GOVERNANCE FRAMEWORK

MALAYSIAN HOSPITAL ACCREDITATION PROGRAMME, -10TH MSQH SURVEYOR TRAINING WORKSHOP

8 May 2014Auditorium Hospital Sungai Buloh, Selangor

REQUIREMENTS OF PRIVATE HEALTHCARE FACILITIES & SERVICES

ACT 1998 [ACT 586] & ITS REGULATIONS

CONTENTS1. Introduction

◦ Goals of Act 586◦ Mode of Control◦ Act 586 and its subsidiary legislation

2. Governance framework under Act 586◦ Governance [Corporate/Clinical (Integrated)]

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INTRODUCTIONPart A:

GOALS OF ACT 5861. Impose and ensure minimum standards in the

private healthcare facilities and services(PHFS).

2. Ensure integrity & professionalism amonghealthcare professionals.

3. Ensure quality of PHFS e.g. Quality Assurance,Mortality Review etc.

4. Address social and national interest.

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MODE OF CONTROL (S.3, 4 & 85, Act 586)

Location (zoning)

1.APPROVAL TO ESTABLISH/MAINTAIN

1. Private Hospital2. Private Psychiatric Hospital3. Private Ambulatory Care Centre4. Private Nursing Home5. Private Psychiatric Nursing Home6. Private Maternity Home7. Private Blood Bank8. Private Haemodialysis Centre (PHC)9. Private Hospice10. Private Community Health Centre11. Any other type of healthcare facility/

service to be gazetted from time to time

3. REGISTRATION 1. Private Medical Clinic2. Private Dental Clinic

2.LICENCE TOOPERATE/PROVIDE

4. SUBMIT INFORMATION Managed Care Organisations

New & Renewal

ACT 586 & ITS SUBSIDIARY LEGISLATION

Act 586◦ An Act to provide for the regulation and control of

private healthcare facilities and services and otherhealth-related facilities and services and for mattersrelated hereto.

Date of gazettement: 27 August 1998.

Date of enforcement: 1 May 2006.

Arrangement of Act 586◦ XIX Parts with122 Sections

The provisions apply to all private healthcare facilities &services in Malaysia as delineated in Section 3 & 4 of the Act.

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Part I –Preliminary

S. 1- 2

Part XIX -Saving & TransitionalS.119-122

Part XVIII –Miscellaneous

S.108-118

Part XVII –YBMKS.101-107

Part XVI –Enforcement

S.87-100

Part II –ControlS. 3-7

Part III –COAS.8-13

Part IV –LicenceS.14-24

Part V – CORS. 25-30

Part XV –MCOS.82-86

Part XIV-BOM & AC

S.77-81

Part XIII –QualityS.74-76

Part XII –ADS.64-73

Part XI –Transfusion

S.59-63

Part VI –Responsibilities

S.31-38

Part VII – General Provisions S.39 - 42

Part VIII –Show cause

S.43-51

Part IX –ClosureS.52-53

19 Parts122 Sections

Part X- Blood Bank

S.54-58

Gazette date: 27 Aug 1998Enforcement date: 1 May 2006

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Act 586 An Act to provide for the regulations and control of PHFS & other health-related facilities and services & for

matters related hereto

[1May 2006, P.U. (B) 93/2006]

SUBSIDIARY LEGISLATIONS1. Private Healthcare Facilities & Services (Private Medical Clinics

or Private Dental Clinics) Regulations, 2006 [P.U. (A) 137/2006]◦ 14 Parts with 109 Regulations & 7 Schedules (1 May 2006)

2. Private Healthcare Facilities & Services (Private Hospitals andOther Private Healthcare Facilities) Regulations, 2006 [P.U.(A) 138/2006]◦ 29 Parts with 434 Regulations & 13 Schedules (1 May 2006)

3. Private Healthcare Facilities & Services (Official IdentificationCard) Order, 2006 [P.U. (A) 139/2006] (1 May 2006)

4. Private Healthcare Facilities & Services (CompoundableOffences) Regulations, 2011 [P.U. (A) 170/2011] (1 August 2011)

5. Private Healthcare Facilities & Services (Private Hospitals andOther Private Healthcare Facilities) (Amendment) Order,2013 [P.U. (A) 358/2013] (17 December 2013)

