SCENARIO 1:
You are the evening shift charge nurse of the postanesthesia care unit (PACU). You have just admitted a 32-year-old woman who 2, hours ago, was thrown from a Car in which she was a passenger. She was rushed to the emergency department and subsequently to surgery, where cranial burr holes were completed, and an intracranial monitor was placed. No further cranial exploration was attempted because the patient sustained extensive and massive neurologic damage. She will probably not survive your shift. The plan is to hold her in the PACU for 1 hour and, if she is still alive, transfer her to the intensive care unit (ICU).
Shortly after receiving the patient, you are approached by the evening house supervisor, who says that the patient’s sister is pleading to be allowed into the PACU. Normally, visitors are not allowed into the PACU when patients are only temporarily held there, but exceptions are occasionally made. Tonight, the PACU is empty except for this patient. You decide to bend the rules and allow the young woman’s sister to come in. The visiting sister is near collapse; it is obvious that she had been the driver of the Car. As the visitor continues to speak to the comatose patient, her behavior and words make you begin to wonder if she is indeed the sister.
Within 15 minutes, the house supervisor returns and states, “I have made a terrible mistake. The patient’s family just arrived, and they say that the visitor we just allowed into the PACU is not a member of the family but is the patient’s lover. They are very angry and demand that this woman not be allowed to see the patient.”
You approach the visitor and confront her kindly regarding the information you have just received. She looks at you with tears streaming down her face and says, “Yes, it is true. Mary and I have been together for 6 years. Her family disowned her because of it, but we were everything to each other. She has been my life, and I have been hers. Please, please let me stay. I will never see her again. I know the family will not allow me to attend the funeral. I need to say my goodbyes. Please let me stay. It is not fair that they have the legal right to be family when I have been the one to love and care for Mary.”
ON SETTING UP OF
IN MALAYSIA PRIVATE HOSPITALS
REQUIREMENTS AND PROCEDURES UNDER ACT 586
H A N D B O O K
MINISTRY OF HEALTH MALAYSIA
Private Medical Practice Control Section (CKAPS), Medical Practice Division
July 2019
Handbook on Setting up of Private Hospital in Malaysia
www.medicalprac.moh.gov.myI
© Malaysia Productivity Corporation 2019
ON SETTING UP OF
IN MALAYSIA PRIVATE HOSPITALS
REQUIREMENTS AND PROCEDURES UNDER ACT 586
H A N D B O O K
Prepared By:
Private Medical Practice Control Section Medical Practice Division
Ministry of Health Malaysia Level 3, Block E1, Parcel E
Federal Government Administration Centre 62590 Putrajaya
Tel : 03-8883 1307
In Collaboration With:
Malaysia Productivity Corporation Lorong Produktiviti
Jalan Sultan 46200 Petaling Jaya Selangor Darul Ehsan
Tel : 03-7955 7266
ALL RIGHTS RESERVED
Ministry of Health Malaysia
All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case of brief quotations embodied in critical reviews and certain other
noncommercial uses permitted by copyright law.
PRODUCTIVITY AND REGULATION
Productivity is the only driver of income growth that is unlimited, as opposed to resource exploitation or increase in population and labour force participation, each of which faces natural limits. The potential for productivity growth to generate higher income for Malaysians makes it a natural and important consideration for decision makers. As such the continuing need to stimulate productivity rightly remains at the forefront of government policies. Regulation is the lifeblood of a modern, well-functioning economy.
Almost all regulations have the potential to impact on productivity, either through the incentives which they provide to businesses to change operating and investment decisions, or more directly through their impacts on compliance costs. It is inconceivable to think of a modern economy functioning without regulation. However, poor regulation can cause frustration and unintended consequences, or simply add red tape that adds nothing useful to the economy, society or the environment.
Handbook on Setting up of Private Hospital in Malaysia
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Private healthcare is an important component of Malaysia’s healthcare system and has constantly received intense policy attention. The Private Healthcare Facilities and Services Act 1998 [Act 586] and its regulations is a formulation of public policy toward private healthcare providers and their services.
The Private Medical Practice Control Section (CKAPS), Medical Practice Division is the regulator responsible to purview, control, regulate and monitor that the private healthcare operators comply with the relevant requirements under the act. At Ministry of Health (MOH), we acknowledge that an e�ective regulatory system contributes toward high growth and creates both economic and social benefits for all. We also recognise that regulation is a dynamic process and must be scrutinized, challenged and improved to ensure it takes account of our changing environment. This handbook is drafted with its main objective to facilitate the submitting persons to complete and comply with the requirements under the Act and thus, achieve the goal to reduce the number of days in obtaining planning approval.
