Doctors, nurses, and others providing healthcare go to work every day

intending to provide good care for their patients.

Play video starting at :3:21 and follow transcript3:21

They adhere to no harm", the ancient Greek dictum of, "First do and

they believe that they provide the best care possible.

Yet the seminal report from the US Institute of Medicine,

that captured people's attention in 1999, indicated that nearly 100,000 people

die in US hospitals from medical errors and quality lapses every year.

Play video starting at :3:45 and follow transcript3:45

That's the equivalent of a jumbo jet crashing every single day.

Play video starting at :3:51 and follow transcript3:51

We're exacting calculations from the work of John James and

others, suggests that the number may actually be much higher,

upwards of a quarter of a million, to 400,000 a year.

More recent evidence suggests that the situation has improved in many areas, but

overall, the improvement is still only marginal.

Evidence from other countries shows that medical errors in hospitals

are a significant cause of death around the world.

As healthcare providers we believe we are providing excellent care.

But objective studies indicate that in all to many instances

that is not always the case.

Why do we have such and unacceptable rate of medical errors and poor quality?

Play video starting at :4:52 and follow transcript4:52

Empiric studies of quality and safety suggest it is because we have not

paid sufficient attention to building quality and

safety into the technologies and the systems that we use.

Or indeed, into the education of those of us who provide the care.

Or to measuring, monitoring, and improving quality and safety.

In this course, we'll take a closer look at each of these contributing factors.

And provide you with an overview of strategies and

skills that can start you on the path to lead, or at least participate in,

critical quality and safety improvement initiatives in your own practice setting.

>> We're excited to be working with you and others like you who are interested in

making a difference in the quality of healthcare around the world.

The Gobal Burden and Unsettling Facts

In the US and throughout the world, poor quality and safety lapses not

only cause suffering to patients, but there is strong evidence that these lapses

result in extraordinarily large social and economic costs.

A study by faculty at the Harvard School of Public Health estimated that

least 43 million people worldwide experience medical harm,

resulting in the loss of 23 million healthy days each year.

While the statistics we've presented in this episode are a source of great

interest, data alone do not result in any change.

In our next episode, we'll take a look at some of the primary causes of quality and

safety problems, the importance of identifying preventable errors, and

how lessons learned from other industries provide models for positive change

In the US and throughout the world, poor quality and safety lapses not
only cause suffering to patients, but there is strong evidence that these lapses
result in extraordinarily large social and economic costs.
A study by faculty at the Harvard School of Public Health estimated that
least 43 million people worldwide experience medical harm,
resulting in the loss of 23 million healthy days each year.
While the statistics we've presented in this episode are a source of great
interest, data alone do not result in any change.
In our next episode, we'll take a look at some of the primary causes of quality and
safety problems, the importance of identifying preventable errors, and
how lessons learned from other industries provide models for positive change
In order for an error to be classified as preventable,
it must first be identifiable and measurable.

intervention that resulted in the error must have been shown to be modifiable.
Play video starting at ::46 and follow transcript0:46
And third, there must be one or
more modifications that can actually be implemented and tested in a given setting
to prove that the intervention does indeed lead to fewer errors.
Play video starting at :1: and follow transcript1:00
An example of a clearly preventable error
is having two vials of a medication that look exactly the same but
have vastly different concentrations of the medication.

Required

Jha, A. K., Larizgoitia, I., Audera-Lopez, C., Prasopa-Plaizier, N., Waters, H., & Bates, D. W.
(2013). The global burden of unsafe medical care: analytic modelling of observational
studies. BMJ Quality & Safety.

Kapur, N., Parand, A., Soukup, T., Reader, T., & Sevdalis, N. (2016). Aviation and
Healthcare: A comparative Review with Implications for Patient Safety.

Recommended

James, J. (2013). A new, Evidence-based Estimate of Patient Harms with Hospital Care.

Hübner, N.O.,Fleßa, S., Haak, J., Wilke, F., Hübner, C., Dahms,C., Hoffmann, W., & Kramer,
A. (2011). Can the Hazard Assessment and Critical Control Points (HACCP) be used to
Design Process-based Hygiene Concepts

Share Experiences with Quality &

Safety
Please share any professional experiences you’ve had related to quality problems, medical error
or unsafe systems in your workplace. Discuss with your peers your perceptions about what may
have caused these problems, and steps that could be taken to prevent them from occurring in
the future.

Please note: We acknowledge that many of us have had personal experiences with medical
errors that may be emotionally challenging. While we do not want to dismiss the importance of
these experiences, to ensure a productive learning experience for everyone, it is important to
keep our discussions professional. We will be monitoring the discussion boards and deleting any
inappropriate postings.

QUIZ
Share Experiences with Quality &
Safety
Please share any professional experiences you’ve had related to quality problems, medical error
or unsafe systems in your workplace. Discuss with your peers your perceptions about what may
have caused these problems, and steps that could be taken to prevent them from occurring in
the future.

