It is ridiculous to hear that man from Peru complaining about America’s poverty. Peru has twice as much poverty

1. SALALE UNIVERSITY
COLLEGE OF HEALTH SCIENCE
DEPARTMENT OF MEDICAL LABORATORY SCIENCES
ASSESSMENT OF FACTORS AFFECTING THE QUALITY OF MEDICAL
LABORATORY SERVICES IN SELECTED PUBLIC HEALTH
FACILITIES IN NORTH SHOA ZONE, OROMIA REGION, ETHIOPIA
Investigators:
1 MEKEYAS TESHOME Ru 0987/11
2 ESHETU HABTAMU Ru 0916/11
3 MERON TESFAYE R 0736/11
4 YALEW WORKNEH Ru 0234/11
5 GOJJAM NEGESSE Ru 0204/11
JULY, 2022
FITCHE, ETHIOPIA

2. SALALE UNIVERSITY
COLLEGE OF HEALTH SCIENCE
DEPARTMENT OF MEDICAL LABORATORY SCIENCES
A STUDENT RESEARCH PROPOSAL TO BE SUBMITTED TO SALALE UNIVERSITY
COLLEGE OF HEALTH SCIENCE DEPARTMRNT OF MEDICAL LABORATORY
SCIENCES FOR A PARTIAL FULLFILMENT OF BACHELOR SCIENCE DEGREE IN
MEDICAL LABORATORY SCIENCES
Investigators:
1 MEKEYAS TESHOME Ru 0987/11
2 ESHETU HABTAMU Ru 0916/11
3 MERON TESFAYE Ru 0736/11
4 YALEW WORKNEH Ru 0234/11
5 GOJJAM NEGESSE Ru 0204/11
JULY, 2022
FITCHE, ETHIOPIA

3. I
ACKNOWLEDGEMENT
First and for the most we would like to address our deepest gratitude to our almighty GOD for
his support, gracefulness and his mercy who direct us in any circumstance in our life. Next our
heart full thanks go to our advisor Mr. Berhanu Asefa (Bsc, Msc) for his generous assistance
while we were developing this proposal. We would also like to thanks Salale University, College
of Health Science department of medical Laboratory Sciences, for giving this chance to conduct
this proposal. We would also like to thanks anybody who supports us anything in our activities
such as Salale university medical laboratory students and staffs.

4. II
Table of Contents
ACKNOWLEDGEMENT .............................................................................................................................I
Table of Contents..........................................................................................................................................II
Abbreviations and Acronyms........................................................................................................................V
ABSTRACT..................................................................................................................................................... vi
1.1 INTRODUCTION.................................................................................................................................1
Background...............................................................................................................................................1
1.2 Statement of the problem ..................................................................................................................3
1.3 Significance of the study.....................................................................................................................5
CHAPTER TWO ..........................................................................................................................................6
LITERATURE REVIEW .............................................................................................................................6
CHAPTER THREE............................................................................................................................................9
OBJECTIVE .................................................................................................................................................9
3.1 General Objective............................................................................................................................9
3.2 Specific Objectives ..........................................................................................................................9
CHAPTER FOUR ...........................................................................................................................................10
MATERIALS AND METHODS................................................................................................................10
4.1 Study area..........................................................................................................................................10
4.2 Study design and period....................................................................................................................10
4.3 Population .........................................................................................................................................10
4.3.1 Source population ..........................................................................................................................10
4.3.2 Study population ............................................................................................................................10
4.4 Exclusion and Inclusion Criteria.......................................................................................................10
4.4.1 Inclusion Criteria........................................................................................................................10
4.4.2 Exclusion Criteria........................................................................................................................10
4.5 Study variables..................................................................................................................................11
4.5.1 Independent Variable.....................................................................................................................11
4.5.2 Dependent variable ....................................................................................................................11
4.6 Operational definition.......................................................................................................................11
4.7 Sample size and sampling technique ................................................................................................12
4.8 Data collection and processing .......................................................................................................12

5. III
4.8.1 Data collection, Analysis and interpretation..................................................................................12
4.9 Ethical consideration.........................................................................................................................12
4.10 Dissemination of results..................................................................................................................13
UNIT – FIVE RESULT..............................................................................................................................14
UNIT 6; DISCUSSION ..............................................................................................................................25
UNIT SEVEN.............................................................................................................................................27
CONCLUSION AND RECOMMENDATION..........................................................................................27
REFERANCES.......................................................................................................................................28
Annex I ...................................................................................................................................................30
Annex II ..................................................................................................................................................31
Annex III.................................................................................................................................................32

6. IV
List Of Table
Table 1 Socio-demographic characteristics of Laboratory professionals in selected public health
facilities of North Shewa Zone, Oromia, Ethiopia, 2022............................................................... 14
Table 2 Question to assess knowledge and laboratory management activity of Laboratory
professionals working in selected public health facilities North Shewa zone health facilities,
Oromia, Ethiopia, 2022................................................................................................................. 15
Table 3 questions to assess the quality assurance practices and provision of laboratory service in
selected public health facilities North Shewa zone health facilities, Oromia, Ethiopia, 2022. .... 18

7. V
Abbreviations and Acronyms
AIDS: Acquired Immunodeficiency Syndrome
ART: Antiretroviral Therapy
CBC: Complete Blood Count
EPHI: Ethiopian public health institution
EQA: External Quality Assurance
HIV: Human Immune Virus
IQC: Internal Quality Control
ISO: International organization for standards
NPHL: National Public Health Laboratory
QA: Quality Assurance
PPT; Personal protective equipment
SOP: Standard Operating Procedure
SPSS: Statistical Package for Social Science
TAT: Turnaround time
USA: United States of America
WHO: World Health Organization

