Accred Qual Assur (2002) 7:345–350
DOI 10.1007/s00769-002-0510-y
© Springer-Verlag 2002
Jane Y. Carter
Orgenes E. Lema
Christine G. Adhiambo
Sadiki F. Materu
Received: 13 April 2002
Accepted: 5 July 2002
Presented at GLOBAL ODYSSEY 2002 –
International Conference on Proficiency
Testing/External Quality Assessment for
Medical Laboratories, 24–26 February 2002,
Atlanta, GA, USA
J.Y. Carter (✉) · O.E. Lema
C.G. Adhiambo · S.F. Materu
Laboratory Programme,
African Medical and Research Foundation,
(AMREF), Nairobi, Kenya
e-mail: amrefclinical@amrefke.org
GENERAL PAPER
Developing external quality assessment
programmes for primary health:
care level in resource limited countries
Abstract Laboratory services are an
essential component of health care
delivery in tropical countries and
play a vital role in improving the ac-
curacy of clinical diagnosis and the
investigation of disease outbreaks. In
developing countries, laboratories
face numerous constraints to provid-
ing quality services, including poor
selection of techniques, difficulties
in equipment availability and main-
tenance, and shortages of supplies,
staffing and supervision. Currently
in the eastern African countries
(Kenya, Tanzania and Uganda), in-
ternal quality control procedures are
inconsistently carried out in most
laboratories. National External Qual-
ity Assessment Schemes (EQAS)
have been established in all countries
addressing a limited number of tests,
but are constrained by difficulties of
sustainability and poor coverage.
The Laboratory Programme of the
African Medical and Research Foun-
dation (AMREF) has been operating
a simple EQAS for primary heath
care laboratories since 1993. Tests
addressed are those carried out in
primary health care laboratories in
eastern Africa. A total of 81 labora-
tories from 5 countries in the eastern
African region have participated in
the scheme since 1993 and 9 distri-
butions were submitted since the
start of the scheme. No laboratory
participated in all distributions;
24 (30%) laboratories participated in
4 or more distributions. Of these, the
hospital laboratories in Kenya and
Tanzania showed improved average
mean scores between the first two
and subsequent distributions. The
educational benefit of participation
in the scheme is emphasised. There
was an overall low rate of participa-
tion of laboratories (35%) once the
scheme was expanded to include lab-
oratories outside direct AMREF pro-
ject activities. Contributing factors
include shortages of staff and lack of
time in busy rural laboratories, to-
gether with difficulties in communi-
cation; however, the voluntary nature
and lack of appreciation of the bene-
fits of participation may also play a
role. To increase participation in the
scheme and to address the quality of
laboratory services throughout the
region, AMREF is currently devel-
oping a Regional EQAS in collabo-
ration with the Ministries of Health
of Kenya, Tanzania and Uganda, in
affiliation with the World Health Or-
ganisation (WHO). The approaches
used to establish reference values for
haemoglobin samples are discussed.
The scheme has also been utilised to
examine the performance of different
techniques for haemoglobin estima-
tion, demonstrating the inaccuracy of
the visual comparator methods.
Keywords Laboratory · Primary
health care · Quality assurance ·
Developing countries
346
Introduction
Laboratory services are an integral part of health servic-
es delivery, and in the countries of eastern Africa
(Kenya, Tanzania and Uganda) diagnostic laboratories
are established at every level of health facility from ter-
tiary level hospital to health centre (primary health care)
level. In eastern Africa, diagnostic services play a vital
role in health care delivery at primary health care level,
where simple laboratory tests contribute to an accurate
diagnosis in six out of ten of the most common diseases
recorded by District Hospitals and Health Centres [1]. In
an AMREF study conducted in six health centres in
Kenya between 1992–1994, 62% of outpatients attend-
ing routine curative clinics required laboratory investiga-
tions to assist in diagnosis and management, and there
was a change in diagnosis and drug management in 45%
of tested patients [2]. The misdiagnosis and incorrect
treatment that may occur in the absence of laboratory
support are wasteful in both time and resources, for pa-
tients who have to travel long distances for second or
third visits, and when multiple drugs are prescribed by
health workers unsure of a diagnosis.
The central laboratory administrations of the three
eastern African countries have taken steps to establish
national standards for the operation of the health labora-
