12.—(1) The Director or an authorised officer may, at any time and without warrant, enter, inspect and search any premises which is being used, or which he has reasonable cause to believe is being used, as a private hospital, medical clinic, clinical laboratory or healthcare establishment in order to —(a) | investigate whether this Act or any regulations made thereunder has been or is being contravened; or | (b) | assess the quality and appropriateness of the facilities and services provided and the practices and procedures being carried out at the private hospital, medical clinic, clinical laboratory or healthcare establishment. [19/99] |
(2) For the purposes of subsection (1), the Director or authorised officer may —(a) | inspect any apparatus, appliance, equipment or instrument used or found in the private hospital, medical clinic, clinical laboratory or healthcare establishment; | (b) | inspect, test, examine, take, remove and detain samples of blood, blood products, human tissue or fluid or any product of the human body, dialysate, chemicals, pharmaceuticals or any other substance found in the private hospital, medical clinic, clinical laboratory or healthcare establishment; | (c) | inspect, test, examine, take and remove all containers, articles and other things that the Director or authorised officer reasonably believes to contain or to have contained blood, blood products, human tissue or fluid or any product of the human body, dialysate, chemicals, pharmaceuticals or any other substance; | (d) | inspect any test or procedure performed or carried out at the private hospital, medical clinic, clinical laboratory or healthcare establishment in order to ensure compliance with the provisions of this Act and any regulations made thereunder; | (e) | inspect and make copies of and take extracts from, or require the licensee or person having the management or control of the private hospital, medical clinic, clinical laboratory or healthcare establishment to provide copies of or extracts from, any book, document, record or electronic material relating to the affairs of the private hospital, medical clinic, clinical laboratory or healthcare establishment or the facilities or services provided or the practices or procedures being carried out thereat; | (f) | inspect and make copies of and take extracts from, or require the licensee or person having the management or control of the private hospital, medical clinic, clinical laboratory or healthcare establishment to provide copies of or extracts from, the medical record of any person who has been or who is being treated or examined at the private hospital, medical clinic, clinical laboratory or healthcare establishment, notwithstanding that the prior consent of such person has not been obtained; and | (g) | seize and remove from the private hospital, medical clinic, clinical laboratory or healthcare establishment any book, record, document, apparatus, equipment, instrument, material, article, sample, blood, blood product, human tissue or fluid or any product of the human body, dialysate, chemical, pharmaceutical or other substance which the Director or authorised officer reasonably believes to be the subject-matter of, or to be connected with the commission of, an offence under this Act or any regulations made thereunder. [19/99] |
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(3) The Director in order to —(a) | ascertain whether the provisions of this Act or any regulations made thereunder are being complied with; or | (b) | assess the quality and appropriateness of the facilities and services provided and the practices and procedures being carried out at the private hospital, medical clinic, clinical laboratory or healthcare establishment, |
may, at any time, require the licensee or person having the management or control of a private hospital, medical clinic, clinical laboratory or healthcare establishment to furnish such information as the Director may require relating to — |
(i) | the persons employed thereat; | (ii) | any apparatus, appliance, equipment or instrument used or any practice or procedure being carried out at the private hospital, medical clinic, clinical laboratory or healthcare establishment; or | (iii) | the condition, treatment or diagnosis of any person who has been or who is being treated or examined at the private hospital, medical clinic, clinical laboratory or healthcare establishment, notwithstanding that the prior consent of such person has not been obtained. [19/99] |
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(4) Any licensee or person having the management or control of the private hospital, medical clinic, clinical laboratory or healthcare establishment who —(a) | refuses or fails, without reasonable excuse, to furnish any information to the Director in contravention of subsection (3); or | (b) | gives any false or misleading information, |
shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000. |
[11 [19/99] |
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