PATHOLOGY LABORATORY ACT 2007

Pathology Laboratory LAWS OF MALAYSIA REPRINT Act 674 PATHOLOGY LABORATORY ACT 2007 As at 1 November 2017 PUBLISHED BY THE COMMISSIONER OF LAW REVISION, MALAYSIA UNDER THE AUTHORITY OF THE REVISION OF LAWS ACT 1968 2017 1 2 Act 674 Laws of Malaysia PATHOLOGY LABORATORY ACT 2007 Date of Royal Assent … … … … 29 August 2007 Date of publication in the Gazette … … 30 August 2007 Pathology Laboratory 3 LAWS OF MALAYSIA Act 674 PATHOLOGY LABORATORY ACT 2007 ARRANGEMENT OF SECTIONS Part I PRELIMINARY Section 1. 2. Short title and commencement Interpretation Part II CONTROL OF PATHOLOGY LABORATORY 3. 4. Approval and licence to establish or maintain, etc., pathology laboratory Approval or licence may be issued to a sole proprietor, partnership or body corporate Part III APPROVAL TO ESTABLISH OR MAINTAIN A PATHOLOGY LABORATORY 5. Application for approval 6. Matters to be considered before approval is granted 8. Grant of or refusal to grant approval 7. 9. 10. 11. Reasons for refusal to grant approval Duration of approval Separate approval for pathology laboratory Approval to specify class and speciality of pathology laboratory 4 Laws of Malaysia Act 674 Part IV LICENCE TO OPERATE OR PROVIDE A PATHOLOGY LABORATORY Section 12. Application for licence 14. Inspection of premises 13. 15. 16. 17. 18. 19. 20. 21. 22. 23. Application for licence to be made within three years Reasons for refusal to grant licence Grant of or refusal to grant licence Licence to specify class and speciality of pathology laboratory Separate licence for pathology laboratory Duration of licence Licence to be exhibited Renewal of licence Additional class and speciality Cessation of providing class and speciality Part V RESPONSIBILITIES OF A LICENSEE OR PERSON IN CHARGE 24. Responsibilities of licensee 26. Change of person in charge 25. 27. 28. 29. Person in charge Grievance mechanism Incident reporting Records to be kept and produced Part VI SUSPENSION AND REVOCATION OF APPROVAL OR LICENCE 30. Suspension or revocation of approval or licence 32. Power of Director General to suspend or revoke 31. 33. 34. Show cause notice Effect of suspension Effect of revocation Pathology Laboratory 5 Part VII CLOSURE OF PATHOLOGY LABORATORY Section 35. Order for closure of pathology laboratory 37. No costs, damages, etc., on order for closure 36. Closure of a licensed pathology laboratory Part VIII GENERAL PROVISIONS RELATING TO APPROVAL OR LICENCE 38. Power to vary terms or conditions of approval or licence 40. Restriction on use of premise 39. 41. 42. 43. Assessment of operation Prohibition on extension and alteration Transfer of approval or licence Register Part IX QUALITY OF PATHOLOGY LABORATORY 44. 45. Quality of pathology laboratory Power of Director General to give directives Part X PATHOLOGY LABORATORY ADVISORY COMMITTEE 46. Pathology Laboratory Advisory Committee Part XI MANAGED CARE ORGANIZATION 47. Interpretation 49. Obligation to furnish information on contract with managed care organization 48. Contract between licensed pathology laboratory and managed care organization 6 Laws of Malaysia Section 50. 51. Act 674 Information by managed care organization Register of managed care organization Part XII ENFORCEMENT 52. Appointment of authorized officer 54. Power to search and seize 53. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. 68. Power of authorized officer to enter and inspect Search and seizure without warrant Access to computerized data List of things seized Release of things seized Power to seal Power to require attendance of person acquainted with case Examination of person acquainted with case Admissibility of statements in evidence Duty to assist authorized officer Forfeiture of goods, etc., seized Cost of holding goods, etc., seized Production of official identification card or badge Compounding of offences Institution of prosecution Part XIII MISCELLANEOUS 69. Non-application of the Act 71. Offences committed by body corporate or partnership 70. 72. 73. 74. 75. Offences in relation to inspection Appeal Power to exempt Fee schedule Advertisement Pathology Laboratory Section 76. Delegation by Director General 78. Service of notice 77. 79. 80. 81. 82. 83. 84. 85. 86. 87. Furnishing of information Officers deemed to be public servants Protection of officers Disclosure of confidential information Social or welfare contribution General offence and penalty Contravention of subsidiary legislation Power to amend Schedule Power to make regulations Transitional First Schedule Second Schedule Third Schedule 7 8 Laws of Malaysia Act 674 Pathology Laboratory 9 LAWS OF MALAYSIA Act 674 *PATHOLOGY LABORATORY ACT 2007 An Act to provide for the regulation and control of pathology laboratories and for matters connected therewith. [ ] ENACTED by the Parliament of Malaysia as follows: Part I PRELIMINARY Short title and commencement 1. (1) This Act may be cited as the Pathology Laboratory Act 2007. (2) This Act comes into operation on a date to be appointed by the Minister by notification in the Gazette and the Minister may appoint different dates for the coming into operation of different provisions of this Act. Interpretation 2. In this Act, unless the context otherwise requires— “pathologist” means a registered medical practitioner who possesses the qualifications, training and experience in the discipline of pathology as approved by the Director General; *NOTE—This Act is not yet in force. 