The Private Health Laboratories (Regulation) Act

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CHAPTER 136
THE PRIVATE HEALTH LABORATORIES
(REGULATION) ACT
[PRINCIPAL LEGISLATION]
Arrangement of Sections
Section Title
part i
PRELIMINARY PROVISIONS
1. Short title.
2. Application.
3. Interpretation.
part ii
ESTABLISHMENT AND FUNCTIONS OF THE BOARD
4. Establishment of Board.
5. Functions of Board.
6. Power of Board to approve persons and set fees.
7. Revocation of certificate of registration.
8. Sources of funds of Board.
part iii
APPOINTMENT OF REGISTRAR AND MANAGEMENT OF
PRIVATE HEALTH LABORATORIES
9. Appointment of Registrar and Assistant Registrar.
10. Duties of Registrar in relation to registered private health laboratories.
11. Registration and publication of particulars of approved persons.
12. Restriction on management by private health laboratories.
part iv
REGISTRATION OF PRIVATE HEALTH LABORATORIES
13. Identification of private health laboratory.
14. Registration of private health laboratories.
15. Cancellation of registration of private health laboratories.

cation of private health laboratory.
14. Registration of private health laboratories.
15. Cancellation of registration of private health laboratories.

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
part v
GENERAL PROVISIONS
16. Inspection and search.
17. Offences by approved persons.
18. Regulations.
19. Entitlement to practise for fees.
20. Fees not recoverable unless approved person or private health laboratory
is registered under this Act.
21. Appeal.
SCHEDULE

to practise for fees.
20. Fees not recoverable unless approved person or private health laboratory
is registered under this Act.
21. Appeal.
SCHEDULE

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CHAPTER 136
THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT
An Act to regulate the registration and management of private health
laboratories managed by approved persons and in respect of private
health laboratory services to be rendered by private health laboratories
and for related matters. [1st December, 1997]
[GN. No. 766 of 1997]
Act No. 10 of 1997
PART I
PRELIMINARY PROVISIONS
1. This Act may be cited as the Private Health Laboratories
(Regulation) Act. 2. This Act shall apply to all private health laboratories,
approved persons and to any other person engaged in the
management of a private health laboratory, whether as an
owner or as an employee of that private health laboratory. 3.

any other person engaged in the
management of a private health laboratory, whether as an
owner or as an employee of that private health laboratory. 3.

In this Act, unless the context otherwise requires-
“approved person” means a registered health laboratory
technologist or a pathologist approved by the Board to
manage a private health laboratory in accordance with
the provisions of this Act;
“Assistant Registrar” means Assistant Registrar appointed
under section 9 of this Act;
“Board” means the Private Health Laboratories Board
established under section 4 of this Act;
“Minister” means the Minister responsible for matters
relating to medical and health services;
Short title
Application
Interpretation

n 4 of this Act;
“Minister” means the Minister responsible for matters
relating to medical and health services;
Short title
Application
Interpretation

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E.

d. No part of this book may be reproduced or distributed without permission of OAG.682
THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E.

2023]
“pathologist” means a medical practitioner who holds or
possesses a post graduate qualification in either clinical
chemistry, hematology, histopathology, microbiology,
parasitology and registered with the Medical, Dental and
Allied Health Professionals Act;
“private health laboratory” means any health laboratory
registered by the Board to provide private health
laboratory services in accordance with this Act;
“private health laboratory services” means services provided
by a health laboratory to an individual and the community
and includes clinical chemistry; hematology and blood
transfusions; histopathology and cytology; microbiology
and immunology; parasitology and medical entomology
and research, health education and the provision of
laboratory investigations supplies;
“registered health laboratory technologist” means any duly
qualified person who is authorised to practise the health
laboratory profession by virtue of that person being
registered or licensed under the provisions of the Health
Laboratory Practitioners Act;
“Registrar” means the Registrar of Private Health
Laboratories appointed under section 9.

r the provisions of the Health
Laboratory Practitioners Act;
“Registrar” means the Registrar of Private Health
Laboratories appointed under section 9.

