MORBIDITY & MORTALITY TOOL

KIT FOR LOW AND MIDDLE

INCOME COUNTRIES (LMICs)

January 2023
 INDEX

Introduction to the Toolkit 3

General introduction 3
Toolkit development group 3
Needs analysis 4
How to use the Toolkit 5
Definitions 6
What is quality improvement: Its application to morbidity and mortality 10
Stages of Quality Assessment Cycle 12
Quality Indicators13
Risk management techniques 15
Process analysis and quality improvement tools 17
Introduction 17
The learning organization: Capturing process and outcome failures 17
Quality Assessment tools to measure process and reliability 18
Failure Modes and Effects Analysis 24
Risk Management Tools: An Introduction to Root Cause Analysis 28
What? 28
Why? 28
When? 28
Who? 28
How? 29
The major steps in an RCA investigation 29
Solutions 30
Challenges 33
Improving Systems 36
Improve Communication 37
Team Building Strategies 37
Develop a safety culture 38

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 Incident reporting systems 38
Searching for evidence-based literature 41
Performing a clinical audit 44
The Audit Cycle 44
Why do this audit? 45
Indicators 46
Proposed standard for best practice 46

Organizing a departmental morbidity and mortality meeting 48

Purpose of a Morbidity and Mortality Meeting 48
Setting the stage 48
Goals of the Morbidity and Mortality Meeting 48
Structure of the morbidity and mortality meeting 49
Morbidity & Mortality Tool 53
List of Contributors 55

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 INTRODUCTION
Patient safety is a serious global public health concern. Studies have suggested that there is a 1 in

300 chance of a patient being harmed during health care. Once patients are harmed, Morbidity

and Mortality (M & M) meetings are used to analyse cases with adverse outcomes and identify

the underlying causes to bring about process changes, improve practices and patient safety. In

many hospitals in lower- and middle-income countries (LMIC) this peer review mechanism does

not yet exist, either due to unfamiliarity with the process or lack of human resources. In many of

the smaller hospitals, only a single anaesthesia provider may cater to the surgical workload. In

response, the World Federation of The Societies of Anaesthesiologists (WFSA) Safety and

Quality of Practice Committee initiated the Mortality and Morbidity Toolkit project to develop a

practical resource that includes the essential elements for anaesthesiologists to do analyse patient

morbidity and mortality events and to improve their patient care.

A toolkit is intended to guide frontline staff using a collection of authoritative and adaptable

resources that can be implemented using practical approaches for addressing key issues. Toolkits

provide a collection of open-source techniques and open access design, technical, and

implementation resources that can help you plan and effectively implement M & M meetings in

your hospital. The toolkit was developed after conducting an extensive needs-analysis survey in

five LMICs and following a group consensus of the committee members. We have also included

background reading materials to guide the readers on essential topics related to advancing patient

safety and risk management. Each chapter provides a suggested reading list for deep reflection

and further self-learning to support optimal care delivery.

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Toolkit development group

The Toolkit development group was comprised of a sub-committee of the WFSA Safety and

Quality of Practice Committee (SQP). The members were from both LMIC and High-Income

Countries (HIC). LMICs were represented by members from Pakistan (Fauzia Khan), Nigeria

(Bisola Onajin-Obembe), Lebanon (Rola Hammoud), the Philippines (Erlinda C Oracion) and

Sri Lanka (Anuja Abayadeera), and the HIC by members from Australia (Philip Blum) and USA

(Paul Barach).

Needs analysis

A “needs assessment” was conducted to identify and determine the patient safety needs, examine

the nature, and causes of continuous patient harm, and set priorities for future education and

training action. The needs analysis survey was completed in 2018 among anaesthesiologists

working in five LMICs including Pakistan, Lebanon, Nigeria, the Philippines, and Sri Lanka.

The survey results indicated a compelling need for an easy- to-use resource that would provide

practical tools and information to increase learning from adverse events. We have also included

background reading to guide the readers on essential topics related to advancing patient safety

and risk management. Each chapter provides a suggested reading list for further self-learning.

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HOW TO USE THIS TOOLKIT
The Toolkit should be used a guide in setting up a patient safety program. When a patient

undergoing anaesthesia is harmed or dies you must first write down the sequence of events while

fresh in your mind. The next step is to collect all relevant information from patient notes, talking

to other involved providers and your documentation. The next step is to fill in all relevant

information in the Morbidity and Mortality form provided (see page 54). Consider the questions

“Why did it happen?”, “What happened?”, “Who was involved?”, “Where did it happen? and

clearly start to identify further steps needed by you and/or by the institution / hospital to prevent

such an event from occurring again. While you want clear and concise answers, you want to

avoid answers that are too simple and overlook important details. Set up a meeting with your

administrator/administrators and discuss your findings and analysis with them. Discuss what can

be done practically to prevent harm to other patients. Assign responsible parties as needed.

Create a timeline on what needs to be done and what is possible given your resources. Set a

further date to review changes and assess their impact.

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DEFINITIONS

PATIENT SAFETY

Patient Safety is a health care discipline that aims to prevent and reduce risks, errors, and harm

that occur to patients during provision of health care. https://www.who.int/news-room/fact-

sheets/detail/patient-safety

INCIDENT

An “incident” is an event that, under slightly different circumstances, could have been an
accident.

National Research Council, Assembly of Engineering, Committee on FF Airworthiness

Certification Procedures, Improving Aircraft Safety: FAA Certification of Commercial Passenger
Aircraft. Washington, D.C.: National Academy of Sciences, 1980.

ACCIDENT

Unplanned, unexpected, and undesired event, usually with adverse consequences.

Committee on Quality of Health Care in America, Institute of Medicine. To Err is Human:

Building a Safer Health System. Washington, DC: National Academy Press, 1999.

ERROR

An error is something you have done which is considered to be incorrect or wrong, or which
should not have been done.

https://www.collinsdictionary.com/dictionary/english/error

Failure to perform intended action that was correct given the circumstances.

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Thomas MJ, Studdert DM, Burtsin H, et al. Incidents and types of adverse events and negligent
care in Utah and Colorado. Med Care 2000;38:261-271.

Failure to complete action as intended, or use of wrong plan to achieve aim.

Dedication to, Essays on the First Hundred Years of Anesthesia: Sykes WS, Volume 1, pp.1,
Churchill Livingston, London, 1960.

Medical errors can be defined as the failure of a planned action to be completed as intended or
the use of a wrong plan to achieve an aim (commission). The definition also includes failure of
an unplanned action that should have been completed (omission).

https://sphweb.bumc.bu.edu/otlt/mph-modules/hpm/americanhealthcare_quality/
AmericanHealthCare_Quality4.html

ACTIVE ERROR/FACTOR

An active error is one that occurs at the level of the front-line operator and whose effects are felt
almost immediately.

https://psnet.ahrq.gov/glossary-0

LATENT ERROR/FACTORS

A latent error (or latent conditions) refers to less apparent failures of organization or design that
contributes to the occurrence of errors or allowed them to cause harm to the patient.

https://psnet.ahrq.gov/glossary-0

NEAR MISS

Case where an accident was narrowly averted or an error that almost happened but was
prevented.

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Baker SP, O’Neill B, Ginsburg M, Guohua L. The Injury Fact Book, 2nd edition, New York:
Oxford University. Press, 1992.

ROOT CAUSE

A root cause is defined as a factor that caused a nonconformance and should be permanently
eliminated through process improvement.

https://asq.org/quality-resources/root-cause-analysis

Root cause analysis (RCA) is a widely used method deployed following adverse events in health
care. RCA seeks to understand what happened and why and to identify how to prevent future
incidents.

Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight SD, Mannos DM. The Veterans Affairs root
cause analysis system in action. Jt Comm J Qual Improv. 2002;28:531-545.

CONTRIBUTING FACTORS

These are additional reasons, not necessarily the most basic reason, that an event has occurred.

https://www.patientsafety.va.gov/professionals/publications/glossary.asp

SENTINEL EVENTS (SE)

These are defined by the Joint Commission as “are unexpected occurrences involving death or
serious physical or psychological injury, or risk thereof. SE is a patient safety event that results in
death, permanent harm, or severe temporary harm.

https://www.jointcommision.org/resources/patient-saety-topics/sentinel-event/

OUTCOME

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Health outcomes are changes in health that result from measures or specific health care
investments or interventions.

https://www.cihi.ca/en/outcomes

TOOLKIT

The term has been used to describe a combination of educational materials including templates,
instruction sheets, literature reviews, videos, and posters, presented in a variety of formats (hard
copy, web).