Please note: We acknowledge that many of us have had personal experiences with medical
errors that may be emotionally challenging. While we do not want to dismiss the importance of
these experiences, to ensure a productive learning experience for everyone, it is important to
keep our discussions professional. We will be monitoring the discussion boards and deleting any
inappropriate postings.

Safety – First Principle of Quality

Every system is perfectly designed to create the results that it gets.

This quote, attributed to Dr. Paul Batalden
most healthcare systems were not designed or developed with safety as a core focus.
most healthcare systems were not designed or
developed with safety as a core focus.

scientific study of systems and processes of healthcare,

we have started to learn a great deal about the multiple factors in design and
engineering that contribute to error, and how to use this information
to re-engineer systems and processes to produce safer care.

The U.S. Institute of Medicine defined the desirable characteristics

of high quality healthcare systems using the acronym STEEEP.
Namely, care that is Safe, Timely, Effective,
Efficient, Equitable, and Patient centered.
Play video starting at :1:32 and follow transcript1:32
In this formulation, patient safety is a fundamental,
core component, of a high functioning health care delivery system.

from a scientific systems perspective.

Health care systems include processes, technologies, and human behaviors.
All of which have a profound influence on the safety of patients.

Definition/Patient Safety as a Science

The World Health Organization defines patient safety as the prevention of errors
and adverse effects to patients associated with health care.
This simple definition focuses on preventing harm, and
provides a starting point for our discussion.
The National Quality Forum has adopted a more comprehensive view of patient safety,
defining it as the prevention and mitigation of harm caused by error of
omission or commission that are associated with healthcare.
And involving the establishment of operational systems and
processes that minimize the likelihood of errors and
maximize the likelihood of intercepting them when they occur.
This definition recognizes the need to have systems in place
to minimize the possibility of harm.

Patient safety can be thought of as an applied science

that involves the systematic study of errors and
the rigorous design and testing of change interventions.
Some of the underlying elements of safety science include systems engineering,
psychology, and human factors research

One example of Dr Pronovost pioneering work was the development,

testing, and now widespread use of a checklist for insertion and
maintenance of central venous lines which alone,
has had a major positive infect on the rates of infection using these devices

Patient Safety Goals

The goals, establish safety targets and they also provide guidelines for
achieving them.
The Joint Commission, who's also responsible for
codifying in 1996 a set of definitions, standard and
procedures for investigating and reporting of Sentinel Events,
defined as an error or series of errors which result in the death,
permanent harm or severe temporary harm.
The Joint Commission Accredited Institutions are required to conduct
a prompt comprehensive systematic analysis of all sentinel events and
to report events both within the hospital and to the Joint Commission.
Institutions must also develop an action plan that includes corrective actions
to reduce the likelihood of future errors and implementation plan including
timelines for completion and strategies for evaluating and sustaining the actions.
Arguably, the most critical element of this approach is the comprehensive,
systematic analysis.
It's essential to conduct a very careful, thorough and detailed examination
of what actions omissions or other factors may have contributed to the incident.
When carefully followed, this approach can be a powerful tool and
understanding in preventing future harm.
While the primary focus of the Joint Commission is on Sentinel Events,
events where serious harm or death has occurred,
the same analytic approach can be applied to situations such as near misses,
or even where an error is noted that doesn't even reach the patient.

TYPOLOGY OF EVENTS
The Joint Commission has developed a typology of harms other than sentinel
events, and that includes the following categories.
An adverse event is a patient safety event that results in harm to a patient.
A no harm event is a patient safety event that reaches the patient, but
does not cause harm.
A close call, or near miss,
is a patient safety event that did not reach the patient.
A hazardous condition is a circumstance other than the patient's own disease
process, or condition that increases the probability of an adverse event.

Established standards for patient safety

Australian Safety and

Quality Framework for Healthcare.
This framework is consumer centered, driven by information, organized for
safety, and covers all healthcare settings.
Another example comes from South Africa,
where the Council for Health Services Accreditation of South Africa
has established the quality standards for healthcare establishments.
International organizations have also developed patient safety standards.
As an example, the Joint Commission, while US based,
has developed international goals for patient safety on common problems found,
during their accreditation process of facilities across many countries.
While we have noted that there is substantial variations in the rates of
errors in different countries,
the basic type of errors that occur in most settings are relatively similar.
Suggesting that sharing information on safety and
safety improvements is a worthwhile international endeavor.
In 2004 the World Health Organization, or WHO, established
a patient safety committee that works to improve patient safety worldwide.
The WHO's Conceptual Framework for the International Classification for
Patient Safety is intended to be a standard guideline for
comparison of patient safety incidents worldwide.
The classification includes ten elements, so hang in there with me.
Number one, incident type, then patient outcomes, patient characteristics,
incident characteristics, contributing factors or hazards,
organizational outcomes, detection, mitigating factors Amelia
rating actions and then finally, actions taken to reduce risk.