PART II
ESTABLISHMENT AND FUNCTIONS
OF THE BOARD
4.–(1) There is hereby established a board to be known as
the Private Health Laboratories Board which shall, subject to
the provisions of this Act, be responsible for the registration,
control and regulation of private health laboratories. (2) The composition, appointment, tenure, quorum,
proceedings and meetings of the members of the Board, shall
be as provided in the Schedule to this Act. (3) The Minister may, by order in the Gazette, amend any or
replace the Schedule to this Act. Cap. 152
Cap. 48
Establishment of
Board

ule to this Act. (3) The Minister may, by order in the Gazette, amend any or
replace the Schedule to this Act. Cap. 152
Cap. 48
Establishment of
Board

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
(4) In appointing members of the Board, the Minister shall
have regard to the need to appoint persons with qualifications
and experience in health laboratory technology and the
conduct or management of public affairs as would enable
members to effectively and fully contribute to the discharge of
the functions of the Board. 5.

conduct or management of public affairs as would enable
members to effectively and fully contribute to the discharge of
the functions of the Board. 5.

The functions of the Board shall be-
(a) to receive, scrutinize-
(i) approve and register; or
(ii) disapprove and not register,
all applications for establishing private health laboratories
within Tanzania;
(b) to monitor or regulate all private health laboratories
within Tanzania;
(c) to receive, scrutinize-
(i) approve and register; or
(ii) disapprove and not register,
all applications of approved persons to run or manage private
health laboratories;
(d) to keep and maintain a register for-
(i) private health laboratories; and
(ii) approved persons;
(e) to hold regular meetings to deliberate on matters
relating to private health laboratories;
(f) to carry out any other functions as may be deemed
necessary under the provisions of this Act; and
(g) to hold regular meetings to deliberate on matters
relating to private health laboratories. 6.–(1) The Board shall have powers to approve or disapprove,
any application by a person to establish or manage a private
health laboratory under the provisions of this Act. (2) The Board shall, by order published in the Gazette,
prescribe requirements which persons shall fulfil in order to
qualify for approval under this section.

Board shall, by order published in the Gazette,
prescribe requirements which persons shall fulfil in order to
qualify for approval under this section.

Functions of
Board
Power of Board to
approve persons
and set fees

Functions of
Board
Power of Board to
approve persons
and set fees

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
(3) The Board shall set fees payable by owners of private
health laboratories which shall include-
(a) application fees;
(b) registration fees; and
(c) any other fees, as may be prescribed by the Board. (4) The funds collected under subsection (3) of this section
shall be retained by the Board for the purpose of facilitating
the activities and functions of the Board as are provided for by
this Act. (5) The Board shall authorise a person appointed by the
Board to inspect or search any private health laboratory
registered in accordance with the provisions of this Act. (6) Where a person contravenes the provisions of this
Act, the Board shall warn, suspend or cancel a certificate of
registration issued pursuant to the provisions of this Act.

venes the provisions of this
Act, the Board shall warn, suspend or cancel a certificate of
registration issued pursuant to the provisions of this Act.

(7) Where the Board approves the registration of a
private health laboratory or an approved person under this
section, the Board shall issue a certificate of registration
which shall-
(a) be in writing and under the hand of the Registrar;
(b) subject to section 11, be valid for a period as may be
specified by the Board in that certificate of registration
and may be renewed; and
(c) not be transferable. 7. The Board may, at any time and after assigning reasons,
revoke any certificate of registration issued to a private health
laboratory or to an approved person in accordance with section
6 where the Board is satisfied that, the approved person-
(a) has ceased to be eligible for approval under this Act; or
(b) is no longer able to effectively and fully manage a
private health laboratory. 8.–(1) The sources of funds of the Board shall be from-
(a) fees to be collected by the Board under this Act and to
be kept by the Registrar; and
Revocation of
certificate of
registration
Sources of funds
of Board

s to be collected by the Board under this Act and to
be kept by the Registrar; and
Revocation of
certificate of
registration
Sources of funds
of Board

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
(b) other moneys and assets as may vest in or accrue to the
Board whether in the course of the exercise of functions
of the Board or otherwise. (2) The accounts of the Board shall be audited in accordance
with the provisions of the Public Finance Act. PART III
APPOINTMENT OF REGISTRAR AND
MANAGEMENT OF PRIVATE HEALTH
LABORATORIES
9.–(1) The Minister shall appoint a public officer to be the
Registrar of Private Health Laboratories and may appoint
any other public officer to be an Assistant Registrar of Private
Health Laboratories, as the Minister may deem fit. (2) The Registrar shall be the Secretary to the Board. (3) The Registrar shall perform all duties prescribed in
relation to the office by or under this Act and discharge other
functions and duties as the Board may direct or prescribe by
regulations made under this Act.

n to the office by or under this Act and discharge other
functions and duties as the Board may direct or prescribe by
regulations made under this Act.