This handbook is intended to provide a clear guide on the needs to comply with Act 586 (on the technical requirements) and help private hospital operators to submit a quality submission for a new private hospital development. A quality submission should have very minimal or no correction at all and this shall translate into less rework and resubmission – which means less time spent on the submission. I understand that numerous workshops and public consultations were organized by the
Focus Group on Dealing with Construction Permits (FGDCP) on Private Hospitals and progress reported to PEMUDAH. The Focus Group has also built in a capacity building, where MPC and CKAPS jointly organized a series of workshops and trainings were conducted directly by CKAPS to the technical and submitting persons (applicants) on how to submit a plan that satisfies the requirements of Act 586. I trust that this handbook will be followed through and advance further as a ground for continuous improvement in future.
I would like to congratulate and commend everyone who has contributed in accomplishing this handbook.
FROM FOREWORD
MINISTER OF HEALTH MALAYSIA
YB DATO' SERI DR HJ DZULKEFLY AHMAD
Handbook on Setting up of Private Hospital in Malaysia
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It gives me great pleasure to share with you this Handbook on Setting up of Private Hospitals in Malaysia. The first edition of this handbook will provide clarity on the requirements, processes and procedures for the licensing of private hospitals under the jurisdiction of the Ministry of Health.
Understanding Legislative requirements for hospital planning, design and construction process is critical when dealing with issues and activities associated with health and safety of the people is under the responsibility of the owner's supervisor.
Healthcare facilities and services licensing is essential to ensure the minimum acceptable standards are complied with, accountability of private healthcare provider towards patient’s safety is transparent, patient’s rights are upheld and quality assurance and processes are clearly defined.
This new handbook details the legislative framework which governs the operation of private hospitals. Clear description are provided to assist the processes and requirements for pre-establishment approval, approval to establish or maintain and license to operate or provide for private healthcare facilities and services.
I would like to express my appreciation to PEMUDAH members and Malaysia Productivity Corporation (as the secretariat of PEMUDAH) for their kind support and collaboration which has made this publication a success. My acknowledgement to all parties from the Ministry of Health who have directly or indirectly contributed their resources and experiences to
enrich the contents of the Handbook. We hope that this Handbook will serve as an important reference source for the ongoing improvement of the healthcare and professional standards in the non-Government sector in Malaysia.
FROM FOREWORD
CHIEF SECRETARY TO THE GOVERNMENT OF MALAYSIA
DATUK SERI DR. ISMAIL HJ BAKAR
Handbook on Setting up of Private Hospital in Malaysia
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I would like to congratulate Private Medical Practice Control Section, (CKAPS), Ministry of Health on the successful publication of this Handbook and delighted that PEMUDAH and Malaysia Productivity Corporation (MPC) is part of the collaborative e�ort. This is in line with our innovative collaboration with stakeholders in facilitating ease of doing business. PEMUDAH and MPC undertake regulatory review mandate by working closely with other government ministries and agencies to set out principles and guidelines on the conduct of regulatory reviews and design of new regulations, with a view that the new and revised regulations will reduce unnecessary regulatory burden (RURB) on business and contribute to the private sector’s competitiveness.
MPC has embarked on review of existing business regulations with the focus on the Productivity Nexus of the 9 priority subsectors and Healthcare being one of them. Among the completed RURB projects include ‘Reducing Unnecessary Regulatory Burdens in Business: Private Healthcare’ which sought commitment from the public and private sectors to remove unnecessary compliance costs and administrative burden while enhancing regulatory consistency in the private healthcare sector. The focus is on the private hospital sector as it is a high value added, high knowledge-based and growing sector of importance.
Although it is emphasized that compliance with these guidelines forms only one element of the private hospital licensing process, the comprehensive guidelines in this Handbook demonstrate the intent of the standard,
requirements, processes and procedures from the perspective of the Ministry of Health. It is critical as setting up a private hospital involves tremendous planning, finance, resources, approvals, certifications and guidelines. Thus if there are no clear guidelines it can lead to longer waiting time and this would a�ect the hospital planning e�ciency. Process uncertainty and unreliability would give rise to unnecessary burdens and high compliance costs. This Handbook is indeed timely in view of the increasing emphasis and demand for quality healthcare and services. Clear guidelines would greatly facilitate the establishment and maintenance of private hospitals and a variety of related healthcare facilities and services for both new and existing facility and operational processes.
I believe that this publication will have the widest possible circulation and be a useful reference for all those who are involved in providing healthcare.
