manual - jknpenang.moh.gov.my...8 general objectives: to facilitate a learning organisation through...

From Information to ActionIncident Reporting & Learning System:

Building organizational learning and a culture of safety through reporting,analysing and learning from adverse patient incidents,

“near misses” and hazards

MANUAL

Medical Care Quality SectionMedical Development Division

Ministry of Health Malaysia

In collaboration withFamily Health Division of the Public Health Department

And Dental Health DivisionMinistry of Health Malaysia

Layout Incident Reporting.qxp:Layout 1 11/1/12 8:31 AM

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 anretrieval system now known or here afterinvented, without written permission from the publisher.

First Edition 2013

Produced & Distributed by :Medical Care Quality SectionMedical Development DivisionMinistry of Health Malaysia

In Collaboration withFamily Health Division of the Public Health Departmentand Dental Health Divison,Ministry of Health MalaysiaLevel 4, Block E1, Parcel E,Federal Government Administrative Centre62590 Putrajaya

ISBN 978 - 967 - 0399 - 17 - 1


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ACKNOWLEDGEMENTThe authors would like to gratefully acknowledge the following individuals andorganizations, whose works have been referred to, in the preparation of thismanual:

• The World Health Organisation, for the WHO Draft Guidelines forAdverse 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 ofthe NHS document "Doing Less Harm" and WHO Consultant for PatientSafety, Malaysia, who developed the Incident Reporting manual, RootCause Analysis Framework and provided his invaluable guidance to theKuala Lumpur Hospital team during the pilot and follow-up of the IncidentReporting Manual.

• Dato' Dr. Zaininiah bt. Mohd Zain, Director of Kuala Lumpur Hospitaland her team at the Quality Unit, for their untiring efforts in piloting theIncident Reporting programme in HKL and producing the HKL IncidentReporting Guidelines.

• Dr. Ng Siew Hian and Dr. Tai Li Ling, principal authors of the 1998Quality Manual entitled "Incident Reporting"


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ADVISORS :Dato' Sri Dr. Hasan bin Abdul RahmanDirector-General of Health Malaysia

Tan Sri Dato' Seri Dr. Hj. Mohd Ismail MericanDirector-General of Health Malaysia (2005-March 2011)

Datuk Dr. Noor Hisham bin AbdullahDeputy Director-General of Health (Medical)

Dato' Dr. Maimunah bt. Abdul HamidDeputy Director-General of Health (Research & Technical Support)

Datuk Dr. Lokman Hakim bin SulaimanDeputy Director-General of Health (Public Health)

Dr. Khairiyah bt. Abdul MuttalibSenior Director of Dental Health

Dato’ Dr. Norain bt. Abu TalibSenior Director of Dental Health ( Until Dec 2011 )

Dato’ Eisah bt. A.RahmanSenior Director of Pharmaceutical Services

Dato’ Hjh. Fathilah bt. Hj. Abd. WahabDirector of Nursing Services

Dato' Dr. Azmi bin ShapieDirector of Medical Development, Medical Development Division

Dr. Hjh. Safurah binti JaafarDirector of Family Health Development, Family Health Development Division

Datuk Dr. Harjit Singh a/l Pritam SinghSenior Consultant Surgeon and Head of Surgical Department,Hospital SelayangNational Head of Surgical Services

Dato' Dr. Jeyaindran a/l Tan Sri SinnaduraiSenior Consultant Physician and Head of Medical Department,Hospital Kuala LumpurNational Head of Medical Services

Dato' Dr. Jahizah binti HassanSenior Consultant Anaesthetist and Head of Anesthesia Department,Hospital Pulau PinangNational Head of Cardiac Anesthesia Services


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Dato' Dr. Ghazali bin AhmadSenior Consultant Physician and Head of Nephrology Department,Hospital Kuala LumpurNational Head of Nephrology Services

Dato' Dr. Ravichandran a/l JeganathanSenior Consultant Obstetrician and Head of O&G Department,Hospital Sultanah Aminah, Johor BahruNational Head of O & G Services

Datin Dr. V. SivasakthiSenior Consultant Anaesthetist and Head of Anesthesia Department,Hospital Kuala LumpurNational Head of Anesthesiology Services

Dato’ Dr. Hussein Imam bin Muhammad IsmailSenior Consultant Physician and Head of Paediatric Department,Hospital Kuala LumpurNational Head of Paediatric Services

Dr. Siti Zaleha binti Mohd SallehDirector, Hospital Selayang

Dato' Dr. Abdul Jamil bin AbdullahSenior Consultant Surgeon and Head of Surgical Department,Hospital Sultanah Nur Zahirah, Kuala Terengganu

Dato' Dr. Ravindran a/l JegasothySenior Consultant Obstetrician & Gynecologist and Head of O&G Department,Hospital Kuala Lumpur

Dr. Kauthaman a/l MahendranSenior Consultant Physician and Head of Medical Department, Hospital Melaka

Dr. Tan Kah KeeSenior Consultant Physician and Head of Paediatric Department,Hospital Tuanku Jaafar, Seremban

Dr. Wan Jazilah binti Wan IsmailConsultant Physician and Head of Paediatric Department, Hospital Selayang

Dr. Valyakalayil Daniel PhilipConsultant Obstetrician & Gynecologist, Hospital Selayang


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PRINCIPAL AUTHORS :Dr. PAA Mohamed Nazir bin Abdul RahmanPublic Health Physician and Senior Principal Assistant DirectorMedical Care Quality Section, Medical Development Division, MOH

Dr. Lily ManoramahConsultant Pathologist, Hospital Kuala Lumpur

Dr. Kalsom binti MaskonPublic Health Physician and Senior Duputy DirectorMedical Care Quality Section, Medical Development Division, MOH


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CONTRIBUTING AUTHORS :Dr. Kamaliah bt. Mohamad NohPublic Health Physician and Senior Deputy DirectorPrimary Health Care Section, Family Health Development Division, MOH

Dr. Nor ‘Aishah bt. Abu BakarPublic Health Physician and Senior Principal Assistant DirectorMedical Care Quality Section Medical Development Division, MOH

Dr. Nik Jasmin bt. Nik MahirPublic Health Physician and Senior Principal Assistant DirectorSpecial Officer to the Director-General of Health Malaysia

Dr. Amin Sah bin AhmadPublic Health Physician and Senior Principal Assistant DirectorMedical Care Quality Section, Medical Development Division, MOH

Dr. Noraini binti Mohd YusofPublic Health Physician and Senior Principal Assistant DirectorPrimary Health Care Section, Family Health Development Division, MOH

Dr Noridah binti Mohd SalehPublic Health Physician and Senior Principal Assistant DirectorPrimary Health Care Section, Family Health Development Division, MOH

Dr. Khurul Ain bt. Ahmad SamsuriPrincipal Assistant DirectorMedical 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

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

Tuan Hj. Saidi b. Abd. RahmanAssistant Medical OfficerPrimary Health Care Section, Family Health Development Division, MOH

Secretariat:

Sr. Rashidah binti NgahNursing SisterMedical Care Quality Section, Medical Development Division, MOH


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GENERAL OBJECTIVES :To facilitate a learning organisation through the reporting of and learning fromadverse incidents, "near misses" and hazards so that a just and safe culture will benurtured amongst health care providers, in our efforts to enhance the safety of theMalaysian 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 ofevery health care leader to manage events while ensuring that his/herorganization monitors and acts on the incidents that can potentially compromisepatient safety

• to ensure that all staff are empowered to alert the organization to problemsthat can affect the safety of health care provided

• to facilitate hospital management to set up systems for identifying, reportingand managing "incidents" i.e. reportable events

• to provide a basis for which everyone concerned can review and furtherimprove on their own event reporting system

• to ensure the sharing of lessons learnt from incidents, root cause analyses andgood practices in patient safety

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


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TABLE OF CONTENTS1. Introduction to Incident Reporting, Management and

Learning

2. The Malaysian Incident Reporting and Learning System

3. Success in Incident Reporting

4. Key Requirements for Health Care Providers

5. IR1.1 form

6. Mandatory Reportable Incidents (Code No.Included):Hospitals and Health Clinics/ Dental Clinics

7. Reportable Incidents : Guidance on MinimumInvestigation Level, Notification Time and Reporting Time(for Hospitals and Health/ Dental Clinics)