(4) The Assistant Registrar shall assist the Registrar in the
performance of duties under this Act and may, under the
direction of the Registrar, exercise any of the functions of the
Registrar. 10.–(1) The Registrar shall keep a register in the prescribed
form in which the Registrar shall enter the name of a private
health laboratory registered by the Board and other particulars
relating to a registered private health laboratory as the Registrar
may consider relevant. (2) The Registrar shall delete or amend any of the particulars
under subsection (1) as circumstances may require. (3) At least once in every year, the Registrar shall publish in
the Gazette, or in any newspaper which circulates throughout
Tanzania, a list of all private health laboratories, the registration
of which is still in force. Cap. 348
Appointment
of Registrar
and Assistant
Registrar
Duties of
Registrar in
relation to
registered
private health
laboratories

is still in force. Cap. 348
Appointment
of Registrar
and Assistant
Registrar
Duties of
Registrar in
relation to
registered
private health
laboratories

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
11.–(1) The Registrar shall keep a register in the prescribed
form in which the Registrar shall enter the name of an
approved person and other particulars relating to the persons
as the Registrar may consider relevant. (2) The Registrar shall delete from the Register or amend
any of the particulars as circumstances may require. (3) The Minister shall, by order in the Gazette, prescribe the
form of register. (4) At least once in every year, the Registrar shall publish in
the Gazette or in any newspaper which circulates throughout
Tanzania, a list of all approved persons whose approval is still
in force. 12.–(1) A person shall not manage or cause to be managed
a private health laboratory unless that person is an approved
person. (2) A person shall not manage a private health laboratory
unless that person is an approved person who is registered
under this Act and possesses a certificate of registration in
respect of that private health laboratory.

erson is an approved person who is registered
under this Act and possesses a certificate of registration in
respect of that private health laboratory.

(3) A person who contravenes the provisions of this Act
commits an offence and on conviction shall be liable to a
fine of not less than fifty thousand shillings or to a term of
imprisonment not exceeding two years or to both. PART IV
REGISTRATION OF PRIVATE HEALTH
LABORATORIES
13.–(1) For the purposes of enabling members of the public
to identify private health laboratory, the Board may give
directions in writing requiring private health laboratories to
be identified by means as it may prescribe in the directions. (2) An approved person shall comply with the directions
given by the Board under subsection (1). Registration and
publication of
particulars of
approved persons
Restriction on
management by
private health
laboratories
Identification of
private health
laboratory

nd
publication of
particulars of
approved persons
Restriction on
management by
private health
laboratories
Identification of
private health
laboratory

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
(3) A person shall be deemed to manage a private health
laboratory under this Act where, for himself or on behalf of
any other person, that person actually renders or holds himself
out as ready and willing to render health laboratory services. 14.–(1) A person or approved person shall not manage any
private health laboratory unless that private health laboratory
is registered under this section. (2) An application for the registration of a private health
laboratory shall be made by the approved person or the owner
to the Board. (3) An application made under subsection (2) shall be in
writing, specifying the private health laboratory in respect
of which the application is made, setting out such other
particulars relating to the approved person or to the private
health laboratory as the Minister may, by order in the Gazette,
prescribe.

ut such other
particulars relating to the approved person or to the private
health laboratory as the Minister may, by order in the Gazette,
prescribe.

(4) There shall be a separate application and if registered, a
separate certificate of registration, in respect of a private health
laboratory managed by the approved person. (5) The registration of a private health laboratory under this
section shall become void upon the expiration of thirty days
from the date of any change in the ownership or management
of the private health laboratory. (6) Upon receipt of an application together with the
prescribed fees for the registration of a private health laboratory
under this section, the Board may or may not accept the
application. (7) Where the Board approves the application, the Board
shall direct the Registrar to register the private health
laboratory specified in the application and issue a certificate
of registration in the prescribed form to be prescribed by the
Minister, by regulations published in the Gazette. (8) Where the Board issues a certificate of registration
under subsection (7), may set conditions as may be prescribe
under that certificate of registration. Registration of
private health
laboratories

ation
under subsection (7), may set conditions as may be prescribe
under that certificate of registration. Registration of
private health
laboratories

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
(9) An original certificate of registration issued under
this section in respect of a private health laboratory shall be
displayed in a conspicuous position within the premises of the
laboratory.

ssued under
this section in respect of a private health laboratory shall be
displayed in a conspicuous position within the premises of the
laboratory.

