pa ent safety unit quality in medical care sec on medical

Pa�ent Safety UnitQuality in Medical Care Sec�onMedical Development Division

Ministry of Health&

Pa�ent Safety Council of Malaysia

01.Layout:Layout 1 6/13/13 5:09 PM

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 :Patient Safety UnitQuality in Medical Care SectionMedical Development DivisionMinistry of Health&Patient Safety Council of Malaysia

ISBN : 978-967-0399-52-2


CONTENTSPAGE

1. ACKNOWLEDGEMENT 4

2. FOREWORD BY THE DIRECTOR-GENERAL OF HEALTH MALAYSIA 5

3. MESSAGE BY THE DEPUTY DIRECTOR-GENERAL OF HEALTH (MEDICAL) 7

4. ADVISORS, AUTHORS,CONTRIBUTORS & TECHNICAL COORDINATORS OF PSCoM 9

5. INTRODUCTION 13

6. BACKGROUND 13

7. INTENT OF THE MALAYSIAN PATIENT SAFETY GOALS 14

8. PHILOSOPHY OF THE MALAYSIAN PATIENT SAFETY GOALS 14

9. KEY AREAS FOR THE MALAYSIAN PATIENT SAFETY GOALS 15

10. TARGET SETTING 18

11. EVALUATION OF THE MALAYSIAN PATIENT SAFETY GOALS AND INDICATORS 18

12. DATA COLLECTION SYSTEM 18

13. TECHNICAL SPECIFICATIONS OF THE MALAYSIAN PATIENT SAFETY GOALS 20

14. APPENDICES 35

APPENDIX I - PATIENT SAFETY GOALS (PSG FORM 1) 36

APPENDIX II - REFERENCES AND GUIDELINES 38

APPENDIX III - PATIENT IDENTIFICATION MANUAL 41

APPENDIX IV - HAND HYGIENE AUDIT TOOL & OBSERVATION FORM 57

APPENDIX V - CIRCULAR OF THE DIRECTOR-GENERAL OF HEALTH MALAYSIA (BIL 2/ 2013) 66


4 Malaysian Patient Safety GoalsGuidelines on Implementation & Surveillance

Acknowledgement

We would like to thank the following for their invaluable contribution to the production of thisguideline:

• The previous Patient Safety Council Chairpersons- YBhg. Tan Sri Dato’ Seri Dr. Hj Mohd Ismail Merican- YBhg. Dato’ Sri Dr. Hasan bin Abdul Rahman

• Members of the Patient Safety Council of Malaysia

• Technical Coordinators of the Patient Safety Council of Malaysia: Patient Safety Unit, Qualityin Medical Care Section, Medical Development Division, MOH.

We would also like to thank all individuals and organizations that have contributed directly orindirectly to the production of this guideline, whom we have not listed by name. Immensegratitude is also extended in advance to everyone who will be involved in implementing andmonitoring of the Patient Safety Goals.

Technical Coordinators of the Patient Safety Council of MalaysiaPatient Safety UnitQuality in Medical Care SectionMedical Development DivisionMinistry of Health Malaysia2013


Malaysian Patient Safety GoalsGuidelines on Implementation & Surveillance 5

BY THE DIRECTOR-GENERAL OF HEALTH, MALAYSIACHAIRMAN OF THE PATIENT SAFETY COUNCIL OF MALAYSIA

The Ministry of Health has a “Vision for Health” which mandates thedevelopment of a safe healthcare system that is attained throughthe coordinated efforts of all the major stakeholders, which is whythe Patient Safety Council was set up in 2003 by decree of theMalaysian Cabinet. This Council is entrusted with the verychallenging responsibility of leading national efforts in ensuring asafe Malaysian health care system.

However, in our noble quest and zest to attain patient safety, we must be mindful of the fact thatpatient safety is a very tough problem. Prof. Charles Vincent, an international expert in patientsafety once said, “In health care, we are beginning to understand how difficult the safety problemis, in cultural, technical, clinical and psychological terms NOT TO MENTION its massive scale andheterogeneity”. This is because its scope is enormous as health care is extraordinarily diverse interms of activities involved and the way it is delivered, from the hospitals to primary care, dentalservices, laboratory services etc.

Patient Safety can be defined as the avoidance, prevention, detection andamelioration of adverse outcomes or injuries stemming from the process of healthcare. In addition, it also refers to the amelioration of adverse outcomes or injuries,i.e. the need for rapid medical intervention to deal with the immediate medicalmishap. It also includes the need to care for injured patients and to support theunfortunate staff involved (often termed as the “second victim of medical errors”) inthe serious incident.

In this electronic age of quick solutions, the sad reality is that there are no “magic bullets”or easysolutions for this very serious problem, which has the potential to undermine the trust that thepublic has for the medical professions, as the champions and the guardians of the patient safety.Prof. Vincent demonstrated this by saying that: “One of the greatest obstacles to progress onpatient safety is, paradoxically, the attraction of “neat solutions, whether political, organisationalor clinical”.

The Safety Council has been promulgating the adoption of a “systems approach” to patientsafety i.e. errors are more commonly caused by faulty systems, processes, and conditions thatcause people to make mistakes or fail to prevent them. This is because, the reality in medicine

FOREWORD


Malaysian Patient Safety GoalsGuidelines on Implementation & Surveillance6

is that there is much uncertainty and complexity ....…in history-taking, diagnosis,investigations and finally treatment. However, this does not absolve the health care professionalfrom individual accountability for the demonstration of a high level of professional competence,which has always been the key to professionalism, a value much honoured by the medicalprofession.

Developing a safe Malaysian health care system necessitates the institutionalization of a cultureof quality and safety. One of the ways that this can be achieved is through the implementationof Patient Safety Goals, which focus our attention to key areas for patient safety. While thesegoals “do not tell the whole picture”, in view of the enormity of the issue of patient safety, theyare useful as a baseline to further improve patient safety in Malaysia. Needless to say, theseSafety Goals will be further refined upon or expanded as we progress in this vital field of ClinicalRisk Management and Patient safety.

A safe culture can only BEGIN TO BE engineered into our healthcare system or organisations,when we adopt a “just and non-blaming culture”. One of the important products of a non-blaming culture is a mandatory “Incident Reporting and Learning System” where national datacan be obtained regarding “Clinical Incidents” and “Root Cause Analyses” are conducted toinvestigate the incidents in order to determine the contributory factors for certain high priorityincidents. In fact, an Incident Reporting System is one of the Patient Safety Goals for Malaysia.The MOH believes that “A clever person learns from his or her mistakes while a wise person learnsfrom the mistakes of others”.

A National Report Card on patient safety is the outcome of this ambitious endeavor by thePatient Safety Council. The patient safety KPIs that accompany these Safety Goals 2013 indicatorswill provide a strong impetus for the measurement and improvement of patient safety in allMalaysian health care institutions.

“Safety is everyone’s business! Let us all work together in the spirit of teamwork andlearning to make our health care system a safer one in 2013 and beyond! “Successdoes not consist in never making mistakes but in never making the same one asecond time”.

Datuk Dr. Noor Hisham bin AbdullahDirector-General of Health Malaysia



MESSAGEBY THE DEPUTY DIRECTOR-GENERAL OF HEALTH (MEDICAL)

Rapid scientific development in the field of clinical research andclinical practice leading to new modalities of treatment , makes itnecessary for healthcare providers to ensure that the safety ofpatients is guaranteed at all times. Patients must be protected fromunethical practices and harmful treatment or procedures.

Medicine is viewed as a noble profession and patients come to usseeking treatment in the belief that we will provide them with thebest possible solution or cure for their ailment. As such, it is ourmoral and professional responsibility to ensure that this trust in the profession is upheld at alltimes.

Patient safety is an integral part of Clinical Governance; as such, all practitioners of clinicalgovernance will automatically be advocates of patient safety. The term “clinical governance” is acombination of several activities which have and are being practised in most Ministry of Healthhospitals. For years we have, been carrying out various activities which measure the quality ofthe delivery of healthcare by activities such as such as NIA and quality assurance.

The Ministry of Health has and will always promote patient safety, for example in 2005, weconducted the first local study on the prevalence of adverse events and we had a rate of 3%which is comparable if not better that many developed nations.

In an effort to ensure that staff are up-to-date with the current medical advances, we haveimplemented various activities that ensure continuous professional development such as CMEand CPD and in some centers we also carry out research.

To ensure patient complaints and other grievances are dealt with in an effective manner, wehave various mechanisms to deal with these complaints such as in-hospital reviews with rootcause analysis and when indicated, independent investigations.