FOREWORD FROM PEMUDAH CO-CHAIR
YBHG DATO’ DR. IR. ANDY K H SEO
Handbook on Setting up of Private Hospital in Malaysia
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To achieve an inclusive and profound level of technical understanding, it is highly encouraged for this handbook to be read in tandem with the Handbook on Setting Up of Private Hospitals in Malaysia: Submission Process and Harmonisation of Technical Requirements which addresses fundamental requirements from various technical agencies involved in setting up a new private hospital. The list of harmonized requirements, procedures and/or guidelines are outlined in that handbook as reference and information for all stakeholders in both public and private sector.
By applying references to both handbook- users will be guided in a methodological way of application and submission processes whilst acquiring best practice of clinical, operational and framework of setting-up exemplary new private hospitals described in this handbook.
Both handbooks correlate and anticipated to serve as a guidance to facilitate businesses in their e�orts to comply with the technical requirements for setting up a new private hospital.
Option 3
Private Medical Practice Control Section (CKAPS), Medical Practice Division
July 2019
MINISTRY OF HEALTH MALAYSIA
ON SETTING UP OF
IN MALAYSIA PRIVATE HOSPITALS
H A N D B O O K
Submission Process & Harmonisation of Technical Requirements
Handbook on Setting up of Private Hospital in Malaysia
www.medicalprac.moh.gov.my VI www.medicalprac.moh.gov.my
C O N T E N T S
1 2 3
4 7
9 9 10
12 12 12
22
111 111 111
113
CHAPTER 1: OVERVIEW
1.0 Introduction 1.1 Private Healthcare Facilities and Services Act 1998 1.2 Other Laws Pertaining to Establishment and Operation of a Private Hospital 1.3 Approval and Licensing Procedures Under Act 586 1.4 Who Can Apply?
CHAPTER 2: APPLICATION FOR PRE-ESTABLISHMENT APPROVAL
2.0 Introduction 2.1 How to Apply? 2.2 Factors Considered in Pre-Establishment Approval
CHAPTER 3: APPLICATION FOR APPROVAL TO ESTABLISH
3.0 Introduction 3.1 How to Apply? 3.2 Factors Considered in Approval Application 3.2.1 Legal and Basic Considerations Providers’ Concept and
Intention 3.2.2 What is a Hospital? 3.2.3 Responsibilities of Person-In-Charge 3.2.4 Separate Approval & Licence 3.3 Floor Plans 3.3.1 General Provisions 3.3.2 Wards 3.3.3 Specific Provisions According to Facilities
CHAPTER 4: APPLICATION FOR LICENCE TO OPERATE
4.0 Introduction 4.1 How to Apply? 4.2 Factors to be Considered
CHAPTER 5: QUESTIONS AND ANSWERS
5.0 Questions and Answers
Handbook on Setting up of Private Hospital in Malaysia
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CHAPTER 1 OVERVIEW
Handbook on Setting up of Private Hospital in Malaysia
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Before establishing a private hospital, various factors have to be considered and carefully planned as healthcare industry is unlike others, whereby it involves human lives and impacts significantly on socioeconomic status on a community or a country. Among those factors are
It is imperative that the provider is clear on the intention of setting up a private healthcare facility or service (PHFS); what type of PHFS, what services that they will be o�ering and who are the professionals o�ering those services. For that matter, healthcare industry is a highly regulated industry as a the main aim is to protect the public from harm or from the adverse implications of business activities within healthcare system . Among the statutes that are aimed to safeguard the patients’ safety are as follows:
In 1948, the World Health Organization (WHO) defined health with a phrase that is still used today
“Health is a state of complete physical mental and social
well-being and not merely the absence of disease
or infirmity.”
START WITH A THOUGHT
HEALTHCARE: ACCESSIBILITY, EQUALITY SAFETY AND QUALITY
Resources
Legal Requirement & Authorities
Non-stop operation
1
2
3
1.0 Introduction
What Are Needed Before Establishment?
Intention Land and Asset
Money and Investment
All relevant Professionals
and Healthcare
Professionals
Legal Requirements
and Authorities
Private Hospital
Water Services Industry
Act 2006
Electricity Supply
Act 1990
Information & Technology
Security
Fire Services Act 1988
Equipment and
Technology
Factories & Machinery Act 1967
HCP Acts & Employment
Act 2011
Environmental Quality
Act 1974
Others Relevant
Laws
Land-Local Authority
Allopathic Medicine Evidence Based Medicine
=
Handbook on Setting up of Private Hospital in Malaysia
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Although there are various statutes governing the establishment of a private healthcare facilities, the approvals to establish/maintain and licences to operate/provide are issued under the Private Healthcare Facilities and Services Act 1998 [Act 586] and its Regulations. This Act was gazetted in 1998 and enforced in 2006 whereby the Ministry of Health (MOH) is the guardian and implementor of this Act. This book will address the approval and licensing processes under MOH.
