GOVERNANCE FRAMEWORK
MALAYSIAN HOSPITAL ACCREDITATION PROGRAMME,
-10
TH
MSQH SURVEYOR TRAINING WORKSHOP
8 May 2014
Auditorium Hospital Sungai Buloh, Selangor
REQUIREMENTS OF PRIVATE
HEALTHCARE FACILITIES & SERVICES
ACT 1998 [ACT 586] & ITS REGULATIONS
CONTENTS
1.
Introduction
◦
Goals of Act 586
◦
Mode of Control
◦
Act 586 and its subsidiary legislation
2.
Governance framework under Act 586
◦
Governance [Corporate/Clinical (Integrated)]
INTRODUCTION
GOALS OF ACT 586
1.
Impose and ensure
minimum standards
in the
private healthcare facilities and services
(PHFS).
2.
Ensure
integrity
&
professionalism
among
healthcare professionals.
3.
Ensure
quality
of PHFS e.g. Quality Assurance,
Mortality Review etc.
4.
Address
social and national interest
.
MODE OF CONTROL (S.3, 4 & 85, Act 586)
Location (zoning)
1.APPROVAL TO
ESTABLISH/MAINTAIN
1.
Private Hospital
2.
Private Psychiatric Hospital
3.
Private Ambulatory Care Centre
4.
Private Nursing Home
5.
Private Psychiatric Nursing Home
6.
Private Maternity Home
7.
Private Blood Bank
8.
Private Haemodialysis Centre (PHC)
9.
Private Hospice
10. Private Community Health Centre
11. Any other type of healthcare facility/
service to be gazetted from time to time
3. REGISTRATION
1. Private Medical Clinic
2. Private Dental Clinic
2.LICENCE TO
OPERATE/PROVIDE
4. SUBMIT INFORMATION
Managed Care Organisations
ACT 586 & ITS SUBSIDIARY
LEGISLATION
Act 586
◦
An Act to provide for the
regulation and control of
private healthcare facilities
and
services
and other
health-related facilities and services and for matters
related 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.
Part I – Preliminary
S. 1- 2
Part XIX -Saving & Transitional
S.119-122
Part XVIII – Miscellaneous
S.108-118
Part XVII –YBMK S.101-107 Part XVI – Enforcement S.87-100 Part II –Control S. 3-7
Part III –COA S.8-13 Part IV –Licence S.14-24 Part V – COR S. 25-30 Part XV –MCO S.82-86
Part XIV-BOM & AC
S.77-81
Part XIII –Quality S.74-76
Part XII –AD S.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 –Closure S.52-53
19 Parts
122 Sections
Part X- Blood Bank S.54-58Gazette date: 27 Aug 1998
Enforcement date: 1 May 2006
7
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 LEGISLATIONS
1.
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 and
Other 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 Identification
Card) Order, 2006 [P.U. (A) 139/2006] (1 May 2006)
4.
Private Healthcare Facilities & Services (
Compoundable
Offences) Regulations, 2011 [P.U. (A) 170/2011] (1 August 2011)
5.
Private Healthcare Facilities & Services (
Private Hospitals and
Other Private Healthcare Facilities) (Amendment) Order,
2013 [P.U. (A) 358/2013] (17 December 2013)
Part I –Preliminary r.1- 2
Part II –Application r.3-6
Part III –Organisation & Management
r.7-13
Part IV –Policy r.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 Record
r.28-32
Part VIII –Infection Control
r.33
Part IX –General Provisions for Standards
r.34-72 Part X- Emergencies r.73-75
14 Parts
109 Regulations &
7 Schedules
Private Healthcare Facilities &
Services (
Private Medical Clinics or
Private Dental Clinics
) Regulations
2006
Gazette date: 1 April 2006
Enforcement 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 Medical
Part I –Preliminary r.1- 2 Part II –Application
r.3-10
Part III –Organization & Management
r.11-20 Part IV –Policy
r.21-27
Part V – Registers, Rosters & Returns
r.28-37
Part XIV- Anesthesia r.176-185 Part XIII –Paediatric
r.170-175 Part XII –Nursery
r.149-169 Part XI – O & G r.133-148 Part VI –Grievance Mechanism r.38-41
Part VII –Patient’s Medical Record
r.42-46 Part VIII –Consent
r.47-48
Part IX –Infection Control r.49
Part X- General Provisions for Standards of PHFS
r.50-132
29 Parts
434 Regulations &
13 Schedule
PRIVATE HEALTHCARE FACILITIES
AND SERVICES (PRIVATE HOSPITALS
AND OTHER PRIVATE HEALTHCARE
FACILITIES) REGULATIONS 2006
Gazette date : 1 April 2006
Enforcement date: 1 May 2006
Part XXVI –Radiology or Imaging
r.345-352 Part XXVII –PNH
r.353-387 Part XXVIII –Hospice
r.388-416 Part
XXIX-Miscellaneous r.416-434
Part XVI – ICU r.218-227 Part XV- Surgical
r.186-217
Part XXV –ACC r.339-344 Part XXIV –Specialist
Outpt r.333-338
Part XXIII – Rehabilitation r.323-332
Part XXII – Hemodialysis r.301-322 Part XXI –Blood bank
r.277-300 Part XX–Dietary
r.263 - 276 Part XIX –CSSD
r.250-262
Part XVIII –Pharmaceutical r.238-249
Part XVII- Emergency r.228-237
29 Parts
434 Regulations & 13 Schedules
PRIVATE HEALTHCARE FACILITIES AND SERVICES
(PRIVATE HOSPITALS AND OTHER PRIVATE HEALTHCARE
FACILITIES) REGULATIONS 2006
Gazette date: 1 April 2006
Enforcement 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
GOVERNANCE FRAMEWORK
UNDER ACT 586