8. vi
ABSTRACT
Background: The service of laboratory quality is an important part in the health care system to deliver
health services to the community to diagnosis, prognosis and give treatment. Without a good laboratory
services no one could manage ,control ,and prognosis the outbreaks and epidemics of specific disease
that arise in certain areas or as a whole in the country ;but in sub Saharan Africa’s countries like
Ethiopia the laboratory health care delivery system is poor due to different factors that affect the quality
of the laboratory services which in turn affects for the treatment of specific disease.
Objective: Assessment of factors affecting the quality of medical laboratory services in selected public
health facilities in North shoa zone, Oromia Region, Ethiopia, 2022.
Methods: A cross-sectional study design was conducted in selected north shoa zone government health
facilities from July- 30 to September- 1, 2022.The Socio-demographic information was collected by semi-
structured questionnaire and checklist of the study participants to assess factors affecting the quality of
medical laboratory service. All the study participants were taken due to small numbers of study
population in the study area for the sake of data quality and entered and analyzed by SPSS version 25.
Results; A total of 30 medical laboratory professionals participated in the study. Of these 18 (60%) were
males and 12 (40%) were females. Of them 22(73.33%) were not satisfied with their salary. Sixteen
(53.33%) of the participants reported that their laboratory did not provide quality and adequate laboratory
equipment’s. Lack of Quality Manual, Lack of staff recognition (50%) and not conducting Internal
Quality control activities were the major factors significantly associated with poor quality laboratory
service. High work load was identified as the highest technical factor influenced the provision of quality
laboratory services 80%, followed by Equipment Failure 53.33%.
Conclusion; More than half of the study participants reported that their laboratory did not provide quality
laboratory services
Keywords; Quality; Laboratory

9. 1
CHAPTER ONE
1.1 INTRODUCTION
Background
Medical laboratory is an essential part of health care delivery system and play a crucial role in
the health of the people by disease control, surveillance and in individual patient diagnosis and
treatment. In developed countries, like USA most of medical decisions are based on medical
laboratory tests and investigations that account an estimate of around 70% that is performed
annually. The World Health Organization (WHO) observes the quality of laboratory services as a
key to improve the health of the world and to fulfill a standard development goal. Encouraging
the horizon of laboratory services are accessible to patient and ensuring that the laboratory
results to be accurate, reliable, reproducible, and rapid enough is important to improve the
health outcomes (WHO report, 2012).
There are three phases in laboratory quality assurance to improve that the laboratory services are
accurate, reliable, and rapid and timeline. These includes: pre- analytical phase, analytical phase
and post analytical phase.
Pre-analytical phase of Quality Assurance
This phase includes many processes that they take place in different places and at different times
which made it difficult to define and express it. Typically, the pre analytical phase
consists of all processes that take place from the time a laboratory request form is made by a
Clinician until the client sample is ready for a test. Even though this definition is very
informative later it made a significant change in the analytical and post analytical phases.
For instance, interference effects can be determined while analyzing a laboratory sample
(analytical phase) or during clinical interpretation (post analytical phase). Therefore, laboratory
error can be defined as “the defect occurring at any phase in the cycle from request form made
by the physician to the interpretation of results”.
The processes that should be considered during this phase include: test selection; patient
preparation; collection, transportation, handling and preservation of the sample, reagents,
personnel competence, standard operating procedures (SOPs), method evaluation (Plebani M,
2006).

10. 2
It has been documented that the laboratory errors decreased for the past forty years but the
scientific evidence reveals that most laboratory errors occur in the pre analytical phase of QA.
The large majority of laboratory errors occur in poorly standardized or manual processes and
short cut procedure (Cornelia M. et al, 2002).
Analytical phase of Quality Assurance (Quality Control Phase)
Analytical phase includes all the procedures involved in the testing of patient sample. Errors in
this phase less frequently occurred due to:
 The qualifications of personnel in performing the test.
 The Internal quality control programs is effective and
 The external assessment practices assist in identifying analytical errors and detecting
possible sources of errors.
In the past ten years, the number of laboratory errors in the analytical phase has been decreased
dramatically. This is due to: The increase in automation of laboratory processes and
introduction of the External Quality Assurance Program (EQAs) to assess the quality of testing
results. Still, analytical quality is a critical issue in diagnosing and examination of patient
sample.
Post-Analytical phase
This phase occurs after the analytical phase of quality assurance that comprises all steps begin
with the verification and review of patient results, passing to the communication of the results
and their interpretation by the attending clinician.
Laboratory diagnostic tests are parts of medical care that provide objective based information
about a person’s health, which can be used for many purposes, including risk assessment
purposes, monitoring the course of the disease or to assess a patient’s response to treatments.
Quality medical laboratory service provision is important in order to enhance diagnostic
value and save lives of patients, this is because recognition of disease is the foundation of disease
control and prevention. The quality of medical laboratory procedures is driven by technical
skills, quality management systems and the motivation of human resources (Beyene K. 2015).

