Pathology Laboratory 1

LAWS OF MALAYSIA
REPRINT

Act 674

PATHOLOGY LABORATORY
ACT 2007
As at 1 November 2017

PUBLISHED BY
THE COMMISSIONER OF LAW REVISION, MALAYSIA
UNDER THE AUTHORITY OF THE REVISION OF LAWS ACT 1968
2017
2 Laws of Malaysia Act 674

PATHOLOGY LABORATORY ACT 2007

Date of Royal Assent … … … … 29 August 2007

Date of publication in the Gazette … … 30 August 2007

 Pathology Laboratory 3

LAWS OF MALAYSIA

Act 674

PATHOLOGY LABORATORY ACT 2007

ARRANGEMENT OF SECTIONS

Part I

PRELIMINARY

Section

1. Short title and commencement

2. Interpretation

Part II

CONTROL OF PATHOLOGY LABORATORY

3. Approval and licence to establish or maintain, etc., pathology laboratory

4. Approval or licence may be issued to a sole proprietor, partnership
or body corporate

Part III

APPROVAL TO ESTABLISH OR MAINTAIN A PATHOLOGY

LABORATORY

5. Application for approval

6. Matters to be considered before approval is granted
7. Reasons for refusal to grant approval
8. Grant of or refusal to grant approval
9. Duration of approval
10. Separate approval for pathology laboratory
11. Approval to specify class and speciality of pathology laboratory
4 Laws of Malaysia Act 674
Part IV

LICENCE TO OPERATE OR PROVIDE A PATHOLOGY

LABORATORY

Section

12. Application for licence

13. Application for licence to be made within three years
14. Inspection of premises
15. Reasons for refusal to grant licence
16. Grant of or refusal to grant licence
17. Licence to specify class and speciality of pathology laboratory
18. Separate licence for pathology laboratory
19. Duration of licence
20. Licence to be exhibited
21. Renewal of licence
22. Additional class and speciality
23. Cessation of providing class and speciality

Part V

RESPONSIBILITIES OF A LICENSEE OR PERSON IN CHARGE

24. Responsibilities of licensee

25. Person in charge
26. Change of person in charge
27. Grievance mechanism
28. Incident reporting
29. Records to be kept and produced

Part VI

SUSPENSION AND REVOCATION OF APPROVAL OR LICENCE

30. Suspension or revocation of approval or licence

31. Show cause notice
32. Power of Director General to suspend or revoke
33. Effect of suspension
34. Effect of revocation
 Pathology Laboratory 5
Part VII

CLOSURE OF PATHOLOGY LABORATORY

Section

35. Order for closure of pathology laboratory

36. Closure of a licensed pathology laboratory
37. No costs, damages, etc., on order for closure

Part VIII

GENERAL PROVISIONS RELATING TO APPROVAL OR LICENCE

38. Power to vary terms or conditions of approval or licence

39. Assessment of operation
40. Restriction on use of premise
41. Prohibition on extension and alteration
42. Transfer of approval or licence
43. Register

Part IX

QUALITY OF PATHOLOGY LABORATORY

44. Quality of pathology laboratory

45. Power of Director General to give directives

Part X

PATHOLOGY LABORATORY ADVISORY COMMITTEE

46. Pathology Laboratory Advisory Committee

Part XI

MANAGED CARE ORGANIZATION

47. Interpretation
48. Contract between licensed pathology laboratory and managed care
organization
49. Obligation to furnish information on contract with managed care
organization
6 Laws of Malaysia Act 674
Section

50. Information by managed care organization

51. Register of managed care organization

Part XII

ENFORCEMENT

52. Appointment of authorized officer

53. Power of authorized officer to enter and inspect
54. Power to search and seize
55. Search and seizure without warrant
56. Access to computerized data
57. List of things seized
58. Release of things seized
59. Power to seal
60. Power to require attendance of person acquainted with case
61. Examination of person acquainted with case
62. Admissibility of statements in evidence
63. Duty to assist authorized officer
64. Forfeiture of goods, etc., seized
65. Cost of holding goods, etc., seized
66. Production of official identification card or badge
67. Compounding of offences
68. Institution of prosecution

Part XIII

MISCELLANEOUS

69. Non-application of the Act

70. Offences in relation to inspection
71. Offences committed by body corporate or partnership
72. Appeal
73. Power to exempt
74. Fee schedule
75. Advertisement
 Pathology Laboratory 7
Section

76. Delegation by Director General

77. Furnishing of information
78. Service of notice
79. Officers deemed to be public servants
80. Protection of officers
81. Disclosure of confidential information
82. Social or welfare contribution
83. General offence and penalty
84. Contravention of subsidiary legislation
85. Power to amend Schedule
86. Power to make regulations
87. Transitional
First Schedule
Second Schedule
Third Schedule
8 Laws of Malaysia Act 674
 Pathology Laboratory 9

LAWS OF MALAYSIA

Act 674

*PATHOLOGY LABORATORY ACT 2007

An Act to provide for the regulation and control of pathology

laboratories and for matters connected therewith.

[ ]

ENACTED by the Parliament of Malaysia as follows:

Part I

PRELIMINARY

Short title and commencement

1. (1) This Act may be cited as the Pathology Laboratory Act 2007.

(2) This Act comes into operation on a date to be appointed by

the Minister by notification in the Gazette and the Minister may
appoint different dates for the coming into operation of different
provisions of this Act.

Interpretation

2. In this Act, unless the context otherwise requires—

“pathologist” means a registered medical practitioner who

possesses the qualifications, training and experience in the
discipline of pathology as approved by the Director General;

*NOTE—This Act is not yet in force.

10 Laws of Malaysia Act 674

“prescribed” means prescribed by the Minister by order or

regulations made under this Act;

“Pathology Laboratory Advisory Committee” means a

Pathology Laboratory Advisory Committee established under
subsection 46(1);

“medical laboratory technologist” means any person who holds

a qualification in medical laboratory technology as approved by
the Director General;

“class and speciality” means the classification or categorization

of the pathology laboratory into the different level of services
according to the class or speciality of the pathology laboratory;

“approval” means an approval to establish or maintain a

pathology laboratory granted under paragraph 8(a);

“Director General” means the Director General of Health,

Malaysia;

“private dental clinic” means a private dental clinic registered

under the Private Healthcare Facilities and Services Act 1998
[Act 586];

“private medical clinic” means a private medical clinic registered

under the Private Healthcare Facilities and Services Act 1998;

“licence” means a licence to operate or provide a pathology

laboratory granted under paragraph 16(a);

“pathology laboratory” means any premises in which pathology

services are provided;

“licensed pathology laboratory” means a pathology laboratory

in respect of which a licence is in force;

“approved pathology laboratory” means a pathology laboratory

in respect of which an approval is in force;

“person in charge” means a person appointed under section 25;

“scientific officer” means any person who holds a qualification

in science and having the experience in pathology laboratory as
approved by the Director General;
 Pathology Laboratory 11

“authorized officer” means any pathologist, scientific officer,

medical laboratory technologist or any other person authorized
by the Director General under section 52;

“holder of an approval” means a person to whom an approval

is granted under this Act;

“licensee” means a person to whom a licence is granted under

this Act;

“registered dental practitioner” means any person who is

registered as such under the Dental Act 1971 [Act 51] and who
holds a valid practising certificate;

“registered medical practitioner” means any person who is

registered as such under the Medical Act 1971 [Act 50] and who
holds a valid practising certificate;

“pathology services” means any services in the analysis and

examination of samples of human tissue or fluid or any other
product of the human body or for assessing any change in the
physiological state of human beings for the purposes of preventing,
diagnosing or treating diseases in human beings;

“body corporate” means a body incorporated under the *Companies

Act 1965 [Act 125] or a statutory body under the relevant statute;

“premises” means any place, building or vehicle, whether

permanent or temporary;

“healthcare professional” has the meaning assigned to it in the

Private Healthcare Facilities and Services Act 1998;

“record” includes slides, blocks, documents or data in respect

of the operation of the pathology laboratory.

*NOTE—Companies Act 1965 [Act 125] was repealed by Companies Act 2016 [Act 777]—w.e.f.
31 January 2017.
12 Laws of Malaysia Act 674

Part II

CONTROL OF PATHOLOGY LABORATORY

Approval and licence to establish or maintain, etc., pathology

laboratory

3. (1) No person shall—

establish or maintain a pathology laboratory in any premises

(a)
without an approval granted under paragraph 8(a); or

operate or provide a pathology laboratory without a licence

(b)
granted under paragraph 16(a).