tory services. In Tanzania, Standard Guidelines for
Health Laboratory Facilities were published by the Na-
tional Health Laboratory Services in 1998, addressing
administrative structure, essential tests and techniques,
equipment and equipment maintenance, essential facili-
ties, staffing, the supply system, training and continuing
education. In Kenya and Uganda, National Policy Guide-
lines are close to completion. In Kenya and Tanzania,
legislation regulating the operation of laboratories and
the practice of laboratory technology were recently intro-
duced (Tanzania 1997, Kenya 1999).
In all three countries, the responsibility for the plan-
ning and operation of all health care services, including
those provided by the government, non-governmental or-
ganisations and private facilities, has been decentralised
to District level. In Kenya and Tanzania, a District Labo-
ratory Technologist is now appointed as part of the Dis-
trict Health Management Team. Although much has been
accomplished in establishing the administrative struc-
ture, considerable inputs are still needed to attain a basic
minimum standard of laboratory services. Currently, lab-
oratory facilities are poorly equipped, and equipment is
poorly maintained due to lack of spare parts, a shortage
of qualified maintenance engineers, and lack of simple
care and maintenance procedures by equipment users.
Techniques employed for laboratory testing are poorly
standardised, and uneconomic, outdated and inaccurate
methods are still widely used. Few internal and external
quality control procedures are carried out leading to un-
reliable laboratory results. In addition, safety, sterilisat-
ion and disinfection procedures, and all aspects of labo-
ratory management, are poorly addressed in rural health
facilities. Although the standard of basic training of
medical laboratory technologists is high, there are no es-
tablished continuing education programmes for laborato-
ry staff, who may be posted to work alone in remote sta-
tions for long periods with no access to reference books
and journals, and with few effective means of communi-
cation. Despite the potential for a supervisory network
throughout each country, supervisory visits by senior
staff are infrequent and poorly structured. These factors
have undermined the confidence of clinicians in the lab-
oratory services, such that results may be ignored or tests
not requested. Clinical and laboratory professional asso-
ciations in all three countries have expressed concern
over the quality of the laboratory services, and the lack
of proper monitoring and regulation of laboratory prac-
tice. In addition, the World Health Organization has
voiced increasing concern over the ability of the labora-
tory services in the region to contribute effectively to the
diagnosis of diseases of outbreak potential which may
cross national boundaries, mainly cholera, dysentery,
meningitis, malaria and typhoid.
The tool most commonly used to ensure quality in
clinical laboratories is Internal Quality Control (IQC).
IQC is mainly performed by checking newly prepared
reagents against known positive samples, and by using
controls provided in commercially produced biological
reagent kits. However, quality control procedures are not
consistently performed and records are rarely kept for
verification. Involvement in external quality assessment
activities includes participation in International External
Quality Assessment Schemes (IEQAS) organised by
overseas institutions, and in schemes organised by na-
tional laboratory administrations. Participants of IEQAS
are mainly large reference laboratories or laboratories at-
tached to tertiary care centres in major cities. All three
countries operate limited national schemes, mainly or-
ganised through the donor funded vertical disease con-
trol programmes. All three countries have schemes ad-
dressing the quality of slides for tuberculosis diagnosis
as part of National Tuberculosis and Leprosy Control
Programmes. In Uganda there are also schemes address-
ing HIV screening and tests for sexually transmitted dis-
eases. The most comprehensive country wide scheme
operates in Tanzania, which established national and re-
gional schemes in 1994. In the regional scheme, Region-
al Hospitals produce materials for distribution to labora-
tories within their own region.
The AMREF Laboratory Programme has been work-
ing since 1985 to promote and improve diagnostic ser-
vices at primary health care level in collaboration with
the governments and non-governmental agencies
throughout the eastern African region. Since 1993,
AMREF has been operating a limited External Quality
Assessment Scheme for primary level hospital and
 347