11. 3
Reliable and timely results from laboratory investigations are critical elements for decision-
making in almost all aspects of health care, and are essential for the surveillance and control of
diseases of public health importance
1.2 Statement of the problem
The service of laboratory quality is affected by the competence of the laboratory personnel who
are both the practitioners and the availability of the recommended working conditions. Poor
quality assurance (QA) in the health of laboratories encompasses all the factors that may affect
the generation of reliable test results, including factors such as pre-analytical, analytical and
post-analytical errors. Poor quality control measurement and poor turnaround time, were also
affects the quality of medical laboratory services. To decrease those errors and enhance
laboratory quality services, WHO provide technical support to countries to strengthen Internal
Quality Control (IQC) and External Quality Assurance (EQA), and its integration into health
care laboratories at various levels of the health care system .The poor interpretations of
laboratory results can cause incorrect interventions and treatment, and adversely affects the
credibility of the laboratory results(WHO-AFRO, 2015).
While quality control systems are designed to ensure the quality of the analytical phase that are
highly developed and in use at most clinical laboratories, this is not the case for the pre analytical
phase. This is because that the laboratory professionals may have always
considered the analytical phase (but not the pre analytical phase) to be the most important
process in their job. Sending out or transportation of the sampling process to another place could
be another cause. Both of these factors lead to a decrease in quality, or increase in pre analytical
errors, which in turn, these errors have required that quality control systems should be
established for the process, including registration and notification of the errors detected at the
collection sites and sampling (Sonntag O. 2009).
Like that of the pre-analytic phase errors, the errors of the post-analytical phase can occur
either inside or outside of the laboratory.
The post-analytical phase is dealing with the actions of the clinicians including the review and
interpretation of the results which is very important for the future patient care that may depend
on this component; the quality of laboratory report can also influence the overall quality of the
laboratory results. It also includes the procedures performed in the laboratory, including the

12. 4
verification of the results, entering the results in to the laboratory computer information system
and the proper communication of the results to the corresponding clinician. The most common
errors found in this phase are: delay of the delivery of the results, failure to report or reporting to
the wrong health care provider, transcription errors, incorrect results, misunderstanding of the
results by the clinician and failure of clinician to see the report (Hawkins RC, 2010)
Giving health care services in sub-Saharan Africa like Ethiopia is very complex, because policy
makers, clinicians, and the public frequently fail to understand that the laboratory diagnosis is
essential to prevent and treat a disease. The laboratories encountered many challenges including
the lack of reliable laboratory support, lack of management of patient , clinical misdiagnosis,
lack of human capacity and laboratory policies, weak strategic plans; and limited synergies
between clinical and research laboratories, inadequate health care, poor laboratory infrastructure,
poor quality control practices, weak proficiency practice ,late turnaround time, low diagnostic
accuracy, poor laboratory management and accreditation were reported (Petti CA. et al,2006).
Many of the resource-limited countries like Ethiopia, do not have a national tiered
laboratory structure with government oversight facilitated by government-approved national
laboratory policy, a strategic plan, or dedicated budgets for laboratories. It is extremely difficult
in those countries to find an articulated laboratory leadership and direction for effective
laboratory management. As a result, one could find inadequately trained laboratory personnel for
deployment at each level of health care delivery system. In addition, the QA at any national
level is poorly established; hence the quality of laboratory results is sub_standard. It is therefore
imperative that laboratory systems be strengthened within broader efforts toward health care
delivery system (Ethiopian health and nutritional institute, 2009).
In most developing countries like Ethiopia, most funding from government is spent on high-
profile projects in teaching institutions in large urban centers. Small and medium sized
laboratories, not attached to a teaching institute, also run on a low-cost level as the patient pays
for his tests rather than the government or insurance companies, and many times these
laboratories use technicians who are unqualified or have inadequate training, to cut down salary
costs. As a result, the quality of reports generated from these laboratories is highly questionable.
Moreover, the diagnostic support of laboratories is essential for a wide range of diseases and
testing purposes, both from clinical and public health perspectives (Tilahun M,et al, 2014).

13. 5
To achieve the quality of the laboratory service, the laboratory professionals need both targeted
training and an appropriate working environment, management support to turn acquired
knowledge into technical skills (ISO 15189, 2012).
Laboratory testing is one of the most widely used diagnostic interventions supporting medical
decisions, yet evidence demonstrating its value and impact on health outcomes is limited. This
contributes to wide variations in test utilization including under diagnosis, over diagnosis and
misdiagnosis, which may impact the quality and the clinical- and cost-effectiveness of care and
patient safety (Zhang HL et al, 2016)
In Ethiopia various efforts have focused on expanding basic laboratories with new technologies
at different levels of the health system, both in terms of the amount of equipment and in
technology, which requires additional skills for laboratory professionals for implementation of
overall practice of laboratory testing. However, many laboratories that have implemented new
technology have not effectively supported the process of developing technical skills with
appropriate training (Ethiopian ministry of health, 2009). Therefore, the aim of this study will be
to assess the factors affecting the quality of laboratory services at government health institution
in selected north shoa zone.
1.3 Significance of the study
The study provides experimental evidence of the quality of medical laboratory service and it also
supports a base line information for the health professionals, academicians and policy makers
regarding factors affecting the quality of laboratory services.
Quality of medical laboratory service is an essential part of a health care delivery for
diagnosing and monitoring of disease. But there are different factors that affect the quality of
medical laboratory service in many developing countries including the lack of awareness on the
role of laboratory service, shortage of resource, poor management support, ineffective services,
low quality control measures, absence of quality assurance programs in all health institutions,
shortages of training and poor staff motivation and trained man power displacement are reported
in previous studies in different countries. There are few studies conducted regarding the factors
affecting the quality of laboratory service in Ethiopia and no data indicating the problem in the
study area. Therefore, the aim of this study is to assess the factors affecting the quality of
medical laboratory service in selected North shoa zone government health facilities, Ethiopia.

