PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998

LAWS OF MALAYSIA _____________ ONLINE VERSION OF UPDATED TEXT OF REPRINT _____________ Act 586 PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998 As at 1 December 2015 2 PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998 Date of Royal Assent … … … 18 August 1998 Date of publication in the Gazette … … … 27 August 1998 PREVIOUS REPRINT First Reprint … … … … … 2002 Second Reprint … … … … … 2006 3 LAWS OF MALAYSIA Act 586 PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998 ARRANGEMENT OF SECTIONS PART I PRELIMINARY Section 1. Short title 2. Interpretation PART II CONTROL OF PRIVATE HEALTHCARE FACILITIES AND SERVICES 3. Approval and licence 4. Registration 5. Unlicensed and unregistered private healthcare facility or service 6. Approval and licence may be issued to a sole proprietor, partnership or body corporate 7. Certificate of registration to operate private medical and private dental clinic PART III APPROVAL TO ESTABLISH OR MAINTAIN PRIVATE HEALTHCARE FACILITIES OR SERVICES OTHER THAN A PRIVATE MEDICAL CLINIC OR A PRIVATE DENTAL CLINIC 8. Application for approval to establish or maintain 9. Matters to be considered before approval to establish or maintain is granted 4 Laws of Malaysia ACT 586 Section 10. Refusal to process application for approval to establish or maintain 11. Reasons for refusal to grant approval to establish or maintain 12. Grant of or refusal to grant approval to establish or maintain 13. Separate approval to establish or maintain private healthcare facilities or services which are not physically, administratively or organizationally linked PART IV LICENCE TO OPERATE OR PROVIDE PRIVATE HEALTHCARE FACILITY OR SERVICE OTHER THAN PRIVATE MEDICAL CLINIC OR PRIVATE DENTAL CLINIC 14. Application for a licence to operate or provide to be made within three years 15. Application for licence to operate or provide 16. Inspection of premises 17. Refusal to process application for licence 18. Reasons for refusal to issue or renew a licence to operate or provide 19. Grant of or refusal to grant licence 20. Licence to specify type of private healthcare facility or service 21. Separate licence for private healthcare facilities or services which are not physically, administratively or organizationally linked 22. Duration and renewal of licence to operate or provide 23. Licence to be exhibited 24. Power to vary terms or conditions, or purpose of approval or licence PART V REGISTRATION OF A PRIVATE MEDICAL CLINIC AND A PRIVATE DENTAL CLINIC 25. Application for registration 26. Refusal to process application for registration 27. Grant of certificate of registration 28. Certificate of registration to be exhibited 29. Power to vary terms or conditions of registration 30. Separate registration Private Healthcare Facilities and Services 5 PART VI RESPONSIBILITIES OF A LICENSEE, HOLDER OF CERTIFICATE OF REGISTRATION AND PERSON IN CHARGE Section 31. Responsibilities 32. Person in charge 33. Change of person in charge 34. Personal care aide 35. Policy statement 36. Patient grievance mechanism 37. Incident reporting 38. Emergency treatment and services PART VII GENERAL PROVISIONS RELATING TO APPROVAL, LICENCE AND REGISTRATION 39. Restriction on use of premises 40. Prohibition on extension and alteration 41. Transfer, etc., of approval, licence and certificate 42. Registers PART VIII SUSPENSION AND REVOCATION OF APPROVAL AND LICENCE, REFUSAL TO RENEW THE LICENCE, AND SUSPENSION, AND REVOCATION OF REGISTRATION 43. Show cause 44. Grounds for suspension, etc., relating to administration of private healthcare facility or service 45. Grounds for suspension, revocation, refusal to renew licence, etc., relating to qualification of sole proprietor 46. Grounds for suspension, revocation, or refusal to renew approval, licence or certificate of registration 6 Laws of Malaysia ACT 586 Section 47. Additional grounds 48. Representations 49. Power of Director General to suspend, revoke, or refuse renewal 50. Surrender of licence or certificate 51. Cessation of operation PART IX CLOSURE OF PRIVATE HEALTHCARE FACILITIES OR SERVICES 52. Order for temporary closure of private healthcare facilities of services 53. Conditions for closure, selling or otherwise disposing of private healthcare facility or service PART X BLOOD BANK 54. Interpretation 55. Prohibition on supply of natural human blood and blood product 56. Import and export of natural human blood and blood product 57. Issue of certificate to import and export natural human blood and blood product 58. Consent to test blood from donors PART XI BLOOD TRANSFUSION SERVICES 59. Storage facilities 60. Minimum blood supply 61. Maintain records of receipt and disposition of blood 62. Transfusion reactions 63. Recommendations to the Medical Advisory Committee Private Healthcare Facilities and Services 7 PART XII MORTALITY ASSESSMENT Section 64. Interpretation 65. Establishment of National Mortality Assessment Committee 66. Functions of National Mortality Assessment Committee 67. Reporting of assessable deaths 68. Medical and dental practitioners to provide information 69. Publication of information 70. Secrecy of information obtained by Committee 71. Protection of persons carrying out functions as members of Committee 72. Mortality assessment committee at private healthcare facility or service level 73. Independent investigation PART XIII QUALITY OF HEALTHCARE FACILITIES AND SERVICES 74. Quality of health care and services 75. Power of Director General to give directions 76. Power of Director General to issue directives, orders or guidelines relating to quality assurance PART XIV BOARD OF MANAGEMENT AND ADVISORY COMMITTEE 77. Board of Management 78. Medical or Dental Advisory Committee 79. Midwifery Care Advisory