Collectively, all these above-mentioned activities constitute clinical governance.WHO places great emphasis on patient safety, so much so in October 2004 , they launched theWorld Alliance for Patient Safety. Malaysia ratified this alliance in May 2006 becoming one of thepioneering members of this global effort to enhance patient safety.



Today’s patients are educated and empowered persons, who demand a lot from the healthcaresystem. They have access to a wide variety of information from the media and as such, it is ourduty to ensure that they acquire the right knowledge. Once that is done, then, we can empowerthem to take a certain amount of responsibility of their own health.

Based on the number and types complaints that are received from patients or the care-givers, avast majority can be attributed to human factors. They can be categorized as being due to lack ofadequate communication, either between the care provider and the patient or their relativesresulting misunderstanding leading to undue worry.

We must move to an era where there has to be adequate communication between all partiesinvolved in the care of the patient. It has been shown in hospitals where this is practised, therehas been improvement in patient safety and improved patient satisfaction.

Datuk Dr. Jeyaindran Tan Sri Dr. SinnaduraiDeputy Director-General of Health (Medical)



Advisors

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

YBhg. Dato’ Sri Dr. Hasan bin Abdul RahmanDirector General of Health Malaysia (2011-2012)

YBhg. Datuk Dr. Noor Hisham bin AbdullahDirector General of Health Malaysia (2013-Current)

YBhg. Datuk Dr. Jeyaindran Tan Sri Dr. SinnaduraiDeputy Director-General of Health (Medical)

YBhg. Dato’ Dr. Maimunah Abdul HamidDeputy Director General of Health (Research & Technical Support)

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

Dr. Khairiyah bt Abdul MuttalibSenior Director (Oral Health)

YBhg. Dato’ Eisah A. RahmanSenior Director (Pharmacy)

Past and present Members of the Patient Safety Council of Malaysia

Dr. Nor’ Aishah Abu BakarHead, Patient Safety UnitPublic Health Physician & Senior Principal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MOHTechnical Coordinator of The Patient Safety Council of Malaysia

Dr. PAA Mohamed Nazir Abdul RahmanPublic Health Physician & Senior Principal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MOHTechnical Coordinator of The Patient Safety Council of Malaysia

Dr. Maisarah Md NujidPrincipal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MOHTechnical Coordinator of The Patient Safety Council of Malaysia

Principal Authors



YBhg. Dato’ Dr. Azmi bin ShapieDirector (Medical Development Division)

Dr. Ahmad Razid bin SallehDirector, Medical Practice Division

Dr. Hjh Kalsom MaskonDeputy Director, Quality in Medical Care Section

YBhg. Tan Sri Dato’ Dr. Abu Bakar bin SuleimanAppointed member of the Patient Safety Council of Malaysia

Dr. Milton Lum Siew WahDirector of Medical DefenceAppointed member of the Patient Safety Council of Malaysia

Sir Liam DonaldsonAdvisor to WHO Director General on strategic issues in patient safetyFormer Principal Advisor to National Health Services(NHS), United Kingdom

YBhg. Prof. Dato’. Dr. Patrick Tan Seow KoonUniversiti Malaya Medical Center

Prof. Dr. Jaafar Md ZainUniversiti Kebangsaan Malaysia Medical Center

YBhg. Dato’ Dr. Zaidon bin KamariHospital Universiti Sains Malaysia

Assoc. Prof. Dr Kadar MarikarMalaysian Society for Quality in Health (MSQH)

Dr. Chang Keng WeeMaster of Academy of Medicine Malaysia

Dr. M. PonnusamyMalaysian Medical Association (MMA)

Dr Abu Hasan SamadPresident, Academy of Occupational and EnvironmentalMedicine Malaysia

Contributors



Dr. Roshida bt HassanDirector, National Blood Centre

Datin Dr. V. SivasakhtiSenior Consultant Anaesthetist and Head of Anaesthesia DepartmentHospital Kuala LumpurNational Head of Anaesthesiology Services

Dr. T. MahadevanHonorary Secretary, Association of Private Hospital Malaysia (APHM)

Dr. Lily ManoramahConsultant Pathologist, Hospital Kuala Lumpur

Dr. Khalid IbrahimDirector, Sungai Buloh Hospital

Dr. Rona RidzuanHead of Dermatological Department, Hospital Selayang

Dr. Hajah Siti Zaleha Mohd SallehDirector, Selayang Hospital

Dr. Lee Fatt SoonConsultant Geriatrician, Geriatric Unit, Department of Medicine, Hospital Kuala Lumpur

Dr. Tengku Intan Norleen Tengku SharifSenior Principal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MoH

Dr. Suraya Amir HusinSenior Principal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MoH

Dr. Nooraini bt Mohd YusoffPublic Health Physician and Senior Principal Assistant DirectorPrimary Health Care Section, Family Health Development Division, MoH

Datin Dr. Ang Kim TengInstitute for Health Management

Dr. Sondi SararaksInstitute for Health Systems Research



Dr. Elise MonerasingheDental Health Division, MoH

Dr. Zurina bt Abu BakarDental Health Division, MoH

Dr. Nor Hayati IbrahimPublic Health PhysicianSelangor State Health Department

Puan Wan Mohaina Wan MohammadSenior Principal Assistant DirectorPharmaceutical Service Division

Matron TSelvin A/P SubramaniamNursing Division, MoH

Dr Khairulina Haireen KhalidPrincipal Assistant DirectorQuality in Medical Care Section, Medical Development Division, MOH

Puan Rokayah EddieNursing MatronQuality in Medical Care Section, Medical Development Division, MOH

Puan Rashidah NgahNursing SisterQuality in Medical Care Section, Medical Development Division, MOH

Puan Nor Fadzilah IsaInformation Technology Assisant OfficerQuality in Medical Care Section, Medical Development Division, MOH

Puan Roshaida Othman & Puan Norazila Mohd SayuthiAdministrative AssistantQuality in Medical Care Section, Medical Development Division, MOH

Technical Coordinators of The Patient Safety Council Of Malaysia



“Malaysian Patient Safety Goals: Guidelines on Implementation and Surveillance” explains thedetails of the Goals as well as the implementation and surveillance for their associated KeyPerformance Indicators.

It describes the 13 Patient Safety Goals, the technical specification of the associated 19 KPIs, i.e.definitions, criteria, indicators, numerators, denominators and targets as well as the datacollection format. It is hoped that these guidelines will assist healthcare facilities in theimplementation and surveillance of Patient Safety Goals so that objective evaluation on thestatus of patient safety in Malaysia can be made.

The Patient Safety Council of Malaysia is committed to establishing a safe Malaysian healthcaresystem. Hence, the Malaysian Patient Safety Goals were developed by the Patient Safety Councilof Malaysia to encourage and challenge our healthcare organizations to improve some of themost significant, challenging and enduring patient safety issues in Malaysia. These goals areapplicable to both public and private healthcare facilities in Malaysia.

The Malaysian Patient Safety Goals will allow systematic monitoring and evaluation of patientsafety status in Malaysia. The first version of these goals was prepared by Dr. PAA Mohamed Nazirbin Abdul Rahman and included 15 goals and 59 KPIs. Subsequently, Dr. Nazir and Dr.Nor’Aishah, through a series of consultative meetings with the key stakeholders, reduced themto a more implementable 13 safety goals and 19KPIs.

The goals, strategies, key performance indicators and targets are based on the WHO’s as well asinternational goals for patient safety as well as national issues. They were developed as a resultof discussions with various stakeholders including the MSQH, University Hospitals, the MalaysianMedical Association, other associations, hospital directors and clinicians as well as discussionswith Sir Liam Donaldson (Advisor to WHO Director-General on strategic issues in patient safetyand former Principal Advisor to National Health Services, United Kingdom).

Introduction

Background



Intent of The Malaysian Patient Safety Goals

1. To stimulate healthcare organizations to improve key patient safety areas as well as patientsafety in general

2. To outline important patient safety areas that need to be focused on and improved upon

3. To provide a measurable (and improvable) “bird’s eye view” or “dashboard” of the status ofpatient safety in public as well as private health care facilities in Malaysia

4. Their associated KPIs will act as “Performance Measurement Tools” in areas that are criticalto a safe healthcare system

5. An objective means for the Patient Safety Council of Malaysia to monitor and evaluate aswell as improve the status of patient safety in the country

“Patient safety is a key dimension of quality in health care and should be given primeimportance by the healthcare fraternity. If possible, preventable adverse events should be

avoided, at all costs”

1. Ensure a systematic framework for healthcare sectors by integrating quality, safety and riskmanagement

2. Manage major and significant aspects of safety risk to patients receiving healthcare

3. Implement evidence-based best practices, safety measures and solutions

4. Assess and understanding issues of unsafe care

Each strategy underpins the goal/ goals and performance indicator/s.