This Act’s main objectives are as below:
The basic principle of Act 586 is to ensure that the three essential components (healthcare facilities, services and personnels) in healthcare facilities and services commensurate with each other.
1.1 Private Healthcare Facilities and Services Act 1998
Subsidiary Legislations Under Private Healthcare Facilities & Services Act 1998 [Act 586]
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)
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)
Private Healthcare Facilities & Services (O�cial Identification Card) Order, 2006 [P.U. (A) 139/2006] (1 May 2006)
Private Healthcare Facilities & Services (Private Hospitals and other Private Healthcare Facilities) (Amendment) Order, 2013 [P.U. (A) 358/2013] (17 December 2013) & 2016 [P.U. (A) 260/2016] (15 Oktober 2016)
1.
2.
3.
4.
Private Healthcare Facilities & Services (Compoundable O�ences) Regulations, 2011 [P.U. (A) 170/2011] (1 August 2011) REPLACED BY Private Healthcare Facilities & Services (Compoundable O�ences) Regulations, 2017 [P.U. (A) 227/2017] (1 August 2017)
5.
Objectives of Act 586
Main Focus: To Safeguard Patients’ Interest & Ensure Patients Receive Safe Treatment
Impose and ensure minimum standards in the private healthcare facilities and services.
Ensure integrity among healthcare
Ensure quality of healthcare facilities and services e.g. Quality Assurance, Mortality Review etc.
Ensure professionalism among all healthcare professions.
Address social and national interest.
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The Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 [P.U. (A) 138/2006] provides for the licensing of private hospitals and other private healthcare facilities to ensure that the minimum acceptable standards are complied with the provisions of the legislation, together with the mandated accountability of private healthcare providers towards patient safety, the upholding of patient rights, and the assurance of quality care. The provisions under the Act 586 stipulated the mandatory approval and licensing of all private hospitals and other private healthcare facilities and services for the protection of patients and the accessibility of healthcare consumers in the country.
Other than MOH, the hospital need to have approval from various regulatory bodies governing other aspects in the running of a hospital, such as below:
Healthcare Facilities
(Including equipments)
Healthcare Services
Healthcare Personnel
– all healthcare & healthcare related
professional & technical etc.
COMMENSURATES
1.2 Other Laws Pertaining to Establishment and Operation of a Private Hospital
Approvals needed for the HEALTHCARE FACILITIES & SERVICES from di�erent agencies
ACT REGULATE Private Healthcare Facilities & Services Act 1998
(Act 586) – MOH Healthcare Facilities & Services & its related matters.
The Atomic Energy Licensing Ct 1984(Act 304) – MOH Radioactive material, nuclear material / prescribed
substance
Factories and Machinery Act, 1967 (64/1967) By Department of Occupational Safety and Health
Steam boiler, Unfired Pressure Vessel + machinery equipment e.g. Autoclave, lift
Uniform Building By-Laws 1984 By Local Authorities Land, Certificate of Completion and Compliance of buildings or equivalent & signboard approval
Fire Services Act 1988 (Act 241) By Fire Department Safety for fire exit
Environmental Quality Act 1974 (Act 127) By Department of Environment
Environment safety and clinical waste management
Workers’ Minimum Standards of Housing and Amenities Act 1990 (Act 446) – Human Resource Ministry Healthcare Facilities For estate workers
Medical Device Act 2012 (Act 737) – MDA Medical Device
Pathology Laboratory Act 2007 (Act 674) – MOH Pathology Laboratory (yet to be enforced)
Handbook on Setting up of Private Hospital in Malaysia
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Registration and standard of training of healthcare professionals are governed by professional bodies, made up of 10 Boards and Councils. Professionals employed need to be registered and have their Annual Practicing Certificates renewed, while the medical practices are regulated by other statutes containing provisions related to medical and healthcare.