Committee 80. Nursing Advisory Committee 81. Penalty for non-compliance with any of the provision of this Part 8 Laws of Malaysia ACT 586 PART XV MANAGED CARE ORGANIZATION Section 82. Interpretation of managed care organization 83. Contracts between private healthcare facility or service and managed care organization 84. Licensee and holder of certificate of registration to furnish information on managed care organization to Director General 85. Information by managed care organization 86. Register of managed care organizations PART XVI ENFORCEMENT 87. Appointment of Inspectors 88. Power of Inspector to enter and inspect 89. Power to search and seize 90. Search and seizure without warrant 91. Power to seal 92. Power to require information and examine persons 93. Duty to assist Inspector 94. Offences in relation to inspection 95. List of things seized 96. Forfeiture of things seized 97. No person entitled to costs, etc., on seizure 98. Production of official identification card or badge 99. Compounding of offences 100. Institutions and conduct of prosecution PART XVII POWER OF MINISTER 101. Appeal Private Healthcare Facilities and Services 9 Section 102. Power of Minister to issue general directions 103. Power of Minister to exempt 104. Board of Visitors 105. Social or welfare contribution 106. Fee schedule 107. Power to make regulations PART XVIII MISCELLANEOUS 108. Advertisement 109. National Register 110. Service of notice 111. Delegation by Director General 112. Furnishing of information 113. Officers deemed to be public servants 114. Protection against suit and legal proceedings 115. Confidentiality of information 116. Private psychiatric hospital, psychiatric nursing home and community mental health centre 117. General offence and penalty 118. Contravention of subsidiary legislation PART XIX SAVING AND TRANSITIONAL PROVISIONS 119. Repeal 120. Saving and transitional provisions relating to existing licensed private hospital, maternity homes and nursing homes 121. Power of Minister to make additional transitional provisions 122. Saving and transitional provisions relating to existing private medical clinics and private dental clinics 11 LAWS OF MALAYSIA Act 586 PRIVATE HEALTHCARE FACILITIES AND SERVICES ACT 1998 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. [1 May 2006, P.U. (B) 93/2006] BE IT ENACTED by the Seri Paduka Baginda Yang di-Pertuan Agong with the advice and consent of the Dewan Negara and Dewan Rakyat in Parliament assembled, and by the authority of the same, as follows: PART I PRELIMINARY Short title 1. This Act may be cited as the Private Healthcare Facilities and Services Act 1998. Interpretation 2. In this Act, unless the context otherwise requires— “approval to establish or maintain” means approval to establish or maintain a private healthcare facility or service other than a private medical clinic or a private dental clinic granted under paragraph 12(a); 12 Laws of Malaysia ACT 586 “Board of Management” means a board of trustees or directors, or any other governing body in whom the ultimate authority and responsibility for the conduct of the private healthcare facilities or services specified in Part XIV are vested; “Board of Visitors” means the Board of Visitors established under section 104; “body corporate” means a body incorporated under the Companies Act 1965 [Act 125]; “certificate” means a certificate issued under section 57 authorizing the importation or exportation of blood products or natural human blood for transfusion purposes; “certificate of registration” means a certificate issued under section 27; “Director General” means the Director General of Health, Malaysia; “Government healthcare facility” means any facility used or intended to be used for the provision of healthcare services established, maintained, operated or provided by the Government but excludes privatized or corporatized Government healthcare facilities; “Government healthcare services” means any healthcare services provided, operated or maintained by the Government but excludes privatized or corporatized Government healthcare services; “healthcare facility” means any premises in which one or more members of the public receive healthcare services; “healthcare professional” includes a medical practitioner, dental practitioner, pharmacist, clinical psychologist, nurse, midwife, medical assistant, physiotherapist, occupational therapist and other allied healthcare professional and any other person involved in the giving of medical, health, dental, pharmaceutical or any other healthcare services under the jurisdiction of the Ministry of Health; Private Healthcare Facilities and Services 13 “healthcare services” includes— (a) medical, dental, nursing, midwifery, allied health, pharmacy, and ambulance services and any other service provided by a healthcare professional; (b) accommodation for the purpose of any service provided under this Act; (c) any service for the screening, diagnosis, or treatment of persons suffering from, or believed to be suffering from, any disease, injury or disability of mind or body; (d) any service for preventive or promotive health purposes; (e) any service provided by any healthcare para-professional; (f) any service for curing or alleviating any abnormal condition of the human body by the application of any apparatus, equipment, instrument or device or any other medical technology; or (g) any health-related services; “licence to operate or provide” means a licence to operate or provide a private healthcare facility or service other than a private medical clinic or private dental clinic granted under paragraph 19(a); “licensee” means a person to whom a licence to operate or provide a private healthcare facility or service other than a private medical clinic or private dental clin