Philosophy of The Malaysian Patient Safety Goals

Strategic Directions of The Malaysian Patient Safety Goals



Table

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Target Setting

The targets are based on:

• Current MOH standards• Statistics on previous performance of Malaysian healthcare facilities• Consensus amongst clinical experts• National and international standards or data (where available, from literature search)• Discussion with Sir Liam Donaldson (Advisor to WHO Director-General on strategic issues in

patient safety and former Principal Advisor to National Health Services, United Kingdom)- 19th September 2012

The usefulness of the goals, indicators and targets will be reviewed by the Patient Safety Councilregularly (eg: every 5 years).

• At facility level, each healthcare facility is required to collect the data based on the datacollection format (PSG Form 1). (Page 36 and 37)

• The data shall be analyzed by the facility at regular intervals (e.g. every month or 3 months).• The facility shall then take pro-active measures to improve performance or prevent

recurrence of similar “incident” at the facility.• The data shall be submitted to the Technical Coordinators of the Patient Safety Council,

Quality in Medical Care Section, MOH once a year only(by 31st January of the next year).

• The Technical Coordinators of the Patient Safety Council will then analyze the data andpresent it to the Patient Safety Council. The data will be used to plan and prioritize actions tofurther improve patient safety at the national level.

Evaluation of Malaysian Patient Safety Goals & Indicators

Data Collection System



Diagram 1: Summary of Patient Safety Goals Data Collection Process

Data is collected by respective personnel or department in charge

Data is compiled regularly by health care facility throughout the year

Appropriate action is taken by health care facility based on Patient Safety Goals achievement

Cumulative annual data (Jan-Dec) is submitted to the Technical Coordinators of the PatientSafety Council by 31st January every year via “e-goals patient safety”

(http://patientsafety.moh.gov.my/)

Data is analyzed by the Technical Coordinators of the Patient Safety Council

Goals and indicators are reviewed by the Patient Safety Council regularly(eg. every 5 years)



Technical Specifications of Malaysian Patient Safety Goals & KPIs

Patient SafetyGoal No. 1

Rationale

Strategies &Implementation

KPI No. 1

Definition ofTerms

Indicator

Reference

To implement Clinical Governance

Clinical Governance is the systematic framework of accountability for thehealth care sector that integrates quality, safety and risk management. It is alsoknown as corporate responsibility for safe care and encompasses executivemanagement being accountable for patient safety. The objectives of clinicalgovernance are:

• To ensure that there is a systematic framework for the healthcare sector tosupport and drive the provision of safe health care

• To drive core programmes for quality, safety and risk management• To ensure that the appropriate accountability, leadership and oversight

arrangements are in place to institutionalize and internalize quality andsafety

Set up organizational structure/ accountability arrangements. Six (6) essentialunderpinning requirements need to be implemented for Clinical Governance tofunction in an organization and they are:

1. Communication and consultation with key stakeholders2. Clear accountability arrangements3. Adequate capacity and accountability4. Standardised policies, procedures, protocols and guidelines5. Monitoring and review arrangements6. Assurance arrangements

Implementation of Clinical Governance

Clinical governance Clinical governance is a framework of accountabilitythrough which organizations are accountable for continually improving thequality of their health services and safe-guarding high standards of care bycreating an environment in which excellence in clinical care will flourish. It isalso defined as corporate accountability for clinical performance.

Implementation of Clinical Governance (i.e. good clinical governance will bemanifested as compliance to the patient safety goals)

Information on Clinical Governance is available in “Achieving Excellence InClinical Governance”, produced by the Patient Safety Council of Malaysia &Ministry of Health Malaysia (http://patientsafety.moh.gov.my/)




Rationale


KPI No. 2

Definitions

Inclusion Criteria

Numerator (N)

Denominator (D)

Formula

Target

Data collection atfacility level

Remarks

To implement the WHO’s 1st Global Patient Safety Challenge:“ CleanCare is Safer Care”

Infection control is acknowledged universally as a key patient safety issue asnosocomial (healthcare –associated) infections are a major cause of morbidityand mortality in healthcare facilities world-wide. The 1st Global Patient SafetyChallenge was initiated by the WHO in late 2004 and mandates signatorycountries to work diligently towards the reduction of healthcare-associatedinfections and their consequences. Malaysia became one of the earliestsignatories in the world, in early 2005, to the promotion and implementationof hand hygiene in its health care facilities.

Hand Hygiene Campaigns and Training Programmes are regularly conducted.

Hand Hygiene Compliance Rate (refer page 57)

Hand hygiene: Any action of hygienic hand antisepsis in order to reducetransient microbial flora (generally performed either by hand rubbing with analcohol-based formulation or hand washing with plain or antimicrobial soapand water)

The opportunity: is an accounting unit for the action; it determines the needto perform hand hygiene action, whether the reason (the indication that leadsto the action) be single or multiple

Any health care worker involved in direct or indirect patient care

Number of hand hygiene actions (wash or rub) performed

Number of opportunities observed

(N/D) x 100

≥ 75% compliance rate at each audit (quarterly audit)

Quarterly (Every 3 months)

5 indications have been adopted for the assessment of hand hygieneperformance ‘My 5 Moments for Hand Hygiene’:

• Before patient contact• Before aseptic task• After body fluid exposure risk• After patient contact• After contact with patient’s surroundings



To implement the WHO’s 2nd Global Patient Safety Challenge:“Safe Surgery Saves Lives”

The regular use of Surgical Checklists can increase adherence to safetystandards and prevent errors during surgery. It can also reduce the rate ofcomplications and mortality associated with surgical care.

As per the WHO “Safe Surgery Saves Lives” implementation guidelines. Eachhealthcare facility is required to establish the relevant committees and to eitheradopt the WHO check-list or develop their own local check-list to suit their localconditions.

Number of “Wrong Surgeries” Performed

Zero (0) cases

Number of Cases of “Unintended Retained Foreign Body”

Zero (0) cases

• Wrong surgeries performed: surgery which involved wrong-procedure,wrong-person or wrong-site surgery.Risks can be reduced with compliance to Surgical Safety Peri-operativeChecklist, pre-operative verification process, surgical site marking andconducting a time-out.

• Unintended retained foreign body in patients: surgical instruments,gauze, abdominal packs or any unintended objects that were left in thepatients’ body peri-operatively.

• Surgical Safety Checklist: This is a check list developed by World HealthOrganization to ensure surgical safety. This check list was adapted, modifiedand standardized for the used in MOH hospitals and known as the ‘Peri-operative Check List’.

Surgery involving general or regional anesthesia.

Data (numbers of cases) to be collected on a monthly basis.


Rationale


KPI No. 3

Target

KPI No. 4

Target

Definitions ofTerms

Inclusion Criteria





Rationale


KPI No. 5

Numerator (N)

Denominator (D)

Formula

Target

KPI No. 6

Numerator (N)

Denominator (D)

Formula

Target

KPI No. 7

Numerator (N)

Denominator (D)

Formula

Target

Definition ofTerms

To implement the WHO’s 3rd Global Patient Safety Challenges-“Tackling Antimicrobial Resistance”

Antimicrobial resistance poses a growing threat to the treatment and control ofinfections.

1. The Malaysian National Antibiotic Guidelines are implemented.2. National and State Campaign on Containment of Antimicrobial Resistance3. Antibiotic Stewardship Programme

Incidence Rate of MRSA Infection

Number of patients with MRSA infection in the hospital

Total number of hospital admissions

(N/D) x 100

≤ 0.4%

Incidence Rate of ESBL- Klebsiella pneumonia Infection

Number of patients with ESBL- Klebsiella pneumoniae infection in the hospital


(N/D) x 100

≤ 0.3%

Incidence Rate of ESBL- E.coli Infection

Number of patients with ESBL- E.coli infection in the hospital


(N/D) x 100

≤ 0.2%

Case definitions:MDRO (Multi-Drug Resistent Organism) case definition must fulfill ALL of thefollowing criteria:

1) Isolation of an MDRO from any body sites2) The patient must be admitted to the ward3) The case must be “Newly Identified”




Reference

“Newly Identified” include:I. MDRO identified for the first time during current hospital admissionII. Cases that have been identified at your site but acquired “new infection”

(infection with organism having different antibiogram or defined as newinfection by the attending clinician)

Population under surveillance is all in-patients except:1) Cases from Emergency department, clinic or other outpatient services2) Cases previously identified at other acute care facilities/hospitals3) Cases re-admitted with same alert organisms within one year4) Cases with insufficient information on healthcare exposure5) Cases from screening culture6) Coloniser

Monthly

Alert Organism Surveillance Manual, Ministry Of Health 2012




Rationale

Strategies &implementation

KPI No. 8

Definition ofTerms

Examples ofprocesses/proceduresrequiringpatientidentification

Numerator (N)

Denominator (D)

Formula

Target


To improve the accuracy of patient identification

Patient identification is essential step in ensuring that the correct treatment isbeing given to the correct patient.

