CHAPTER 136
PRIVATE HEALTH LABORATORIES (REGULATION) ACT

[SUBSIDIARY LEGISLATION]

INDEX TO SUBSIDIARY LEGISLATION

   NOTICES

      The Private Health Laboratories Regulation (List of Health Laboratories Registered by the Board) Notice

   REGULATIONS

      The Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations

NOTICES

THE PRIVATE HEALTH LABORATORIES REGULATION (LIST OF HEALTH LABORATORIES REGISTERED BY THE BOARD) NOTICE

(Section 10(3) and Regulation 4(4))

   1. This Notice may be cited as the Private Health Laboratories Regulation (List of Health Laboratories Registered by the Board) Notice, 1999.

   2. Notice is hereby given to the general public that in the exercise of the powers conferred on the Registrar of the Board in pursuance of the provisions of section 10(3) and Regulation 4(4) of the Private Health Laboratories Regulation Act * requiring the Registrar to publish a list of Private Health Laboratories Registered by the Board. Now therefore, under the powers conferred on me, Mr. S. M. Marina the Registrar, I hereby notify the public that the following Schedule is a list of Private Health Laboratories registered by the Board.

SCHEDULE

A:   AUTONOMOUS HEALTH LABORATORIES

REGION

NAME OF LABORATORY

TYPE OF SERVICES TO BE PROVIDED

Arusha

1.

Highway Laboratory

group C

Dodoma

2.

Upendo Medical Laboratory

group C

3.

Yulia Diagnostic Laboratory

group C

Dar es Salaam

4.

Kelgho Laboratory

group C

5.

Magana Medical Laboratory

group C

6.

Rika Health Laboratory

group C

7.

AMREF-DSM

group A single purpose - Microbiology/Immunology

8.

Universal Clinical Laboratory

group C

9.

Wela Medical Laboratory

group C

10.

Hope Modem Laboratory

group C

11.

Decie Medical Diagnostic Laboratory

group C

12.

Santa Maria Salus Infirmorium Laboratory

group C

13.

Nyangao Medical Laboratory

group C

14.

Azimio Medical Laboratory

group C

15.

S.E.S. Medical Laboratory

group C

Iringa

16.

Tawakali Health Laboratory

group C

17.

Mafinga Diagnostic Laboratory

group C

Kagera

18.

Mutegeki Medical Laboratory

group C

19.

Isingiro Medical Laboratory

group C

20.

Muleba Medical Diagnostic Laboratory

group C

Kigoma

21.

Kalunde Diagnostic Health Laboratory

group C

22.

Kalihamwe Diagnostic Health Laboratory

group C

23.

Continental Medical Laboratory

group C

Kilimanjaro

24.

EDCON Diagnostic Health Laboratory

group C

25.

Tusaidiane Health Laboratory

group C

Mara

26.

Mwasi Health Laboratory

group C

27.

Tarime EMASAM Diagnostics Laboratory

group C

Mbeya

28.

Magoma Health Laboratory

group C

29.

Mbeya Polyclinic Laboratory

group C

30.

J.D.K. Laboratory

group C

31.

Matumaini Medical Laboratory

group C

32.

E.J.M. Laboratory

group C

33.

Makoa Medical Laboratory

group C

Mtwara

34.

Mdeka Laboratory

group C

Mwanza

35.

Nansio Clinical Laboratory

group C

36.

Donatabi Medical Laboratory

group C

Pwani

37.

Lola Medical Laboratory

group C

Shinyanga

38.

Luckensa Medical Laboratory

group C

39.

Mkude Medical Laboratory

group C

40.

Paul Mhoja Laboratory

group C

Tabora

41.

Cheyo Medical Laboratory

group C

42.

Health Diagnostic Laboratory - Tabora

group C

Tanga

43.

Pace Medical Laboratory

group C

B:   ATTACHED HEALTH LABORATORIES

Arusha

1.

Church of Gospel I.N.T. Dispensary

group C

2.

Ngorongoro Conservation Authority (NCAA) Dispensary

group C

3.

Arusha Shirati and Human Diagnostic Centre

group C

4.

Seliani Lutheran Hospital

group B2

5.

Dar es Salaam Tanzania Occupational Health Service (TOHS) Hospital - DSM

group B2

6.

Mudalifah Mbagala Dispensary

group C

7.

NPF Clinic

group C

8.

