Malaysia legislation

Section 77

of PATHOLOGY LABORATORY ACT 2007

Section 77

(a)

its staff;

(b)

any equipment, materials or any other things used or to be used;

(c)

the diagnosis of any person whose sample has been tested;

(d)

any analytical method or procedure used in carrying out any test;

(e)

its operation;

(f)

all matters relating to policy statement; or

(g)

the duties, functions and experience of locum tenens and honorary consultants, their experience and supervision and restrictions on their activities.

(2)

A holder of an approval or the licensee who refuses or fails to furnish information under subsection (1) or gives any false or misleading information, commits an offence and shall, on conviction, be liable—

(a)

in the case of sole proprietor, to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding one year, or to both; and

(b)

in the case of a body corporate or partnership to a fine not exceeding thirty thousand ringgit.

(3)

Nothing in this section shall authorize the Director General or any officer authorized by him to inspect the medical record of any person whose sample has been tested in a licensed pathology laboratory or to obtain any information in respect of any person on any matter specified under paragraph (1)(c) without the prior written consent of the person or his representative.

Pathology Laboratory 61

(4)

Notwithstanding subsection (3), the Director General or any officer authorized by him may inspect any record or material for the purposes of section 53, 54, 55 or 56 without the prior written consent of the person or his representative.

(5)

The inspection under subsection (4) shall be for the purpose of determining the compliance with the provisions of this Act and regulations made under this Act by the licensee, the holder of an approval or the person in charge of the licensed pathology laboratory, and the confidentiality of any information of any person obtained during such inspection shall be observed.

(6)

For the purposes of subsections (3) and (4), “representative”

of a person means—

(a)

if a person is a deceased, his executor, administrator or next of kin;

(b)

if the person is a minor, his mother, father or guardian;

or

(c)

if the person is not capable of giving consent, his next of kin.

Service of notice

Section 77 — AKTA MAKMAL PATOLOGI 2007 | mylaw.my