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Strengthening Public Laboratory Service in Sub-Saharan Africa: Uganda Case

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DOI: 10.1309/LM2OBNYY9D0UXZJO

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Submitted 2.25.11 | Accepted 3.17.11

Strengthening Public Laboratory Service

in Sub-Saharan Africa: Uganda Case Study
Ali M. Elbireer, MBA, MT(ASCP),1,3,4 Alex A. Opio, MD, PhD,2 Richard L. Brough, PhD,4 J. Brooks Jackson, MD, MBA,1,3
Yukari C. Manabe, MD4,5
(1Makerere University-Johns Hopkins University (MU-JHU) Clinical Core Laboratory at the Infectious Diseases Institute (IDI), 2Ministry
of Health, Kampala, 3Department of Pathology, Johns Hopkins University School of Medicine, 4IDI, Makerere University, Kampala,
Uganda, 5Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD)
DOI: 10.1309/LM2OBNYY9D0UXZJO

Abstract Africa, there is an opportunity to establish based clinical care to care based on accessible
In developed countries, the majority of medical quality laboratory testing by overcoming test-based accurate diagnoses.
decisions are made on the basis of quality barriers such as physical infrastructure, quality
laboratory testing according to established management plans according to external Keywords: laboratory, accreditation, quality,
standards and enforced regulations. With the standards, and human resource capacity sub-Saharan Africa
large investments of global health initiatives building. Strengthening laboratories could
into resource-limited settings in sub-Saharan change the paradigm from empiric, algorithm-

In many sub-Saharan African (SSA) countries, such as are affected by the political, economic, and social context.
Uganda, health care is provided free of charge in govern- Beaglehole and Dal Poz described the main functions of the
ment health care facilities. As a result, health care advance- health care system as financing, stewardship, resource genera-
ments in SSA are often hampered by resource limitations and tion, and provision of services.1 As applied to laboratories,
the importance of accurate and appropriate diagnostic testing
is increasingly recognized as a key strategy to improve global
health and to reach the Millennium Development Goals
(MDGs).2 Control strategies for infectious diseases such as
Corresponding Author HIV, tuberculosis (TB), and malaria depend on the efficient
Ali Elbireer, MBA, MT(ASCP) application of diagnostic and monitoring methods performed
aelbireer@mu-jhu.idi.co.ug to a reproducible standard. In this paper, we explore the role
of clinical laboratories in health care delivery, the current
status of public laboratories in Uganda, and the critical ele-
Abbreviations ments to building sustainable laboratories in resource-limited
SSA, sub-Saharan Africa; MDGs, Millennium Development Goals;
settings (RLS).
TB, tuberculosis; RLS, resource-limited settings; UNGASS, United
Nations General Assembly Special Session; HC, health centers;
CPHL, Central Public Health Laboratories; DST, Direct Sensitivity Role of Clinical Laboratories in Health Care
Testing; NTCL, National TB Central Laboratory; DBS, Dried Blood Delivery
Spots; JCRC, Joint Clinical Research Centre; IDI, Infectious
Diseases Institute; HR, human resource; ISO, International
In more developed countries, the vast majority of medical
Organization for Standardization; GCLP, Good Clinical Laboratory
decisions are based on medical laboratory tests; in the United
Practices; CLSI, Clinical and Laboratory Standards Institute; CDC,
States, billions of laboratory tests are performed annually,
Centers for Disease Control and Prevention; WHO-AFRO, World
influencing an estimated 70% of all medical decisions.3 Thus,
Health Organization-Africa Regional Office; SLMTA, Strengthening
building adequate and sustainable laboratory medicine capac-
Laboratory Management Toward Accreditation; MU-JHU/IDI,
ity is essential in developing basic health care infrastructure.
Makerere University-Johns Hopkins University at the Infectious
Clinical laboratories in RLS have been neglected and are not
Diseases Institute; CAP, College of American Pathologists; COQ,
optimized to ensure accurate diagnoses.4 The majority of
cost of quality; EQA, external quality assurance; NGO, non-govern-
treatment decisions in many RLS are based on clinical judg-
mental organization
ment and empiric diagnoses. Only a few simple microscopic
and kit-based laboratory tests have become widely used at
point of care such as HIV and malaria rapid diagnostic tests.

