Updated Incident Reporting 2012 Kkm-1

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Incident Reporting & Learning System:

From Information to Action
MANUAL
Building organizational learning and a culture of safety through reporting,
analysing and learning from adverse patient incidents,
“near misses” and hazards
Medical Care Quality Section

Medical Development Division
Ministry of Health Malaysia
In collaboration with
Family Health Division of the Public Health Department
And Dental Health Division
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Copyright © Ministry of Health Malaysia
All rights reserved. This book may not be reproduced,

in whole or in part, in any form or means,
electronic or mechanical, including photocopying,
recording, or by any information storage an
retrieval system now known or here after
invented, without written permission from the publisher.
First Edition 2013
Produced & Distributed by :

Medical Care Quality Section
Medical Development Division
In Collaboration with
Family Health Division of the Public Health Department
and Dental Health Divison,
Level 4, Block E1, Parcel E,
Federal Government Administrative Centre
62590 Putrajaya
ISBN 978 - 967 - 0399 - 17 - 1

ACKNOWLEDGEMENT
The authors would like to gratefully acknowledge the following individuals and
organizations, whose works have been referred to, in the preparation of this
manual:
• The World Health Organisation, for the WHO Draft Guidelines for
Adverse Event Reporting and Learning Systems 2005 (primary authors :
Professor Lucian Leape and Dr. Susan Abookire)
• The Ministry of Health New Zealand "Reportable Events Guidelines 2001"
• Prof. Stuart Emslie, formerly of the National Audit Office, UK, editor of
the NHS document "Doing Less Harm" and WHO Consultant for Patient
Safety, Malaysia, who developed the Incident Reporting manual, Root
Cause Analysis Framework and provided his invaluable guidance to the
Kuala Lumpur Hospital team during the pilot and follow-up of the Incident
Reporting Manual.
• Dato' Dr. Zaininiah bt. Mohd Zain, Director of Kuala Lumpur Hospital
and her team at the Quality Unit, for their untiring efforts in piloting the
Incident Reporting programme in HKL and producing the HKL Incident
Reporting Guidelines.
3
• Dr. Ng Siew Hian and Dr. Tai Li Ling, principal authors of the 1998
Quality Manual entitled "Incident Reporting"
ADVISORS :
Dato' Sri Dr. Hasan bin Abdul Rahman
Director-General of Health Malaysia
Tan Sri Dato' Seri Dr. Hj. Mohd Ismail Merican

Director-General of Health Malaysia (2005-March 2011)
Datuk Dr. Noor Hisham bin Abdullah

Deputy Director-General of Health (Medical)
Dato' Dr. Maimunah bt. Abdul Hamid

Deputy Director-General of Health (Research & Technical Support)
Datuk Dr. Lokman Hakim bin Sulaiman

Deputy Director-General of Health (Public Health)
Dr. Khairiyah bt. Abdul Muttalib

Senior Director of Dental Health
Dato’ Dr. Norain bt. Abu Talib

4 Senior Director of Dental Health ( Until Dec 2011 )
Dato’ Eisah bt. A.Rahman

Senior Director of Pharmaceutical Services
Dato’ Hjh. Fathilah bt. Hj. Abd. Wahab

Director of Nursing Services
Dato' Dr. Azmi bin Shapie

Director of Medical Development, Medical Development Division
Dr. Hjh. Safurah binti Jaafar

Director of Family Health Development, Family Health Development Division
Datuk Dr. Harjit Singh a/l Pritam Singh

Senior Consultant Surgeon and Head of Surgical Department,
Hospital Selayang
National Head of Surgical Services
Dato' Dr. Jeyaindran a/l Tan Sri Sinnadurai

Senior Consultant Physician and Head of Medical Department,
Hospital Kuala Lumpur
National Head of Medical Services
Dato' Dr. Jahizah binti Hassan

Senior Consultant Anaesthetist and Head of Anesthesia Department,
Hospital Pulau Pinang
National Head of Cardiac Anesthesia Services
Dato' Dr. Ghazali bin Ahmad

Senior Consultant Physician and Head of Nephrology Department,
National Head of Nephrology Services
Dato' Dr. Ravichandran a/l Jeganathan

Senior Consultant Obstetrician and Head of O&G Department,
Hospital Sultanah Aminah, Johor Bahru
National Head of O & G Services
Datin Dr. V. Sivasakthi

Senior Consultant Anaesthetist and Head of Anesthesia Department,
National Head of Anesthesiology Services
Dato’ Dr. Hussein Imam bin Muhammad Ismail

Senior Consultant Physician and Head of Paediatric Department,
National Head of Paediatric Services
Dr. Siti Zaleha binti Mohd Salleh

Director, Hospital Selayang
Dato' Dr. Abdul Jamil bin Abdullah

Senior Consultant Surgeon and Head of Surgical Department,
Hospital Sultanah Nur Zahirah, Kuala Terengganu
Dato' Dr. Ravindran a/l Jegasothy

Senior Consultant Obstetrician & Gynecologist and Head of O&G Department,
Dr. Kauthaman a/l Mahendran

Senior Consultant Physician and Head of Medical Department, Hospital Melaka
5
Dr. Tan Kah Kee

Senior Consultant Physician and Head of Paediatric Department,
Hospital Tuanku Jaafar, Seremban
Dr. Wan Jazilah binti Wan Ismail

Consultant Physician and Head of Paediatric Department, Hospital Selayang
Dr. Valyakalayil Daniel Philip

Consultant Obstetrician & Gynecologist, Hospital Selayang
PRINCIPAL AUTHORS :
Dr. PAA Mohamed Nazir bin Abdul Rahman
Public Health Physician and Senior Principal Assistant Director
Medical Care Quality Section, Medical Development Division, MOH
Dr. Lily Manoramah

Consultant Pathologist, Hospital Kuala Lumpur
Dr. Kalsom binti Maskon

Public Health Physician and Senior Duputy Director
6
CONTRIBUTING AUTHORS :
Dr. Kamaliah bt. Mohamad Noh
Public Health Physician and Senior Deputy Director
Primary Health Care Section, Family Health Development Division, MOH
Dr. Nor ‘Aishah bt. Abu Bakar

Medical Care Quality Section Medical Development Division, MOH
Dr. Nik Jasmin bt. Nik Mahir

Special Officer to the Director-General of Health Malaysia
Dr. Amin Sah bin Ahmad

Dr. Noraini binti Mohd Yusof

Dr Noridah binti Mohd Saleh

Dr. Khurul Ain bt. Ahmad Samsuri

Principal Assistant Director
Medical Care Quality Section, Medical Development Division MOH
Dr. Zurina bt. Abu Bakar, Dental Health Division, MOH
Dr. Savithri a/p Vengadasalam, Dental Health Division, MOH 7
Dr. Nuryastri bt. Md Mustaffa, Dental Health Division, MOH
Tuan Hj. Saidi b. Abd. Rahman

Assistant Medical Officer
Secretariat:
Sr. Rashidah binti Ngah

Nursing Sister
GENERAL OBJECTIVES :
To facilitate a learning organisation through the reporting of and learning from
adverse incidents, "near misses" and hazards so that a just and safe culture will be
nurtured amongst health care providers, in our efforts to enhance the safety of the
Malaysian health care system.
SPECIFIC OBJECTIVES :
• to implement a key component of the MOH Clinical Governance
Framework
• to reinforce the principle that in clinical governance, it is the responsibility of

every health care leader to manage events while ensuring that his/her
organization monitors and acts on the incidents that can potentially compromise
patient safety
8 • to ensure that all staff are empowered to alert the organization to problems
that can affect the safety of health care provided
• to facilitate hospital management to set up systems for identifying, reporting

and managing "incidents" i.e. reportable events
• to provide a basis for which everyone concerned can review and further
improve on their own event reporting system
• to ensure the sharing of lessons learnt from incidents, root cause analyses and
good practices in patient safety
• to facilitate patient safety efforts including the reduction of risk to patients

TABLE OF CONTENTS PAGE

1. Introduction to Incident Reporting, Management and 11
Learning
2. The Malaysian Incident Reporting and Learning System 14
3. Success in Incident Reporting 18

4. Key Requirements for Health Care Providers 20
5. IR1.1 form 23
6. Mandatory Reportable Incidents (Code No.Included): 26

Hospitals and Health Clinics/ Dental Clinics
7. Reportable Incidents : Guidance on Minimum 35

Investigation Level, Notification Time and Reporting Time
(for Hospitals and Health/ Dental Clinics)
8. Actions that need to be Taken Immediately After 39

Category Red or Yellow "Incident"
9. Investigation : Table 1.1 - Summary of the RCA Process 40
10. Investigation Reports to State and MOH 42
11. How to fill Part I of IR1.1 form- Section A-C (Staff Involved) 50
12. How to fill Part II of IR1.1 form - Section D 53
(Immediate Supervisor)
13. How to fill Part III of IR1.1 form - Section E 54
(Designated Person)
14. "Triaging" : 5 key steps in determining the level of 54 9

investigation response
15. How to fill Part III Section F of IR1.1 form - 61
(Designated Person)
16. Identifying contributing factors 62
17. How to fill Part III section G of IR1.1 form 69

(Designated Person)
18. How to fill Part IV section H of IR1.1 form (Head of 70

Department)
19. Flow chart : how to Investigate an incident 72
20. Annex II : Contributing Factors Framework and Codes - The 73

London Protocol
FOREWORD
The pursuit of quality and safety requires the institutionalization
of a culture of safety within the Malaysian health care system.
The first step is to do away with the present "blaming culture",
so pervasive in health care systems throughout the world, and
to replace it with a "just" or "non-punitive", learning culture. This
"just culture" is a collective understanding of the difference
between blameless and blameworthy actions. When things
go wrong during the process of health care, no one is
immediately blamed or summarily punished until a scientific
investigation is undertaken. When people are not afraid to
report adverse incidents, we will be able to collect data about incidents, analyse
them scientifically in a structured manner such as through Systems Analysis (also
called Root Cause Analysis), learn important lessons from them and, in the process,
improve our systems and processes.
Experts agree that knowledge of how to prevent harm to patients during

treatment and care is amongst the most important knowledge in the field of
10 patient safety. One of the accepted best practices for patient safety is to establish
a "No Blame, Reporting culture" by initiating an Incident Reporting and Learning
System for adverse events. Through the systems approach and human factor
analysis pioneered by Dr. James Reason, it is known that many safety problems
are not just a series of random, unconnected one-off events but are provoked by
weak systems. They often have common root causes which can be generalized
and corrected, if they are reported and analysed. Learning from the mistakes of
others is a key tool for patient safety and thus, "a clever person learns from his or her
mistakes while a wise person learns from the mistakes of others". Bear in mind also
that information must lead to meaningful action. Critically, it is the action we take
in response to reporting - not reporting itself - that leads to change and safer care.
On its own, Incident Reporting will not provide a complete picture of all
sources of risk and patient harm. Thus, other sources of patient safety information
should also be used e.g. periodic medical record review for preventable adverse
events, clinical audit, monitoring safety using patient safety indicators etc. The
value of our patient safety efforts will ultimately be measured in terms of harm
prevented and lives saved. It is hoped that effective patient safety reporting
systems will help to make this a reality for our patients.
Dato' Sri Dr. Hasan bin Abdul Rahman

Director-General of Health Malaysia and
Chairman of the Patient Safety Council of Malaysia
1. INTRODUCTION TO INCIDENT
REPORTING, MANAGEMENT AND
LEARNING
In 2004, the World Alliance for Patient Safety movement was launched by the
WHO to galvanize and facilitate global efforts to make health care safer. Incident
Reporting, also known as Adverse Event Reporting or Event Reporting, has been
widely-regarded as an essential step towards the development of a safe health
care system, whereby lessons learnt from mishaps, near misses and hazards can be
used to prevent future occurrences.
According to the World Health Organization, to improve safety, health-care

systems must :
• learn from their mistakes.
• advise others when a mishap occurs,
• share what they have learned when an investigation has been carried
out.
This is to prevent the same mistakes and preventable patient harm from occurring
repeatedly. At the very least, reporting can help identify hazards and risks (through
a "Risk Register"), and provide information as to where the system is breaking down.
This can help target improvement efforts and systems changes to reduce the
likelihood of injury to future patients.
A reporting system refers to the processes and technology involved in the

standardization, formatting, communication, feedback, analysis, learning,
response, and dissemination of lessons learned from reported events.
This manual focuses on reporting and learning to improve the safety of patient
11
care in the Malaysian health care system through Incident Reporting, which is an
important component of the Malaysian Clinical Governance Framework. Safety
experts believe that an effective reporting system is a key element of safe practice
and reflects progress towards achieving a safety culture.
1a. Reasons for reporting:
Having a reporting system ensures that there is:
• an accountability mechanism
• evidence of a standardized incident investigation, analysis
and reporting system
• evidence of a systematic approach to the implementation of
safety procedures
• an audit trail
• a record of risks and information for the organisation's knowledge
base
(adapted from the New Zealand Ministry of Health