Examining a an Incident using the Lewis Beckwit Story

Let's take a minute to think about how this framework in the Joint Commission
tools can assist in understanding the factors
contributing to Louis Blackman's death.
Classifying the incident type is a useful first step.
What happened to Lewis can be termed a sentinel event,
because it was a series of errors that resulted in the outcome of death.
Recognizing that Louis's age was an important patient characteristic, the fact
he was placed in an adult unit was an incident characteristic, and the failure
of staff to notify an attending physician was a contributing factor.
Play video starting at :9:26 and follow transcript9:26
These were some of the elements that were important in the set
of circumstances that resulted in this preventable event.
One of the most important lessons gained from using a structured approach is
the realization that nearly all harmful events are not the result of a single
person's action, but rather the complex interaction of the environment technology
and the patient as well as the actions or inactions of health care providers.
Play video starting at :9:54 and follow transcript9:54
Hopefully, this brief illustration has helped you recognize the importance of
using structured approaches to examine the different types of factors
related to patient harm across multiple types of incidents.
The approach will reveal key data to guide re-engineering to improve patient safety.
Later in this module you'll be asked to apply this frame work in more detailed,
to the Lewis Blackman case.
The WHO framework and the Joint Commission's sentinel events processes
are provided as supplemental resources for this module.
We encourage you to take some time to further analyze the Lewis Blackman story
through the lens of these frameworks and processes.
Play video starting at :10:36 and follow transcript10:36
Gathering and analyzing data from lapses in patient safety provides
a critical first step and foundation for
reducing the possibility of harm and re-engineering systems for
improvement while examination of past error is essential.
Ideally, we would be able to anticipate what human behaviors or
breakdowns in technology led to harm, and
create systems in training that minimizes the chance of harm in the first place.
In our next episode, we'll look at some of the approaches used to systematically
design, develop, and test improvement interventions.

Resources
Required

AHRQ. (2015). Systems Approach.

Bataldan, P. (2013). Leaders in Healthcare Management Symposium (Video).

President’s Council of Advisors on Science and Technology. (2014). Report to the President Better
Health Care at Lower Costs: Accelerating Improvement Through Systems Engineering.

World Health Organization. (2009). Conceptual Framework for the International Classification for Patient
Safety.

Recommended

Australian Commission on Safety and Quality in Health Care. (2010). Australian Safety and Quality
Framework for Health Care.

Council for Health Service Accreditation for Southern Africa. (2015). Quality Improvement and Patient
Safety Programmes.

Joint Commission. (2012). Creating a Safety Culture. Video. Overview of the need for a culture of safety.

Joint Commission. (2016). National Patient Safety Goals.

Reason, J. (1990). Human Error. Cambridge University Press: Cambridge, United Kingdom. SBN-13: 978-
0521314190. A concise overview.

Shappell, S. A., & Wiegmann, D. A. (2000). The Human Factors Analysis Classification System.

Eurocontrol Agency. (2006). Revisiting the Swiss Cheese Model of Accidents. Analysis of the useful of the
Swiss Cheese Model to airline safety,

The Lewis Blackman Story

Review Episode 2 and watch the following videos to learn more about the Lewis Blackman case:

QSEN: The Lewis Blackman Story, Part 1. (6:46 min.)Talk by his mother, Helen Haskell.

Lewis Blackman Story (12.41 min.)

1. What is your emotional reaction to this case?

2. Using the Human Factors Analysis classification system, analyze the factors that
contributed to Lewis’s death?
3. What actions/factors would have been important key in preventing the death of Lewis?
4. How is the case study applicable to your practice if a clinician or area of concern if you
are a patient or family member?
5. How could a just culture be applied to this case?

QuiZ

You are new to the risk management-safety committee in your institution working to better understand
the science of safety. While there are several different definitions of the science of safety, a significant
part of the definitions includes the idea that to create a safe health care system providers need to think
about systems of care. Understanding the components of a system is important to changing the system
for the better. Which of the following components of a healthcare system must be considered in efforts
to improve healthcare safety? Select all that apply.
1 point

Processes

Technologies

Human Behaviors
None of the Above
2.
Question 2

You have been reviewing incidents in your institution and have noted that there are several incidents
that involve a medication error in which a wrong dose of medication was given to a patient. An
example is that one patient was given an excess dose of a sleeping agent. The patient fell and cut his
chin while on his way to the bathroom. The incident occurred 2 hours after receiving the dose. Based
on the Joint Commission approach to classifying the severity of errors, what type of incident would this
be considered? Select the best answer.
1 point

Close Call

No harm event

Adverse Event

Sentinel event
3.
Question 3

One of the cases you reviewed includes the experience of a 44-year old man that had a scheduled
surgical procedure for a repair of a cardiac valve. The surgeon did not conduct a pre-surgery checklist
nor a post surgery checklist to make sure that all items were accounted for. He left the surgical room as
soon as surgical assistant was closing the patient’s chest. However, the surgical nurse in doing a
sponge count noted that one was missing. It was determined through a scan that the sponge was still
in the patient’s chest cavity. Within the context of the World Health Organizations Conceptual
Framework For the International Classification for Patient Safety, which of the following represents the
issue related to not doing a post surgical review? Select the best answer.
1 point

Detection

Contributing factors/hazards

Mitigating factors

Patient characteristics.
4.
Question 4

Another case that comes to your attention is a case of surgery done on a skin lesion. The tissue was
placed by the surgeon on a surgical drape in front of a surgical technician and shortly thereafter the
surgeon left the room without any specific instructions. The surgical tech discarded the tissue with the
drape. There was communication between the charge nurse and tech and the charge nurse didn’t
notice that the specimen had not been handed off to the lab. Which of the following actions would
likely be MOST effective in addressing this issue? Select the best answer.
1 point

Implementing a reprimand to the tech and charge nurse for not following protocol.