8. Actions that need to be Taken Immediately AfterCategory Red or Yellow "Incident"

9. Investigation : Table 1.1 - Summary of the RCA Process

10. Investigation Reports to State and MOH

11. How to fill Part I of IR1.1 form- Section A-C (Staff Involved)

12. How to fill Part II of IR1.1 form - Section D(Immediate Supervisor)

13. How to fill Part III of IR1.1 form - Section E(Designated Person)

14. "Triaging" : 5 key steps in determining the level ofinvestigation response

15. How to fill Part III Section F of IR1.1 form -(Designated Person)

16. Identifying contributing factors

17. How to fill Part III section G of IR1.1 form(Designated Person)

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

19. Flow chart : how to Investigate an incident

20. Annex II : Contributing Factors Framework and Codes - TheLondon Protocol

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FOREWORD

The pursuit of quality and safety requires the institutionalizationof 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, andto replace it with a "just" or "non-punitive", learning culture. This"just culture" is a collective understanding of the differencebetween blameless and blameworthy actions. When thingsgo wrong during the process of health care, no one isimmediately blamed or summarily punished until a scientificinvestigation is undertaken. When people are not afraid to

report adverse incidents, we will be able to collect data about incidents, analysethem scientifically in a structured manner such as through Systems Analysis (alsocalled 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 duringtreatment and care is amongst the most important knowledge in the field ofpatient safety. One of the accepted best practices for patient safety is to establisha "No Blame, Reporting culture" by initiating an Incident Reporting and LearningSystem for adverse events. Through the systems approach and human factoranalysis pioneered by Dr. James Reason, it is known that many safety problemsare not just a series of random, unconnected one-off events but are provoked byweak systems. They often have common root causes which can be generalizedand corrected, if they are reported and analysed. Learning from the mistakes ofothers is a key tool for patient safety and thus, "a clever person learns from his or hermistakes while a wise person learns from the mistakes of others". Bear in mind alsothat information must lead to meaningful action. Critically, it is the action we takein 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 allsources of risk and patient harm. Thus, other sources of patient safety informationshould also be used e.g. periodic medical record review for preventable adverseevents, clinical audit, monitoring safety using patient safety indicators etc. Thevalue of our patient safety efforts will ultimately be measured in terms of harmprevented and lives saved. It is hoped that effective patient safety reportingsystems will help to make this a reality for our patients.

Dato' Sri Dr. Hasan bin Abdul RahmanDirector-General of Health Malaysia andChairman of the Patient Safety Council of Malaysia


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1. INTRODUCTION TO INCIDENTREPORTING, MANAGEMENT ANDLEARNINGIn 2004, the World Alliance for Patient Safety movement was launched by theWHO to galvanize and facilitate global efforts to make health care safer. IncidentReporting, also known as Adverse Event Reporting or Event Reporting, has beenwidely-regarded as an essential step towards the development of a safe healthcare system, whereby lessons learnt from mishaps, near misses and hazards can beused to prevent future occurrences.

According to the World Health Organization, to improve safety, health-caresystems 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 occurringrepeatedly. At the very least, reporting can help identify hazards and risks (througha "Risk Register"), and provide information as to where the system is breaking down.This can help target improvement efforts and systems changes to reduce thelikelihood of injury to future patients.

A reporting system refers to the processes and technology involved in thestandardization, 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 patientcare in the Malaysian health care system through Incident Reporting, which is animportant component of the Malaysian Clinical Governance Framework. Safetyexperts believe that an effective reporting system is a key element of safe practiceand 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 HealthDocument, "Reportable Event Guidelines 2001)


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Reporting systems should be established at the department, hospital, state andnational 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 THERESPONSE TO REPORTS THAT LEADS TO CHANGE. Thus, the response system is moreimportant 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 asintended (i.e. error of execution) or the use of a wrongplan to achieve an aim (i.e. error of planning). Errors maybe errors of commission or omission, and usually reflectdeficiencies 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. Includesincident) errors, preventable adverse events, and hazards.

iv. Adverse event An injury related to medical management, rather thanthe complications of disease.Medical management includes all aspects of care,including diagnosis and treatment, failure to diagnose ortreat, and the systems and equipment used todeliver care.Adverse events may be preventable or non-preventable.

v. "Near-miss" Serious error or mishap that has the potential to causeor "close call" an adverse event but fails to do so because of chance

or because it is intercepted. Also called potentialadverse 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 eventsand errors?

Health care organizations or individuals benefit from reporting incidents if theyreceive back useful information gained by generalizing and analysing similar casesfrom other institutions. The International Society for Quality in Health Care or ISQuahad previously included in its ISQua journal, a segment entitled "Every Defect is aTreasure", which means that there are opportunities for learning from medicalmishaps.


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Consider the following example:

In an intensive care unit at a hospital, the oxygen tubing is accidentally connectedto an intravenous line and causes an air embolism. A "Root Cause Analysis" (RCA)investigation reveals that the tubing connectors are similar, the oxygen tubing hadbeen left disconnected from a prior respiratory treatment, and the lights in the unitwere dim. The hospital's response might include implementing a new policyrequiring that all tubing be labeled, a "weak" solution.

If the event and the results of the analysis are not reported, the lessons learnedremain 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 areentered into a database, the event can be aggregated with similar incidents toelucidate common underlying causes.

A variety of solutions could emerge, ranging from nursing practice standards tolabel and trace all tubing, to a requirement for medical device manufacturers todevelop 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 enhancepatient safety by learning from failures of the health-care system. Thesystem is oriented towards learning from mistakes and preventingrecurrences of adverse events that have happened.

• Openness about failures -Individuals who report incidents must not bepunished or suffer other ill-effects from reporting("non-blaming" or"non-punitive culture"). Errors are reported and acknowledged withoutfear of inap propriate blame, and thus, this is part of the Just Culture,where individuals are treated fairly and understand when they may beheld accountable for their actions.

• Reporting is only of value if it leads to "action". At a minimum, datacollecting agencies must provide feedback of findings from data analysis.Ideally, it also includes recommendations for changes in processes andsystems of healthcare. Appropriate prioritisation of action to addressproblems occurs when resources are directed to those areas where thegreatest improvements are possible. The most important function of areporting system is to use the results of data analysis and investigationto formulate and disseminate recommendations for systems change.

• Teamwork is recognized as the best defense of system failures and isexplicitly encouraged and fostered within a culture of trust and mutualrespect.

• Adverse events and errors are recognized as symptoms of defectivesystems, not defects in themselves.


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2. THE MALAYSIAN INCIDENT REPORTINGAND LEARNING SYSTEM2.1 The Malaysian IR System as a Learning system

This is a national reporting system for the reporting of incidents in Malaysian healthcare facility. It is a confidential system (patients' and caregivers' names are not tobe disclosed).

The Reporting System has been developed to provide information to improvepatient safety by focusing on learning and contributing to system re-design.Experience has shown that learning systems are most successful when reports areconfidential. 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",

"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 narrativedescription of events for analysis. Narrative reports provide the opportunity tocapture the rich context and story-line that allow the conditions that contributedto the error to be explored and understood. They are capable of providinginformation that provides meaningful insight into the nature of the underlyingsystems defects that caused the incident.

Rather than assure a minimum standard of care, learning systems are designed tofoster continuous improvements in care delivery by identifying themes, reducingvariation, facilitating the sharing of best practices, and stimulating system-wideimprovements. Following careful expert analysis of underlying causes through mini-root cause analysis (RCA) or full RCA, recommendations are made for systemre-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 wellas “hazards" are reported using the voluntary reporting system thatshould be established by health care organizations together with themandatory system. The same reporting form (IR1.1) is to be used for themandatory as well as voluntary reporting systems


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2.1.1a Adverse events (preventable and non-preventable):An adverse events is an injury related to medical management, in contrastto complications of a disease.

Adverse events are not always caused by an error (non-preventableAE). For example, one form of adverse drug event, "adverse drug reaction"is, according to the WHO definition, a complication that occurs when themedication is used as directed and in the usual dosage. Adverse drugreactions are, therefore, adverse drug events that are not caused byerrors. However, many adverse events are caused by errors (preventableAE), either of commission or omission, and do, in fact, reflect deficienciesin the systems of care.

2.2 Additional "internal" reporting of incidents

An organization that values patient safety will have an internal reporting systemthat captures much more than what the mandatory system requires, i.e.otheradverse 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 itsvulnerabilities 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 thepotential to cause an adverse event, but fails to do so because, by thegrace of God, it was intercepted in time before any damage could occur.It is assumed (though not proven) that the underlying systems failures fornear-misses are the same as that for actual adverse events. Therefore,understanding their causes should lead to systems design changes thatwill improve safety.

A key advantage of a near miss reporting system is that, because therehas been no harm to the patient, the reporter is not at risk of blame orlitigation. On the contrary, he or she may be deserving of praise for havingintercepted an error and prevented an injury! Thus, near-miss reportingsystems are an important component of incident reporting.

2.2b Hazards and unsafe conditions:

Reporting of hazards, or "accidents waiting to happen" is another way toachieve prevention without the need to learn from an injury. Within ahealth-care organization, hazard reports raise alerts about unsafeconditions. Providers can imagine accidents waiting to happen based ontheir observations of weakness in the system and their experience asusers. With appropriate analysis, these reports can provide valuableinformation for changes to systems design. The Institute for SafeMedication Practices USA system for medication-related events has beenconsidered as the most successful at capturing hazards (e.g. "look-alike"packaging and "sound- alike" names) and calling for their remedy beforea predictable error occurs.


