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KEMENTERIAN KESIHATAN MALAYSIA ARAHAN KETUA PENGARAH KESIHATAN BILANGAN 1 TAHUN 2010 PELAKSANAAN MELAPORKAN KEJADIAN TIDAK DAPAT DIRAMALKAN ATAU TIDAK DIJANGKA DAN KEMATIAN BOLEH NILAI MENGIKUT PERUNTUKAN AKTA KEMUDAHAN DAN PERKHIDMATAN JAGAAN KESIHATAN SWASTA 1998 [AKTA 586] TUJUAN 1. Tujuan Arahan ini adalah untuk memaklumkan tatacara dan proses kerja bagi memastikan pematuhan pelaksanaannya oleh kemudahan dan perkhidmatan jagaan kesihatan swasta (KPJKS) mengikut kehendak Akta 586 untuk melaporkan: 1.1. kejadian yang tidak dapat diramalkan (unforeseeable incidenfs) atau tidak dijangka (unanficipafed incidenfs); dan 1.2. kematian boleh nilai (assessable deafhs). LATAR BELAKANG 2. Akta 586 dan peraturan-peraturannya mula dikuatkuasakan pada 1 Mei 2006. 3. Kejadian yang tidak dapat diramalkan atau yang tidak dapat dijangka yang berlaku di KPJKS perlu dilaporkan kepada Ketua Pengarah dalam tempoh 24 jam. 4. Manakala, kematian boleh nilai yang berlaku di KPJKS pula perlu dilaporkan kepada Ketua Pengarah dalam tempoh 72 jam kematian tersebut diketahui.

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Page 1: Pelaksanaan Melaporkan Kejadian Tidak Dapat Diramal atau Tidak

KEMENTERIAN KESIHATAN MALAYSIA

ARAHAN KETUA PENGARAH KESIHATAN

BILANGAN 1 TAHUN 2010

PELAKSANAAN MELAPORKAN KEJADIAN TIDAK DAPAT DIRAMALKANATAU TIDAK DIJANGKA DAN KEMATIAN BOLEH NILAI MENGIKUTPERUNTUKAN AKTA KEMUDAHAN DAN PERKHIDMATAN JAGAAN

KESIHATAN SWASTA 1998 [AKTA 586]

TUJUAN

1. Tujuan Arahan ini adalah untuk memaklumkan tatacara dan proses kerja bagimemastikan pematuhan pelaksanaannya oleh kemudahan dan perkhidmatan jagaankesihatan swasta (KPJKS) mengikut kehendak Akta 586 untuk melaporkan:

1.1. kejadian yang tidak dapat diramalkan (unforeseeable incidenfs) atau tidakdijangka (unanficipafed incidenfs); dan

1.2. kematian boleh nilai (assessable deafhs).

LATAR BELAKANG

2. Akta 586 dan peraturan-peraturannya mula dikuatkuasakan pada 1 Mei 2006.

3. Kejadian yang tidak dapat diramalkan atau yang tidak dapat dijangka yangberlaku di KPJKS perlu dilaporkan kepada Ketua Pengarah dalam tempoh 24 jam.

4. Manakala, kematian boleh nilai yang berlaku di KPJKS pula perlu dilaporkankepada Ketua Pengarah dalam tempoh 72 jam kematian tersebut diketahui.

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5. Kementerian Kesihatan Malaysia menyediakan satu set borang dan manual yangberasingan bagi kegunaan KPJKS melaporkan kejadian dan kematian tersebut.

SUMBER KUASA

6. Arahan ini disediakan selaras dengan peruntukan Akta 586 seperti berikut:

6.1. Seksyen 76, Akta 586 memberi kuasa kepada Ketua Pengarah untukmengeluarkan arahan, perintah atau garis panduan berkaitan dengankualiti dan piawaian KPJKS sebagaimana yang difikirkannya perlu.