It is important that person who is establishing or operating a private hospital understands the licensing procedure under Act 586 to ensure that the operation of the hospital is not jeopardized in any way. The licensing procedures related to private hospitals are as below :
BEFORE OPERATION 1. No objection on location (Pre-establishment Approval) –Section 9, Act 586 2. Approval to establish (Form 1) – Section 8 – 13, Act 586 3. Licence to operate (Form 3) = New Licence – Section 14-23, Act 586
Laws Governing Healthcare Professionals and Para Professionals
Allied Health Professional Act 2016 [Act 774]
Allied Health Professionals
Traditional & Complementary Medicine Act 2016 [Act 775] TCM Practitioner
Estate hospital Assistants (Registration) Act 1965
(Revised 1990) [Act 435]
Estate Hospital Assistant
Midwives Act 1966 (Revised 1990) [Act 436] Midwives
Nurses Act 1950 [Act 180] Nurses
Medical Assistants (Registration) Act 1977 [Act 180]
Medical Assistants
Act 586 Technical Sta�/ Personal Care Aides etc
Registration of Pharmacists Act 1951 [Act 50],
(Revised 1989)[Act 371] Pharmacists
Optical Act 1991 [Act 469] Optician & Optometrist
Medical Act 1971 [Act 50] Medical Doctors
DentistsDental Act 1971 [Act 51]
Drugs & Medicines Poisons Act 1952 (Revised 1989)[Act366]
Dangerous Drugs Act 1952 (Revised 1980)[Act 234]
Sale of Drugs Act (Revised 1989)[Act 368]
Therapeutic, Medical Education & Research Human Tissues Act 1974 [Act 136]
Health Promotion Programmes and Activities Malaysian Health Promotion Board
Act 2006 [Act 651]
Advertisements Medicines (Advertisement and Sale) Act 1956
(Revised 1983)[Act 290]
Infectious Diseases Control Destruction of Disease-Bearing Insects Act 1975
[Act 342]
Regulation and Control Practices Telemedicine
Telemedicine Act 1997 [Act 564]
Consent and Causing Miscarriage Penal Code [Act 574]
Health & Welfare of Children Child Act 2001 [Act 611]
Fumigation of Premises Hydrogen Cyanide (Fumigation)
Act 1953 (Revised 1981)[Act 260]
Psychiatric Services Mental Health Act 2001 [Act 615]
Food Safety Food Act 1983 [Act 281]
Example of Laws Related to Healthcare Practices
1.3 Approval and Licensing Procedures Under Act 586
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DURING OPERATION 1. Extension or alteration licensed Healthcare facility (Form 5) – Section 40, Act 586 2. Renewal of Licence (Form 3) – Section 22 (Section 16-19) (Lampiran A, B, C) 3. Amendment of an Approval and/or Licence (In writing) – Section 24, Act 586 4. Transfer of an Approval and/or Licence (Form 8) – Section 53, Act 586 5. Duplication of an Approval or Licence (In writing) – regulation 9 (section 107, Act 586)
TO END THE ESTABLISHMENT/OPERATION 1. Disposal of an Approval or licence (Form 9) – Section 53, Act 586
The regulatory framework under Act 586 stipulates the procedure for establishing a private hospital, starting with the intention to provide or providing private healthcare facilities or services up until the closure of the hospital, particularly for continuing services such as haemodialysis treatment, critical care services and others.
Form 1 Form 3
Form 5 Amendment @ Form 8
Form 9
Form 2 Form 4
Form 6 Form 10/7
Letter
APPLICANT MINISTRY OF HEALTH
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Handbook on Setting up of Private Hospital in Malaysia
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Approval (COA) and Licence for private hospital may only be issued to a : 1. Sole proprietor – RMP 2. Partnership – partner ≥ 1 RMP 3. Body corporate (Companies Act 2016) BOD ≥ 1 RMP
*RMP = “Registered medical practitioner” means any person who is registered as such under the Medical Act 1971 and who holds a valid practising certificate
1.4 Who Can Apply?
Handbook on Setting up of Private Hospital in Malaysia
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CHAPTER 2 APPLICATION FOR PRE-ESTABLISHMENT APPROVAL
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Pre-establishment approval application to Director General of Health, MOH is the first preliminary stage in the application to establish a private hospital, as stipulated under Section 9, Act 586.
2.0 Introduction
The application for pre-establishment approval is in writing and includes the following information :
2.1 How to Apply?
Application entity, as stated under Section 6, Act 586
Extensive renovation
Justification for the establishment of the private hospital in the area
Estimate of establishment costs
Exact location of the proposed hospital – full address of the proposed site and the map
Details of facilities – number of beds, number of operation rooms, equipment such as mammogram, MRI, CT Scan and other related equipment
Type of services that would be provided – whether multidisciplinary (surgery, obstetric) or niche
If there is any special equipment or services (such as haemodialysis or oncology), the name of the specialist (for example the nephrologist and clinical oncologist & nuclear medicine specialists) have to be stated
Other relevant matters for example to replace existing private hospitals or for the purpose of medical tourism, provided that the applicant can justify the reason
Proposed manpower (relevant healthcare professionals and para professionals) : number of specialists and sub-specialists, number of trained nurses, post basic trained nurses, allied health professionals etc, commensurating with the proposed healthcare facilities and service