10 Laws of Malaysia Act 674 “prescribed” means prescribed by the Minister by order or regulations made under this Act; “Pathology Laboratory Advisory Committee” means a Pathology Laboratory Advisory Committee established under subsection 46(1); “medical laboratory technologist” means any person who holds a qualification in medical laboratory technology as approved by the Director General; “class and speciality” means the classification or categorization of the pathology laboratory into the different level of services according to the class or speciality of the pathology laboratory; “approval” means an approval to establish or maintain a pathology laboratory granted under paragraph 8(a); “Director General” means the Director General of Health, Malaysia; “private dental clinic” means a private dental clinic registered under the Private Healthcare Facilities and Services Act 1998 [Act 586]; “private medical clinic” means a private medical clinic registered under the Private Healthcare Facilities and Services Act 1998; “licence” means a licence to operate or provide a pathology laboratory granted under paragraph 16(a); “pathology laboratory” means any premises in which pathology services are provided; “licensed pathology laboratory” means a pathology laboratory in respect of which a licence is in force; “approved pathology laboratory” means a pathology laboratory in respect of which an approval is in force; “person in charge” means a person appointed under section 25; “scientific officer” means any person who holds a qualification in science and having the experience in pathology laboratory as approved by the Director General; Pathology Laboratory 11 “authorized officer” means any pathologist, scientific officer, medical laboratory technologist or any other person authorized by the Director General under section 52; “holder of an approval” means a person to whom an approval is granted under this Act; “licensee” means a person to whom a licence is granted under this Act; “registered dental practitioner” means any person who is registered as such under the Dental Act 1971 [Act 51] and who holds a valid practising certificate; “registered medical practitioner” means any person who is registered as such under the Medical Act 1971 [Act 50] and who holds a valid practising certificate; “pathology services” means any services in the analysis and examination of samples of human tissue or fluid or any other product of the human body or for assessing any change in the physiological state of human beings for the purposes of preventing, diagnosing or treating diseases in human beings; “body corporate” means a body incorporated under the *Companies Act 1965 [Act 125] or a statutory body under the relevant statute; “premises” means any place, building or vehicle, whether permanent or temporary; “healthcare professional” has the meaning assigned to it in the Private Healthcare Facilities and Services Act 1998; “record” includes slides, blocks, documents or data in respect of the operation of the pathology laboratory. *NOTE—Companies Act 1965 [Act 125] was repealed by Companies Act 2016 [Act 777]—w.e.f. 31 January 2017. 12 Laws of Malaysia Act 674 Part II CONTROL OF PATHOLOGY LABORATORY Approval and licence to establish or maintain, etc., pathology laboratory 3. (1) No person shall— (a) establish or maintain a pathology laboratory in any premises without an approval granted under paragraph 8(a); or (b) operate or provide a pathology laboratory without a licence granted under paragraph 16(a). (2) A person who contravenes subsection (1) commits an offence and shall, on conviction, be liable— (a) in the case of a sole proprietor— (i) to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding ten years, or to both; and (ii) for a continuing offence, to a fine not exceeding two thousand ringgit for every day or part of a day during which the offence continues after conviction; or (b) in the case of a body corporate or partnership— (i) to a fine not exceeding three hundred thousand ringgit; and (ii) for a continuing offence, to a fine not exceeding three thousand ringgit for every day or part of a day during which the offence continues after conviction. Pathology Laboratory 13 Approval or licence may be issued to a sole proprietor, partnership or body corporate 4. (1) An approval to establish or maintain or a licence to operate or provide a pathology laboratory may only be granted or issued to— (a) a sole proprietor who is a registered medical practitioner; (b) a partnership which consists of at least one partner who is a registered medical practitioner; or (c) a body corporate whose board of directors consists of at least one person who is a registered medical practitioner. Part III APPROVAL TO ESTABLISH OR MAINTAIN A PATHOLOGY LABORATORY Application for approval 5. (1) An application for an approval to establish or maintain a pathology laboratory shall be made to the Director General— (a) in the prescribed form and manner; (b) accompanied by the prescribed fees; and (c) by submitting together with the application— (i) a comprehensive plan for the establishment or maintenance of the proposed pathology laboratory including the site plan, building layout plan, design, construction material and any other prescribed requirement; (ii) the proposed class and speciality to be provided; (iii) the proposed arrangements for manpower recruitment including arrangements for manpower training; (iv) the proposed laboratory equipment for the class and speciality to be provided; 14 Laws of Malaysia Act 674 (v) if the applicant is a body corporate or partnership, a copy of its constituent document, duly verified by a statutory declaration made by an authorized officer of the applicant; and (vi) such other information, particulars or documents as may be specified by the Director General for the purpose of determining the application and the suitability of the applicant. (2) At any time after receiving the application, the Director General may by a written notice require the applicant to provide any additional information, particulars or documents. (3) Where any additional information, particulars or documents required under subsection (2) is not provided by the applicant within the period specified in the notice or any extension of time as may be granted by the Director General, the ap