health centre laboratories, initially as a means of evaluat- Results

ing its own training and development activities. Over the
years the scheme has provided an objective tool to mea- Between 1993 and 2000, a total of nine distributions
sure laboratory performance, identify problem areas, and were submitted to primary health care laboratories in
provide continuing education to clinical and laboratory five countries. One distribution was submitted per year
staff working in remote health facilities in AMREF relat- between 1993 and 1996, and in 1998; two distributions
ed projects in five countries. were submitted in 1999 and 2000. There was no distribu-
tion in 1997. Each distribution included two to seven
(average four) specimens for processing and examina-
Materials and methods tion. Materials submitted included both positive and neg-
ative samples. Table 1 shows a summary of the materials
Laboratory specimens appropriate for examination in primary produced between 1993–2000.
heath care laboratories were selected for inclusion in AMREF’s
external quality assessment scheme. The tests addressed were: A total of 81 laboratories participated in the scheme
thick and thin blood slides for parasites and blood cell morpholo- from 1993 to 2000. Of these, 57 were primary level hos-
gy; haemoglobin estimation; stool for parasites; urine for para- pital laboratories and 24 were health centre laboratories
sites; Ziehl Nielsen staining; Gram staining. Techniques were se- from the following countries: Tanzania (35); Kenya (34);
lected as the most appropriate for primary health care level with
respect to simplicity, economy and accuracy [3]. Materials were
Southern Sudan (6); Uganda (4); Somalia (2). No labora-
prepared from specimens obtained from patients attending tory participated in every distribution of the scheme: 27
AMREF’s central laboratory in Nairobi, or from laboratories in laboratories participated in 1; 16 laboratories participat-
major hospitals in Nairobi. Slides for blood parasites and blood ed in 2; 14 laboratories participated in 3; 11 laboratories
cell morphology were stained with Field stain or reverse Field participated in 4; 7 laboratories participated in 5; 3 labo-
stain [3]. Preserved blood lysate and haemiglobincyanide solution
were prepared according to standard methods [4]; at the start of
the programme these materials were verified by the International Table 1 Materials produced between 1993–2000
External Quality Assessment Scheme (IEQAS) for Haematology
(NEQAS UK). To assign haemoglobin values, the average of hae- Thick blood film positive, negative for malaria parasites
moglobin estimations performed by four laboratory technologists Haemiglobincyanide solution with Hb levels in g/dl:
at AMREF and by five major laboratories in Nairobi using either 4.6; 5.6; 7.6; 7.7; 8.5; 9.2; 11.2; 13.8, 18.0
the reference colorimetric method, or automatic blood cell coun- Haemoglobin lysate with Hb levels in g/dl:
ters, was taken as the final value. Haemiglobincyanide standard 4.5; 5.0; 5.8; 6.9; 8.1, 13.2
solutions of known value were also provided in each distribution. Thin blood film for red blood cell morphology
Stool and urine samples were preserved in 10% formalin with (hypochromic, microcytic; sickle cells, target cells;
glycerol and sealed onto glass slides with nail varnish. Smears normochromic, normocytic)
from patients with tuberculosis and leprosy were submitted fixed Thin blood film for differential white blood cell count
and either stained with Ziehl Nielsen stain or left unstained. Stool for Schistosoma mansoni ova; hookworm ova;
Smears of bacteria from culture media were fixed ready for Gram Ascaris lumbricoides; Taenia sp.
staining. Urine for Schistosoma haematobium ova
In order to provide an opportunity for continuing education, Smear stained with modified Ziehl Nielsen stain
and to enhance communication between the laboratory staff, clini- for Cryptosporidium sp.
cians and public health staff within a health facility, each sample Sputum smear, fixed stained or unstained, positive for AFB
was submitted with a clinical history and questions addressing the Fixed unstained smear of cerebrospinal fluid deposit
problem, such as alternative diagnoses, mode of transmission of for neutrophils, Gram negative bacilli; Gram positive cocci
disease, and possible management and control strategies. Partici-
pants were provided with an answer sheet for completion and re-
turn to AMREF. Distributions were sent out to health facilities by
any of the following means: AMREF’s regular outreach flights; Table 2 Number of packages distributed, number returned, and
the postal service; hand delivery by AMREF project managers or time taken for return of results
non-governmental organisation officers. A marking key and scor-
ing system were devised, as follows: 3: fully correct answer; Year Number Number Average
2 partially correct/acceptable answer; 1: some correct interpreta- distributed returned time taken
tion; 0: wrong, misleading or no answer. Answers were marked by (%) (range) –
two AMREF laboratory technologists independently; for any dis- both in days
crepancy greater than 1 mark, marking was re-evaluated and
agreed through consensus. 1993 21 21 (100%) –a
Each participant was provided with their results, the highest 1994 13 13 (100%) –a
and lowest results of the other participating laboratories (anony- 1995 8 8 (100%) –a
mously), the correct answers, and comments and suggestions for 1996 72 33 (46%) 18 (4–70)
improved performance. Starting in 1999, relevant health learning 1998 72 25 (35%) 32 (4–58)
materials and teaching aids were also provided to participating 1999 (1) 70 27 (39%) 22 (4–70)
laboratories. 1999 (2) 70 36 (51%) 14 (4–80)
2000 (1) 68 25 (37%) 32 (4–111)
2000 (2) 68 31 (46%) 40 (4–173)
a Materials and results were hand carried to and from each site
348

Table 3 Response time accord-

ing to country and means of Country Average Means of dispatch Days – range
dispatch days – range

Kenya 27 (4–111) AMREF outreach services 4

Tanzania 19 (4–75) AMREF field sites 28 (22–30)
Uganda 43 (13–173) Postal services 90 (13–173)
Southern Sudan 38 (9–125) NGOs 38 (9–80)
Somalia 27

Table 4 Numbers of participating health facilities by level and country

1993 1994 1995 1996 1998 1999 (1) 1999 (2) 2000 (1) 2000 (2)

Tanzania Hospitals 11 6 5 13 7 11 15 9 14
Health centres – – – – – – 1 1 –
Kenya Hospitals – – – 10 3 5 7 4 2
Health centres 10 6 2 9 10 6 8 6 6
Southern Sudan Hospitals – – – 1 1 3 3 2 5
Uganda Hospitals – – – – 3 2 2 3 4
Somalia Hospitals – 1 1 – 1 – – – –
Total 21 13 8 33 25 27 36 25 31