6.2. Seksyen 37, Akta 586 menetapkan keperluan bagi KPJKS melaporkankepada Ketua Pengarah, atau mana-mana orang yang diberi kuasaolehnya, apa-apa kejadian yang tidak dapat diramalkan atau tidakdijangka yang berlaku pada atau selepas tarikh permulaan kuat kuasaAkta 586 ini.

6.3. Seksyen 67, Akta 586 mewajibkan orang yang bertanggungjawab bagiKPJKS, memastikan bahawa setiap pengamal perubatan atau pengamalpergigian yang menjalankan apa-apa anestesia atau tatacara anestetikatau perubatan atau pembedahan atau menggunakan apa-apa teknologiperubatan ke atas pesakit yang berkesudahan dengan kematian bolehnilai hendaklah dengan seberapa segera tidak melebihi daripada 72 jamsetelah mendapat tahu tentang berlakunya kematian itu, memberitahuKetua Pengarah mengenai kematian boleh nilai tersebut.

6.4. Seksyen 43, Akta 586 memberi kuasa kepada Ketua Pengarah untukmengeluarkan notis tunjuk sebab mengenai niatnya kepada pemegangLesen KPJKS untuk menggantung, membatalkan, atau engganmemperbaharui Lesen KPJKS tersebut sekiranya apa-apa arahan,perintah atau garis panduan yang diberikan kepadanya oleh Menteri atauKetua Pengarah tidak dipatuhi sepertimana yang diperuntukkan di bawahperenggan 44(d) , Akta 586.

PEMAKAIAN

7. Arahan ini adalah terpakai ke atas KPJKS yang diberikan lesen di bawahperenggan 19(a), Akta 586.

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PEMATUHAN

8. Semua pemegang lesen, orang yang bertanggungjawab atau pengamalperubatan dan pergigian bagi KPJKS (di mana yang berkenaan) hendaklah mematuhiArahan ini.

MANUAL DAN BORANG

9. Bagi tujuan melaporkan kejadian:

9.1. Manual dan Borang untuk melaporkan kejadian yang tidak dapatdiramalkan atau tidak dijangka yang telah disediakan oleh KementerianKesihatan Malaysia (rujuk LAMPIRAN 1) adalah seperti berikut:

a. MANUAL ON INCIDENT REPORTING;

b. FORM IR-1;

c. FORM IR-2A; dan

d. FORM IR-2B.

9.2. KPJKS perlu menggunakan FORM IR-1 bagi melaporkan kejadian yangtidak dapat diramalkan atau tidak dijangka yang berlaku di KPJKS kepadaKetua Pengarah dalam tempoh 24 jam, seperti berikut:

a. Kematian pesakit di KPJKS oleh sebab yang tidak dapat diterangkanatau dalam keadaan yang mencurigakan yang dikehendakidilaporkan kepada polis;

b. Kecederaan yang tidak dapat diramal atau yang tidak dijangka olehpesakit semasa mereka berada di KPJKS:

i. kecederaan otak atau saraf tunjang;

ii. jatuh yang menyebabkan kepatahan, konkusi atau luka melecetyang melampaui epidermis ke tisu dalam atau yangmengancam struktur penting:

iii. komplikasi anestesia yang mengancam nyawa (atau yangberpotensi membawa maut);

iv. kesilapan atau tindak balas transfusi yang mengancam nyawa(atau yang berpotensi membawa maut); atau

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V. luka terbakar darjah kedua atau ketiga yang melibatkan duapuluh peratus atau lebih bagi kawasan permukaan badan orangdewasa atau lima belas peratus atau lebih bagi kawasanpermukaan badan kanak-kanak;

c. Kebakaran di KPJKS yang menyebabkan kematian atau kecederaandiri;

d. Serangan atau serangan sentuh pesakit di KPJKS oleh pekerja; dan

e. Pincang tugas atau salah guna kelengkapan jagaan pesakit secarasengaja atau tidak sengaja yang berlaku semasa rawatan ataudiagnosis pesakit di KPJKS dan yang dihindarkan atau jika tidakdihindarkan akan menjejaskan pesakit atau pekerja di KPJKS.