Document, "Reportable Event Guidelines 2001)
Reporting systems should be established at the department, hospital, state and

national levels. Within a health-care institution, reporting of a serious event or serious
"near-miss" should trigger an investigation to identify underlying systems failures (e.g.
through Root Cause Analysis) and lead to efforts to prevent recurrence e.g.
through the redesign of systems.
The primary purpose of patient safety reporting systems is to learn from experience.
It is important to note that reporting in itself does not improve safety. IT IS THE
RESPONSE TO REPORTS THAT LEADS TO CHANGE. Thus, the response system is more
important than the reporting system.
1b. Definition of Terms

(WHO Draft Guidelines for Adverse Event Reporting & Learning Systems 2005)
No. Term Definition
i. Safety Freedom from accidental injuries.
ii. Error The failure of a planned action to be completed as

intended (i.e. error of execution) or the use of a wrong
plan to achieve an aim (i.e. error of planning). Errors may
be errors of commission or omission, and usually reflect
12 deficiencies in the systems of care.
iii. Incident Any deviation from usual medical care that causes an
(or adverse injury to the patient or poses a risk of harm. Includes
incident) errors, preventable adverse events, and hazards.
iv. Adverse event An injury related to medical management, rather than

the complications of disease.
Medical management includes all aspects of care,
including diagnosis and treatment, failure to diagnose or
treat, and the systems and equipment used to
deliver care.
Adverse events may be preventable or non-preventable.
v. "Near-miss" Serious error or mishap that has the potential to cause

or "close call" an adverse event but fails to do so because of chance
or because it is intercepted. Also called potential
adverse event.
vi Hazard Any threat to safety, e.g. unsafe practices, conduct,

equipment, labels, names.
vi. System A set of interdependent elements (people, processes,

equipment) that interact to achieve a common aim.
1c. Why should individuals or health care organizations report adverse events
and errors?
Health care organizations or individuals benefit from reporting incidents if they
receive back useful information gained by generalizing and analysing similar cases
from other institutions. The International Society for Quality in Health Care or ISQua
had previously included in its ISQua journal, a segment entitled "Every Defect is a
Treasure", which means that there are opportunities for learning from medical
mishaps.
Consider the following example:
In an intensive care unit at a hospital, the oxygen tubing is accidentally connected

to an intravenous line and causes an air embolism. A "Root Cause Analysis" (RCA)
investigation reveals that the tubing connectors are similar, the oxygen tubing had
been left disconnected from a prior respiratory treatment, and the lights in the unit
were dim. The hospital's response might include implementing a new policy
requiring that all tubing be labeled, a "weak" solution.
If the event and the results of the analysis are not reported, the lessons learned
remain within the walls of that health care facility. A learning opportunity is lost.
However, if the event is reported and the findings from the investigation are
entered into a database, the event can be aggregated with similar incidents to
elucidate common underlying causes.
A variety of solutions could emerge, ranging from nursing practice standards to

label and trace all tubing, to a requirement for medical device manufacturers to
develop incompatible connectors for all medical tubing.
1d. Core principles:
The core principles underlying these guidelines are:
• The fundamental role of patient safety reporting systems is to enhance

patient safety by learning from failures of the health-care system. The
system is oriented towards learning from mistakes and preventing
recurrences of adverse events that have happened.
• Openness about failures -Individuals who report incidents must not be

punished or suffer other ill-effects from reporting("non-blaming" or
"non-punitive culture"). Errors are reported and acknowledged without 13
fear of inap propriate blame, and thus, this is part of the Just Culture,
where individuals are treated fairly and understand when they may be
held accountable for their actions.
• Reporting is only of value if it leads to "action". At a minimum, data

collecting agencies must provide feedback of findings from data analysis.
Ideally, it also includes recommendations for changes in processes and
systems of healthcare. Appropriate prioritisation of action to address
problems occurs when resources are directed to those areas where the
greatest improvements are possible. The most important function of a
reporting system is to use the results of data analysis and investigation
to formulate and disseminate recommendations for systems change.
• Teamwork is recognized as the best defense of system failures and is

explicitly encouraged and fostered within a culture of trust and mutual
respect.
• Adverse events and errors are recognized as symptoms of defective

systems, not defects in themselves.
2. THE MALAYSIAN INCIDENT REPORTING

AND LEARNING SYSTEM
2.1 The Malaysian IR System as a Learning system
This is a national reporting system for the reporting of incidents in Malaysian health
care facility. It is a confidential system (patients' and caregivers' names are not to
be disclosed).
The Reporting System has been developed to provide information to improve

patient safety by focusing on learning and contributing to system re-design.
Experience has shown that learning systems are most successful when reports are
confidential. From a pragmatic standpoint, protecting the confidentiality of health-
care organizations significantly enhances participation in reporting.
The Malaysian Incident Reporting and Learning System consists of the following:
• a mandatory list of "must report" incidents ("external system")

• all appropriate voluntary incidents : usually consisting of "near misses",
14 "hazards" and other "incidents" not in the "mandatory" list
("internal system")
The Malaysian reporting system form IR1.1, is a combination of structured i.e.

requiring standardized types of information as well as providing for a narrative
description of events for analysis. Narrative reports provide the opportunity to
capture the rich context and story-line that allow the conditions that contributed
to the error to be explored and understood. They are capable of providing
information that provides meaningful insight into the nature of the underlying
systems defects that caused the incident.
Rather than assure a minimum standard of care, learning systems are designed to
foster continuous improvements in care delivery by identifying themes, reducing
variation, facilitating the sharing of best practices, and stimulating system-wide
improvements. Following careful expert analysis of underlying causes through mini-
root cause analysis (RCA) or full RCA, recommendations are made for system
re-design to improve performance and reduce errors and injuries.
2.1.1 The Malaysian IR System as a MANDATORY (must report) reporting system
• The mandatory reporting system focuses on a number of pre-defined

"incidents" such as serious injuries or adverse events.
• Incidents not in the pre-defined list, "near misses" (or "close calls") as well
as “hazards" are reported using the voluntary reporting system that
should be established by health care organizations together with the
mandatory system. The same reporting form (IR1.1) is to be used for the
mandatory as well as voluntary reporting systems
2.1.1a Adverse events (preventable and non-preventable):

An adverse events is an injury related to medical management, in contrast
to complications of a disease.
Adverse events are not always caused by an error (non-preventable

AE). For example, one form of adverse drug event, "adverse drug reaction"
is, according to the WHO definition, a complication that occurs when the
medication is used as directed and in the usual dosage. Adverse drug
reactions are, therefore, adverse drug events that are not caused by
errors. However, many adverse events are caused by errors (preventable
AE), either of commission or omission, and do, in fact, reflect deficiencies
in the systems of care.
2.2 Additional "internal" reporting of incidents
An organization that values patient safety will have an internal reporting system
that captures much more than what the mandatory system requires, i.e.other
adverse events that are not in the mandatory list, "near-misses" as well as hazards.
These can be listed in a "Risk Register" for the organization as it identifies its
vulnerabilities with regard to patient safety.
2.2a "Near-misses" or "close calls"
A "near miss" or "close call" is a serious error or mishap that has the
potential to cause an adverse event, but fails to do so because, by the
grace of God, it was intercepted in time before any damage could occur.
It is assumed (though not proven) that the underlying systems failures for
near-misses are the same as that for actual adverse events. Therefore,
understanding their causes should lead to systems design changes that
will improve safety.
15
A key advantage of a near miss reporting system is that, because there
has been no harm to the patient, the reporter is not at risk of blame or
litigation. On the contrary, he or she may be deserving of praise for having
intercepted an error and prevented an injury! Thus, near-miss reporting
systems are an important component of incident reporting.
2.2b Hazards and unsafe conditions:
Reporting of hazards, or "accidents waiting to happen" is another way to

achieve prevention without the need to learn from an injury. Within a
health-care organization, hazard reports raise alerts about unsafe
conditions. Providers can imagine accidents waiting to happen based on
their observations of weakness in the system and their experience as
users. With appropriate analysis, these reports can provide valuable
information for changes to systems design. The Institute for Safe
Medication Practices USA system for medication-related events has been
considered as the most successful at capturing hazards (e.g. "look-alike"
packaging and "sound- alike" names) and calling for their remedy before
a predictable error occurs.
The objectives of an internal reporting system for learning are first, to identify errors
and hazards, and then through investigation, to uncover the underlying systems
failures, with the goal of redesigning systems to reduce the likelihood of future
patient injury.
Reporting, whether retrospective (adverse events and errors) or prospective

("hazards", or "errors waiting to happen") provides the entry point into investigation
and analysis of systems' defects, which, if skillfully done, can lead to substantial
system improvements. Reporting is one way to get this type of information, but not
the only way.
The internal reporting systems should go hand-in-hand with external reporting

systems, by identifying and analysing events that warrant forwarding to external
reporting agencies such as the MOH head-quarters. Conversely, external reporting
systems are most effective when they are an extension of internal systems.
2.3 Learning from reporting
Reporting can lead to learning and improved safety through:
2.3.1 Generation of "alerts" regarding significant new hazards, for example,

16 complications of a new drug.
2.3.2 Dissemination of "lessons learnt" by health-care organizations from
investigating a serious event.
2.3.3 Analysis of many reports can reveal unrecognized trends and
hazards requiring attention, insights into underlying systems failures
and generate recommendations for "best practices" for all to
follow.
2.3.1 Alerts
Even a small number of reports can provide sufficient data to enable expert
analysts to recognize a significant new hazard and generate an alert e.g. the series
of warnings issued every 2 weeks by the Institute for Safe Medication Practices
entitled "Medication Alert", which was one of the first to highlight the high risk of
death following accidental injection of concentrated potassium chloride and
recommend that this substance be removed from patient care units.
Sir Liam Donaldson, Chairperson of the World Alliance for Patient Safety and a key
proponent of patient safety in the world, has exhorted the health care community
to work hard to ensure that it passes the "orange-wire test". Hypothetically, he asks
us to imagine that an orange coloured wire that is necessary for the safe
functioning of a jet aircraft, was found to be damaged. This damage was not due
to routine wear and tear, but rather, due to a critical fault. In the aviation industry,
what would probably happen following this discovery is that, within days, world-
wide, most similar jet engines would be inspected and the orange wire, if faulty,
would be renewed. This represents the sharing of critical safety information and is
a powerful element of the vision behind the WHO World Alliance for Patient Safety.
The hope for the health care industry is that, one day, it may be possible for the bad
experience suffered by a patient in one part of the world to be a source of
transmitted learning that benefits future patients in many other countries.
2.3.2 Investigation of serious events
A serious (especially disabling or life-threatening) event (sometimes called a

"sentinel event") will trigger an investigation to search for underlying causes and
contributing factors. Ideally, every institution will respond to a serious event with an
investigation (e.g. RCA or mini RCA).
Alternatively, an external authority (such as the MOH) can conduct an

independent investigation. If the investigation is done well, systems analysis of a
serious adverse event can yield significant insights into the various contributing
factors that lead to a mishap, and often suggest potential remedies. This
information can then be disseminated to other organizations. Solutions to some
common hazards, such as wrong site surgery, have been developed in response to
lessons learned from investigations of serious incidents.
2.3.3 Analysis of large data sets & Systems analysis and development of
recommendations
Detailed analysis of many individual reports also makes it possible to identify

hazards. The most important function that a large reporting system can perform is
to use the results of investigations and data analyses to formulate and disseminate
recommendations for systems changes. Examples include the Joint Commission of
the USA, which has performed this function using a relatively small number of
thoroughly-investigated incidents reported to its "Sentinel Events" monitoring
programme.
17
3. SUCCESS IN INCIDENT REPORTING

