PRIVATE HEALTHCARE FACILlTIES AND SERVICES ACT 1998 [ACT 586]

&

PRIVATE HEALTHCARE FACILlTIES AND SERVICES

(PRIVATE HOSPITALS AND OTHER PRIVATE HEALTHCARE FACILlTIES)

REGULATIONS 2006

MANUAL ON

INCIDENT REPORTING

Private Medical Practice Control Section (CKAPS)

Medical Practice Division

Ministry of Health Malaysia

DECEMBER 2010

# CONTENTS PAGE

1. Charter 3

2. Goals of Incident Reporting 3

3. Objectives of Incident Reporting 3

4. Guiding Principles 4

5. Monitoring and Evaluating the Implementation of Incident Reporting 4

6. Methodology

6.1. Definition of "Incident" 5

6.2. Policies and Procedures 5

6.3. Notification and Data Collection for Incident Reporting 5

6.4. Follow-up of Notification and Data Collection for Incident Reporting 6

6.5. Fate of Incident Reporting Forms and Reports 6

7. Incident Reporting at Facility and Unit Levels 6

8. The Secretariat 6

9. Access to the Incident Reporting Secretariat, Ministry of Health 7

Acknowledgement 8

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INCIDENT REPORTING

1. CharterA private healthcare facility ar service (PHFS) shall report to the Director General,ar any person authorised by him any unforeseeable ar unanticipated incidents thatoccurs within the PHFS, as required under Section 37, Act 586 and delineated inregulation 19 of the Private Healthcare Facilities and Services (Private Hospitaisand Other Private Healthcare Facilities) Regulations 2006.

2. Goals of Incident Reporting

2.1. As a tool for improving the safety and quality of patient care.

2.2. To focus the attention of a PHFS that has experienced an "unforeseeable arunanticipated incident" on understanding the causes that underlie the eventand on making changes in the healthcare facility ar service's systems andprocesses to reduce ar eliminate the probability of the event occurring in thefuture.

2.3. To increase knowledge about incidents, their causes and strategies for theirprevention and management.

2.4. To maintain and enhance public confidence in the quality and safety of careand services provided by PHFS.

3. Objectives of Incident Reporting

3.1. To systematically assess the quality and safety of PHFS by reporting anyunforeseeable ar unanticipated incidents as required by law.

3.2. To systematically review the information relating to incident reports, identifyshortfaIIs in service and take remedial measures to prevent the futureoccurrence of similar incidents.

3.3. To evaluate the effectiveness of the remedial ar preventive measures.

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4. Guiding PrinciplesThe Incident Reporting implementation procedures are bound by the folIowingguiding principles:

4.1. ConfidentialityAbsolute confidentiality of all information is assured and strictly adhered to.All identification data from the reports are expunged before being coded.They are then reviewed by the members of the Incident Reporting WorkingCommittee (Ministry of Health) who thus have no knowledge of the origin ofthe cases.

4.2. Non-punitiveThe inquiry looks at system problems and deficiencies. It does not apportionblame to any individual.

4.3. ObjectivityEach case is independently assessed by the Incident Reporting WorkingCommittee members who are in no way connected with the "incident" case inquestion. They will then discuss these findings and make conclusions andrecommendations.

5. Monitoring and Evaluating the Implementation of Incident Reporting

5.1. There is a need to systematically monitor and evaluate the implementation ofIncident Reporting as well as assess their impact on the quality of care.

5.2. If similar incidents recur at the facility, the Incident Reporting WorkingCommittee requires to determine why this is so and if the previousrecommendations had been ineffective or had not been implemented, thecommittee need to analyse the reasons of the ineffectiveness or why theyhad not been implemented.

5.3. The notification, report and statistical summary of the incidents that occurredin the PHFS can be addressed to the Incident Reporting Secretariat, Ministryof Health Malaysia.

5.4. In addition, all licensed PHFS are encouraged to establish local IncidentReporting Committee.

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6. MethodologyThis is a reporting mechanism involving notification of all designated "incidents"that occur in the PHFS.

6.1. Definition"Incident" refers to any unforeseeable or unanticipated incidents stipulated inthe Fifth Schedule of the Private Healthcare Facilities and Services (PrivateHospitais and Other Private Healthcare Facilities) Regulations 2006 whichrequires mandatory notification.

6.2. Policies and ProceduresThe PHFS must establish -

(a) policies for requiring its employees to report unexpected orunanticipated incidents; and

(b) in-house policies/procedures as well as organisational structurefor incident reporting, identifying root causes and rectifying suchincidents.