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(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

in the case of a body corporate or partnership—

(b)

(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.
 Pathology Laboratory 13

Approval or licence may be issued to a sole proprietor,

partnership or body corporate

4. (1) An approval to establish or maintain or a licence to operate

or provide a pathology laboratory may only be granted or issued
to—

a sole proprietor who is a registered medical practitioner;

(a)

a partnership which consists of at least one partner who

(b)
is a registered medical practitioner; or

a body corporate whose board of directors consists of at

(c)
least one person who is a registered medical practitioner.

Part III

APPROVAL TO ESTABLISH OR MAINTAIN A

PATHOLOGY LABORATORY

Application for approval

5. (1) An application for an approval to establish or maintain a

pathology laboratory shall be made to the Director General—

in the prescribed form and manner;

(a)

accompanied by the prescribed fees; and

(b)

by submitting together with the application—

(c)

(i) a comprehensive plan for the establishment or

maintenance of the proposed pathology laboratory
including the site plan, building layout plan,
design, construction material and any other
prescribed requirement;

(ii) the proposed class and speciality to be provided;

(iii) the proposed arrangements for manpower recruitment

including arrangements for manpower training;

(iv) the proposed laboratory equipment for the class

and speciality to be provided;
14 Laws of Malaysia Act 674

(v) if the applicant is a body corporate or partnership,

a copy of its constituent document, duly verified
by a statutory declaration made by an authorized
officer of the applicant; and

(vi) such other information, particulars or documents

as may be specified by the Director General for
the purpose of determining the application and
the suitability of the applicant.

(2) At any time after receiving the application, the Director

General may by a written notice require the applicant to provide
any additional information, particulars or documents.

(3) Where any additional information, particulars or documents

required under subsection (2) is not provided by the applicant
within the period specified in the notice or any extension of time
as may be granted by the Director General, the application shall
be deemed to be withdrawn and shall not be further proceeded
with, without prejudice to a fresh application being made by the
applicant.

(4) An application for an approval may be withdrawn by a

written notice to the Director General at any time before the
application is granted or refused.

Matters to be considered before approval is granted

6. In deciding whether or not to grant an approval to establish

or maintain a pathology laboratory, the Director General shall
consider the following matters:

the class and speciality to be provided;

(a)

the extent to which the pathology laboratory is already

(b)
available in an area;

the need for the pathology laboratory in an area;

(c)

the future need for the pathology laboratory in an

(d)
area; or

any other matter which in his opinion is relevant.

(e)
 Pathology Laboratory 15

Reasons for refusal to grant approval

7. An application for an approval to establish or maintain a

pathology laboratory shall not be granted by the Director General
unless he is satisfied that—

the applicant is capable of providing the pathology

(a)
laboratory services;

the applicant is capable of providing adequate and efficient

(b)
management and administration for the proper conduct
of the pathology laboratory;

where the applicant is a sole proprietor, he has not been

(c)
convicted of an offence involving fraud or dishonesty
or is not an undischarged bankrupt;

where the applicant is a partnership, no partner has been

(d)
convicted of an offence involving fraud or dishonesty
or is an undischarged bankrupt; or

where the applicant is a body corporate, no member of

(e)
the board of directors or person responsible for the body
corporate has been convicted of an offence involving
fraud or dishonesty or is an undischarged bankrupt.

Grant of or refusal to grant approval

8. Upon receiving and having considered the application for

an approval to establish or maintain a pathology laboratory, the
Director General may—

grant the approval with or without any terms or conditions

(a)
and upon payment of the prescribed fees; or

refuse the application with or without assigning any reason

(b)
for such refusal.

Duration of approval

9. (1) An approval shall, unless sooner suspended or revoked,

be valid for a period not exceeding three years from the date the
approval is granted.
16 Laws of Malaysia Act 674

(2) Subject to subsection (1), where a holder of an approval

faces any technical difficulties in establishing or maintaining a
pathology laboratory, he may apply in writing to the Director
General for an extension of time accompanied with any proof
of the difficulties and the prescribed fees.

(3) The Director General may grant an extension of time applied

under subsection (2) with or without any terms or conditions if
he is satisfied with the proof submitted under subsection (1).

Separate approval for pathology laboratory

10. A separate approval shall be applied for each pathology

laboratory irrespective of whether the pathology laboratory is
physically, administratively or organizationally linked with another
pathology laboratory.

Approval to specify class and speciality of pathology laboratory

11. An approval to establish or maintain a pathology laboratory

shall specify the class and speciality of the pathology service
for which it is granted and the purpose for which the pathology
laboratory may be established or maintained.

Part IV

LICENCE TO OPERATE OR PROVIDE A PATHOLOGY

LABORATORY

Application for licence

12. (1) An application for a licence to operate or provide a

pathology laboratory shall be made to the Director General after
an approval has been granted to establish or maintain a pathology
laboratory—

in the prescribed form and manner;

(a)

accompanied by the prescribed fee; and

(b)
 Pathology Laboratory 17

by submitting together with the application—

(c)

(i) the approval letter; and

(ii) any information, particulars and documents as

may be specified by the Director General.

(2) At any time after receiving the application, the Director

General may by a written notice require the applicant to provide
additional information, particulars or documents.

(3) Where any additional information, particulars or documents

required under subsection (2) is not provided by the applicant within
the period specified in the notice or any extension of the time as
may be granted by the Director General, the application shall be
deemed to be withdrawn and shall not be further proceeded with,
without prejudice to a fresh application being made by the applicant.

(4) An application for a licence may be withdrawn by a written

notice to the Director General at any time before the application
is granted or refused.

Application for licence to be made within three years

13. (1) An application for a licence under section 12 shall be

made within three years from the date of the granting of the
approval in respect of the pathology laboratory.

(2) If no application for a licence is made within the time

specified in subsection (1), the approval shall be deemed to
have been revoked unless an extension of time is granted by the
Director General under subsection 9(3).

Inspection of premises

14. (1) Upon receipt of an application for a licence under

section 12, at least two authorized officers shall inspect—

the premises of the pathology laboratory to ascertain

(a)
that it complies with the site plan, building layout plan,
design, construction material and any other prescribed
requirements;
18 Laws of Malaysia Act 674

any equipment, material or any other thing found in the

(b)
pathology laboratory to ascertain that it complies with
the requirement or standard as may be prescribed; and

any record, policy, standard operating procedure, clinical

(c)
practice guideline, document pertaining to quality
management system, manpower requirement, organizational
structure or any other matters connected therewith.

(2) Where the authorized officers find that the pathology

laboratory does not comply with any of the matter specified under
subsection (1), they shall give a written notice to the applicant
of the non-compliance and any rectification which shall be made
within a specified time and re-inspect the pathology laboratory
after the expiry of that period.

(3) The authorized officers shall submit a report of the inspection

to the Director General as soon as practicable.

Reasons for refusal to grant licence

15. The Director General may refuse to grant a licence unless—

he is satisfied that—
(a)

(i) where the applicant is a natural person, as to the

character and fitness of the applicant;

(ii) where the applicant is a body corporate, as to

the character and fitness of any member of the
board of directors; or

(iii) where the applicant is a partnership, as to the

character and fitness of any partner,

and the premises complies with the requirement of subsection 14(1);

and

in his opinion—
(b)

(i) the premises in respect of which the application

is made is safe, clean, sanitary and adequately
equipped;
 Pathology Laboratory 19

(ii) the staff is adequate or competent for the purpose

of the pathology laboratory; and

(iii) the proposed arrangement for the management of

the pathology laboratory is adequate or suitable.

Grant of or refusal to grant licence

16. After having considered an application under subsection 12(1)

and the report submitted under subsection 14(3) and after giving
it due consideration, the Director General may—

grant a licence to operate or provide a pathology laboratory

(a)
with or without any terms or conditions and upon payment
of the prescribed fee; or

refuse the application with or without assigning any reason

(b)
for such refusal.

Licence to specify class and speciality of pathology laboratory

17. (1) A licence shall specify the class and speciality of pathology
laboratory for which it is granted and the purpose for which the
licence may be maintained.

(2) A licensee who operates or provides any class and speciality

which is not specified in the licence commits an offence and
shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or
20 Laws of Malaysia Act 674

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.

Separate licence for pathology laboratory

18. A separate licence shall be applied for each pathology

laboratory irrespective of whether the pathology laboratory is
physically, administratively or organizationally linked with another
pathology laboratory.

Duration of licence

19. A licence shall, unless sooner suspended or revoked, be valid

for a period not exceeding three years.

Licence to be exhibited

20. (1) The licence shall be exhibited in a conspicuous part of

the premises of the pathology laboratory.

(2) A licensee who contravenes subsection (1) commits an

offence.

Renewal of licence

21. (1) A licensee may make an application for the renewal of

a licence not later than one hundred and eighty days before the
date of expiry of the licence—

in the prescribed form and manner;

(a)

accompanied by the prescribed fees; and

(b)
 Pathology Laboratory 21

by submitting together with the application any information,

(c)
particulars or documents as may be specified by the
Director General.

