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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)]
2
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.
4
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.
6
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
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 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)
8
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: [email protected] ; [email protected] applications: http://medpcs.moh.gov.my
Website: http://medicalprac.moh.gov.myIncident Reporting & Assessable Death: [email protected]
31