9.3. KPJKS juga perlu mengemukakan FORM IR-2A dan FORM IR-2Btentang ringkasan statistik kejadian yang tidak dapat diramalkan atau tidakdijangka yang berlaku di KPJKS kepada Ketua Pengarah bagi tempohsetiap enam (6) bulan sekali untuk kejadian seperti berikut:

a. Kecederaan yang tidak dapat diramal atau yang tidak dijangka yangdialami oleh pesakit semasa mereka tinggal di KPJKS tersebut selainkecederaan yang dikehendaki dilaporkan di bawah perenggan 9.2 diatas, yang menyebabkan atau mungkin menyebabkan hilang upayakekal;

b. Kebakaran di KPJKS yang tidak dapat dilaporkan di bawahperenggan 9.2 di atas;

c. Penggera kebakaran palsu di KPJKS yang tidak dapat diterangkan;

d. Penamatan perkhidmatan yang menjejaskan operasi yang selamatyang berterusan di KPJKS atau kesihatan atau keselamatan pesakittermasuk penamatan perkhidmatan telefon, bekalan air atau elektrikselama lebih daripada dua (2) jam atau jika sistem pengesan,penggera atau pembanteras kebakaran yang tidak berfungsi selamalebih daripada dua (2) jam; dan

e. Kehilangan pesakit dari KPJKS tanpa kebenaran selama lebihdaripada dua (2) jam.

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10. Bagi tujuan melaporkan kematian boleh nilai:

10.1. Manual dan Borang untuk melaporkan kematian boleh nilai yang berlakudi KPJKS yang telah disediakan oleh Kementerian Kesihatan Malaysia(rujuk LAMPIRAN 2) adalah seperti berikut:

a. MANUAL ON ASSESSABLE DEATH REPORTING; dan

b. FORMAD-1

10.2. KPJKS perlu menggunakan FORM AD-1 untuk melaporkan kematianboleh nilai yang berlaku di KPJKS kepada Ketua Pengarah dalam tempoh72 jam setelah mengetahui hal kematian tersebut, dimana pada pendapatmana-mana pengamal perubatan atau pengamal pergigian, kematiantersebut boleh dihubungkan dengan -

a. anestesia atau apa-apa tatacara anestetik;

b. teknologi perubatan atau apa-apa tatacara perubatan; atau

c. pembedahan atau apa-apa tatacara pembedahan

URUSETIA

11. Urusetia yang mengendalikan kejadian yang tidak dapat diramalkan atau tidakdijangka dan kematian boleh nilai yang dilaporkan terdiri daripada pegawai-pegawai di Cawangan Kawalan Amalan Perubatan Swasta, Bahagian AmalanPerubatan, Kementerian Kesihatan Malaysia.

TARIKH KUAT KUASA

12. Arahan ini berkuat kuasa mulai 1 Januari 2011.

I aIIO-{IOTan Sri Dato' Seri Dr. Haji Mohd Ismail bin MericanKetua Pengarah Kesihatan, Malaysia

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LAMPIRAN 1

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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

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# 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: [email protected]: 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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CONFIDENTIAL

PATIENT SAFETY EVENTINCIDENT REPORTING NOTIFICATION FOR PRIVATE SECTOR

A. INCIDENT PARTICULARS

FORM IR-1

24 Hour ClockNote: "Specialties involved" refers to any specia/ty involved in managing the patient.

Facility Date of rOTDTMTMTYTYl Time ofCode: Incident: ~ Incident: H M

Location whereIncidentOccurred:

UnitlDept.where IncidentOccurred:

Specialties IInvolved: . _

B. PATIENT PARTlCULARS (TlCK (./")WHERE NECESSARY)

Gender: Male D Female D Type of Services: Inpatient D Outpatient DNRIC/PassportNo.:

Admission Diagnosis:

Race: Communication Problemwith Patient:

Date of Sirth:

Yes D No D

Native Language: 1 _Language Used to Communicate:

C. TICK (yI') THE RELEVANT UNFORESEEABLE OR UNANTICIPATED INCIDENTS

Note: (1) "Patient" means a person accepted on ei/her inpatient or outpatient basis and may include brought in dead (BID) patients.(2) 'Chi/d" means any person aged 12 years and below.