The ultimate measure of the success of a reporting system is whether the
information it yields is used appropriately to improve patient safety.
A successful reporting and learning system to enhance patient safety should have
the following characteristics:
• reporting is safe (i.e. non-punitive) for the individuals who report;

• reporting leads to a constructive response;
• expertise and adequate financial resources are available to allow for
meaningful analysis of reports;
• the reporting system must be capable of disseminating information on
hazards and recommendations for changes.
The reporting of incidents is most effective when the data collected are analysed
(at local, regional as well as national levels) and recommendations are
disseminated and acted upon by those with the responsibility and mandate to act.
3.1 Safe or Non-punitive

18
The most important characteristic for success of a patient safety reporting system is
that it must be non-punitive. Neither reporters nor others involved in the incidents
can be punished as a result of reporting. For public systems, this requirement is the
most difficult to achieve, since the public often assumes an individual is to blame,
and there can be strong pressure to punish the "culprit". According to the WHO, this
approach is doomed to fail even though it is emotionally satisfying, temporarily.
People will not report any errors they can hide. Thus, it is important for national
systems to protect reporters from blame. The best way to do this is by keeping the
reports confidential.
3.2 Confidential
The identities of the patient and reporter must never be revealed to any third party.
At the institutional level, confidentiality also refers to not making public specific
information that can be used in litigation. Concern about disclosure is a major
factor inhibiting reporting for many voluntary reporting programmes.
3.3 Independent
According to the WHO, the reporting system should be independent of any
authority with the power to punish the reporter or organization with a stake in the
outcome. Maintaining a "firewall" between the reporting agency and the
disciplinary agency in a governmental system can be difficult, but it is considered
essential by the WHO if trust in reporting is to be maintained.
3.4 Expert analysis

Reports must be evaluated (during the RCA) by experts who understand the
clinical circumstances under which the incidents occur and who are trained to
recognize underlying systems causes. According to the WHO, while it seems
obvious that collecting data and not analysing it is of little value, the most common
failure of governmentally-run reporting systems is to require reporting but not to
provide the resources needed to analyse the reports, resulting in the reports being
kept in boxes or on computers. Expertise is a major, and essential, resource
requirement for any reporting system.
3.5 Timely
When serious hazards are identified, notification should take place rapidly.
Recommendations must be promptly disseminated to those who need to know.
For example, the Institute for Safe Medication Practice issues prompt alerts through
its regular publication when new hazards in drugs are discovered.
3.6 Systems-oriented
Recommendations should focus on changes in systems, processes or products,
rather than being targeted at individual performance. This is a cardinal principle of
safety that must be reinforced by the nature of recommendations that come from
any reporting system. It is based on the concept that individual error results from
systems defects, and will recure with another person at another time if those
systems defects are not remedied.
3.7 Responsive
For recommendations to result in widespread systems changes, the organization
receiving the reports (such as the hospital, State Health Department and the MOH
headquarters) must be capable of making and disseminating effective
recommendations. Hospitals and States must also be committed to implement
recommendations, where applicable (and possible) at their level.
19
Recommendations that require the attention of the MOH headquarters must be
speedily attended to.
4. POLICY DIRECTIVE : KEY REQUIREMENTS

FOR HEALTH CARE PROVIDERS
The purpose of this Incident Reporting and Learning Policy Directive is to advise
clinicians and managers on how to respond effectively to all incidents that occur
in their organisation. The following are key local requirements in this policy directive:
i. The organization has a written policy requiring its staff to document

events that are deemed "reportable" (i.e. the mandatory list as well as
any incidents not listed in the mandatory list".
ii. The written policy must reinforce the stand that incident reporting is a
patient safety tool and is not to be used as a punitive tool by managers
etc.
iii. Every health care provider must be made aware of what constitutes an
adverse patient incident (i.e. she must know the "mandatory" incidents to
be reported). Organisations should actively promote awareness and
understanding of adverse patient incidents to all individuals directly or
indirectly involved in patient care. This can be effected through, for
20 example, induction and on-going training programmes, and poster
campaigns, and could be a consideration as part of the ongoing job
appraisal processes.
iv. The incident is managed and reported to a designated person, or

persons, in accordance with local arrangements. The following persons
can fill in the incident reports:
a. the employee/staff member who first becomes aware of the

event
b. the employee/staff member most involved in the event
c. the employee/staff member to whom an event is reported (if a
form is not already completed)
v. All serious incidents (Category Red or **"Sentinel event") are reported

immediately to a locally designated person, or persons, and, where
appropriate, information on these incidents is 'fast-tracked' to relevant
external stakeholders (e.g. State Health Office and Medical Care Quality
Section, Medical Development Division, MOH).
vi. All reported incidents are graded ("triaged") using the prioritisation
matrix that grades incidents according to the actual impact on the
patient(s), and the potential future risk to patients and to the
organization.
vii. Adverse patient incidents are subject to an appropriate level of local

investigation and causal analysis and, where relevant, an improvement
strategy is prepared.
viii. Incidents graded as RED, are reported to the relevant State Health
Departments within five working days of the date of occurrence.
ix. For all CATEGORY RED incidents and sentinel events, a full root cause
analysis is undertaken by the local organisation and reported to the
relevant State Health Departments within 60 working days of occurrence
of the incident.
x. Where appropriate, the organisation co-operates with the Ministry of
Health to establish the need for an independent investigation or
inquiry, and also co-operates with other stakeholders who might be
required to undertake investigations and/ or inquiries into the
circumstances surrounding a particular adverse patient incident.
xi. Aggregate reviews of local incident data are carried out on an on-going
basis by the organisation and the significant results communicated to
local stakeholders. Aggregate review reports are sent to the Medical
Care Quality Section, Medical Development Division, MOH on a 3 monthly
basis.
xii. Prevention of Incident recurrence:
When a root cause or contributory factors have been identified and
documented, responsibility must be allocated for developing an action
plan to address them. The recommended action plan includes: person
responsible, actions needed to develop and implement the plan, the
required timeline for implementation, methods to assess the effectiveness
of the actions. If the resolution of the problem requires organization- wide
changes, there is a process for referring it to the appropriate forum. There
are also systems to ensure that the recommended actions are
communicated to staff /employees.
xiii. Improvement strategies aimed at reducing risk to future patients are
implemented and monitored by the organisation. Where appropriate,
local staff learn lessons and change practice in order to improve the
safety and quality of care for patients.
xiv. Lessons are learned from individual adverse patient incidents, from local
aggregate reviews and from wider experience, including feedback from 21
the MOH, other agencies/bodies (e.g. the MSQH), and benchmarking
** Sentinel event : an undesired event that signals something serious or "sentinel" has
occurred and warrants in-depth investigation. Characteristics of a sentinel event
include:
• Major system failure
• Multiple teams, departments or services are involved
• The potential for serious adverse media attention
• The potential to seriously undermine public confidence
Examples of sentinel events include an event which has resulted in an
unanticipated death or major permanent loss of function not related to the natural
course of the patient's illness/underlying condition (MOH New Zealand 2001)
INCIDENT
REPORTING
FORM IR1.1
CONFIDENTIAL FORM IR1.1
PATIENT SAFETY INCIDENT- MANAGEMENT & REPORTING FORM

Part I - Initial Report
A. Incident particulars (refer to guidance notes for sentinel event and incident codes)
Enter Incident Code
24 hour clock
Date of incident D D M M Y Y Time of Incident H H M M Date of reporting D D M M Y Y
Unit/Dept. Location where

incident happened
Specialties involved
B. Patient particulars
Name Male Female Inpatient Outpatient
ID/Passport No. RN
Date of admission D D M M Y Y Admission Diagnosis

24
Date of Birth
Age
Race Communication problem with patient? Yes No
Native language Language used to communicate
C. Incident description
Provide a brief description of the incident, other people involved (including staff), any harm suffered by patient
and any immediate staff response. Please state facts and not opinion.
People Involved : Patient Family Staff
Any Harm suffered : No Yes If yes, what type of harm : ................................................................
Brief description of the incident :
Immediate correction :
Full name
Designation
Continue on separate sheet if necessary.
PART II - Immediate Supervisor Report(e.g. specialist, consultant, ward manager, matron, etc.)
D. Further action to prevent similar incident/ to reduce risk
Provide a brief description of any action taken to prevent similar incident
Full Name
Designation Date
Official Use Only : Date received _____________ Incident Reference __________________

Part III - Designated Person Report (Full name _________________________________ Date__________)
E. Investigation priority assessment (triage) and response

1. Actual patient impact/outcome (circle appropriate box/ number) 4. Circle the A P Response
None Minor Moderate Major Death A(Actual H H Full RCA
L M M H H impact) and H M Mini RCA*
P(Potential
H L Mini RCA*
risk) boxes.
M H Mini RCA
2. Duration of impact Temp. Permanent N/A Unsure M M Mini RCA
* A full RCA M L Minimal
3. Potential risk to future patients and organisation if no further action may be
L H Mini RCA
taken (circle) required for
Most likely Impact/ Outcome L M Minimal
accountabilit
Likelihood None Minor Moderate Major Death L L None
y purposes.
Almost certain L M M H H
5. Investigation response
Likely L M M H H
Suggested Actual
Possible L M M M M None
*Unlikely L L M M M
Minimal
Remote L L L L L
Mini RCA
L = Low, M = Moderate, H = High Full RCA
F. Contributing factors (write / select codes from list and attach copy of RCA report or fishbone diagram)
1 Patient
2 Task and technology
3 Individual staff
4 Team
5 Work and care environment
6 Management and organisational
7 External
G. Further action proposed to reduce risk (write or attach a copy of RCA report or action plan)
No Description Person responsible Date action completed
25
1
PART IV - Head of Department Comments
H. Organisational impact/outcomes, learning points and general comments
Full name
Designation Date
Continue on a separate sheet if necessary.

MANDATORY REPORTABLE
INCIDENTS (HOSPITALS)
A. “ALL LOCATIONS”
Code Data to be
Incident Definition
No: reported
1. Adverse outcome of Outcomes that are not intended Number of cases
clinical procedures or desired to occur as a result of
(includes known performing a particular
complications): procedure. (e.g. Pneumothorax
following central venous access,
GIT perforation following
endoscopy, perforation of bowel
following peritoneal dialysis
catheter insertion etc.
*2. Death of patient by Applies to death in health care Number of cases

unexplained cause or facility only
under suspicious
26 circumstances that are
required to be reported to
police
*3 Unforeseeable or Number of cases

unanticipated injuries to
patients during their stay in
3a. hospital:
Brain or spinal cord injuries

3b.
Falls resulting in fractures,
concussions or lacerations
extending beyond the
epidermis into deep tissue
or which threaten vital
structures
3c.
Life-threatening (or
potentially fatal) transfusion
errors or reactions
3d. 2nd or 3rd degree burns

involving 20% more of the
body surface area of an
adult or 15% or more of the
body surface area of a
child
*4. Fire in hospital resulting in Number of

death or injury injuries or death
Code Data to be
Incident Definition
No: reported
*5. Malfunction / intentional or (e.g. wrong ventilator setting, Number of cases

accidental misuse of diathermy burn etc.)
patient care equipment Number of cases
that occurs during
treatment or diagnosis of
patient and that was
averted, OR, IF NOT
AVERTED, would have
significantly adversely
affected patients or
employees of the hospital
*6. Assault or battery of Number of cases
patients by employees
and/or contractors (e.g.
security personnel)
including physical, mental
or emotional abuse,
7. Dislodgement of catheter/ Includes CVP/ chest drains/ Number of cases

tube resulting in serious intra-arterial catheters)
harm/danger to patient's
life
8. Infant discharged to the Number of cases

wrong person / missing
infant
9. Patient suicide, or
Number of cases
attempted suicide while
being cared for in a health
care facility
10. Patient death or serious

27
Number of cases
disability due to electric
shock while being cared
for in a health care facility
11. Patient death or serious Number of cases

disability associated with
the use of restraints or
bedrails while being cared
for in a health care facility
12. Abduction of a patient (of Number of cases
any age)
13. Medication error resulting in A serious AE is one where there is Number of cases
serious adverse much pain and suffering or
event/death temporary / permanent disability
B. OPERATION THEATRE / ANESTHESIA