To implement the use of at least two identifiers for a patient at point ofproviding care, treatment or health services.

Compliance Rate For “At least 2 identifiers Implemented” (refer page 41)

• Patient identifier: person-specific information, not the medium on whichthat information resides

• The opportunity: is an accounting unit for the action; it determines theneed to perform or observe process of patient identification at point ofproviding care, treatment or health services

“Acceptable method of Identification”: Patient’s name, patient’s tag,registration number (RN), NRIC and date of birth

“Unacceptable method of Identification”: Patient’s room number orpatient’s bed number

• upon admission or transfer/ transport to another hospital or other healthcare setting

• administration of all medicines• X- ray or imaging procedures• Surgical intervention or procedures• Blood transfusion or blood products• Collecting of patient’s bodily fluid samples• Confirmation of death

Number of process whereby at least 2 identifiers are being used


(N/D) x 100

100% compliance rate at each audit

6 monthly




Rationale


Definitions

KPI No. 9

Target

KPI No. 10

Target


To ensure the safety of transfusion of blood and blood products

The need to ensure the provision of universal access to safe, quality andefficacious blood and blood products for transfusion, their safe and appropriateuse and also ensuring blood donor and patient safety are key elements of a safeand high quality transfusion programme

1. To ensure that the use of blood and blood products adhere to the NationalTransfusion Guidelines

2. A local hemo-vigilance programme is developed

Transfusion Error (“Actual”) : Wrong pack of blood or its product for theintended patient is given

Transfusion Error (“Near misses”) : Transfusion error that almost occurs butwas prevented/ intervened resulting in no harm

Number of Transfusion Errors (“Actual”)

Zero (0) cases

Number of Transfusion Errors (“Near Misses”)

To be determined later pending national data analysis and trending

Monthly




Rationale


KPI No. 11

Target

KPI No. 12

Target

Definition ofTerms

Types ofmedication error

Data collection

To ensure medication safety

Medication errors may occur at various points of care and often go undetected.Some error may lead to serious morbidity and even mortality. Hence, ensuringmedication safety is vital.

1. Implement information technology to support prescribing, dispensing andadministering medicine – example: Computerised Prescribers’ Order Entry(CPOE)

2. Report medication errors through the Medication Error Reporting System(MERS) to enable sharing of lesson learnt

3. Implement safety solutions for “Look Alike Sound Alike (LASA) medication”

4. Control of concentrated electrolyte solutions

5. Application of 6Rs and verbalization when administering injectablemedication

Number of Medication Errors (“Actual”)

Zero (0) cases

Number of Medication Errors (“Near Misses”)

To be determined later pending national data analysis and trending

• Medication Error (“Actual”) : An error occurred and reached the patient

• Medication Error (“Near Misses”) : Any medication error that does notreach patient

• Concentrated Electrolyte Solution : examples include Sodium Chloridemore than 0.9%, Potassium Chloride or Phosphate

• 6Rs: During administering any medication; it is proposed that thehealthcare providers check whether it is the RIGHT patient, medication,time, dose and route ( per oral, sublingual, patch, etc), documentation

Prescribing error, Omission error, Wrong time error, Unauthorized drug error,Dose error, Dosage form error, Drug preparation error , Route of administrationerror, Administration Technique error, Deteriorated drug error, Monitoring error,Compliance error (from MERS, Pharmaceutical Service Division, MOH)

Monthly




Rationale


To improve clinical communication by implementing critical valueprogramme

Failure of timely communication and follow-up of critical laboratory values(results) can lead to errors, increased morbidity and mortality.

1. Identify and maintain the list of critical values for the laboratory (Ref: ISO15189:2008: Medical Laboratories – the particular requirements for qualityand competence in clause 5.8.8 “In order that local clinical needs can beserved, the laboratory shall determine the critical properties and their‘alert/critical’ intervals, in agreement with the clinicians using thelaboratory”)

2. Establish procedures for immediate notification of critical laboratory valuesand establish records of turnaround time for the notification (ISO15189:2007 clause 5.8.7)

3. Analysis of specimen (routine/urgent/stat) and if the results are withincritical limits:-

a) Verify the results and check for common analytical interferences or pre-analytical, analytical and post-analytical factors that can affect the testresult.

b) Notify the results immediately to the requestor or any authorizedpersonnel through suitable mechanism.What to inform :- Informer name and designation- Patient ID (name and RN/IC)- Sample date & time- Test name and result

c) Ask the recipient to read back the results which was notified.

d) Maintain records of the notification and the relevant information such as :-• Informer name and designation• Patient destination (location)• Patient ID (name and RN/IC)• Test name and result• Sample date & time• Name of recipient

4. Dispatch the original report to the requestor



KPI No. 13

Definition ofTerms

Inclusion Criteria

Numerator (N)

Denominator (D)

Formula

Target


References

Percentage Of Critical Values Notified Within 30 Minutes or Less

1) Critical laboratory value (results)Test result or value that falls outside the critical limits or the presence of anyunexpected abnormal findings, cells or organisms which may causeimminent danger to the patient, and/or require immediate medicalattention.

2) Critical limitsBoundaries of low and high laboratory test values beyond which may causeimminent danger to the patient and/or require immediate medicalattention.

Critical laboratory value (results) for the identified Chemical Pathology andHematology tests for the laboratory.

Total number of critical laboratory values (results) notified within 30 minutesor less

Total number of critical laboratory values (results) identified and notified forthe month

(N/D) x 100

100%

Monthly

1. Lily M, Sararaks S, Norita TTY, Noor Aishah MD, Low LL, Ainul NMH, Keah KC,Mohdsadek, Maimunah AH, Habibah B, Irdayu H &Suria J. 2010. ImprovingNotification Of Critical Results In MOH Hospitals. A Project for ImprovingPatient Safety [Lab 7; PS 21/2010 (41)] Institute for Health SystemsResearch, Kuala Lumpur, Malaysia.

2. Massachusetts Coalition for the Prevention of Medicalhttp://www.macoalition.org/Initiatives/docs/CTRgriswold.pdf




Rationale


KPI No. 14

Formula

Target

KPI No. 15

Formula

Target

Definition ofTerms

Exclusion Criteria


To reduce patient fall

Patient falls are a potentially serious form of incident and are considered largelypreventable

To implement a patient fall prevention program

Percentage reduction in the Number of falls (adults)

No. of falls this year –(minus) no. of falls last year x 100No. of falls last year

10% reduction or more* Negative value means reduction in the number of falls whereas positive

value means increment in the number of falls

Percentage reduction in the Number of falls (pediatric patients)

No. of falls this year –(minus) no. of falls last year x 100No. of falls last year

10% reduction or more* Negative value means reduction in the number of falls whereas positive

value means increment in the number of falls

Fall: fall that happens at the facility’s premisesPediatric fall: fall amongst patients aged 12 years old and below

Exclusion criteria for pediatric fall: non injurious developmental fall for infants/toddlers as they are learning to walk

Monthly




Rationale


KPI No. 16

Definition ofTerms

Criteria

Numerator (N)

Denominator (D)

Formula

Target


To reduce the incidence of Healthcare Associated Pressure Ulcers

Pressure ulcers cause considerable harm to patients and can lead to morbidity,mortality. Moreover, it is largely preventable.