Firing the tech.

Forbidding surgeons from leaving the operating room until the procedure is fully completed.

Creating a post surgical check list including specimen confirmation.

5.
Question 5

As you continue to review medical harm cases, you are struck by how so many things seem to have to
come together at the same time in most instances in which the end result is harm to patients. Which
model describes the alignment of factors leading to medical error? Select the best answer.
1 point

Human Factors Analysis Classification System

World Health Organization Conceptual Framework For the International Classification for Patient
Safety

Results Pyramid

Swiss Cheese Model

6.
Question 6

As part of the efforts to improve patient safety, you really want to prevent errors from happening rather
than having to respond after the fact. You know that Weick and Sutcliff have described the
characteristics high reliability organizations and collective mindfulness or awareness of safety. Which
of the following are components of a mindful organization? Select all that apply.
1 point

Ability to adapt when the unexpected occurs.

A constant concern about the possibility of failure.

Ability to concentrate on a task while having a sense of the big picture.

Deference to expertise regardless of rank or status.

7.
Question 7

You are focusing on the human factors issues related to medical error and have reviewed the material
on the human factors analysis classification system. In a case that you reviewed, a patient came to the
ER with chest pain at 9 am and was sent home with a diagnosis of gastric reflux only to return that night
with severe chest pain. He experienced a cardiac arrest and could not be resuscitated. You determined
that he had been misdiagnosed on the patient’s first visit. Within the Human Factors Classification and
Analysis System (HFACS) framework, what is the most likely high-level factor that came into play?
Select the best answer.
1 point

Patient characteristics.

Organizational influences.

Unsafe supervision.

Unsafe acts.
8.
Question 8

In addition to the categories of behavior that lead to error, Marx has identified basic responsibilities of
all health professionals. These responsibilities include which of the following? Select the best answer.
1 point

The duty to participate in quality improvement projects.

The duty to avoid causing unjustifiable harm.

The responsibility to care about each of your patients.

The responsibility to report employees who do not follow the rules.

9.
Question 9

Systems engineering and reengineering at the heart of safety science. Which of the following accurately
describes systems engineering? Select the best answer.
1 point

The goal of systems engineering is to optimize efficiency.

All of the above.

It is a process of analyzing, designing and managing complex systems.

Systems engineering is intended to produce high reliability and productivity.

10.
Question 10

You recognize that your organization has historically had a shame and blame culture that discourages
error reporting. As a leader, you have an opportunity to move your organization toward a just culture.
Which of the following elements are essential for a just culture? Select all that apply.
1 point

Concealing errors from patients and families.

Supporting staff who report errors and near misses.

Open communication.

Accountability to report errors.

Key facts
 The occurrence of adverse events due to unsafe care is likely one of the 10
leading causes of death and disability in the world (1).
 In high-income countries, it is estimated that one in every 10 patients is
harmed while receiving hospital care (2). The harm can be caused by a range of
adverse events, with nearly 50% of them being preventable (3).
 Each year, 134 million adverse events occur in hospitals in low- and middle-
income countries (LMICs), due to unsafe care, resulting in 2.6 million deaths
(4).
 Another study has estimated that around two-thirds of all adverse events
resulting from unsafe care, and the years lost to disability and death (known as
disability adjusted life years, or DALYs) occur in LMICs (5).
 Globally, as many as 4 in 10 patients are harmed in primary and outpatient
health care. Up to 80% of harm is preventable. The most detrimental errors are
related to diagnosis, prescription and the use of medicines (6).
 In OECD countries, 15% of total hospital activity and expenditure is a direct
result of adverse events (2).
 Investments in reducing patient harm can lead to significant financial savings,
and more importantly better patient outcomes (2). An example of prevention is
engaging patients, if done well, it can reduce the burden of harm by up to 15%
(6).
What is Patient Safety?
Patient Safety is a health care discipline that emerged with the evolving complexity in
health care systems and the resulting rise of patient harm in health care facilities. It
aims to prevent and reduce risks, errors and harm that occur to patients during
provision of health care. A cornerstone of the discipline is continuous improvement
based on learning from errors and adverse events.

Patient safety is fundamental to delivering quality essential health services. Indeed,

there is a clear consensus that quality health services across the world should be
effective, safe and people-centred. In addition, to realize the benefits of quality health
care, health services must be timely, equitable, integrated and efficient.

To ensure successful implementation of patient safety strategies; clear policies,

leadership capacity, data to drive safety improvements, skilled health care
professionals and effective involvement of patients in their care, are all needed.