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The objectives of an internal reporting system for learning are first, to identify errorsand hazards, and then through investigation, to uncover the underlying systemsfailures, with the goal of redesigning systems to reduce the likelihood of futurepatient injury.

Reporting, whether retrospective (adverse events and errors) or prospective("hazards", or "errors waiting to happen") provides the entry point into investigationand analysis of systems' defects, which, if skillfully done, can lead to substantialsystem improvements. Reporting is one way to get this type of information, but notthe only way.

The internal reporting systems should go hand-in-hand with external reportingsystems, by identifying and analysing events that warrant forwarding to externalreporting agencies such as the MOH head-quarters. Conversely, external reportingsystems 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,complications of a new drug.

2.3.2 Dissemination of "lessons learnt" by health-care organizations frominvestigating a serious event.

2.3.3 Analysis of many reports can reveal unrecognized trends andhazards requiring attention, insights into underlying systems failuresand generate recommendations for "best practices" for all tofollow.

2.3.1 Alerts

Even a small number of reports can provide sufficient data to enable expertanalysts to recognize a significant new hazard and generate an alert e.g. the seriesof warnings issued every 2 weeks by the Institute for Safe Medication Practicesentitled "Medication Alert", which was one of the first to highlight the high risk ofdeath following accidental injection of concentrated potassium chloride andrecommend that this substance be removed from patient care units.

Sir Liam Donaldson, Chairperson of the World Alliance for Patient Safety and a keyproponent of patient safety in the world, has exhorted the health care communityto work hard to ensure that it passes the "orange-wire test". Hypothetically, he asksus to imagine that an orange coloured wire that is necessary for the safefunctioning of a jet aircraft, was found to be damaged. This damage was not dueto 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 isa 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 badexperience suffered by a patient in one part of the world to be a source oftransmitted learning that benefits future patients in many other countries.


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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 andcontributing factors. Ideally, every institution will respond to a serious event with aninvestigation (e.g. RCA or mini RCA).

Alternatively, an external authority (such as the MOH) can conduct anindependent investigation. If the investigation is done well, systems analysis of aserious adverse event can yield significant insights into the various contributingfactors that lead to a mishap, and often suggest potential remedies. Thisinformation can then be disseminated to other organizations. Solutions to somecommon hazards, such as wrong site surgery, have been developed in response tolessons learned from investigations of serious incidents.

2.3.3 Analysis of large data sets & Systems analysis and development ofrecommendations

Detailed analysis of many individual reports also makes it possible to identifyhazards. The most important function that a large reporting system can perform isto use the results of investigations and data analyses to formulate and disseminaterecommendations for systems changes. Examples include the Joint Commission ofthe USA, which has performed this function using a relatively small number ofthoroughly-investigated incidents reported to its "Sentinel Events" monitoringprogramme.


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3. SUCCESS IN INCIDENT REPORTINGThe ultimate measure of the success of a reporting system is whether theinformation it yields is used appropriately to improve patient safety.

A successful reporting and learning system to enhance patient safety should havethe 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 aredisseminated and acted upon by those with the responsibility and mandate to act.

3.1 Safe or Non-punitive

The most important characteristic for success of a patient safety reporting system isthat it must be non-punitive. Neither reporters nor others involved in the incidentscan be punished as a result of reporting. For public systems, this requirement is themost 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, thisapproach 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 nationalsystems to protect reporters from blame. The best way to do this is by keeping thereports 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 specificinformation that can be used in litigation. Concern about disclosure is a majorfactor inhibiting reporting for many voluntary reporting programmes.

3.3 Independent

According to the WHO, the reporting system should be independent of anyauthority with the power to punish the reporter or organization with a stake in theoutcome. Maintaining a "firewall" between the reporting agency and thedisciplinary agency in a governmental system can be difficult, but it is consideredessential by the WHO if trust in reporting is to be maintained.


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3.4 Expert analysis

Reports must be evaluated (during the RCA) by experts who understand theclinical circumstances under which the incidents occur and who are trained torecognize underlying systems causes. According to the WHO, while it seemsobvious that collecting data and not analysing it is of little value, the most commonfailure of governmentally-run reporting systems is to require reporting but not toprovide the resources needed to analyse the reports, resulting in the reports beingkept in boxes or on computers. Expertise is a major, and essential, resourcerequirement 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 throughits 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 ofsafety that must be reinforced by the nature of recommendations that come fromany reporting system. It is based on the concept that individual error results fromsystems defects, and will recure with another person at another time if thosesystems defects are not remedied.

3.7 Responsive

For recommendations to result in widespread systems changes, the organizationreceiving the reports (such as the hospital, State Health Department and the MOHheadquarters) must be capable of making and disseminating effectiverecommendations. Hospitals and States must also be committed to implementrecommendations, where applicable (and possible) at their level.Recommendations that require the attention of the MOH headquarters must bespeedily attended to.


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4. POLICY DIRECTIVE : KEY REQUIREMENTSFOR HEALTH CARE PROVIDERSThe purpose of this Incident Reporting and Learning Policy Directive is to adviseclinicians and managers on how to respond effectively to all incidents that occurin their organisation. The following are key local requirements in this policy directive:

i. The organization has a written policy requiring its staff to documentevents that are deemed "reportable" (i.e. the mandatory list as well asany incidents not listed in the mandatory list".

ii. The written policy must reinforce the stand that incident reporting is apatient safety tool and is not to be used as a punitive tool by managersetc.

iii. Every health care provider must be made aware of what constitutes anadverse patient incident (i.e. she must know the "mandatory" incidents tobe reported). Organisations should actively promote awareness andunderstanding of adverse patient incidents to all individuals directly orindirectly involved in patient care. This can be effected through, forexample, induction and on-going training programmes, and postercampaigns, and could be a consideration as part of the ongoing jobappraisal processes.

iv. The incident is managed and reported to a designated person, orpersons, in accordance with local arrangements. The following personscan fill in the incident reports:

a. the employee/staff member who first becomes aware of theevent

b. the employee/staff member most involved in the eventc. 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 reportedimmediately to a locally designated person, or persons, and, whereappropriate, information on these incidents is 'fast-tracked' to relevantexternal stakeholders (e.g. State Health Office and Medical Care QualitySection, Medical Development Division, MOH).

vi. All reported incidents are graded ("triaged") using the prioritisationmatrix that grades incidents according to the actual impact on thepatient(s), and the potential future risk to patients and to theorganization.

vii. Adverse patient incidents are subject to an appropriate level of localinvestigation and causal analysis and, where relevant, an improvementstrategy is prepared.

viii. Incidents graded as RED, are reported to the relevant State HealthDepartments within five working days of the date of occurrence.


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ix. For all CATEGORY RED incidents and sentinel events, a full root causeanalysis is undertaken by the local organisation and reported to therelevant State Health Departments within 60 working days of occurrenceof the incident.

x. Where appropriate, the organisation co-operates with the Ministry ofHealth to establish the need for an independent investigation orinquiry, and also co-operates with other stakeholders who might berequired to undertake investigations and/ or inquiries into thecircumstances surrounding a particular adverse patient incident.

xi. Aggregate reviews of local incident data are carried out on an on-goingbasis by the organisation and the significant results communicated tolocal stakeholders. Aggregate review reports are sent to the MedicalCare Quality Section, Medical Development Division, MOH on a 3 monthlybasis.

xii. Prevention of Incident recurrence:When a root cause or contributory factors have been identified anddocumented, responsibility must be allocated for developing an actionplan to address them. The recommended action plan includes: personresponsible, actions needed to develop and implement the plan, therequired timeline for implementation, methods to assess the effectivenessof the actions. If the resolution of the problem requires organization- widechanges, there is a process for referring it to the appropriate forum. Thereare also systems to ensure that the recommended actions arecommunicated to staff /employees.

xiii. Improvement strategies aimed at reducing risk to future patients areimplemented and monitored by the organisation. Where appropriate,local staff learn lessons and change practice in order to improve thesafety and quality of care for patients.

xiv. Lessons are learned from individual adverse patient incidents, from localaggregate reviews and from wider experience, including feedback fromthe MOH, other agencies/bodies (e.g. the MSQH), and benchmarking

** Sentinel event : an undesired event that signals something serious or "sentinel" hasoccurred and warrants in-depth investigation. Characteristics of a sentinel eventinclude:

• 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 anunanticipated death or major permanent loss of function not related to the naturalcourse of the patient's illness/underlying condition (MOH New Zealand 2001)


INCIDENTREPORTINGFORM IR1.1


24

CONFIDENTIAL FORM IR1.1

PATIENT SAFETY INCIDENT- MANAGEMENT & REPORTING FORMPart I - Initial Report

A. Incident particulars (refer to guidance notes for sentinel event and incident codes)

Enter Incident Code

24 hour clockDate 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 whereincident 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

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 patientand 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 nameDesignation

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 NameDesignation Date


Official Use Only : Date received _____________ Incident Reference __________________


25

1. Actual patient impact/outcome (circle appropriate box/ number)None Minor Moderate Major Death

L M M H H

2. Duration of impact Temp. Permanent N/A Unsure

3. Potential risk to future patients and organisation if no further actiontaken (circle)

Most likely Impact/ OutcomeLikelihood None Minor Moderate Major Death

Almost certain L M M H HLikely L M M H HPossible L M M M M*Unlikely L L M M MRemote L L L L L

Part III - Designated Person Report (Full name _________________________________ Date__________)

E. Investigation priority assessment (triage) and response4. Circle theA(Actualimpact) andP(Potentialrisk) boxes.

* A full RCAmay berequired foraccountability purposes.

