3.

Organization of Health Laboratory

Service in Ethiopia

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 Learning Objectives

At the end of this chapter, students will be able to:

Discuss history of health laboratory services in Ethiopia

Explain various level and structure of laboratory services

Elaborate how to organize and administer the laboratory for

delivery of quality laboratory service

Explain the structure, staffing and function of various health

laboratories

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 Introduction
• In Ethiopia, the first health laboratory was established by Italians
during the second world war

• Then, it were taken over by British scientist and organized under the
name of the Imperial Medical Research Institute

• Then, handed over by French team that developed the first well-
organized laboratory under the name of Institute Pasteur d’ Ethiopie

• They established facilities for the production of vaccines, and some

diagnostic service.

• Rabies was the main research area for French team in Ethiopia.

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 Cont…
• Then, the name of institute was changed to Central Laboratory and
Research Institute (CLRI) or currently Ethiopian Public Health
Institute Laboratory

• The Ethiopian Scientific and Medical Officers who took over the
responsibility somehow managed to keep its activities.

• They attracted some Ethiopian candidates and introduced more

activities

• Meanwhile, laboratory technicians training programs were launched

at Gondar Public Health College, Menelik II Hospital and Jimma
Health science college.
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 Cont…

• Recently, there are many laboratories throughout the country

ranging from a huge central laboratory of EPHI to the smallest
health center laboratories.

• The COVID-19 pandemic scaled up the role of laboratory

testing capacity and established numerous testing centers

• Nowadays, Ethiopia continues to work towards improving the

quality and accessibility of health laboratory services

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 Levels of Laboratory Service
• The laboratory services are integrated with the 3-tier public health
system at the primary, secondary and tertiary levels

• Besides these, there are also reference laboratories, research

laboratories, and specific disease laboratories to provide services
for complex and special tests

• The private sector provides laboratory support at all levels of

health care both in rural and urban areas

• Collaboration between the public and private sectors is crucial for

a comprehensive and effective healthcare system
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Laboratory Structure

National
Reference
Lab
Integrated Services and Testing

Planning
Policy and Strategic
Regional
Reference
Lab

Zonal/District
Hospital Labs

Health Center Labs

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 Cont…
• Each laboratory should identify the scope, functions and the
capacity of the services offered by it and appropriate
infrastructure with requisite bio-safety measures should be
planned.

• Qualified and trained staff should be employed with periodic

up-gradation of their skills

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 Primary Level
• They are Primary Health Centers (PHCs) and Urban Health
Centers (UHCs)

• Require trained laboratory technicians

• Have microscope facilities and a cold chain system

• Carry out simple laboratory tests such as:

 Hemoglobin estimation and urine examination

 Stool examination for intestinal parasites,

 Blood film examination for malaria parasite and

 Sputum smear examination for acid-fast bacilli (AFB)

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 Community Based Health Centers
• Receive referrals from PHCs

• The role of these labs is to support primary health care in

investigating, controlling, and preventing major diseases in the
community, and in promoting health care by integrated health
education

• The laboratory technicians are trained and equipped to handle

additional laboratory investigations for the management of medical
and surgical emergencies and making etiological diagnosis of STIs.

• Equipped with centrifuge, CBC analyzer and ESR racks and tubes

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 Secondary level
• The district hospitals have facilities and manpower for carrying
out pathology, biochemistry, serology and microbiological
investigations.

• They also carry out tests of water quality and receive referrals
from primary level facilities.

• The laboratory staff includes pathologists, microbiologists,

cytotechnicians, laboratory technicians, blood bank technicians
and laboratory attendants.

e.g. General hospital laboratories, Primary hospital lab.

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 Tertiary level

• The medical college hospitals and non-teaching large hospitals

are equipped with sophisticated diagnostic and investigative
facilities to provide tertiary level health care

• These hospitals receive referrals from the primary as well as

the secondary levels

• E.g. Comprehensive and Specialized hospital lab, Teaching

hospital lab,

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 Reference, Research and Specific Disease Reference
Laboratories
• They provide services in a specialized field or area of importance

• These may be located in a medical college, research institution or a

private institution.

• They set and should maintain high standards of quality in one or

more particular area and therefore receive referrals specific to that
field

• They also offer consultancy, standardize diagnostic tests and carry

out training pertaining to that specific area.

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Laboratory Infrastructure
• Infrastructure of laboratories should be planned according to the
services provided by the laboratory.