14. 6
CHAPTER TWO
LITERATURE REVIEW
Quality systems in any medical laboratory can be defined as the comprehensive and coordinated
efforts to meet the standard goal. For these objectives to be achievable, concerted efforts have to
be invested towards quality improvement at different stages within the organization (Abay
Sisay,et al,2015). In sub-Saharan Africa, laboratory services are one of the most neglected areas
of health care provision and are disproportionately affected by the staff shortages, poor
communications, inadequate equipment, low morale, and lack of training that impinges on all
those involved in delivering health care (WHO, 2015).
A cross sectional retrospective study conducted in United State of America (USA) in 1990
indicates that, individual physician test-ordering behavior often becomes reutilized over time and
the lack of consensus in test ordering behavior had been observed as it affects quality of
laboratory service (Naugler C Ma, 2018).
The descriptive cross-sectional study conducted at American clinical chemistry department in
2002, show that pre-analytical, analytical and post-analytical errors affected the quality of
laboratory service. The study was also indicating the most problems occurred in the pre- or post-
analytical phases, whereas a minority (13–32%) occurred in the analytical portion (Tiwari E et
al, 2017).
A cross sectional study conducted in Iranian healthcare organizations, in 2014, show that
hospital laboratories burdened with heavy workloads, poor compensation packages, poor
communication among technologist and laboratory head, lack of training and educational
opportunities, lack of laboratory supply management, and poor leadership were affected quality
of laboratory service (Mohammed A, 2014).
The Ethiopian public health institute (EPHI) is working with region, partners and stakeholders to
coordinate efforts on bringing each tier of the network up to the standards. This is done in
coordination with the quality program, which were utilized in the context of identifying gaps
between the state of laboratories and the national standards (EHNRI, 2010).
A cross sectional study conducted in Nepal by the National Public Health Laboratory (NPHL)
concluded that few hospital laboratories and private laboratories and the majority of laboratories

15. 7
surveyed were “not up to the standard”. Lack of attention to safety measures that ensure the
accuracy of test results and lack of neither competency assessment nor laboratory-related activity
and staff evaluations and lack of Laboratory standardization were the major factor affecting
quality of laboratory service (Prakash S, 2017).
A descriptive cross-sectional survey conducted in selected hospitals in Sri Lanka in, 2015; show
that Lack of enough staff, staff workload, lack of communication, poor leadership, and certain
attitudes of some laboratory technologist such as laziness, complacency and absenteeism affected
the quality of medical laboratory service (Masfin EA et al, 2017).
A descriptive cross-sectional study conducted at infectious diseases hospital, Kano Nigeria in
2014, indicate that poor internal quality control, external quality assurance, repair and
maintenance problems, policy maker, clinician and public misunderstanding of laboratory
diagnostic purpose were the major factors affecting the quality of laboratory service (Abuboker
A, 2014).
Across sectional study conducted in Nyahururu District Hospital, Kenya, in 2016 indicate that,
poor communication among laboratory staff themselves and physician, lack of technological
instrument, lack of enough man power, health care management problem and lack of sufficient
budget, affected the quality of laboratory service and as general affected all health care delivery
service (Njoroge W, 2014)
A cross sectional prospective study conducted in Addis Ababa Ethiopia, in 2015, indicate that
low salary, absence of risk payment, absence of over time payment and absence of good
laboratory equipment and enough training cause, the skill gap and the professionals could not
contributed their time, effort, skill, knowledge, and they do not work by keeping quality due to
absence of motivation (Abay S et al, 2020).
A hospital based cross-sectional study conducted in Hawasa referral hospital, southern Ethiopia,
in 2012, indicate that, Information provided to patients during specimen collection, location of
the latrine for collection of specimen and length of time patients wait between phlebotomy and
notification of results (TAT) affected the quality of medical laboratory service (Fenta D, et al,
2020).

16. 8
Another cross-sectional study conducted in Ethiopia, Jimma zone, in 2017 indicate that shortage
of laboratory equipment, reagents and consumables, inadequate trained human resource, absence
of electricity, inadequate water supply, weak laboratory quality assurance system, the shortage of
care provider with the frequent turnover and poor commitment of care providers are significant
problem of diagnosis. And poor laboratory information systems were the major factors affecting
quality of medical laboratory service (Belete T et al, 2014).
In general many researches were conducted in different countries, in different period of time
indicates that so many factors like, lack of reliable laboratory support, management of patient
care, clinical misdiagnosis, inadequate health care, poor laboratory infrastructure, poor quality
control practices, lack of risk and over time payment, salary dissatisfaction, heavy work load,
lack of knowledge, no strong proficiency practice ,limited test menus, poor equipment
maintenance, poor turnaround time, poor laboratory management, low diagnostic accuracy and
poor communication among laboratory technologist and physician are affect quality of medical
laboratory service.

17. 9
CHAPTER THREE
OBJECTIVE
3.1 General Objective
 The aim of this study is to assess factors affecting the quality of medical laboratory
services in selected public health facilities in North shoa zone, Oromia region, Ethiopia,
2022
3.2 Specific Objectives
 To assess the quality of medical laboratory service in selected public health facilities in
North shoa zone, Oromia region, Ethiopia, 2022
 To determine factors affecting medical laboratory service in selected public health
facilities in North shoa zone, Oromia region, Ethiopia, 2022.

