care workers’ skills. Many
countries are reasonably successful at ensuring
a certain standard as part of undergraduate
training. However, all too often, the last
assessment of a health-care worker’s skills and
competencies takes place upon graduation
from their university or college.
Education deserves a higher profile within
health-care provision. Investing in protected
teaching time, which is not disturbed by
normal duties, is one way of emphasising the
importance of training. Assessments are not
just about ensuring a certain and sustainable
level of skill, knowledge or competence, they
are also a reflection of a wider culture of safe
and effective practice.
Education and validation of competency are
critical components in the quest to improve
patient safety. At the very least, all health-care
workers must be competent to deliver safe
care, and their organization must have
mechanisms to check this. Education needs
to be broadened to include explicit patient
safety topics, such as human factors, and
methods, such as simulation, designed to
create a generation of health-care workers
who deliver consistently safe care.
Selected References
1. Wakefield A, Attree M, Braidman I, Carlisle C,
Johnson M, Cooke H. Patient safety: do nursing and
medical curricula address this theme? Nurse Educ
Today 2005; 25(4): 333-340.
2. Glavin RJ, Maran NJ. Integrating human factors
into the medical curriculum. Med Educ. 2003; 37
(Suppl. I): 59-64.
3. Moorthy K, Munz Y, Adams S, Pandey V, Darzi A.
A human factors analysis of technical and team
skills among surgical trainees during procedural
simulations in a simulated operating theatre.
Ann Surg. 2005; 242(5): 640-1.
4. Paparella SF, Mariani BA, Layton K, Carpenter AM.
Patient safety simulation: learning about safety
never seemed more fun. J Nurses Staff Dev. 2004;
20(6): 247-252.
5. Moorthy K, Vincent C, Darzi A. Simulation based
training. BMJ 2005; 330: 493-494.
6. Donaldson L. Good doctors, safer patients: Proposals
to strengthen the system to assure and improve the
performance of doctors and to protect the safety of
patients. Department of Health, London, 2006.
7. Walton MM, Elliott SL. Improving safety and quality:
how can education help? Med J Aust. 2006; 184(10):
8. Perry SJ. An overlooked alliance: using human
factors engineering to reduce patient harm. Jt
Comm J Qual Saf. 2004; 30(8): 455-9.
9. Reason J. Understanding adverse events: human
factors. Qual Health Care 1995; 4(2): 80-9.
10. Patey R, Flin R, Cuthbertson BH, MacDonald L,
Mearns K, Cleland J, Williams D. Patient safety:
helping medical students understand error in
healthcare. Qual Saf Health Care 2007; 16(4): 256-9.
Patient Safety Workshop

Effective communication is key to patient
safety. A review of root cause analyses
suggests that in over 60% of errors, poor
communication was an important causal
factor. Effective communication is also crucial
to managing an incident once it has occurred.
Communication in the health-care setting may
be divided into two types: those between one
health-care worker and another, and those
between the patient (and/or family member)
and a health-care worker. Each has different
elements that can contribute to medical errors.
Communication between patients and
health-care workers
The patient/ health-care worker interaction is
complex and only beginning to be understood.
Part of the complexity is due to changing
expectations. Fifty years ago, patients were
accustomed to a health-care worker being
dogmatic and paternalistic. Today, patients
usually look to their health-care worker to
help them navigate through a complicated
system and expect communication to be
based on shared decision-making. However,
neither model is correct all of the time. The
type of communication model that is needed
depends very much on the specific situation.
During an interaction between a patient
and a health-care worker, various forms of
communication may be used. The least studied
area is non-verbal communication. The clues
that patients pick up from their health-care
worker’s body language have been shown to
be crucial in the way the patients interpret
the information they are given.
Verbal communication studies have shown
differences between how health-care workers
think they are communicating and how
patients perceive the transfer of information.
One of the most important factors that
contributes to communication is the ability
of patients and health-care workers to
communicate in the same language. Studies
have shown that providing interpreters is not
only better for patients but also cost-effective.
What is not clear is how best to provide such
interpretation. All are agreed that professional
interpreters are the most accurate. However,
they are not always available and are costly.
Patients prefer family members as a second
best, whereas health-care workers seem to
prefer using telephone interpreting.
Even when both speak the same language,
research has highlighted further verbal
communication issues, which arise in part
from lack of training on the part of health-
care workers. The language that health-care
workers think is clear may still appear as
confusing medical jargon to a patient.
Health-care workers also tend to control
the flow of communication with patients.
For example, they too often ask closed
questions (where the expected response is
‘yes’ or ‘no’), which put up barriers to the
patient communicating freely. Another
difficult area is how to communicate risk
without frightening patients. Teaching can
improve health-care worker communication,
but access to this is often limited.
The final method that may be used to
communicate between patients and health-
care workers is written information. This too
has pitfalls. Many patients find understanding
written health-related information difficult.
Studies show that the ability to understand
this sort of material – also known as Functional
Health Literacy (FHL) – is not correlated
to other forms of literacy. Furthermore,
the average FHL appears to be much lower
than the FHL required to read the material
generally produced. In addition, novel
techniques like patient support material on
the internet require literacy skills to navigate
the sites, that not everyone possesses.
Institutions are succeeding in overcoming
these barriers, but it requires new methods,
like the use of DVDs or pictograms.