(2) Upon receipt of the application under subsection (1), the

authorized officer may inspect the licensed pathology laboratory.

(3) When renewing a licence, the Director General may vary

the terms and conditions of the licence, or impose additional
terms and conditions.

(4) The Director General may refuse to renew a licence if the

licensee—

has failed to comply with any of the provisions of this

(a)
Act; or

has failed to comply with any terms or conditions of the

(b)
licence.

Additional class and speciality

22. (1) Where a licensee intends to provide additional class and

speciality other than the class and speciality specified in the
existing licence, he shall make an application for an approval
to provide additional class and speciality, and if the approval is
granted, he shall make an application for a licence.

(2) Where the Director General approved the application for

a licence to provide the additional class and speciality, he shall
notify the licensee of his decision and request the licensee to
submit the existing licence.

(3) Upon receipt of the existing licence, the Director General

shall grant a new licence to the licensee which shall specify the
additional class and speciality approved in addition to the class
and speciality specified in the existing licence.

(4) The licence granted under subsection (3) shall, unless sooner
suspended or revoked, be valid for a period not exceeding the
existing licence.
22 Laws of Malaysia Act 674

(5) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding one
year, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.

Cessation of providing class and speciality

23. (1) Where a licensee intends to cease providing any class

and speciality, he shall—

inform the Director General by a written notice of his

(a)
intention and the date he decides to cease providing the
class and speciality; and

submit the existing licence to the Director General.

(b)

(2) The notice of cessation shall be accompanied by the

prescribed fees.

(3) Upon receiving the notice of cessation and the licence

under subsection (1), the Director General may—

issue a direction with regard to the care of patients’ samples

(a)
and medical records including patients’ laboratory results
in the licensed pathology laboratory; and
 Pathology Laboratory 23

vary the licence by deleting the class and speciality

(b)
the provision of which is ceased, with or without any
additional terms or conditions.

(4) A person who contravenes subsection (1) commits an

offence.

Part V

RESPONSIBILITIES OF A LICENSEE OR PERSON

IN CHARGE

Responsibilities of licensee

24. (1) A licensee shall—

appoint a person in charge who shall be responsible in

(a)
the management and control of the licensed pathology
laboratory and the supervision of the staff employed or
engaged in different class and speciality of the laboratory;

inspect the licensed pathology laboratory in such manner

(b)
and at such frequency as may be prescribed;

ensure that any healthcare professional employed or

(c)
engaged in the pathology laboratory is registered under
any law regulating their registration;

ensure that any healthcare professional other than the

(d)
healthcare professional under paragraph (c) shall possess
the qualification and experience as approved by the
Director General;

ensure that samples received and results issued shall

(e)
be made through a registered medical practitioner or
registered dental practitioner accordingly;

ensure that medical and dental management of the patients

(f)
vests in a registered medical practitioner and a registered
dental practitioner respectively;

maintain a policy to comply with any code of professional

(g)
conduct issued by the relevant body governing the
healthcare professional under paragraph (c);
24 Laws of Malaysia Act 674

establish and maintain the methods to be followed and

(h)
the minimum standards to be observed in the use,
maintenance, storage or disposal of equipment, dangerous
substances or other hazardous materials in the licensed
pathology laboratory;

establish and maintain the measures to be taken and the

(i)
practices to be followed or avoided for the protection and
safety of the public, persons employed or engaged in,
and the working environment of the licensed pathology
laboratory; and

comply with other duties and responsibilities as may be

(j)
specified by the Director General.

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding one hundred thousand

ringgit or to imprisonment for a term not
exceeding five years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding two hundred thousand

ringgit; 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.

Person in charge

25. (1) A person in charge of a licensed pathology laboratory

shall hold such qualification, have undergone such training and
possess such experience as may be specified by the Director
General.
 Pathology Laboratory 25

(2) Notwithstanding subsection (1), a licensee who is a sole

proprietor, may appoint himself as a person in charge.

(3) If a licensee holds more than one licence, he shall appoint

a different person to be a person in charge of different class and
speciality in each licensed pathology laboratory.

Change of person in charge

26. (1) A licensee shall notify the Director General within fourteen
days of its occurrence of any change in the person in charge of
any class and speciality of the licensed pathology laboratory to
which the licence relates and of the qualifications, training and
experience of the new person in charge.

(2) A person who contravenes subsection (1) commits an

offence.

Grievance mechanism

27. (1) The licensee shall establish a plan for grievance mechanism
for clients of the licensed pathology laboratory.

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding thirty thousand ringgit or

to imprisonment for a term not exceeding two
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding fifty thousand ringgit;

and
26 Laws of Malaysia Act 674

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction.

Incident reporting

28. (1) Notwithstanding any other report required by any other

written law, the licensee shall report to the Director General, any
unforeseeable or unanticipated incidents as may be prescribed.

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.

Records to be kept and produced

29. (1) The licensee shall keep or caused to be kept records

relating to the operation of the licensed pathology laboratory for
a period as may be specified by the Director General.

(2) The Director General may require the licensee to produce

the records for inspection.
 Pathology Laboratory 27

(3) A person who fails to keep or refuses to produce the records

under subsection (1) or (2) commits an offence and shall, on
conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding thirty thousand ringgit or

to imprisonment for a term not exceeding two
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding fifty thousand ringgit;

and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction.

Part VI

SUSPENSION AND REVOCATION OF APPROVAL

OR LICENCE

Suspension or revocation of approval or licence

30. (1) The Director General may suspend or revoke an approval

or a licence if he is satisfied that—

the holder of an approval or the licensee has—

(a)

(i) obtained the approval or licence by any false or

misleading statement;

(ii) breached any term or condition imposed by the

Director General on the approval or licence;
28 Laws of Malaysia Act 674

(iii) failed to comply with any of the provisions of

this Act;

(iv) been convicted for an offence under this Act or

any other written law;

(v) failed to comply with any directive, order or

guideline given to him or it by the Minister or
the Director General;

(vi) used the premises to which the approval or licence

relates contrary to the purpose of which the
approval or licence is granted;

(vii) operated or provided the licensed pathology

laboratory in a manner which is detrimental to
the interest of the public as the Director General
may decide;

(viii) established or maintained policies or issued

directives that result in the healthcare professional
employed or engaged by the pathology laboratory
contravening the code of professional conduct
issued by the relevant body governing such
healthcare professional;

(ix) ceased to operate or provide the licensed pathology

laboratory for more than thirty days without
prior notice given and approval obtained from
the Director General; or

(x) failed to maintain the standard and quality required

for the operation of the licensed pathology
laboratory; or

where the holder of an approval or the licensee—

(b)

(i) is a sole proprietor, whose name has been struck

off or suspended from the Malaysian Medical
Register pursuant to subparagraph 30(i) or (ii)
of the Medical Act 1971; or

(ii) is a body corporate or partnership, which does not

remove a member of its board of directors or
 Pathology Laboratory 29

partner, as the case may be, who is a registered

medical practitioner, whose name has been struck
off or suspended from the Malaysian Medical
Register pursuant to subparagraph 30(i) or (ii)
of the Medical Act 1971.

Show cause notice

31. The Director General may, before suspending or revoking

an approval or a licence, give the holder of the approval or the
licensee a show cause notice in writing of his intention to do so
and require the holder of the approval or the licensee to make a
representation within twenty one days from the date the notice is
received by the holder of the approval or the licensee as to why
the approval or the licence should not be suspended or revoked.

Power of Director General to suspend or revoke

32. (1) The Director General shall, after the expiry of the period
of twenty-one days and after considering any representation made
by the holder of an approval or the licensee under section 31,
decide whether to suspend or revoke the approval or the licence
or to take no further action.

(2) Where the Director General decides to suspend an approval

or a licence, he shall issue to the holder of the approval or the
licensee a suspension order with recommendations for rectification
and on how to manage a patient’s sample or medical records
including a patient’s laboratory result with or without any terms
or conditions.

(3) The suspension order issued under subsection (2) shall take
effect from the date on which the suspension order is served on
the holder of an approval or the licensee.

(4) A suspension order shall be withdrawn if the holder of an

approval or the licensee complies with the recommendations for
rectification and any terms and conditions as may be specified in
the suspension order to the satisfaction of the Director General.
30 Laws of Malaysia Act 674

(5) Where a holder of an approval or licensee fails to comply

with any recommendation for rectification and any terms and
conditions as may be specified in the suspension order to the
satisfaction of the Director General, the Director General shall
issue a revocation order to the holder of the approval or the
licensee.