18. 10
CHAPTER FOUR
MATERIALS AND METHODS
4.1 Study area
The study was conducted in selected public health facilities in north shoa zone, Oromia regional
state, which is bordered on the south by Addis Ababa, on the southwest by west Shewa, on the
north by the Amhara region and on the southeast by East Shewa. Based on the 2019 census
conducted by the central statistical agency of Ethiopia this zone has a total population of
1,639,587 of whom 362,841 are women and 1,276,746 men with an area of 10,3222.48square
kilometers and a total household of 78,700 were conducted in this zone. The town is located
2,827 meters above sea level and has Weynadega weather condition. Currently, the zone has four
hospitals, 63 health centers and 267 health posts.
4.2 Study design and period
A cross-sectional study was conducted in selected public health facilities in north shoa zone,
Oromia regional state, from July 30 to September 1, 2022.
4.3 Population
4.3.1 Source population
All laboratory professionals working in governmental health facilities found in North shoa zone.
4.3.2 Study population
All laboratory professionals working in governmental health facilities during the study period
was included in the study.
4.4 Exclusion and Inclusion Criteria
4.4.1 Inclusion Criteria
Laboratory personnel who worked at least three months in the governmental health facility
4.4.2 Exclusion Criteria
Laboratory personnel who were on annual leave during the study period and on those
governmental health facilities the study is not conducted like Dera gundo meskel and Ali doro.
The laboratory personnel who were not volunteer to participate in the study were also excluded
from the study.

19. 11
4.5 Study variables
4.5.1 Independent Variable
 Socio-demography
 Training
 Education,
 Motivation,
 Salary satisfaction,
 Laboratory management,
 Communication
 Quality assurance activities
 Availability of laboratory reagents and equipment
 Workload
 Work experience
4.5.2 Dependent variable
Quality of laboratory service
4.6 Operational definition
Quality – means a degree of excellence, conformance to requirements, totality of characteristics
which act to satisfy a need, fitness for use, fitness for purpose, freedom from defects and
delighting customers.
Good Laboratory service - the laboratory service which is practiced based on Laboratory Quality
Standards. These standards contain twelve essential Laboratory quality management system
essentials to meet the International Standard Organization (ISO). These include;
1. Organization; is the party responsible for establishing and managing the overall quality
program.
2. Personnel; is the people who provide orientation, develop job description, training and
continuing education program to assess employee competence and performance on each
procedure.
3. Equipment; materials with which we can perform any activities and procedures.
4. Purchasing and inventory; define criteria for product and service to be purchased
5. Process control; it directly relates to analysis in the laboratory.

20. 12
6. Documents and records; used to standardize forms, document approval, document
distribution, document storage, and destruction.
7. Information management; managing incoming and outgoing information.
8. Occurrence management; is a problem situation or error.
9. Quality assessment; conduct periodic assessment of the quality system.
10. Possess improvement; a systematic and periodic approach to improve the quality of
laboratory.
11. Service satisfaction Customer; is a patient, clinician, doctors, nurses, and anyone who
interacts with a laboratory and receives a laboratory report.
12. Facilities and safety; assure the adequacy of testing and storage areas, safety practice,
safety procedure and records.
4.7 Sample size and sampling technique
All study participants under the study were taken due to small number of study population for the
sake of data quality. Convenience sampling method were applied to select the study participant.
So, we planned to study on medical laboratory professionals who fulfils the inclusion criteria
from health facilities in north shoa zone. The sample size of the study participants were 30.
4.8 Data collection and processing
4.8.1 Data collection, Analysis and interpretation
Semi-structured questionnaire and checklist used to collect data like socio-demography, educational
background, work experience, motivation, communication, training, quality assurance activities, and other
factors affecting the quality of medical laboratory service was collected by the investigators in North shoa
zone governmental Health facilities. Data was checked for completeness and entered by using Statistical
Package for Social Sciences (SPSS) version 25 (IBM Corporation, Armonk, NY, USA). Data was
reported as percentages and figures
4.9 Ethical consideration
s. Ethical clearance was obtained from Salale University college of health science department of
medical laboratory science. The participants that are recruited to the study are informed about the
objectives of the study. A written consent obtained from all study participants were involved in
the study. Data collected during the study period used only for the study objectives and

21. 13
participants were participated only once. Information obtained at any course of the study is
confidential.
4.10 Dissemination of results
The final will be presented for Department of Medical Laboratory Sciences of Salale University. The
report will also be disseminated to North Shewa zonal health office, Oromia regional health bureau and
for the study centers. Efforts will be made to present the results on scientific Conferences and for
publication.

22. 14
UNIT – FIVE RESULT
Table 1 Socio-demographic characteristics of Laboratory professionals in selected public health facilities of North Shewa
Zone, Oromia, Ethiopia, 2022
Frequency Percentages
Sex
Male 18 60
Female 12 40
Educational level
Bachelor degree (laboratory technician) 23 76.67
Diploma (laboratory technician) 7 23.33
What is your current position?
Expert 19 63.33
Laboratory Head 7 23.33
Other 3 10
Quality officer 1 3.33
Quality officer 1 3.33
In which laboratory discipline you are doing?
General laboratory 26 86.67
Microbiology 1 3.33
Other 1 3.33
Hematology 1 3.33

23. 15
Table 2 Question to assess knowledge and laboratory management activity of Laboratory professionals working in selected
public health facilities North Shewa zone health facilities, Oromia, Ethiopia, 2022.
Do you have enough knowledge on laboratory quality system?
Yes 25 83.33
No 5 16.67
Are laboratory staff communicate with upper management?
Yes 29 96.67
No 1 3.33
Is there communication among laboratory staff?
Yes 28 93.33
No 2 6.67
Is there over time and risk payments for laboratory worker?
No 23 76.67
Yes 7 23.33
Are you satisfied with your salary?
No 22 73.33
Yes 8 26.67
Is there recognition system for employees in your institution?
Yes 15 50
No 15 50

24. 16
Are you attending continuing educational program?
No 21 70
Yes 9 30
Is there Job descriptions for assigned task?
Yes 29 96.67
No 1 3.33
Is there quality and adequate equipment in your laboratory?
No 16 53.33
Yes 14 46.67
Does your laboratory have adequate number of staff?
No 20 66.67
Yes 10 33.33
Is there a separate budgetary line item for laboratory services?
No 26 86.67
Yes 4 13.33
Is laboratory area is maintained in good condition?
Yes 23 76.67
No 7 23.33
Is there a laboratory services management
information system?
Yes 27 90