1. Deaths of patients of the private healthcare facilities or services by unexplained cause or under suspicious Dcircumstances that are required to be reported to police.

2. Unforeseeable or unanticipated injuries by patients during the stay in the private healthcare facilities or services:

(a) brain or spinal cord injuries; D(b) falls resulting in fractures, concussions ar lacerations extending beyond the epidermis into deep tissue or which D

threaten vital structures;

(c) life-threatening complications of anaesthesia; D(d) life-threatening transfusion errors or reactions; or D(e) second or third degree burns involving twenty per cent or more of the body surface area of an adult or fifteen D

per cent or more of the body surface area of a child.

3. Fires in the private healthcare facilities or services resulting in death or personnel injury. D4. Assault or battery of patients of the private healthcare facilities or services by employees including physical, mental D

ar emotional abuse, mistreatment or harmful neglect of any patient.

5. Malfunction or intentionalor accidental misuse of patient care equipment that occurs during treatment or diagnosis Dof patient of the private healthcare facilities or services and that was averted, or if not averted would havesignificantly adversely affected patients or employees of the private healthcare facilities or services.

6. Seroconversion to positive Hepatitis S ar Hepatitis C while on course of dialysis treatment. D

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D. INCIDENT DESCRIPTION

Please state facts and not opinion on the folio wing matters (if necessary, please use attachment):(a) A brief description of the incident;(b) Any harm (physical and emotional) suffered by patient; and(c) Summarise sequence of events leading to the inciden/.

E. STAFF RESPONSE AND CORRECTIVE ACTION TAKEN

Provide a brief description of any corrective action taken immediately folIowing the event e.g. - (if necessary, please use attachment).- Work flow/Process redesign - Documentation changes - Equipment/Facility upgrading etc.- Change of poticy - SOP addition/revision - Equipment taken out of seN/ce - Education tofTraining of staff

F. REPORTING PERSON PARTICULARS (PERSON IN CHARGE OF FACILlTY)

Name:

Tel. No.:

Date:

G. For Official Use Only:

Email:

Date Received: Incident Reference:

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Page /3

H. For Officia/ Use On/y:WHO IC4PS (Incident Classification for Patient Safety): Incident Type

Incident Type Tick V)

Clinical Administration DClinical Process/Procedure DDocumentation DHealthcare Associated Infection DMedication/IV Fluids DBlood/Blood Products DNutrition DOxygen/GasNapour DMedical Device/Equipment DBehaviour DPatient Accidents DInfrastructu re/Bu iIding/Fixtu res DResources/Organisational Management D

I. For Officia/ Use On/y:Further Secretariat Action

Name:

Date:

Designation: . _

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CONFIDENTIAL FORM IR-2A

BIANNUAL STATISTICAL INCIDENT SUMMARYINCIDENT REPORTING NOTIFICATION FOR PRIVATE SECTOR FOR JANUARY - JUNE

A. FACILlTY PARTICULARS

Facility I I I I I I I - I I I I I I - I I I (Licence No.)Code:

B. STATISTICAL SUMMARY TO BE REPORTED (FOR 6 MONTHS)

MONTHINCIDENT JAN FEB MARCH APRIL MAY JUNE TOTAL

1. Unforeseeable or unanticipated injuries incurred bypatients during the stay in the private healthcare facilities orservices other than those required to be reporled underPART l, which have led or are reasonably likely to lead topermanent disability.

2. All fires in the private healthcare facilities and services notreporlable under Part I of this Schedule.

3. Unexplained false fire alarms in the private healthcarefacilities and services that did not result in death orpersonal injury.

