Ethiopian Public Health Institute

Food science and Nutrition Directorate

National Food safety and Food microbiology
Laboratory

A Proposal on

Baseline Assessment of
Regional Public Health Laboratories
for Routine Tests and Their
Preparedness for Laboratory
Outbreak Investigation

TABLE OF CONTENTS

1. Introduction.............................................................................................................................3

2. Objectives...............................................................................................................................4

2.1 General Objectives...............................................................................................................4

2.2 Specific objectives................................................................................................................4

3. Scope.......................................................................................................................................5

3.1 Minimum requirements of laboratory services....................................................................5

4. Methodology...........................................................................................................................6

4.1 Assessment planning and implementation...............................................................................6

4.1.1 Build and prepare the assessment team.........................................................................6

4.1.2Who will perform the auditing?......................................................................................6

4.1.3 Schedule Period.............................................................................................................7

May05-June 05/2021..............................................................................................................7

5. List of Regional Laboratories.................................................................................................8

6. Budget Break down................................................................................................................9

7. Recommendations, analysis of the results and summary.....................................................10

Annexes........................................................................................................................................11

I Assessment questionnaire......................................................................................................11
1. Introduction
The right to have safe food and drinking water is a matter of human right which is also declared by the
United Nations, though globally the problem is of high disease burden in terms of causing diarrheal
illness. This is also true in Ethiopia a country with a population of more than 110 million people,
demanding to have safe and clean water as well as safe food. The role and significance of food and
drinking water microbiology has been undermined or have not came to the big picture of the health
system.

Laboratory services are an essential and fundamental part of all health systems. Reliable and timely
laboratory tests are the pillar of the health system for the efficient prevention and intervention of
infectious diseases. The importance of public health laboratories, particularly food and drinking water
microbiology is of great significance in the prevention and mitigating the disease burden of food and
waterborne borne diseases.

The Case team of national Public health microbiology and Food safety Reference laboratory is one of
public health teamunder the directorate of food science and nutrition of Ethiopian public health
institute. Until now, the national public health microbiology laboratory is the pioneer laboratory which
is capable of running an investigation and surveillance related to food and waterborne outbreaks as well
as routine food, water, environmental sample, medical equipment microbial analysis. In addition to the
above mentioned duties , the other frontline work performed by these laboratories are the monitoring,
surveillance response to outbreaks and giving scientific advices, training of professional from different
sectors such as governmental organization, factories, Universities, etc.
The importance of this base line assessment is unquestionable in terms of establishing a recognized and
functional regional laboratories which are capable of serving the community in assuring the safety of
drinking water and food and investigating of food and water borne outbreak for the different regions of
Ethiopia.
The development of this proposal is part of a team effort by the different professionals of the laboratory
services in trying to achieve its mission which is generally aimed at providing baseline assessment for
regional laboratories.
2. Objectives
2.1 General Objectives

The overall objective of this baseline assessment is to assess the current capacity of Public Health
Microbiology/Food and Water Microbiology laboratory in Regional laboratories for routine food
and water test as well as preparedness for water and food borne outbreaks.

2.2 Specific objectives

To provide information on the current status of the regional public Health Laboratory.
To assess available resources (Man power, laboratory set up, Laboratory materials) in Regional
Laboratories.
To assess their preparedness for Food and Water borne outbreak investigation of regional
laboratories.
Identifygaps inregional public health laboratories capacitytomeet performance objectives.
Identifystrengths and weaknesses ofthe health laboratorysystem
Provide objective datato nationaldecision-makers forplanningand implementing
laboratorycapacitystrengtheningactivities.
 3. Scope

This baseline assessment covers the requirements of operating an appropriate Quality Management System
and the requirements of an appropriate international quality standard, such as ISO/IEC 17025:2017. It does
not cover the requirements of Environmental Management or Occupational Health and Safety Management
(such as ISO 14001:2015 or BS OHSAS 18001:2007).