Ebrahim Haji 1.a. Charitable Hospital

group B2

9.

Dr. Mahmood F.H. Dispensary

group B2

10.

The Aga Khan Hospital - DSM

group A

11.

Prince Saud Health Centre

group C

12.

Bakwata Yombo Dispensary

group C

13.

Hafford Dispensary

group C

14.

Nordic Clinic

group C

15.

1st Medical Scheme Clinic

group C

16.

Mashuda Dispensary

group C

17.

Dahoma Dispensary

group C

18.

Kwezi Dispensary

group C

19.

Family Medical Service

group C

20.

Nsekya Dispensary

group C

21.

Dr. S. I Massawe Dispensary

group C

Dodoma

22.

Area "A" Health Centre

group C

23.

Mackey House Medical Clinic

group C

Iringa

24.

Uwemba Health Centre

group C

25.

Consolata Hospital - Ikonda

group B2

26.

St. Raymonds Health Centre

group C

27.

Mavaga Dispensary

group C

28.

Wambi Dispensary

group C

29.

Aga Khan Health Centre - Iringa

group C

30.

Mshindo Dispensary

group C

31.

Chachu Dispensary

group C

32.

Iringa Medical Centre

group C

33.

SPM Health Centre

group C

34.

Maria Stopes Iringa

group C

35.

Ilula Lutheran Health Centre

group C

36.

llembula Hospital

group C

37.

Mandela Dispensary

group C

Kagera

38.

Bukoba Medical Centre

group C

39.

St. Therese Dispensary

group C

40.

Medivision Health Care

group C

41.

Nyakaiga Hospital

group C

Kigoma

42.

Kigoma International Dispensary

group C

43.

Embassy Consultant Dispensary

group C

44.

Medical Consultant Dispensary

group C

45.

Al-ehsaa Health Centre

group C

46.

Kishamba Dispensary

group C

47.

Tughenjonye Dispensary

group C

48.

Y.M.C.A. Tanzania Referral Dispensary

group C

49.

Jaffery Charitable Medical Services

group C

50.

Kilimanjaro Dispensary

group C

51.

Gonja Lutheran Hospital

group C

52.

R.M. Nina Dispensary

group C

53.

Siima Charitable Hospital

group C

Lindi

54.

Brigita Dispensary

group C

55.

Pole Dispensary

group C

Mara

56.

Mkono Huruma Dispensary

group C

57.

Kowak Health Centre

group C

58.

Tarime Dispensary

group C

59.

Kigera Health Centre

group C

60.

Lake Victoria Dispensary

group C

61.

Musoma M.S. Dispensary

group C

Mbeya

62.

St. Paulliness Rural Health Centre

group C

63.

Mbeya Surgical Dispensary

group C

64.

K's Hospital

group C

65.

Lot's Dispensary

group C

66.

Kyela S.D.A. Dispensary

group C

67.

Sifika Dispensary

group C

68.

Ilasi Dispensary Tunduma

group C

69.

Mwambani D.D.H.

group B2

70.

Mbozi Mission D.D.H.

group B2

71.

Ilasi Health Centre

group C

Morogoro

72.

Tumaini Health Centre

group C

73.

Mikumi Health Centre

group C

74.

Ahmadiya Medical Centre

group C

Mtwara

75.

Seventh Day-Adventist (S.D.A.) Mtwara Dispensary

group C

Mwanza

76.

Kulwa Dispensary

group C

77.

Aga Khan Medical Centre - Mwanza

group C

Pwani an 1

78.

Kellen Dispensary

group C

Rukwa

79.

Kasema Dispensary

group C

80.

Dr. Atman Health Centre

group C

81.

Dr. Mnzavas Dispensary

group C

82.

Seventh Day Adventist - Mpanda Dispensary

group C

83.

SDA Church Health Service - Sumbawanga

group C

Ruvuma

84.

Mbinga Huduma Dispensary

group C

85.

Songea Private Dispensary

group C

86.

Mfaranyaki Charity Dispensary

group C

87.

Day and Night Dispensary

group C

Singida

88.

St. Gaspar Hospital

group B2

89.

Mzalendo Dispensary

group C

90.

Tumaini Charitable Dispensary

group C

91.

Bikira Maria Mama wa Neema Health Centre

group B2

92.

Huduma Dispensary

group C

93.

St. Carolus - Mtinko Health Centre

group C

94.

