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 or authorised officer may, 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, |
exercise any of the following powers at any time: |
(i) | by order in writing require any person —(A) | to furnish any information within his knowledge; or | (B) | to produce any book, document, paper or other record, or any article or thing which may be in his custody or possession and which may be related to or be connected with the subject-matter of the investigation or assessment for inspection by the Director or authorised officer and for making copies thereof, or to provide copies of such book, document, paper or other record, |
and may, if necessary, further require such person to attend at a specified time and place for the purpose of complying with sub-paragraph (A) or (B); |
| (ii) | by order in writing require the attendance before him of any person who, from any information given or otherwise, appears to be acquainted with the facts and circumstances of the matter under investigation or assessment; | (iii) | examine orally any person apparently acquainted with the facts and circumstances of the matter under investigation or assessment, and to reduce into writing the answer given or statement made by that person who shall be bound to state truly the facts and circumstances with which he is acquainted, and the statement made by that person shall be read over to him and shall, after correction, be signed by him. [1/2010 wef 01/12/2010] |
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(4) Any person who —(a) | refuses or fails, without reasonable excuse, to furnish any information or thing to the Director or authorised officer 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 or to imprisonment for a term not exceeding 12 months or to both. |
[1/2010 wef 01/12/2010] |
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