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Part I –Preliminary r.1- 2

Part II –Applicationr.3-6

Part III –Organisation & Management

r.7-13

Part IV –Policyr.14-18

Part V – Registers, Rosters & Returns

r.19-25

Part XIV- Miscellaneous r.100-109

Part XIII –Radiological /Diagnostic

r.93-99

Part XII –Standards for Outpatient

r.89-92

Part XI –Pharmaceutical r.76-88

Part VI –Patient Grievance Mechanism

r.26-27

Part VII –Pts Medical Recordr.28-32

Part VIII –Infection Control

r.33

Part IX –General Provisions for Standards

r.34-72

Part X- Emergenciesr.73-75

14 Parts109 Regulations &

7 Schedules

Private Healthcare Facilities & Services (Private Medical Clinics or Private Dental Clinics) Regulations

2006

Gazette date: 1 April 2006Enforcement date: 1 May 2006

FIRST SCH SECOND SCH THIRD SCH FOURTH

SCH FIFTH SCH SIXTH SCH SEVENTH SCH

Form A-G Application Fees PIC Patient MedicalRecord

Emergency Services

Social Contribution

ProfessionalFees

Part I –Preliminary r.1- 2

Part II –Applicationr.3-10

Part III –Organization & Management

r.11-20

Part IV –Policyr.21-27

Part V – Registers, Rosters & Returns

r.28-37

Part XIV- Anesthesia r.176-185

Part XIII –Paediatricr.170-175

Part XII –Nurseryr.149-169

Part XI – O & Gr.133-148

Part VI –Grievance Mechanism

r.38-41

Part VII –Patient’s Medical Recordr.42-46

Part VIII –Consentr.47-48

Part IX –Infection Control r.49

Part X- General Provisions for Standards of PHFS

r.50-132

29 Parts434 Regulations &

13 Schedule

PRIVATE HEALTHCARE FACILITIES AND SERVICES (PRIVATE HOSPITALS AND OTHER PRIVATE HEALTHCARE

FACILITIES) REGULATIONS 2006

Gazette date : 1 April 2006Enforcement date: 1 May 2006

Part XXVI –Radiology or Imaging

r.345-352

Part XXVII –PNHr.353-387

Part XXVIII –Hospicer.388-416

Part XXIX-Miscellaneous

r.416-434

Part XVI – ICUr.218-227

Part XV- Surgicalr.186-217

Part XXV –ACCr.339-344

Part XXIV –Specialist Outpt

r.333-338

Part XXIII – Rehabilitationr.323-332

Part XXII – Hemodialysisr.301-322

Part XXI –Blood bankr.277-300

Part XX–Dietaryr.263 - 276

Part XIX –CSSDr.250-262

Part XVIII –Pharmaceutical r.238-249

Part XVII- Emergency r.228-237

29 Parts434 Regulations & 13 Schedules

PRIVATE HEALTHCARE FACILITIES AND SERVICES (PRIVATE HOSPITALS AND OTHER PRIVATE HEALTHCARE

FACILITIES) REGULATIONS 2006

Gazette date: 1 April 2006Enforcement date: 1 May 2006

EIGHTH SCH NINTH SCH TENTH SCH ELEVENTH SCH TWELFTH SCH THIRTHEENTH

SCH

Basic Emergency Services

Ambulances Collecting Blood Code of Ethics for Blood

Donation & Transfusion

Social or Welfare Contribution

Fee Schedule

FISRT SCH SECOND SCH THIRD SCH FOURTH SCH FIFTH SCH SIXTH SCH SEVENTH SCH

Form 1-10 Type of Service

ApplicationFees

PIC IR Patient’s Medical Record

Personal Care

GOVERNANCE FRAMEWORK UNDER ACT 586

Part B:

For healthcare it is integrated –Perspectives Act 586

CORPORATE GOVERNANCE CLINICAL GOVERNANCE

The system of structures, rights, duties, and obligations by which corporations are directed and controlled

A systematic approach to maintaining and improving the quality of patient care within a health system

GOVERNING PROCESS Entity of Applicant: Licensee/Certificate Holder & Person in Charge

Type of Facilities: infrastructures & equipments

(Location, Flow, Minimum dimension, Clear Areas etc)

Type of Services: General, specialty, subspecialtiesSupport services – Clinical & non clinical

Personnel:◦ Healthcare professional (S.2),Technical staff (S.2), Personal care aides (S.34)

◦ All healthcare professional, technical and para-professional shall be qualified, trained and experienced toprovide the healthcare facilities and services (including part-time, volunteer, locum tenens orhonorarium)

Performance/Outcome: continuous monitoring & renewal of licence (written policies, complaint,incident reporting, assessable death notification, patient medical records)