Code Data to be
No: Incident Definition reported
14. Delayed discharge from "Delay" is considered as more Number of cases

the recovery room than (>) 2 hours in the recovery
following an operation due room
to complications arising
from surgery or anaesthesia
15. Wrong surgery Patient received unintended Number of cases

operation (e.g. Surgery
performed on the wrong body
part, surgery performed on the
wrong patient, wrong surgical
procedure performed on a
patient, wrong site, wrong level
operated on etc.)
16. Unplanned return to OT e.g. Re-laporatomy to secure Number of cases

within 24 hours of surgery haemostasis following
for elective case cholecystectomy
Note: Patient must be sent back
to e.g. the ward first for a "return"
to OT happen.
28 17. No consent or improper

operation consent
**Excluded are: changes in Number of cases
operative plan due to intra-op.
findings
Life-threatening (or e.g. 1 : Failed intubation in Number of cases

*18. patients undergoing general
potentially fatal)
complications of anaesthesia (Inability to secure
anaesthesia endo-tracheal intubation after
two attempts by skilled operator)
e.g. 2 : Aspiration of gastric
contents (A clinical diagnosis
supported by signs e.g. diffuse
crepitations and rhonchi, after
exclusion of other causes.
e.g. 3 : Re-intubation in the
operation room or recovery
room such as inadequate
reversal, overdose of opioids
19. Unintended retention of a Number of cases
foreign object in a patient
after surgery or other
procedure
20. Incorrect Instrument or Instrument or Swab Count which Number of cases

Swab Count is not reconciled at the end of
an operation
21. Surgery Cancelled in OT Elective and emergency surgery Number of cases

cancelled before patient arrived
in OT is not included
C. CRITICAL CARE AREAS

Code Data to be
No: Incident Definition reported
22. Readmission to ICU within Patients who had been Number of cases
24 hours of discharge to discharged from ICU to general
ward ward, now requires readmission
to ICU within 24 hours of the
discharge to ward
participating in National ICU
Audit)
D. LABOUR ROOM
23. Delay in delivery of patients Decision for delivery interval Number of cases
with cord prolapse where should be less than 30 minutes
the fetus is alive
24. Injury to neonate at Includes any type of injury

delivery suffered by the infant during the Number of cases
process of delivery irrespective
of the mode of delivery
25. Unplanned admission of Admission that is not an Number of cases

mother to ICU/CCU/HDW expected outcome of delivery.
Excludes cases of placenta
post-delivery praevia and heart disease in
pregnancy
26. Unplanned post-delivery e.g. Caesarian hysterectomy, Number of cases

procedure on mother EUA / laparotomy for cervical
tear post-delivery, re-EUA after
MRP
27. Failed instrumental delivery An unsuccessful delivery is one in Number of cases

which the doctor had to resort
to a Caesarian section following
failure to deliver using the initial 29
choice instrument
E. HEMODIALYSIS UNIT
Code Data to be
Incident Definition
No: reported
*28. Intra-dialytic death while Number of cases

on regular chronic
haemodialysis treatment
*29. Sero-conversion to positive Number of cases

Hepatitis B or Hepatitis C
while on dialysis treatment
* Incidents that are reported under the Private Healthcare Facilities and Services
Act 1998 and Regulations 2006 (also to be reported by MOH hospitals)
Incidents that green shaded are Sentinel events (equivalent to Category red and
30 require at least a mini-RCA or full RCA investigation)
Besides these mandatory incidents, organisations are encouraged to report and

learn from other incidents that are not listed in the mandatory list, through their
INTERNAL REPORTING SYSTEM, (which they will not need to report individually to the
MOH).
MANDATORY REPORTABLE INCIDENTS

(FOR “KLINIK KESIHATAN/ PERGIGIAN”)
Code Data to be
Incident Definition
No: reported
30. Incidents related to any Examples: Number of cases

clinical procedures in • vaccination given to the
"Klinik Kesihatan" wrong site, procedure done
at wrong site, etc.
• Adverse outcomes i.e.
outcomes that are not
intended or desired to occur as
a result of performing a
particular procedure
31. Malfunction / intentional or Number of cases

accidental misuse of
equipment / incidents
related to use of
equipment that occur
during treatment or
diagnosis of patient
32. Assault or battery of

Number of cases
patients by employees
and/or contractors (e.g.
security personnel)
including physical, mental
or emotional abuse,
mistreatment or harmful
neglect of any patient
33. Investigation Error An "Investigation error" has Number of cases

occurred if any of the following
were present at the time:
- An investigation was done but 31
the interpretation / action
taken was wrong
- Appropriate investigations
were not performed
- Inappropriate investigation
were performed
- No documentation on follow-
up of investigations ordered
- If the investigation results were
not reviewed or abnormality
was undetected
34. Diagnostic Error Incorrect diagnosis after clinical Number of cases

examination (history taking and
physical examination) or
technical diagnostic procedures
Code Data to be
Incident Definition
No: reported
35. Decision-making Error Occurs if one of the following is Number of cases

present
• Inappropriate interval of
follow-up appointment
(includes cases where there
was no follow-up
appointment given when it
should have been given)
• Patient was sent home
inappropriately
• Inappropriate referral
• Patient required referral but
was not referred
36. Medication error resulting in Number of cases

serious adverse
event/death
Patient fall (while seeking Number of cases

37.
treatment in Klinik
Kesihatan)
32
Patient death or serious Number of cases
38.
disability due to electric
shock which occurred
while he/she was at the
Klinik Kesihatan
Fire in Klinik Kesihatan Number of

39.
resulting in death or injury injuries or death
Box 1 - HOSPITAL SENTINEL EVENTS

( Serious events i.e. CATEGORY RED that require urgent reporting and
investigation (mini /full RCA )
Sentinel Event Name Code
• Death of patient by unexplained cause or under suspicious circumstances 2
that are required to be reported to police
Unforeseeable or unanticipated injuries by patients during their stay in hospital: 3

• brain or spinal cord injuries 3a
• falls resulting in fractures, concussions or lacerations extending beyond the 3b

epidermis into deep tissue or which threaten vital structures
• life-threatening (or potentially fatal) transfusion errors or reactions 3c
• 2nd or 3rd degree burns involving 20% more of the body surface area of an 3d
adult or 15% or more of the body surface area of a child
• Fire in hospital resulting in death or personnel injury 4
• Malfunction/ intentional or accidental misuse of patient care equipment 5

that occurs during treatment or diagnosis of patient and that was averted,
OR, IF NOT AVERTED, would have significantly adversely affected patients or
employees of the hospital
• Assault or battery of patients by employees and/or contractors (e.g. security 6

personnel) including physical, mental or emotional abuse, mistreatment or
harmful neglect of any patient
• Dislodgement of catheter resulting in serious harm/danger to patient's life 7
• Infant discharged to the wrong person/ missing infant 8
• Patient suicide, or attempted suicide, resulting in serious disability while being 9
cared for in a healthcare facility
• Patient death or serious disability due to electric shock while being cared for 10
in a healthcare facility 33
• Patient death or serious disability associated with the use of restraints or
11
bedrails while being cared for in a healthcare facility
• Abduction of a patient (of any age) 12
• Medication error resulting in serious adverse event/death 13
• Wrong surgery 15
• Life-threatening (or potentially fatal) complications of anaesthesia 18
• Unintended retention of a foreign object in a patient after surgery or other 19
procedure
• Delay in delivery of patients with cord prolapse where the fetus is alive 23
• Injury to neonate at delivery 24
• Intra-dialytic death while on regular chronic haemodialysis treatment 28
Box 2 - KLINIK KESIHATAN / KLINIK PERGIGIAN SENTINEL EVENTS

( Serious events i.e. category red that require urgent reporting and investigation
(mini /full RCA )
Sentinel Event Name Code
• Malfunction / intentional or accidental misuse of equipment / incidents 31.

related to use of equipment that occur during treatment or diagnosis of
patient
• Assault or battery of patients by employees and/or contractors (e.g. security 32.

personnel) including physical, mental or emotional abuse, mistreatment or
• Medication error resulting in serious adverse event/death 36.
• Patient fall (while seeking treatment in Klinik Kesihatan) 37.
• Patient death or serious disability due to electric shock which occurred while 38.
he/she was at the Klinik Kesihatan
• Fire in Klinik Kesihatan resulting in death or injury 39.
34
HOSPITALS REPORTABLE INCIDENTS CATEGORY :

(Please refer to Table 1.0 for Minimum Investigation Level, Notification Time and Reporting Time)
Recommended
Category
Code (depends on
Incident
No : severity of
outcome)
1. Unexpected adverse outcome of clinical procedures: Green/Yellow/

Red
*2. Death of patient by unexplained cause or under suspicious Red
circumstances that are required to be reported to police
*3a. Unforeseeable or unanticipated injuries by patients during their stay Red

in hospital:
brain or spinal cord injuries
3b. Falls resulting in fractures, concussions or lacerations extending Red

beyond the epidermis into deep tissue or which threaten vital
structures
3c. life-threatening (or potentially fatal) transfusion errors or reactions Red
3d. 2nd or 3rd degree burns involving 20% more of the body surface area Red
of an adult or 15% or more of the body surface area of a child
*4. Fire in hospital resulting in death or personnel injury Red
*5. Malfunction/ intentional or accidental misuse of patient care Red

equipment that occurs during treatment or diagnosis of patient
and that was averted, OR, IF NOT AVERTED, would have significantly
adversely affected patients or employees of the hospital
*6. Assault or battery of patients by EMPLOYEES Red

including physical, mental or emotional abuse, mistreatment or
35
7. Dislodgement of catheter resulting in serious harm/ danger to Red
patient's life
8. Infant discharged to the wrong person/ missing infant Red
9. Patient suicide, or attempted suicide, resulting in serious disability Red

while being cared for in a healthcare facility
10. Patient death or serious disability due to electric shock while being Red
cared for in a healthcare facility
11. Patient death or serious disability associated with the use of restraints Red
or bedrails while being cared for in a healthcare facility
12. Abduction of a patient (of any age) Red
13. Medication error resulting in serious adverse event/ death Red
14. Delayed discharge from the recovery room following an operation Green / Yellow
due to complications arising from surgery or anaesthesia / Red
15. Wrong Surgery Red
16. Unplanned return to OT within 24 hours of surgery for elective case Green / Yellow
Recommended
Code Category
Incident (depends on
No : severity of
outcome)
17. No consent or improper operation consent Green / Yellow
18. Life-threatening (or potentially fatal) complications of Red

anaesthesia
e.g. 1 : Failed intubation in patients undergoing general
anaesthesia (Inability to secure endotracheal intubation after
two attempts by skilled operator)
e.g. 2 : Aspiration of gastric contents (A clinical diagnosis
supported by signs e.g. diffuse crepitations and rhonchi, after
exclusion of other causes.
e.g. 3 : Re-intubation in the operation room or recovery room
(Re-intubation in the operating room or recovery room e.g.
inadequate reversal, overdose of opioids)
19. Unintended retention of a foreign object in a patient after Red

surgery or other procedure
20. Incorrect Instrument or Swab Count Green / Yellow

36 21. Surgery Cancelled in OT Green
22. Readmission to ICU within 24 hours of discharge to ward Green / Yellow
23. Delay in delivery of patients with cord prolapse where the fetus is Red
alive
24. Injury to neonate at delivery Yellow / Red
25. Unplanned admission of mother to ICU/ CCU/ HDW post-delivery Green / Yellow
26. Unplanned post-delivery procedure on mother Green
27. Failed instrumental delivery Green / Yellow
*28. Intradialytic death while on regular chronic haemodialysis Red

treatment
*29. Sero-conversion to positive Hepatitis B or Hepatitis C while on Green / Yellow

dialysis treatment
KLINIK KESIHATAN/ PERGIGIAN REPORTABLE INCIDENTS :

Please refer to Table 1.0 for Minimum Investigation Level, Notification Time and
Reporting Time
Recommended
Code Category
Incident (depends on severity
No :
of outcome)
30. Incidents related to any clinical procedures in Klinik Kesihatan/ Green / Yellow
Klinik Pergigian / Red
31. Malfunction/ intentional or accidental misuse of equipment/ Red

incidents related to use of equipment that occur during
treatment or diagnosis of patient
32. Assault or battery of patients by employees and/ or contractors Red