AHHHMMMLLL

PHMLHMLHML

ResponseFull RCAMini RCA*Mini RCA*Mini RCAMini RCAMinimalMini RCAMinimalNone

5. Investigation responseSuggested Actual

NoneMinimal

Mini RCAFull RCA

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.

Person responsible Date action completed

F. Contributing factors (write / select codes from list and attach copy of RCA report or fishbone diagram)

1 Patient2 Task and technology3 Individual staff4 Team5 Work and care environment6 Management and organisational7 External

G. Further action proposed to reduce risk (write or attach a copy of RCA report or action plan)

No Description

1

2

3

4

5

L = Low, M = Moderate, H = High


26

MANDATORY REPORTABLEINCIDENTS (HOSPITALS)

1.

*2.

*3

3a.

3b.

3c.

3d.

*4.

Adverse outcome ofclinical procedures(includes knowncomplications):

Death of patient byunexplained cause orunder suspiciouscircumstances that arerequired to be reported topolice

Unforeseeable orunanticipated injuries topatients during their stay inhospital:

Brain or spinal cord injuries

Falls resulting in fractures,concussions or lacerationsextending beyond theepidermis into deep tissueor which threaten vitalstructures

Life-threatening (orpotentially fatal) transfusionerrors or reactions

2nd or 3rd degree burnsinvolving 20% more of thebody surface area of anadult or 15% or more of thebody surface area of achild

Fire in hospital resulting indeath or injury

Outcomes that are not intendedor desired to occur as a result ofperforming a particularprocedure. (e.g. Pneumothoraxfollowing central venous access,GIT perforation followingendoscopy, perforation of bowelfollowing peritoneal dialysiscatheter insertion etc.

Applies to death in health carefacility only

Number of cases

Number of cases

Number of cases

Number ofinjuries or death

CodeNo: Incident Definition Data to be

reported

A. “ALL LOCATIONS”


27

*5.

*6.

7.

8.

9.

10.

11.

12.

13.

Malfunction / intentional oraccidental misuse ofpatient care equipmentthat occurs duringtreatment or diagnosis ofpatient and that wasaverted, OR, IF NOTAVERTED, would havesignificantly adverselyaffected patients oremployees of the hospital

Assault or battery ofpatients by employeesand/or contractors (e.g.security personnel)including physical, mentalor emotional abuse,

Dislodgement of catheter/tube resulting in seriousharm/danger to patient'slife

Infant discharged to thewrong person / missinginfant

Patient suicide, orattempted suicide whilebeing cared for in a healthcare facility

Patient death or seriousdisability due to electricshock while being caredfor in a health care facility

Patient death or seriousdisability associated withthe use of restraints orbedrails while being caredfor in a health care facility

Abduction of a patient (ofany age)

Medication error resulting inserious adverseevent/death

(e.g. wrong ventilator setting,diathermy burn etc.)Number of cases

Includes CVP/ chest drains/intra-arterial catheters)

A serious AE is one where there ismuch pain and suffering ortemporary / permanent disability

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases


reported


28

14.

15.

16.

17.

*18.

19.

20.

21.

Delayed discharge fromthe recovery roomfollowing an operation dueto complications arisingfrom surgery or anaesthesia

Wrong surgery

Unplanned return to OTwithin 24 hours of surgeryfor elective case

No consent or improperoperation consent

Life-threatening (orpotentially fatal)complications ofanaesthesia

Unintended retention of aforeign object in a patientafter surgery or otherprocedure

Incorrect Instrument orSwab Count

Surgery Cancelled in OT

"Delay" is considered as morethan (>) 2 hours in the recoveryroom

Patient received unintendedoperation (e.g. Surgeryperformed on the wrong bodypart, surgery performed on thewrong patient, wrong surgicalprocedure performed on apatient, wrong site, wrong leveloperated on etc.)e.g. Re-laporatomy to securehaemostasis followingcholecystectomyNote: Patient must be sent backto e.g. the ward first for a "return"to OT happen.**Excluded are: changes inoperative plan due to intra-op.findings

e.g. 1 : Failed intubation inpatients undergoing generalanaesthesia (Inability to secureendo-tracheal intubation aftertwo attempts by skilled operator)e.g. 2 : Aspiration of gastriccontents (A clinical diagnosissupported by signs e.g. diffusecrepitations and rhonchi, afterexclusion of other causes.e.g. 3 : Re-intubation in theoperation room or recoveryroom such as inadequatereversal, overdose of opioids

Instrument or Swab Count whichis not reconciled at the end ofan operation

Elective and emergency surgerycancelled before patient arrivedin OT is not included

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases


reported

B. OPERATION THEATRE / ANESTHESIA


29

22.

23.

24.

25.

26.

27.

Readmission to ICU within24 hours of discharge toward

Delay in delivery of patientswith cord prolapse wherethe fetus is alive

Injury to neonate atdelivery

Unplanned admission ofmother to ICU/CCU/HDWpost-delivery

Unplanned post-deliveryprocedure on mother

Failed instrumental delivery

Patients who had beendischarged from ICU to generalward, now requires readmissionto ICU within 24 hours of thedischarge to wardparticipating in National ICUAudit)

Decision for delivery intervalshould be less than 30 minutes

Includes any type of injurysuffered by the infant during theprocess of delivery irrespectiveof the mode of delivery

Admission that is not anexpected outcome of delivery.Excludes cases of placentapraevia and heart disease inpregnancy

e.g. Caesarian hysterectomy,EUA / laparotomy for cervicaltear post-delivery, re-EUA afterMRP

An unsuccessful delivery is one inwhich the doctor had to resortto a Caesarian section followingfailure to deliver using the initialchoice instrument


reportedNumber of cases

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases

C. CRITICAL CARE AREAS

D. LABOUR ROOM


30

*28.

*29.

Intra-dialytic death whileon regular chronichaemodialysis treatment

Sero-conversion to positiveHepatitis B or Hepatitis Cwhile on dialysis treatment

Number of cases

Number of cases


reported

* Incidents that are reported under the Private Healthcare Facilities and ServicesAct 1998 and Regulations 2006 (also to be reported by MOH hospitals)

Incidents that green shaded are Sentinel events (equivalent to Category red andrequire at least a mini-RCA or full RCA investigation)

Besides these mandatory incidents, organisations are encouraged to report andlearn from other incidents that are not listed in the mandatory list, through theirINTERNAL REPORTING SYSTEM, (which they will not need to report individually to theMOH).

E. HEMODIALYSIS UNIT


31

MANDATORY REPORTABLE INCIDENTS(FOR “KLINIK KESIHATAN/ PERGIGIAN”)

Incidents related to anyclinical procedures in"Klinik Kesihatan"

Malfunction / intentional oraccidental misuse ofequipment / incidentsrelated to use ofequipment that occurduring treatment ordiagnosis of patient

Assault or battery ofpatients by employeesand/or contractors (e.g.security personnel)including physical, mentalor emotional abuse,mistreatment or harmfulneglect of any patient

Investigation Error

Diagnostic Error

Examples:• vaccination given to the

wrong site, procedure doneat wrong site, etc.

• Adverse outcomes i.e.outcomes that are notintended or desired to occur asa result of performing aparticular procedure

An "Investigation error" hasoccurred if any of the followingwere present at the time:- An investigation was done but

the interpretation / actiontaken was wrong

- Appropriate investigationswere not performed

- Inappropriate investigationwere performed

- No documentation on follow-up of investigations ordered

- If the investigation results werenot reviewed or abnormalitywas undetected

Incorrect diagnosis after clinicalexamination (history taking andphysical examination) ortechnical diagnostic procedures

Number of cases

Number of cases

Number of cases

Number of cases

Number of cases


reported

30.

31.

32.

33.

34.


32

Decision-making Error

Medication error resulting inserious adverseevent/death

Patient fall (while seekingtreatment in KlinikKesihatan)

Patient death or seriousdisability due to electricshock which occurredwhile he/she was at theKlinik Kesihatan

Fire in Klinik Kesihatanresulting in death or injury

Occurs if one of the following ispresent• Inappropriate interval of

follow-up appointment(includes cases where therewas no follow-upappointment given when itshould have been given)

• Patient was sent homeinappropriately

• Inappropriate referral• Patient required referral but

was not referred

Number of cases

Number of cases

Number of cases

Number of cases

Number ofinjuries or death


reported

35.