Enforcement: Show cause notice, compound & court

Closure: Direction, transfer or stop operation

REGULATORY FRAMEWORK UNDER ACT 586 TIME BEFORE OPERATION CERTIFICATE ON OPERATION AFTER CLOSURE

Requirement Comply with Section 3 and 4, Act 586 Comply with Act 586 and its subsidiary legislations

Approval Procedure

Registration Form A InspectionForm B/C; Form F/G NA

Amendment Form B/C;

F/G

Form D (to transfer)

Form E (to dispose)

Preserve Patient Medical Record /Patient

Care Data (Limitation Act 1953 [Act 254]) Licensing

Zoning (No

Objection letter)

Form 1 (Form 2) Form 3 Inspection Form 4/7

Licence Renewal (every 2 years)

InspectionForm 5

(Extension -Form 6)

Amendment Form 4/7/6

Form 8 (to transfer)

Form 9 (to dispose)

Surveillance/ Monitoring NA

Written policies, stds, procedures G/lines &

Quality Assurance

Programme

Statistical/ Data/

Information Submission

Grievance Mechanism (Complaint

Mx)

Incident Reporting

Assessable Death

Notification

Social or Welfare

ContributionNA

Regulate/ Control

Approval ProcedureApproval Procedure

RegisterSection 112 Show Cause

NoticeWritten Notice

DG's Directive

YB MK's Directive

Board of Visitors

Enforcement & Action

Undercover, Raid (with/without warrant); Investigation; Prosecution

NACompound

NAWarning/Direction/Temporary Closure; Suspend or Revoke the Approval, Licence or Registration

Liable person Any person Certificate Holder / Licensee; or Person in Charge

Certificate Holder / Licensee/Any

person

REQUIREMENTS FOR THE REGISTRATION VS LICENSING PROCESS

REGISTRATION & LICENSING ADDITIONAL FOR LICENSING

Organisation & Management Policy Registers, Rosters & Returns Patient Grievance Mechanism Patient’s Medical Record Infection Control Standards of PHFS Emergency Pharmaceutical Standards for Outpatient Radiology or Imaging Miscellaneous

Consent O & G Nursery Paediatric Anaesthesia Surgical ICU CSSD Dietary Blood bank Haemodialysis Rehabilitation ACC PNH Hospice

PART 111: ORGANISATION & MANAGEMENT

CLINICS [P.U. (A) 137/2006] OTHER PHFS [P.U. (A) 138/2006]

Plan of Organisation (r. 7 Vs r.11)

Person in Charge (r. 8 Vs r.12) Healthcare Professional Staff

(r. 9 Vs r.13) Treatment of Patient (r. 10 Vs

r.14) Orders for diagnostic,

procedure, medication or treatment (r.11 vs 15)

Volunteers programme (r.12 vs 17)

Incident reporting (r.13 vs 19)

All as required for clinics + Patient care & treatment

(r.14) Department (r.16) Patient identification (r.18) Resuscitation facilities

(r.20)

Governance Framework

PRIVATE CLINICS (PMC & PDC)

OTHER PHFS(HOSPITAL ETC)

Certificate Holder Person responsible for the

body corporate (Dental) Person in Charge

Certificate Holder/Licensee Person responsible for the

body corporate Board of Management Advisory Committee Person in Charge Head of Department

Certificate Holder/Licensee (Sec 2. Act 586) Approval to establish/maintain means approval to

establish/maintain a PHFS than a PMC/PDC grantedunder paragraph 19(a),Act 586

Licensee means a person to whom a licence tooperate/provide a PHFS other than a PMC/PDCgranted under paragraph 12(a), Act 586

Certificate of Registration means a certificate issuedunder Section 27,Act 586

* Note: Person includes a body of persons, corporate orunincorporated (Section 3, Interpretation Acts 1948 &1967)

Certificate Holder/Licensee vs Facility (S. 6 & 7)Certificate Holder/Licensee

Medical Clinic

Dental Clinic

Nursing Home

MaternityHome

Hospice & Haemodialysis

Others(Hospital, etc)

Registered Medical Practitioner (RMP)

Yes Yes Yes Yes Yes

Registered Dental Practitioner (RDP)

Yes

Registered Nurse (RN)

Yes

Registered Midwife (RM)

Yes

Partnership (+ ≥ 1RMP)

Yes Yes Yes Yes

Body Corporate (Companies Act 1965) (+ BOD ≥ 1RMP)

Yes Yes Yes Yes

Body Corporate (Companies Act 1965) (+ all BOD RDP)

Yes

Society (Societies Act 1966)

Yes

Person in Charge (1/4)S.2, Act 586 “Person in charge” means a person possessing such

qualification, training and experience as may be prescribedand who shall be responsible for the management andcontrol of the private healthcare facility or service to whicha licence or registration relates

S. 31. Responsibilities (1)(a). A licensee or a holder of certificate of

registration in respect of a licensed or registered privatehealthcare facility or service shall ensure that the licensed orregistered private healthcare facility or service ismaintained or operated by a person in charge

Person in Charge (2/4)S.32, Act 586 (1) A person in charge of a licensed or registered

private healthcare facility or service shall hold suchqualification, have undergone such training andpossess such experience as may be prescribed.