(e.g. security personnel)
including physical, mental or emotional abuse, mistreatment or
33. Investigation Error Green / Yellow

/ Red
34. Diagnostic Error Green / Yellow

/ Red
35. Decision-making Error Green / Yellow

/ Red
36. Medication error resulting in serious adverse event/ deat Red
37. Patient Fall (while seeking treatment in Klinik Kesihatan/ Klinik Red
Pergigian
38. Patient Death or serious disability due to electric shock which Red
occurred while he/she was at the Klinik Kesihatan/ Klinik Pergigian
37
39. Fire in Klinik Kesihatan/ Klinik Pergigian resulting in death or injury Red
38
Table 1.0 : Minimum Investigation Level, Notification Time and Reporting Time according to category
NOTIFICATION TIME MINIMUM Report to MOH

Investigation Report
(Borang Notifikasi Investigation (Matrix IR1.1
INCIDENT To State :
IR1.1) Required JKN) :
CATEGORY
HOSPITAL TO JKN HOSPITAL TO JKN JKN TO KKM
Layout Incident Reporting.qxp:Layout 1
Minimal Reporting
GREEN 30 Working Days 90 Working Days
11/1/12
(Basic Investigation)
8:31 AM
EVERY
Summary Report
YELLOW 5 Working Days 60 Working Days
Page 38
(Mini RCA) 3
MONTH
Summary or Full
*RED 5 Working Days 60 Working Days Report Mini / Full
RCA
* Call and inform Patient Safety Unit, Medical Care Quality Section, MOH within 1 working day (03 - 88831180)
* ACTIONS THAT NEED TO BE TAKEN IMMEDIATELY AFTER

SIGNIFICANT (CATEGORY RED OR YELLOW) "INCIDENT" :
1. TAKE EMERGENCY MEASURES to minimize the damage to the patient or

personnel ("damage control") in terms of injury, discomfort, and threat to life
(examples of potential damage include electric shock, lacerations or
contusions, fractures, cardiac arrhythmias or arrest, allergic reaction,
transfusion reaction, respiratory arrest, loss of consciousness etc.)
2. TAKE THE NECESSARY ACTION to minimize damage to equipment and the

environment.
3. NOTIFY the health care professional or doctor who is responsible for the care
of the patient.
4. DO NOT remove any equipment that are attached to or located next to

the injured patient or person. Keep them in the same room or area.
5. DO NOT disconnect or change the relative physical positions of equipment

or connecting cables, unless it is absolutely necessary for example, to avoid
further injury.
39
6. DO NOT throw away any disposable products that may have been involved
(e.g., drapes, electrodes), as well as their packaging materials.
* Adapted from the ECRI

INVESTIGATION : Table 1.1 - Summary of the RCA process (Indicative only)

Process stage Objective Basic investigation Mini RCA Full RCA
1 Identification of Determine the Category 'green' Category 'yellow' Category 'red'

incidents/issues significance of response (minor) response response (major)
and investigation the incidents (moderate)
/analysis level. /issues and
whether
investigation/
RCA is needed
2 Select investigation Bring together Not applicable - RCA team leader RCA team leader
and analysis team people who have basic plus typically 1-2 plus typically 3-4
an intimate investigation others others
knowledge of the undertaken by
context local manager
surrounding the
incident(s),
including the
care process(es)
and clinical issues
involved
3 Plan and conduct Collect facts, Local manager Full determination Full determination
investigation knowledge and collects as little of information. of information.
physical items information as Interview all Interview all
related to the needed in order relevant relevant
40 incident as soon to establish the individuals. individuals.
as possible facts
4 Determine Understand the Basic description Leader develops Leader and team
sequence of incident as fully as of events leading sequence of jointly develop
events possible to ensure up to the incident events/ sequence of
investigation chronology table, events/
accuracy which is agreed chronology table,
at first meeting. which is agreed
at first meeting.
5 Identify the Identify the Possible use of Contributory Contributory

contributing factors causal factors contributory factors checklist factors checklist
that contributed factors checklist and fishbone plus fishbone
to the incident diagram diagram and
probably detailed
events and
causal factors
chart
6 Determine root Find the Possible use of 'Five Whys' 'Five Whys'
causes correctable root 'Five Whys' approach. approach using
cause(s) for the approach Possible use of events and
incident events and causal factors
causal factors chart
chart
7 Develop risk Determine Determination by Brainstorming by Brainstorming by

reduction/quality appropriate risk local manager team team
improvement reduction
strategies strategies to
address root
causes and any
additional
strategies
required to
improve overall
quality
8 Report and action Summarise the Brief paragraph Summary report. Full report.
plan overall setting out Include key risks Include key risks
investigation and summary (i.e. root causes) (i.e. root causes)
analysis and description of the in local risk in local risk
register register
Process stage Objective Basic investigation Mini RCA Full RCA

translate the risk incident, how and
reduction/quality why it happened,
improvement and any actions
strategies into taken to prevent
detailed actions recurrence.
for Consider
implementation summary report.
Where relevant,
include key risks
(i.e. root causes)
in local risk
register
9 Implement action Ensure that risk Local discretion Team leader Team leader
plan reduction ensures ensures
strategies are put responsibilities for responsibilities for
in place action are clearly action are clearly
assigned and assigned and
monitoring/revie monitoring/review
w mechanisms in mechanisms in
place place
10 Evaluate Ensure that risk Local discretion Part of risk Part of risk register
effectiveness of reduction and/or register process process
actions quality
improvement
strategies achieve
desired outcomes
or results
- Suggested Minimise time Not applicable Maximum 2 Typically 3-4

number of taken for RCA
meetings for
process stages 4-8
(sequence of
events to
reportage/action
plan)
- Indicative total Minimise time

time to complete taken for
Less than 10 hours 10-50 hours -
typically 20-25
More than 50
hours, but less
41
- typically 2-3
investigation/RCA investigation/RCA person hours person hours than 100 hours -
to process stage 8 typically 60-70
above, i.e. report person hours
and action plan
INVESTIGATION REPORTS TO STATE HEALTH DEPARTMENT AND

MOH:
There are three basic types of reportage:
1. Very minimal reportage in relation to a basic investigation for a category
green response ;
2. Production of a summary report in relation to a category yellow response
requiring a 'mini RCA' ; and
3. Production of a full report in relation to a category red response requiring a
'full RCA'.
1. MINIMAL REPORTING
At the very minimum, a concise paragraph or two should be recorded indicating

a brief summary description of the incident, how and why it happened, and any
actions taken to prevent recurrence.
2. SUMMARY REPORT
A summary report in relation to a 'mini RCA' should, as a minimum, include the

42 following :
• Summary of incident, including individuals (preferably job titles rather than
names) involved in investigation/analysis
• Contributing factors and root cause(s)
• Risk reduction strategies/proposed corrective actions
• Learning points
• The total time taken to conduct and report on the RCA
Summary report should typically be no more than 2-4 pages in length. Note that in
some instances a summary report may be considered adequate for reporting a full
RCA.
3. FULL REPORT
It is not the intention here to be prescriptive about precisely what format should be
adopted. The key issue must be that the report conveys the results and proposed
risk reduction strategies and action plan from the investigation team in a
comprehensible way. Standards New Zealand provides a useful format for
reporting that can be used as a 'benchmark', and a slightly modified version of their
format is provided here. They suggest that the report should include:
Summary
1. State the incident or issue
2. Summary of root causes
3. Summary of actions
Introduction
1. A brief background description of the incident or issue and a statement
regarding the team assigned to conduct the investigation
2. Descriptions of the scope of the investigation, its purpose, timeframe, time
involved by the team in completing the overall RCA, methodologies employed
in conducting the investigation and the findings.
Analysis and Findings

1. Factual description of the incident/issue, including, where relevant, the
chronology and responses to the incident/issue.
2. Brief description and results of the analyses that were conducted (e.g. fishbone
diagram, events and causal factors analysis). Include charts or diagrams in
either the main body of the report or in the 'attachments' section.
Recommendations
1. Root cause(s) identified and rationale for selecting the root causes.
2. Proposed and/or implemented risk reduction strategies/corrective actions, i.e.
action plan. Correlate actions with root cause(s) to which they apply (A
specimen action plan format that correlates with the requirements of the
specimen Malaysian Ministry of Health risk register is provided below).
3. Rationale for choice of risk reduction strategies.
4. Plans for evaluating the effectiveness of corrective actions.
5. Outline of 'residual risks' that will exist if risk reduction strategies/corrective
actions are not implemented
Learning points
Pass on the knowledge. A specific listing of the learning points that need to be
passed on to appropriate departments and staff, and other stakeholders as
necessary, either through formal training or through some other means, e.g. staff
briefings, newsletters, required reading, etc.
Attachments
A listing of all attachments referred to in the report. This may include but is not
limited to flow charts, existing policy or new policies and external standards.
ACTION PLAN
A simple action plan template is provided below. This can be used to identify the 43
key actions (also known as 'additional controls' in the context of a risk register)
together with any resources requirements (financial, physical, staff, etc.), priority
order, identification of who is responsible for implementing the action (preferably a
named individual), the 'due date' by which the action should be implemented, a
'review date', if appropriate, and the 'completion date' when the action has been
implemented. Progress during any review can be recorded in the final column.
Ref. Root Actions Resource Priority Responsiblity Due Review Completion Progress
Cause requirements H/M/L for action Date Date Date
GUIDELINES
FOR
COMPLETING
INCIDENT
REPORTING FORM
IR1.1
INTRODUCTION
These are updated guidelines for filling the incident report form and subsequent
investigation. Form IR1.1, which is a 2-page proforma intended for reporting
'patient safety incidents' by any category of staff in MOH hospitals.
When an incident is reported by any staff, management must respond

appropriately to try to ensure, wherever possible, that similar incidents do not
happen again.
Management and staff need to learn from incidents and work together to improve
the safety and quality of care for patients, as well as the health, safety and welfare
of front-line staff, and protect the safety of the general public.
There are four parts to the 2 page IR1.1 form:

Section A to C : Initial report from member of staff involved in or witnessing the
incident
Section D : Immediate Supervisor report.
Part E to G : Designated Person report.

46
Part H : Head of Department comments.
Note : A 'designated person' is an individual within a Department etc. Who has

special responsibilities, skills and training in risk management, incident investigation
and root cause analysis (RCA).
Part I - Initial Report
PART II - Immediate Supervisor Report(e.g. specialist, consultant, ward manager, matron, etc.)
47
L = Low, M = Moderate, H = High
H.
FLOW CHART FOR THE MANAGEMENT & REPORTING OF INCIDENTS
Designated Person(s) in Dept. / Hospital /

Patient Staff District Health Office/ Director /Supervisor
in-charge / Specialist / Matron
If Major -
Call and inform
death / permanent Patient Safety Unit,
Staff involved/ witness harm Inform Head of Medical Care Quality
INCIDENT to incident Dept,Hospital Director Section, MOH within
or Pegawai Kesihatan one working day
OCCURS - Correction immediately
Daerah within one hour
(03-88831180)
- Report to immediate
supervisor
- Fill the IR-1.1 incident
reporting form
(Section A-C)
All incidents Gra
Any event or inform Head
of Dept. inc
circumstance SUPERVISOR ac
48
arising during Decide on
to
Investigation
patient care -Take immediate level needed im
that could corrective action po
have or lead to
- Fill the IRI.I incident
unexpected reporting form (Section D)
harm, loss or - Submit IRI.I form to
damage designated person
Implement risk
Learn lessons, reduction strategies
change action plan and
practice, monitor
improve safety
and quality of
care
Occupational
Accident
Red Green Yellow

Investigation requirements Reporting Quality Hospital Director

/ requirements Unit Hospital /Incident
or Committee
it,
ity
hin Consider need
y
for
Inadequate independent
action investigation
Low
Risk
Grade the
incident
Discuss at
according Moderate • Incident Management
to actual Risk Reporting Analyse
impact and Form – IR1.1 review
incident
potential risk • RCA report meeting
Basic Ix = Category
High Green
Risk Mini RCA = Category
Yellow
Full RCA = Category
49
Full Root cause Red
Analysis (RCA)
Occupational Report to
Accident WEHU Occupational
A1/A2 Health Unit
FOR THE INCIDENT REPORTING FORM IR1.1 AND LIST OF INCIDENTS TO BE REPORTED, PLEASE REFER TO page
26 to 37
INITIAL REPORT
Part I of the IR1.1 form is intended to be completed by a members of staff involved
in or witnessing the patient safety incident.
There are three sections in Part I:

Section A records some basis incident particulars;
Section B some patient particulars; and
Section C provides for writing down a brief description of the incident.
HOW TO FILL PART 1 OF IR1.1 FORM - SECTION A

Section A. Incident particulars
50
Figure 1 - IR1.1 form, Part I, Section A
With reference to Figure 1, please fill in the following particulars
Incident code -
Select the appropriate incident code from Mandatory Reportable Incident List.
Insert the relevant incident code in the box provided.(Pages 26 - 32)
Date of Incident -
Insert the date of occurrence of the incident in DD/MM/YY format in the boxes
provided
Time of Incident -
Insert the time of occurrence of the incident in 24 hour clock format (HH/MM) in the
boxes provided. In many instances a precise time will not be known and an
approximate time to the nearest 10 or 15 minutes should be given.
Date of reporting -
In most instances, the date of reporting will be the same as the date of the incident.
However, the date of reporting the incident may, on occasion, be later than the
date of the incident. Enter the date of reporting the incident in DD/MM/YY format
in the boxes provided.
Unit/ Dept. -
Write down the name of the unit or department where the incident occurred in the
box provided.
Location where incident happened -

Write down the name of the ward or clinic where the incident occurred in the box
provided.
Specialties involved -
Name of any other department involved in the incident
HOW TO FILL PART I OF IR1.1 FORM - SECTION B

B. Patient particulars
Name Male Female Inpatient Outpatient
ID/Passport No. RN
Date of admission D D M M Y Y Admission Diagnosis
Date of Birth
Age
Race Communication problem with patient? Yes No
Native language Language used to communicate
Figure 2 - IR1.1 form, Part I, Section B
Name - The patient's full name. 51

Male/ Female - Identification of patient gender. Tick the appropriate box.
In-patient/ Out-patient - Identification of patient type. Tick the appropriate box.
ID/ Passport No. - I/C Number or Passport No.
RN - Hospital Registration Number.
Date of Birth - Date of birth. Leave blank if unknown.
Age - In years/ months/ days
Diagnosis - The patient's confirmed diagnosis after admission into the hospital.
Race - The patient's race or ethnic group.
Communication problem? - If there were problems in communicating with the
patient, for whatever reason, tick the 'Yes' box, else tick 'No'.
Native language - The patient's native language, e.g. Malay, Chinese, Tamil etc.
Language used to communicate -
The language used by clinical staff to communicate with the patient.
HOW TO FILL PART I OF IR1.1 FORM - SECTION C

Section C. : Incident description
C. Incident description
Provide a brief description of the incident, other people involved (including staff), any harm suffered by patient
and any immediate staff response. Please state facts and not opinion.
People Involved : Patient Family Staff
Any Harm suffered : No Yes If yes, what type of harm : ................................................................
Brief description of the incident :
Immediate correction :
Full name
Designation
Figure 3 - IR1.1 form, Part I, Section C
This section should be filled by staff involved in the incident or who had witnessed
the incident
Please give a brief description of the incident :

• Any staff, medical equipment or medicines involved in the incident
52 • Any harm suffered by the patient.
• Corrective action : Any immediate staff response, e.g. to make the patient
comfortable, or to ensure the situation is rendered safe. Should, where
possible, be specified
• It is important that only facts are stated, and not opinion. In some cases it
may be necessary to continue writing the incident description on a
separate sheet.
After completing Section C , please write full name and designation in the
spaces provided. These should preferably be written in CAPITAL LETTERS.
Note:
Please write the immediate corrective action taken by the staff e.g. Stop giving
the medication immediately. Doctor informed; If there is any injury after a patient
fall, the laceration is sutured; In the case of wrong site surgery, the patient was
informed and reassured
Complete the form IR1.1 , inform and pass the form to the immediate supervisor.
Examples of brief descriptions of an incident
On 13th July 2009, in ward Neuro 5B, a patient with a known history of PTB with MS was prescribed Tab
Ethambutol 1000mg b.d x 2/52 instead of daily dose by the ward doctor.
The medication was taken from the impress stock in the ward and was administered to the patient for 3
days by the nurse. The patient developed vomiting. The mistake was realized when the prescription was
reviewed by the ward pharmacist and reported to the consultant-in-charge of the ward
The dosage was corrected and administered to the patient. The vomiting stopped
27 year old lady admitted for (L) sided epistaxis ,on 24th January 2008 . She was scheduled for endoscopic
examination and cauterization under GA. Pre-op blood specimen was sent for group and cross match. The
request was for 2 unit of whole blood for Group, screen and hold.
It was noted that the patient blood group was AB+. Records in the Pusat Darah Negara showed that a
lady with the same I.C. number had a previous request for blood transfusion on 3/11/98;7/11/99 ; 22/4/03
and 15/4/05 . The blood group at all these times was group B.
Staff from Pusat Darah Negara conducted a bed side grouping and confirmed that the blood group was
AB +. History from the patient was taken. She said she lost her IC in 1990 and she was never admitted to
this hospital before.
HOW TO FILL PART II, SECTION D OF IR1.1 FORM - IMMEDIATE

SUPERVISOR REPORT (E.G. SPECIALIST, CONSULTANT, WARD MANAGER,
MATRON, ETC.)
Section D. Further action to prevent similar incident
D. Further action to prevent similar incident/ to reduce risk
Provide a brief description of any action taken to prevent similar incident
Full Name
Designation Date
Official Use Only : Date received _____________ Incident Reference __________________
Figure 4 - IR1.1 form, Part II, Section D

Continue on separate sheet if necessary
The immediate supervisor of the member of staff making the report should provide
a brief description of any corrective action taken immediately following the event.
Who is the immediate supervisor ?
e.g.:
Staff nurse in the ward - the supervisor is the sister in charge of the ward or matron
Houseman - should be the medical officer or specialist in charge
It should be noted that the term * 'corrective action' refers to any management
action taken immediately following the event and does not include action taken
immediately to, for example, make the patient comfortable (which is reported in
53
Section C - see above).
The supervisor should also provide their full name, designation and date of
providing the description.
Definition :
*Corrective action: Action to eliminate the cause of a detected non-conformity
( ISO 9000:2000 clause 3.6.5. )
What it means :
•Determine the cause of non-conformity e.g. through root cause analysis,
braining storming
•Then take action
Example :
In case of wrong site surgery, it was found that there was a mix up of patient's BHT
and "Safe Surgery Saves Lives Checklist " was not used by the staff nurse and
doctor.
Training and remedial measures were implemented immediately and the use of
Safe Surgery Save Lives Checklist is emphasized and monitored.
HOW TO FILL PART III SECTION E OF IR1.1 FORM -

DESIGNATED PERSON
Section E : Investigation priority (triage)
E. Investigation priority assessment (triage) and response
Figure 5 - IR1.1 form, Part III, Section E

L = Low, M = Moderate, H = High
Only for “voluntary” incidents not listed in the mandatory list of reportable incidents.
What to do next :-
54 1. Review the IR1.1 form with Parts I and II completed (as far as possible).
2. Write your full name and date of making the report at the top of the page
3. Do a quick investigation priority assessment for the purposes of 'triaging' the

incident to provide an indication of the required level of incident response
(Section E).
4. Depending on the incident investigation response, complete Sections F and G

as appropriate.
Note :
NOT all incidents require a full Root Cause Analysis (RCA)
To determine what level of investigations this particular incident require (None ;
Minimal ; Mini RCA or Full RCA) take the next 5 steps.
HOW TO DO ?
5 key steps in determining the level of investigation response.
Step 1
•Determine the actual patient impact/ outcome resulting from
the incident as None, Minor, Moderate, Major or Death.
• In a situation where the final impact/ outcome is, as yet,

unknown, select the current level of impact.
For example, a patient may suffer 'moderate ' injury as a result of wrong blood
transfusion and may, some days or weeks later , die as a consequence due to renal
failure. Until the final impact/ outcome is known, the current level of impact
( i.e. moderate) must be selected.
1. Actual patient impact/outcome (circle appropriate box/ number)

None Minor Moderate Major Death
L M M H H
Step 2 : Tick the appropriate box.
Determine the duration of impact as:

· Temporary,
· Permanent,
· Not applicable (e.g. as in the case of death) or
· Unsure, if it is as yet uncertain precisely what the impact is or will be especially the
long-term effect of the incident
2.Duration of impact Temp. √ Permanent N/A Unsure
Step 3
• Determine what are the chances of a similar incident from occurring if no
action is taken'
• This can be determined by using a qualitative method of analysis by
identifying
WHAT IS THE LIKELIHOOD this incident will happen again and WHAT WOULD BE THE
CONSEQUENCE to the patient/ staff if such an incident were to happen?
The consequence and likelihood of a risk occurring should be analysed using
information sources and techniques.
Sources of information may include the following:

• Past records.
• Practice and relevant experience.
• Relevant published literature.
• Specialist and expert judgements
55
Techniques include:
• Structured interviews with experts in the area of interest;
• Use of multi-disciplinary groups of experts;
• Individual evaluations using questionnaires;
LIKELIHOOD :
Definition : Used as a general description of probability or frequency.This can be
expressed qualitatively or quantitatively.
Likelihood Frequency(per procedure/event or within a Probability

specified time frame)
Almost certain Will happen or recur, possibly frequently 99%
Likely Will happen, but it is not a persistent issue 90%
Possible Might happen or recur occasionally 50%
Unlikely Do not expect it to happen or recur but it is possible 10%
Remote Cannot expect it to happen again 1%
Table 1 : - Likelihood table

Review past records such as incident report e.g.
• Mislabeling of the blood specimen vacutainer tube for group and cross
match > It is frequent occurrence > you would put it as "almost certain"
• Wrong person wrong site surgery > Do not expect it to happen or recur but
it is possible you would identify the likelihood as "unlikely" because you
have implemented checklist " Safe Surgery Saves Lives ”
CONSEQUENCE
Outcome or impact of an event
There can be more than one consequence from one event.
Refer the consequence table in next page.
NOTE:
Evaluate the likelihood and consequence in the context of the effectiveness of
the existing strategies and controls in place e.g.
Mislabeling of the blood specimen tube for group and cross match is a frequent
occurrence, it often a "near miss" because of the procedures and checklist in place
to prevent "wrong ABO transfusion error.
56
TABLE 2 : CONSEQUENCE TABLE
ATTRIBUTE Negligible Minor Moderate Major Extreme
1 Patient safety No obvious injury/harm Minor non-permanent Semi–permanent injury/ Incidents involving major Death e.g.: • Death
injury/harm harm (up to 1 year,) e.g.: permanent injury/harm or resulting from
• Medication error due to any of the following: ‘medical error’
wrong drug, wrong patient, • Infant Abduction • Death following
wrong dose, wrong route, • Infant Discharged to adverse outcome
wrong time/omission, Wrong Family of procedure
wrong frequency, wrong • Mismatch (Haemolytic) • Any fatal cardiac or
diluent or wrong infusion Blood Transfusion respiratory arrest
volume/rate • Rape or serious assault that occurs intra-
• Adverse drug/blood • Surgery on Wrong Patient operative or in
reaction e.g. any or Wrong Body Part recovery room
untoward reaction to the • Wrong radiological or

blood transfused or laboratory results causing
correct drug administered wrong treatment or
such as allergic/anaphylactic procedure being carried
reactions, skin rash, out when it is not
11/1/12
nausea and vomiting, etc. necessary or may even

• Equipment failure e.g. cause morbidity to the
cylinder runs out of oxygen patient
while transporting patient;
laser or diathermy burns; etc.
• Patient falls e.g. from bed,
8:31 AM
stretcher, chair, toilet, etc.

