Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations, 1998

Jurisdiction
Tanzania
Citation
Government Notice 399 of 1998
Primary work
Private Health Laboratories (Regulation) Act
Date
31 July 2002
Language
English
Type
Legislation
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Tanzania
Private Health Laboratories (Regulation) Act

Private Health Laboratories (Conditions Pre-requisite to Registration and Management) Regulations, 1998

Government Notice 399 of 1998

  • Published in Tanzania Government Gazette
  • Commenced on 1 July 1998
  • [This is the version of this document at 31 July 2002.]
  • [Note: This legislation has been thoroughly revised and consolidated under the supervision of the Attorney General's Office, in compliance with the Laws Revision Act No. 7 of 1994, the Revised Laws and Annual Revision Act (Chapter 356 (R.L.)), and the Interpretation of Laws and General Clauses Act No. 30 of 1972. This version is up-to-date as at 31st July 2002.]
[Sections 18; 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 Act1;1Cap. 136"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 ChemistryHaematology 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) Act2 shall register their health laboratories and be categorised in groups as provided under regulation 2.2Cap. 151
(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.
(8)Fees for all approved applications for rendering private health laboratory services as shown in the Third Schedule shall be made payable to the Board before rendering any private health laboratory services.
(9)Any person who contravenes or fails or refuses to comply with any of the provision of these regulations commits an offence against the Act.
(10)Subject to subregulation (9) any person convicted of an offence to these regulations is liable to a fine of not less than two hundred thousand shillings or to imprisonment to a term of not less than two years or to both fine and imprisonment.

4. Regional laboratory technologist to become an Assistant Registrar

Subject to subsection (4) of section 9 of the Act, the regional laboratory technologist shall be the Assistant Registrar.

5. Authorized officers to inspect equipment and chemicals

All health laboratory equipment, reagents and chemicals imported or distributed in the country shall be subject to inspection by officers authorized by the Board.

6. Defective equipment, reagents and chemicals to be destroyed

If health laboratory equipment, reagents and chemicals are defective and/or expired, the Board shall cause them to be destroyed at the expense of the owner.

7. Accidents to be recorded

All Private Health Laboratories shall—
(a)record all accidents; and
(b)display standard health laboratory safety rules approved from time to time by the Board.

8. Mechanism of receiving complaints to be set

The Board shall set mechanisms of receiving complaints of poor laboratory investigation services and proper action shall be taken in accordance with provision of subregulation (10) of regulation 3 of these regulations.

9. Appointment of permanent and temporary officers

The Board may from time to time by resolution appoint such permanent or temporary officers as they may deem to be necessary and may remunerate such officers by way of salary.

10. Training for members and staff

The Board shall make sure that its members and staff are trained regularly in order to perfom their duties efficiently.

Part II – The Private Health Laboratories (Material and Supplies (regs 11-27)

11.

Except as otherwise provided in these regulations, no person shall manufacture, sell, supply, import or export any health laboratory supply unless—
(a)the product is in the list of the national health laboratory services supplies or has been approved by the Board;
(b)the person holds the appropriate permit required and issued by the Private Health Laboratories Board.

12.

(1)Subject to regulation 11—
(a)the Board may on application being made in the form PHL FORM B specified in Second Schedule to these regulations, permit any laboratory product subject to such conditions as it may impose;
(b)every application for permit for any laboratory product shall be accompanied by non-refundable application fees provided for under the Third Schedule of these regulations and by such documents, items samples, particulars or information as the Board may require;
(c)the Board may charge any applicant such costs as it may incur, for the purpose of carrying out laboratory investigation prior to the issuing of the permit or inclusion of the product in the national health laboratory services supplies list;
(d)any change in any document, item, sample particulars or information provided under subregulation (b) above shall be notified in writing by the applicant to the Board within fourteen days from the date of such change and shall be accompanied by alteration fee as indicated in the Third Schedule;
(e)subject to subregulation (a) of this regulation, the period of permit of laboratory product shall be specified in the permit certificate issued under subregulation (g) of this regulation and where so specified, the permit shall be valid until the end of the specified period;
(f)upon approval of the laboratory supplies or product or payment of permit fee by the applicant the Registrar shall grant to the applicant a permit certificate;
(g)a permit certificate granted under this regulation shall be issued in the form PHL CERT 3 set out in the Second Schedule to these regulations.
(2)Any person who knowingly supplies false or misleading information to the Board in connection with his application for any health laboratory supplies permit commits an offence.

