Quality of pathology laboratory
(1) A licensed pathology laboratory shall have programmes and activities as may be prescribed to ensure the quality of services provided by the licensed pathology laboratory.
(2) The licensee shall furnish any information in respect of the programmes and activities to the Director General as and when required by the Director General.
(3) 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 fifty thousand ringgit or to imprisonment for a term not exceeding three years, or to both; and
five hundred 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 one hundred thousand ringgit; and
one thousand ringgit for every day or part of a day during which the offence continues after conviction.
(4) A person who contravenes subsection (2) commits an offence and shall, on conviction, be liable—
(a) in the case of a sole proprietor—
(i) to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding one year, or to both; and five hundred 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 thirty thousand ringgit; and five hundred ringgit for every day or part of a day during which the offence continues after conviction.
Power of Director General to give directives
(1) Notwithstanding subsection 44(1), the Director General may issue directives, orders or guidelines relating to the quality and standards of a licensed pathology laboratory as he thinks necessary.
(2) Where the Director General is of the opinion that any prescribed requirement or standard which applies to a licensed pathology laboratory is not being observed by a licensee, the Director General may give to the licensee such directives in writing as he thinks necessary for the observance of the requirement or standard and shall state in the directives the period within which the licensee is required to comply with the directives.
(3) Where the Director General is of the opinion that the use of any equipment in a licensed pathology laboratory or the manner in which any product of the human body is used, collected, handled, stored or transported, or any other activity conducted is detrimental to the health and safety of any person therein or is otherwise unsuitable for the purpose for which it is intended,
the Director General may, by a written notice, direct the licensee to stop using the equipment or product of the human body or to stop the activity.
(4) The Director General may, by a written notice, further direct the licensee to install or replace such equipment or replace the activity therein, and to adhere to such procedures as may be specified in the notice.
(5) The licensee who fails to comply with the directives of the Director General under this section commits an offence.