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Special Reports

Interestingly, in a paper by Petti and colleagues, the cost of management (often from a single sponsor) and have operated
treatment in the pediatric and adult wards was actually lower as a parallel system to government laboratories.
with accurate laboratory testing.5

Capacity Development Expenditure

Current Status of Government Health in Ugandan Laboratories
Laboratories In the fight against HIV/AIDS in Africa, Uganda has
Laboratories in SSA have been adversely affected by many had relative success with a decline in the prevalence of HIV
factors, including political instability, corruption, unmotivated compared to many other countries in SSA.8 In the United
personnel, and lack of effective management systems, par- Nations General Assembly Special Session (UNGASS) dec-
ticularly in the governmental public sector.4 There is a need laration of commitment on HIV & AIDS Uganda Country
for increased investment in laboratory services to avoid com- Annual Report for 2008, the HIV/AIDS total expenditure for
promising patient care.5 Among the many areas of concern financial year 2005/06 was approximately $173 million (more
in laboratory services are the following: clinical misdiagnosis, than 90% from international donors). However, despite the
inadequate health care and laboratory infrastructure, poor qual- vital role of clinical laboratories in HIV diagnosis and anti-
ity assurance and control practices, limited test menus, poor retroviral therapy monitoring, the investment in developing
turnaround time, and low diagnostic accuracy. Misdiagnoses clinical laboratory infrastructure represents only 6% of the
and improper medication use lead to wasted resources due to total UNGASS budget. Furthermore, the majority of the
inappropriate treatment. The annual per capita health expen- clinical laboratory budget was also derived from international
diture in low- and middle-income countries around the world donors.9
may be as little as $10-$20 compared to $5300 in the United In Uganda, the health care system is decentralized into
States.6 As a result of decades of neglect and underfunding, districts with hospitals and health centers (HC) where in-
the health care infrastructure (including medical laboratories creasing levels of health care complexity are offered at each
and overall diagnostic capabilities) in RLS has been deteriorat- level (II, III, IV). Laboratory services are offered at HC III
ing.6 These issues have been increasingly recognized with the and HC IV and are commensurate with the complexity of
emergence and epidemic of HIV first recognized in the early medical services accessible at each level. There are also more
1980s. Several global health initiatives (ie, U.S. government, comprehensive medical laboratory services offered at Regional
WHO, and Global Fund) have funded life-saving treatment and National Referral Hospitals. According to the Ugandan
for HIV/AIDS in RLS. The long-term success of these major National Laboratory Assessment Survey in 2004, conducted
initiatives is dependent on developing diagnostic capabilities by the Central Public Health Laboratories (CPHL), there
through significant strengthening of clinical laboratory services were approximately 502 health laboratories in government
in targeted countries with high HIV/AIDS prevalence, many facilities at the district, regional, and national levels.10 Three
of which are in SSA.7 According to El-Sadr and colleagues, years later in 2007 the number of public laboratories in
the scaling-up of HIV care and treatment should lead to great Uganda has increased by about 146%, from 500 laboratories
improvements in the health status of persons infected by to 1234 laboratories at different HC levels (Figure 1).11
HIV.6 Corresponding efforts by many research funders and An assessment of health facilities in southwestern Uganda
international organizations have led to the development of conducted by the Infectious Diseases Institute (IDI) outreach
many functional laboratories with the capability to monitor laboratory division in January 2010 showed most laboratories
HIV diagnosis and treatment. However, these laboratories in these districts are poorly designed, organized, and managed,
are largely dependent on external funding and outside quality are mostly understaffed, and do not have a logical flow of

1,400
No. of Labs

1,200
1,000
800
600
400 2004
200
0
2007
ls

bs

bs

bs

bs

s
ab
ta

La

La

La

La
pi

.L
os

ls

ls

II

ov
rI
rI
ta

ta
.H

G
te
te
pi

pi

of
ef

en
en
os

os
R

al
C
C
lH

H
al

t
re
re
ct

To
na
n

ca
ca
tr
io

io

ed
is
at

lth
lth
eg

at
N

ea
ea
of
R

im
of

H
H
of

o.

t
o.