To implement healthcare-associated pressure ulcer prevention programmes

Incidence Rate of Pressure Ulcers

Pressure ulcer: an area of localised damage to the skin and underlying tissuecaused by pressure, shear, friction and/or a combination of these

Immobilized patient: patient who is unable to carry out activities of dailyliving (e.g. unable to feed or bathe by him/herself)

Inclusion criteria:1) Immobilized patient2) Pressure ulcer developed 48 hours after admission3) No sign of pressure ulcer during admission

Number of healthcare associated presure ulcer

Total number of immobilized patients

(N/D) x 100

≤ 3%

Quarterly




Rationale


KPI No. 17

Definition ofTerms

Numerator (N)

Denominator (D)

Formula

Target


To reduce Catheter-Related Blood Stream Infections in the ICU*

The occurrence of catheter-related bloodstream infections, particularly inintensive care patients, can be serious or even life threatening

To implement Central Venous Catheter Care Bundle (CVC-CB). It consists of fiveevidence-based procedures recommended by the CDC (Centers for DiseaseControl and Prevention):

1. Hand hygiene2. Maximal barrier precautions upon insertion3. Chlorhexidine skin antisepsis4. Optimal catheter site selection, with subclavian vein as the preferred site

for non-tunneled catheters5. Daily review of line necessity with prompt removal of unnecessary line

Rate of CRBSI (number of CRBSI per 1000 catheter-days)

CRBSI Definition:CRBSI is defined as“the presence of a short -term Central Venous Catheter (CVC)in a patient with clinical evidence of infection (fever, chills and/or hypotension)in the absence of other identifiable course of infection with concordant growthof the same organism from the peripheral blood and the catheter hub

CRBSI Diagnosis:A definitive diagnosis of CRBSI requires the same organism growing from theblood cultures with either:

1. quantitative cultures of blood samples having a ratio of >3:1cfu/ml ofblood (catheter: periphery)

2. Differential time to positivity ( DTP) of at least 2 hours: growth fromcatheter hub of at least 2 hours earlier than the periphery

However, the Malaysian Registry of Intensive Care (MRIC) diagnoses CRBSI byjust having concordant growth of the same organism from the catheter huband periphery only (because the current practice is unable to use either of themethods above to diagnose CRBSI)

Total number of CRBSI cases

Total number of catheter days for all patients with catheter

(N/D) X 1000 catheter-days

<5 per 1000 catheter-days

Monthly

*applicable to hospital with intensive care unit (which is under care of anesthesiology team)




Rationale


KPI No. 18

Definition ofTerms

Numerator (N)

Denominator (D)

Formula

Target


To reduce Ventilator Associated Pneumonia In the ICU*

The prevention of VAP can help reduce the time that the patient is on theventilator, ICU and hospital stay as well as costs and mortality

To implement VAP Care Bundle:

The ventilator care bundle has four key components:1. Elevation of the head of the bed to between 30- 45 degrees2. Daily “sedation vacation”3. Peptic ulcer disease prophylaxis4. Deep venous thrombosis prophylaxis (unless contraindicated)

Rate of VAP (Number of VAP per 1000 ventilator days)

Ventilator-Associated Pneumonia (VAP):Pneumonia that occurs after 48 hours of intubation

Total number of VAP cases

Total number of ventilator days for all ventilated patients

(N/D) x 1000 ventilator-days

< 10 per 1000 ventilator days

Monthly

*applicable to hospital with intensive care unit (which is under care of anesthesiology team)



Rationale


KPI No. 19

Target


Reference

To implement an Incident Reporting and Learning System

The fundamental role of incident reporting systems is to enhance patient safetyby learning from failures of the healthcare system through the investigation ofincidents (e.g. through RCA). In this way, a “non-blaming and learning culture”will be nurtured.

1. An Incident Reporting and Learning System with a mandatory reporting listis implemented

2. Capability and capacity to perform incident investigation such as RootCause Analysis (RCA) (or mini RCA) to support Incident Reporting isdeveloped and strengthened

Implementation of A Facility-Wide Incident Reporting System(Including Root Cause Analysis) Or Other Methods To InvestigateIncidents (e.g. Clinical Audit, Enquiries Etc.)

System implemented

Yearly

PAA Mohamed Nazir AR, Lily M & Kalsom M. 2013. Incident Reporting &Learning System From Information To Action Manual. Medical care QualitySection, Medical Development Division, Ministry of Health Malaysia

Malaysian Patient Safety GoalsImplementation & Surveillance Guidelines34


APPENDICES



APPENDIX IPSG Form 1

Performance Indicator Matrix : Annual Performance (Jan-Dec)State : ____________________________________________________________________________MOH/ University/ Private : ____________________________________________________________________________Hospital/ Clinic : ____________________________________________________________________________Year : ____________________________________________________________________________

Type of facility Goal No PI Indicator Target Frequency of monitoring

Strategic Direction 1Ensuring systematic framework for health care sectors by integrating quality, safety and risk management

Strategic Direction 2Managing major and significant aspect of safety risk to patients receiving health care by implementing Global Patient Safety Challenges

Strategic Direction 3Implementing evidence based best practice and safety measures

1 1 Implementation of CG CG Implemented YearlyClinic Hosp

2 1 Hand hygiene compliance rate > 75% at each audit QuarterlyHosp

31 Number of “wrong surgery” performed Zero (0) MonthlyHosp

2 Number of cases of unintended “retained foreign body” Zero (0) MonthlyHosp

4

1 Incidence rate of MRSA infection < 0.4% MonthlyHosp

2 Incidence rate of ESBL - Klebsiella pneumoniae infection < 0.3% MonthlyHosp

3 Incidence rate of ESBL - E.coli infection < 0.2% MonthlyHosp

5 1 Compliance rate for “at least 2 identifiers implemented” 100% Bi-annuallyHosp

61 Number of transfusion errors (actual) Zero (0) MonthlyHosp

2 Number of transfusion errors (near miss) * MonthlyHosp

71 Medication errors (actual) Zero (0) MonthlyClinic Hosp

2 Medication errors- (near miss) * MonthlyClinic Hosp

8 1 % of critical value notified within 30 minutes 100% MonthlyHosp

91 % reduction in the number of falls (adult) ** MonthlyClinic Hosp

2 % reduction in the number of falls (pediatric) ** MonthlyClinic Hosp

10 1 Incidence rate of pressure ulcers < 3% QuarterlyHosp

11 1 #Rate of CRBSI <5 per 1000 catheter days MonthlyHospw ICU

12 1 #Rate of VAP <10 per 1000 ventilator days MonthlyHospw ICU

Strategic Direction 4Assessing and Understanding Problems of Unsafe Care

13 1Implementation of Incident Reporting or other methods to

investigate incidentsSystem Implemented YearlyClinic

Hospw ICU

#Applicable to hospital with intensive care unit

Officer compiling the data

Name :

Date:

Officer reviewing and verifying the data (Head of Department / Quality officer / Hospital Director / CEO)

Name :

Date :

This form is to be used by health care facilities to quantify annual performance measurement at their level and it must be kept for their record of theirhospital trending.The health care facilities also need to fill in the e-goals-patient safety form which can be assessed at patient safety website.



Performance Indicator Matrix : Annual Performance (Jan-Dec)AverageTotalJ F M A M J J A S O N D

--Yes / No

--Yes / No

* to be determined later pending national data analysis and trending** > 10% reduction each year based on the previous year’s data

Designation :

HP / Fax / E-mail :

Designation :

HP / Fax / E-mail :



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14


PATIENTIDENTIFICATION

MANUAL

APPENDIX III



Accuracy of Patient Identification in Ensuring Patient Safety

The accuracy of patient identification remains a key focus of any healthcare organization. Failureto correctly identify patients constitutes one of the most serious risks to patient safety and canresult in a range of adverse events such as medication errors, transfusion errors, procedures onthe “wrong person” and the discharge of infants to the wrong families.

The failure is not isolated to one area of a hospital but can easily occur in the emergencydepartment, ICU, general wards or in any other department that interacts with patients. It caneven go unnoticed and may involve a medication, specimen or procedure. Moreover, it has beencited in more than 100 individual root cause analyses by the US Department in of Veteran Affairs(VA) National Center for Patient Safety from January 2000 to March 2003.

In response to this major problem and in an effort to reduce harm from misidentification, theJoint Commission on Accreditation of Healthcare Organizations (JCAHO) has recommended usingat least two identifiers when taking blood samples, administering medications or blood products(JCAHO, Patient Safety Goals 2003).

• To ensure patient safety at all times• To provide and ensure general mechanisms to verify correct patient identification• To raise awareness among medical personnel of the importance of correctly identifying

patient at all time and before undertaking any procedure or intervention• To help in reminding all heath care providers to verify that the person they attend to is the

one for whom the treatment or procedure is intended and match the treatment orprocedure to that person

• To educate them on how to monitor the compliance rate of using at least two identifiersfor a patient at point of providing care, treatment or health services

Patient identifier: Person-specific information, not the medium on which that informationresides.