(10) Without prejudice to the general power conferred
upon the Board to accept or not to accept an application under
this section, the Board may refuse to register a private health
laboratory if the Board is satisfied that-
(a) the applicant is not an approved person or is not eligible
for approval under this Act;
(b) the private health laboratory specified in the application
is not under the charge of a private health laboratory
technologist or an approved person who is able to
effectively manage a private health laboratory of the
description given in the application;
(c) for reasons connected with the location, construction,
accommodation, staffing or equipment of the private
health laboratory or of any premises used in connection
with the private health laboratory, it is not up to the
required performance standard to register the private
health laboratory.

es used in connection
with the private health laboratory, it is not up to the
required performance standard to register the private
health laboratory.

(11) A person who manages any private health laboratory
which is not registered under this Act or any private health
laboratory the registration of which has been cancelled or has
ceased to have effect for any other reason, commits an offence
and on conviction shall be liable to a fine not less than twenty
thousand shillings but not exceeding one hundred thousand
shillings or to imprisonment for a term not exceeding two
years or to both. (12) An application for approval or renewal of approval
under this section shall be made to the Board in writing
specifying the name and address of the approved person, the
private health laboratory in respect of which the application
is made, and setting out such other information as may be
prescribed by any regulation made under this Act.

ratory in respect of which the application
is made, and setting out such other information as may be
prescribed by any regulation made under this Act.

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
15.–(1) Where, in respect of any registered private health
laboratory, the Board is satisfied that-
(a) the premises of the private health laboratory are no
longer fit to be used as a laboratory by reason of their
being kept in an unclean or insanitary condition;
(b) the performance standards made for the laboratory
service of persons attending the laboratory is
inadequate; or
(c) the approved person responsible for the management
of the laboratory has failed to comply with any
regulations made under this Act relating to the staff
accommodation or equipment to be provided at a
private health laboratory or prescribing the minimum
standards of services to the persons attending the
laboratory,
the Board may by notice in writing, require the approved
person to remedy the defects specified in the notice to the
satisfaction of the Board within the period as the Board may
specify in the notice.

proved
person to remedy the defects specified in the notice to the
satisfaction of the Board within the period as the Board may
specify in the notice.

(2) Where the approved person fails to comply with the
notice referred to under subsection (1) within the specified
period, the Board may, after calling upon the approved person
to show cause why the registration of the health laboratory
should not be cancelled, cancel the registration. PART V
GENERAL PROVISIONS
16.–(1) The Registrar of Private Health Laboratories and
Assistant Registrar of Private Health Laboratories or any
other public officer authorised by the Board in writing for
that purpose may, where has reasonable cause to believe that,
laboratory services being given on any premises used as a private
health laboratory, demand that the person in charge of those
premises shall allow him free entry to premises and afford him
all reasonable facilities to ascertain whether the private health
Cancellation of
registration of
private health
laboratories
Inspection and
search

im
all reasonable facilities to ascertain whether the private health
Cancellation of
registration of
private health
laboratories
Inspection and
search

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
laboratory service is being rendered in accordance with the
provision of this Act or of the regulations made under the Act. (2) Where the officer after producing proof of his authority
to any person who may reasonably require that proof, is unable
to gain entry to the premises without unreasonable delay or
inconvenience, he may enter the premises without warrant
and inspect them to ascertain the matters specified under
subsection (1). 17. Where any offence under this Act or any regulations made
under this Act is committed by approved persons, a persons
charged with or concerned or acting in the management of the
affairs or activities of the private health laboratory commits
an offence and liable to be proceeded against and punished
accordingly, unless that person proves to the satisfaction of
the court that, he was not aware that, the offence was being
or was intended or about to be committed, or that he took all
reasonable steps to prevent its commission.

he was not aware that, the offence was being
or was intended or about to be committed, or that he took all
reasonable steps to prevent its commission.

18.–(1) The Minister may, after consultation with the Board,
make regulations for the better carrying out of the purposes
and the provisions of this Act. (2) Without prejudice to the provisions of this Act, the
Minister may make regulations-
(a) prescribing forms to be used for the purposes of this
Act;
(b) prescribing fees which shall be payable in respect of
any matters specified in any regulations made under
this section;
(c) requiring approved persons to provide facilities for
the welfare of patients attending the private health
laboratory;
(d) regulating the staff, premises, profile of laboratory
investigations and equipment to be provided at private
health laboratory; and
(e) relating to any matter which is required or permitted to
be prescribed under this Act. Offences by
approved persons
Regulations

th laboratory; and
(e) relating to any matter which is required or permitted to
be prescribed under this Act. Offences by
approved persons
Regulations