Bakwata Dispensary

group C

95.

Makiungu Hospital

group C

Shinyanga

96.

St. Ernest Dispensary

group C

97.

Kolandoto Hospital

group B2

Tabora

98.

Nyachera Dispensary

group C

99.

Itanana Health Centre

group C

100.

Nkinga Hospital

group B2

101.

Bakwata Dispensary No. 11

group C

102.

Isanzu Dispensary

group C

Tanga

103.

Tamta Charitable Dispensary

group C

104.

Hale Dispensary

group C

105.

T.M.C.C. Hospital

group C

106.

Burhani Dispensary

group C

107.

Hindu - Mandal Dispensary

group C

108.

Tanzania Harbours Authority Health Centre - Tanga

group C

REGULATIONS

THE PRIVATE HEALTH LABORATORIES (CONDITIONS PRE-REQUISITE TO REGISTRATION AND MANAGEMENT) REGULATIONS

(Sections 18)

[1st July, 1998]

G.N. No. 399 of 1998

PART I
REGULATIONS (regs 1-10)

1.   Short title

   These regulations may be cited as the Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations.

2.   Interpretation

   In these Regulations, unless the context requires otherwise–

   "the Act" means the Private Health Laboratories Regulation Act *;

   "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 provision of the Act;

   "Board" means the Private Health Laboratories Board established under section 4 of the Act;

   "commencement date" means the 1st day of July 1998;

   "group A laboratory" means a referral health laboratory for group B1 laboratories which is attached to a Tertiary Hospital or may operate as an autonomous Private Health Laboratory;

   "group A multipurpose laboratory" means any group A laboratory which operates health laboratory services in two or more of the following disciplines of the laboratory speciality:

   •   Clinical Chemistry

   •   Haematology and Blood Transfusion;

   •   Histopathology and Cytology;

   •   Microbiology and Immunology;

   •   Parasitology and Medical Entomology;

   •   Any other speciality as approved from time to time by the Board;

   "group A single purpose laboratory" means a health laboratory which operates with one discipline of the laboratory speciality;

   "group B1 laboratory" means the referral health laboratory for group B2 laboratories which is attached to a secondary hospital or may operate as an autonomous private health laboratory;

   "group B2 laboratory" means the first referral health laboratory for group C laboratories which is attached to a primary hospital or can operate as an autonomous private health laboratory;

   "group C laboratory" means health laboratory services which is attached to a dispensary or health centre or can operate as an autonomous private health laboratory;

   "health education" means provision of information on laboratory investigations;

   "private health laboratory services" means services provided by a health laboratory to an individual and the community and includes clinical chemistry, haematology and blood transfusion, histopathology and cytology, microbiology and immunology, parasitology and medical entomology and research, health education and the provision of laboratory investigation supplies;

   "Registrar" means the Registrar of the Private Health Laboratories Board appointed under section 9 of the Act.

3.   Establishment, operation and management of a private health laboratory

   (1) No person shall establish, operate, manage or cause to be managed or operated a private health laboratory facility unless the facility complies with the standard guidelines set out in the First Schedule to these regulations and that the facility has been registered and a certificate issued by the Board.

   (2) No person shall render a private health laboratory service in terms of provision of health laboratory supplies whether by–

   (a)   manufacturing;

   (b)   selling;

   (c)   supplying;

   (d)   importing, exporting or as a representative,

unless the items are included in the national health laboratory services supplies list and application has been approved by the Board and permit certificate granted in accordance with the provisions of the Second Schedule to these regulations.

   (3) No person shall manage a private health laboratory unless that person is an approved person.

   (4) All dispensaries, health centres or hospitals registered under the Private Hospitals (Regulation) Act * shall register their health laboratories and be categorised in groups as provided under regulation 2.

   (5) Subject to subregulation (4) of this regulation that dispensary, health centre or hospital shall be exempted from paying the laboratory registration fees but shall be responsible to pay other fees as required by the Board.

   (6) No health laboratory technologist or pathologist who is in full time employment in the Government or other employer shall manage any of the group B1, B2 or group A private health laboratory, save that such a health laboratory technologist or pathologist may manage a group C health laboratory and may work only on part time basis in any health laboratory group.

   (7) An application to render private health laboratory services under regulation 3 of these regulations shall be made through application form shown in form PHL FORM A and application fees shall be payable to the Board upon collection of the application forms.

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