3.1 Minimum requirements of laboratory services

Laboratory services are functional only if a combination of the following elements is adequate and in
place:
 A well identified national laboratory leadership structure
 A functional organizational structure
 National policy
 National regulations
 Appropriate testing services
 Referring and networking activities (data and specimens sharing)
 Infrastructures
 Human resources
 Reagents and equipment procurement and supplying systems
 Information management
 Financing system
 Quality management system
 Bio-risk management
 4. Methodology
To fully assess the laboratory system, two sorts of areas need to be addressed: strategic organization and
support at the national level from the government (e.g. defining policies and regulatory framework), and
specific technical capacities at the laboratories level.

Assessment of the structure, organization and regulations of the regional laboratory system(s) through
collection of data at regional level (and intermediate/peripheral level) if time and resources allow and
using interviews or meetings. The assessment team can be guided by the laboratory assessment tool.

The assessment team will use checklists or EN ISO17025 assessment tools and onsite observation and
inspection.

4.1 Assessmentplanningand implementation

4.1.1 Buildandpreparetheassessmentteam

The assessment team should be built according to the Terms of Reference of the assessment mission. The
assessment can be carried out by:
 Stafffromthe Ethiopian Public Health Institute, Food microbiology Laboratory

4.1.2Who will perform the auditing?

It willbecompletedbythosefamiliarwith the requirementsofaqualitymanagement

systemandtheappropriatestandard.
 4.1.3 SchedulePeriod

May05-June 05/2021

S. Period Tasks Responsible Remark

N person
0

1. Day 1 Travel and settling Assessment team

2. Day 2 Meeting with officials & ,,

Technical meetings or interviews
with administrative stakeholders

3. Day 3 Assessment of each ,,

laboratory,Debriefing of the
assessment team. Exchange of
information and collection of all
individual assessment files with
officials.

4. Day 4-5 Travel ,,

5. List of Regional Laboratories
S.N0 Regional Laboratory Group Assigned person Remark

1. Group -1 Samson and

Adama Regional Laboratory kaleab
2. Addis Ababa Regional
Laboratory
3.
Afar Regional laboratory
4. Amhara Public Health Group -2 Firhiwot and
Institute Geremew
5.
Tigray Regional Laboratory
6. Sub-regional
Dessei Regional Laboratory
7. Group -3 Getamesay and
Jijiga Regional Laboratory Tatek
8.
Harer Regional Laboratory
9. Diredawa Regional
Laboratory
10. Group -4 Tesifaye and
Hawassa Regional Laboratory Tigist
11. Arbaminch Regional Sub-regional
Laboratory
12. Sub-regional
Jinka Sub regional laboratory
13. Nekemte Regional Laboratory Group -5 Getinetand Sub-regional
Waktola
14. Assosa Health Research
Institute
15. Gambela Regional Laboratory
 6. Budget Break down
S. Tasks Number Number of Total cost Rounds Rem
No of days ark
personnel

1. Per diem for 10 30 days 10*30*650 Round-

assessor =195,000 1
birr

2. Plane ticket 10 6 trip 3000*12=3

6000

Grand 231,000birr
total

7. Expected Outcome

From this baseline assessment, an overview of the general picture and an input of the current status of the
laboratories in terms of their preparedness for serving the community and able to respond for any query to
investigate food and waterborne disease will be known. This is significant in terms of planning for the
long-term coaching and mentoring of the laboratories as the different laboratories is expected to will be at
different levels. Depending upon resources and other factors, the result will be used to choose and select
certain number of regional laboratories to plan and focus for the long term coaching and mentoring until
the laboratories are fully functional.

8. Recommendations, analysis of the results and summary

Recommendations will be made following the observation and inspection. It is important to remember that
assessments will beperformed to improve the condition of the laboratory and understand that maintaining
good relations between the assessor and the laboratory personnel is vital. Hence, all recommendations and
advice will be made in a friendly manner. Comments that may be quite embarrassing or upsetting for the
laboratory should only be mentioned to the manager of the laboratory (or the person in charge) at the end
of the assessment.
It is recommended that the following aspects be noted at the conclusion of the assessment:
 Weaknesses of the laboratory, in order to highlight future actions for improvement of the
laboratory. The assessor should highlight only the three most important indicators that
need to be implemented/improved
 Strengths of the laboratory, in order to highlight the laboratory's positive aspects
 Annexes
I Assessment questionnaire

Food and water microbiology Laboratory National baseline assessment questionnaire

Regional laboratory name-----------------------------------------------------------

S.No Description Remarks
Name of interviewer
1.
Date
2.
Name and title of person being
3.

interviewed:
Name of department
4.
Physical and postal address
5.
Telephone
6.