36.

37.

38.

39.


33

• Death of patient by unexplained cause or under suspicious circumstancesthat are required to be reported to police

Unforeseeable or unanticipated injuries by patients during their stay in hospital:• brain or spinal cord injuries

• falls resulting in fractures, concussions or lacerations extending beyond theepidermis into deep tissue or which threaten vital structures

• life-threatening (or potentially fatal) transfusion errors or reactions

• 2nd or 3rd degree burns involving 20% more of the body surface area of anadult or 15% or more of the body surface area of a child

• Fire in hospital resulting in death or personnel injury

• Malfunction/ intentional or accidental misuse of patient care equipmentthat occurs during treatment or diagnosis of patient and that was averted,OR, IF NOT AVERTED, would have significantly adversely affected patients oremployees of the hospital

• Assault or battery of patients by employees and/or contractors (e.g. securitypersonnel) including physical, mental or emotional abuse, mistreatment orharmful neglect of any patient

• Dislodgement of catheter resulting in serious harm/danger to patient's life

• Infant discharged to the wrong person/ missing infant

• Patient suicide, or attempted suicide, resulting in serious disability while beingcared for in a healthcare facility

• Patient death or serious disability due to electric shock while being cared forin a healthcare facility

• Patient death or serious disability associated with the use of restraints orbedrails while being cared for in a healthcare facility

• Abduction of a patient (of any age)

• Medication error resulting in serious adverse event/death

• Wrong surgery

• Life-threatening (or potentially fatal) complications of anaesthesia

• Unintended retention of a foreign object in a patient after surgery or otherprocedure

• Delay in delivery of patients with cord prolapse where the fetus is alive

• Injury to neonate at delivery

• Intra-dialytic death while on regular chronic haemodialysis treatment

2

33a

3b

3c

3d

4

5

6

7

8

9

10

11

12

13

15

18

19

23

24

28

Sentinel Event Name Code

Box 1 - HOSPITAL SENTINEL EVENTS( Serious events i.e. CATEGORY RED that require urgent reporting and

investigation (mini /full RCA )


34

• Malfunction / intentional or accidental misuse of equipment / incidentsrelated to use of equipment that occur during treatment or diagnosis ofpatient

• Assault or battery of patients by employees and/or contractors (e.g. securitypersonnel) including physical, mental or emotional abuse, mistreatment orharmful neglect of any patient

• Medication error resulting in serious adverse event/death

• Patient fall (while seeking treatment in Klinik Kesihatan)

• Patient death or serious disability due to electric shock which occurred whilehe/she was at the Klinik Kesihatan

• Fire in Klinik Kesihatan resulting in death or injury

31.

32.

36.

37.

38.

39.

Sentinel Event Name Code

Box 2 - KLINIK KESIHATAN / KLINIK PERGIGIAN SENTINEL EVENTS( Serious events i.e. category red that require urgent reporting and investigation(mini /full RCA )


35

HOSPITALS REPORTABLE INCIDENTS CATEGORY :(Please refer to Table 1.0 for Minimum Investigation Level, Notification Time and Reporting Time)

CodeNo : Incident

1.

*2.

*3a.

3b.

3c.

3d.

*4.

*5.

*6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

Unexpected adverse outcome of clinical procedures:

Death of patient by unexplained cause or under suspiciouscircumstances that are required to be reported to police

Unforeseeable or unanticipated injuries by patients during their stayin hospital:brain or spinal cord injuries

Falls resulting in fractures, concussions or lacerations extendingbeyond the epidermis into deep tissue or which threaten vitalstructures

life-threatening (or potentially fatal) transfusion errors or reactions

2nd or 3rd degree burns involving 20% more of the body surface areaof an adult or 15% or more of the body surface area of a child

Fire in hospital resulting in death or personnel injury

Malfunction/ intentional or accidental misuse of patient careequipment that occurs during treatment or diagnosis of patientand that was averted, OR, IF NOT AVERTED, would have significantlyadversely affected patients or employees of the hospital

Assault or battery of patients by EMPLOYEESincluding physical, mental or emotional abuse, mistreatment orharmful neglect of any patient

Dislodgement of catheter resulting in serious harm/ danger topatient's life

Infant discharged to the wrong person/ missing infant

Patient suicide, or attempted suicide, resulting in serious disabilitywhile being cared for in a healthcare facility

Patient death or serious disability due to electric shock while beingcared for in a healthcare facility

Patient death or serious disability associated with the use of restraintsor bedrails while being cared for in a healthcare facility

Abduction of a patient (of any age)

Medication error resulting in serious adverse event/ death

Delayed discharge from the recovery room following an operationdue to complications arising from surgery or anaesthesia

Wrong Surgery

Unplanned return to OT within 24 hours of surgery for elective case

Green/Yellow/RedRed

Red

Red

Red

Red

Red

Red

Red

Red

Red

Red

Red

Red

Red

Red

Green / Yellow/ Red

Red

Green / Yellow

RecommendedCategory

(depends onseverity ofoutcome)


36

CodeNo :

IncidentRecommended

Category(depends on

severity ofoutcome)

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

*28.

*29.

No consent or improper operation consent

Life-threatening (or potentially fatal) complications ofanaesthesiae.g. 1 : Failed intubation in patients undergoing generalanaesthesia (Inability to secure endotracheal intubation aftertwo attempts by skilled operator)e.g. 2 : Aspiration of gastric contents (A clinical diagnosissupported by signs e.g. diffuse crepitations and rhonchi, afterexclusion 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)

Unintended retention of a foreign object in a patient aftersurgery or other procedure

Incorrect Instrument or Swab Count

Surgery Cancelled in OT

Readmission to ICU within 24 hours of discharge to ward

Delay in delivery of patients with cord prolapse where the fetus isalive

Injury to neonate at delivery

Unplanned admission of mother to ICU/ CCU/ HDW post-delivery

Unplanned post-delivery procedure on mother

Failed instrumental delivery

Intradialytic death while on regular chronic haemodialysistreatment

Sero-conversion to positive Hepatitis B or Hepatitis C while ondialysis treatment

Green / Yellow

Red

Red

Green / Yellow

Green

Green / Yellow

Red

Yellow / Red

Green / Yellow

Green

Green / Yellow

Red

Green / Yellow


37

CodeNo : Incident

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

Incidents related to any clinical procedures in Klinik Kesihatan/Klinik Pergigian

Malfunction/ intentional or accidental misuse of equipment/incidents related to use of equipment that occur duringtreatment or diagnosis of patient

Assault or battery of patients by employees and/ or contractors(e.g. security personnel)including physical, mental or emotional abuse, mistreatment orharmful neglect of any patient

Investigation Error

Diagnostic Error

Decision-making Error

Medication error resulting in serious adverse event/ deat

Patient Fall (while seeking treatment in Klinik Kesihatan/ KlinikPergigian

Patient Death or serious disability due to electric shock whichoccurred while he/she was at the Klinik Kesihatan/ Klinik Pergigian

Fire in Klinik Kesihatan/ Klinik Pergigian resulting in death or injury

KLINIK KESIHATAN/ PERGIGIAN REPORTABLE INCIDENTS :Please refer to Table 1.0 for Minimum Investigation Level, Notification Time andReporting Time

Green / Yellow/ Red

Red

Red

Green / Yellow/ Red

Green / Yellow/ Red

Green / Yellow/ Red

Red

Red

Red

Red

RecommendedCategory

(depends on severityof outcome)


38

EVER

Y3

MO

NTH

Min

imal

Repo

rting

(Bas

icIn

vest

igat

ion)

Sum

mar

yRe

port

(Min

iRC

A)

Sum

mar

yor

Full

Repo

rtM

ini/

Full

RCA

90W

orki

ngDa

ys

60W

orki

ngDa

ys

60W

orki

ngDa

ys

30W

orki

ngDa

ys

5W

orki

ngDa

ys

5W

orki

ngDa

ys

GRE

EN

YELL

OW

*RED

Repo

rtto

MO

H(M

atrix

IR1.1

JKN):

MIN

IMUM

Inve

stig

atio

nRe

quire

dIn

vest

igat

ion

Repo

rtTo

Stat

e:

NO

TIFIC

ATIO

NTIM

E(B

oran

gN

otifi

kasi

IR1.

1)IN

CID

ENT

CA

TEG

ORY

JKN

TOKK

MHO

SPITA

LTO

JKN

HOSP

ITAL

TOJK

N

Tabl

e1.

0:M

inim

umIn

vest

igat

ion

Leve

l,N

otifi

catio

nTim

ean

dRe

porti

ngTim

eac

cord

ing

toca

tego

ry

*C

alla

ndin

form

Pat

ient

Saf

ety

Uni

t,M

edic

alC

are

Qua

lity

Sec

tion,

MO

Hw

ithin

1w

orki

ngda

y(0

3-8

8831

180)


39

* ACTIONS THAT NEED TO BE TAKEN IMMEDIATELY AFTERSIGNIFICANT (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.