(6) Where the Director General decides to revoke an approval

or a licence, he shall issue to the holder of the approval or the
licensee a revocation order with recommendations on how to
manage a patient’s sample or medical records including a patient’s
laboratory result.

(7) The revocation order issued under subsections (5) and (6)
shall take effect from the date on which the revocation order is
served on the holder of the approval or the licensee.

Effect of suspension

33. (1) Where a suspension order is issued under subsection 32(2)—

to the holder of an approval, he shall immediately cease

(a)
to establish or maintain the pathology laboratory; or

to a licensee, he shall—
(b)

(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 suspension order.

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding two hundred thousand

ringgit or to imprisonment for a term not
exceeding ten years, or to both; and
 Pathology Laboratory 31

(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

in the case of a body corporate or partnership—

(b)

(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.

Effect of revocation

34. (1) Where a revocation order is issued under subsection 32(5)

or (6)—

to the holder of an approval, he shall immediately cease

(a)
to establish or maintain the pathology laboratory; or

to the licensee, he shall—

(b)

(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—

where there is no appeal against the revocation order,

(a)
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
32 Laws of Malaysia Act 674

where there is an appeal against the revocation order,

(b)
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—

in the case of a sole proprietor—

(a)

(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

in the case of a body corporate or partnership—

(b)

(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.
 Pathology Laboratory 33

Part VII

CLOSURE OF PATHOLOGY LABORATORY

Order for closure of pathology laboratory

35. (1) The Director General may, if it appears to him that the
continued operation of any licensed pathology laboratory would
pose a grave danger to the public, by a written notice order the
closure of the licensed pathology laboratory for such period and
upon such terms and conditions or direction as he thinks fit, and
may take such other measures as are necessary to protect the
public from the grave danger.

(2) Any order under subsection (1) shall be served on the licensee
or any person in charge of the licensed pathology laboratory and
shall take effect from the date the order is served.

(3) A person who fails to comply with the order issued under
subsection (1) commits an offence and shall, on conviction, be
liable—

in the case of a sole proprietor—

(a)

(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

in the case of a body corporate or partnership—

(b)

(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.
34 Laws of Malaysia Act 674

Closure of a licensed pathology laboratory

36. (1) Where a licensee intends to close a licensed pathology

laboratory, he shall give the Director General not less than thirty
days notice in writing of his intention and the date the closure
is to take effect.

(2) Upon receiving the notice under subsection (1), the Director
General may issue an order with regard to the care of a patient’s
samples or medical records including a patient’s laboratory results
in the licensed pathology laboratory.

(3) The licensee shall comply with the order issued under
subsection (2) before closing the licensed pathology laboratory.

(4) The closure of the licensed pathology laboratory shall take

effect on the date specified in the notice under subsection (1) and
within fourteen days of that date, the licensee shall surrender the
licence.

(5) A notice to close the licensed pathology laboratory may

be withdrawn by a written notice to the Director General at any
time before the closure takes effect.

(6) A person who contravenes subsection (1) or (4) commits

an offence.

(7) A person who contravenes subsection (3) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and
 Pathology Laboratory 35

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of a day
during which the offence continues after conviction.

No costs, damages, etc., on order for closure

37. No person shall, in any proceedings before any court in respect

of an order for closure of a licensed pathology laboratory under
subsection 35(1), be entitled to the costs of the proceedings or
to any damages or other relief for any financial loss suffered by
reason of the closure, notwithstanding that the licensed pathology
laboratory has complied with all the provisions of this Act.

Part VIII

GENERAL PROVISIONS RELATING TO APPROVAL OR

LICENCE

Power to vary terms or conditions of approval or licence

38. The Director General may, on an application in writing to

him and upon payment of the prescribed fees, vary the terms and
conditions of an approval or a licence by endorsement thereon
or otherwise in writing by altering, in such manner as he thinks
fit, the purpose to which the pathology laboratory is established
or maintained or operated or provided, or the class and speciality
of the pathology laboratory to which the licence is in force.

Assessment of operation

39. (1) A licensee shall, if required by the Director General to

do so, submit any record or other information relating to the
operation of the licensed pathology laboratory in respect of which
a licence has been granted for the purposes of assessment or
examination of the pathology services provided.

(2) In submitting any record or other information for assessment

or examination under subsection (1), the licensee shall pay to the
Director General the costs of the assessment or examination and
any other costs as may reasonably be incurred in connection with
the assessment or examination.
36 Laws of Malaysia Act 674

(3) The Director General may, after having considered the

record or information submitted under subsection (1) and after
being satisfied that the licensed pathology laboratory has failed
to maintain the standard or quality required of its operation in
respect of which the licence has been granted, suspend or revoke
the licence.

(4) The costs payable under subsection (2) shall be determined

by the Director General.

(5) A person who contravenes subsection (1) commits an

offence.

Restriction on use of premise

40. (1) The premise to which an approval or licence relates shall

not be used for any purpose other than the purpose in respect
of which the approval or the licence is granted and purposes
reasonably incidental thereto.

(2) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.
 Pathology Laboratory 37

Prohibition on extension and alteration

41. (1) Unless with prior written approval of the Director General,
no person shall make any structural extension or alteration to
any licensed pathology laboratory, or to any part thereof which
affects—

the purpose for which the licensed pathology laboratory

(a)
was operated or provided;

any of the terms or conditions of the approval or licence;

(b)
or

any prescribed requirements or standards of the licensed

(c)
pathology laboratory.

(2) An application for the extension or alteration under

subsection (1) shall be made to the Director General in the prescribed
form and manner and shall be accompanied by the prescribed fee.

(3) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding thirty thousand ringgit or

to imprisonment for a term not exceeding two
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding fifty thousand ringgit;

and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction.
38 Laws of Malaysia Act 674

Transfer of approval or licence

42. (1) A holder of an approval or a licensee shall not transfer

or assign the approval or the licence except with the prior written
approval of the Director General.

(2) An application for the transfer or assignment of an approval

or a licence shall be made to the Director General in the prescribed
form and manner and accompanied by the prescribed fees.

(3) The Director General may approve the transfer or assignment

of an approval or a licence subject to the terms and conditions
as he may impose or refuse the application for the transfer or
assignment, with or without assigning any reason.

(4) A person who contravenes subsection (1) commits an offence

and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding one hundred thousand

ringgit or to imprisonment for a term not
exceeding five years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding two hundred thousand

ringgit; 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.

Register

43. (1) The Director General shall keep and maintain or cause
to be kept and maintained a register of the approved pathology
laboratory or the licensed pathology laboratory.
 Pathology Laboratory 39

(2) The register under subsection (1) shall be deemed to be a

public document within the meaning of the Evidence Act 1950
[Act 56] and shall be open for public inspection and the public
may make a search on and obtain extracts from the register upon
payment of a prescribed fee.

Part IX

QUALITY OF PATHOLOGY LABORATORY

Quality of pathology laboratory

44. (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—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.
40 Laws of Malaysia Act 674

(4) A person who contravenes subsection (2) commits an offence

and shall, on conviction, be liable—
in the case of a sole proprietor—
(a)
(i) to a fine not exceeding ten thousand ringgit or
to imprisonment for a term not exceeding one
year, or to both; and
(ii) for a continuing offence, to a fine not exceeding
five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or
in the case of a body corporate or partnership—
(b)
(i) to a fine not exceeding thirty thousand ringgit;
and
(ii) for a continuing offence, to a fine not exceeding
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

45. (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,
 Pathology Laboratory 41

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.

Part X

PATHOLOGY LABORATORY ADVISORY COMMITTEE

Pathology Laboratory Advisory Committee

46. (1) Each licensee shall establish a Pathology Laboratory

Advisory Committee for the licensed pathology laboratory which
membership, duties and responsibilities shall be as may be
prescribed.

(2) A person who contravenes subsection (1) commits an offence.

Part XI

MANAGED CARE ORGANIZATION

Interpretation

47. (1) For the purpose of this Part, “managed care organization”
means any organization or body with whom a licensed pathology
laboratory enters into a contract or has an arrangement or intends
to enter into a contract or have an arrangement to provide specified
quality or quantity of pathology services within a specified
financing system through one or a combination of the following
mechanisms:

providing pathology services to consumers through the

(a)
organization or body’s own healthcare provider or a
42 Laws of Malaysia Act 674

third party healthcare provider in accordance with the

contract or arrangement between all parties concerned;
or

providing pathology services to employees or enrollees

(b)
on behalf of the payers including individuals, employers
or financiers in accordance with contractual agreements
between all parties concerned.

(2) The Minister may from time to time by notification in

the Gazette declare any organization or body that enters into
a pathology laboratory services arrangement, other than those
specified in subsection (1), to be a managed care organization.