13.

(1)The Registrar shall keep and maintain a suppliers register of the approved health laboratory products.
(2)Subject to subregulation (1) of this regulation, the register shall contain—
(a)name and address of the supplier;
(b)the name of the product (generic);
(c)the name and address of the manufacturer;
(d)manufacturer's certificate number;
(e)the date of issue and expiry of the permit certificate.

14.

The Board may require any person applying for permit of any imported laboratory supplies to furnish a written declaration made by or on behalf of the manufacturer of the product that all the legal requirements governing the manufacture of such product imposed by the laws of the country of manufacturer have been complied with.

15.

The Board may without giving any reason, reject any application for permit of any laboratory product.

16.

The Board may at any time and without assigning any reason suspend or cancel the permit certificate of any laboratory supplies and may cancel conditions to which such permit is subject.

17.

The laboratory chemicals or reagents manufacturing laboratory or plant should not be in the same building with living premises, hotel, bar, restaurant, hair salon and other commercial or entertainment activities.

18.

The registration permit for rendering health laboratory services in terms of provisions of laboratory supplies whether as a manufacturer, retail or whole seller, representative, importer or exporter, shall be renewed annually.

19.

Any person who needs to import or export specimens shall make sure that the specimens are put in a sealed and leak-proof container and placed in a polythene bag similarly well sealed. Specimens sent by post shall obey post office regulations and contained in a plastic bag surrounded by absorbent material and then packed in a strong cardboard box or plastic container.

20.

The Board after scrutinizing permit requests shall recommend to the licensing authority whether or not a person may be issued licence for importing, exporting, selling, manufacturing or operating as a company representative for any of the health laboratory supplies.

21.

No person shall be issued a licence to deal with any of the provisions of the health laboratory supplies unless he has received recommendations from the Registrar of the Private Health Laboratories Board.

22.

Where a person is convicted of an offence under the Act, such conviction shall entail automatic revocation of his permit and this shall be a ground of refusal to review the permit after one year.

23.

Every permit shall be personal to the permittee named therein and shall not be transferable to another person.

24.

Every application for permit to import any health laboratory product listed in the national health laboratory supplies list shall be in a form PHL FORM B set out in the Second Schedule to these regulations and shall be accompanied by fees prescribed by the Third Schedule of these regulations.

25.

(1)The Board may issue such directions to any person as it thinks necessary for the better carrying out of the provisions of these regulations and which may in particular relate to the recall of any laboratory product from the market and the disposal of any product.
(2)Any person who contravenes any directions issued by the Board under subregulation 12(2) of these regulations shall be guilty of an offence.

26.

(1)No person or any local manufacturer of health laboratory supplies or products may export any health laboratory supplies or products from the United Republic of Tanzania to a destination outside Tanzania unless authorised by the Board.
(2)Every authorised manufacturer of health laboratory supplies who exports any health laboratory product shall keep a full and accurate record of all his exports to indicate whether the supplies exported were registered and parcel post shall indicate—
(a)name of product;
(b)date of exportation;
(c)batch number, production date and expiry date;
(d)name and address of customer;
(e)mode of exportation if by post or registered;
(f)address of final destination.

27.

Any person convicted of an offence under Part II of these regulations is liable to a fine of not less than two hundred thousand shillings and not exceeding five hundred thousand shillings or to imprisonment for a term not less than six months or both fine and imprisonment.

Part III – Manufacture of health laboratory supplies or products (regs 28-35)

28.

(1)Every application for a permit to manufacture laboratory supplies or products, shall be in the form PHL FORM C set out in the Second Schedule to these regulations.
(2)A permit certificate granted under this regulation shall be issued in the form PHL CERT 2 set out in the Second Schedule to these regulations and shall be valid from 1st April in the year issued to 31st March in the following year.
(3)A permitted manufacturer shall ensure that the personnel employed at all levels of manufacture—
(a)possess suitable qualifications required for their jobs;
(b)have adequate experience and are technically competent;
(c)are regularly trained during their employment for the purpose of keeping up to date with any advancements or changes; and
(d)are regularly medically examined.

29.