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


40

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

1

2

3

4

5

6

7

8

Identification ofincidents/issuesand investigation/analysis level.

Select investigationand analysis team

Plan and conductinvestigation

Determinesequence ofevents

Identify thecontributing factors

Determine rootcauses

Develop riskreduction/qualityimprovementstrategies

Report and actionplan

Determine thesignificance ofthe incidents/issues andwhetherinvestigation/RCA is needed

Bring togetherpeople who havean intimateknowledge of thecontextsurrounding theincident(s),including thecare process(es)and clinical issuesinvolved

Collect facts,knowledge andphysical itemsrelated to theincident as soonas possible

Understand theincident as fully aspossible to ensureinvestigationaccuracy

Identify thecausal factorsthat contributedto the incident

Find thecorrectable rootcause(s) for theincident

Determineappropriate riskreductionstrategies toaddress rootcauses and anyadditionalstrategiesrequired toimprove overallquality

Summarise theoverallinvestigation andanalysis and

Category 'green'response (minor)

Not applicable -basicinvestigationundertaken bylocal manager

Local managercollects as littleinformation asneeded in orderto establish thefacts

Basic descriptionof events leadingup to the incident

Possible use ofcontributoryfactors checklist

Possible use of'Five Whys'approach

Determination bylocal manager

Brief paragraphsetting outsummarydescription of the

Category 'yellow'response(moderate)

RCA team leaderplus typically 1-2others

Full determinationof information.Interview allrelevantindividuals.

Leader developssequence ofevents/chronology table,which is agreedat first meeting.

Contributoryfactors checklistand fishbonediagram

'Five Whys'approach.Possible use ofevents andcausal factorschart

Brainstorming byteam

Summary report.Include key risks(i.e. root causes)in local riskregister

Category 'red'response (major)

RCA team leaderplus typically 3-4others

Full determinationof information.Interview allrelevantindividuals.

Leader and teamjointly developsequence ofevents/chronology table,which is agreedat first meeting.

Contributoryfactors checklistplus fishbonediagram andprobably detailedevents andcausal factorschart

'Five Whys'approach usingevents andcausal factorschart

Brainstorming byteam

Full report.Include key risks(i.e. root causes)in local riskregister

Process stage Objective Basic investigation Mini RCA Full RCA


41

9

10

-

-

Implement actionplan

Evaluateeffectiveness ofactions

Suggestednumber ofmeetings forprocess stages 4-8(sequence ofevents toreportage/actionplan)

Indicative totaltime to completeinvestigation/RCAto process stage 8above, i.e. reportand action plan

translate the riskreduction/qualityimprovementstrategies intodetailed actionsforimplementation

Ensure that riskreductionstrategies are putin place

Ensure that riskreduction and/orqualityimprovementstrategies achievedesired outcomesor results

Minimise timetaken for RCA

Minimise timetaken forinvestigation/RCA

incident, how andwhy it happened,and any actionstaken to preventrecurrence.Considersummary report.Where relevant,include key risks(i.e. root causes)in local riskregister

Local discretion

Local discretion

Not applicable

Less than 10 hours- typically 2-3person hours

Team leaderensuresresponsibilities foraction are clearlyassigned andmonitoring/review mechanisms inplace

Part of riskregister process

Maximum 2

10-50 hours -typically 20-25person hours

Team leaderensuresresponsibilities foraction are clearlyassigned andmonitoring/reviewmechanisms inplace

Part of risk registerprocess

Typically 3-4

More than 50hours, but lessthan 100 hours -typically 60-70person hours

Process stage Objective Basic investigation Mini RCA Full RCA


42

INVESTIGATION REPORTS TO STATE HEALTH DEPARTMENT ANDMOH:

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' ; and3. 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 indicatinga brief summary description of the incident, how and why it happened, and anyactions taken to prevent recurrence.

2. SUMMARY REPORT

A summary report in relation to a 'mini RCA' should, as a minimum, include thefollowing :

• Summary of incident, including individuals (preferably job titles rather thannames) 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 insome instances a summary report may be considered adequate for reporting a fullRCA.

3. FULL REPORT

It is not the intention here to be prescriptive about precisely what format should beadopted. The key issue must be that the report conveys the results and proposedrisk reduction strategies and action plan from the investigation team in acomprehensible way. Standards New Zealand provides a useful format forreporting that can be used as a 'benchmark', and a slightly modified version of theirformat is provided here. They suggest that the report should include:

Summary1. State the incident or issue2. Summary of root causes3. Summary of actions

Introduction1. A brief background description of the incident or issue and a statement

regarding the team assigned to conduct the investigation2. Descriptions of the scope of the investigation, its purpose, timeframe, time

involved by the team in completing the overall RCA, methodologies employedin conducting the investigation and the findings.


43

Analysis and Findings1. 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 ineither the main body of the report or in the 'attachments' section.

Recommendations1. 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 (Aspecimen action plan format that correlates with the requirements of thespecimen 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 pointsPass on the knowledge. A specific listing of the learning points that need to bepassed on to appropriate departments and staff, and other stakeholders asnecessary, either through formal training or through some other means, e.g. staffbriefings, newsletters, required reading, etc.

AttachmentsA listing of all attachments referred to in the report. This may include but is notlimited 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 thekey actions (also known as 'additional controls' in the context of a risk register)together with any resources requirements (financial, physical, staff, etc.), priorityorder, identification of who is responsible for implementing the action (preferably anamed individual), the 'due date' by which the action should be implemented, a'review date', if appropriate, and the 'completion date' when the action has beenimplemented. Progress during any review can be recorded in the final column.

Ref. RootCause

Actions Resourcerequirements

PriorityH/M/L

Responsiblityfor action

DueDate

ReviewDate

CompletionDate

Progress


GUIDELINESFORCOMPLETINGINCIDENTREPORTING FORMIR1.1


46

INTRODUCTIONThese are updated guidelines for filling the incident report form and subsequentinvestigation. 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 respondappropriately to try to ensure, wherever possible, that similar incidents do nothappen again.

Management and staff need to learn from incidents and work together to improvethe safety and quality of care for patients, as well as the health, safety and welfareof 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 theincident

Section D : Immediate Supervisor report.

Part E to G : Designated Person report.

Part H : Head of Department comments.

Note : A 'designated person' is an individual within a Department etc. Who hasspecial responsibilities, skills and training in risk management, incident investigationand root cause analysis (RCA).


47L = Low, M = Moderate, H = High

Part I - Initial Report

PART II - Immediate Supervisor Report(e.g. specialist, consultant, ward manager, matron, etc.)

F. Contributing factors (write / select codes from list and attach copy of RCA report or !shbone diagram)

H.


48

FLOW CHART FOR THE MANAGEMENT & REPORTING OF INCIDENTS

Grade incactoimpo

Designated Person(s) in Dept. / Hospital / District Health Office/ Director /Supervisor in-charge / Specialist

/Matron

Any event or circumstance arising during patient care that could have or lead to unexpected harm, loss or damage

Sta� involved/ witnessto incident- Correction immediately- Report to immediate

supervisor- Fill the IR-1.1 incident

reporting form (Section A-C)

Implement risk reduction strategies action plan and monitor

Learn lessons, change practice, improve safety and quality of care

INCIDENT OCCURS

All incidents inform Head of Dept.

SUPERVISOR

-Take immediate corrective action

- Fill the IRI.I incident reporting form (Section D) - Submit IRI.I form to designated person

Red Green Yellow

Decide on Investigation level needed

If Major -death / permanent

harm Inform Head ofDept,Hospital Directoror Pegawai Kesihatan

Daerah within one hour

Call and informPatient Safety Unit,

Medical Care QualitySection, MOH within

one working day(03-88831180)

Occupational Accident

Staff Patient


49

Investigation requirements Reporting requirements

Quality Unit Hospital

Hospital Director/Incident

Committee

Grade theincidentaccordingto actualimpact andpotential risk

Consider need for independent investigation

Analyse incident

Discuss at Management review meeting

Full Root cause Analysis (RCA)

Inadequate action

• IncidentReporting Form – IR1.1

• RCA report

Basic Ix = CategoryGreen

Mini RCA = CategoryYellow

Full RCA = CategoryRed

Report toOccupational Health UnitA1

Occupational Accident WEHU

/A2

Low Risk

Moderate Risk

High Risk

/or

i

it,ity

hiny


50

FOR THE INCIDENT REPORTING FORM IR1.1 AND LIST OF INCIDENTS TO BE REPORTED, PLEASE REFER TO page26 to 37

INITIAL REPORT

Part I of the IR1.1 form is intended to be completed by a members of staff involvedin 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; andSection 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

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 boxesprovided

Time of Incident -Insert the time of occurrence of the incident in 24 hour clock format (HH/MM) in theboxes provided. In many instances a precise time will not be known and anapproximate time to the nearest 10 or 15 minutes should be given.