Barac R, Stein S, Bruce B, Barwick M. Scoping review of toolkits as a knowledge translation

strategy in health. BMC Med Inform Decis Mak. 2014;14:121. Published 2014 Dec 24.
doi:10.1186/s12911-014-0121-7

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WHAT IS QUALITY IMPROVEMENT?
Its application to Morbidity and Mortality

Erlinda C Oracion
________________________________________________________________
Clinical anaesthesia practice is known as a model for quality and safety in medicine. In the 1999
Institute of Medicine reported, "To Err is Human: Building A Safer Health System," anaesthesia
was explicitly identified as "an area in which very impressive improvements in safety have been
made." Despite the safety of modern anaesthesia, anaesthesiologists must still strive to further
reduce anaesthesia-related morbidity and mortality. Newer developments in anaesthetic
techniques have facilitated quality anaesthesia service delivery. Numerous factors such as
increased awareness among the patient population, newer drugs, advanced monitoring, and
professional competitiveness have mandated quality control and anaesthesia assurance.

The risks associated with anaesthesia are certainly recognized, and anaesthesia is a model for
patient safety improvements. One of these improvements is the continuous monitoring of adverse
outcomes following anaesthesia and the systematic development of strategies to minimize the
adverse effects.

Quality assessment/improvement is a set of methods used to measure and improve the

delivered care and performance against pre-established criteria or standards. It is an organized

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process that assesses and evaluates health services to improve practice and quality of care. The
quality assessment aims to ensure a high standard of anaesthetic care focusing on patient safety
during the perioperative period, risk reduction, and continuous quality improvement through
self-examination.

The morbidity & mortality (M&M) meeting is a dedicated time for physicians to discuss
adverse events among colleagues candidly and has been a long tradition in anaesthesia. It is a
crucial component of both workplace and work-based learning, as well as continuing
professional development (CPD). Goals are to provide the physicians with the opportunity to
discuss patient care aspects where the physician did not anticipate nor intend the outcome and to
review errors and adverse events openly and reflectively. However, the lack of a consistent
approach contributes to a substantial variation in the quality and the educational outcomes. In
recent decades, the discourse around medical errors has shifted from individual responsibility to
a systems-based orientation. The M&M conference needs to be structured in a standardized way
to emphasize patient safety and quality improvement. Therefore, we must find ways to merge the
case-based M&M conference which is focused on individual responsibility, with systems-based
departmental or institutional programs.

The M&M meeting can be revisited and refined through quality improvement systems-based
methods to serve as a patient safety strategy for bringing adverse events to the surface. It can also
serve as a mechanism to understand causation. Implementation of timely interventions is
essential as well.

Applying a system’s approach to the mortality and morbidity review process aids understanding
and supports improvement in the safety and quality of patient care.

There are three principles involved in using the systems approach in mortality and morbidity
analysis. (Figure 1) These are:
• Understanding system relationships and interactions
• Actively seeking multiple perspectives
• Defining the system boundary

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Figure 1: Systems approach in mortality and morbidity analysis

Stages of Quality Assessment Cycle

The four stages of the self-maintained quality assessment cycle are shown in Figure 2 and are:
• problem identification (Define & Measure)

• problem analysis (Analyse)

• problem correction (Improve)

• evaluation of corrective actions (Check).

Quality assessment is a measurable entity for defining and calibrating measurement parameters
(indicators) from available data gathered from the hospital anaesthesia environment. Problem
identification comes from the accumulation of performance measures. Safety, effectiveness, and

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patient experience about the whole anaesthetic procedure are critical indicators to measure the
quality of anaesthesia in modern clinical practice.

Figure 2: The four stages of quality assessment cycle

Quality Indicators (Figure 3)

There are four types of quality indicators
• Structure

• Process

• Outcome

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 • Sentinel indicators

Figure 3: Types of quality indicators

The latter signals a quality defect, independent of outcomes, and easier to analyse by statistical
methods, and are closely related to processes and main targets of quality improvement. The three
approaches to studying the problems (indicators) are:
• peer review

• quantitative methods

• risk management techniques

Qualified anaesthesiologists and other trained clinicians should perform peer reviews. The
review process should be clarified, and conclusions based on standards of practice and literature
references will improve its validity. The quantitative methods are statistical analyses applied to
the collected data and presented in a graphic format (histogram, Pareto diagram, control charts).

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Risk management techniques
These include:
• Critical incident analysis establishing an objective relationship between a 'critical' event
and the associated human behaviours
• System accident analysis, based on the fact that accidents continue to occur despite safety
systems and sophisticated technologies, checks of all the process components leading to
the unpredictable outcome and not just the human factors.
• Cause-effect diagrams to facilitate the problem analysis in reducing its causes to four
fundamental elements (persons, regulations, equipment, process).

The definition and implementation of corrective measures are the third steps of the evaluation
cycle. The Hawthorne effect is an outcome improvement before the performance of any
corrective actions. Verification of the implemented activities is the final and mandatory step in
closing the evaluation cycle.

The assessment and measurement of specific quality indicators helps to determine the
perioperative outcome in anaesthesia and surgical practice. A positive impact of the feedback
mechanism cannot be under-emphasized while improving the delivery of quality anaesthesia
services.

A systems-based approach can help to minimize the culture of blame and encourages an
openness amongst professionals that translates into an environment of safety. Ultimately, the core
of our practice resonates with a desire to provide our patients with safe and excellent anaesthesia.

References and Suggested Readings:

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1. Bechtold ML, Scott S, Nelson K, Cox KR, Dellsperger KC, Hall LW. Educational quality
improvement report: outcomes from a revised morbidity and mortality format that
emphasised patient safety. Qual Saf Health Care. 2007;16(6):422-427.

2. Schwarz D, Schwarz R, Gauchan B, et al. Implementing a systems-oriented morbidity and

mortality conference in remote rural Nepal for quality improvement. BMJ Qual Saf.
2011;20(12):1082-1088.

3. Calder LA, Kwok ES, Adam Cwinn A, et al. Enhancing the quality of morbidity and
mortality rounds: the Ottawa M&M model. Acad Emerg Med. 2014;21(3):314-321.

4. Bechtold ML, Scott S, Nelson K, Cox KR, Dellsperger KC, Hall LW. Educational quality
improvement report: outcomes from a revised morbidity and mortality format that
emphasised patient safety. Qual Saf Health Care. 2007;16(6):422-7.

5. Bowie P, McNaughton E, Bruce D, et al. Enhancing the Effectiveness of Significant Event

Analysis: Exploring Personal Impact and Applying Systems Thinking in Primary Care. J
Contin Educ Health Prof. 2016;36(3):195-205.

6. What is PTAHF? Available from: www.ptahf.org

7. Anaesthesia Patient Safety Foundation Newsletter. Available from: www.apsf.org

8. Holden RJ. People or systems? To blame is human. The fix is to engineer. Prof Saf.
2009;54(12):34-41.

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PROCESS ANALYSIS AND QUALITY IMPROVEMENT TOOLS
Paul Barach
__________________________________________________________________
Introduction
Quality anaesthetic care is a fundamental goal to our tradition and training but defining and
measuring quality in anaesthesia presents special challenges. Anaesthesia causes of preventable
injuries and errors, such as from medication errors, continue to occur even after 30 years of
applied research. Safe and reliable healthcare organizations differentiate themselves by focusing
on improving their service and performance processes and are guided by process-improvement
initiatives to advance patient care. Continuous quality improvement (CQI) offers an approach, a
set of tools, and a way of thinking about how to more effectively study, assess, and improve
surgical flow, safety, including addressing and reducing variations in surgical processes and
operations.

Quality improvement should become a central part of the work of anaesthesiologists where the
patient is the central focus of the service, and all members of the team are focused on optimal
and safe care of the patient moving through the perioperative arena. The performance
improvement tools below can help anaesthesia care providers ask better questions after a patient
has been harmed and how best to drive improvement of the value and flow of anaesthesia care.

The Learning Organization: Capturing Process and Outcomes Failures

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Exceptional outcomes in complex surgical care depends on the integration of individual, team,
technical, and organizational factors. A continuum of cascade effects exists from apparently
trivial incidents to near misses and full-blown adverse events. Consequently, learning
organizations quickly grasp that the same processes and patterns of causes of failure and their
relationships precede both adverse events and near misses. Getting clinicians to report these
events requires psychological safety-an environment that fosters truth-telling trust and a culture
of management support. Information about quality and safety comes in many different forms.
Data may come in hand-written records, electronic reports and may come from electronic event
reporting systems and in unrelated verbal daily safety check-ins. Lastly, quality and safety data
can come from the patients experience assessment either from postoperative telephone calls
made to every outpatient, or from the patient experience team in the form of a survey or free text
comments.

