MANUALON INCIDENT REPORTING - Kami Sedia …

1 PRIVATEHEALTHCAREFACILlTIESAND SERVICESACT 1998[ACT586]&PRIVATEHEALTHCAREFACILlTIES AND SERVICES(PRIVATEHOSPITALSAND OTHERPRIVATEHEALTHCAREFACILlTIES)REGULAT IONS2006 MANUALONINCIDENTREPORTINGP rivateMedicalPracticeControlSection(CKAP S)MedicalPracticeDivisionMinistryof HealthMalaysiaDECEMBER2010# Evaluatingthe Implementationof " INCIDENT " Data Collectionfor Notificationand Data Collectionfor of IncidentReportingFormsand Facilityand Unit Levels68. The the IncidentReportingSecretariat,Ministryof : 13/12/20102 privatehealthcarefacilityar service(PHFS)shall reportto the DirectorGeneral,ar any personauthorisedby him any unforeseeablear unanticipatedincidentsthatoccurswithinth e PHFS,as requiredunderSection37, Act 586 and delineatedinregulation19 of the PrivateHealthcareFacilitiesand Services(PrivateHospitaisand OtherPrivateHealthcareFacilities)

2 As a tool for improvingthe safetyand qualityof To focusthe attentionof a PHFS that has experiencedan "unforeseeablearunanticipatedincident"on understandingthe causesthat underliethe eventand on makingchangesin the healthcarefacilityar service'ssystemsandprocessesto reducear eliminatethe probabilityof the eventoccurringin To increaseknowledgeaboutincidents,their causesand strategiesfor theirpreventionand To maintainand enhancepublicconfidencein the qualityand safetyof careand servicesprovidedby To systematicallyassessthe qualityand safetyof PHFSby reportinganyunforeseeablear unanticipatedincidentsas requiredby To systematicallyreviewthe informationrelatingto incidentreports,identifyshortfaIIsin serviceand takeremedialmeasuresto preventthe futureoccurrenceof To evaluatethe effectivenessof the remedialar.

3 13/12120103 boundby the all informationis assuredand identificationdatafromthe reportsare thenreviewedby the membersof the IncidentReportingWorkingCommittee(Minist ryof Health)who thushaveno knowledgeof the originofthe inquirylooksat systemproblemsand doesnot apportionblameto any independentlyassessedby the IncidentReportingWorkingCommitteemembers who are in no way connectedwith the " INCIDENT " thendiscussthesefindingsand Implementationof a needto systematicallymonitorand evaluatethe implementationofIncidentReportingas well as assesstheirimpacton the qualityof similarincidentsrecurat the facility,the IncidentReportingWorkingCommitteerequire sto determinewhythisis so andif the previousrecommendationshad beenineffectiveor had not beenimplemented.

4 Thecommitteeneedto analysethe reasonsof the ineffectivenessor why theyhad not notification,reportand statisticalsum maryof the incidentsthat occurredin the PHFScan be addressedto the IncidentReportingSecretariat,Ministryof addition,all licensedPHFSare encouragedto : 13/12120104 a reportingmechanisminvolvingnotificationo f all designated"incidents"that occurin the " INCIDENT "refersto any unforeseeableor unanticipatedincidentsstipulatedinthe FifthScheduleof the PrivateHealthcareFacilitiesandServices(P rivateHospitaisandOtherPrivateHealthcare Facilities) ProceduresThePHFS mustestablish-(a)policiesfor requiringits employeesto reportunexpectedorunanticipatedincidents .

5 And(b)in-housepolicies/proceduresas wellas organisationalstructurefor incidentreporting,identifyingroot causesand DataCollectionfor is the dutyof the managementor its representative(s)to-(a)ensurethatinciden tsare reportedusingFormIR-1in writingandpreferablyvia electronicmeansto the DirectorGeneralofHealthMalaysiaor any otherpersonauthorisedby the DirectorGeneralin that behalfthe nextworkingday afterthe incidentoccurredor immediatelyafterthetimetheprivatehealthc arefacilityhasreasonablecauseto believethattheincidentoccurred;(b)provid ea statisticalsummaryof unforeseeableor unanticipatedincidents(referFormIR2-Aand IR2-B)as requiredby theDirectorGeneralof Health,Malaysiaat six (6) months'interval.

6 And(c)ensurethatinformationpertainingto investigation(s)of anyincidentandthe finding(s)as wellas the reportandstatisticalsummarysubmittedto the DirectorGeneralof Health,Malaysiabe retainedat leastfor suchperiodas specifiedunderanywrittenlaw pertainingto : 13/12/20105 addition,theDirector-Generalof HealthMalaysiamayrequestfurtherinformati onor reportof the incidentif he determinesit isnecessaryfor Notificationand DataCollectionfor IncidentReportingIlncidents"thathavebeen notifiedare investigatedusingthe RootCauseAnalysisMethodology(LondonProto col).Investigationof Incidentis essentialto determinecontributoryandrootcausesas wellas to drawup andimplementremedialmeasuresto improvecaresystems, IncidentReportingFormsand ReportsAllincidentreportingformsincludin ginformationaboutanincidentinvestigation andits findingsas wellas the reportandstatisticalsummaryshallbe submittedto the DirectorGeneralof Health.

7 Beretainedat leastfor suchperiodas specifiedunderany writtenlaw pertainingto formationof the IncidentReportingCommitteeat the facilitylevelas wellas unit levelsis highlyrecommendedfor incidentreportingsystemwhichis primarilymaintainedat the individuallocationor unit but coordinatedat the facility'slevelwill allowlocalmanagersto will alsoallowthepersonin chargeto havea generaloverviewor "bird'seyeview"of thefacility' the personincharge,remedialmeasurescanbe moreeffectivelyimplementedacrossunitsand SecretariatTheSecretariatconsistsof the stafffromthe PrivateMedicalControlPracticeSection,Med icalPracticeDivisionof the Ministryof beworkingclosely in collaborationwiththe Sectionon Qualityin Healthcare.

8 13/12/20106/8 DevelopmentDivisionof the Ministryof functionsof the Secretariatincludethe Receivenotificationsof "incidents"as well as reportsfrom the Ensurethe confidentialityby expungingthe namesof patientsand facilitiesinthe Assistin the analysisof Obtainfurtherinformationfrom the relevantPHFSas per Monitoringon performancesof the specificincidentsreportsas requiredbythe Circulatefeedback(conclusionsand recommendations)to the relevantPHFSand Publishthe Ensuresmoothreview,monitoringand evaluationof the implementationofIncidentReportingrecomme ndationsat variouslevelsof the the IncidentReportingSecretariat,Ministryof HealthThe Committeecan be contactedthroughits Secretariatat the folIowing:IncidentReportingSecretariatPr ivateMedicalPracticeControlSectionMedica lPracticeDivisionMinistryof HealthMalaysiaLevel3, BlockE1, :03 - 88831296/1270 Fax No.

9 :03 - 13/12120107/8 Acknowledgement MedicalPracticeDivision,Ministryof MedicalDevelopmentDivision,Ministryof Associationof PrivateHospitaisof MahadevanoPuanJasimahbintiHassan PharmaceuticalServicesDivisionoPuanWanMo hainabintiWanMohammadoPuanNorleenbintiMo hamedAli KPJH ealthcareBerhad PantaiHoldingsBerhad SunwayMedicalCentre GleneaglesMedicalCentre PenangAdventistHospital NationalHeartInstitute SimeDarbyHealthcare AssuntaHospital KPJS elangorSpecialistHospital AlphaSpecialistCentre EconMedicareCentre : 13/12120108/8