(1)A permitted manufacturer shall ensure that the laboratory supplies are manufactured, processed, packed, labelled and tested in the premises which are in accordance with the standards set by the Board.
(2)Subject to subregulation (1) of this regulation a permitted manufacturer shall ensure that—
(a)there is adequate storage space and good sanitation conditions;
(b)manufacturing operations are carried out in accordance with WHO standards of good manufacturing practices, rules and other requirements as may be determined by the Board;
(c)proper records, of every batch of finished products of laboratory materials distributed are maintained to enable information retrieval or for inspection purposes.
(3)A permitted manufacturer may have in his possession or under his control and supply free samples of health laboratory supplies or products for carrying out health laboratory investigations to laboratory which satisfy him that they may lawfully possess those laboratory supplies in accordance with standard guidelines for health laboratory facility.

30.

Every permit shall be personal to the permittee named therein and shall not be transferable to another person.

31.

(1)A permitted manufacturer shall establish a Quality Control Department under the supervision of a suitably qualified person to control—
(a)materials used in manufacturing process;
(b)manufacturing process; and
(c)the quality and suitability of the finished product.
(2)For the purpose of subregulation (1) of this regulation, a permitted manufacturer shall provide such facilities as may be necessary for the Quality Control Department to discharge its duties.

32.

(1)The Board may certify on any matter relating to any laboratory product where such certification is required by any country importing such product.
(2)Subject to subregulation (1) of this regulation a certification fee prescribed under the Third Schedule of these regulations shall be payable on issued certification.

33.

Any person who refuses or fails to comply with the provisions of Part III of these regulations commits an offence.

34.

Any person convicted of an offence under regulation 33 of these regulations is liable to a fine of not less than two hundred thousand shillings or to imprisonment for a term not less than six months or both fine and imprisonment.

35.

Where a person is convicted of an offence under regulation 33 of these regulations, such conviction shall entail automatic revocation of his permit and it shall be a ground of refusal to review the permit after one year.

Part IV – Medical representative/dealer/retail seller for health laboratory supplies (regs 36-40)

36.

(1)Any person practising as a medical representative/dealer/retail seller for health laboratory products with any engagement in the sale or supply of health laboratory products may have in his possession or under his control free samples of health laboratory supplies or products for carrying out laboratory investigations to laboratories which satisfy him that they may lawfully possess those laboratory supplies in accordance with standard guidelines for health laboratory facilities.
(2)Every medical representative/dealer/retail seller shall within twenty-four hours after supplying any laboratory supply enter the following particulars in a book regularly used for the purpose namely—
(a)the date on which any laboratory product is supplied;
(b)the name and quantity of the laboratory product supplied;
(c)the name and address of the person to whom laboratory products were supplied.

37.

(1)Every application for a permit to operate a medical representative or dealer/retail seller for the laboratory supplies or products, made pursuant to regulation 3(2) of these regulations shall be in a form PHL FORM D set out in the Second Schedule to these regulations.
(2)A permit certificate granted under this regulation shall be issued in the form PHL CERT 4 set out in the Second Schedule to these regulations and shall be valid from 1st April in the year issued to 31st March the following year.
(3)No person shall be a representative/dealer/retail seller for health laboratory products unless that person is approved by the Board.

38.

The Board may issue such directions to any medical representative/retail seller for the health laboratory supplies as it thinks necessary, for the better carrying out of the provisions of these regulations and which may be in particular related to the recall of any laboratory product from the market and the disposal of any product.

39.

Any person who refuses or fails to comply with the provisions of Part IV of these regulations commits an offence.

40.

Subject to regulation 39 any person convicted of an offence is liable to a fine of not less than two hundred thousand shillings or to imprisonment to a term of not less than six months or both fine and imprisonment.

Part V – Importation of health laboratory products (regs 41-42)

41.

(1)Subject to subregulation (2) of regulation 3 of these regulations, no person other than a person issued with a permit under the provisions of these regulations may import to the United Republic of Tanzania any health laboratory equipment, chemicals, reagents or any other laboratory product.
(2)The Board may issue a permit for the importation of materials for new technology trials in the form PHL FORM E set out in the Second Schedule to these regulations authorising the permittee to import any laboratory products for purposes of technology trials notwithstanding that the product is not in the national health laboratory Supplies list.
(3)A new technology import permit will include supplies of only one type of method of any health laboratory investigation.
(4)A new technology import permit shall be reviewed and renewed annually for period not exceeding three years from the date of the issue of the permit and may be specified in the permit.
(5)Every permit shall be personal to the permittee named therein and shall not be transferable to another person.
(6)Any person who refuses or fails to comply with the provisions of these regulations commits an offence.