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, subspecialties
Support 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 to provide the healthcare facilities and services (including part-time, volunteer, locum tenens or honorarium)
Performance/Outcome:
continuous monitoring & renewal of licence (written policies, complaint,incident reporting, assessable death notification, patient medical records)
Enforcement:
Show cause notice, compound & courtREGULATORY 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 Inspection Form B/C;
Form F/G NA
Amendment Form B/C;
F/G
Form D (to
transfer) Form E (to dispose) Patient Medical Preserve 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)
Inspection (Extension -Form 5 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 Contribution NA Regulate/
Control Approval Procedure
Approval Procedure
Register Section 112 Show Cause Notice Written Notice Directive DG's DirectiveYB MK's Board of Visitors
Enforcement & Action
Undercover, Raid (with/without warrant); Investigation; Prosecution
NA
Compound
NA
Warning/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
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 HospicePART 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
Governance Framework
PRIVATE CLINICS
(PMC & PDC)
(HOSPITAL ETC)
OTHER PHFS
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
Certificate Holder/Licensee (Sec 2. Act 586)
Approval to establish/maintain means approval to
establish/maintain a PHFS than a PMC/PDC granted
under paragraph 19(a),Act 586
Licensee means a person to whom a licence to
operate/provide a PHFS other than a PMC/PDC
granted under paragraph 12(a), Act 586
Certificate of Registration means a certificate issued
under Section 27,Act 586
*
Note: Person includes a body of persons, corporate or
unincorporated (Section 3, Interpretation Acts 1948 &
1967)
Certificate Holder/Licensee vs Facility (S. 6 & 7)
Certificate
Holder/Licensee
Medical
Clinic
Dental
Clinic
Nursing
Home
Maternity
Home
Haemodialysis
Hospice &
(Hospital, etc)
Others
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
Person in Charge (1/4)
S.2, Act 586
“Person in charge” means a person possessing such
qualification, training and experience as may be prescribed
and who shall be
responsible for the management and
control
of the private healthcare facility or service to which
a 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 private
healthcare facility or service shall ensure that the licensed or
registered private healthcare facility or service is
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 such
qualification, have undergone such training and
possess such experience as may be prescribed.
(2) A person in charge shall carry out such duties
and responsibilities as may be prescribed.
(prescribed ~ by the Minister by order or regulations made
Person in Charge vs Facility : r. 8 3
rd
Schedule
(clinics) & r.12, 4
th
Schedule (other PHFS)
*Person in Charge
RMP
RDP
RN
RM
Medical Clinic
Yes
Dental Clinic
Yes
Nursing Home
(policy)
Yes
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 withstanding
paragraph (1)(a), different persons may be
appointed to manage and assume the duties
and responsibilities relating to
non-clinical
matters including financial, administration
Board of Management (BOM)
S.2,
BOM means a board of trustee or
directors or any other governing body in
whom
the
ultimate
authority
and
responsibility for the conduct of the PHFS
specified in Part XIV are vested.
S. 77 – The licensee shall establish a BOM of
whom 2 members shall be from the Advisory
Committees established under S 78 (b) or 79
(b), Act 586
Advisory Committee
The licensee shall ensure, the establishment of
the Advisory Committee whose members shall
be RMP/RDP
representing all RMP/RDP
practising in the PHFS
to advise the BOM, the
licensee & PIC on
all aspects relating to the
medical/dental practices respectively (patient
care).
Medical Advisory Committee
Medical and Dental Advisory Committee
Midwifery Care Advisory Committee
Person responsible for the body
corporate
Means any person who is a director or
officer of the body corporate or who
purports to act in such capacity or who is
in any manner or to any extent
responsible for the management of
the affairs of the body corporate, or
Head of Department
The licensee or PIC shall appoint a HOD
who will be responsible for the
management and control of the
department (where ≥ 2 RMP/RDP in any
one specialty in the PHFS)
Shall have relevant qualification and
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 procedure reg. 122Written policy & Written policy, reg. 161 Written policy, reg. 215 written policy, reg. 249
written policy on the quantum of fees
to be charged subreg. 433(2)