Es
of
of
N
o.
N

o.
o.

N
N

Figure 1_Number of government laboratories in 2004 and 2007 at different health care levels in Uganda.

720 LABMEDICINE ■ Volume 42 Number 12 ■ December 2011 labmedicine.com

 Special Reports

Tools
enable require…
effective
use of…

Skills

enable require…
effective
use of…
Staff and Infrastructure

enable require…
effective
use of… Structures, Systems, and Roles

Figure 2_Capacity-building Pyramid.

work. Blood samples are drawn from patients inside the labo- including well-defined laboratory management structures,
ratory, raising occupational and patient safety concerns. Even clear roles documented within those structures, and suitable
high volume laboratories analyzing many sputum samples per laboratory systems (ie, laboratory operational management
day have neither good ventilation nor biological safety hoods. and quality systems) to enable laboratory staff to play their
Only about 5% of Health Centre IIIs and IIs have access roles efficiently. In addition to the above mentioned level in
to laboratory tests required to scale-up HIV and TB interven- the ‘capacity-building pyramid,’ we must consider the effect
tions such as HIV and CD4 T lymphocyte testing to detect and of ‘Local Context,’ highlighting the need for durable capacity
monitor therapeutic efficacy. Furthermore, many suspected TB development to be based on the recognition of cultural fac-
patients who live in rural areas are unable to have a sputum tors, alignment with local and national policies and strategies,
examination because TB diagnostic sites are far from where trust between development partners, and local ownership.
they reside and they cannot afford transport. Attention to each level gives laboratories the best chance to
excel and succeed and to achieve the ultimate capacity-build-
ing objective of creating sustainable capabilities that could
be continuously drawn on over time and replicated in other
Medical Laboratories Capacity-building Model similar settings.12
Potter and Brough discussed the concept of “capacity
building” as the primary objective of many international aid
agencies and development programs, and the common mis-
conception that capacity building is synonymous with “train- Critical Elements Needed to Build Sustainable
ing” and the success of a capacity-building program can be Laboratories in RLS
measured by the number of health care professionals trained Wertheim and colleagues analyzed the major challenges
and the training of trainer’s programs.12 Potter and Brough of developing effective laboratory capacity in RLS, includ-
argued that effective capacity building involves recognizing ing lack of infrastructure, failure to create and/or implement
a hierarchy of needs and building blocks to ensure successful national laboratory policies, weak national regulatory and
and sustainable development programs. They developed laboratory networks system, weak procurement and supply
a capacity-building process, or “pyramid” (Figure 2).12 systems, variable quality of laboratory performance due to lack
Applying this approach to laboratory services leads to of standardization and quality standards, lack of equipment
the recognition that various interdependent levels of capac- maintenance, and the inability to follow manufacturers’
ity must be strengthened for optimal results. These levels recommendations to ensure proper operational capacity of
constitute a pyramid with, at the apex, the tools (including laboratory instruments.13 Adequate human resource (HR)
laboratory supplies and equipment) to enhance performance capacity is the backbone of a strong health care system and
capacity. At the next level, there are the laboratory skills consumes the majority of resources allocated to health systems.
acquired through training and ongoing support (which is too Efforts to improve the quality and managerial capacity of
often the extent of many laboratory capacity-building pro- health care workers and to maintain skilled staff, including
grams) building ‘personal’ capacity and enabling good use to laboratory professionals, are central to improving health care
be made of the tools. At the next level, there is the need for systems.2 Based on field experience in RLS, we highlight 3
‘infrastructure’ capacity, which means adequate numbers of major elements needed for sustainable labs in RLS in the
laboratory staff (too few staff, however well trained, will still context of the capacity-building pyramid: infrastructure,
not build lasting capacity) and sufficient laboratory infrastruc- quality systems, and HR capacity.
ture to meet continually assessed needs. At the lowest level,
there is the requirement for ‘management systems’ capacity,