• The basic infrastructure facilities include:

– Reception room/area: where requisition forms are received and reports
distributed

– Specimen collection room/area

– Toilets (Male and Female for both patients and staff)

– Privacy room for special purposes e.g. semen collection

– Facilities for disabled persons

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 Cont…
o Uninterrupted power supply

o Analytical work area

o Specimen/slide storage facility including cold storage where

applicable

o Record room/area

o Facility for cleaning of glassware, sterilization /disinfection

o Waste disposal facility including biomedical wastes

o Fire safety equipment

o Ventilation, climate control and lighting arrangements

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 Cont…
o Separate room/area for meetings/administrative work

o Separate room for staff for resting, eating and storing food,
drinks etc.

o Transport of specimen/samples to referral centers

o Additional infrastructure facilities may be added for special tasks

when needed.

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 Laboratory Personnel
 Each laboratory should designate a Head of the laboratory
who should be overall in-charge of the daily functioning of
the laboratory including administration
 A Quality Manager should be designated for monitoring and
maintaining of day-to-day quality management system.
 The laboratory should maintain a personal file of all the
technical and supportive staff (clerk, cleaner) employed

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 Cont…
Personal file should contain all information on:
Personal bio-data including educational qualification and
experience
Copy of degree/diploma and registration with state authority
if applicable
Copy of appointment letter
The strength of staff employed should be appropriate to the
level of facility and the workload.
The roles and responsibilities of the staff should be clearly
outlined.
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 Cont…
Training and development for personnel

A program for technical training and updating of skills

on a regular basis should be in place

The laboratory management should be committed for

providing continuing professional development and
training opportunities to staff.

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 Cont…
 Action plan for improvement in the laboratory should be
determined and revised according to the feedback received
from previous trainings and experiences.

 Performance appraisal

 Disciplinary action (if any taken by the management)

 Reference letter from previous employer (if applicable)

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 Requisition form

The requisition form should be completed by the physician

requesting the tests and sent along with the specimen/patient to
the laboratory

It should contain the patient's identity, age, address, date of

specimen collection and the investigations requested

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 Accession list
Accession list is a record of all the specimens received by the
laboratory for analysis and is prepared by the laboratory at the time of
specimen receipt

It records the patient's identity including name, age, sex, address in the
hospital/ medical facility, name of requested physician, investigations
requested, date and time of receipt of specimen, condition of the
specimen at receipt (may not be recorded unless it has been rejected),
test results and remarks if any.

The laboratory assigns a unique laboratory code to register each

specimen received, which can be used to trace the specimen in the
laboratory.
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 Reporting test results

Test results approved and signed by the designated authority

should be made available to authorized person(s) only

Results should be reported clearly, without any errors,

specifying measurement procedure where appropriate and
units of measurement as recommended by professional
societies

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 Specimen rejection record

 Laboratories should maintain a record of specimens which

were rejected prior to analysis

Rejection statistics (e.g. number of hemolyzed specimen

etc.) along with reason for rejection and person responsible
for rejection should be maintained

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 Reagents and materials
 Standard reagents of certified quality must be used for the
purpose of analysis.

The batch number of reagents must be recorded.

The reagents, chemicals and consumables materials should be

stored under appropriate environmental conditions

Quality of newly purchased reagents should be validated

against suitable control/reference material prior to use

 Validation data should be properly documented.

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 Cont…
Reagent label should contain name of reagent, concentration, date
of preparation/opening, date of expiry, storage conditions and
warnings e.g. 'do not use if solution is turbid' where applicable

Microbiology laboratories should check activity/potency of each

lot of antibiotic sensitivity discs before using and at least weekly
thereafter with reference strains

Other microbiological consumables such as strips etc. used for

identification should be checked against reference strains

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 Cont…
Laboratories testing microbiology specimens should check
the quality of media by using appropriate reference strain
and pH of the media

All batches of culture containers should be checked for

sterility before issuing to patients for collection of specimen

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 Data management
 Laboratory data management includes recording details of the
patient, findings of analysis, reporting of results and archiving
the data for future reference

 Recording data allows smooth functioning of the internal

quality control measures, internal audit and external quality
assessment

 From the point of view of management, absence of record

implies that the work was never done.

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 Cont…
 The format of recording and reporting results should be described in
the SOPs.

 Data entry should begin as soon as registration number is assigned

to the specimen.

 Further entries should be made in the accession list and worksheet.

 The final report should be recorded after approval of the designated

authority.

 All auto analyzers should be connected with printer and

uninterrupted power supply (UPS).

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 Cont…
 Facilities sending reports electronically should include electronic
signature of the authorized signatory

 Laboratories should be able to provide critical information required

by a physician on telephone

Refer to Basic medical laboratory services standard (for slide 14-

end)
.

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