4. The termination of the services that affect the continuedsafe operation of the private healthcare facilities or servicesor the health or safety of patients including termination oftelephone, water supply or electrical services for more thantwo hours or where fire detection, alarm or suppressionsystems are not functional for more than two hours

5. Unauthorised disappearances of a patient from the privatehealthcare facilities or services for more than two hours.

TOTAL

C. REPORTING PERSON PARTICULARS (PERSON IN CHARGE OF FAC/LlTY)

Name: Designation:

Tel. No.: Email: -- _._-Date: _._----_._-_._------

D. For Officia/ Use On/y:

Date Received: Incident Reference:-------~------ ._--

E. For Officia/ Use On/y:Further Secretariat Action

Name: _._-------------------_._------------- Designation: ___ ._. __ .__ .__ ..__ ...._

Date: -------_._ ..__ .._._-

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CONFIDENTIAL FORM IR-2B

BIANNUAL STATISTICAL INCIDENT SUMMARYINCIDENT REPORTING NOTIFICATION FOR PRIVATE SECTOR FOR JULY - DECEMBER

A. FACILlTY PARTICULARS

Facility I I I I I I I - I I I I I I - I I I (Licence No.)Code:

B. STATISTICAL SUMMARY TO BE REPORTED (FOR 6 MONTHS)

MONTHINCIDENT JUL AUG SEP OCT NOV DEC TOTAL

1. Unforeseeable or unanticipated injuries incurred bypatients during the stay in the private healthcare facilities orservices other than those required to be reported underPART I, which have led or are reasonably likely to lead topermanent disability.

2. All fires in the private healthcare facilities and services notreportable under Part I of this Schedule.

3. Unexplained false fire alarms in the private healthcarefacilities and services that did not result in death orpersonal injury.

4. The termination of the services that affect the continuedsafe operation of the private healthcare facilities or servicesor the health or safety of patients including termination oftelephone, water supply or electrical services for more thantwo hours or where fire detection, alarm or suppressionsystems are not functional for more than two hours

5. Unauthorised disappearances of a patient from the privatehealthcare facilities or services for more than two hours.

TOTAL

C. REPORTING PERSON PARTlCULARS (PERSON IN CHARGE OF FACILlTY)

Name: _ Designation: ______________--------_.

Tel. No.: Email:-- -----------_._-

Date: --------_.~-~---_._-

D. For Official Use Only:

I I

Il Date R_eceived: ..I Incident Reference:-- ~-iE. For Official Use Only:

Further Secretariat Action

Name: ---_._--_ ..._._._---_. __._---------------_._- Designation: .MMM __________________ •

Date: ...•_--

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LAMPIRAN 2

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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

ASSESSABLE DEATH REPORTING

Private Medical Practice Control Section (CKAPS)

Medical Practice Division

Ministry of Health Malaysia

DECEMBER 2010

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# CONTENTS PAGE

1. Charter 3

2. Goals of Reporting of Assessable Death 3

3. Objectives of Reporting of Assessable Death 3

4. Guiding Principles 4

5. Methodology

5.1. Interpretation of "Assessable" Death 5

5.2. Notification and Data Collection of Assessable Death for Mortality 5Review

5.3. Retrieval of Patient Medical Record 5

5.4. Confidentiality 6

5.5. Fate of Notified Form AD-1 6

6. Mortality Assessment Committee at Facility Level 6

7. Access to the NMAC 6

Acknowledgement 7

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ASSESSABLE DEATH REPORTING

1. CharterA person in charge of a private healthcare facility ar service (PHFS) shall ensurethat every medical ar dentai practitioner who administers any anaesthesia aranaesthetic ar medical ar surgical procedure ar uses any medical technology onany patient whose death that occurs within the PHFS, is an assessable death shallnotify the Director General the particulars of the assessable death as requiredunder subsection 67(1), Act 586.

2. Goals of Reporting of Assessable Death

2.1. To provide information relating to the assessable deaths for NationalMortality Assessment Committee (NMAC) consideration.