Information about interview

Name of the team leader/interviewer_____________________________
Date: _____________________________
Time interview started: _____________________________

I. ORGANIZATION
1. How are the laboratories organized? Describe all levels of the
Hierarchy?
2. Are all laboratory supplies managed (reporting, ordering,
distribution, and storage) through one system or through multiple
systems?
3. Is there a laboratory unit/division/committee operating that  Yes (specify)
coordinates laboratory activities in the regional laboratory?  No
  Don’t know/not sure

II. POLICY

4. Is a unit responsible for formulating national policies on  Yes (specify)

Laboratory services?  No
 Don’t know/not sure
5. Does the district have national guidelines and protocols for laboratory  Yes (specify)
procedures?
 No
 Don’t know/not sure
6. Are there documented standard operating procedures (SOP) for tests  Yes (specify)
performed at each level?  No
 Don’t know/not sure
7. Are there written guidelines on safety precautions?  Yes (specify)
 No
 Don’t know/not sure

8. Are there written national laboratory procedures for quality assurance?  Yes (specify)
 No
 Don’t know/not sure
III. FINANCING

9. What are the sources of funds for laboratory services, including a .Government?
infrastructure, supplies (reagents and consumables), and equipment. b. User’s fees/cost recovery?
What percentage of total funding is contributed by each source:
c. Donors (list by donor)
d. Other? (specify)
 IV. LABORATORY SERVICES MANAGEMENT INFORMATIONSYSTEM
10. Is there a laboratory services management information system? Yes
 No
 Don’t know/not sure
11. . Are standard national forms available and used to collect and report Yes
laboratory services management information?  No
 Don’t know/not sure
V. SUPERVISION

12. Is scheduled laboratory supervision available at the following levels: Yes(describe)

 No

VI. LABORATORYPERSONNEL

13. Current working staff by category Number Number who have attended refresher
laboratory- related training course or
workshop in the past 12 months

a. Laboratory Scientific
Officer/microbiologist
b. Laboratory Technologist
c. Laboratory Technician
d. Laboratory Assistants
e. Laboratory Attendants

VII. LABORATORY TESTINGSERVICES

14. Tests Performed at Health Center Laboratory

Laboratory Test: Check
if performed by
laboratory
Water microbiological test
Food microbiological test
Standard Technique: Check if Record reason(s) for not using the
performed by laboratory standard technique or for not doing the
test
Environmental testing
Other public health
microbiological tests
 VIII. LABORATORYINFRASTRUCTURE

15. Type of Room Regional laboratory Remarks

Reception

Sample processing room

Identification room

Media preparation room

Cleaning Room

Mini Store

Comment
 Laboratory Area Yes No Comments
1. Laboratory area is maintained in good condition (e.g.,
clean, all trash removed, shelves are sturdy, etc).
2. Laboratory is secured with a lock and key but is
accessible during normal working hours.
3. Laboratory has shelves and lockable cupboards; access
is limited to authorized personnel.
4. Laboratory has sufficient space to adequately store
existing supplies.
5. Laboratory has:
6. a. Running water
b. Access to filtered rainwater
8. Laboratory has a consistent power supply and/or a (Record average number of
generator with a guaranteed supply of petrol or solar hours per day electric power
power. is available.)
9. Laboratory has separate sinks for washing laboratory
ware and staining, and for washing hands after being
exposed to infected materials.
10. Laboratory has drainage from laboratory sinks that are
closed and that lead to either a septic tank or deep pit.
11. Laboratory has a functioning incinerator or other
nationally acceptable waste management (e.g., a
protected pit) to correctly dispose of all hazardous
waste (e.g., needles, toxic materials) and fuel for the
incinerator (if applicable).
12. Laboratory floors are in good condition without the
need for repair.
13. At all times, roof is maintained in good condition to
avoid sunlight and water penetration.
14. Laboratory is well ventilated and cross-ventilated.
IX. Laboratory area inspection

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