51

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 thedate of the incident. Enter the date of reporting the incident in DD/MM/YY formatin the boxes provided.

Unit/ Dept. -Write down the name of the unit or department where the incident occurred in thebox provided.

Location where incident happened -Write down the name of the ward or clinic where the incident occurred in the boxprovided.

Specialties involved -Name of any other department involved in the incident

HOW TO FILL PART I OF IR1.1 FORM - SECTION B

Figure 2 - IR1.1 form, Part I, Section B

Name - The patient's full name.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/ daysDiagnosis - 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 thepatient, 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.

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


52

HOW TO FILL PART I OF IR1.1 FORM - SECTION CSection C. : Incident description

Figure 3 - IR1.1 form, Part I, Section C

This section should be filled by staff involved in the incident or who had witnessedthe incident

Please give a brief description of the incident :• Any staff, medical equipment or medicines involved in the incident• 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, wherepossible, be specified

• It is important that only facts are stated, and not opinion. In some cases itmay be necessary to continue writing the incident description on aseparate sheet.

After completing Section C , please write full name and designation in thespaces provided. These should preferably be written in CAPITAL LETTERS.

Note:Please write the immediate corrective action taken by the staff e.g. Stop givingthe medication immediately. Doctor informed; If there is any injury after a patientfall, the laceration is sutured; In the case of wrong site surgery, the patient wasinformed and reassured

Complete the form IR1.1 , inform and pass the form to the immediate supervisor.Examples of brief descriptions of an incident

C. Incident description

Provide a brief description of the incident, other people involved (including staff), any harm suffered by patientand 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 nameDesignation


On 13th July 2009, in ward Neuro 5B, a patient with a known history of PTB with MS was prescribed TabEthambutol 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 3days by the nurse. The patient developed vomiting. The mistake was realized when the prescription wasreviewed 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 endoscopicexamination and cauterization under GA. Pre-op blood specimen was sent for group and cross match. Therequest 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 alady with the same I.C. number had a previous request for blood transfusion on 3/11/98;7/11/99 ; 22/4/03and 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 wasAB +. History from the patient was taken. She said she lost her IC in 1990 and she was never admitted tothis hospital before.


53

HOW TO FILL PART II, SECTION D OF IR1.1 FORM - IMMEDIATESUPERVISOR REPORT (E.G. SPECIALIST, CONSULTANT, WARD MANAGER,MATRON, ETC.)

Section D. Further action to prevent similar incident

Figure 4 - IR1.1 form, Part II, Section D

The immediate supervisor of the member of staff making the report should providea 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 managementaction taken immediately following the event and does not include action takenimmediately to, for example, make the patient comfortable (which is reported inSection C - see above).

The supervisor should also provide their full name, designation and date ofproviding 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 BHTand "Safe Surgery Saves Lives Checklist " was not used by the staff nurse anddoctor.

Training and remedial measures were implemented immediately and the use ofSafe Surgery Save Lives Checklist is emphasized and monitored.

D. Further action to prevent similar incident/ to reduce risk

Provide a brief description of any action taken to prevent similar incident

Full NameDesignation Date

Official Use Only : Date received _____________ Incident Reference __________________

Continue on separate sheet if necessary


54

HOW TO FILL PART III SECTION E OF IR1.1 FORM -DESIGNATED PERSONSection E : Investigation priority (triage)

Figure 5 - IR1.1 form, Part III, Section E

What to do next :-

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' theincident to provide an indication of the required level of incident response(Section E).

4. Depending on the incident investigation response, complete Sections F and Gas 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 bloodtransfusion and may, some days or weeks later , die as a consequence due to renalfailure. Until the final impact/ outcome is known, the current level of impact( i.e. moderate) must be selected.

L = Low, M = Moderate, H = High

E. Investigation priority assessment (triage) and response

Only for “voluntary” incidents not listed in the mandatory list of reportable incidents.


55

1. Actual patient impact/outcome (circle appropriate box/ number)None Minor Moderate Major Death

L 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 THECONSEQUENCE to the patient/ staff if such an incident were to happen?The consequence and likelihood of a risk occurring should be analysed usinginformation sources and techniques.

Sources of information may include the following:• Past records.• Practice and relevant experience.• Relevant published literature.• Specialist and expert judgements

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 beexpressed qualitatively or quantitatively.

Likelihood Frequency(per procedure/event or within a Probabilityspecified 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

M


56

Review past records such as incident report e.g.

• Mislabeling of the blood specimen vacutainer tube for group and crossmatch > It is frequent occurrence > you would put it as "almost certain"

• Wrong person wrong site surgery > Do not expect it to happen or recur butit is possible you would identify the likelihood as "unlikely" because youhave implemented checklist " Safe Surgery Saves Lives ”

CONSEQUENCEOutcome or impact of an eventThere 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 ofthe existing strategies and controls in place e.g.

Mislabeling of the blood specimen tube for group and cross match is a frequentoccurrence, it often a "near miss" because of the procedures and checklist in placeto prevent "wrong ABO transfusion error.


57

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58

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59

• Now, knowing the likelihood and consequence, circle the most appropriatebox/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 DeathAlmost certain L M H HLikely L M M H HPossible L L M M HUnlikely L L M M MRemote L L L M M

STEP 4Now since you have identified the actual impact of the present incident, circle theappropriate actual impact (A) and Potential risk to future patients and theorganisation (P) to determine the 'suggested' level of response in Table No 4.

A (Actual Impact ) P( Potential risk) Level of investigationH H Full RCAH M Mini RCAH L Mini RCAM H Mini RCA

Mini RCAM L MinimalL H Mini RCAL M MinimalL L None

STEP 5 : Investigation response

Tick the appropriate boxes.

Suggested ActualNoneMinimalMini RCA √Full RCA √

Note :Although there is some subjectivity in thismethod of analysis, certain incidents mightwarrant a full RCA instead of a minimalinvestigation especially when there issignificant patient safety issues or has apotential medio-legal significance oraccountability purpose

M

M M


60

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 aspossible.

Who should do it ?A specific designated person or delegate the responsibility of collectinginformation 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 .• 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 ortabulate the sequence of events

Flow chart :

Date

10/8/07

10/8/07

Time

9.00am

11.30

Location

NICU

RadiologyDepartment

Event description

Requested forappointment for MRIunder GA

Patient in Radiology dept

Key person involved

Dr. R

Radiographer

Comment

Indication forMRI:

Did not verify Idof patient

Tabulation :


61

HOW TO FILL PART III SECTION F OF IR1.1 FORM -DESIGNATED PERSON

Section F : Contributing factors

Figure 8 - IR1.1 form, Part III, Section F

Contributing factors can be identified using a 'root cause analysis' approach toinvestigate an incident.

WHAT IS ROOT CAUSE ANALYSIS ?

• "Root Cause Analysis is a structured investigation that aims to identify thetrue cause of a problem, and the actions necessary to eliminate it"

(Bjorn Andersen and Tom Fagerhaug. Root Cause Analysis : Simplified Toolsand Techniques. McGraw-Hill, 2000).

• A risk management tool to understand WHY did it happen, which isabout identifying the causation, or causal factors.

There are three types of causal factors:

(1) Direct cause : The event (s) that occurred, including any condition(s) thatexisted immediately before the undesired outcome, directly resulted in itsoccurrence and, if eliminated or modified, would have prevented theundesired 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 reducefuture risk

Root cause Contributing factors Direct cause Incident

Figure 9 : Diagrammatic representation of the 3 causal fact

F. Contributing factors (write / select codes from list and attach copy of RCA report or Þshbone diagram)

1 Patient2 Task and technology3 Individual sta!4 Team5 Work and care environment6 Management and organisational7 External

Shortage of staff

No policy &procedure onverbalcommunication

Failure to concentrate- Similar looking package- Patient did not realize a

different tablet wasgiven.

- Verbal communication

FatiguedNurse Medication error


62

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 swabbefore wound closure).

Lapses arise from failure of memory (forgetting two drugs interact e.g. heparinand NSAIDS).

Fumbles actions performed incorrectly (damage to nerve during surgery).

Mistakes where actions are as per plan but plan is inadequate to achieve theoutcome

Omission : Failed to do something required

(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 managementand 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 contributoryfactors

• 5 Why's• Events and Causal Factors (ECF) charting


63

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64

Example :

Patient with breast cancer in Radiotherapy Ward sustained:a) Fracture neck of left femur during transfer from bed to trolleyb) 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

* 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 framee.g. Hoist

* Change in the policy- high risk patient to have portal x-ray instead sending toRadiology 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


65

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66

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 donecould result in patients and staff mishap.

Root cause of the problem :The specification of the automatic door for high volume of traffic in out-patientsetting was not verified and safety check done before use.

EVENTS AND CAUSAL FACTORS (ECF) CHARTINGIn defining causal factors/conditions, the basic approach is to take each event inturn 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.

Why did the automatic door close before the patient could gothrough ?�e sensor had mal-functioned and not suitable for heavytra�c area.Why was this not detected earlier ?No safety check done.