42.

Any person convicted of an offence under regulation 41(6) of these regulations is liable to a fine of not less than two hundred thousand shillings or imprisonment to a term not less than six months or both fine and imprisonment.

First Schedule (Regulation 4(1))

General standard guidelines for private health laboratory services

1.Any approved person shall not work in another similar health laboratory facility registered under his or her name.
2.The health laboratory facility should have an identified address and should not be in the same building with living premises, hotel, bar and restaurant, hair salon and other commercial or other entertainment activities.
3.The building should be easily accessible by road throughout the year.
4.The premises should have good and properly functioning toilets, shower or bath rooms, sluicing room or washing slab.
5.The premises should have reliable clean running water, effective ventilation, lighting system, incinerator and burial area for sharps after sterilization.
6.There should be an effective communication system between the laboratory and other health care facilities to ensure early management and referral of patients.
7.Each health laboratory facility shall keep records on specimens from patients and or public sources including examination results, such records shall be kept for 5 years before throwing them away, and shall be accessible for inspection by required authority.
8.There should be adequate space for all rooms offering different kinds of health laboratory services, minimum size for reception room should be floor area 2 x 2 metres, working room floor area 5 x 4 metres.
9.Any professional malpractice, misconduct or gross negligence may result in closure of the premises and the Board may take any disciplinary action.
10.
(1)The health laboratory facility shall be allowed to operate after—
(a)the premises have been inspected by the regional laboratory technologist who may be accompanied by any other person(s) approved by the Board;
(b)an application has been approved by the private health laboratory Board and a certificate of registration issued by the Registrar of the Private Health Laboratory Board.
(2)The registration shall be renewed annually.
11.There shall be an inspection fee for re-registration charged yearly by the Private Health Laboratory Board to any private health laboratory facility.
12.The approved person should always be available at the health laboratory facility in case of the Group B2, Group B1 and Group A laboratories and must always personally be present at the Group C laboratory for a minimum of 2 hours twice a week.
13.The Manager or owner of the laboratory facility must employ at least the minimum number of workers in accordance with the standard guidelines for a health laboratory facility.
14.The operation of the private health laboratory will be done in accordance with the guidelines issued from time to time by the Ministry of Health.
15.The private health laboratory facility shall have appropriate standard equipment and other supplies according to the laboratory groups before offering different kinds of service.
16.The equipment shall have a regular system of maintenance and operational and service manuals should be available.
17.
(1)The costing mechanisms for various health laboratory services provided shall be made available to the Board or its inspectors on demand.
(2)Patients or clients have full right to get an invoice with details on how the total cost was arrived at.
(3)Each charged component must be shown separately.
18.There shall be no advertising either in mass media or through posters or signs. Any sign should be made no more than 300 metres from the private health laboratory facility itself and shall only be for directional purposes.
19.Private health laboratories are not allowed to undertake clinical examinations or prescribe or provide prescriptions or medicines to patients.
20.The health laboratories facility should make use of the standard bench work manuals provided for or approved by the Ministry of Health.
21.Walls and floors of the health laboratory should be impervious to water and have smooth washable surfaces.
22.The windows should readily be opened to allow adequate ventilation and sufficient light.
23.The bench tops should be smooth without cracks by using formica or similar hard material allowing easily cleaning and disinfection.
24.The roof should be of corrugated sheets or concrete roofing or tiles.
25.It is mandatory for a private health laboratory to participate in National Quality Assurance programs and a fee set out in the Third Schedule shall be paid annually for this activity.