25. 17
No 3 10
Are national guidelines and protocols for laboratory procedures available in this laboratory?
Yes 27 90
No 3 10
Is there a laboratory services management information system?
Yes 23 76.67
No 7 23.33
Laboratory workload in your laboratory
Yes 24 80
No 6 20

26. 18
Table 3 questions to assess the quality assurance practices and provision of laboratory service in selected public health
facilities North Shewa zone health facilities, Oromia, Ethiopia, 2022.
Is there proper laboratory documentation in these facilities?
Yes 28 93.33
No 2 6.67
Are there documented SOPs for the tests
performed at this facility?
Yes 30 100
Do the testing procedures in this laboratory follow the national SOPs?
Yes 28 93.33
No 2 6.67
Is there proper customer service management?
Yes 11 36.67
No 19 63.3
Does your laboratory undertake equipment calibration and maintenance?
Yes 19 63.33

27. 19
No 11 36.67
Does your laboratory perform quality improvement activity?
Yes 27 90
No 3 10
Does your laboratory participate in any external quality assurance assessment?
Yes 30 100
check each batch of reagents using known positive and negative specimens?
Yes 29 96.67
No 1 3.33
Is there countercheck test reports with other colleagues before dispatching?
Yes 19 63.33
No 11 36.67
Is laboratory networked and alert for disease outbreak?
Yes 22 73.33

28. 20
No 8 26.67
Can your laboratory always perform all tests for requested test?
No 16 53.33
Yes 14 46.67
Is your laboratory always functional?
Yes 21 70
No 9 30
Are the laboratory results reported within turnaround time?
Yes 9 30
No 21 70
Are there laboratory safety practices in your laboratory?
Yes 25 83.33
No 5 16.67

29. 21
Do you achieve acceptable PT/EQA results on the two most recent PT challenges?
Yes 27 90
No 3 10
Has the laboratory provided uninterrupted testing services, with no disruptions due to stock outs in
the last six months?
No 17 56.67
Yes 13 43.33
Is equipment installed and placed as specified in the operators’ manuals and Uniquely labeled or
marked
Yes 28 93.33
No 2 6.67
Are inventory records complete and accurate, with minimum and maximum stock levels denoted?
Yes 28 93.33
No 2 6.67
Are all reagents/test kits in use (and in Stock) currently within the manufacturer assigned expiry

30. 22
dates?
Yes 29 96.67
No 1 3.33
Is there Organized and implemented Work
flow?
Yes 28 93.33
No 2 6.67
Has the laboratory provided uninterrupted testing services, with no disruptions due to Electric
failure?
Yes 16 53.33
No 14 46.67

31. 23
Socio-demographic characteristics of the study participants
A total of 30 laboratory professionals participated in this study from 2 heath centers and 3
hospitals in selected north shoa zone and the majority 18 (60%) of participants were male and
about 12 (40%) of respondents were female. The age of the participants are between 25-35 years
old with an average mean of 30 years. Twenty-three (76.67%) were Medical Laboratory
Technologist (Bachelor Degree) referred to as highly trained laboratory professionals and 7
(23.33%) were Medical Laboratory Technologist (Diploma) referred to as mid-level trained
laboratory professionals. In terms of work experience 20(66.6%) of the respondents had 3 and
above years of experience and they worked as head, quality officer and expertise and 10(33.3%)
of the professionals worked at general laboratory which perform basic chemistry, hematology,
parasitology, microbiology and serology tests.
Laboratory Quality Management Activities of the respondents
In this study 22 (73.33%) of the laboratory professionals were not satisfied with their salary and
the rest of the study participants were satisfied with their salary. About 21 (70%) of the
laboratory professionals did not attend any task specific training and 21 (70 %) of respondents
did not get opportunity of continuing education program and 15(50%) respondents indicated that
there was no system for staff recognition. Additionally, 24(80%) of the laboratory professionals
claimed that they had high workload while 6(20%) of the laboratory professionals had fair work
load. Moreover, 10(33.3%) of the respondents indicated a shortage of human resources in their
laboratories. Concerning to communication, the laboratory professionals indicated that there
were no systems to communicate with laboratory staff, upper management, and clinicians with
respondents 2 (6.67%), 1 (3.33%) and 24(80%) respectively. Regarding to laboratory equipment
high proportion of the participants 16(53.3%) of the laboratory professionals claimed that there
was shortage of equipment in their laboratory and 6 (20) of the participants reported shortage of
reagents.

32. 24
Quality assurance practices and provision of quality laboratory service of the respondents.
According to this study from all participants only 23 (76.67%) of the participants believed that
they provide quality laboratory service and the rest 7 (23.3%) of them mentioned that they do not
provide quality laboratory service. Regarding to quality assurance practice and provision of
laboratory service, findings from this study revealed that 13 (43.3%) of the respondents indicated
that there was reagent interruption and 17 (36.67%) laboratory professionals did not perform
equipment preventive maintenance as per instruction. Additionally, there was no countercheck
among different laboratory units as stated by respondents and it accounts to 11(36.67%) within
the laboratory professionals. Of the respondents only 10(33.33%) of the laboratory professionals
verify the laboratory results. Additionally, 9(30%) of respondents claimed that laboratory results
were not released within pre-defined turnaround time (TAT) and 19(63.33%) laboratory
professionals also indicated that customer services management system was poor in their
respective laboratories. One (3.33%) laboratory professionals did not monitor laboratory safety
practices and 5 (16.67%) of the professionals also did not use personal protective equipment
(PPE). In addition to this,13 (43.33%) of professionals reported that there was frequently
laboratory service interruption in their respective laboratories due to electric failure, stock out of
reagents, equipment failure, absence of laboratory supplies and other reason. Among the stated
laboratories 3(10%) didn’t achieve acceptable PT and 7(23.33) of the respondents didn’t have a
laboratory service information management system.