Why not done ?

Why took a long time ?

Why had to use urgently ?

�e 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.

�e renovation work took a long time (3 years).

�ere was no supervision done and the certiÞcation was not veriÞed.


67

Example : Figure 11 : Event and Causal charting : Incident : Medication error caused by wrong dosageresulting in allergic reaction


68

Use the various contributing factors listed in Annex II as a checklist of factorsthat 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 youhave identified as a consequence of any investigation activity, systematically workthorough the contributory factors framework asking appropriate questions to arriveat a list of factors contributing to the incident.

Once you have determined the contributing factors, put the appropriate codes inthe relevant categories in Section F or write down in word or in code refer Annex II

Example:-

1. Patient Patient not educated about the medication2. Task and technology Misinterpretation of verbal communication

between junior and senior staff3. Individual staff Inexperience doctor ( Not aware about the

correct dosage)4. Team No counterchecking done by the ward

pharmacist / senior doctor5. Work and care -

environment6. Management & No policy and procedure about educating

organisational patient about medicationDuties of the ward pharmacies not documentedDrug formulary not available in the ward forreference

7. External


69

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 qualityimprovement ) strategies and action plan must be identified to ensure the actionsare implemented to eliminate or reduce the impact of similar type of incident

A person responsible for implementing the action should be identified (by name incapital letters)

To get rids of weeds, dig up the root; tostop a pot from boiling, withdraw the fuel

Chinese Proverb

No

No policy and procedureon educating patientabout medication theyare taking

No policy andprocedure about allforms of verbalcommunication

Drug dosage referencebook not available inthe ward .

No counter-checkingdone by the wardpharmacist / seniordoctor

Duties of the wardpharmacist not defined

Description of actionto be taken

PersonResponsible

Date actioncompleted

1.

2.

3.

4.

5.

Root cause

Implement "Know yourmedication program" forpatient in order toStrengthen MedicationSafety Program

All verbalcommunication has tobe documented andimplement "read back "policy

Ensure PharmaceuticalBlue Book or DIMMs isavailable in the ward

Document roles andresponsibilities of theward pharmacist

Cik FChairperson,CommitteeMedicationSafety

Dr.LChairpersonRiskManagementCommittee

Cik FHead ofPharmacy Dept

Cik FHead ofPharmacy Dept

June 2011

30 Jan 2011

Feb 2011

Immediately15th Jan 2011


70

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 generalcomments

Figure 14 - IR1.1 form, Part IV, Section H

Before filling this section, please review the actions taken by the designated person.

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.

REPORT1) Investigation required : None

Fill the IR1.1 form ( Part A - D ) and submit to ‘Unit Pengurusan Kualiti’ of thehospital/ clinic.

2) Investigation required : Minimal

A concise, brief summary description of the incident, how andwhy it happened, in section C and D of the Form IR1.1 by the staff involved orwitnessing the incident. Any actions taken to prevent recurrence should be filledin 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

PART IV - Head of Department CommentsH. Organisational impact/outcomes, learning points amd general comments

Continue on separate sheet if necessary

Full name

Designation Date


71

4) Investigation required : Full RCA ( may be included as appendix to the FormIR1.1) Full report is required, which should include the following:

Introduction

A brief background description of the incident or issue and a statementregarding 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 theincident .

2. Brief description and result of the analysis to identify the contributingfactors and root causes. (e.g. fishbone diagram, events and causal factorsanalysis). Include charts or diagrams in either the main body of the reportor 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 apply3. 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 bepassed on to appropriate departments and staff, and other stakeholders asnecessary, either through formal training or through some other means, e.g. staffbriefings, 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 andexternal standards.


72

FLOW CHART : INVESTIGATING AN INCIDENT -FULL ROOT CAUSE ANALYSIS


73

CONTRIBUTORY FACTORS FRAMEWORK AND CODES - THE LONDON PROTOCOL

Clinical

Personnel

Inter-personal

Known risk associated with treatmentPre-existing co-morbidityComplexity of conditionSeriousness of conditionInTreatability of conditionDifficulty in diagnosisClinical / health historyInexplicable / Unknown factorsPersonalityPhysical state ( e.g. malnourished, poor sleep pattern,Cultural backgroundReligious beliefsLanguage and communicationSocial and family circumstancesExternal supportStressDisclosure of health historyPatient-staff relationshipPatient-patient relationship

101102103104105106107108110111112113114115116117118120121

Patient Factors Code

ANNEX II


74

Availabilityand use ofprotocols(includingguidelines)

Availabilityand

accuracy ofhealth

information,includingmedical

record andtest results

Task design

Decisionmaking aids

Medication-related

Availability of protocols to staffUse of protocolsPoor quality of information included in the protocolProcedures for reviewing and updating protocolsInappropriate use of protocolAvailability of informationReliability of informationInformation inaccessible to staffMisinterpretation by staffDisagreements regarding the interpretation ofinformationInadequately flagged information/alertNeed to chase up informationRelevanceEase of task executionDesign deficiencyAvailability, use and reliability of specific types ofequipment e.g. CTGAvailability, use and reliability of specific types of tests,e.g. blood testingAvailability and use of a senior clinicianWrong medicationAdverse drug reactionMiscalculationComplicated dosage designMislabellingIncorrect computer entryPoor/ Similar packaging and labellingSimilar looking or sounding names

201202203204205207208209210211

212213215216217219

220

221223224225226227228229230

Task and technology factors Code


75

Competence

Compliance

Personal

Inter-personal

Inadequate knowledge 301

Inadequate skills 302

Inadequate experience 303

Failure to comply with policy / 305Procedure / Protocol

Intentional violation 306

Unintentional violation 307

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

Domestic issue 318

Staff-patient relationship 320

Staff-staff / team relationship 321

Staff - organisation relationship 322

Other 323

Staff factors Code


76

VerbalCommunication

Writtencommunication

Supervision andseeking help

Congruency/consistency

Leadership&Responsibility

Staffcolleaguesresponse to

incident

Communication between junior and senior staffCommunication between professionsCommunication outside of the ward/departmentInadequate hand overCommunication between staff and patientCommunication between specialists anddepartmentsCommunication between staff of the same gradeVoicing disagreements and concernsCommunication between staff and relatives orcarersIncomplete/absent information (e.g. test results)Incomplete/ absent information (e.g. test results,handover)Discrepancies in the notes/ documentationIncomplete documentationIllegibleMissing signaturePoor quality of information in thenotes/documentationInter-dept communicationCommunication with MoH/ other hospitals/agenciesMisinterpretationDecision/willingness of staff to seek helpUnavailability of staff to helpResponsiveness of staff to helpDefinition of tasks between professionsDefinition of tasks between different grades of staffDefinition of tasks between same grades of staffIneffective leadershipUnclear definitions of responsibilityInadequate support by peers after incident

Inadequate support by staff of comparable gradesacross professions e.g. senior nurse and juniordoctor

401402403404405406

407408409

411412

413414415416417

418419

420422423424426427428430431433434

Team Factors Code


77

Maintenance ManagementFunctionality (ergonomic assessment e.g. lighting,spaces, etc.)HousekeepingControl of the physical environment (e.g. temp,light, etc.)Movement of patient between wards/sitesStorageMalfunction/failure/reliabilityUnavailabilityMaintenance managementFunctionality (e.g. ergonomic design,fail safe,standardisation)System designMalfunction/failure/reliabilityUnavailabilityMaintenance managementFunctionality (e.g. ergonomic design,fail safe,standardisation)System designUnavailabilityAllocation of stafRecruitmentInduction/OrientationOngoing and refresher trainingInadequate regular rest breaksHeavy workloadLong working hoursDelayMissedInappropriate

Building anddesign

Physicalenvironment

Equipment /supplies

Informationtechnology

Staffing

Education andtraining

Workload / Hoursof work

Service delivery

501502

504505

506507509510511512

513515516517518519521522523525526528529

530532533534

Work and care enviroment Code


78

Leadership presenceLeadership styleGovernance arrangements

Hierarchical arrangement of staff within theorganizational contextSpan of controlUnclear roles/ responsibilityManagement arrangements (function)Operation (e.g. Facility Management, MaterialsManagement, Contract Management)Human resources policyFinancial policyInformation policyRisk management (e.g. incident reporting,Investigation and analysis, safety culture)OSH managementHuman resourcesFinancialInadequate safety cultureWrong priorities

601602603605

606607609610

611612613

614615617618620621

Management and Organizational Code

Leadershipand

governance

Organisationalstructure

Objectives,policies and

standards

Resource& constraints

Safetyculture &priorities


79

Political

EconomicRegulatory

Partnershipworking with

externalorganisation

GoalsPerceptionsClimateLaws and regulationsMinistry of Health requirementsRequirements of other regulatory agencies/bodiesGovernance arrangementsManagement arrangementsContractual arrangementsCommunication

701702704706707708710711712713

External Factor Code


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