Quality Assessment Tools to Measure Processes and Reliability

There are four main quality assessment and improvement tools that are recommend for
anaesthesiologist to improve the process, flow and outcomes of anaesthesia and surgical care.
These are
1. Process maps

2. Ishikawa diagrams

3. Run charts

4. Control charts

The tools help visualize, analyse, and track process and outcome data for both individual and
groups of patients and can be used routinely by clinicians to evaluate and improve their care.
The tools can be used to achieve measurable improvements in the efficiency, effectiveness,
performance, accountability, and outcomes of surgical quality in services or processes of care.
1. Process maps (Figures 1 and 2)
Process maps are the most important quality assessment and improvement tool. A process map or
a flowchart is a visual representation of the care process that is created with information

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provided by team members. The process mapping exercise can help clinicians clarify through
visualization what they know about their environment and determine what they want to improve
about it. The process maps use common flow chart symbols and can describe the current state or
baseline, the improved state in transition, and the optimal state. This exercise can help clinicians
share their assumptions and expectations. It can also provoke insights from reflecting on their
current state. More importantly, clinicians gain insight on how to improve the process of
anaesthesia care or how to overcome perceived barriers to its improvement. Working with
clinicians to understand how they perceive safe care is essential to sustain their interest and
engagement in long-term continuous improvement.

Begin:
Patients & Doctors
Perioperative Services Flow Chart End:
1st Post-
Initiate Surgical Discharge Follow-
Orders up Appointment
System and Hospital
Elective Administration
Legend:
Surgery
BDA Teams
Walk- Ins
Before

During

In-Patients Scheduling After

Surgical Leadership and

Committees Follow-up
From Clinics

Post Surgical
ICU
ED Including Units
Trauma
Patients

Pre-Admissions/ Surgery
Pre-Op PACU Discharge
Registration

IR, ENDO & Cath Lab

EHR’s and Imaging

Supply Blood Environ. Quality & Infection Central Bed Case Home
HR other IT Labs Transport
Chain Bank Services Safety Control Sterilization Mgnt. Mgnt. Health
Systems Pharmacy

Support and Ancillary Services V6.1 October 11, 2020

Figure 1. A process map of surgical services that stars before patient is admitted to hospital
and continues through to their post-operative recovery at home1

1 Barach P. Designing the future of surgical services, Monument Health, 2021.

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Process mapping describes precisely what an individual provider is required to do and when, in
terms of cognitive processes, actions, or both, to achieve the system’s goal. Data are collected
from observations or interviews that carefully break down complex clinical processes into
discrete, measurable, and clear tasks. Ultimately, improving patient outcomes requires
appreciating the inherent links between process and results. Process maps help focus
improvement efforts, not just for the individual, but for the entire clinical microsystem.
Visualizing the process can also help identify inefficiencies (e.g., parallel, or redundant processes
that have emerged for whatever reason), clarify roles, and reduce ambiguity among team
members, all of which can help coordinate patient care across services and microsystems.

It is important to map the current process, not the desired process, to best identify opportunities
for improvement. Once the process has been graphically depicted, several questions arise to
generate improvement ideas:
• What is the goal of the process?
• Does the process work optimally as it should for the patient and for the clinician?
• Are there obvious redundancies or complexities?
• How different is the current process from the ideal process?

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Figure 2. A process map showing the relative incidence of minor and major adverse
event data in cardiac surgery*
*Barach, P., Johnson, J., Ahmed, A., et al. Intraoperative Adverse Events and their impact
on Pediatric Cardiac Surgery: A Prospective Observational Study. Journal of Thoracic and
Cardiovascular Surgery 2008 Dec; 136 (6): 1422-1428.

2. Ishikawa diagrams (Figure 3)

Ishikawa diagrams, also known as “cause-and-effect diagrams,” or “fishbone diagrams,” are

visual representations of the sources of variation in a clinical process. The diagram is often
created by brainstorming with key stakeholders or during a M&M investigation to identify the
causes of patient harm. The causes can be allocated to five general main headers/categories:

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place (environment), equipment, procedures, and methods (processes), people (patients and
providers), and policies.

Routine surgical root cause analysis with Ishikawa diagrams can be very powerful in analysing
surgical adverse events. A detailed analysis in one major hospital over 4 years (Table 1)
established the fact that excellent surgical outcomes depend on integrating individual, team,
technical, and organizational factors. (Table 1)

Figure 3: An Ishikawa diagram for cardiac surgery

*Johnson J, Barach P. Quality improvement methods to study and improve the process and
outcomes of pediatric cardiac surgery. Prog Pediatr Cardiol. 2011;32(2):147–154.

Table 1: Results of surgical adverse event root cause analyses

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* Cassin B, Barach P. Making Sense of Root Cause Analysis Investigations of Surgery-Related
Adverse Events. Surg Clin North America 2012, 1-15, doi: 10.1016/j.suc.2011.12.008.

3. Run charts (Figure 4)

A run chart is a graphic representation of process performance data tracked over time and is
particularly useful because the run charts can reveal subtle changes over time that would
otherwise go noticed. The run chart is a simple plot of a measurement over time with a line
drawn at the median value. Important uses of the run chart for improvement are to:
• Display data to make process performance visible
• Determine whether tested changes improve the process or endpoints
• Determine whether the changes are lasting

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 • Allow for a temporal view of data versus a static view

Figure 4. A run chart of time-to-extubation for patients undergoing closure of atrial septal
defect and ventricular septal defect in the ICU*
*Johnson J, Barach P. Improving Pediatric Cardiac Care with Continuous Quality Improvement
Methods and Tools. In Barach P, Jacobs J, Laussen P, Lipshultz S. (Eds), Outcomes Analysis,
Quality Improvement, and Patient Safety for Pediatric and Congenital Cardiac Disease. Springer
Books, New York, NY, 2014, SBN 978-1-4471-4618-6

4. Control charts (Figure 5)

Control charts display data over time and provide upper and lower control limits of variation that
help determine whether a process is stable or unstable. The control limits are calculated using
median values and the moving ranges of the data. The factors leading to instability must be
addressed before the process can be improved. We define two types of variation in a process:
“Common cause variation” is the usual, historical, quantifiable variation in a system, and might
include fluctuations in the severity of a patient’s risk factors, the skills of operating team
members, or changes in equipment settings. Common cause variation suggests that improving
patient outcomes will require changing the processes that produced the results.

“Special cause variation” is unusual, not previously observed, and non-quantifiable variation in
surgical procedures. Special cause variation is the result of factors extraneous to the process, for
example, variation introduced by a new surgeon, management drive for more productivity, or

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equipment breaking during a procedure. It is not possible to predict (or control) variation caused
by special causes.

If the control chart indicates that the process is currently under control (i.e., it is stable, with
variation only coming from sources common to the process), then the data from the process can
be used to predict the future performance of the process. If the chart indicates that the process is
not under control, the chart can help determine the sources of variation, which can then be
eliminated to bring the clinical process back under control. These data can inform the surgical
team about when to act, but also, especially in systems that are constantly tweaking their
systems, when to hold and not to act, depending on the cause of the variation.

Control charts are appropriate for analysing data from procedures that are performed frequently,
and consistently, and are relatively standardized such as with cardiac and orthopaedic surgery.

Figure 5: A control chart of Surgical Site infections by months2

Failure Modes and Effects Analysis (FMEA-Figure 6)

2 Barach P. Designing the future of surgical services, Monument Health, 2021.

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A FMEA is a useful tool to prospectively analyse workflows through the perioperative suite. A
team brain storming may identify that an aspect of surgical operations within the perioperative
suite is not performing as intended. The analysis of the failure modes and effects involves
identifying the elements and their sequence in the procedure under review, the conditions that
could result in failure at each step, the effects of each failure on the performance of the
procedure, the likelihood that the failure could occur under local conditions, the impact of the
failure on patient safety, and what remedial action could reduce the risk of failure.

Measurable activities in the perioperative setting include standardized processes with multiple
steps performed in sequence such as when administering medications. FMEA is a useful adjunct
to an adverse event investigation to help break a procedure or protocol into separate steps using a
process mapping methodology and consider the stages where something unexpected happened or
there is potential for the sequence to break down. Rather than look at the prevailing conditions in
the perioperative suite, the FMEA looks specifically at human interaction with technology or
equipment and the potential for procedural failure at a systems level.