Contract between licensed pathology laboratory and managed

care organization

48. (1) No licensee shall enter into a contract or make any

arrangement with any managed care organization that results in—

a change in the duties or responsibilities of the Pathology

(a)
Laboratory Advisory Committee;

the contravention of the code of professional conduct

(b)
issued by the relevant body governing the healthcare
professional; or

the contravention of any provisions of this Act or any

(c)
other written law.

(2) The licensee or managed care organization who enters

into a contract or makes any arrangement in contravention of
subsection (1) commits an offence and shall, on conviction, be
liable—

in the case of a licensee who is a sole proprietor, to a fine

(a)
not exceeding fifty thousand ringgit or to imprisonment
for a term not exceeding three years, or to both;

in the case of a licensee who is a body corporate or

(b)
partnership, a fine not exceeding one hundred thousand
ringgit; or
 Pathology Laboratory 43

in the case of a managed care organization, a fine not

(c)
exceeding one hundred thousand ringgit.

(3) Where an offence under subsection (2) is committed by a

managed care organization, the person responsible for the managed
care organization shall also be guilty of the offence and shall,
on conviction, be liable to a fine not exceeding fifty thousand
ringgit or to imprisonment for a term not exceeding five years,
or to both.

Obligation to furnish information on contract with managed

care organization

49. (1) A licensee who enters into a contract or has an arrangement

with a managed care organization shall furnish such information
relating to the contract or arrangement to the Director General
as may be required by the Director General.

(2) A licensee who refuses or fails to furnish the information

required under subsection (1) or furnishes false or misleading
information commits an offence and shall, on conviction, be
liable—

in the case of a sole proprietor, to a fine not exceeding

(a)
ten thousand ringgit or imprisonment for a term not
exceeding one year, or to both; or

in the case of a body corporate or partnership, to a fine

(b)
not exceeding thirty thousand ringgit.

Information by managed care organization

50. (1) A managed care organization which enters into a contract or

has an arrangement with a licensee shall furnish such information
relating to the managed care organization as may be required by
the Director General.

(2) A managed care organization who refuses or fails to furnish

the information required under subsection (1) or furnishes false
or misleading information commits an offence and shall, on
conviction, be liable to a fine not exceeding fifty thousand ringgit.
44 Laws of Malaysia Act 674

(3) Where an offence under subsection (2) is committed, the

person responsible for the managed care organization shall also
be guilty of the offence and shall, on conviction, be liable to a
fine not exceeding thirty thousand ringgit or to imprisonment for
a term not exceeding two years, or to both.

Register of managed care organization

51. (1) The Director General shall keep and maintain a register
of managed care organizations which enter into any contract or
have any arrangement with any licensee and such register may
contain such particulars as may be determined by the Director
General.

(2) The register under subsection (1) shall be deemed to be a

public document within the meaning of the Evidence Act 1950
and shall be open for public inspection and the public may make
a search on and obtain extracts from the register upon payment
of a prescribed fee.

Part XII

ENFORCEMENT

Appointment of authorized officer

52. (1) The Director General may appoint in writing such number
of persons to be authorized officer as he thinks necessary for the
purposes of this Act.

(2) An authorized officer may exercise all of the powers vested

in him under this Act.

(3) The appointment of an authorized officer shall be published

in the Gazette as soon as practicable.

Power of authorized officer to enter and inspect

53. (1) An authorized officer shall have the power to enter and
inspect at any time any licensed pathology laboratory or any
premises which he suspects or has reason to believe is being
used as a pathology laboratory without licence.
 Pathology Laboratory 45

(2) In the course of an inspection under this section, the

authorized officer may—

test, examine, take, remove or detain any equipment used

(a)
or found in the pathology laboratory or premises;

test, examine, take, remove or detain samples of blood,

(b)
blood product, human tissue or fluid or any product of
the human body, dialysate, chemical, pharmaceutical,
substance or any other similar things found in the
pathology laboratory or premises;

test, examine, take, remove or detain any containers,

(c)
articles and other things that the authorized officer
reasonably believes to contain or to have contained blood,
blood product, human tissue or fluid or any product of
the human body, dialysate, chemical, pharmaceutical,
substance or any other similar things found in the
pathology laboratory or premises;

inspect any test or procedure or operation performed

(d)
or carried out in the pathology laboratory to ensure
compliance with the provisions of this Act; or

inspect, take, make copies of or make extracts from any

(e)
record found in the pathology laboratory or premises.

Power to search and seize

54. (1) If it appears to a Magistrate, upon written information

on oath and after such enquiry as he considers necessary, that
there is reasonable cause to believe that—

any pathology laboratory or premises has been used or

(a)
is about to be used for; or

there is in any pathology laboratory or premises evidence

(b)
necessary to establish,
46 Laws of Malaysia Act 674

the commission of an offence under this Act, the Magistrate may

issue a warrant authorising any authorized officer named therein
to enter the pathology laboratory or premises at any reasonable
time by day or by night with or without assistance and if need
be by force and there to—

(i) search the pathology laboratory and seize any book,

record, apparatus, equipment, instrument, material,
article, sample, blood, blood product, human tissue
or fluid or any product of the human body, dialysate,
chemical, pharmaceutical, substance or any other thing
that is reasonably believed to furnish evidence of the
commission of the offence;

(ii) take samples of any sample, blood, blood product, human

tissue or fluid or any product of the human body, dialysate,
chemical, pharmaceutical, substance or any other thing
found in the pathology laboratory or premises for the
purpose of ascertaining, by testing or otherwise, whether
an offence has been committed; and

(iii) make copies of or take extracts from any book, record,

material or any other article found in the pathology
laboratory or premises.

(2) An authorized officer may in the exercise of his powers

under this section if it is necessary to do so—

break open any outer or inner door of, or any fence,

(a)
enclosure, gate or other obstruction to the pathology
laboratory or premises, in order to effect entry;

remove by force any obstruction to entry, search, seizure

(b)
or removal as he is empowered to effect; and

detain every person found in the pathology laboratory or

(c)
premises until the pathology laboratory or premises has
been searched.

(3) Where the pathology laboratory or premises is mobile in

nature, the authorized officer may seize the pathology laboratory
or premises.
 Pathology Laboratory 47

Search and seizure without warrant

55. If an authorized officer has reasonable cause to believe

that by reason of delay in obtaining a search warrant under
section 54—
the investigation would be affected;
(a)
the object of the entry is likely to be frustrated; or
(b)
the book, record, apparatus, equipment, instrument,
(c)
material, article, sample, blood, blood product, human
tissue or fluid or any product of the human body,
dialysate, chemical, pharmaceutical, substance or other
thing which are the evidence of contravention is likely
to be tampered with, removed, damaged or destroyed,

he may enter the pathology laboratory or premises and exercise,

in respect of the pathology laboratory or premises, all the powers
referred to in section 54 as if he were authorized to do so by a
warrant issued under that section.

Access to computerized data

56. (1) An authorized officer conducting a search under this Act

shall be given access to computerized data whether stored in a
computer or otherwise.

(2) For the purpose of subsection (1), the authorized officer

shall be provided with the necessary password, encryption code,
decryption code, software or hardware or any other means required
for his access to enable comprehension of the computerized data.

List of things seized

57. (1) Except as provided in subsection (2), where any book,

record, apparatus, equipment, instrument, material, article, sample,
blood, blood product, human tissue or fluid or any product of
the human body, dialysate, chemical, pharmaceutical, substance
or other thing is seized under this Act, the seizing officer shall
prepare a list of things seized and a copy of the list shall be given
to the licensee, person in charge, or occupier of the pathology
laboratory or premises, as the case may be, which has been
searched under section 53, 54 or 55.
48 Laws of Malaysia Act 674

(2) Where the licensed pathology laboratory or premises is

unoccupied, the authorized officer shall whenever possible post a
list of the things seized conspicuously on the pathology laboratory
or premises.

Release of things seized

58. If any thing has been seized under this Act, the Director
General may at any time after that, but before it is forfeited
under this Act, release the things seized which are not otherwise
required for the purpose of any proceedings under this Act, or
for the purpose of any prosecution under any other law, to the
person as he determines to be lawfully entitled to the thing, and
in such event, neither the Director General nor the Government
shall be liable to any proceedings by any person if the seizure
and the release of the thing had been effected in good faith.

Power to seal

59. (1) Where, by reason of their nature, size or amount, it is

not practicable to remove any book, record, apparatus, equipment,
instrument, material, article, sample, blood or blood product,
human tissue or fluid or any product of the human body,
dialysate, chemical, pharmaceutical, substance or other thing under
section 53, 54 or 55, the authorized officer shall by any means—

place the book, record, apparatus, equipment, instrument,

(a)
material, article, sample, blood, blood product, human
tissue or fluid or any product of the human body,
dialysate, chemical, pharmaceutical, substance or other
thing in a room, compartment or cabinet located in that
licensed pathology laboratory or premises; and

mark, fasten and seal the container, door or opening

(b)
providing access to the room, compartment or cabinet.