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
19. The approved person and a private health laboratory shall,
subject to this Act, be entitled to demand, sue for, and recover
in any court of competent jurisdiction, reasonable charges for
professional aid, advice and visits, and the value of any private
health laboratory professional service or appliances supplied. 20. A person shall not be entitled to recover any charge in any
court by way of claim, counter claim, set off or otherwise for
any professional advice, attention or for the performance of
any private health laboratory service as or by a private health
laboratory service as prescribed or supplied within Tanzania
unless such person or the private health laboratory, is at the
time, approved and registered as such under this Act. 21. A person who is aggrieved by the decision of the Board in
the performance of its functions under this Act may appeal to
the High Court.

this Act. 21. A person who is aggrieved by the decision of the Board in
the performance of its functions under this Act may appeal to
the High Court.

SCHEDULE
(Made under section 4(2))
THE BOARD
1.–(1) The Board shall consist of the following persons to be appointed
by the Minister, namely-
(a) the Director of Hospital Services, who shall be Chairman of
the Board;
(b) a pathologist;
(c) the Principal Health Laboratory Technologist;
(d) a senior health laboratory technologist from any private
health laboratory;
(e) a senior health laboratory technologist representing
voluntary agency organisations;
(f) a legally qualified person representing and nominated by the
Attorney General from persons employed in the Office of the
Attorney General; and
(g) not more than two other members appointed by the Minister. (2) A member appointed under this paragraph-
(a) shall, unless his appointment is sooner terminated by the
appointing authority or he ceases in any other way to be a
Entitlement to
practise for fees. Fees not
recoverable
unless approved
person or private
health laboratory
is registered
under this Act
Appeal
Appointment,
composition and
tenure of office of
Board

verable
unless approved
person or private
health laboratory
is registered
under this Act
Appeal
Appointment,
composition and
tenure of office of
Board

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
member, hold office for a period of three years but shall be
eligible for re-appointment;
(b) may at any time resign from his office by giving notice in
writing addressed to the Minister, and from the date specified
in the notice or, if no date is so specified, from the date of the
receipt of the notice by the Minister, he shall cease to be a
member. 2. The members of the Board shall elect from their number a Vice-
Chairman of the Board and who shall, subject to his continuing to be a
member, hold office for a term of one year from the date of his election,
but shall be eligible for re-election. 3.–(1) The Board shall ordinarily meet at times and places as it deems
necessary for the transaction of its business as required under this Act
but shall meet at least once in every three months. (2) The Chairman or on his absence, the Vice-chairman, may at any
time convene a special meeting of the Board, and shall, on request by
majority of the members in office, convene a special meeting.

airman, may at any
time convene a special meeting of the Board, and shall, on request by
majority of the members in office, convene a special meeting.

(3) The Chairman or in his absence, the Vice-Chairman, shall pre-
side at every meeting of the Board. (4) In the absence of both the Chairman and the Vice-Chairman,
members present shall elect a member from amongst themselves to pre-
side over the meeting. 4. The quorum at any meeting of the Board shall be half of the members. 5.–(1) Subject to subparagraph (2), questions proposed at a meeting of
the Board shall be decided by a majority of votes of members present
and voting, and in the event of an equality of votes, the person presiding
shall have a casting vote in addition to his deliberative vote. (2) A decision may be made by the Board without a meeting, by cir-
culation of the relevant papers among the members and the expression
of the views of the members in writing, but any member may require
the decision be deferred and the subject matter be considered at a meet-
ing of the Board. 6.–(1) The Board shall cause to be recorded and kept details of all
business conducted or transacted at its meetings, and the minutes of
each meeting of the Board shall be read and confirmed, or amended
and confirmed, at the next meeting of the Board signed by the person
presiding at that meeting.

g of the Board shall be read and confirmed, or amended
and confirmed, at the next meeting of the Board signed by the person
presiding at that meeting.

(2) Any minutes purporting to be signed by the person presiding at
a meeting of the Board shall, in the absence of proof of error, be deemed
to be a correct record of the meeting. Vice Chairman
Meetings of
Board
Quorum
Decision of Board
Minutes of
meetings

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THE PRIVATE HEALTH LABORATORIES (REGULATION) ACT [CAP. 136 R.E. 2023]
7. The validity of any act or proceeding of the Board shall not be affected
by any vacancy among its members or by any defect in the appointment
of any of them.
8. Subject to the provisions of this Schedule, the Board may regulate its
own proceedings.
Vacancies, etc.,
not to invalidate
proceedings
Board to
regulate its own
proceedings

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