An example of an adverse event where the consequences of a procedural failure needed to be

mapped out involved a patient who had a spinal fusion performed at the incorrect level. The local
neurosurgical practice for sighting and marking of spinal levels was a contributing factor to the
adverse event. The FMEA identified that the timing of access to radiological images was critical
as was the ability of the members of the surgical team to visualize and confirm the spinal level
with the radiology team. A key finding was that the position of the surgeon relative to the patient
and the position of the assisting surgeon on the opposite side of the operating table could give the
perception of different spinal levels depending on the viewing angle. Visualization of the
radiological image was not always completed at the same time by each surgeon due to movement
within the operating room relative to the position of the viewing box. During the adverse event,
this was compounded by the fact that the two surgeons did not provide clear verbal confirmation
to each other or to others on the team in the room about the spinal level to be operated on.

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The FMEA suggested the high probability of recurrence suggested by the FMEA led to a change
in the local procedure whereby both surgeons had to provide clear verbal confirmation citing
specific anatomical markers and read-back their interpretation of the radiology image to the
entire OR team. Before the investigation, the neurosurgeons had varying individual practice for
sighting and marking spinal levels. The FMEA provided an opportunity to develop a consistent
and reliable practice for marking sided surgical and anaesthesia procedures.

Figure 6: Application of FMEA and the steps involved for an anaesthesia process*

*George Tewfik, G. Proactive Perioperative Risk Analysis: Use of Failure Mode and
Effects Analysis (FMEA). Anesthesia Patient Safety Newsletter. Volume 36, No. 1,
February 2021.

Selected References and Suggested Readings:

1. Nanji KC, Patel A, Shaikh S, et al. Evaluation of perioperative medication errors and adverse
drug events. Anesthesiology. 2016;124(1):25–34.

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2. Perla RJ, Provost LP, Murray SK. The run chart: a simple analytical tool for learning from
variation in healthcare processes. BMJ Qual Saf. 2011;20(1):46–51.

3. Lehmann M, Monte K, Barach P, Kindler CH. Postoperative patient complaints: a

prospective interview study of 12,276 patients. J Clin Anesth. 2010;22(1):13-21.

4. Thor J, Lundberg J, Ask J, et al. Application of statistical process control in healthcare

improvement: systematic review. Qual Saf Health Care. 2007;16(5):387–99.

5. Sanduende Otero Y, Villalón Coca J, Romero García E et al. A. Ten-Year Review of

Adverse Medication Incidents in a National Incident Reporting System, British
Journal of Anesthesia, 2019, doi: 10.1016/j.bja.2019.10.013

6. Martin LD, Grigg EB, Verma S. et al. Outcomes of a Failure Mode and Effects Analysis for
medication errors in pediatric anesthesia. Paediatr Anaesth. 2017 Jun;27(6):571-580. doi:
10.1111/pan.13136. Epub 2017 Mar 28. PMID: 28370645.

7. Barach P, Johnson J. Assessing Risk and Preventing Harm in the Clinical Microsystem In:
Sollecito, W and Johnson, J (eds). Continuous Quality Improvement in Health Care: Theory,
Implementations, and Applications. pp.235-252, 5th edition. Jones and Bartlett, 2019, ISBN
978-1-284-12695-4.

8. Schraagen JM, et al. Improving methods for studying teamwork in cardiac surgery. Qual Saf
Health Care 2010; 19:1-6 doi:10.1136/qshc.2009.040105.

9. Barach P, Johnson JK, Ahmad A, et al. A prospective observational study of human factors,
adverse events, and patient outcomes in surgery for pediatric cardiac disease. J Thoracic
Cardiovascular Surgery. 2008;136(6):1422-1428.

10. Cassin BR, Barach PR. Making sense of root cause analysis investigations of surgery-related
adverse events. Surg Clin North Am. 2012;92(1):101–115.

11. Shahian DM, Williamson WA, Svensson LG. Restuccia JD, D'Agostino RS. Applications of
statistical quality control to cardiac surgery. Ann Thorac Surg. 1996;62(5):1351–1358.

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12. Cassin B, Barach P. How Not to Run an Incident Investigation? In Sanchez J, Barach P,
Johnson H, Jacobs J (eds.). Perioperative Patient Safety and Quality: Principles and Practice,
Springer, 2017. ISBN 978-3-319-44010-1.

13. Perotti V, Sheridan MM. Root cause analysis of critical events in neurosurgery, New South
Wales. ANZ J Surg. 2015;85(9):626-630.

14. Barach P, Johnson JK. Understanding the complexity of redesigning care around the clinical
microsystem. Qual Saf Health Care. 2006;15 Suppl 1(Suppl 1): i10-i16.

15. Schraagen JM, Schouten T, Smit M, et al. A prospective study of paediatric cardiac surgical
microsystems: assessing the relationships between non-routine events, teamwork, and patient
outcomes. BMJ Qual Saf. 2011;20(7):599-603.

RISK MANAGEMENT TOOLS

AN INTRODUCTION TO ROOT CAUSE ANALYSIS
Phil Blum
______________________________________________________________________________

What?
Root Cause Analysis (RCA) is a structured process to review an adverse incident. It investigates
the chain of events and identifies the underlying causes which resulted in the incident. Analysis
delves deep to find answers based on hidden causes rather than the most apparent or superficial
(1). The response to the incident is included in the review. A resilient system will minimize
patient harm after an incident whereas “failure to rescue” can result in significant injury or death
(2). The aim is to be fair and thorough; using recognized analytical methods to develop sound
implementable and achievable recommendations.

Why?
Humans will always make mistakes and health care systems are complex. It is easy to blame an
individual for a bad outcome, but individual errors should be viewed as consequences rather than
causes (1). There are latent (hidden) errors in system design that wait quietly with the potential to

29
facilitate and exacerbate human error. RCA is a tool to reduce healthcare system vulnerability to
human error and mitigate poor outcomes if an error occurs. Systems should be designed such that
it is difficult for people to do the wrong thing and easy for people to do the right thing (1).

When?
RCA is usually performed for an adverse incident where the outcome was poor or the potential
for significant harm was high (a near-miss). The investigation process should begin as soon as
practical. The longer the time between the incident and the RCA, the harder it is to gather
reliable information. An RCA should not be performed for incidents involving deliberate
malevolent or criminal acts.

Who?
A team of independent multidisciplinary senior clinicians should be assembled. A leader should
be appointed who is responsible for following the process to completion. The team should avoid
bias and personal opinion. It will be evidence based and free to present information and
recommendations without fear.

How?
All meetings and interviews undertaken during a review are conducted in a non-confrontational
manner. RCA avoids judging an individual’s competence as that does not strengthen the system
in the long run (3). Patient and staff are de-identified. “Hindsight bias” should be avoided when
assessing an incident. The course of action needed to prevent an incident may appear obvious in
retrospect, but the situation needs to be looked at based on the information available at the time
of decision making (3).

The major steps in an RCA investigation (3):

What happened? Identify.
1. Define the problem and its severity

2. Gather the information – documentation, interviews, and relevant current policy/

protocols

30
 3. Identify a timeline of events

Why did it happen? Analyse.

4. Identify root causes

What can be done to prevent it happening again? Resolve.

5. Identify the best solutions based on a scale of effectiveness

6. Develop recommendations

7. Write a report

Has the risk of it happening again been reduced? Resolve

8. Implementing solutions and long term-follow up

When thinking about why an incident has occurred, consider clearly describing the cause-and
-effect relationship. Every action or decision a person makes (the proximate cause) must have
underlying contributing factors and deeper causes. Contributing factors are important and may
have influenced the proximate cause e.g., working a long shift to cover a sick colleague.
Eliminating these factors alone would not prevent the event from happening again though.
Deeper causes can be more easily identified by drilling down further by continuing to ask
“why?” Helping to understand the “why?” may be facilitated using a variety of frameworks, for
example, an Ishikawa (Fishbone) diagram (1) or bow-tie methodology (2).
The Ishikawa diagram is like a fish skeleton. The ribs and fins being the many potential human
and system causes. These join at the backbone and are directed towards the incident represented
by the fish head. Human causes may be divided into competency, consciousness,
communication, critical thinking, and compliance. System causes include policy and protocol,
structure, technology and environment, process, and culture (1).

