Malaysia legislation

Section 34

of PATHOLOGY LABORATORY ACT 2007

Section 34

(a)

to the holder of an approval, he shall immediately cease to establish or maintain the pathology laboratory; or

(b)

to the licensee, he shall—

(i)

immediately cease to operate or provide partly or wholly the licensed pathology laboratory; and

(ii)

comply with recommendations on how to manage a patient’s sample or medical records including a patient’s laboratory result as may be specified in the revocation order.

(2)

An approved pathology laboratory or licensed pathology laboratory under subsection (1) shall be closed—

(a)

where there is no appeal against the revocation order, on the expiration of fourteen days from the date on which the revocation order is served on the holder of an approval or the licensee; or

Act 674

(b)

where there is an appeal against the revocation order, and—

(i)

the revocation order is confirmed by the Minister without any terms or conditions, from the date of the confirmation; or

(ii)

the appeal is confirmed by the Minister with terms and conditions, from the date the licensee fails to comply with the terms and conditions.

(3)

Where an approval or a licence has been revoked, the holder of the approval or the licensee shall surrender the approval or the licence to the Director General within fourteen days after the closure of the approved pathology laboratory or the licensed pathology laboratory.

(4)

A person who contravenes this section 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.

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