(2) The authorized officer may by any means seal any pathology
laboratory or premises where he has reasonable cause to believe
that—

the pathology laboratory is contravening any of the terms

(a)
and conditions imposed by the Director General or
prescribed requirements or standards; or
 Pathology Laboratory 49

the premises is being used as a pathology laboratory

(b)
without being licensed under this Act.

(3) Where any licensed pathology laboratory has been sealed,

the licensee shall, within twenty-one days of such sealing produce
to the Director General the proof that the licensee has complied
with the terms and conditions or prescribed requirements or
standards and bear any cost incurred arising out of such action.

(4) Where any premises has been sealed, the person occupying
or using the premises as a pathology laboratory shall, within
twenty-one days of such sealing produce to the Director General
the licence and bear any cost incurred arising out of such action.

(5) The seal under subsection (2) shall be removed if the person
referred to in subsection (3) complies with the requirement of that
subsection or an order of the court is obtained for such person
to cease using the licensed pathology laboratory.

(6) The seal under subsection (2) shall be removed if the person
referred to in subsection (4) complies with the requirement of that
subsection or an order of the court is obtained for such person
to cease using the premises as a pathology laboratory.

(7) It shall be an offence for any person without lawful

authority to break, tamper with or damage the seal referred to
in subsection (1) or (2) or remove any book, record, apparatus,
equipment, instrument, material, article, sample, blood, blood
product, human tissue or fluid or any product of the human body,
dialysate, pharmaceutical, substance or other things under seal or
to attempt to do so.

Power to require attendance of person acquainted with case

60. (1) An authorized officer making an investigation under this

Act may by order in writing require the attendance before him of
any person who appears to the authorized officer to be acquainted
with the facts and circumstances of the case, and such person
shall attend as so required.

(2) If any such person refuses to attend as so required, the

authorized officer may report such refusal to a Magistrate who
shall issue a summons to secure the attendance of such person
as may be required by the order made under subsection (1).
50 Laws of Malaysia Act 674

Examination of person acquainted with case

61. (1) An authorized officer making an investigation under this

Act may examine orally or in writing any person supposed to be
acquainted with the facts and circumstances of the case.

(2) The person shall be legally bound to answer all questions

relating to such case put to him by the authorized officer, but
such person may refuse to answer any questions the answer to
which would have a tendency to expose him to criminal charge,
penalty or forfeiture.

(3) A person making a statement under this section shall be

legally bound to tell the truth, whether or not such statement is
made wholly or partly in an answer to questions.

(4) An authorized officer examining a person under subsection (1)

shall first inform that person of the provisions of subsections (2)
and (3).

(5) A statement made by any person under this section, whether

or not caution has been administered to him under subsection (2)
shall, whenever possible, be reduced into writing and signed by
the person making it or affixed with his thumb-print, as the case
may be—

after it has been read to him in the language in which

(a)
he made it; and

after he has been given an opportunity to make any

(b)
correction he may wish.

Admissibility of statements in evidence

62. (1) Except as provided in this section, no statement made by

any person to an authorized officer in the course of an investigation
made under this Act shall be used in evidence.

(2) When any witness is called for the prosecution or for the
defence, other than the accused, the court shall, on the request of
the accused or the prosecutor, refer to any statement made by the
witness to an authorized officer in the course of an investigation
under this Act and may then, if the court thinks fit in the interest
 Pathology Laboratory 51

of justice, direct the accused to be furnished with a copy of it and

the statement may be used to impeach the credit of the witness
in the manner provided by the Evidence Act 1950.

(3) Where the accused had made a statement during the course
of an investigation, such statement may be admitted in evidence
in support of his defence during the course of the trial.

(4) Nothing in this section shall be deemed to apply to any

statement made in the course of an identification parade or
falling within section 27 or paragraphs 32(1)(a), (i) and (j) of
the Evidence Act 1950.

(5) When any person is charged with any offence in relation to—

(a) the making; or

(b) the contents,

of any statement made by him to an authorized officer in the

course of an investigation made under this Act, the statement
may be used as evidence in the prosecution’s case.

Duty to assist authorized officer

63. Whenever an authorized officer exercises his powers under

this Act it shall be the duty of the licensee or person in charge
or an employee of the licensed pathology laboratory or the owner
or occupier of any premises used as a pathology laboratory and
any person found therein—
to provide the authorized officer all facilities and assistance
(a)
as the authorized officer may reasonably require;
to give the authorized officer all reasonable information
(b)
required by him in respect of the licensed pathology
laboratory or premises, as the case may be, relating to
its management or any other matter connected therewith;
and
to produce any book, record or document in his possession
(c)
or custody or under his control or within his power to
furnish, relating to the affairs of the licensed pathology
laboratory or premises.
52 Laws of Malaysia Act 674

Forfeiture of goods, etc., seized

64. (1) Any book, record, apparatus, equipment, instrument,

material, article, sample, blood, blood product, human tissue or
fluid or any product of the human body, dialysate, chemical,
pharmaceutical, substance or any other thing seized in exercise of
any power conferred under this Act shall be liable to forfeiture.

(2) An order for the forfeiture or for the release of all the things
seized and liable to forfeiture under this Act shall be made by the
court before which the prosecution with regard thereto has been
held and an order for the forfeiture of the things seized shall be
made if it is proved to the satisfaction of the court that an offence
under this Act has been committed and that the things seized
were the subject matter of or were used in the commission of
the offence, notwithstanding that no person have been convicted
of such offence.

(3) Where there is no prosecution with regard to anything

seized, such thing shall be taken and deemed to be forfeited at
the expiration of one calendar month from the date of service
of a notice to the last known address of the person from whom
the thing was seized indicating that there is no prosecution in
respect of such thing, unless before that date a claim thereto is
made in the manner as set out in subsections (4), (5) and (6).

(4) Any person asserting that he is the owner of the thing

seized under subsection (3) and that it is not liable to forfeiture
may personally or by his agent authorized in writing give written
notice to the authorized officer in whose custody such thing is
held that he claims the thing.

(5) On receipt of the notice referred to in subsection (4), the

authorized officer shall refer the matter to a Judge of a Sessions
Court for a decision.

(6) The Judge to whom a matter is referred under subsection (5)

shall issue a summons requiring the person asserting that he
is the owner of the thing seized and the person from whom it
was seized, to appear before the Judge, and on his appearance
or default to appear, due service of the summons having been
proved, the Judge shall proceed to the examination of the matter
and on proof that an offence under this Act has been committed
and that the thing seized was the subject matter of or was used
 Pathology Laboratory 53

in the commission of such offence, shall order the thing to be

forfeited and shall, in the absence of such proof, order its release.

(7) Subject to subsection (2), any things forfeited or deemed

to be forfeited shall be delivered to the authorized officer and
shall be disposed of in a manner to be determined by the Director
General.

(8) If the authorized officer is satisfied that any blood, blood

product, human tissue or fluid or any product of the human body,
dialysate, chemical, pharmaceutical, substance or any other thing,
contains a hazardous contaminant, the authorized officer shall
cause the blood, blood product, human tissue or fluid or any
product of the human body, dialysate, chemical, pharmaceutical,
substance or any other thing, to be destroyed in a manner to be
determined by the Director General.

Cost of holding goods, etc., seized

65. Where anything seized under this Act is held in the custody
of the Government pending completion of any proceedings in
respect of an offence under this Act, the cost of holding such
thing in custody shall, in the event of any person being found
guilty of an offence, be a debt due to the Government by such
person and shall be recoverable accordingly.

Production of official identification card or badge

66. Every authorized officer exercising powers under this Act

shall at all times carry an official identification card or badge in
such form as may be prescribed and no person shall admit into
the pathology laboratory or premises any person purporting to
be an authorized officer except upon production of the official
identification card or badge.

Compounding of offences

67. (1) The Director General may, with the written consent of the
Public Prosecutor, compound any offence which is prescribed to
be a compoundable offence committed by any person under this
Act by making a written offer to such person to compound the
54 Laws of Malaysia Act 674

offence upon payment to the Director General such amount not

exceeding fifty per centum of the amount of maximum fine for
that offence within such time as may be specified in the offer.

(2) An offer under subsection (1) may be made at any time after
the offence has been committed but before any prosecution for it
has been instituted and where the amount specified in the offer
is not paid within the time specified in the offer or within such
extended period as the Director General may grant, prosecution
for the offence may be instituted at any time thereafter against
the person to whom the offer was made.