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Laboratory Infrastructure
the Becton Dickinson-PEPFAR partnership in transportation
Laboratory infrastructure includes the space where labora- of sputum samples for Culture and Direct Sensitivity Testing
tory technicians or other health care professionals can perform (DST) to the Ugandan National TB Central Laboratory
analytical testing. This space must be defined and allocated (NTCL), and transportation of Dried Blood Spots (DBS)
based on the number and types of analytical tests performed for HIV Viral Load testing and samples for flow cytometry
within the facility. Functional electricity and water supply (ie, CD4/8) from the Uganda Joint Clinical Research Centre
must be consistently available to allow for uninterrupted (JCRC) and the Ugandan IDI to specialized laboratories at a
modern testing services within each health unit. regional or national level in Uganda.
The Uganda National Laboratory Policy14 states that An investment in proper laboratory equipment and au-
there should be appropriate and effective linkages among tomated instrumentation is crucial to sustainable laboratories.
health sector laboratories. The linkages of laboratory services Even where equipment is available, the instruments are often
from higher level to lower level laboratories (eg, national neglected due to limited technical support in less developed
specialized laboratories to regional, district, Health Center countries.15 Many instrument manufacturers continue to sell
IV, III, and II laboratories) should be strengthened to form instruments in RLS without providing in-country support and
an effective network and a regional approach; fewer, larger without teaching basic preventive maintenance.
laboratories acting as diagnostic hubs and QA/QC centers
with excellent courier systems to lower level HC may be more
economical and sustainable. A few countries in SSA, such as
Uganda, Swaziland, Rwanda, Tanzania, and Ethiopia, have Laboratory HR
used a combination of commercial courier and facility trans- Skilled medical laboratory professionals with the appro-
port to provide an effective and reliable sample transportation priate competencies and motivation are vital to the delivery
system (Figure 3). of adequate laboratory services to all the appropriate levels of
There are ongoing efforts by various funders in Uganda health care centers. Also, the quality of these staff needs to be
to support creation of laboratory networks. Examples include assessed at all facilities in order to provide quality services at
all levels. There are many special-
ized laboratory technical schools
at different levels within the quali-
fied laboratory cadres in Uganda.
However, many of the laboratory
professionals serving in rural public
laboratories are laboratory assistants
and microscopists, who are insuf-
ficiently prepared to understand the
complexities of the proposed WHO
laboratory accreditations scheme.
Unfortunately, many of the
qualified laboratory technologists
and laboratory scientists are reluc-
tant to serve in the public sector
due to the inadequate resources,
low compensation, and poor career
advancement opportunities within
the medical laboratory profession.
Therefore, on-site continuous
educational opportunities should
be made available in the areas of
professional development, quality
management systems, and career
advancement for laboratory staff
to increase retention and improve
medical laboratory services at differ-
ent levels.

Laboratories Quality
Systems
Laboratory quality systems are
critical to the success of any labora-
tory service. The most important
Figure 3_Proposed diagram of an effective laboratory referral network for laboratories at prerequisite for the establishment of
different Districts’ Health Care Center levels to develop a cohesive, robust, and well-coordinated an effective laboratory quality system
service that reaches lower level facilities (Health Center IIIs and IIs). is to create and/or adopt medical

722 LABMEDICINE ■ Volume 42 Number 12 ■ December 2011 labmedicine.com

 Special Reports

laboratory standards and regula-

tions specific for each country’s
unique setting. Currently, some
countries in SSA, such as Uganda, International Laboratory
follow international laboratory Accreditation
standards such as the International By ISO,CAP, JCI,SAINAS
Organization for Standardization
(ISO 15189), Good Clinical
Laboratory Practices (GCLP), and
Clinical and Laboratory Standards
Institute (CLSI), although the
degree to which government labo- 5 STARS Accreditation
ratories adhere to these guidelines Must attain a >95%

s
ar
is not assessed. As a baseline, a score on on-site evaluation

Ye
quantitative audit assessment of 4 STARS Accreditation

o5
the quality of laboratory systems Must attain a 85%-94%

1t
score on on-site evaluation

~
should be performed to evaluate the

ne
3 STARS Accreditation
organizational quality management

eli
Must attain a 75%-85%

im
of the laboratory, including assess-

sT
score on on-site evaluation
ments of personnel training and
s
2 STARS Accreditation
competency, laboratory equipment re
og
Must attain a 65%-75%
Pr