Solutions

Solutions should be SMART (Specific, Measurable, Achievable, Relevant and Timely) (3).
Solutions may be easy to implement but usually are not very effective in reducing the risk of the

31
critical incident happening again. Weak but easy solutions include written warnings and labels,
new policies, and re-education. Stronger actions include the use of checklists/cognitive aids,
reducing distractions and more effective use of skill mix. The strongest actions are usually
difficult to successfully implement and include changing the organization’s cultural approach,
changing building architecture, and standardizing equipment (1).

An example
Let us take an example, a case where a patient is given the incorrect surgical prophylactic
antibiotic by the anaesthesia provider prior to surgery. The patient has a known allergy to that
antibiotic and subsequently develops severe anaphylaxis.

The patient developed a mild anaphylactic reaction after taking a 1st generation cephalosporin
orally for a urinary tract infection prescribed by a local family practitioner. The patient developed
a rash, urticaria and facial oedema which resolved rapidly with intramuscular adrenaline
(epinephrine).

The patient presents two years later for an elective urological procedure. He describes his
cephalosporin allergy to the junior ward doctor on his admission to hospital and it is documented
deep in the thick progress notes of the patient.

An anaesthetic provider has been up all-night working 18hrs straight covering a sick colleague.
She is under time pressure to start the first case for the elective morning list. The day anaesthetist
is running a few minutes late. The surgeon is angry and pacing. The night anaesthetist does a pre-
anaesthetic assessment, obtains an accurate allergy history and is just about to write it on the
anaesthetic chart when the flustered day anaesthetist arrives. There is a rushed handover as the
surgeon stands over both. The night anaesthetist forgets to mention the patient’s allergy history
during the handover.

32
The day anaesthetist takes the patient into theatre. A WHO surgical safety checklist takes place.
The anaesthetist is busy checking his machine and drawing up induction drugs and misses
participating during the checklist. No one asks the patient if she has any allergies during the
checklist.

The harried anaesthetist gives the patient the standard 1st generation cephalosporin intravenously
soon after induction and the patient develop an anaphylactic reaction requiring an adrenaline
(epinephrine) infusion, crystalloids, and intubation. Surgery is not performed. The anaphylaxis is
well managed, and the patient is extubated 6hrs later with no sequelae but is understandably
angry.

So, the proximate error is the anaesthetist giving the wrong drug resulting in anaphylaxis. It
would be easy to blame the day anaesthetist for not being more careful. The junior doctor knew
so why didn’t she? But there is a series of events, contributing factors and underlying causes for
this “never” event.

What is the usual policy regarding allergy identification in the patient notes or on the patient?
Was it followed? Why not? Allergies are often recorded inaccurately by clerical non-medical
staff on the cover of the patient notes in this hospital. No medical staff takes any notice of it
because it is inaccurate.

Is there a preadmission clinic this patient could have attended in the days before his admission
where an anaesthetist could have seen this man and documented the allergy on the anaesthetic
chart? Do patients regularly turn up for elective lists without being seen by an anaesthetic
provider? Why?
Fatigue is an obvious contributing factor. What is the process to cover for a sick colleague? How
does the culture of the theatre influence whether staff can say they are tired and that they need to
be relieved?

33
Why did the handover fail? Is there a formal handover process? Is there a way we can improve
handover? What about the pressure from the surgeon? Is that acceptable behaviour in the
hospital? Why? What effect does that have on team performance? Is that something we can
change?

Do anaesthesiologists regularly miss being part of the WHO surgical safety check list? Why?
Why are they often too busy getting ready for case? When does their shift start in relation to the
elective theatre start? Can we change the roster to change shift start and finish times? Can we
change policy so that the checklist doesn’t happen until everyone gives their full attention?
Do the staff look at the patient notes when they do the WHO checklist? They check the consent,
but do they check for allergy documentation? The answer is no as the staff say the allergy
documentation in the notes is inaccurate and it’s the anaesthetist’s job anyway. What about
identification on the patient? Well, that didn’t work because allergy identification on wrist bands
was inaccurate also. Can we improve allergy documentation throughout the hospital? Can we
make it everyone’s responsibility during the WHO checklist to make this incident never happen
again?

When is the best time to administer surgical prophylactic antibiotics? Can we change behaviour,
so anaesthetists give the antibiotics before the patient is anaesthetised? They can ask the patient
one last time if they have any allergies as they attach the syringe to the intravenous line.
Contributory factors include fatigue, the anaesthetist being late, poor rostering and the bullying
surgeon. Eliminating these is helpful but on their own would not prevent a recurrence of the
incident.

See Figure 1 as an example of an Ishikawa (Fishbone) diagram for this case history of
anaphylaxis.
Would the following have prevented or reduced the chance of the proximate error? Maybe these
are the root cause issues that need to be addressed to prevent this happening again?
• All elective patients seen by an anaesthesia provider before coming to theatre

34
 • A robust system to document known allergies clearly and accurately in the patients notes

• Formal handover checklist

• All staff involved in Surgical Safety Checklist engages the patient and includes asking the
patient if they have any allergies along with name, birth date, surgical site, and side

• Staff check the allergy record in the patient notes during the surgical checklist

• Prophylactic antibiotics given to all patients prior to induction

Challenges
RCA is a powerful tool to improve quality and safety for patients. Unfortunately, it is a fact that
many health centres have limited budgets and resources to institute change. Broad solutions like;
“We need more staff” or “We need more basic equipment” although true, may not be achievable
in the short term. Follow up to see whether RCA recommendations have resulted in
improvements in patient outcomes requires staff time and funds. The great challenge is to find
locally appropriate solutions that are achievable and cost effective.

Figure 1: Ishikawa (Fishbone) diagram for case history of anaphylaxis

35
Education and Patient factors:
training: - Known allergy
- No regular - Quiet and shy
ongoing training
of WHO

Equipment and Individual

resources: factors:
- No clerical staff - Fatigue
to help document - Unsettled by
allergies in

Work conditions: Task factors:

- No formal - Time pressure
system to cover - Antibiotics
for staff illness routinely given
- Long shifts once patient is
asleep

Organisation and Communication

strategic: and team factors:
- No standardised - Not everyone
system to document engages in WHO
allergies clearly in checklist
patients files - No patient
- No preadmission handover
clinic checklist at shift
- Bullying
behaviour by
surgeon tolerated by Event: Wrong
administration antibiotics
given resulting
in anaphylaxis

36
Selected References and Suggested Readings.

1. Tjia I, Rampersad S, Varughese A, et al. Wake Up Safe and root cause analysis: quality
improvement in pediatric anesthesia. Anesth Analg. 2014;119(1):122-136.

2. Culwick MD, Merry AF, Clarke DM, Taraporewalla KJ, Gibbs NM. Bow-tie diagrams for
risk management in anaesthesia. Anaesth Intensive Care. 2016;44(6):712-718.

3. Jhugursing M, Dimmock V, Mulchandani H. Error and Root cause Analysis. BJA Education
2017;17(10):323-333.

37
IMPROVING SYSTEMS

Rola Hammoud
_____________________________________________________________________________
Healthcare systems are complex by design. This complexity is potentiated by the diversity of the
human resources, the number of interfaces between human and technology and by the multiple
handovers of information. Those are predisposing factors for error occurrence.

To establish a safety culture, healthcare organizations employees are encouraged to report errors
and near misses in a very objective way. Such reporting enhances learning in a fair and just
environment far from blame and shame aiming towards a shared responsibility.
Reporting errors is important to identify gaps in our systems. Correction of those gaps is
fundamental for system improvement. This “systems approach” will enhance patient safety and
promote safe environments for patients, families, and staff.

Whenever an error is reported, a thorough investigation using various tools (Ishikawa fishbone,
Root Cause Analysis) is conducted to identify gaps in the system that might have contributed to
the occurrence of the error or near miss.

The operating room setup is a small sample of a healthcare organization. The number and
diversity of employees add complexity to this environment where humans, technology, biology,
pharmacology, and physiology all interact together making the risk of mishaps and adverse
events to increase. The coordination between members of the operating room team (surgeons,
anaesthesiologist, nurses, and technicians) is important to prevent the occurrence of errors.

Actions that help in creating a safe operating room environment include:

• Improving communication skills and handover processes among operating room staff

• Use of efficient team building strategies (Team STEPPS*, CUSP**)

38
 • Ensuring adequate staffing ratio

• Optimization of patient condition before surgery

• Use of checklists before the induction of anaesthesia (WHO safe surgery checklist or
other)

• Maintaining safe equipment needed for anaesthesia and surgeries.

• Developing and maintaining safe practices for medication use.