Communication between health-care workers
Research has identified that communication
amoung health-care workers plays a significant
role in the development of errors: incomplete
handovers, illegible handwriting and unclear
instructions are a few examples. Health care
is also very hierarchical and juniors rarely feel
confident to speak out about concerns they
may have. Many of these problems are not
unique to health care, and we can learn from
external examples.
Crew Resource Management is a technique
borrowed from the aviation industry and
designed specifically to try to break down
hierarchy. Through team-building exercises,
professionals are empowered to speak out.
This is crucial in identifying errors before they
occur. This technique has been used in
anaesthesia, emergency medicine and
obstetrics. Others have tried to reengineer
the team structure. At Harvard University,
they have redesigned the ward round. By
actively including pharmacists on the round,
they have dramatically reduced medication-
related errors.
Communication and the management
of incidents
When an incident does occur, communication
is fundamental to managing the adverse
event. Apologising and explaining to the
patient and their family is morally necessary,
albeit difficult. Receiving an apology is one
of the main objectives of patients when
campaigning for increased error disclosure,
and lack of information and apology are key
reasons for patients taking legal action.
Apologising has even been shown to be cost-
effective. Patients and their families want
to know that the lessons learned in one place
will be communicated more widely. The role
of communicating with patients after an
error is explored further in the chapter on
‘Patient Engagement’.
Communicating with the health-care team
after an error has occurred is also vitally
important. Health-care workers may be
personally affected after involvement in care
which has resulted in error. Understanding
this and providing support to health-care
workers is challenging, but vitally important.
Communication plays a significant role in all
aspects of error. Firstly, improving the quality
of communication among health-care workers
and between patients and health-care workers
can help prevent errors. Secondly, good
communication is imperative when dealing
with errors once they have occurred.
Selected References
1. Bourhis RY, Roth S, MacQueen G. Communication
in the hospital setting: a survey of medical and
everyday language use amongst patients, nurses
and doctors. Soc Sci Med. 1989; 28(4): 339-346.
2. Davis TC, Mayeaux EJ, Fredrickson D, Bocchini JA Jr,
Jackson RH, Murphy PW. Reading ability of parents
compared with reading level of pediatric patient
education materials. Pediatrics 1994; 93(3): 460-468.
3. Hampers LC, Cha S, Gutglass DJ, Binns HJ, Krug SE.
Language barriers and resource utilization in a
pediatric emergency department. Pediatrics 1999;
103(6 Pt 1): 1253-1256.
4. Kraman SS, Hamm G. Risk management: extreme
honesty may be the best policy. Ann Intern Med
1999; 131(12): 963-967.
5. Leape LL. Reporting of adverse events. N Engl J Med
2002; 347(20): 1633-1638.
6. Murphy PW, Chesson AL, Walker L, Arnold CL,
Chesson LM. Comparing the effectiveness of video
and written material for improving knowledge
among sleep disorders clinic patients with limited
literacy skills. South Med J. 2000; 93(3): 297-304.
7. Ong LM, de Haes JC, Hoos AM, Lammes FB. Doctor-
patient communication: a review of the literature.
Soc Sci Med. 1995; 40(7): 903-918.
8. Kaplan SH, Greenfield S, Gandek B, Rogers WH,
Ware JE Jr. Characteristics of physicians with
participatory decision-making styles. Ann Intern
Med. 1996; 124(5): 497-504.
9. Maguire P, Fairbairn S, Fletcher C. Consultation skills
of young doctors: I--Benefits of feedback training
in interviewing as students persist. Br Med J (Clin
Res Ed) 1986; 292(6535): 1573-6.
Patient Safety Workshop