• Adverse outcome of procedure,
e.g. perforation of bowel
following peritoneal dialysis
catheter insertion
Page 57
2 Patient experience No significant impact on Unsatisfactory patient Unsatisfactory patient experience Unsatisfactory patient
patient experience experience related to related to poor treatment/care experience related to poor
treatment/care given, e.g. resulting in short term effects treatment/care resulting in
inadequate information or (less than 1 week) long term effects
not being treated with
honesty, dignity and
respect - readily
resolvable
3 Staff safety, health and welfare No significant impact on Minor non-permanent Semi-permanent injury or ill Major permanent injury or Death
staff safety, health or injury or ill health health (up to 1 year) ill health
welfare
57
58
ATTRIBUTE Negligible Minor Moderate Major Extreme
4 Staff morale No significant impact on Minor short-term staff Significant staff discontent Major prolonged staff
staff morale discontent – readily resolvable causing some staff turnover discontent resulting in high
staff turnover
5 Public safety No significant impact on Minor non-permanent injury or Semi-permanent injury or ill Major permanent injury or Death
public (e.g. visitor) safety ill health health (up to 1 year) ill health
6 Compliance with standards No significant non- Single failure to meet internal Repeated failure to meet internal Gross failure to meet
e.g. statutory/legal, clinical, compliance standards or follow protocol. standards or follow protocols. external standards.
professional, managerial, etc.)
Minor recommendations Important recommendations that Repeated failure to meet

which can be easily can be addressed with an national norms and
addressed by local appropriate management action standards / regulations.
management plan.
7 Impact on service(s)
11/1/12
Insignificant interruption of Short term disruption to Some disruption to service(s) Sustained loss of service
service(s) which does not service(s) with minor impact provision with unacceptable short which has serious impact
impact on the delivery of on patient care term impact on patient care. on patient care resulting in
patient care or the ability to Temporary loss of ability to major contingency plans
continue to provide service provide service(s). being involved.
8:31 AM
8 Adverse publicity/reputation No significant adverse Local media coverage – short Local media – adverse publicity. National media/ adverse Political intervention
publicity or impact on term. Some public concern. Significant effect on staff morale publicity. Public confidence
reputation Minor effect on staff morale / & public perception of the in the National Healthcare
public attitudes. organisation. Public calls Group undermined. Use of
Page 58
(at local level) for specific resources questioned.

remedial actions. Need to report to MOH.
Review/investigation necessary.
9 Financial impact <SGD 1k SGD 1k – 50k SGD 50k – 5M SGD 5M – 100M > SGD 100M
10 Impact on environment No significant damage to Short-term minor pollutant Short-term minor pollutant release Major spill of toxic/ Major spill of toxic
environment release to air or water. to air or water on-site causing hazardous substance(s) /hazardous
Non-damaging. Includes some non-lasting damage with potential to seriously substance(s)
noise and fire pollution. affect people, animals causing harm
and/or plants life /damage to people,
animals and/or plant
life
• Now, knowing the likelihood and consequence, circle the most appropriate
box/letter. Note that letters H, M and L correspond to 'High', 'Moderate' and 'Low'
impact in Table 3.
3.Potential risk to future patients and organisation if no further action taken (circle)
Consequence
Likelihood None Minor Moderate Major Death

Almost certain L M M H H
Likely L M M H H
Possible L L M M H
Unlikely L L M M M
Remote L L L M M
STEP 4
Now since you have identified the actual impact of the present incident, circle the
appropriate actual impact (A) and Potential risk to future patients and the
organisation (P) to determine the 'suggested' level of response in Table No 4.
A (Actual Impact ) P( Potential risk) Level of investigation

H H Full RCA
H M Mini RCA
H L Mini RCA
M H Mini RCA
M M Mini RCA
M L Minimal
L H Mini RCA
L M Minimal 59
L L None
STEP 5 : Investigation response
Tick the appropriate boxes. Note :

Although there is some subjectivity in this
Suggested Actual method of analysis, certain incidents might
warrant a full RCA instead of a minimal
None investigation especially when there is
Minimal significant patient safety issues or has a
Mini RCA √ potential medio-legal significance or
accountability purpose
Full RCA √
HOW TO FILL PART III SECTION E OF IR-1.1 FORM -

DESIGNATED PERSON
Regardless of the suggested level of response required, it is essential that all facts,
knowledge and physical items related to the incident be collected as soon as
possible.
Who should do it ?
A specific designated person or delegate the responsibility of collecting
information to other members of the team.
What information that needs to be collected ? It may include:

• All medical records from the various departments involved if more than one
discipline involved
• Documentation and forms related to the incident (e.g. protocols and
procedures).
• Immediate statements by the people involved (could be from the part C
and D of the IR1.1 form)
• Conduct interviews with those involved in the incident.
• Physical evidence from the site of the incident .
60 • Identify equipment involved in incident
• Information about relevant conditions affecting the event (e.g. staff call
duty
• Availability of trained staff, etc).
• Where appropriate, photographs should be taken to capture visual
information
• That might assist with subsequent analysis activity.
• Interviews the people as soon as possible after the incident .
Determine and document the sequence of events :
Use Flow chart method
A flow chart can be helpful in visually determining the precise sequence of events,
and can be useful in presenting information on the sequence of events to others or
tabulate the sequence of events
Flow chart :
Tabulation :
Date Time Location Event description Key person involved Comment
10/8/07 9.00am NICU Requested for Dr. R Indication for

appointment for MRI MRI:
under GA
10/8/07 11.30 Radiology Patient in Radiology dept Radiographer Did not verify Id
Department of patient
HOW TO FILL PART III SECTION F OF IR1.1 FORM -

DESIGNATED PERSON
Section F : Contributing factors
1 Patient
2 Task and technology
3 Individual staff
4 Team
5 Work and care environment
6 Management and organisational
7 External
Figure 8 - IR1.1 form, Part III, Section F
Contributing factors can be identified using a 'root cause analysis' approach to

investigate an incident.
WHAT IS ROOT CAUSE ANALYSIS ?
• "Root Cause Analysis is a structured investigation that aims to identify the

true cause of a problem, and the actions necessary to eliminate it"
(Bjorn Andersen and Tom Fagerhaug. Root Cause Analysis : Simplified Tools
and Techniques. McGraw-Hill, 2000).
• A risk management tool to understand WHY did it happen, which is

about identifying the causation, or causal factors.
There are three types of causal factors: 61

(1) Direct cause : The event (s) that occurred, including any condition(s) that
existed immediately before the undesired outcome, directly resulted in its
occurrence and, if eliminated or modified, would have prevented the
undesired outcome.
(2) Contributory causes to the incident or issue, e.g. pressure of work,

inadequately labelled medicines, lack of staff training, etc.
(3) The root causes which would eliminate or significantly reduce

future risk
Root cause Contributing factors Direct cause Incident

Shortage of staff Failure to concentrate Fatigued
Medication error
- Similar looking package Nurse
No policy & - Patient did not realize a
procedure on different tablet was
verbal given.
communication - Verbal communication
Figure 9 : Diagrammatic representation of the 3 causal fact

IDENTIFY CONTRIBUTORY FACTORS
What to look for :

(1) Patient factors- clinical condition, personality , and inter-personal relationship.
(2) Task and technology factors- lack of procedures, shortfall in the care processes
(3) Staff factors - Attitude , inter-personnel factors , others such as:
Slips occur due to failure of concentration ( e.g. failure to remove wound swab
before wound closure).
Lapses arise from failure of memory (forgetting two drugs interact e.g. heparin
and NSAIDS).
Fumbles actions performed incorrectly (damage to nerve during surgery).
Mistakes where actions are as per plan but plan is inadequate to achieve the
outcome
Omission : Failed to do something required

62
(4) Team factors - lack of communication, supervision and leadership
(5) Work and care environment factors - the working or care environment ,
occupational and safety hazards
(6) Management and organisational factors - shortcomings in the management

and organisation of a hospital or department
(7) External factors - factors external to the organisation can contribute to the risk
, such as regulatory or financial constraints
Tools to identity the contributing factors and root cause:
• The Fishbone, or Ishikawa diagram -

A useful tool to use during brainstorming session to identify contributory
factors
• 5 Why's
• Events and Causal Factors (ECF) charting
Figure 10a : Fishbone Diagram ( based on London Protocol )
Management and Task and

Organisational Team Technology
Factors Factors Factors
11/1/12
Incident /
issue
8:31 AM
being
explored
Page 63
External Work / Care Individual Patient

Factors Environment Staff Factors
Factors Factors
63
Example :
Patient with breast cancer in Radiotherapy Ward sustained:
a) Fracture neck of left femur during transfer from bed to trolley
b) Fracture mid shaft of right femur during changing of soiled pampers
Investigation showed:
Contributing factors:
Patient Factors :
* Predisposing factors to fracture -extensive bone metastases

* old age (67)
* Refuses help e.g. transfer herself from bed to trolley
Task/ Technology Factors

* No lifting frame equipment
* No risk assessment mechanism to alert staff which patient is susceptible for
fractures
Staff Factors
64 * Lack of training on transfer techniques.
* Did not advise patient on the risks.
Management and Organisational Factors

* Shortage of staff-need 3 persons to transfer patient in the absence of lift frame
e.g. Hoist
* Change in the policy- high risk patient to have portal x-ray instead sending to
Radiology Department.
* No training conducted
Team Factor
* Did not communicate with Radiology Dept about the risk
Risk Reduction strategies

¨ Risk assessment tool
¨ Staff training
¨ Patient education
¨ Purchase lifting frame equipment
Figure 10b : Fishbone illustrating contributory factors for delayed discharge
11/1/12
8:31 AM
Page 65
65
FIVE WHYS' APPROACH
The simplest, technique to determine root cause is simply to repeatedly ask 'why?’
Risk :
Usage of premises before proper safety check and commissioning are done
could result in patients and staff mishap.
Root cause of the problem :

The specification of the automatic door for high volume of traffic in out-patient
setting was not verified and safety check done before use.
Why did the automatic door close before the patient could go
through ?
The sensor had mal-functioned and not suitable for heavy
66
traffic area.
Why was this not detected earlier ?
No safety check done.
Why not done ?
The automatic door and all equipments not commissioned yet.
Why was it not commissioned yet but already in use ?

Need to use the OPD premises urgently.
Why had to use urgently ?
The renovation work took a long time (3 years).
Why took a long time ?
There was no supervision done and the certification was not verified.
EVENTS AND CAUSAL FACTORS (ECF) CHARTING

In defining causal factors/conditions, the basic approach is to take each event in
turn and as 'Why?'
• For each event ask why?
- Look for condition and actions.
• Connect all the causes with “a caused by”
• Support causes with evidence
• Find out
- what happened?
- what should happen?
- whether policies and procedures are already exist.
67
Example : Figure 11 : Event and Causal charting : Incident : Medication error caused by wrong dosage
resulting in allergic reaction
Use the various contributing factors listed in Annex II as a checklist of factors

that can be used to help you identify the contributing factors leading to incident.
Starting with the patient factors, and taking into consideration all that factors you
have identified as a consequence of any investigation activity, systematically work
thorough the contributory factors framework asking appropriate questions to arrive
at a list of factors contributing to the incident.
Once you have determined the contributing factors, put the appropriate codes in
the relevant categories in Section F or write down in word or in code refer Annex II
Example:-
1. Patient Patient not educated about the medication

2. Task and technology Misinterpretation of verbal communication
between junior and senior staff
3. Individual staff Inexperience doctor ( Not aware about the
correct dosage)
4. Team No counterchecking done by the ward
68
pharmacist / senior doctor
5. Work and care -
environment
6. Management & No policy and procedure about educating
organisational patient about medication
Duties of the ward pharmacies not documented
Drug formulary not available in the ward for
reference
7. External
HOW TO FILL PART III SECTION G OF IR1.1 FORM

(DESIGNATED PERSON)
Section G. Further action proposed to reduce risk ( Preventive action)
Figure 13 - IR1.1 form, Part III, Section G
Root causes that are identified must be translated into risk reduction ( or quality
improvement ) strategies and action plan must be identified to ensure the actions
are implemented to eliminate or reduce the impact of similar type of incident
To get rids of weeds, dig up the root; to
stop a pot from boiling, withdraw the fuel
Chinese Proverb
A person responsible for implementing the action should be identified (by name in
capital letters)
Description of action Person Date action