Standard guidlines for each health laboratory group

1.Group C LaboratoriesThe Group C laboratories should have the following:
1.1Premises:Reception and one working room;Two washing sinks, one at the reception and another at working room;Two bench and wall shelves one for working reagents and another for manuals and record files;Two wastebins (a) one for sharp and (b) another for disposable waste.
1.2Furniture:One table for reception;One chair for reception;One bench for patients at reception;Two stools at the working room;Two working benches.
1.3Essential major equipment:Binocular powered microscope (electrical or light);Centrifuge machine electrical or manual;Haemoglobinometer/Lovibond comparator;Weighing scale;Timer;Kerosene stove;Spirit lamp/bunsen burner;Staining rack;Tally counter;Boxes for microscope slides;Cover glass for haemoglobinometer;Differential counter;One refrigerator with freezing compartment for reagents and/or vaccines;Glucometer;Improved Neubauer's chamber.
1.4Essential tests and methods:
SpecimenTestMethod
1. BloodHaemoglobinHaemoglobincyanide method
Blood filmRomanowsky and field stain
Total leucocyte countTurk's method
Differential leucocyte count and cell morphologyRomanowsky stain
Sickle cellSodium metabisulphite slide test
screening test
Syphilis screeningRPR
GlucoseGlucometry
2. UrineGlucoseGlucostix/Benedict's test
ProteinAlbustix/Sulphosalicylic acid
SedimentDirect microscopy
3. StoolProtozoa/OvaDirect microscopy saline and iodine preparation
4. SputumAFBZiehl Neelsen stain
5. SkinAFBZiehl Neelsen stain
Fungal elementsDirect potassium hydroxide preparation
Onchocerca volvulusDirect saline preparation
Romanowsky staining microscopy
6. Pus/ ExudatesTrichomonasDirect saline preparation miocroscopy
 BacteriaGram staining
7. Any other essential tests and methods as may be approved by the Board.
1.5Preservation and posting of:
(a)Swab specimens — culture: use Stuarts transport medium;
(b)Sputum — TB culture: use empty sterile container.
1.6Human resources:Licensed Laboratories TechnologistLaboratory Attendant
2.Group B2 LaboratoriesThe Group B2 Laboratories should have the following:
2.1Premises:Reception and two working roomsOne room for stool, urine examinations, Gram staining and Z/N stainingAnother room for Haematology and Clinical Chemistry[N.B. If the laboratory is going to perform Blood Group Serology (B/T) then separate rooms for blood donation and blood group serology are required.]Three washing sinks: one at reception and others one at each working roomLockable cupboardsLaboratory store with shelves for reagents/chemicalWall/bench shelves for reagentsThree working benches.
2.2Furniture:Wall/bench shelves for reagentsLockable cupboardsReception to have one table, one chair, one bench for patients, one sink and pigeonholes for the laboratory resultsEach working room to have one table, one chair, one sink and 2 stoolsDonation room to have donation beds, one bench, a compartment for resting, room to which will have one set of couches, one coffee table, wall shelf/cupboard and one fan in area with hot climateLaboratory store with shelves for reagents/chemicals.
2.3Essential major equipment:All equipment found at the Group C Laboratories plus the following:VDRL rotatorFuchs-Rosenthal chamberAutoclave/Pressure cookerWaterbathHot air ovenDistillerMaximum/Minimum thermometerSterilizer/kerosene stoveElectrical stabilizer for sensitive equipmentWestergren standELISA reader or optionalELISA washer.
2.4Essential tests and methods—All tests and methods of Group C Laboratories plus the following:
SpecimenTestMethods
UrineBile pigmentsFouchet's test
Ketone bodiesRothera's test
UrobilinogenEhrlich's test
BloodReagent tablet
Pregnancy testSlide latex agglutination
StoolOccult bloodReagent tablet
Blood/SerumESRWestergren
Platelet countAmmonium oxalate
Reticulocytes countBrilliant cresyl blue test
Bleeding timeIV
Clotting timeLee and White
ABO and Rhesus groupingTile and tube method
Compatibility testingTube bovine albumin
SyphilisVDRL
HIV testsVisual or ELISA
GlucoseO-toluidine method
Total proteinBiuret reaction
CreatinineJaffé
BilirubinJendrassik - Grof
UreaReagent strips
Alkaline phosphatasePNPP
ALAT/ASATCommercial Kit
CSFTotal proteinCoomassie brilliant blue
GlucoseO-toluidine
Cell countFuchs-Rosenthal counting chamber
Differential cell countRomanowsky stain
Deposit: direct with preparation organismsGram stain and Z/N stain
2.5Human resources:Registered laboratory technologistsLicensed laboratory technologistLaboratory attendantsA full time Pathologist may replace one registered laboratory technologist
3.Group B1 LaboratoriesGroup B1 Laboratories should have the following—
3.1Premises:Reception and three working roomsOne room for stool, urine, gram stain and Z/N stainAnother room for haematology, B/S and Clinical Chemistry and another room for Serology and BacteriologyN.B. If the laboratory is going to perform Blood Group Serology (B/T) then separate rooms for blood donation and blood group serology are required.Laboratory store with shelves for reagentsPreparation and washing room (2 x 2m)Office for the laboratory headLockable cupboardsWalls/bench shelves for working reagents
3.2Furniture:Reception to have one table, one chair, one bench for patients, and a pigeon hole for the laboratory resultsEach working room to have one table, one chair and two stools and two working benchesDonation room to have donation bed, one bench and compartment for resting room to which will have one set of couches, one coffee table wall self/cupboard and one fan in areas with hot climateLockable cupboardsWalls/bench shelves for working reagents