Medication Safety
In the past, safety issues surrounding
medication have centred on adverse drug
reactions due to the side-effects of correct
medication. Medication safety is a broader
term that encompasses errors which are not
side-effects of the intended drug, but, for
example, the result of the wrong drug being
administered in error or the right drug being
given in the wrong dose or via the wrong
route. These are termed adverse drug events.
Harm from adverse drug events occurs across
the world. Some studies suggest that they
account for a quarter of all medical errors.
In the United States, Australia and France,
adverse drug events occur in approximately
4% of hospital admissions and death results
from these errors 5-10% of the time. In the
United Kingdom, over 1000 people died from
adverse drug events in 2001 alone. It has
been suggested that 75% of these errors
are preventable.
Causation of errors
We all know how bad a doctor’s handwriting
can be! Yet, sometimes written medical notes
are the only means health-care workers have
of communicating with each other. Medical
records need to be clear and unambiguous.
They need to provide an accurate way of
conveying important information. This is
especially important when the written
information concerns drug dosages, delivery
timings and changes to the current regime.
All too often, medical notes are not kept
up-to-date, and in addition to illegibility,
transcription is problematic. These contributing
factors have been shown to be at the root
cause of many adverse drug events.
In much of the world, drug labelling is still
carried out by hand. Often, despite rigorous
double-checking procedures being in place,
errors still occur. Standard operating
procedures should dictate exactly how drugs,
in particular high-risk drugs, should be
checked, prescribed, dispensed and delivered.
Technology should be used wherever possible.
It is critical that all hospitals, clinics and
treatment centres have established policies
to ensure medication safety.
There are certain principles that underpin
safe operating in this area. For example, all
drugs need to be clearly labeled with unique
identifiers, labels need to be easily visible
and storage precautions on the ward need
to be considered. Drugs need to be properly
checked by the designated person against
the patient’s medical records and drug chart.
For high-risk treatments like chemotherapy,
drugs should only be given by nurses and
doctors with specialized registered training.
Health-care workers are often unaware of the
level of competence of their contemporaries
and the prevailing culture frequently makes
this awkward to challenge.
At an organizational level there are also
barriers that can be put in place to prevent
adverse drug events. For example, look-alike
sound-alike medicines that have similar
names, such as lasix (furosemide) and losec
(omeprazole), can cause confusion unless
safeguards are in place to prevent this.
Medication reconciliation
Medication reconciliation seeks to establish
what medications a patient should be
receiving in a formal record to prevent
communication breakdowns. At the local
level, WHO recommends that a complete list
of medications is kept for each patient, which:
• is provided at every care transfer;
• includes hospital and over the counter
• specifies the timing, dose and route; and
• matches the patient’s actual habits.
It is likely that involvement of the patient in
the medication reconciliation process would
help reduce adverse drug events still further.