Why does patient harm occur?

A mature health system takes into account the increasing complexity in health care
settings that make humans more prone to mistakes. For example, a patient in
hospital might receive a wrong medication because of a mix-up that occurs due to
similar packaging. In this case, the prescription passes through different levels of
care starting with the doctor in the ward, then to the pharmacy for dispensing and
finally to the nurse who administers the wrong medication to the patient. Had there
been safe guarding processes in place at the different levels, this error could have
been quickly identified and corrected. In this situation, a lack of standard procedures
for storage of medications that look alike, poor communication between the different
providers, lack of verification before medication administration and lack of
involvement of patients in their own care might all be underlying factors that led to
the occurrence of errors. Traditionally, the individual provider who actively made the
mistake (active error) would take the blame for such an incident occurring and might
also be punished as a result. Unfortunately, this does not consider the factors in the
system previously described that led to the occurrence of error (latent errors). It is
when multiple latent errors align that an active error reaches the patient.

To err is human, and expecting flawless performance from human beings working in
complex, high-stress environments is unrealistic. Assuming that individual perfection
is possible will not improve safety (7). Humans are guarded from making mistakes
when placed in an error-proof environment where the systems, tasks and processes
they work in are well designed (8). Therefore, focusing on the system that allows
harm to occur is the beginning of improvement, and this can only occur in an open
and transparent environment where a safety culture prevails. This is a culture where
a high level of importance is placed on safety beliefs, values and attitudes and
shared by most people within the workplace (9).

The burden of harm

Every year, millions of patients suffer injuries or die because of unsafe and poor-
quality health care. Many medical practices and risks associated with health care are
emerging as major challenges for patient safety and contribute significantly to the
burden of harm due to unsafe care. Below are some of the patient safety situations
causing most concern.

Medication errors are a leading cause of injury and avoidable harm in health care
systems: globally, the cost associated with medication errors has been estimated at
US$ 42 billion annually (10).

Health care-associated infections occur in 7 and 10 out of every 100 hospitalized

patients in high-income countries and low- and middle-income countries
respectively (11).

Unsafe surgical care procedures cause complications in up to 25% of patients.

Almost 7 million surgical patients suffer significant complications annually, 1 million
of whom die during or immediately following surgery (12).

Unsafe injections practices in health care settings can transmit infections,

including HIV and hepatitis B and C, and pose direct danger to patients and health
care workers; they account for a burden of harm estimated at 9.2 million years of life
lost to disability and death worldwide (known as Disability Adjusted Life Years
(DALYs)) (5).

Diagnostic errors occur in about 5% of adults in outpatient care settings, more than
half of which have the potential to cause severe harm. Most people will suffer a
diagnostic error in their lifetime (13).

Unsafe transfusion practices expose patients to the risk of adverse transfusion

reactions and the transmission of infections (14). Data on adverse transfusion
reactions from a group of 21 countries show an average incidence of 8.7 serious
reactions per 100 000 distributed blood components (15).

Radiation errors involve overexposure to radiation and cases of wrong-patient and

wrong-site identification (16). A review of 30 years of published data on safety in
radiotherapy estimates that the overall incidence of errors is around 15 per 10 000
treatment courses (17).

Sepsis is frequently not diagnosed early enough to save a patient’s life. Because
these infections are often resistant to antibiotics, they can rapidly lead to
deteriorating clinical conditions, affecting an estimated 31 million people worldwide
and causing over 5 million deaths per year (18).

Venous thromboembolism (blood clots) is one of the most common and

preventable causes of patient harm, contributing to one third of the complications
attributed to hospitalization. Annually, there are an estimated 3.9 million cases in
high-income countries and 6 million cases in low- and middle-income countries (19).

Patient Safety - a fundamental component for

Universal Health Coverage
Safety of patients during the provision of health services that are safe and of high
quality is a prerequisite for strengthening health care systems and making progress
towards effective universal health coverage (UHC) under Sustainable Development
Goal 3 (Ensure healthy lives and promote health and well-being for all at all
ages) (7).

Target 3.8 of the SDGs is focused on achieving UHC “including financial risk
protection, access to quality essential health care services, and access to safe,
effective, quality, and affordable essential medicines and vaccines for all.” In working
towards the target, WHO pursues the concept of effective coverage: seeing UHC as
an approach to achieving better health and ensuring that quality services are
delivered to patients safely (20).

It is also important to recognize the impact of patient safety in reducing costs related
to patient harm and improving efficiency in health care systems. The provision of
safe services will also help to reassure and restore communities’ trust in their health
care systems (21).
WHO response
Resolution (WHA 72.6) on Patient Safety

Recognizing that Patient Safety is a global health priority, the World Health
Assembly (WHA) adopted a resolution on Patient Safety which endorsed the
establishment of World Patient Safety Day to be observed annually by Member
States on 17 September.