2.2. To determine the extent (if any) to which anaesthesia ar any anaestheticprocedure, medical technology ar any medical procedure ar surgery ar anysurgical procedure contributed to the assessable death.

2.3. To determine whether the assessable death might have been averted hadthe effects ar consequences of anaesthesia ar anaesthetic procedure,medical technology ar any medical procedure ar surgery ar any surgicalprocedure, had been better ar more fully understood ar provided for.

2.4. To improve the quality and standards of PHFS by promoting the safe andefficient use of anaesthetic, medical ar surgical procedures, ar medicaltechnology based on NMAC's finding(s) and recommendation(s).

3. Objectives of Reporting of Assessable Death

3.1. To collate data on "assessable" mortality in PHFS.

3.2. To systematically assess the quality of anaesthetic, medical (includingmedical technology) and surgical (including dentai) services and the qualityof supporting services and logistics by systematically reviewing theinformation relating to assessable deaths which is aimed at identifyingshortfaIIs in such services hence taking remedial measures to prevent thefuture occurrence of similar deaths.

3.3. To look into relevant aspects of anaesthetic, medical and surgical care.

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3.4. To identify shortfaIIs in the delivery of the anaesthetic, medical and surgicalservices.

3.5. To recommend remedial measures in order to promote and attain the safeand efficient use of anaesthetic, medical or surgical (including dentai)procedures, or medical technology.

3.6. To provide feedback on the results of the investigations to the relevantprivate healthcare facility or service as well as the registered medicalpractitioner.

4. Guiding PrinciplesIn fulfilling its functions, the reporting of assessable death is bound by the folIowingstatutory guiding principles:

4.1. Secrecy and Confidentiality (section 70)

4.1.1. Confidentiality of all information is assured and strictly adhered to,except for the folIowing purposes:

(a) Purposes connected with the functions of NMAC;

(b) Purpose of an investigation of any alleged crime; or

(c) Purpose of any criminal proceeding,

where all identification data from the reports are expunged beforebeing coded and reviewed by the members or "assessors" of theNMAC who thus have no knowledge of the origin of the cases.

4.1.2. No person shall be compelled or permitted to divulge, in any civilproceeding, any information relating to assessable death and no suchinformation shall be admissible as evidence in any civil proceedings.

4.2. Non-punitive (subsection 66(3))

The inquiry looks at system problems and deficiencies and does notapportion blame to any individual.

4.3. Objectivity

Each case is independently assessed by members or "assessors" of theNMAC who are specially chosen and who are in no way connected with the

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institution or persons in question before making any conclusion and/arrecommendation.

5. MethodologyThis is a retrospective study of assessable death s in the PHFS.

5.1. Interpretation

"Assessable death", under section 64 of the Private Healthcare Facilities andServices Act 1998 refers to death that, in the opinion of any medicalpractitioner or dentai practitioner, may be related to anaesthesia or anyanaesthetic procedure, or medical technology or any medical procedure, orsurgery or any surgical procedure.

5.2. Notification and Data Collection of Assessable Death for Mortality Review

5.2.1. It is the duty of the person in charge of the private healthcare facilityor service to ensure that the relevant medical or dentai practitioner(s)notify the Director General of Health, Malaysia (Secretariat) in writingand preferably via electronic means of that death with in 72 hoursafter he learns the occurrence of the death (subsection 67(1)) usingForm AD-1.

5.2.2. All assessable death patients' medical records are retained in theprivate healthcare facility or service and marked "CONFIDENTIAL".Completed notification forms (AD-1) will be sent to the NMACSecretariat at the Ministry of Health.

5.2.3. In addition, the medical or dentai practitioner(s) or any other relevantpersons may be required to furnish all or any specified information intheir possession relating to the assessable death including c1inical ormedical records or any other material or documents that are withintheir control and may be required to assist the NMAC WorkingCommittee in any possible way as delineated under subsections 68(1)and (2), Act 586.

5.2.4. Form AD-1 can be accessed and downloadable athttp://medicalprac.moh .gov .my

5.3. Retrieval of Patient Medical Record

The patient medical record shall be kept in a safe place after any assessabledeath to enable medical or dentai practitioners to have access to them forreporting.