Patient Safety Workshop
On the ward, the medication chart needs
to be highly visible and checked and updated
regularly at specified times. The list should
be updated and clearly communicated at all
transitions between care providers, such as shift
handovers and patient discharge. Standardized
forms should be used wherever possible.
In the longer term, an international
standardized card that a patient could carry
might help eliminate errors in the transfer
of information. In addition, electronic
versions of the above systems, although
not yet available globally, have been shown
to significantly reduce adverse drug events.
One hospital which has dedicated itself
to a medication reconciliation programme,
based on many of the standards above,
reduced adverse drug events by 85% over
a 10-month period.
Reporting and learning systems that are
non-punitive and include adverse drug events
are potentially of high value to health care.
These types of errors frequently reveal deficits
in underlying systems rather than individual
failures. Reporting systems need to be
strengthened so that this type of information
can be elicited from them.
The high prevalence of adverse drug events,
the extent of harm and the existence of viable
solutions, all make the reduction of injury
in this area a very important and urgent
goal. Strategies of medication reconciliation
at the local level and organizational policy
implementation, regarding procurement and
other drug-related issues, should remain high
on the agenda. Medication safety continues
to be one of the most pressing issues of the
patient safety agenda.
Selected References
1. The Importance of Pharmacovigilance (Safety
monitoring of medicinal products). World Health
Organization, Geneva, Switzerland, 2002.
2. Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD,
Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et
al. Incidence of adverse drug events and potential
adverse drug events. Implications for prevention. ADE
Prevention Study Group. JAMA 1995; 274(1): 29-34.
3. Bates DW, Boyle DL, Vander Vliet MB, Schneider J,
Leape L. Relationship between medication errors
and adverse drug events. J Gen Intern Med. 1995;
10(4): 199-205.
4. Brennan TA, Leape LL, Laird NM, Hebert L, Localio
AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH.
Incidence of adverse events and negligence in
hospitalized patients. Results of the Harvard Medical
Practice Study I. N Engl J Med. 1991;324(6):370-6.
5. Thomas EJ, Studdert DM, Burstin HR, Orav EJ,
Zeena T, Williams EJ, Howard KM, Weiler PC,
Brennan TA. Incidence and types of adverse events
and negligent care in Utah and Colorado. Med Care.
2000; 38(3): 261-71.
6. Baune B, Kessler V, Patris S, Descamps V, Casalino E,
Quenon JL, Farinotti R. Iatrogénie médicamenteuse
à l’hôpital: enquôte un jour donné. Presse Med.
2003; 32(15): 683-8.
7. Lazarou J, Pomeranz BH, Corey PN. Incidence
of adverse drug reactions in hospitalized patients:
a meta-analysis of prospective studies. JAMA. 1998;
279(15): 1200-5.
8. Audit Commission. A Spoonful of Sugar – Medicines
Management in NHS Hospitals. Audit Commission
Publications, Wetherby, UK, 2001. http://www.audit-
9. The Quality in Australian Health Care Study. Wilson
RM, Runciman WB, Gibberd RW, Harrison BT, Newby
L, Hamilton JD. Med J Aust. 1995; 163(9): 458-71.
10. World Health Organization Collaborating Centre
for Patient Safety Solutions. Assuring Medication
Accuracy at Transitions in Care. World Health
Organization, Geneva, Switzerland, 2007.
11. Institute of Medicine. Preventing Medication Errors.
The National Academies Press, Washington, USA, 2006.