• Ensure proper infection control program

• Maintaining the continuity of care during day and night and during weekdays and
weekends

• Developing a safety culture based on a non-hierarchical and open communication

• Having an adverse event and error-reporting system for all operating room staff

*Team STEPPS is an evidence-based set of teamwork tools, assumed at optimizing patient

outcomes by improving communications and teamwork skills among health care
professionals.

** CUSP- The Comprehensive Unit-based Safety Program

These elements can enhance both learning and contribute to patient safety whether by preventing
errors from happening or by identifying those and setting improvement actions.

1. Improve communication

The effective communication consists of a clear and accurate message (verbal or non-verbal)
from a transmitter that is delivered to a receiver. The message shall be clear and audible. The
recipient is requested to be focused and undistracted to ensure effectiveness in transmission of
the information.

Communication in the operating room where many stakeholders (surgeons, anaesthesiologists,

nurses, technicians, and administrators) are interacting and where many distractions take place

39
(monitors, alarms, phones etc.) is a very challenging process. It needs to be effective to ensure
teamwork and safe patient care.

Standardizing communication process in the OR has proven its effectiveness in ensuring safe
care. Thus, surgical checklists and time-out procedures are now implemented in OR setups as per
the recommendations of the WHO. The “Safe Surgery Checklist” is now a universal tool that
identifies three phases of a procedure; “Sign in” before the patient goes to sleep, “Time out”
before the incision and “Sign out” at the end of the procedure. On each step, OR staff completes,
the checklist as a team. The postoperative debriefings are also effective in team functioning to
ensure proper continuity of care.

2. Team building strategies

Perioperative communication can be improved through new strategies. Team STEPPS was
developed by the US Department of Defence and the Agency for Health Care Quality and
Research (AHRQ) in 2005 and was developed based on risk management programs to enhance
safety in the air traffic industry in 1973. It was adopted by The Department of Health and Human
Services Agency for Healthcare Quality and Research (AHRQ) to improve patient safety
(Plonien & Williams, 2015) and implemented in healthcare.

TeamSTEPPS, focuses on five elements: “Team Structure, Communication, Leadership,

Situational Monitoring, and Mutual Support”. “STEP – Status of the patient, team members,
environment, and progress toward goals”. TeamSTEPPS® involves a series of tools, briefings,
and debriefings to allow better communication and create a culture of safety.

Over two-thirds of surgical adverse events result of poor communication and poor teamwork
(Tibbs and Moss; 2014). Communications can also be improved with another tool like SBAR –
situation, background, assessment, and recommendations, which is used in improving patient
handovers between health care providers. Approximately 39% of the errors in the operating room
are preventable. Evidence shows that using those tools is associated with improved operating
room efficiency and decreasing rate of errors.

3. Develop a safety culture

40
The safety culture is the product of values, attitudes, perceptions, competencies, and behaviours
that determine the commitment to an organization's safety management. It is based on speaking
up and reporting errors without any fear, for the objective of systems improvement. It is a
learning culture based on sharing experiences in an open forum free of blame and on fairness in
judgment where people are reassured after a human error and punished after a reckless
behaviour.

Speaking up in a “No blame, no shame” environment is essential to encourage errors reporting

and allow systems improvement. It is essential to have in the operating room processes in place
for reporting.

4. Incident reporting systems

Incident reporting and investigation was first used in aviation in the 1940s to improve safety and
performance. Incident reporting was introduced in anaesthesiology and is recommended to
gather information about adverse events in hospital care.

Adverse events can be collected from patient medical records review, from patients’ complaints
or from self-reporting. ‘Near-miss events can only be detected by self-reporting, or via reports
from other team members.

Around 20% of the incidents reported are the result of violation from existing protocols.

Key factors that help encourage open reporting about and learning from every adverse event
include:

• Open non-punitive reporting culture

• Self-reporting of adverse events

• A thorough analysis to learn from events, get details of the number, type, risk and causes

• Adequate feedback to the reporter

• Clear definitions and benchmarking with other operating rooms

41
Investigating and analyzing incidents in the operating rooms require engagement of surgeons,
anaesthesiologists, and nurses. It is recommended to use a standardized framework for analysis
of events.

Incident reporting may capture only 4% to 50% of adverse events. This underreporting is due to
clinical factors, time constraints, lack of a hospital policy and training on types of incidents and
lack of anonymity and feedback.

Upon investigating errors in the operating room, staff are asked to remember the smallest details
in a blameless way, and the process is described and compared to the system process to identify
gaps. All gaps identified are called opportunities for improvement (OFI). Specialized teams with
hospital leadership on board will act on improving those OFI. This can be done by adding
resources (human, supplies or equipment), correcting procedures, revisiting policies, adding
boundaries, and checking lists, adding tools for better communication, monitoring practices and
most of all commitment and follow up from leadership.

These OFI represent the potential gaps in a system where we need to study, investigate, and act
upon to have safer practices and ensure better care for our patients in the operating room.

Selected References and Suggested Readings:

1. Tørring B, Gittell JH, Laursen M, Rasmussen BS, Sørensen EE. Communication and
relationship dynamics in surgical teams in the operating room: An ethnographic study. BMC
Health Services Research. 2019 Jul 29;19(1).528.

2. World Alliance for Patient Safety. WHO Guidelines for Safe Surgery. Geneva,

Switzerland: World Health Organization; 2008.

3. Heideveld-Chevalking AJ, Calsbeek H, Damen J, Gooszen H, Wolff AP. The impact of a

standardized incident reporting system in the perioperative setting: a single center experience
on 2,563 ‘near-misses’ and adverse events. Patient Saf Surg. 2014; 8(46).

42
4. Baker, D. Battles J, King H, Salas, E., Barach, P. The Role of Teamwork in the Professional
Education of Physicians: Current Status and Assessment Recommendations. Joint
Commission Journal on Quality and Safety 2005; 31:4:185-202.

5. TeamSTEPPS, Strategies and Tools to Enhance Performance and Patient Safety, CD/DVD,
Curriculum Kit, AHRQ Pub. No. 06-0020-3, 2006. ISBN 1-58763-192-X.

SEARCHING FOR EVIDENCE BASED LITERATURE

Fauzia Anis Khan
____________________________________________________________________________
Evidence-based medicine (EBM) is defined as the conscientious, explicit, and judicious use of
current best evidence in making decisions about the care of individual patient (1). A revised
version came later which defines it as a systematic approach to clinical problem solving which
allows the integration of the best available research evidence with clinical expertise and patient
values (2).

The aim in using this methodology is to decrease the bias either due to personal opinions or lack
of awareness of literature regarding a clinical question.

Steps to Search for Best Evidence

Certain steps need to be followed to search for best scientific evidence.

Step 1: Construct a clear question which you need the answer. The question has four
components based on PICO principle or pneumonic.
P = Patients/ context problem (what/who)

43
I = Intervention or action which is being studied/ or exposure
C = Comparison or the relationship. What is the main alternative to compare with the
intervention?
O = Outcome or effect of intervention

Step 2: List all keywords to be used in your search and consider editing all synonyms (these are
possible words with the same meaning.)

Step 3: Decide on the literature and databases that you would search.
Commonly Used Databases
Following are the commonly used databases:
• Medline is the medical database compiled by National Library of Medicine of USA.
• PubMed is the freely available version of MEDLINE. Pub Med retrieves the citations i.e.,
title, authors, journal and abstract. If a free full text is available a link is provided.
• COCHRANE Library: Cochrane is a global independent network that provides high
quality, summarized information to make health care decisions. Currently, there are
nearly 7500 Cochrane systematic reviews published in the Cochrane library.
• EMBASE (Excerpta Medica DataBASE): This is a biomedical and pharmacological
bibliographic database of published literature produced by Elsevier (Netherlands) which
covers 8500 journals. (www.elsevier.com/solutions/embase). Access needs subscription
• CINHAL: It is the cumulative index to Nursing and Allied Health (www.cinahl.com). It
contains information from 1982 and relates more to nursing and allied health.

Other Sources
Other sources that can be used are:
• Clinical Practice Guidelines: These are systematically developed statements to assist
practitioners and patients. These are not fixed protocols (some of the websites are NIH
clinical practice guidelines, NICE guideline)

44
 • Up To Date (www.uptodate.com) is an evidence based, physician authored clinical
decision support resource. UpToDate mobile application needs to be downloaded. Use of
up to 2 devices is free of charge.

Journals: Many journals have their websites available on the internet that can be accessed freely.
The journal website indicates which article can be downloaded free. Other articles may be
available with payment.