(3) W h e r e a n o ff e n c e h a s b e e n c o m p o u n d e d u n d e r
subsection (1)—

no prosecution shall thereafter be instituted in respect

(a)
of such offence against the person whom the offer to
compound was made; and

any book, record, apparatus, equipment, instrument, material,

(b)
article or any other thing seized in connection with the
offence, may be forfeited, destroyed or returned to that
person, as the Director General deems fit after taking
into consideration the nature of the offence and subject
to such terms and conditions as may be imposed.

Institution of prosecution

68. No prosecution for or in respect of an offence under this

Act shall be instituted except by or with the consent in writing
of the Public Prosecutor.

Part XIII

MISCELLANEOUS

Non-application of the Act

69. This Act shall not apply to—

any public pathology laboratory established, maintained,

(a)
operated or provided by the Government;
 Pathology Laboratory 55

any pathology laboratory established, maintained, operated

(b)
or provided by a registered medical practitioner in a
private medical clinic for the purpose of performing
any tests specified in the First Schedule in the course
of treating his patients;

any pathology laboratory established, maintained, operated

(c)
or provided by a registered dental practitioner in a private
dental clinic for the purpose of performing any of the
tests specified in the Second Schedule in the course of
treating his patients; or

any test specified in the Third Schedule conducted by a

(d)
person in a premises other than a licensed pathology
laboratory.

Offences in relation to inspection

70. A person who—

assaults, impedes, obstructs or interferes with, or refuses

(a)
an authorized officer access to any pathology laboratory
or premises;

fails to provide assistance, or refuses to furnish the

(b)
information required by an authorized officer;

without reasonable excuse fails or refuses to produce any

(c)
thing required by an authorized officer in the course of
his inspection; or

alters the approval or licence,

(d)

shall be guilty of an offence and shall, on conviction, be liable

to a fine not exceeding fifty thousand ringgit or to imprisonment
for a term not exceeding three years, or to both.

Offences committed by body corporate or partnership

71. (1) Where a body corporate contravenes any provision

of this Act or any regulations made thereunder, every person
who at the time of the commission of the offence is a director,
56 Laws of Malaysia Act 674

manager, secretary or other like officers of the body corporate or

was purporting to act in any such capacity or was in any extent
responsible for the management of any of the affairs of the body
corporate or was assisting in such management—
may be charged severally or jointly in the same proceedings
(a)
with the body corporate; and
be deemed to be guilty of the offence unless, having
(b)
regard to the nature of his functions in that capacity
and to all circumstances, he proves that—
(i) the offence was committed without his knowledge,
consent or connivance; and
(ii) he took all reasonable precautions and had exercised
due diligence to prevent the commission of the
offence.

(2) Where a partnership contravenes any provision of this Act or

any regulations made thereunder, every partner of the partnership
at the time of the commission of the offence shall be deemed
to have contravened the provision and may be charged jointly
in the same proceedings with the partnership, or severally, and
every such partner shall be deemed to be guilty of the offence
unless he proves that—
(i) the offence was committed without his knowledge,
consent or connivance; and
(ii) he took all reasonable precautions and had exercised
due diligence to prevent the commission of the
offence.

(3) A person guilty of an offence under subsection (1) or (2)

shall, on conviction, be liable to the same amount of fine and
period of imprisonment as the fine and imprisonment imposed
on the sole proprietor committing the offence.

Appeal

72. (1) Any person who is aggrieved by any decision of the

Director General as specified in subsection (2) may appeal to the
Minister in the prescribed form and manner within thirty days
from the date the decision is communicated to such person.
 Pathology Laboratory 57

(2) The decisions of the Director General which may be appealed

are—
the refusal to grant an approval or licence under this Act;
(a)
the refusal to renew a licence under this Act;
(b)
the imposition of any terms and conditions on an approval
(c)
or licence under this Act;
the imposition of any terms and conditions on the renewal
(d)
of a licence upon its renewal under this Act;
the refusal of an extension of time under subsection 9(3);
(e)
the issuance of a revocation order under this Act;
(f)
the issuance of an order of closure under subsection 35(1);
(g)
the refusal to approve any extension or alteration under
(h)
subsection 41(1);
the refusal to approve any transfer or assignment under
(i)
subsection 42(3); or
any other decisions made by the Director General under
(j)
this Act.

(3) The Minister may, after scrutinizing the appeal, confirm,

revoke or vary any decision of the Director General as specified
under subsection (2) and impose any terms or conditions to the
decision, as he deems just or necessary.

(4) The decision of the Minister under this section shall be

final and conclusive.

Power to exempt

73. (1) The Minister may exempt any licensed pathology laboratory
from the application of any of the provisions of this Act subject
to such restrictions or conditions as he may imposed.

(2) An exemption under subsection (1) may be withdrawn at

any time by the Minister and shall cease to have effect from the
date of service of notice of such withdrawal.
58 Laws of Malaysia Act 674

Fee schedule

74. (1) The Minister may make regulations prescribing a fee

schedule for any licensed pathology laboratory.

(2) The Minister may amend the fee schedule by order published
in the Gazette.

(3) A licensed pathology laboratory for which a fee schedule

has been prescribed under this section shall comply with such
fee schedule.

(4) A person who fails to comply with subsection (3) commits

an offence and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.

Advertisement

75. (1) No licensed pathology laboratory shall publish any

advertisement—

in such a manner as to mislead the public on the class

(a)
and speciality of the licensed pathology laboratory;
 Pathology Laboratory 59

which contravenes any written law regulating advertisement

(b)
for medical matters or purposes; or

(c) which is contrary to any directive on advertisement issued

by the Director General.

(2) A person who contravenes subsection (1) commits an offence
and shall, on conviction, be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding fifty thousand ringgit or

to imprisonment for a term not exceeding three
years, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding one hundred thousand

ringgit; and

(ii) for a continuing offence, to a fine not exceeding

one thousand ringgit for every day or part of
a day during which the offence continues after
conviction.

Delegation by Director General

76. (1) The Director General may delegate to any officer under
his control, direction and supervision any of his power, duty or
function under this Act, except the power under sections 52 and
67, and when so delegated such power shall be exercised by the
officer under the control of and subject to such direction and
restriction as may be specified by the Director General.

(2) A delegation under subsection (1) may be revoked at any

time by the Director General and shall not prevent the Director
General from exercising the delegated powers himself.
60 Laws of Malaysia Act 674

Furnishing of information

77. (1) The Director General may from time to time direct the
holder of an approval or the licensee to furnish such information
on the licensed pathology laboratory as he may require relating
to—

its staff;
(a)

any equipment, materials or any other things used or to

(b)
be used;

the diagnosis of any person whose sample has been tested;

(c)

any analytical method or procedure used in carrying out

(d)
any test;

its operation;
(e)

all matters relating to policy statement; or

(f)

the duties, functions and experience of locum tenens and

(g)
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—

in the case of sole proprietor, to a fine not exceeding

(a)
ten thousand ringgit or to imprisonment for a term not
exceeding one year, or to both; and

in the case of a body corporate or partnership to a fine

(b)
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—
if a person is a deceased, his executor, administrator or
(a)
next of kin;
if the person is a minor, his mother, father or guardian;
(b)
or
if the person is not capable of giving consent, his next
(c)
of kin.

Service of notice

78. (1) A notice or order required or authorized to be served

under this Act may be served personally or by registered post.

(2) Where a notice or order is served by registered post, it

shall be deemed to have been served on the day on which the
notice or order would have been received in the ordinary course
of the post if the notice or order is addressed—

in the case of an individual, to the person’s usual or last

(a)
known residential address or place of business; or

in the case of a body corporate or partnership, to its

(b)
registered place of business.

(3) Where the person, body corporate or partnership to whom

there has been addressed a registered letter containing any notice
which may be given under the provisions of this Act is informed
of the fact that there is a registered letter awaiting him at the
62 Laws of Malaysia Act 674

post office, and such person, body corporate or partnership refuses

or neglects to take delivery of such registered letter, such notice
shall be deemed to have been served upon him on the date on
which he was informed.

Officers deemed to be public servants

79. An authorized officer appointed under this Act shall be

deemed to be a public servant within the meaning of the Penal
Code [Act 574].

Protection of officers

80. No action or prosecution shall be brought, instituted or

maintained in any court against—

the Director General, an authorized officer or any officer

(a)
duly appointed under this Act for or on account of or
in respect of any act ordered or done for the purpose
of carrying into effect this Act; and

any other person for or on account of or in respect of

(b)
any act done or purported to be done by him under the
order, directives or instruction of the Director General,
an authorized officer or any officer duly appointed
under this Act or if the act was done in good faith in a
reasonable belief that it was necessary for the purpose
intended to be served thereby.