No Root cause
to be taken Responsible completed
1. No policy and procedure Implement "Know your Cik F June 2011
on educating patient medication program" for Chairperson,
about medication they patient in order to Committee 69
are taking Strengthen Medication Medication
Safety Program Safety
2. No policy and All verbal Dr.L 30 Jan 2011

procedure about all communication has to Chairperson
forms of verbal be documented and Risk
communication implement "read back " Management
policy Committee
3. Drug dosage reference Ensure Pharmaceutical Cik F Feb 2011

book not available in Blue Book or DIMMs is Head of
the ward . available in the ward Pharmacy Dept
4. No counter-checking
done by the ward
pharmacist / senior Document roles and Cik F Immediately
doctor responsibilities of the Head of 15th Jan 2011
ward pharmacist Pharmacy Dept
5. Duties of the ward
pharmacist not defined
HOW TO FILL PART IV SECTION H OF IR1.1 FORM

Completing Part IV - Head of Department's comments
Section H. Organisational impact/outcomes, learning points and general

comments
PART IV - Head of Department Comments
H. Organisational impact/outcomes, learning points amd general comments
Full name
Designation Date
Figure 14 - IR1.1 form, Part IV, Section H

Continue on separate sheet if necessary
Before filling this section, please review the actions taken by the designated person.
70 The Head of department must briefly
• describe the organisational impact/outcomes attributable to the incident,
• include any key learning points for sharing with others, and
• provide any additional general comments relating to the incident.
REPORT
1) Investigation required : None
Fill the IR1.1 form ( Part A - D ) and submit to ‘Unit Pengurusan Kualiti’ of the
hospital/ clinic.
2) Investigation required : Minimal

A concise, brief summary description of the incident, how and
why it happened, in section C and D of the Form IR1.1 by the staff involved or
witnessing the incident. Any actions taken to prevent recurrence should be filled
in section F and G of the form by the designated person.
No additional supporting document is required.
3) Investigation required : Mini RCA (Include as appendix to the Form IR1.1)

A summary which includes the following:
• Summary of incident, including individuals (preferably job titles rather than
names) involved in investigation/analysis
• Contributing factors and root cause(s)
• Risk reduction strategies/proposed corrective actions
• Learning points
4) Investigation required : Full RCA ( may be included as appendix to the Form

IR1.1) Full report is required, which should include the following:
Introduction
A brief background description of the incident or issue and a statement

regarding the team assigned to conduct the investigation
Analysis and Findings
1. Factual description of the incident/ issue, including, where relevant,

the chronology photographs and responses by the staff involved in the
incident .
2. Brief description and result of the analysis to identify the contributing

factors and root causes. (e.g. fishbone diagram, events and causal factors
analysis). Include charts or diagrams in either the main body of the report
or in the ' attachments' section.
Recommendations
1. Root cause(s) identified and rationale for selecting the root causes.
2. Proposed and/or implemented risk reduction strategies/corrective action,
Correlate actions with root cause(s) to which they apply
3. Rationale for choice of risk reduction strategies.
4. Plans for evaluating the effectiveness of corrective actions.
5. Outline of 'residual risks' that will exist if risk reduction strategies/corrective
actions are not implemented
Learning points
Pass on the knowledge. A specific listing of the learning points that need to be
passed on to appropriate departments and staff, and other stakeholders as 71
necessary, either through formal training or through some other means, e.g. staff
briefings, newsletters, required reading, etc.
Attachments
A listing of all attachments referred to in the report.

This may include but is not limited to flow charts, existing policy or new policies and
external standards.
FLOW CHART : INVESTIGATING AN INCIDENT -

FULL ROOT CAUSE ANALYSIS
72
ANNEX II
CONTRIBUTORY FACTORS FRAMEWORK AND CODES - THE LONDON PROTOCOL
Patient Factors Code

Clinical Known risk associated with treatment 101
Pre-existing co-morbidity 102
Complexity of condition 103
Seriousness of conditionIn 104
Treatability of condition 105
Difficulty in diagnosis 106
Clinical / health history 107
Inexplicable / Unknown factors 108
Personnel Personality 110
Physical state ( e.g. malnourished, poor sleep pattern, 111
Cultural background 112
Religious beliefs 113
Language and communication 114
Social and family circumstances 115
External support 116
Stress 117
Disclosure of health history 118
Inter- Patient-staff relationship 120
personal Patient-patient relationship 121
73
Task and technology factors Code

Availability Availability of protocols to staff 201
and use of Use of protocols 202
protocols
Poor quality of information included in the protocol 203
(including
guidelines) Procedures for reviewing and updating protocols 204
Inappropriate use of protocol 205
Availability Availability of information 207

and Reliability of information 208
accuracy of Information inaccessible to staff 209
health
information, Misinterpretation by staff 210
including Disagreements regarding the interpretation of 211
medical
information
record and
test results Inadequately flagged information/alert 212
Need to chase up information 213
Task design Relevance 215
74 Ease of task execution 216
Design deficiency 217
Availability, use and reliability of specific types of 219
Decision equipment e.g. CTG
making aids
Availability, use and reliability of specific types of tests, 220
e.g. blood testing
Availability and use of a senior clinician 221
Medication- Wrong medication 223
related Adverse drug reaction 224
Miscalculation 225
Complicated dosage design 226
Mislabelling 227
Incorrect computer entry 228
Poor/ Similar packaging and labelling 229
Similar looking or sounding names 230
Staff factors Code

Inadequate knowledge 301
Competence
Inadequate skills 302
Inadequate experience 303
Compliance Failure to comply with policy / 305

Procedure / Protocol
Intentional violation 306
Unintentional violation 307
Personal Personality 309
Stress 310
Fatigue 311
Distraction 312
Attitude 313
Inadequate motivation 314
Lapse of concentration 315
Mental impairment
( e.g. illness, drugs, alcohol, pain ) 316
Specific mental health illness

( e.g. depression ) 317
Inter-personal Domestic issue 318
Staff-patient relationship 320

75
Staff-staff / team relationship 321
Staff - organisation relationship 322
Other 323
Team Factors Code

Communication between junior and senior staff 401
Communication between professions 402
Communication outside of the ward/department 403
Inadequate hand over 404
Verbal Communication between staff and patient 405
Communication Communication between specialists and 406
departments
Communication between staff of the same grade 407
Voicing disagreements and concerns 408
Communication between staff and relatives or 409
carers
Incomplete/absent information (e.g. test results) 411
Incomplete/ absent information (e.g. test results, 412
Written handover)
76 communication Discrepancies in the notes/ documentation 413
Incomplete documentation 414
Illegible 415
Missing signature 416
Poor quality of information in the 417
notes/documentation
Inter-dept communication 418
Communication with MoH/ other hospitals/ 419
agencies
Misinterpretation 420
Supervision and Decision/willingness of staff to seek help 422
seeking help
Unavailability of staff to help 423
Responsiveness of staff to help 424
Congruency/
consistency Definition of tasks between professions 426
Definition of tasks between different grades of staff 427
Definition of tasks between same grades of staff 428
Leadership Ineffective leadership 430
&Responsibility
Unclear definitions of responsibility 431
Inadequate support by peers after incident 433
Staff
colleagues Inadequate support by staff of comparable grades 434
response to
incident across professions e.g. senior nurse and junior
doctor
Work and care enviroment Code

Building and Maintenance Management 501
design Functionality (ergonomic assessment e.g. lighting, 502
spaces, etc.)
Housekeeping 504
Control of the physical environment (e.g. temp, 505
Physical
environment light, etc.)
Movement of patient between wards/sites 506
Storage 507
Malfunction/failure/reliability 509
Unavailability 510
Equipment /
supplies Maintenance management 511
Functionality (e.g. ergonomic design,fail safe, 512
standardisation)
System design 513
Malfunction/failure/reliability 515
Unavailability 516
Information Maintenance management 517
technology
Functionality (e.g. ergonomic design,fail safe, 518
standardisation) 519
System design 521
Unavailability 522
Staffing Allocation of staf 523 77
Recruitment 525
Education and Induction/Orientation 526
training Ongoing and refresher training 528
Workload / Hours Inadequate regular rest breaks 529

of work Heavy workload
Long working hours 530
Delay 532
Service delivery Missed 533
Inappropriate 534
Management and Organizational Code

Leadership Leadership presence 601
and
Leadership style 602
governance
Governance arrangements 603
Organisational Hierarchical arrangement of staff within the 605

structure organizational context
Span of control 606
Unclear roles/ responsibility 607
Management arrangements (function) 609
Operation (e.g. Facility Management, Materials 610
Objectives,
policies and Management, Contract Management)
standards
Human resources policy 611
Financial policy 612
Information policy 613
Risk management (e.g. incident reporting,
78
Investigation and analysis, safety culture) 614
OSH management 615
Resource Human resources 617
& constraints
Financial 618
Safety Inadequate safety culture 620
culture &
priorities
Wrong priorities 621
External Factor Code

Political Goals 701
Perceptions 702
Economic Climate 704
Regulatory Laws and regulations 706
Ministry of Health requirements 707
Requirements of other regulatory agencies/bodies 708
Partnership Governance arrangements 710
working with Management arrangements 711
external
organisation Contractual arrangements 712
Communication 713
79

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Incident Reporting & Learning System:

Medical Care Quality Section

Copyright © Ministry of Health Malaysia

All rights reserved. This book may not be reproduced,

First Edition 2013

Produced & Distributed by :

ISBN 978 - 967 - 0399 - 17 - 1

• The Ministry of Health New Zealand "Reportable Events Guidelines 2001"

Tan Sri Dato' Seri Dr. Hj. Mohd Ismail Merican

Datuk Dr. Noor Hisham bin Abdullah

Dato' Dr. Maimunah bt. Abdul Hamid

Datuk Dr. Lokman Hakim bin Sulaiman

Dr. Khairiyah bt. Abdul Muttalib

Dato’ Dr. Norain bt. Abu Talib

Dato’ Eisah bt. A.Rahman

Dato’ Hjh. Fathilah bt. Hj. Abd. Wahab

Dato' Dr. Azmi bin Shapie

Dr. Hjh. Safurah binti Jaafar

Datuk Dr. Harjit Singh a/l Pritam Singh

Dato' Dr. Jeyaindran a/l Tan Sri Sinnadurai

Dato' Dr. Jahizah binti Hassan

Dato' Dr. Ghazali bin Ahmad

Dato' Dr. Ravichandran a/l Jeganathan

Datin Dr. V. Sivasakthi

Dato’ Dr. Hussein Imam bin Muhammad Ismail

Dr. Siti Zaleha binti Mohd Salleh

Dato' Dr. Abdul Jamil bin Abdullah

Dato' Dr. Ravindran a/l Jegasothy

Dr. Kauthaman a/l Mahendran

Dr. Tan Kah Kee

Dr. Wan Jazilah binti Wan Ismail

Dr. Valyakalayil Daniel Philip

Dr. Lily Manoramah

Dr. Kalsom binti Maskon

Dr. Nor ‘Aishah bt. Abu Bakar

Dr. Nik Jasmin bt. Nik Mahir

Dr. Amin Sah bin Ahmad

Dr. Noraini binti Mohd Yusof

Dr Noridah binti Mohd Saleh

Dr. Khurul Ain bt. Ahmad Samsuri

Dr. Zurina bt. Abu Bakar, Dental Health Division, MOH

Dr. Savithri a/p Vengadasalam, Dental Health Division, MOH 7

Dr. Nuryastri bt. Md Mustaffa, Dental Health Division, MOH

Tuan Hj. Saidi b. Abd. Rahman

Sr. Rashidah binti Ngah

• to reinforce the principle that in clinical governance, it is the responsibility of

• to facilitate hospital management to set up systems for identifying, reporting

• to facilitate patient safety efforts including the reduction of risk to patients

TABLE OF CONTENTS PAGE

3. Success in Incident Reporting 18

6. Mandatory Reportable Incidents (Code No.Included): 26

7. Reportable Incidents : Guidance on Minimum 35

8. Actions that need to be Taken Immediately After 39

14. "Triaging" : 5 key steps in determining the level of 54 9

16. Identifying contributing factors 62

17. How to fill Part III section G of IR1.1 form 69

18. How to fill Part IV section H of IR1.1 form (Head of 70

19. Flow chart : how to Investigate an incident 72

20. Annex II : Contributing Factors Framework and Codes - The 73

Experts agree that knowledge of how to prevent harm to patients during

Dato' Sri Dr. Hasan bin Abdul Rahman

According to the World Health Organization, to improve safety, health-care

Official Use Only : Date received _ Incident Reference ______

Part III - Designated Person Report (Full name _______________________ Date)