The opportunity: is an accounting unit for the action; it determines the need to perform orobserve process of patient identification at point of providing care,treatment or health services.

1. Introduction

2. Aims & Objectives

3. Definition



4. The Procedure for Patient Identification Accuracy

4.1 Who must wear the identity wristband:

• All patients in the Emergency Department• All patients in hospital departments• All day case patients, excluding dialysis out-patients except when they are to receive

blood transfusions or any other intravenous therapy or medication, when a patientidentity wristband must be applied

• All out-patients undergoing diagnostic or invasive procedures and/or treatment thatimpair their conscious levels during the appointment excluding dialysis out-patientsas mentioned above

• Any out-patient who is cognitively compromised and/or impaired

4.2 Initial identification

Upon initial admission or seeing the patient, it is crucial to identify his or heridentification correctly.

Steps identifying the patient include:

a) Ask the patient to tell you;

• Name (full name includes surname)• Identification card number• Date of birth• Address

DO NOT state their name first and then ask to confirm or deny by a yes/ no response

b) Ask their caregiver or relative if the patient is unable to tell you their name (inunconscious patient, babies, children, mental disability and patient withdysphasia).

c) Do cross referencing with the patient’s previous health record (if available at handor if he/she has previous admission).

d) Use a translator if communication breakdown occur.

e) The inability to identify patient accurately by using methods given above, must bedocumented properly in the patient’s health care record.



f) Once the patient is suspected to be admitted; a written (black)/ printed wristbandwhich consists of the name of the patient, IC or registration number must beplaced on the patient’s wrist.

4.3 Identity wristband

a) The information or identifiers to be recorded on it; (at least 4 identifiers) include:

• Full name of the patient• Date of admission• Date of birth and/or ID number (last four digit)• Hospital registration number• Name of the ward

b) The information on the wristband must only be in black and this may be writtenby pen or printed directly on the wristband with certain printers.

c) Patients who have been admitted to a ward following initial treatment in theEmergency Department (ED) must use the hospital registration number instead oftheir ED number.

4.4 Applying the identity wristband

a) Before putting it on the patient’s wrist, the patient should be asked to read backthe information written on the wristband and confirm its correctness(authenticity).

b) Where: on dominant limb/ do not apply to the hand with arterio-venous shuntfistula (renal failure patient who is on dialysis).

c) How to apply it: tight enough to avoid it from sliding off, but loose enough to allowblood circulation.

d) The identity wristband must be applied on admission to the hospital or once thepatient has entered a department for a treatment.

e) There are few occasions where patients may refuse to wear the wristband. Whereappropriate, they must be explained about the risk of not wearing the wristband.The discussion and reasons why the patients do not want to wear it must beproperly documented in the patients’ health record.

f) No alteration must be made on the wristband after it has been attached to thepatient. If alteration is required, a new ID wristband must be printed and attachedby the health care worker who made or recognized the error.



4.5 Procedures requiring patient identification

a) The procedures include:

• upon admission or transfer/ transport to another hospital or other care setting• administration of all medicines• X- ray or imaging procedures• Surgical intervention or procedures• Blood transfusion/ blood products• Collecting of patient bodily fluid samples• Confirmation of death

b) Prior to any procedure, the clinician/ staff nurse must confirm the identification ofcorrect patient by asking (where possible) the patient to state their name andhospital registration number and checking these details against the identitywristband and their medical record. DO NOT state their name and ask them to denyor confirm by a yes or no reply.

c) If the patient is unable to tell his or her name, refer to the identity wristband orverify the details with a relative or caretaker. If the relative is not available, two (2)clinical staffs have to check and confirm the patient identification and document itin the patient’s clinical record.

d) DO NOT proceed any procedure if the patient is not wearing his or her identitywristband. If any clinician or staff nurse found a patient with a missing identitywristband, he or she must immediately inform the in-charge staff nurse of theward or department.

e) The identity wristband must remain on during the whole admission and to beremoved only on the day of discharge.



Technical Specification of the 5th Malaysian Patient Safety Goals


Rationale

Strategies &implementation

KPI No. 8

Definition ofTerms

Examples ofprocesses/proceduresrequiringpatientidentification

Numerator (N)

Denominator (D)

Formula

Target


To improve the accuracy of patient identification

Patient identification is essential step in ensuring that the correct treatment isbeing given to the correct patient.

To implement the use of at least two identifiers for a patient at point ofproviding care, treatment or health services.

Compliance Rate For “At Least 2 Identifiers Implemented”

• Patient identifier: person-specific information, not the medium on whichthat information resides

• The opportunity: is an accounting unit for the action; it determines theneed to perform or observe process of patient identification at point ofproviding care, treatment or health services

“Acceptable method of Identification”: Patient’s name, patient’s tag,registration number (RN), NRIC and date of birth

“Unacceptable method of Identification”: Patient’s room number orpatient’s bed number

• upon admission or transfer/ transport to another hospital or other caresetting

• administration of all medicines• X- ray or imaging procedures• Surgical intervention or procedures• Blood transfusion or blood products• Collecting of patient’s bodily fluid samples• Confirmation of death

Number of process whereby at least 2 identifiers are being used


(N/D) x 100

100% compliance rate at each audit

6 monthly



Compliance audit of using two (2) identifiers need to be conducted six (6) monthly. The objectiveis to ensure two (2) identifiers are used when giving medication, transfusion or performingimportant procedures. The process of conducting compliance audit is as follows:

5.1 How to conduct the audit

5.1.1. Select auditor

5.1.2. Train the auditors and health care workers

5.1.3. Decide when to do the audit (twice a year) and how many opportunities needfor each session

5.1.3 (a) Number of opportunities (sampling) to be observed based onallocated bed per year

5.1.4. Auditor performs the audit;

5.1.4 (a) He/ she introduces and explains the purpose of the audit to thehealthcare workers and patients

5.1.4 (b) Observe the healthcare workers during the delivery of healthcareactivities to the patients

5.1.4 (c) Record the audit findings in the audit form A (Appendix i)

How to use the form A (Appendix i)

• Each column of the grid to identify indication of using 2 identifiers is intendedto be dedicated to a specific category of staff. Therefore, numerous healthcareworkers may be included during one session in the column dedicated to theircategory.

• Observe the opportunities requiring using 2 identifiers.

5. Monitoring Compliance

No. of hospital beds Total no. of opportunities

< 350 100351- 600 125601- 800 150351- 600 200>1000 250



• If the healthcare worker uses 2 identifiers for any indication, count anopportunity in the appropriate box ,tick square corresponding to theindication you have detected and then tick at Yes box next to indicationcolumn

• Each opportunity refers to one line in each column; each line is independentfrom one column to another

5.1.5. After completing the audit, the auditor needs to analyze and calculate thecompliance rate of using 2 identifiers by filling up form B (Appendix ii). Followthe instruction given on how to use the form.

5.1.6. Form C (Appendix iii) is an optional form to be filled up by the auditor if theywant to see the indication related compliance with using 2 identifiers.

5.1.7. Submit the bi-annual compliance rate data by using the Patient Safety GoalForm (PSG Form 1) to the Patient Safety Council Secretariat once a year only (by31st January every year).

5.1.8. The process flowchart of conducting the audit is shown in Appendix iv.



APPENDIX

iPa

tient

Iden

tifica

tionC

ompli

ance

Audit

Form

(Form

A)

CATE

GORY

OFST

AFFB

EING

AUDI

TED:

Docto

r/Nu

rsing

Staff

/Assi

stant

MO/

Allie

dHea

lthPr

ofes

siona

ls

*Plea

setic

k√wh

ichis

relev

anti

nthe

box

Cat

No Opp

Indic

ation

2ide

ntifi

er1.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

vasiv

ePro

cedu

reBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

Cat

No

Cat

No

Cat

No

Hosp

ital/

Clinic

:Se

ssion

num

ber:

War

d(ifa

pplic

able)

:Da

te:

Depa

rtmen

t(ifa

pplic

abale

):Tim

e:to

Nam

eofo

bser

ver:

Opp

Indic

ation

2ide

ntifi

er1.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

vasiv

ePro

cedu

reBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

Opp

Indic

ation

2ide

ntifi

er1.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

vasiv

ePro

cedu

reBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

Opp

Indic

ation

2ide

ntifi

er1.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

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ePro

cedu

reBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

2.Ad

mini

strat

ionof

Med

icatio

nX-

Ray&

Imag

ingPr

oced

ure

Inva

siveP

roce

dure

Bloo

dTra

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sion

Yes

No2.