1. Patient Safety as a global health priority

 https://mailchi.mp/who.int/wha-72-achievements-commitment-accountability
 https://www.who.int/patientsafety/policies/global-health-priority/en/
 (WHA 72.6)

The purpose of World Patient Safety Day is to promote patient safety by increasing
public awareness and engagement, enhancing global understanding and working
towards global solidarity and action.

2. World Patient Safety Day

Key strategic action areas

The Patient Safety and Risk Management unit at WHO has been instrumental in
advancing and shaping the patient safety agenda globally by focusing on driving
improvements in some key strategic areas through:

 providing global leadership and fostering collaboration between Member States and
relevant stakeholders
 setting global priorities for action
 developing guidelines and tools
 providing technical support and building capacity of Member States
 engaging patients and families for safer health care
 monitoring improvements in patient safety
 conducting research in the area

By focusing on these key areas to facilitate sustainable improvements in patient safety, WHO aims to
enhance patient experience, reduce risks and harm, achieve better health outcomes and lower costs.
WHO initiatives to date

WHO's work on patient safety began with the launch of the World Alliance for Patient
Safety in 2004 and this work has continued to evolve over time. WHO has facilitated
improvements in the safety of health care within Member States through
establishment of Global Patient Safety Challenges. Each of the Challenges has
identified a patient safety burden that poses a major and significant risk. The
challenges thus far have been:

 Clean Care is Safer Care (2005); with the goal of reducing health care-associated infection, by
focusing on improved hand hygiene.
 Safe Surgery Saves Lives (2008); dedicated to reducing risks associated with surgery.
 Medication Without Harm (2017); with the aim of reducing the level of severe, avoidable
harm related to medications globally by 50% over five years.

WHO has also provided strategic guidance and leadership to countries through the
annual Global Ministerial Summits on Patient Safety, which seek to advance the
patient safety agenda at the political leadership level with the support of health
ministers, high-level delegates, experts and representatives from international
organizations.

WHO has been pivotal in the production of technical guidance and resources such
as the Multi-Professional Patient Safety Curriculum Guide, Safe Childbirth Checklist,
the Surgical Safety Checklist, Patient Safety solutions, and 5 Moments for
Medication Safety (available in print and in App form).

To promote global solidarity, WHO has also encouraged the creation of networking
and collaborative initiatives such as the Global Patient Safety Network and the
Global Patient Safety Collaborative. Recognizing the importance of patients’ active
involvement in the governance, policy, health system improvement and their own
care, the WHO also established the Patients for Patient Safety programme to foster
the engagement of patients and families.

References

1. Jha AK. Presentation at the “Patient Safety – A Grand Challenge for Healthcare
Professionals and Policymakers Alike” a Roundtable at the Grand Challenges
Meeting of the Bill & Melinda Gates Foundation, 18 October 2018
(https://globalhealth.harvard.edu/qualitypowerpoint, accessed 23 July 2019).

2. Slawomirski L, Auraaen A, Klazinga N. The economics of patient safety:

strengthening a value-based approach to reducing patient harm at national level.
Paris: OECD; 2017 (http://www.oecd.org/els/health-systems/The-economics-of-
patient-safety-March-2017.pdf, accessed 26 July 2019).
3. de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The
incidence and nature of in-hospital adverse events: a systematic review. Qual Saf
Health Care. 2008;17(3):216–23. http://doi.org/10.1136/qshc.2007.023622
https://www.ncbi.nlm.nih.gov/pubmed/18519629

4.National Academies of Sciences, Engineering, and Medicine. Crossing the global

quality chasm: Improving health care worldwide. Washington (DC): The National
Academies Press; 2018 (https://www.nap.edu/catalog/25152/crossing-the-global-
quality-chasm-improving-health-care-worldwide, accessed 26 July 2019).

5. Jha AK, Larizgoitia I, Audera-Lopez C, Prasopa-Plaizier N, Waters H, W Bates D.

The global burden of unsafe medical care: analytic modelling of observational
studies. BMJ Qual Saf Published Online First: 18 September 2013.
https://doi.org/10.1136/bmjqs-2012-001748
https://www.ncbi.nlm.nih.gov/pubmed/24048616

6. Slawomirski L, Auraaen A, Klazinga N. The Economics of Patient Safety in

Primary and Ambulatory Care: Flying blind. Paris: OECD; 2018
(http://www.oecd.org/health/health-systems/The-Economics-of-Patient-Safety-in-
Primary-and-Ambulatory-Care-April2018.pdf, accessed 23 July 2019).

7. Systems Approach. In: Patient Safety Network [website]. Rockville (MD): Agency
for Healthcare Research and Quality; 2019 (https://psnet.ahrq.gov/primers/primer/21,
accessed 23 July 2019).

8. Leape L. Testimony before the President’s Advisory Commission on Consumer

Production and Quality in the Health Care Industry, November 19, 1997.

9. Workplace Health and Safety Queensland. Understanding safety culture.

Brisbane: The State of Queensland; 2013
(https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0004/82705/understanding-
safety-culture.pdf, accessed 26 July 2019).