33. 25
UNIT 6; DISCUSSION
The findings from this study revealed that 13(43.3%) of the respondents indicated that there was
supplies and reagents interruption and 11 (36.67%) of the laboratory professionals did not
perform equipment preventive maintenance as per instruction. Additionally, there was only
11(36.76%) of the respondent counter check among each other and only 10(33.33%) of the
laboratory professionals verify the laboratory results
But according to Abay S. et al, 2020 revealed that training, motivation, supplement and resources
are the major factors for implementation of quality system and nontrained professionals can also
be highly affects the quality laboratory system. In addition to this, more than 73% of the
professionals were not satisfied with their salary and staff recognition system, as well as poor
communication system affects the quality of good laboratory services.
Turnaround time (TAT) is one of the most noticeable signs of laboratory service and is often
used as a key performance indicator of laboratory performance. In this study, about 30% of the
participants believe that TAT was not followed for most laboratory tests performed and they do
not report the laboratory result within a stated turnaround time.
Higher than this finding was reported from south west shoa zone 40% of laboratory results were
claimed not to be released within predefined turnaround time. This difference may be due to the
difference in human resource, workload, and workflow arrangement differences in the study
institutions. Therefore, the laboratory, in consultation with the users, should establish turnaround
times for each of its examinations that reflect clinical needs and periodically evaluate their work
to monitoring TAT.
Finding from this study shows high work load 80% and 70% of the participants reported lack of
refreshment training.
This study also found out that result verification and reporting system, quality control activities,
equipment preventive maintenance, customer management and adherences and usage of SOP
were not implemented as per the standards. But International Organization for Standardization
(ISO-15189) revealed that implementation of laboratory standards helps laboratories to
demonstrate a well-functioning quality management system. So poor quality management system
directly affects the provision of both quality laboratory services and patient health care services

34. 26
at large. According to this study the findings indicated that 53% of laboratory professionals
reported that there was scarcity of laboratory equipment and reagents in their laboratories and 11
(36.67%) of laboratory professionals did not perform equipment preventive maintenance as per
instruction.
In general, the major findings from this study were factors associated with human resource,
quality management system and polices, and these challenges facing laboratory systems in
selected public health facilities in north shoa zone. So, improving laboratory quality systems
requires political commitment, financial support, follow up from the health system leaders, and
motivated laboratory staff.

35. 27
UNIT SEVEN
CONCLUSION AND RECOMMENDATION
7.1 CONCLUSION
In general, the aim of this study was to identify the factors affecting the quality of laboratory
service delivery system. Most of the laboratories did not have: continuing education/training
program and more than half of the study participants reported that their laboratory did not
provide quality laboratory services.
In addition, in this finding high number of the participants revealed that there is no quality
manual in their laboratory and majority of the participants did not satisfied with their salary. This
study also disclosed that conducting internal quality control activities regularly, human resource,
lack of staff recognition, reagent stockout, lack of time of test result dispatched or to be released
(TAT) had significant association with provision of quality laboratory service in selected public
health facilities in north shoa zone.
7.2 Recommendation
To hospitals and health centers found in selected public health north shoa zone.
The analysis should be made on human resource management for medical laboratory professionals,
staff motivation and recognition by continuous education training program.
 The government should participate in those health facilities for the sake of improving the health
of the community by giving different appraisal to the medical laboratory professionals and setting
strategies for formal communication between laboratory professionals and physicians.
 Regulation of laboratory services through activities such as setting and supervising laboratory
standards

36. 28
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Annex I
Participant Information sheet
Title; Assessment of Factors Affecting Quality of laboratory service in selected public health
facilities found in north shoa zone, Ethiopia
Name of Principal Investigator: Group five students
This information sheet was prepared for Medical laboratory professionals who will be involved
in project entitled above. I will tell you about the whole processes that have been undertaken in
the study and requesting them to participate voluntarily.
Introduction
We are Medical Laboratory Science graduate students at Salale University. First of all, we would
like to thank you just to spend your time with us. As you know, lots of factors affect quality of
laboratory service.
Lack of quality of laboratory service is one of the major diagnostic problems in our country. So,
we want to assess factors affecting quality of laboratory service.

39. 31
You are one of the inputs for this study by responding the questions. You have the right not to
participate or to withdraw any time from the interview. The response you give us will be used for
the purpose of explaining factors affecting quality of laboratory service only and kept
confidential.
Name of data collector: ____________________ Signature: _________ Date: ___________
Procedure: - This questionnaire will take about 10 minutes of your time and your honest answer
to these questions will help me to identify factors affecting quality of laboratory service and will
enable to design better mechanism to improve provision of quality service.
Benefit: - This study will help you and your organization to identify factors affecting quality of
laboratory in your institution
Risk: -There is no risk to you from answering the questions.
Payment: - There is no payment to you for being part of the study.
Confidentiality: - All information collected during this study will be kept private and will only
be known by the investigators
Annex II
Consent form
Participant Agreement
I have read the information above or it has been read to me. I have been given the opportunity to
ask questions and my questions have been answered to my satisfaction. I would participate in
this study and understand that I have the right to withdraw from the study at any time.
Participant name___________________ signature________ Date, _____, ____, ______
Name of investigator _____________Signature ______Date____________
You can contact the principal investigator for any questions about any part of the research study
by the following address.
E-mail; mikitashoma87@gmail.com Cell phone; +251945329857
eshetuhabtamu28@gmail.com Cell phone; +251940813888
Thank you for your cooperation