Websites: One of the barriers in Lower-and Middle-Income Countries (LMIC)is the availability
or cost of electronic resources and time constraints.

Textbooks: Can be used but can be behind current evidence by a few years.

HINARI: provides free or very low cost online access to major journals in biomedical and related
social sciences to local, not for profit institutions in developing countries. (http://who.int/hinari/
about/en)

If after searching the above sites you have too many results, use filters to reduce the numbers.
For example, you can limit the results to “reviews” only or put a limit according to time.

Step 4: Evaluate synthesize and review the evidence. Look at the quality and type of papers.
Not all evidence sources are of similar merit. The hierarchy of evidence from top to bottom is
systematic review, RCTS, observational studies, case studies, reports, and expert opinion.
Have a system for recording of evidence. Making a summary table at this stage helps. Make the
table outlining the studies, its designs, population, outcome, and findings.

Step 5: After evaluating the level of evidence, see the strength of the findings and see if they are
significant. Are the benefits of intervention worth the risk & costs.

Step 6: Last but not the least, implement the change in your practice, if feasible.

45
Selected References and Suggested Readings:
1. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based
medicine: what it is and what it isn’t. BMJ 1996; 312:71-72.
2. Sackett DL, Strauss SE, Richardson WS et al Evidence based medicine: how to practice and
teach EBM. London: Churchill- Livingstone, 2000. Available from: https://med.fsu.edu/
medicalInformatics/ebmTutorial
3. Cochrane Library. Available from: http://www.cochranelibrary.com/
4. ELSEVIER. Available from: http://www.elsevier.com/solutions/embase
5. CINAHL. Available from: http://www.cinahl.com
6. The National Center for Biotechnology Information. Available from: http://ncbi.nlm.nih.gov
7. The National Institute for Health and Care Excellence. Available from: http://
www.nice.org.uk
8. UpToDate. Available from: http://www.uptodate.com
9. WHO. Hinari. Available from: http://who.int/hinari/about/en
10. Oxford Centre for Evidence-Based Medicine: Levels of Evidence (March 2009) Available
from: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/oxford-centre-for-evidence-
based-medicine-levels-of-evidence-march-2009

PERFORMING A CLINICAL AUDIT

Anuja Abayadeera
______________________________________________________________________________

The clinical audit consists of measuring a clinical outcome or a process, against well-defined
standard. Audit is a quality improvement measure and is one of the 7 pillars of clinical
governance. It allows health care institutions to show where their service is doing well and where
it is falling short of standards. It allows them to continually improve patient care, look for

46
deficiencies, and allow for changes for the better. Re auditing the same aspect following changes
made and closing the cycle would see whether beneficial changes have taken place (1).

Steps of a Clinical Audit

Clinical audits are based on a cycle with several steps.

From East Midland Emergency Medicine educational media

1. Identify a problem

2. Define a standard based on a local or international standard

3. Collect data – on a day or over a week, etc

4. Analyse the data against the standard

5. Implement the change towards the standard

6. Re audit after a period by re-doing Steps 1-5.

47
Involvement in audit is good as you will help to improve patient care, shows your interest in a
field, learn many skills such as teamwork and time management. You will also be able to present
your audit at meetings, publish it, and use it as part of your appraisal and assessments.
In planning your own audit, you are free to select an area of your choice. Use the SMART
criteria to plan the audit.
i. Specific – choose an area of your interest and keep it simple.

ii. Measurable – it should be some aspect you can audit against a local, naDonal, or internaDonal
standard.

iii. Achievable – have 1-2 outcomes and the data should be easily collectable. Ensure that you have
the required faciliDes to start. E.g., Data sheets, computer access.

iv. RealisDc- audit what you are familiar with and what you have access to.

v. Timely – choose a topic that you can do in a short period, keeps you moDvated and allows room
for re-audit.

Remember to get the required permissions from your department, hospital authorities, and
individual consultants. It is important to involve all team members early so that implementation
of change is easier, and they would provide constructive feedback. Involving seniors will allow
easy implementation of the implementation process. Re-auditing is mandatory. An audit that has
a higher number of patients and an easy change to implement is easier to re-audit.
An Example
An example of an audit that can be done during the intraoperative period is the “Compliance to
WHO surgical safety check list” (2).
Why do this audit?
The checklist identifies a set of surgical standards that can be applied in all operating theatres
and aids improved communication and leadership. The core document focuses on correct site
surgery, haemorrhage, antibiotic prophylaxis, airway management and allergy. There are three
stages of checks.
1. ‘Sign In’ before the induction of anaesthesia

2. ‘Time Out’ before skin incision

48
 3. ‘Sign Out’ before the patient leaves the operating room

Indicators
Sign In
i. % PaDents should confirm his/her idenDty and the site, procedure and consent should be
checked?

ii. % Surgical sites marked prior to the point of anaesthesia?

iii. % AnaestheDc machine and medicaDon check complete?

iv. % Any risk factors including allergy, difficult airway, aspiraDon, or major blood loss should be
communicated, and appropriate plans put in place?

Time Out
i. % Team members introduced themselves by name and role?

ii. % Surgeon, anaestheDst, and registered pracDDoner verbally confirm: paDent’s name,
procedure, site, posiDon and communicate any criDcal events/concerns?

iii. % Care bundles for surgical site infecDon and thromboprophylaxis undertaken?

Sign Out
i. % The name of the procedure been recorded?

ii. % Confirmed that instruments, swabs, and sharps counts are complete (or not applicable)?

iii. % Specimens been labelled appropriately?

iv. % Any equipment problems been idenDfied that need to be addressed?

v. % Key concerns for recovery and management of this paDent are noted?

Proposed standard for best practice

Sign In
i. 100% of paDents should confirm their idenDty and the site, procedure and consent should be
checked.

49
 ii. 100% surgical sites marked prior to the point of anaesthesia (where deemed appropriate).

iii. 100% anaestheDc machine and medicaDon check complete.

iv. 100% risk factors including allergy, difficult airway, aspiraDon, or major blood loss should be
communicated, and appropriate plans put in place.

Time Out
i. 100% team members introduced themselves by name and role.

ii. 100% surgeon, anaestheDst and registered pracDDoner verbally confirm: paDent’s name,
procedure, site, posiDon and communicate any criDcal events/concerns.

iii. 100% care bundles for surgical site infecDon and thromboprophylaxis undertaken.

Sign Out
i. 100% the name of the procedure been recorded.

ii. 100% confirm that instruments, swabs, and sharps counts are complete (or not applicable).

iii. 100% specimens been labelled appropriately.

iv. 100% any equipment problems been idenDfied that need to be addressed.

v. 100% key concerns for recovery and management of this paDent are noted.

Suggested data to be collected are the indicators identified.

There are common reasons for failure to meet the standard. They are time pressures, lack of
information to staff, lack of leadership, treating as a tick box exercise and poor communication.
In summary, audit is a good way to learn more about a certain aspect, show interest and learn
new skills. Always plan well and re-audit. Try to present your results locally and internationally
and publish.

Selected References and Suggested Readings:

1. Limb C, Fowler A, Gundogan B, Koshy K, Agha R. How to conduct a clinical audit and
quality improvement project? Int J Surg Oncol (N Y). 2017;2(6): e24.

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2. Raising the Standard: a compendium of audit recipes. Royal College of Anaesthetists.
2012;3:144-145.

ORGANIZING A DEPARTMENTAL MORBIDITY AND MORTALITY

MEETING
Bisola Onajin-Obembe
__________________________________________________________________
Purpose of Conducting a Morbidity and Mortality Meeting
The purpose of a departmental morbidity and mortality meeting is to learn and to avoid mishaps
from happening in future. The meeting should offer all the participants an opportunity to reflect
and engage. It should offer much more than the usual meeting where a group of people come
together to discuss the issues on an agenda. While a morbidity and mortality meeting can
improve communication and promote coordination, it is better described as a peer review
discussion of events that occurred perioperatively during the care of patients that resulted in
complications or death.

Setting the stage

Morbidity and mortality meetings are extremely sensitive because of the nature of the events. It
is therefore important to have a healthy department with good interpersonal relationships
between colleagues and members of the team. A good rapport between members of the
department, trust, and respect, as well as maintaining a cordial relationship and transparency in
the department are pre-requisites for the success and outcomes of morbidity and mortality
meetings. The meeting should not be perceived as a gathering for apportioning blames or conflict
resolution.