10. Aitken M, Gorokhovich L. Advancing the Responsible Use of Medicines: Applying

Levers for Change. Parsippany (NJ): IMS Institute for Healthcare Informatics; 2012
(https://ssrn.com/abstract=2222541, accessed 26 July 2019).

11. Report on the burden of endemic health care-associated infection worldwide.

Geneva: World Health Organization; 2011
(http://apps.who.int/iris/bitstream/handle/10665/80135/9789241501507_eng.pdf?
sequence=1, accessed 26 July 2019).

12. WHO guidelines for safe surgery 2009: safe surgery saves lives. Geneva: World
Health Organization; 2009
(http://apps.who.int/iris/bitstream/handle/10665/44185/9789241598552_eng.pdf?
sequence=1, accessed 26 July 2019).

13. Singh H, Meyer AN, Thomas EJ. The frequency of diagnostic errors in outpatient
care: estimations from three large observational studies involving US adult
populations. BMJ Qual Saf. 2014;23(9):727–31. https://doi.org/10.1136/bmjqs-2013-
002627 https://www.ncbi.nlm.nih.gov/pubmed/24742777

14. Clinical transfusion process and patient safety: Aide-mémoire for national health
authorities and hospital management. Geneva: World Health Organization; 2010
(http://www.who.int/bloodsafety/clinical_use/who_eht_10_05_en.pdf?ua=1,
accessed 26 July 2019).

15. Janssen MP, Rautmann G. The collection, testing and use of blood and blood
components in Europe. Strasbourg: European Directorate for the Quality of
Medicines and HealthCare (EDQM) of the Council of Europe; 2014
(https://www.edqm.eu/sites/default/files/report-blood-and-blood-components-
2014.pdf, accessed 26 July 2019).

16. Boadu M, Rehani MM. Unintended exposure in radiotherapy: identification of

prominent causes. Radiother Oncol. 2009; 93(3):609–17.
https://doi.org/10.1016/j.radonc.2009.08.044
https://www.ncbi.nlm.nih.gov/pubmed/19783058

17. Shafiq J, Barton M, Noble D, Lemer C, Donaldson LJ. An international review of

patient safety measures in radiotherapy practice. Radiother Oncol. 2009;92:15-21
https://doi.org/10.1016/j.radonc.2009.03.007

18. Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of Global Incidence

and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J
Respir Crit Care Med 2016; 193(3): 259-72. https://doi.org/10.1164/rccm.201504-
0781OC https://www.ncbi.nlm.nih.gov/pubmed/26414292

19. Raskob E, Angchaisuksiri P, Blanco N, Buller H, Gallus A, Hunt B, et al.

Thrombosis: A major contributor to global disease burden. Thrombosis Research.
2014; 134(5): 931–938
(https://www.sciencedirect.com/science/article/pii/S0049384814004502, accessed
23 July, 2019).

20. Proposed programme budget 2020–2021. Seventy-Second World Health

Assembly, provisional agenda item 11.1. Geneva: World Health Organization; 2019
(http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_4-en.pdf, accessed 23 July
2019).

21. Patient safety- Global action on patient safety. Report by the Director-General.
Geneva: World Health Organization; 2019
(https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_26-en.pdf, accessed 23 July
2019).