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inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

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eIn

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cedu

reBl

oodT

rans

fusio

n

Yes

No2.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

vasiv

ePro

cedu

reBl

oodT

rans

fusio

n

Yes

No2.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

eIn

vasiv

ePro

cedu

reBl

oodT

rans

fusio

n

Yes

No



Cat

No Opp

Indic

ation

2ide

ntifi

erBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

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nsfer

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tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

Cat

No

Cat

No

Cat

No

Bloo

dTra

nsfu

sion

Colle

cting

ofPa

tient

Body

Fluid,

Bloo

dsa

mple

Trans

ferof

Patie

ntCo

nfirm

ation

ofDe

ath

Othe

rs___

_

Yes

NoBl

oodT

rans

fusio

nCo

llecti

ngof

Patie

ntBo

dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

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oodT

rans

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llecti

ngof

Patie

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dyFlu

id,Bl

ood

sam

pleTra

nsfer

ofPa

tient

Conf

irmat

ionof

Deat

hOt

hers_

___

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Opp

Indic

ation

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ntifi

erOp

pIn

dicat

ion2i

dent

ifier

Opp

Indic

ation

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ntifi

er

3.Ad

mini

strat

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icatio

nX-

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oced

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siveP

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nfirm

ation

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ath

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rs___

_

Yes

No3.

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ation

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edica

tion

X-Ra

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aging

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Patie

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id,Bl

ood

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tient

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irmat

ionof

Deat

hOt

hers_

___

Yes

No3.

Adm

inistr

ation

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edica

tion

X-Ra

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___

Yes

No3.

Adm

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edica

tion

X-Ra

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aging

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dyFlu

id,Bl

ood

sam

pleTra

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tient

Conf

irmat

ionof

Deat

hOt

hers_

___

Yes

No

4.Ad

mini

strat

ionof

Med

icatio

nX-

Ray&

Imag

ingPr

oced

ure

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siveP

roce

dure

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sion

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Body

Fluid,

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mple

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ferof

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nfirm

ation

ofDe

ath

Othe

rs___

_

Yes

No4.

Adm

inistr

ation

ofM

edica

tion

X-Ra

y&Im

aging

Proc

edur

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cedu

reBl

oodT

rans

fusio

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ngof

Patie

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dyFlu

id,Bl

ood

sam

pleTra

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tient

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ionof

Deat

hOt

hers_

___

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No4.

Adm

inistr

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ofM

edica

tion

X-Ra

y&Im

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oodT

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fusio

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llecti

ngof

Patie

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dyFlu

id,Bl

ood

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tient

Conf

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ionof

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hOt

hers_

___

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No4.

Adm

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X-Ra

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ionof

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hers_

___

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No

*Tob

ecom

plete

dbyt

heda

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anag

er.



Shor

tdes

cript

ionof

item

s(fo

rFor

mA)

Hosp

ital/

clinic

War

d(ifa

pplic

able)

Depa

rtmen

t(ifa

pplic

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Sessi

onnu

mbe

r

Date

Time

Nam

eofo

bser

ver

Cat(e

gory

)

Nu(m

ber)

Opp(

ortu

nity)

Indic

ation

2ide

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ers

Toco

mple

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thel

ocal

nom

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thel

ocal

nom

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ocal

nom

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is

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/minu

te

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rver

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ials(

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ff

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ctor

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ealth

Prof

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Num

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ecifi

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ation

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orm

ation

resid

es.A

ccept

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ifier

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lude;

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tient

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e

•Pa

tient

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eofb

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IC

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spita

lreg

istra

tionn

umbe

r



Patie

ntId

entif

icatio

nCom

plian

ceAu

ditFo

rm-B

asic

Com

plian

ceCa

lculat

ion(Fo

rmB)

APPENDIX

ii

Sessi

onNo

Cat:

Hosp

:Pe

riod:

Cat:

Cat:

Cat:

Tota

lPer

Sessi

on:

Noof

Y(n)

=Op

p(n)

=No

ofY(

n)=

Opp(

n)=

Noof

Y(n)

=Op

p(n)

=No

ofY(

n)=

Opp(

n)=

Noof

Y(n)

=Op

p(n)

=

Opp

(n)

Yes

(n)

No (n)

Opp

(n)

Yes

(n)

No (n)

Opp

(n)

Yes

(n)

No (n)

Opp

(n)

Yes

(n)

No (n)

Opp

(n)

Yes

(n)

No (n)

Calcu

lation

Com

plian

ce

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Tota

l



Compliance of using 2 identifiers (%) = No. of “Yes” x 100Total Number of Opportunities

Instructions for use:

1. Check data in the audit compliance form (form A).

2. Report the session number and the related observation data in the same line. Thisattribution of session number validates the fact that the data has been taken into countfor compliance calculation

3. Results per category of staff and per session (vertical):a. Sum up recorded opportunities (opp) in the case report for per staff category:

report the sum in the corresponding cell in the calculation formb. Sum up the no. of yes using 2 identifiers related to the total of opportunities above:

report the sum in corresponding cell in the calculation formc. Proceed in the same way for each sessiond. Add up all sums per each category of staff and put the calculation to calculate the

compliance rate (given in percent)

4. The addition of results of each line permits to get global compliance at the end of lastright column



APPENDIX

iiiPa

tient

Iden

tifica

tionC

ompli

ance

Audit

Form

-Opt

ional

Calcu

lation

Form

(Form

C)(In

dicat

ion-re

lated

com

plian

cewi

thus

ingat

least

2ide

ntifi

ers)

Sessi

onNo

Adm

inistr

ation

ofm

edica

tion

Hosp

:

X-ra

y/im

aging

Proc

edur

eIn

vasiv

ePr

oced

ure

Bloo

dtra

nsfu

sion/

blood

prod

ucts

Colle

cting

patie

ntbo

dyflu

id/blo

odsa

mple

Trans

ferof

patie

ntCo

nfirm

ation

ofde

ath

Othe

rs

Y(n)

=In

d(n)

=

Ind(

n)Y (n

)In

d(n)

Y (n)

Ind(

n)Y (n

)In

d(n)

Y (n)

Ind(

n)Y (n

)In

d(n)

Y (n)

Ind(

n)Y (n

)In

d(n)

Y (n)

Calcu

lation

Ratio

Y/ind

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Tota

l

Y(n)

=In

d(n)

=Y(

n)=

Ind(

n)=

Y(n)

=In

d(n)

=Y(

n)=

Ind(

n)=

Y(n)

=In

d(n)

=Y(

n)=

Ind(

n)=

Y(n)

=In

d(n)

=



Instructions for use:

1. Check data in the audit compliance form (Form A and B)

2. If several indications occur within the same opportunity, each one of the indicationshould be considered separately

3. Report the session number and the related observation data in the same line. Thisattribution of session number validates the fact that the data has been taken into countfor compliance calculation

4. Results per indication (ind) and per session (vertical):a. Sum up indications per indication in the observation form: report the sum in the

corresponding cell in the calculation formb. Sum up the no. of yes (Y) using at least 2 identifiers related to the total of indications

above: report the sum in corresponding cell in the calculation formc. Proceed in the same way for each sessiond. Add up all sums per each indication and put the calculation to calculate the ratio

(given in percent)

Note: This calculation is not exactly a compliance result, as the denominator of the calculation isan indication instead of an opportunity. However, it gives overall picture of healthcareworker’s behavior towards each type of indication



APPENDIX iv

Process Flowchart of Conducting An Audit

Select an auditor

Train the auditors & health care workers

Decide when to do the audit (twice a year) and determine number of opportunities to do eachsession

Perform the audit

Record the audit findings using form A

Analyze and calculate the compliance using form B

Submit bi-annual compliance rate data to the Technical Coordinators of Patient Safety Councilby using PSG Form 1


HAND HYGIENEAUDIT TOOLS &

OBSERVATION FORM

APPENDIX IV



Hand

Hygie

neAu

ditTo

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rm

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rvat

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rm

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ity:

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ssion

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ber*

:

Serv

ice:

Date

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serv

er:

(dd/

mm

/yy)

(initi

als)

War

d:St

art/E

ndtim

e:Pa

geNo

:(h

h:m

m)

Depa

rtmen

t:Se

ssion

dura

tion:

City*

*:(m

m)

Coun

try**

:

//

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bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves



3

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

3

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

3

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

3

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

4

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

4

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

4

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

4

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

5

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

5

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

5

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

5

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

6

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

6

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

6

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

6

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

7

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

7

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

7

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

7

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

8

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

8

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

8

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

8

bef-p

at.

bef-a

sept

.af

t-b.f.

aft-p

at.

aft.p

.surr.