6.3. Notification and Data Collection for Incident Reporting

6.3.1. It is the duty of the management or its representative(s) to-

(a) ensure that incidents are reported using Form IR-1 in writingand preferably via electronic means to the Director General ofHealth Malaysia or any other person authorised by the DirectorGeneral in that behalf the next working day after the incidentoccurred or immediately after the time the privatehealthcare facility has reasonable cause to believe that theincident occurred;

(b) provide a statistical summary of unforeseeable or unanticipatedincidents (refer Form IR2-A and IR2-B) as required by theDirector General of Health, Malaysia at six (6) months' interval;and

(c) ensure that information pertaining to investigation(s) of anyincident and the finding(s) as well as the report and statisticalsummary submitted to the Director General of Health, Malaysiabe retained at least for such period as specified under anywritten law pertaining to limitation period.

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6.3.2. In addition, the Director-General of Health Malaysia may requestfurther information or report of the incident if he determines it isnecessary for further investigation.

6.3.3. The notification forms can be accessed and downloadable athttp://medicalprac.moh.gov .my

6.4. Follow-up of Notification and Data Collection for Incident ReportingIlncidents" that have been notified are investigated using the Root CauseAnalysis Methodology (London Protocol). Investigation of Incident is essentialto determine contributory and root causes as well as to draw up andimplement remedial measures to improve care systems, thus preventing theincident from recurring.

6.5. Fate of Incident Reporting Forms and ReportsAll incident reporting forms including information about an incidentinvestigation and its findings as well as the report and statistical summaryshall be submitted to the Director General of Health, Malaysia. They will beretained at least for such period as specified under any written law pertainingto Iimitation period.

7. Incident Reporting at Facility and Unit Levels

7.1. The formation of the Incident Reporting Committee at the facility level as wellas unit levels is highly recommended for each PHFS.

7.2. An incident reporting system which is primarily maintained at the individuallocation or unit but coordinated at the facility's level will allow local managersto develop ownership and manage their own problems. It will also allow theperson in charge to have a general overview or "bird's eye view" of thefacility's strengths and weaknesses. Being coordinated by the person incharge, remedial measures can be more effectively implemented acrossunits and services.

8. The SecretariatThe Secretariat consists of the staff from the Private Medical Control PracticeSection, Medical Practice Division of the Ministry of Health. The Secretariat will beworking close ly in collaboration with the Section on Quality in Healthcare, Medical

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Development Division of the Ministry of Health. The functions of the Secretariatinclude the folIowing:

8.1. Receive notifications of "incidents" as well as reports from the relevant PHFS.

8.2. Ensure the confidentiality by expunging the names of patients and facilities inthe reports.

8.3. Assist in the analysis of Incident Reporting findings.

8.4. Obtain further information from the relevant PHFS as per request.

8.5. Monitoring on performances of the specific incidents reports as required bythe Regulations.

8.6. Circulate feedback (conclusions and recommendations) to the relevant PHFSand practitioners.

8.7. Publish the Annual Reports.

8.8. Ensure smooth review, monitoring and evaluation of the implementation ofIncident Reporting recommendations at various levels of the privatehealthcare facilities.

9. Access to the Incident Reporting Secretariat, Ministry of HealthThe Committee can be contacted through its Secretariat at the folIowing:

Incident Reporting SecretariatPrivate Medical Practice Control SectionMedical Practice DivisionMinistry of Health MalaysiaLevel 3, Block E1, Complex EFederal Government Administrative Centre62590 PUTRAJAYA

Tel. No.: 03 - 8883 1296/1270Fax No.: 03 - 8881 0901/0902Email: irad@moh.gov.myWebsite: http://medicalprac.moh.gov.my

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Acknowledgement

• Medical Practice Division, Ministry of Healtho Dr. Nooraini binti Babao Dr. Ahmad Razid bin Salleho Dr. Mohd Anis bin Haron @ Haruno Dr. Afidah binti Ali

• Medical Development Division, Ministry of Healtho Dr. PAA Mohamed Nazir bin Abdul Rahman

• Association of Private Hospitais of Malaysiao Dr. T. Mahadevano Puan Jasimah binti Hassan

• Pharmaceutical Services Divisiono Puan Wan Mohaina binti Wan Mohammado Puan Norleen binti Mohamed Ali

• KPJ Healthcare Berhad

• Pantai Holdings Berhad

• Sunway Medical Centre

• Gleneagles Medical Centre

• Penang Adventist Hospital

• National Heart Institute

• Columbia Asia Sdn. Bhd.

• Sime Darby Healthcare

• Assunta Hospital

• KPJ Selangor Specialist Hospital

• Alpha Specialist Centre

• Econ Medicare Centre

• Lions Nursing Homes

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