3.3Essential major equipment:All equipments found at the Group B2 laboratories plus the following:Analytical balanceIncubatorFlame photometer or any other appropriate equipmentGas cylindersVacuum pumpAnaerobic jarspH meterELISA reader or any other appropriate equipmentELISA washerVoltage stabilizerSpectrophotometerBlood cell counter
3.4Essential test and methods:All tests and methods of group B2 laboratories plus the following:
SpecimenTestMethods
Blood SerumProthrombin timeManufacturer's manual
Partial Thromboplastin timeManufacturer's manual
Full Blood PictureAutomation method
Bone marrow aspirationRomanowsky stain and microscopy
Widal testScreening and titration method
Uric AcidCaraway
AlbuminBromocresol green
ElectrolytesFlame emission or any other approved method
Bacteriological BloodCulture and sensitivityApproved Standard Inoculation
PusCulture and sensitivityApproved Standard Inoculation
UrineCulture and sensitivityApproved Standard Inoculation
CSFCulture and sensitivityApproved Standard Inoculation
Other body fluidCulture and sensitivityApproved Standard Inoculation
StoolCulture and sensitivityApproved Standard Inoculation
Skin scrapings or other tissuesSpecific test for fungusApproved method
3.5Human resources:
Registered Specialist Laboratory Technologists or Pathologists
Haematology/Blood transfusion1
Clinical Chemistry1
Microbiology1
Registered laboratory technologist4
Licensed laboratory technologist5
Laboratory Attendants5
4.Group A Laboratories
4.1Single purpose group A laboratoryThis type of laboratory operates with one speciality as:Group A single purpose Haematology LaboratoryGroup A single purpose Clinical Chemistry LaboratoryGroup A single purpose Blood Group SerologyGroup A single purpose Histopathology LaboratoryGroup A single purpose Parasitology LaboratoryGroup A single purpose TB LaboratoryGroup A single purpose Microbiology LaboratoryGroup A single purpose Laboratory for any specific health problemEach single purpose group A laboratory should have the following:
4.1.1Premises:Reception and two working rooms and store
4.1.2Furniture:As for B2 Laboratory
4.1.3Essential major equipment:As per speciality according to standard guidelines for health laboratory facility
4.1.4Essential tests and methods:According to laboratory discipline, all tests at B1 level
4.1.5Human resources:Registered specialist health laboratory technologistLaboratory attendant
4.2Multipurpose group A laboratoryThe specification of the laboratory will be same as that of Group B1 with additional space depending on additional specialised activities
4.2.1Premises:The laboratory building shall have adequate rooms for each of the required specialities (departments)HaematologyBlood group serologyMicrobiologyTB laboratoryClinical ChemistryParasitologyHistopathologyOffice room for the laboratory headSluiceWeighing roomCollection of blood for transfusionMedia preparation (microbiology)Cold roomStaff roomToilet rooms for staff, male patients and female patientsIncinerator and closed drainage facility
4.2.2Furniture:As for B1 Laboratory
4.2.3Essential major equipment
(a)HaematologyVoltage stabilizerHaemoglobinometerHaematocrit centrifugeBinocular microscopeDark ground/phase microscopeImproved Neubauer's chamberDifferential counterBlood mixerElectrophoretic tankElectrophoretic powerSlide cabinetCounterCoagulometerRefrigerator with freezerHot air ovenSterilizerAnalytical balance
(b)Blood transfusion (Blood Group Serology)Voltage stabilizerBinocular microscopeBlood cabinet with alarmCentrifuge refrigeratorVacuum pumpPlatelet shakerElectric sealerELISA readerHaemoglobinometerSafety cabinetFreeze-drierVDRL rotatorCold roomIncubator (air)WaterbathSterilizerELISA washerManual balanceRefrigeratorDeep freezer -20°C
(c)Microbiology/Immunology:Voltage stabilizerBinocular microscopeIncubatorWaterbathCentrifuge, electricalVDRL rotatorFuchs-Rosenthal chamberFluorescent microscopeCabinet (safety)Centrifuge refrigeratorDeep freezer -70°CHot blocksMicroserology equipmentMicrofiltration apparatusELISA readerELISA washer - manualFreeze-drierCarbon dioxide incubatorAnalytical balanceManual balance
(d)TB LaboratoryVoltage stabilizerBinocular microscopeIncubatorShielder centrifugeInspissatorSafety cabinet — Class IIFluorescent microscopeWalk-in incubator (37°C)
(e)Clinical ChemistryVoltage stabilizerElectric centrifugeSpectrophotometerWaterbathFlame photometerElectrophoretic tankElectrophoretic power supplypH meterBlood mixerHot plate with magnetic stirrerReflux flaskPipette washerBlood gas analyzerChloride meterOsmometerFreeze-drierEnzyme analyzerHot air ovenElectrophoretic scanner
(f)Parasitology:Voltage stabilizerBinocular microscopepH meterSlide cabinetMechanical shakerELISA readerELISA washerDissection microscopeFluorescent microscopeFume cupboardIncubatorElectrical balanceFreeze-drier (small)Analytical balanceHot air ovenRefrigerator with freezer
(g)HistopathologyVoltage stabilizerAutomatic knife sharpenerEmbedding machineVacuum filtration machineAutomatic tissue processorMicrotomeHot plate with magnetic stirrerWaterbathCryostatBinocular microscopeSafety cabinetAutomatic staining equipmentFreeze-drier (small)Analytical balance
4.2.4Essential tests methods:According to laboratory disciplines all tests at B1 level.
4.2.5Human resources:
Registered specialist health laboratory technologist or pathologist1
Registered health laboratory technologists1
Laboratory attendant1