Disclosure of confidential information

81. (1) Any person who makes use of or discloses to any other
person any confidential information obtained by virtue of the
provisions of this Act commits an offence.

(2) Nothing in subsection (1) shall operate to prevent the

disclosure of information where the disclosure is made—

for or in connection with the due administration of this

(a)
Act;
 Pathology Laboratory 63

for the purpose of any legal proceedings;

(b)

for the purpose of any investigation conducted under this

(c)
Act;

in connection with any matter relating to professional

(d)
disciplinary proceedings;

to a body established under any law regulating a healthcare

(e)
professional;

to any counsel who is approved in writing by the client

(f)
of the licensed pathology laboratory, requesting for the
information which relates to any pathology services
provided to that person;

to any person or any officer who is approved in writing

(g)
by the Minister as a proper person to receive the
information; or

for or in connection with the preparation by the Government

(h)
of relevant health statistics or health registries in respect
of the operation of this Act.

(3) Any person who contravenes subsection (1) commits an

offence and shall, on conviction, be liable to a fine not exceeding
fifty thousand ringgit or to imprisonment for a term not exceeding
three years, or to both.

Social or welfare contribution

82. (1) The Minister may prescribe the type of social or welfare
contribution or the quantum of social or welfare contribution not
inconsistent with the provision of this Act that shall be provided
by any licensed pathology laboratory.

(2) The Minister may, from time to time, amend the type of
social or welfare contribution or the quantum of social or welfare
contribution imposed under subsection (1).

(3) Any licensed pathology laboratory which fails to comply

with subsection (1) commits an offence.
64 Laws of Malaysia Act 674

General offence and penalty

83. Where no penalty is expressly provided for an offence under

this Act, a person who commits such offence shall, on conviction,
be liable—

in the case of a sole proprietor—

(a)

(i) to a fine not exceeding ten thousand ringgit or

to imprisonment for a term not exceeding one
year, or to both; and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction; or

in the case of a body corporate or partnership—

(b)

(i) to a fine not exceeding thirty thousand ringgit;

and

(ii) for a continuing offence, to a fine not exceeding

five hundred ringgit for every day or part of a
day during which the offence continues after
conviction.

Contravention of subsidiary legislation

84. Any subsidiary legislation made under this Act may provide
that the contravention of any provision in the subsidiary legislation
shall be an offence and that the person who commits the offence
shall, on conviction, be liable to a fine or a term of imprisonment,
or both but may not provide for a fine which exceeds ten thousand
ringgit or a term of imprisonment which exceeds one year.

Power to amend Schedule

85. The Minister may from time to time amend the Schedules
by order published in the Gazette.
 Pathology Laboratory 65

Power to make regulations

86. (1) The Minister may make such regulations as may be

necessary or expedient for the purpose of carrying into effect
the provisions of this Act.

(2) Without prejudice to the generality of the powers conferred

by subsection (1), such regulations may be made for all or any
of the following purposes:

to prescribe the circumstances under which a duplicate

(a)
approval or licence may be issued and the fee payable;

to prescribe the procedure of amendment of any particulars

(b)
contained in any approval or licence or its replacement
with a new approval or licence and the fee payable;

to prescribe the records of persons whose sample has

(c)
been tested in the licensed pathology laboratory and
the manner in which such records are to be kept and
issued;

to prescribe the manner of accessing a person’s laboratory

(d)
results and the manner of obtaining the laboratory results
by the person, the person’s representative or a healthcare
provider;

to prescribe the records to be kept of the healthcare

(e)
professional, staff or any other person employed or
engaged by a licensed pathology laboratory;

to prescribe the minimum number, qualification or experience

(f)
required of healthcare professionals including pathologists,
scientific officers, medical laboratory technologists or
other technical staff or other categories of staff to be
employed or engaged in a licensed pathology laboratory;

to prescribe the minimum standards of the equipment,

(g)
materials and other things to be used, provided and
maintained by a licensed pathology laboratory;

to prescribe the type of training, continuing technical

(h)
or medical education or any other type of healthcare
professional education to be provided by a licensee to
the healthcare professional, staff or any other person
employed or engaged by the licensed pathology laboratory;
66 Laws of Malaysia Act 674

to prescribe the minimum standards and specifications in

(i)
respect of design and construction of a licensed pathology
laboratory;

to prescribe the minimum standards of sanitation or other

(j)
amenities in a licensed pathology laboratory;

to prescribe the minimum standards of cleanliness and

(k)
hygiene, including infection control in a licensed pathology
laboratory;

to prescribe the minimum standards and conditions required

(l)
of pathology services with respect to the collection,
screening, analysis, processing, handling, transportation,
distribution, storage, or disposal of samples;

to prescribe the management, control, and supervision of

(m)
a licensed pathology laboratory;

to prescribe the acceptable quality assurance and quality

(n)
control in respect of a licensed pathology laboratory;

to prescribe the programmes and activities of a licensed

(o)
pathology laboratory to ensure the quality of services
provided;

to prescribe the form and particulars to be contained in

(p)
the records or register kept or maintained under this
Act;

to prescribe the statistical information to be furnished by

(q)
the licensee to the Director General and the manner of
furnishing such information;

to prescribe the procedure for notification of the closure

(r)
of a licensed pathology laboratory;

to prescribe the manner and form of applying for the

(s)
transfer or assignment of the approval or licence in
respect of, and the extension or alteration to the licensed
pathology laboratory;

to prescribe the procedure for reporting incidents, the

(t)
report and statistical data to be submitted by a licensee;
 Pathology Laboratory 67

to prescribe the categorization of pathology laboratories

(u)
into different classes and specialities which may or may
not be performed in particular classes and specialities
of licensed pathology laboratories;

to prescribe the membership, duties and responsibilities

(v)
of a Pathology Laboratory Advisory Committee; or

to provide for any matter which under this Act is required

(w)
or permitted to be prescribed or which are necessary or
expedient to be prescribed to give effect to this Act.

Transitional

87. (1) Any person who is operating or providing a pathology

laboratory before the commencement of this Act and intends to
continue to operate or provide the pathology laboratory on or
after such commencement shall, not later than six months from
the date of commencement of this Act, apply to the Director
General for a licence under this Act.

(2) Pending the decision by the Director General on the

application for a licence made under subsection (1), the applicant
shall be deemed to be licensed under this Act and no action
shall be taken against the applicant for operating or providing a
pathology laboratory without a licence.

(3) Where a licence is granted by the Director General under

paragraph 16(a) pursuant to an application made under subsection (1),
the applicant shall within six months from the date the licence
is granted, take the necessary action to comply with the terms
and conditions imposed in the licence, if any.

(4) Where a licence is not granted by the Director General

under paragraph 16(b), the applicant referred to in subsection (2)
shall cease to be deemed to be licensed under that subsection
from the date the applicant is notified of the decision of the
Director General or, if there is an appeal under section 72, the
date of the decision of the Minister on that appeal.
68 Laws of Malaysia Act 674
First Schedule

[Paragraph 69(b)]

TESTS EXEMPTED WHEN PERFORMED BY REGISTERED

MEDICAL PRACTITIONER IN HIS OWN PREMISES

Blood glucose estimation

Haematocrit estimation
Haemoglobin estimation
Erythrocyte sedimentation rate
Total and differential white cell count
Platelet count
Clotting time
Bleeding time
Examination of blood film
Microscopic examination of urine
Microscopic examination of Gram and Ziehl-Nielson stained film
Microscopic examination for fungi in skin, hair and nails
Rapid Plasma Reagin card test
Pregnancy test by immune chemical method
Chemical test for occult blood
Sreening test for urine by using dipstick or its equivalent

Second Schedule

[Paragraph 69(c)]

TESTS EXEMPTED WHEN PERFORMED BY REGISTERED

DENTAL PRACTITIONER IN HIS OWN PREMISES

Blood glucose estimation

Haematocrit estimation
Haemoglobin estimation
Total and differential white cell count
Platelet count
Clotting time
 Pathology Laboratory 69
Bleeding time
Rapid Plasma Reagin card test
Screening test for urine by using dipstick or its equivalent

Third Schedule

[Paragraph 69(d)]

TESTS EXEMPTED GENERALLY

Blood glucose estimation by using simple instrumentation specifically designed

for home use
Urine test for glucose
Urine pregnancy test
70 Laws of Malaysia Act 674

LAWS OF MALAYSIA

Act 674

PATHOLOGY LABORATORY ACT 2007

LIST OF AMENDMENTS

Amending law Short title In force from

– NIL –
 Pathology Laboratory 71

LAWS OF MALAYSIA

Act 674

PATHOLOGY LABORATORY ACT 2007

LIST OF SECTIONS AMENDED

Section Amending authority In force from

– NIL –