Patient Engagement
To many patients, the risk of unsafe health
care is far from their thoughts when they
consult a doctor. Patients hope and expect
that health-care workers will provide them
with safe and appropriate care. Providing
and receiving health care is an act of
partnership and trust between patients
and health-care workers. Involving patients
more in the process of their care is one
of the routes to providing safer care.
Involving individual patients to
prevent errors
Many health-care organizations are actively
encouraging patient engagement to reduce
errors and help understand the causes
of harm. Patients have a unique perspective;
they are often the only ones to see the
whole pathway of care and have a valuable
insight into the way care is communicated
and delivered.
There are many ways in which patients
can become involved in making health
care safer. First of these are patients who
are better informed about their condition
and treatment, through the provision of
information on their diagnosis and the
treatment options available. Patients and
their families need to be encouraged to
report safety concerns whenever they occur,
either through formal reporting systems
or by speaking to dedicated and trained
staff. Having a relative or friend present
can support patients in understanding the
decisions being made and who can be an
advocate for safety on their behalf if they
are anxious, unwell or confused.
Patient advocacy and patients’ rights
organizations are increasingly being set up
to work with health-care organizations to
promote safer care. These can play important
roles, for example in campaigns to support
and encourage patients to ask questions
and to check that their treatment is right.
This has been extended to campaigns to
remind staff about hand washing. Many of
these organizations are run by patients and
families who have experienced unsafe care
and are passionately committed to patient
safety and the prevention of future harm.
Sharing patients’ experiences with health-
care workers in training encourages a culture
where patients are valued and their active
participation in the decisions about their
treatment is the normal practice. Patients’ own
stories of unsafe care are an important source
of information and insight and can be used
effectively to better understand the causes
of error and the devastation that can follow.
Barriers to patient participation
Patients are often reluctant to participate
because they feel unauthorised to do so.
Patients are often unaware of the risks of
health care, and greater awareness of patient
safety is needed at international, national
and institutional levels. Errors can and do
happen in the health-care setting, and
patients need to be informed of this and
that their participation can help reduce risks.
However, the most effective way to educate
patients remains to be determined. It will
probably necessitate a combination of
verbal and written information, reminders
and incentives.
Effectiveness of patient involvement
programmes requires further research.
Even though many have suggested patients
can play a role in preventing medical errors,
evidence in the medical literature concerning
its effectiveness is limited.
Health-care workers need to change their
habits to encourage patient involvement.
Health-care workers often refuse to hand over
power to patients. This refusal is multifactorial:
during their teaching they were not taught
to involve patients, and they are reluctant
to abandon the paternalistic model of health
care. This is especially true in relation to
patients from the lower socio-economic levels,
who are sometimes perceived as being
incapable of contributing to their own care.
Health-care workers also often perceive that
involving patients would be time consuming,
even though this has not been proven in
clinical studies.

Patient Safety Workshop
Patients and families report that when
things go wrong, they are often met with
a wall of silence, denial and even hostility.
In these circumstances, patients can quickly
lose confidence and trust in their carers.
In addition to any physical effects, patients
may also suffer emotionally from knowing
that they have been harmed. Patients should
be provided with information, support and
advice after an error has occurred.
In many countries, patients may be grateful
just to be able to access health facilities and
may therefore be unwilling to seek out the
reasons for errors in their care or the causes
of any harm. Patients may feel a sense of
disloyalty to professional staff or may fear
the real or perceived consequences of raising
questions about how the care is provided.
Patients also report that the opportunity to
learn is often frustrated by efforts to conceal
error. Such conduct encourages
confrontation, potentially damaging the
relationship of trust between health-care
workers and patients. This often leads to
litigation, rather than offering healing to all
Patients are becoming engaged with local
health-care organizations, nationally and
globally. Promoting open and honest
relationships between health-care workers
and patients will create forums for dialogue
and effective mechanisms to build safer
health-care systems. Health-care workers
must embrace the concept of patient
engagement. Each individual caregiver, and
the whole health-care system, must openly
support and encourage their participation.
Selected References:
1. Hibbard JH, Peters E, Slovic P, Tusler M. Can patients
be part of the solution? Views on their role in
preventing medical errors. Med Care Res Rev. 2005;
62(5): 601-16.
2. Mansell D, Poses RM, Kazis L, Duefield CA. Clinical
factors that influence patients’ desire for
participation in decisions about illness. Arch Intern
Med. 2000; 160(19): 2991-6.
3. Henderson S. Power imbalance between nurses and
patients: a potential inhibitor of partnership in care.
J Clin Nurs. 2003; 12(4): 501-8.
4. Cahill J. Patient participation-a review of the
literature. J Clin Nurs. 1998; 7(2): 119-28.
5. Willems S, De Maesschalk S, Deveugele M, Derese A,
De Maeseneer J. Socio-economic status of the
patient and doctor-patient communication: does it
make a difference? Patient Educ Couns. 2005; 56(2):
6. Brennan PE, and Safran C. Patient Safety: Remember
who it’s really for. Int J Med Inform 2004; 73: 547-550.
7. International Alliance of Patients’ Organizations
8. World Health Organization. World Alliance for
Patient Safety: Patients for Patient Safety.