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5.4. Confidentiality

Information in the Form AD-1 shall be expunged of all identification data(such as the name of the deceased person, the names of the relevantmedical or dentai practitioners involved and the name of the privatehealthcare facility or service or place where the death occurred pursuant tosubsection 68(3), Act 586.

5.5. Fate of Notified Form AD-1

All Form AD-1 which have been completed and notified shall be kept untilsuch a time as when analysis of data and the annual report have beencompleted, after which they may be destroyed.

6. Mortality Assessment Committee at Facility LevelA PHFS is encouraged to conduct its own investigation into any assessable deathby form ing an internal or in-house mortality assessment committee as providedunder subsections 72(1), (2) and (3), Act 586 and the findings of such investigationmay be used to improve services of the PHFS.

7. Access to the NMACThe Committee can be contacted through its Secretariat at the folIowing:

NMAC Secretariat.Private Medical Practice Control SectionMedical Practice DivisionMinistry of Health MalaysiaLevel 3, Block E1, Complex EFederal Government Administrative Centre62590 PUTRAJAYA

Tel. No.: 03 - 88831296/1270Fax No.: 03 - 8881 0901/0902Email: [email protected]: http://medicalprac.moh.gov.my

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Acknowledgement

• Medical Practice Division, Ministry of HealthD Dr. Nooraini binti BabaD Dr. Ahmad Razid bin SallehD Dr. Mohd Anis bin Haron @ HarunD Dr. Afidah binti Ali

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

• Association of Private Hospitais of MalaysiaD Dr. T. MahadevanD Puan Jasimah binti Hassan

• Pharmaceutical Services DivisionD Puan Wan Mohaina binti Wan MohammadD 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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CONFIDENTIAL

ASSESSABLE DEATH NOTIFICATION FORM FORPRIVATE HEALTHCARE FACILlTY OR SERVICE

FORM AD-1

(Licence No.)

Localion whereIncidenlOccurred:

Note: (1) This notification form shall be submitted by the person in charge as soon as possible within 72 hours of theoccurrence of death.

(2) The Chairman of the National Mortality Assessment Committee may require additional specified information.

A. INCIDENT PARTICULARS

FacililyCode:

Unit/Dep!.where IncidenlOccurred:

Speciallies IInvolved: ~ _

B. PATIENT PARTICULARS (TICK V) WHERE NECESSARY)

Name

NRIC/PassportNo.:

Admission Diagnosis:

Gender: Male DFemale D

Date of8irth:

Type of Inpatient DServices:

Outpatient D

~

DaIe ofAdmission:

Dateof ~Death: ~

Time ofDeath:

Race

Native Language:

Communication Problem with Patient: Yes D No DLanguage Used to Communicate:

C. SUMMARY OF CHRONOLOGY OF EVENTS

Provide a brief description of the events (during this admission including investigations performed with significantfindings and treatment given) leading to death (if necessary, please use attachment).

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Pa e /2

D. PROBABLE CAUSE OF DEATH (TICK (,f) WHERE NECESSARY)

Related to: Anesthesia D Anesthetic D Surgery Dprocedure

Medical technology D Medical procedure D Surgical procedure DE. NOTIFYING PERSON PARTICULARS (ATTENDING REGISTERED MEDICAL OR DENTAL PRACTITIONER)

Name: Designation: --

Tel. No.: Email:

Date: ---Signature:

F. PERSON IN CHARGE PARTICULARSw ii ..

Name: Designation: -

Tel. No.: Email:

Date: ------------Signature: _ _.-

G. For Official Use Only:

Date Received: Incident Reference:----------_._---~- - _.__ .._----_ ..

H. For Official Use Only:Further Secretariat Action

Name: Designation: ------------_._----_.__ ._--------_._--------------_.-

Date: _ .._ .._-_ .._--_._----_ ..__ .._.__ ...... -