SURGICAL
TYPE OF DESCRIPTION SETTING GUIDANCE
EVENT
1 Wrong site A surgical intervention
surgery performed on the wrong site (for
example wrong knee, wrong eye,
wrong patient, wrong limb, or
wrong organ); the incident is
detected at any time after the
start of the operation and the
patient requires further surgery,
on the correct site, and/or may
have complications following the
wrong surgery.
 Includes biopsy, radiological
procedures and drain insertion,
where the intervention is
considered surgical.
 Excludes wrong site anaesthetic
block.
 Excludes interventions where
the wrong site is selected
because of unknown/unexpected
abnormalities in the patient’s
anatomy. This should be
documented in the patient’s
notes.
All patient safety incidents have four basic components. Each of these components should be
considered in the systems approach to safety: 1 Causal factors:these factors play a significant part
in any patient safety incident. Removing them can prevent or reduce the chance of a similar
incident happening again. Causal factors are classified into the following groups 3: • Active
failures: these are actions or omissions that are sometimes called ‘unsafe acts’. They are actions
by frontline healthcare staff who are in direct contact with patients, and include slips, lapses,
mistakes or violations of a procedure, guideline or policy. Usually short lived and often
unpredictable, they are influenced by latent system conditions and contributory factors (see
below) such as stress, inadequate training and assessment, poor supervision or high workload.
Examples of active failures include:– an infusion bag with added potassium is incorrectly stored on
the first shelf (for saline only) rather than the normal place on the second shelf. In an emergency a
staff member picks up the bag from the first shelf assuming it is saline and gives the patient the
wrong bag;– aheart monitor used in an ambulance constantly alarms. When checked there appear
to be no problems with either the patient or the monitor. As this continues and the crew are
distracted, they ignore the alarm when in fact the patient has had a cardiac arrest; • Latent system
conditions:These are the underlying rather than26 Seven steps to patient safety Step 1: Build a
safety culture National Patient Safety Agency July 2004 © immediate factors that can lead to
patient safety incidents. They relate to aspects of the system in which people work. They are
usually actions or decisions taken at the higher levels of an organisation, which seem well thought
out and appropriate at the time but can create potential problems within the system. These
factors can lie dormant and unrecognised for some time. Alternatively they may be recognised but
changing them is not a priority. The latent conditions combined with local conditions (active
failures and contributory factors) create the potential for incidents to happen. Examples of latent
system factors include decisions on:– Planning:fixed staffing levels may be adequate until extreme
situations occur, such as more than the usual numbers of staff are on sick leave, or there are more
than the usual number of critically ill patients;– Designing:designing a new clinic, practice, ward or
diagnostic centre without considering vulnerable groups, such as children or mental health
patients, and leaving dangerous equipment within their reach; – Policy-making:having a strict
take-home policy for drugs, which doesn’t take into account difficult times to get to a pharmacy
(holidays such as Christmas) or rare drugs that may not be local stock items;–
Communicating:having only a limited reporting structure for patient safety incidents, which means
vital lessons are not learned across the organisation. • Violations:these are when individuals or
groups deliberately do not follow a known procedure or choose not to follow a procedure for a
number of reasons, including:– they may not be aware of the procedure;– the situation dictates a
deviation;– it has become habit;– the procedure has been found not to work; – the procedure has
been surpassed by a new one but it has yet to be rewritten. • Contributory factors:these are
factors that can contribute to an incident in relation to: – Patients:these are unique to the
patient(s) involved in the incident, such as the complexity of their condition or factors such as
their age or language;– Individuals: these are unique to the individual(s) involved in the
incident.27 National Patient Safety Agency July 2004 © Seven steps to patient safety Step 1: Build
a safety culture They include psychological factors, home factors, and work relationships;– Tasks:
these include aids that support the delivery of patient care, such as policies, guidelines and
procedural documents. They need to be up to date, available, understandable, useable, relevant
and correct;– Communication:these include communication in all forms: written, verbal and non-
verbal. Communication can contribute to an incident if it is inadequate, ineffective, confusing, or if
it is too late. These factors are relevant between individuals, within and between teams, and
within and between organisations; – Team and social factors:these can adversely affect the
cohesiveness of a team. They involve communication within a team, management style,
traditional hierarchical structures, lack of respect for less senior members of the team and
perception of roles; – Education and training:the availability and quality of training programmes
for staff can directly affect their ability to perform their job or to respond to difficult or emergency
circumstances. The effectiveness of training as a method of safety improvement is influenced by
content, delivery style, understanding and assessment of skill acquisition, monitoring and
updates;– Equipment and resources:equipment factors include whether the equipment is fit for
purpose, whether staff know how to use the equipment, where it is stored and how often it is
maintained. Resource factors include the capacity to deliver the care required, budget allocation,
staffing allocation and skill mix;– Working conditions and environmental factors:these affect
ability to function at optimum levels in the workplace, and include distractions, interruptions,
uncomfortable heat, poor lighting, noise and lack of or inappropriate use of space. There may be
more than one causal factor in any incident. In Step 6 we will describe root cause analysis (RCA), a
fundamental component of which is to understand and identify the casual factors that influence
risk and safety. 2 Timing: this is the point at which the causal factors combine with failures in the
system (defences or controls) that lead to an incident happening3. 3 Consequences: these are the
impact an incident can have, ranging from no harm to the patient to various levels of severity of
harm: low, moderate, severe and death3. 4 Mitigating factors:some factors, whether actions or
inaction such as28 Seven steps to patient safety Step 1: Build a safety culture National Patient
Safety Agency July 2004 © chance or luck, may have mitigated or minimised a more serious
outcome. It is important that these factors are also drawn out during any investigation so that the
lessons can be used to support and promote good safety practice.

Pretest

An incident can be defined as

a non-reportable circumstance,

An adverse event only

A reportable circumstance, near miss, no harm incident or harmful incident (adverse event)

Patient safety measurement includes all the following except;

Risk Based measures

Error Based measures

Injury based Measures

Incident based measures

All the following can be classified as Never Events except;

◦ Wrong site surgery

◦ Retained foreign object post-operation

◦ Transfusion of ABO-incompatible blood components

◦ The use of standard wristband identification processes

major methods for detecting errors and associated adverse events are

• chart review,

• computerized monitoring

• administrative databases, and claims data,

• using direct observation,

• incident reporting

• patient monitoring.

• Clinical Audits

• Medical Records Reviews

• Safety Surveys

World Health Organization. Regional Office for the Eastern Mediterranean. (2015). Patient safety tool kit.
World Health Organization. Regional Office for the Eastern Mediterranean.
https://apps.who.int/iris/handle/10665/195709

World Health Organization. Regional Office for the Eastern Mediterranean. (2016). Patient safety
assessment manual : second edition, 2nd ed.. World Health Organization. Regional Office for the Eastern
Mediterranean. https://apps.who.int/iris/handle/10665/249569