Learning from Error
Session One: Root Cause Analysis
In a safe clinical environment, systems are
in place to prevent errors and to try to ensure
that patients are not harmed when errors
inevitably occur.
When error occurs, the customary focus
on blaming the individual care-giver overlooks
the conditions in which the error occurred.
This misses the opportunity for the organization
to learn how to make its environment safer.
Human error cannot be eliminated from
the clinical setting. Systems can be designed
to help individuals avoid error and minimise
the harmful effect of errors.
Root cause analysis is the systematic analysis
of all the factors which predisposed to,
or had the potential to prevent, an error.
It can be applied to incidents in which there
was avoidable patient harm, or in ‘near misses’
in which a situation or event put patients
at risk of harm. Organizations can use root
cause analysis both to explain how the
incident occurred and to design mechanisms
to prevent it from happening again.
There are many tools available for use in
root cause analysis. One tool is the ‘fishbone
technique’. Nine groups of contributory
factors are identified in this example. These
may be broken down into subgroups. For
example, patient factors may be subdivided
into clinical condition, social factors, physical
factors, mental and psychological factors and
interpersonal relationships. Each group of
factors can then be considered individually,
to assess its relevance to the specific incident
being studied. This method provides a prompt
for considering each of a wide range of
factors. It also allows contributing factors that
are identified to be displayed in a simple
schematic diagram.
To conduct root cause analysis certain steps
need to be taken:
1. Define which events require investigation;
for example those which were, or could
have been, fatal and might be repeated,
but which are felt to be preventable.
2. Select a multidisciplinary team, including
an expert in the specialty and a person
experienced in incident investigation.
3. Gather information by interviewing all
of the people involved (using free recall
and semi-structured interviews), reading
all available documentation, examining
equipment and inspecting the site at which
the event occurred. This may include
reconstruction of the event.
4. Collate information from all sources into
one user-friendly form, such as a timeline.
5. Ask all those who were involved to
identify what aspects of service delivery
they think contributed to the event, for
example by identifying how the event
deviated from normal practice.
6. Use an investigation tool such as the
fishbone template to identify factors that
contributed to, or had the potential to
prevent, the event.
7. Develop targeted recommendations
that could be implemented to reduce
the potential for this event to recur.
Recommendations should be simple,
specific and measurable; it is easy
to say but hard to implement a
recommendation that “everyone
should try not to do that again”.
8. Publish a report to share the lessons that
have been learnt within the organization
and more widely in health care.

“When error occurs, the
customary focus on blaming
the individual care-giver
overlooks the conditions in
which the error occurred.”

Fishbone Analysis: discussion prompt for course facilitators
Tool developed by the NHS National Patient Safety Agency, UK
Working Conditions
• Senior doctor and
nurse absent
• Junior doctor
covering job outside
• Busy unit
Equipment &
• Lacked separate
storage area for
intrathecal drugs
• Short-staffed
• Lack of clarity as to
new doctor’s skills
• Pharmacists and
nurse who
challenged doctors
were not respected
Organizational &
Strategic factors
• New doctor
started work
before induction
• Culture of
disregarding local
Individual factors
• Doctors did not
perceive risk of
ignoring guidelines
• Human error
checking drug
Patient factors
• Not invited to
engage with her
• Stressed and late
Task factors
• Vincristine toxic
• Intrathecal
delivery demanding
and distracting
from safety check
Education & Training
• Doctor unfamiliar
with local protocol
• Doctor gave
chemotherapy when
skills unconfirmed
Team & Social factors
• Hierarchical
structure e.g.
doctor persuaded
pharmacist to
break with
delivered by
spinal route