40. 32
Annex III
Questionnaire
Part one: socio demographic characteristic of laboratory profession
S.NO Question Answer
01 Sex A. Male
B. Female
02 Age __________ years
03 What is your educational level?
A. Diploma (Laboratory Technician)
B. Bachelor degree (Laboratory
technologist)
C. Master degree (Laboratory scientist)
d. Other
04 How long you work in laboratory
fields?
For ________ years
05 What is your current Position? A. Laboratory head
B. Supervisor
C. Expert
D. Quality officer
06 In which Laboratory discipline you
are doing
A. General laboratory
B. Clinical chemistry
C. Hematology
D. Parasitology
E. Microbiology
F. Immunology/Serology
G. Urinalysis
H. Other

41. 33
Part Two: Question to assess knowledge and laboratory management activity
NO. Question Answer
1 Do you have enough knowledge on laboratory
quality system?
a. yes
b. no
c. other
2 Is there communication between laboratory
staff and clinicians?
a. yes
b. no
3 Are laboratory staff communicate with upper
management
a. yes
b. no
c. other
4 Is there communication among laboratory
staff?
a. yes
b. no
5 Is there over time and risk payments for
laboratory worker?
a. yes
b. no
c. other
6 Are you satisfied with your salary? a. yes
b. no
7 Is there recognition system for employees in
your institution
a. yes
b. no
c. other
8 Are you attending continuing educational
program?
a. yes
b. no
9 Is there training for laboratory refreshment? a. yes
b. no
10 Is there Job descriptions for assigned task? a. yes
b. no
c. other
11 Is there quality and adequate equipment in
your laboratory?
a. yes
b. no
c. other
12 Is there quality and adequate supplies &
reagents in your laboratory?
a. yes
b. no

42. 34
13 Does your laboratory have adequate number of
staff?
a. yes
b. no
14 Is there a separate budgetary line item for
laboratory services?
a. yes
b. no
15 Is laboratory maintained in good condition?
(e.g., clean, all trash removed, shelves are
sturdy,
Etc).
a. yes
b. no
16 Are national guidelines and protocols for
laboratory procedures available in this
laboratory?
a. yes
b. no
17 Is there a laboratory services management
information system?
a. yes
b. no
18 Level of Laboratory workload in your
laboratory
a. high
b. medium
c. fair
Part Three: questions to assess the quality assurance practices and provision of laboratory
service.
NO Question Answer
1 Is there proper laboratory documentation in these
facilities?
a. yes
b. no
2 Are there documented SOPs for the tests performed
at this facility?
a. yes
b. no
3 Do the testing procedures in this laboratory follow
the national SOPs?
a. yes
b. no
4 Is there proper customer service management? a. yes
b. no
5 Does your laboratory undertake equipment
calibration and maintenance?
a. yes
b. no

43. 35
c other
6 Does your laboratory perform quality improvement
activity?
a. yes
b. no
7 Does your laboratory participate in any external
quality assurance assessment?
a. yes
b. no
c. other
8 does the laboratory undertake the following internal quality control procedures?
A: check each batch of reagents using known
positive and negative specimens?
a. yes
b. no
B: include commercially prepared quality controls
whenever a batch of tests is run?
a. yes
b. no
C: countercheck test reports with other colleagues
before dispatch?
a. yes
b. no
9 Are laboratory networked and alert for disease
outbreak?
a. yes
b. no
10 Can your laboratory always perform all tests for
requested test?
a. yes
b. no
11 Is your laboratory always functional? a. yes
b. no
12 Is the test result is verified at the end in this
laboratory?
a. yes
b. no
13 Are the laboratory results reported within
turnaround time?
a. yes
b. no
14 Are there laboratory safety practices in your
laboratory?
a. yes
b. no
c. other
15 Utilization of personal protective equipment? a. yes
b. no
16 Is there training for laboratory refreshment? a yes
b no

44. 36
17 Do you have written Job descriptions for assigned
task?
a yes
b no
18 Are all reagents/test kits in use and in
Stock currently within the manufacturer assigned
expiry Dates Check………
a yes
b no
19 Are stock counts routinely performed and
documented
a yes
b no
20 Are inventory records complete and accurate, with
Minimum and maximum stock levels denoted?
a yes
b no
c other
21 Is there Organized and implemented Work flow in
the lab
a no
b yes
c other
22 Has the laboratory provided uninterrupted testing
services, With no disruptions due to Electric failure?
a yes
b no
23 Is routine preventive maintenance performed on all
Equipment and recorded according to SOPs?
a yes
b no
24 Is equipment installed and placed as specified in the
Operators’ manuals and Uniquely labeled or marked?
a yes
b no
25 Are there documented standard operating procedures
(SOP) for tests performed
a yes
b no
26 Do you achieve acceptable PT/EQA results on the
two Most recent PT challenges?
a yes
b no
27 Has the laboratory provided uninterrupted testing
services, with no disruptions due to stock outs in the
last six months
a yes
b no
28 Is routine preventive maintenance performed on all a yes

45. 37
Equipment and recorded according to SOPs? b no
29 Is there developed and monitored Laboratory TAT
Document?
a yes
b no
30 Is there improvement measure and follow-ups to fill
the gaps from quality indicators monitoring?
(EQA/IQC)
a yes
b no
31 Is there lab safety practice in your lab? a yes
b no