needs and preventive maintenance score on on-site evaluation

al

plan, supply chain and supply avail- 1 STAR Accreditation

t
To

ability, quality systems and policies Must attain a 55%-64%

ed

score on on-site evaluation

at

for specimen management, and

tim

test accuracy and precision. There

Es

Labs must attain a score of 50% to get

is a need to design proper flow of

to the 1st STAR in the Step-wise

specimens and results reporting (es- WHO-AFRO Framework to establish an effective

pecially of urgent results) to health Quality Management System for Medical Laboratory Testing
Accrecitation Process

care providers and patients. Finally, Based on ISO-15189 Quality Laboratory Standards
laboratories should create a mecha-
nism for periodic evaluation of service
and satisfaction of the health care
providers and patients.14
Following the international
conference on health laboratory
quality systems in Lyon, France,
hosted by the WHO and U.S.
Centers for Disease Control and
Prevention (CDC) in 2008, a
stepwise accreditation approach Figure 4_The WHO-AFRO Accreditation stepwise approach model.
was developed to improve medi-
cal laboratories services in RLS.16
The WHO-Africa Regional Office
(WHO-AFRO) schema uses a 0- to 5-star scale for the rec- However, improving laboratory quality systems requires finan-
ognition of evolving fulfillment of the ISO 15189 standard cial commitment and support from the country’s leadership
rather than pass-fail grading. Laboratories achieving an and a time commitment from laboratory professionals in all
assessment score of at least 55% will be awarded a star ranking. health care settings. It is also critical to have political resolve
Laboratories achieving 95% or more will receive a 5-star and conviction that quality laboratory services are indispens-
rating.17 This stepwise approach is intended to help identify able to ensuring delivery of good quality health care. Research
weakness, show laboratories where they stand, guide them and internationally funded laboratory activities should not
with a series of evaluations to help them demonstrate im- be solely responsible for funding the running costs of quality
provement, and recognize and reward their quality advance- systems as this would not be sustainable with the systems
ment (Figure 4). potentially ending when the research or funding stops.14
To help facilitate the newly established WHO-AFRO A marketing survey of 50 selected private health care
accreditation process, an innovative program was created practitioners (ie, mostly senior medical doctors and clinic
called “Strengthening Laboratory Management Toward directors in clinics and hospitals in Kampala, Uganda)
Accreditation” (SLMTA); a road map for strengthening labo- was conducted in 2010 by the Makerere University-
ratory systems in Africa leading to accreditation.18 A capacity- Johns Hopkins University at the IDI (MU-JHU/IDI)
building program should be tailored to each laboratory, taking Core Laboratory, which has been a College of American
cultural, technical, and financial differences into account. Pathologists (CAP)-certified laboratory since 2003. One of
Working toward accreditation is a tangible and achievable the marketing survey questions asked the participants to pri-
goal, helping to motivate laboratory staff and management. oritize 5 “Laboratory Excellence Criteria” in order of their

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0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Accuracy/Quality of
Test Results

Turnaround Time

Test Price

External
Accreditation

Offerings for
Education About
Test Results
# of 1st # of 2nd # of 3rd # of 4th # of 5th

Figure 5_Proportion of participants who ranked each criterion first through fifth in response to the survey question on “Laboratory Excellence
Criteria.”