Developed by the Vincristine Safety Team within the World Alliance for Patient Safety with
support and contributions from:Brendan Flannigan, Rhona Flynn and team, James Ip, Eugenia
Lee and Rona Patey.
World Alliance for Patient Safety Secretariat
(All teams and members listed in alphabetical order following the team responsible for the
Vincristine Safety:
Felix Greaves, Helen Hughes, Claire Lemer, Douglas Noble, Kristine Stave, Helen Woodward
Blood Stream Infections:
Katthyana Aparicio, Gabriela García Castillejos, Sebastiana Gianci, Chris Goeschel,
Maria Teresa Diaz Navarlaz, Edward Kelley, Itziar Larizgoitia, Peter Pronovost, Angela Lashoher
Central Support & Administration:
Sooyeon Hwang, Sean Moir, John Shumbusho, Fiona Stewart-Mills
Clean Care is Safer Care:
Benedetta Allegranzi, Sepideh Bagheri Nejad, Pascal Bonnabry, Marie-Noelle Chraiti, Nadia
Colaizzi, Nizam Damani, Sasi Dharan, Cyrus Engineer, Michal Frances, Claude Ginet, Wilco
Graafmans, Lidvina Grand, William Griffiths, Pascale Herrault, Claire Kilpatrick, Agnès Leotsakos,
Yves Longtin, Elizabeth Mathai, Hazel Morse, Didier Pittet, Hervé Richet, Hugo Sax, Kristine
Stave, Julie Storr, Rosemary Sudan, Shams Syed, Albert Wu, Walter Zingg
Communications & country engagement:
Vivienne Allan, Agnès Leotsakos, Laura Pearson, Gillian Perkins, Kristine Stave
Bruce Barraclough, Gerald Dziekan, Benjamin Ellis, Felix Greaves, Helen Hughes, Ruth Jennings,
Itziar Larizgoitia, Claire Lemer, Douglas Noble, Rona Patey, Gillian Perkins, Samantha Van
Staalduinen, Merrilyn Walton, Helen Woodward
International Classification for Patient Safety:
Martin Fletcher, Edward Kelley, Itziar Larizgoitia, Fiona Stewart-Mills
Patient safety prize & indicators:
Benjamin Ellis, Itziar Larizgoitia, Claire Lemer
Patients for Patient Safety:
Joanna Groves , Martin Hatlie, Rachel Heath, Helen Hughes, Anna Lee, Peter Mansell, Margaret
Murphy, Susan Sheridan, Garance Upham
Michael Barton, Felix Greaves, Ruth Jennings, Claire Lemer, Douglas Noble, Gillian Perkins, Jesmin
Shafiq, Helen Woodward
Reporting & Learning:
Gabriela Garcia Castillejos, Martin Fletcher, Sebastiana Gianci, Christine Goeschel, Helen Hughes,
Edward Kelley, Kristine Stave
Patient Safety Workshop

Research and Knowledge Management:
Maria Ahmed, Katthyana Aparicio, David Bates, Helen Hughes, Itziar Larizgoitia, Pat Martin,
Carolina Nakandi, Nittita Prasopa-Plaizier, Kristine Stave, Albert Wu
Safe Surgery Saves Lives:
William Berry, Mobasher Butt, Priya Desai, Gerald Dziekan, Lizabeth Edmondson, Luke Funk, Atul
Gawande, Alex Haynes, Sooyeon Hwang, Agnès Leotsakos, Elizabeth Morse, Douglas Noble,
Sukhmeet Panesar, Paul Rutter, Laura Schoenherr, Kristine Stave, Thomas Weiser, Iain Yardley
Solutions & High 5s:
Laura Caisley, Gabriela Garcia-Castillejos, Felix Greaves, Edward Kelley, Claire Lemer, Agnès
Leotsakos, Douglas Noble, Dennis O'Leary, Karen Timmons, Helen Woodward
Tackling Antimicrobial Resistance:
Gerald Dziekan, Felix Greaves, David Heymann, Sooyeon Hwang, Sarah Jonas, Iain Kennedy,
Vivian Tang
Rajesh Aggarwal, Lord Ara Darzi, Rachel Davies, Gabriela Garcia Castillejos, Felix Greaves, Edward
Kelley, Oliver Mytton, Charles Vincent, Guang-Zhong Yang
Patient Safety Workshop