HR HW miss

edglo

ves

*Tob

ecom

plete

dbyt

heda

tam

anag

er



General Recommendations(refer to the Hand Hygiene Technical Reference Manual)

1. In the context of open and direct observations, the observer introduces him/ herself to the health-careworker and to the patient when appropriate, explains his/her task and proposes immediate informal feedback.

2. The health-care worker, belonging to one of the main four following professional categories (see below),isobserved during the delivery of health-care activities to patients.

3. Detected and observed data should be recorded with a pencil in order to be immediately corrected ifneeded.

4. The top of the form (header) is completed before starting data collection (excepted end time and sessionduration).

5. The session should last no more than 20 minutes (± 10 minutes according to the observed activity); theend time and the session duration are to be completed at the end of the observation session.

6. The observer may observe up to three health-care workers simultaneously, if the density of hand hygieneopportunities permits.

7. Each column of the grid to record hand hygiene practices is intended to be dedicated to a specificprofessional category. Therefore numerous health-care workers may be sequentially included during onesession in the column dedicated to their category. Alternatively each column may be dedicated to a singlehealth-care worker only of whom the professionall category should be indicated.

8. As soon as you detect an indication for hand hygiene, count an opportunity in the appropriate column andcross the square corresponding to the indication(s) you detected. Then complete all the indications thatapply and the related hand hygiene actions observed or missed.

9. Each opportunity refers to one line in each column; each line is independent from one column to another.10. Cross items in squares (several may apply for one opportunity) or circles (only a single item may apply at

one moment).11. When several indications fall in one opportunity, each one must be recorded by crossing the squares.12. Performed or missed actions must always be registered within the context of an opportunity.13. Glove use may be recorded only when the hand hygiene action is missed while the health-care worker is

wearing gloves.

Short description of items

Facility:

Service:

Ward:

Department:

Period N°:

Date:

Start/end time:

to complete according to the local nomenclature



to complete according to the following standardized nomenclature:medical, including dermatology, neurology,haematology, oncology, etc.

mixed (medical & surgical), including gynaecology

paediatrics, including related surgery

emergency unit

ambulatory care, including related surgery

1) pre- / 2) post-intervention; and then according to the institutional counter.

day (dd) / month (mm) / year (yy)

hour (hh) / minute (mm).

surgery, including neurosurgery, urology, ENT,ophthalmology, etc.

obstetrics, including related surgery

intensive care & resuscitation

long term care & rehabilitation

other (to specify)



Session duration:

Session N°:

Observer:

Page N°:

Prof.cat:

Number:

Opp(ortunity):

Indication:

HH action:

difference between start and end time, resulting in minutes of observation.

attributed at the moment of data entry for analysis.

observer’s initials (the observer is responsible for the data collection and for checking their accuracy

before submitting the form for analysis.

to write only when more than one form is used for one session.

according to the following classification:

1. nurse / midwife

2. auxiliary

3. medical doctor

4. other health-care worker

number of observed health-care workers belonging to the same professional category (same code) as

they enter the field of observation and you detect opportunities.

defined by one indication at least

reason(s) that motivate(s) hand hygiene action; all indications that apply at one moment must be

recorded

bef.pat: before touching a patient aft.b.f: after body fluid exposure risk

bef.asept: before clean/aseptic procedure aft.pat: after touching a patient

aft.p.surr: after touching patient surroundings

response to the hand hygiene indication(s); it can be either a positive action by performing handrub or

handwash, or a negative action by missing handrub or handwash

HR: hand hygiene action by handrubbing with an Missed: no hand hygiene action performed

alcohol-based formula

HW: hand hygiene action by handwashing with

soap and water

1.1 nurse, 1.2 midwife, 1.3 student.

3.1 in internal medicine, 3.2 surgeon,

3.3 anaesthetist/ resuscitator/ emergency physician,

3.4 paediatrician, 3.5 gynaecologist, 3.6 consultant,

3.7 medical student.

4.1 therapist (physiotherapist, occupational therapist,

audiologist, speech therapist),

4.2 technician (radiologist, cardiology technician, operating

room technician, laboratory technician, etc),

4.3 other (dietician, dentist, social worker and any other

health-related professional involved in patient care),

4.4 student.



Sessi

onNo

Prof.

cat.

Facil

ity:

Perio

d:

Prof.

cat.

Prof.

cat.

Prof.

cat.

Tota

lPer

Sessi

on:

Act(

n)=

Opp(

n)=

Act(

n)=

Opp(

n)=

Act(

n)=

Opp(

n)=

Act(

n)=

Opp(

n)=

Act(

n)=

Opp(

n)=

Opp

(n)

HW (n)

HR (n)

Opp

(n)

HW (n)

HR (n)

Opp

(n)

HW (n)

HR (n)

Opp

(n)

HW (n)

HR (n)

Opp

(n)

HW (n)

HR (n)

Setti

ng:

Calcu

lation

Com

plian

ce

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Tota

l

Obse

rvat

ionFo

rm–

Basic

Com

plian

ceCa

lculat

ion

Com

plian

ce(%

)=

Actio

nsx1

00Op

portu

nities



Instructions for use

1. Define the setting outlining the scope for analysis and report related data according to the chosen setting.

2. Check data in the observation form. Hand hygiene actions not related to an indication should not be takeninto account and vice versa.

3. Report the session number and the related observation data in the same line. This attribution of sessionnumber validates the fact that data has been taken into count for compliance calculation.

4. Results per professional category and per session (vertical):4.1 Sum up recorded opportunities (opp) in the case report form per professional category: report the

sum in the corresponding cell in the calculation form.4.2 Sum up the positive hand hygiene actions related to the total of opportunities above, making

difference between handwash (HW) and handrub (HR): report the sum in the corresponding cell inthe calculation form.

4.3 Proceed in the same way for each session (data record form).4.4 Add up all sums per each professional category and put the calculation to calculate the compliance

rate (given in percent)

5. The addition of results of each line permits to get the global compliance at the end of the last right column.



Obse

rvat

ionFo

rm–

Optio

nalC

alcula

tionF

orm

(Indic

ation

-relat

edco

mpli

ance

with

hand

hygie

ne)

Befo

reto

uchin

gapa

tient

Facil

ity:

Perio

d:

Befo

recle

an/a

sept

icpr

oced

ure

Afte

rbod

yflui

dexp

osur

erisk

Afte

rtou

ching

apat

ient

Afte

rtou

ching

patie

ntsu

rroun

dings

Setti

ng:

Sessi

onNo

Act(

n)=

Indic

1(n)

=Ac

t(n)

=In

dic2(

n)=

Act(

n)=

Indic

3(n)

=Ac

t(n)

=In

dic4(

n)=

Act(

n)=

Indic

5(n)

=

Indic (n

)HW (n

)HR (n

)In

dic (n)

HW (n)

HR (n)

Indic (n

)HW (n

)HR (n

)In

dic (n)

HW (n)

HR (n)

Indic (n

)HW (n

)HR (n

)

Calcu

lation

Ratio

act/

indic*

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Tota

l



Instructions for use

1. Define the setting outlining the scope for analysis and report related data according to the chosen setting.

2. Check data in the observation form. Hand hygiene actions not related to an indication should not be takeninto account and vice versa.

3. If several indications occur within the same opportunity, each one should be considered separately as wellas the related action.

4. Report the session number and the related observation data in the same line. This attribution of sessionnumber validates the fact that data has been taken into count for compliance calculation.

5. Results per indication (indic) and per session (vertical):4.1 Sum up indications per indication in the observation form: report the sum in the corresponding cell

in the calculation form.4.2 Sum up positive hand hygiene actions related to the total of indications above, making the difference

between handwash (HW) and handrub (HR): report the sum in the corresponding cell in thecalculation form.

4.3 Proceed in the same way for each session (observation form).4.4 Add up all sums per each indication and put the calculation to calculate the ratio (given in percent)

*Note: This calculation is not exactly a compliance result, as the denominator of the calculation is an indication instead ofan opportunity. Action is artificially overestimated according to each indication. However, the result gives an overallidea of health-care worker’s behaviour towards each type of indication.



APPENDIX V

CIRCULAR OF THE DIRECTOR GENERAL OF HEALTH MALAYSIA No. 2/ 2013 ON THE ESTABLISHMENT OFPATIENT SAFETY COMMITTEE IN ALL HEALTH CARE FACILITIES AND THE IMPLEMENTATION OFMALAYSIAN PATIENT SAFETY GOALS


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