importance for them as health care providers. The criteria medical laboratory services and how the medical laboratories
included: test prices; accuracy/quality of test results; turn- evolve to meet health care consumers demands in RLS.
around time; offerings for education about test results; exter-
nal accreditation; and other. All clinics/hospitals in the survey
selected “accuracy/quality of test results” as the most important
criteria for laboratory excellence, and the “external accreditation” Laboratory Accreditation Misconception
was perceived by almost half of all clinics/hospitals to be the There is a common misconception that the accredited
least important of the 5 criteria (Figure 5). This survey clearly laboratory’s higher cost structure is primarily due to the cost
demonstrates that the majority of health care providers seek of accreditation, yet most of the cost is actually spent on apply-
quality laboratory testing but do not perceive the linkage of ing basic operational quality standards. In a research study
quality outcomes with accreditation. Therefore, before intro- conducted by Elbireer and colleagues,21 in the MU-JHU core
ducing the WHO-AFRO step-wise accreditation scheme, it laboratory in Uganda, more than 50% of the total cost of
will be critical to sensitize all health care providers about the quality (COQ) was spent in routine daily QC and calibra-
importance of standardization and accreditation as a path to tion costs, the total annual costs of direct CAP accreditation
achieving quality in laboratory services. and inspection costs were about $15,000, while the QC and
In Uganda there are many enabling factors for labora- calibration testing costs were around $337,000. Even though
tory accreditation, as evidenced by the existence of many some of these QC costs can be theoretically reduced, in many
internationally accredited clinical laboratories, including the higher income countries the medical laboratory standards were
MU-JHU/IDI Core Laboratory, which was the second CAP- designed to err on the side of investing too much in ensuring
accredited laboratory on the African continent. In a paper good quality activities since it is generally more acceptable than
written by Opio and colleagues,19 the authors highlighted investing less if the impact on patient outcomes is detrimen-
the steps taken by the Ugandan Ministry of Health in col- tal. On the other hand, it is certainly possible that decreasing
laboration with other health care/laboratories stakeholders to certain quality costs might not lead to an increase in poor
help put the country in a state of “accreditation-readiness.” outcomes; laboratories could become more cost effective
Supportive leadership is among the key factors that helped without sacrificing good patient care.21 The cost of imple-
Uganda prepare for laboratory accreditation. Also, the exis- menting the step wise WHO’s accreditation scheme, based
tence of a national laboratory policy with the explicit objective on the ISO 15189, is still relatively unaffordable for many
of laboratory accreditation and the availability of HR develop- laboratories in RLS. Nevertheless, medical laboratories can-
ment programs for preparing the laboratory professionals for not circumvent the cost of daily QC, calibrations, external
national accreditation programs are critical.19 quality assurance (EQA), preventive maintenance, periodic
As SSA populations increase and national economies staff competency and trainings, and other essential require-
grow, there will be an expanding middle class demanding the ments and still ensure quality reliable laboratory test results.21
quality health care services and adequate diagnostic laboratory Resources are often wasted on producing unreliable labora-
services they currently seek in other countries with more tory testing results. To a large extent, this cost is not easily
advanced health care services in the region.20 This middle quantifiable but can be significant in terms of disease com-
class will demand the creation of sustainable high-quality plications, loss in productivity, and adverse events resulting
laboratory services. The need for adequate diagnostic and labora- from inaccurate laboratory results. Furthermore, the loss in
tory services will continue to rise during the next few years. health care provider confidence and over reliance on clinical
Thus, there is a great opportunity for the medical laboratory symptoms rather than accurate laboratory diagnostics are also
discipline to close the gap between how consumers view the not known.

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 Special Reports

The WHO-proposed accreditation process is not in- organizations including the World Health Organization
tended to replace established accreditation schemes (eg, ISO, (WHO), has been mandated to begin implementing a Step
CAP) but rather to provide an interim pathway to achieve Wise Laboratory Improvement Process Towards Accreditation
international laboratory standards through gradual accredita- (SLIPTA) for laboratories in Africa.
tion by an international and/or in-country recognized labora- Acknowledgements: The authors gratefully acknowledge
tory accreditation agency. However, there is still uncertainty the editorial advice and contributions of Dr. Alex Coutinho
surrounding who will be the responsible party to apply and and Mr. Richard Walwema from the IDI, in Uganda.
accredit laboratories within each country. There is currently
no mechanism for laboratories in many RLS to apply or obtain
the required information directly for accreditation*; only 1. Beaglehole R, Dal Poz MR. Public health workforce: Challenges and policy
responsible government officials and some non-governmental issues. Hum Resour Health. 2003;1:4.
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ments have been fully informed. Thus, there is a gap in the services are critical in global health: Time to end the neglect? Am J Clin Pathol.
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