Goals of the Morbidity and Mortality Meeting

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The long-term purpose is to make morbidity and mortality meeting an acceptable culture at all
levels of the health care facility. Reporting near misses will help team members develop
communication skills, as well as form a habit of error disclosure. The department must establish
a non-punitive culture in eliminating error and develop a culture of no-fault. Every member of
the department, irrespective of their status should feel at ease and look forward to participating in
such meetings.
The goals, although not limited to the following, include five interacting principles that
constitute a learning organization:
1. Collaborative Learning Culture (Systems Thinking): To help anaesthesiologists and
their team members review the morbidity associated cases and mortalities or near misses
within the context of the hospital and considering current practices. By the end of the
meeting, participants should be able to see loopholes in patient care, as well as appreciate
what needs to be improved, safety measures to be taken, and areas of good practice that
need further strengthening.
2. Having a lifelong learning mind-set (Personal Mastery): The members of the
department become lifelong learners by creating a forum for learning from the mistakes
made. This provides personal mastery and the enablement to prevent errors from
occurring in future.

3. Room for Innovation (Mental Models): The meeting enables auditing and re-auditing of
practice within the hospital. It ensures that the practice is in line with international best
practice.
4. Forward-Thinking Leadership (Shared Vision): Creating an open mind-set to see
possibilities rather than difficulties. The members of the department are able to ignite
change within themselves, their teams, the department, and the hospital to improve the
outcome of anaesthesia management and patient care for the future.
5. Knowledge Sharing (Team Learning): Serves as an important learning avenue where
information, skills and expertise are exchanged within the department. Knowledge
sharing is important for members to be able to perform better, and eventually leading to
higher performance, as well as reduction in morbidity and mortality.

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Structure of the morbidity and mortality meeting
A meeting is only as good as its structure. The major planning tool is the agenda, or outline of
major discussion points. Most meetings focus on a presentation, discussions and remarks, and the
plan of action.
To get the best from morbidity and mortality meetings the structure should include:
1. A regular routine, organizing team and timeline: The morbidity and mortality meeting
must be sustainable. The department must therefore determine how often the meetings
should be held. A team should be responsible for organizing and coordinating the
meeting as well as ensure that all morbidity or mortality are presented as at when due.
The timeline should consider how soon after a near miss, morbidity or mortality should
the case be shared or presented. If it is too late, other events may have overtaken the
incident.

2. Participants at the meeting: It is important to send out a notice of the meeting, the
invitation and preliminary agenda to key participants and stakeholders. It may be
necessary to invite multidisciplinary teams directly involved in the incident. These may
include surgical, obstetrics, trauma, anaesthesia, and critical care, as well as nursing
teams. In some instances, participants may be invited from medical laboratory, and
radiology or pharmacy. This is important to enable collaboration, cooperation, and
communication across specialties.

3. Create a relaxed meeting environment: Avoid a controlled, sterile, uninviting,

oppressive, strictly managed classroom environment. It is important to develop a
collaborative environment. A dedicated venue, time and day should be assigned for such
meetings, and this should be communicated early enough to the members of the
department and those involved in the presentation including those from other
departments.

4. Roles and responsibilities: During the meeting, there should be a predetermined case for
presentation. The roles and responsibilities of presenting members must be clear.

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 Considering that critical incidents usually involve a team, there must be a team head as
well as time for questions, answers, and discussions. The facilitator must ensure that only
relevant questions are asked and must discourage fault finding.

5. Simple standard reporting and presentation system: The format of presentation must be
technologically appropriate for the department. The use of flip charts, cardboards and
white boards are easy, user-friendly and do not depend on electrical power supply. The
use of visual aids like power point presentation will require a projector, computer, and the
skills to prepare slide decks, including a reliable source of electrical power supply. It is
important to keep the report in a retrievable format in the department for future reference.

6. Ensuring a blame free scenario: During discussion, avoid the blame game. Keep in
mind that the team leader and the members of the team in charge of the patient at the time
of the incident may feel deep shame, guilt, and a sense of failure. Most individuals
involved would probably be going through an emotional time.

7. Encourage contributions from all participants, a constructive discussion, debate, and

value different opinions. Use non-threatening language and focus on interactive learning.

At the end of the morbidity and mortality meeting recommendations/outcomes are expected.
These should include:
1. Recognition of errors, teaching ways to prevent them, and the value of disclosing them
thereby contributing to the education of the team.

2. Process and system failure should be identified and addressed. We must assume that
when things do not go the way it is supposed to, our systems are at fault, or we did not
follow the system correctly.

3. Develop error reporting projects – if you do not report errors, it will happen again, and
this can lead to morbidity and mortality.

4. Recommendations must be made to eliminate errors or near misses, improve patient

safety and outcome. We must also share safety tips.

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 In conclusion, a departmental morbidity and mortality meeting, if meticulously
organized, will ensure a better patient outcome through learning, reflecting, and engaging
multidisciplinary and departmental teams.

Selected References and Suggested Readings:

1. Medical Errors: Focusing More on What and Why, Less on Who. Journal of Oncology

Practice 2007;3(2):66–70.

2. Gottschalk A, Van Aken H, Zenz M, Standl T. Is anesthesia dangerous? Dtsch Arztebl Int.
2011;108(27):469-474.

3. The Royal College of Surgeons of England. Morbidity and Mortality Meeting. A guide to
good practice. London: RCS; 2015.

4. Steadman J, Catalani B, Sharp C, Cooper L. Life-threatening perioperative anesthetic

complications: major issues surrounding perioperative morbidity and mortality. Trauma Surg
Acute Care Open. 2017;2(1):e000113.

5. Sinitsky DM, Gowda SB, Dawas K, Fernando BS. Morbidity and mortality meetings to
improve patient safety: a survey of 109 consultant surgeons in London, United
Kingdom. Patient Safety in Surgery 2019;13(27):1-7.

6. Senge P. The fifth discipline: The art and practice of the learning organization. New York,
NY: Currency/Doubleday, 2006.

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56
 MORBIDITY & MORTALITY TOOL
Background Information
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
________________________
Patient Demographics and Information
Age _______ ASA status __________ Gender Female Male
Other
Co-morbidity
________________________________________________________________
Surgical procedure
____________________________________________________________
Elective Emergency
Pre-operative assessment done Yes No
Time between pre-op assessment and surgery _______________________
Type of anaesthesia: General With ETT? Yes No
Regional Combined general and regional
Pre -Induction parameters: Heart rate _______ BP _______ SaO2 ______ Temperature
____
Respiratory rate __________
Nature of Incident (what happened)
Event: Airway Neurological
CVS Others
Respiratory Death within 24 hours

Timing of Incident (when did it happen)

Timing on 24 hours clock _______________

Where did it happen?

Induction High dependency unit
Maintenance Intensive care unit
Reversal Ward
Recovery Room

How did it happen? (Sequence of pre-event leading to event)

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

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_______________________________________________________________________
_______________________________________________________________________
______________________________

Why did it happen?

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
________________________

What were the active factors? (See definition of active factors)

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
________________________

What were the latent factors? (See definition of latent factors)

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
________________________

What are the steps to be taken to modify practice if a similar case presents again?

Individual practice change (By whom and when?)

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
__________________

Institutional practice change (By whom and when?)

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
__________________
What will be your next step?

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 _______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
__________________

CONTRIBUTORS

• Abayadeera A. Professor in Anaesthesiology, Department of Anaesthesiology and Critical

Care, Faculty of Medicine, University of Colombo, Sri Lanka.

• Barach P, Professor; Faculty Thomas Jefferson University School of Medicine, PA, USA.;

Sigmund Freud University, Vienna, Austria

• Blum P, Senior Staff Anaesthetist, Department of Anaesthesia, Top End Health Services,

Royal Darwin Hospital, Casuarina, NT, Australia.

• Hamoud R, Anesthesiologist, and Chief Medical Executive, Clemenceau Medical Center,

Dubai, UAE.

• Khan FA, Professor of Anaesthesiology, Faculty of Medicine, Aga Khan University,

Karachi, Pakistan.

• Onajin-Obembe B, Professor of Anaesthesiology, Faculty of Clinical Sciences, College of

Health Sciences, University of Post Harcourt Teaching Hospital, River State, Nigeria.

• Oracion EC, Senior Consultant Anaesthesiologist, Rizal Medical Center, Cardinal Santos

Medical Center, The Medical City, Metro Manila, Philippines; Senior Consultant

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Anesthesiologist and Board of Directors, Craniofacial Foundation of the Philippines,

Philippines.

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