The Fishbone Template
Copy Sheet One:
Fishbone Template
ool developed by the NHS National Patient Safety Agency, UK
Individual factors
Patient factors
Task factors
Education & Training
Team & Social factors
delivered by spinal route
Equipment & Resources
Organizational & Strategic factors

Copy Sheet Two: Questions to Consider
Please use these questions to reflect on your
experience of providing health care within
your own organization.
1. Standard operating procedures and
1. Could standard operating procedures
and guidelines be put in place to make
delivery of care safer?
2. Are standard operating procedures
and guidelines adhered to, and
if not, which pressures prevent their
3. Is there a culture of contempt for
standard operating procedures and
guidelines in your organization?
2. Ensuring valid and up-to-date training:
1. How do you know that the colleagues
you work with have received the
training they need to do their job well?
2. Do you have a way of assessing the
colleagues you work with to ensure
they are competent?
3. Do you have a framework in place to
ensure induction with local procedures?
4. Do you know what you should do if you
have concerns about the competence
of your colleagues and the safety of
their practice? Would you be supported
if you were to voice your concerns?
5. How would you know if your
health-care system allowed an
unskilled/untrained health-care
worker to practise?
3. Communication:
1. To what extent, in your health-care
setting, have you addressed the need
to have effective multidisciplinary
2. Do staff value, or even know about,
each other’s roles?
3. Can junior staff approach senior staff
and make a legitimate enquiry about
the safety of a situation?
4. Do you work well as a team?
4. Medication Safety:
1. Are medical notes easily accessible, kept
regularly up-to-date and legible?
2. Do your procurement policies ensure
consistency of drug purchasing
and checking mechanisms to detect
potential errors such as look-alike
and sound-alike medications?
3. Do you have systems in place to
ensure only those properly trained
are able to be involved in delivering
high-risk drugs?
5. Patient engagement:
1. What happens in your organization
to ensure that patients are active
partners in their own treatment?
2. How could your organization play
a more active role in this challenge?
3. Could other means of engaging
patients be used, such as posters,
leaflets and patient treatment cards?
1. Do you have standard operating
procedures and guidelines in
your workplace?
Are they adhered to?
If not, why not?
Could you develop some?
2. Do you have a framework in place
to ensure that health-care workers
are up-to-date with training and
safe to practise?
3. Do you communicate effectively
with your colleagues as part of
a multidisciplinary team?
4. Is information about the safe use
of drugs accessible to you?
5. Have you engaged your patients
in their care?

Copy Sheet Three: Evaluation Form
Thank you for taking the time to complete this evaluation form.
It will help us improve our workshops in future.
I am a (please circle)
Nurse Doctor Pharmacist Manager Other (please state) ....................................................
How important do you think patient safety
is in your clinical practice?
Not at all important
Not very important
Quite important
Very important
Do you believe that other people in
your team think that patient safety is
Definitely no
Possibly no
Possibly yes
Definitely yes
How confident are you that you could
identify factors in your workplace that are
likely to play a role in patient safety?
Very unconfident
Quite unconfident
Quite confident
Very confident
How easy would it be for you to suggest
changes in your workplace?
Very difficult
Quite difficult
Quite easy
Very easy
How likely is it that you will suggest changes
in your workplace in the next three months?
Very unlikely
Quite unlikely
Quite likely
Very likely
What changes might you suggest?
How likely is it that other factors will
make it difficult for you to suggest changes
in your workplace?
Very unlikely
Quite unlikely
Quite likely
Very likely
What might make it difficult for you?
How important do you think each of
these factors is in patient safety in your
clinical area?
• Standard operating procedures or
Not at all important
Not very important
Quite important
Very important

• Communication
Not at all important
Not very important
Quite important
Very important
• Training
Not at all important
Not very important
Quite important
Very important
• Medication safety
Not at all important
Not very important
Quite important
Very important
• Patient engagement
Not at all important
Not very important
Quite important
Very important
very poor
very good
1. How did you rate the workshop overall?
2. What was the quality of the material
3. How relevant was the workshop to your
clinical work?
4. What was done well?
5. What could be improved?
Thank you for attending the Learning from Error Patient Safety Workshop