Second Schedule

Forms

[Editorial note: The forms have not been reproduced.]

Third Schedule (Section 6(3))

Fees

The following fees shall be paid in respect of matters arising under the Act.
1.Application feesT.Shs. 5,000/-
2.Registration fees
1.Group C laboratoryT.Shs. 30,000/
2.Group B2 laboratoryT.Shs. 40,000/
3.Group B1 laboratoryT.Shs. 50,000/
4.Group A single purpose laboratoryT.Shs. 50,000/
5.Group A multipurpose laboratoryT.Shs. 80,000/
6.Health laboratory attached to private dispensary health centre or hospitalNIL
3.Inspection fee for re-registration fees
1.Group C laboratoryT.Shs. 15,000/-
2.Group B2 laboratoryT.Shs. 20,000/-
3.Group B1 laboratoryT.Shs. 25,000/-
4.Group A single purpose laboratoryT.Shs. 25,000/-
5.Group B multipurpose laboratoryT.Shs. 40,000/-
4.Payment for Quality Assurance Activity:
1.Group C laboratoryT.Shs. 5,000/-
2.Group B2 laboratoryT.Shs. 5,000/-
3.Group B1 laboratoryT.Shs. 10,000/-
4.Group A single purpose laboratoryT.Shs. 10,000/-
5.Group B multipurpose laboratoryT.Shs. 15,000/-
5.Other Fees:
1.Importation permitT.Shs. 2% of Free on Board
2.Exportation permitT.Shs. 60,000/-
3.Manufacturing permitT.Shs. 120,000/-
4.Manufacturing certificate feesT.Shs. 30,000/-
5.Medical representative for health laboratory supplies and productsT.Shs. 120,000/-
6.Dealer or wholesaler of health laboratory supplies/productsT.Shs. 100,000/-
7.Retail seller or health laboratory supplies or productsT.Shs. 30,000/-
8.Alteration feeT.Shs. 30,000/-
9.Importing materials for new technology trialT.Shs. 50,000/-
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History of this document

31 July 2002 this version
Consolidation
01 July 1998
Commenced

Cited documents 2

Legislation 2
  1. Private Health Laboratories (Regulation) Act
  2. Private Hospitals (Regulation) Act

Documents citing this one 0