(2) A person in charge shall carry out such dutiesand responsibilities as may be prescribed.

(prescribed ~ by the Minister by order or regulations madeunder this Act)

Person in Charge vs Facility : r. 8 3rd Schedule (clinics) & r.12, 4th Schedule (other PHFS)

*Person in Charge RMP RDP RN RM

Medical Clinic Yes

Dental Clinic Yes

Nursing HomeYes

(policy) Yes

Maternity Home Yes Yes

Ambulatory Care Yes Yes

Others (Hospital, etc) Yes

* Qualified, trained and experiences, in accordance to the healthcare facilities and services/specialties provided

PIC: Exclusion (4/4)

S.31(2), Act 586 – not withstandingparagraph (1)(a), different persons may beappointed to manage and assume the dutiesand responsibilities relating to non-clinicalmatters including financial, administrationand management of non-clinical resources

Board of Management (BOM) S.2, BOM means a board of trustee or

directors or any other governing body inwhom the ultimate authority andresponsibility for the conduct of the PHFSspecified in Part XIV are vested.

S. 77 – The licensee shall establish a BOM ofwhom 2 members shall be from the AdvisoryCommittees established under S 78 (b) or 79(b), Act 586

Advisory Committee The licensee shall ensure, the establishment of

the Advisory Committee whose members shallbe RMP/RDP representing all RMP/RDPpractising in the PHFS to advise the BOM, thelicensee & PIC on all aspects relating to themedical/dental practices respectively (patientcare).

Medical Advisory Committee Medical and Dental Advisory Committee Midwifery Care Advisory Committee Nursing Advisory Committee

Person responsible for the bodycorporate Means any person who is a director or

officer of the body corporate or whopurports to act in such capacity or who isin any manner or to any extentresponsible for the management ofthe affairs of the body corporate, orwas assisting in such management.

Head of Department

The licensee or PIC shall appoint a HODwho will be responsible for themanagement and control of thedepartment (where ≥ 2 RMP/RDP in anyone specialty in the PHFS)

Shall have relevant qualification andexperience on the specialty.

Governance Framework (Other PHFS)

Medical/ Dental Advisory

Committee (Patient care)

LICENSEE Certificate Holder

Board of Management

(ultimate authority & responsibility)

Person responsible for body corporate

PERSON IN CHARGE Non Clinical Matters

Head of Department Nursing Department Medical Assistant

Mortality Assessment Committee (PHFS

level) S. 72, Act 586

Quality Assurance Programme, S.74, Act

586

Infection Control

Committee, reg. 49 (4/12)

Committee of Consulting Physician (+ ≥ 1 O&G), subreg.

145 (4)

Committee of Consulting Surgeon & Anesthetist, reg. 186

Pharmacy & Therapeutic

Committee, reg. 248

Transfusion Committee, reg.300

Medical Record Review Committee,

reg.413 (6/12)

Written policy, reg. 21

Written policy & procedure reg. 122 Written policy, reg. 161 Written policy, reg.

215written policy, reg.

249

written policy on the quantum of fees

to be charged subreg. 433(2)

Governance Framework (Clinics)Certificate Holder of

Registration

Person responsible for body corporate (Dental

Clinic)

Person in Charge non-clinical matter

Head of Pharmaceutical Services, reg. 78

Head of Radiological or diagnostic imaging

Services, reg.94

Mortality Assessment Committee (PHFS level) S. 72,

Act 586

Quality Assurance Programme, S.74, Act 586

Written policy, reg. 14Written policy on the quantum of fees to be

charged subreg. 108 (2)

THANK YOUTelephone: 03-8883 1307/1296

Fax: 03-8881 0901/0902

E-mail: ckaps@moh.gov.my ; afidah@moh.gov.myOnline applications: http://medpcs.moh.gov.my

Website: http://medicalprac.moh.gov.myIncident Reporting & Assessable Death: irad@moh.gov.my

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