Table 5 Average scores (%) obtained by participating health facilities in each country

1993 1994 1995 1996 1998 1999 (1) 1999 (2) 2000 (1) 2001 (2)

Tanzania Hospitals 51 42 39 60 65 64 71 62 64
Health centres – – – – – – 50 42 –
Kenya Hospitals – – – 61 58 56 82 61 71
Health centres 61 59 74 55 52 49 71 47 55
Southern Sudan Hospitals – – – 60 63 49 49 39 49
Uganda Hospitals – – – – 66 75 89 65 65
Somalia Hospitals – 48 81 – 67 – – – –

Table 6 Health learning materials distributed to participating lab- The questions supplied with each distribution were di-
oratories vided into clinical, laboratory and public health categories
Anaemia for primary health care workers to assess areas requiring the most remedial action. Taking
Flow sheet for approach to anaemia an average of the years 1993–2000, there was little differ-
Malaria counting sheets ence in the number of unsatisfactory responses in each ar-
Clinical use of laboratory tests ea (clinical 30%; laboratory 33%; public health 31%).
Information on blood transfusion as a treatment for anaemia Table 6 shows the health learning materials distribut-
Sickle cell anaemia
Meningitis ed to participating laboratories since 1999. All materials
were produced by the AMREF Laboratory Programme.

ratories participated in 6; and 3 laboratories participated Discussion

in 7 distributions. Table 2 shows the number of distribu-
tions, the number of responses received, and the time
taken for the return of results.
Table 3 shows the response time from the time of dis-
patch to receiving the results starting from 1996, listed
according to country and means of dispatch.
Table 4 shows the numbers of participating health fa-
cilities by level and country for each distribution, and
Table 5 summarises the average scores obtained by the
health facilities.
There is a scarcity of published information on the oper-
ation of external quality assessment schemes at primary
health care level in developing countries. An external
quality assessment scheme organised by the Pacific
Paramedical Training Centre (PPTC) currently operates
in the Pacific Islands and South East Asia, supported fi-
nancially by the World Health Organization (WHO
Western Pacific Regional EQAS). In this scheme, sam-
ples in each discipline are dispatched three times a year

[5]. A national laboratory package for primary health
care laboratories, including internal and external quality
assurance programmes, is also under development in
Malawi, supported by the Liverpool School of Tropical
Medicine, UK [6].
The operation of an external quality assessment
scheme at primary health care level may serve several
purposes. The results provide valuable information for
central authorities on the quality of services provided in
health facilities, and can be used as a regulatory tool for
licensing and registration purposes. In addition, the re-
sults can give an indication of specific laboratory activi-
ties that require remedial action. Perhaps more valuable
for developing countries, the exercise provides a useful
source of continuing education for the participants, espe-
cially as the materials can be stored and re-examined af-
ter the results are returned. In developing countries,
many health facilities are situated in remote areas, where
reference books are scarce and communications are
poor; in these situations the scheme can act as a form of
distance learning. In the AMREF scheme, 24 (30%) lab-
oratories participated in 4 or more distributions; 11 in
Tanzania, 9 in Kenya; 2 in Southern Sudan and 2 in
Uganda. Of these, hospital laboratories in Kenya and
Tanzania showed an increase in the average mean scores
between their performances in the first two and subse-
quent distributions (Kenya 55% and 68%; Tanzania 56%
and 64% respectively). The Kenya health centres showed
little change (57% and 58%). Uganda hospitals showed
consistent performances (69% and 68%) but the hospi-
tals in Southern Sudan showed a decline in performance
(57% to 48%). An improvement in performance may re-
sult not only from participation in the scheme, but also
from regular visits through AMREF’s outreach pro-
grammes, when advice is offered to hospital authorities
on improvement of basic facilities, procurement and re-
pair of equipment, and recruitment of staff. In Southern
Sudan, the decline in performance may reflect the poor
basic training of the available technical staff, and the
very high turnover of supervisors. The AMREF scheme
has demonstrated that, even with conditions encountered
in developing countries, regular participation can assist
in improving the quality of performance.
In the first three years of the AMREF scheme, materi-
als were hand carried as part of specific development
projects, and participation was therefore 100%. Howev-
er, once the scheme was expanded, no laboratory partici-
pated regularly in every distribution, and the overall rate
of participation has been low (35–51%). Regular and
continued participation on a voluntary basis by busy lab-
oratories with limited resources requires considerable in-
terest and discipline, together with knowledge and un-
derstanding of the benefits of participation; however,
poor participation is costly to the scheme organisers in
terms of manpower and materials. In addition, there was
a wide range in the time taken for laboratories to respond
349
to distributions, with an average of 14–40 days; some re-
sults took 173 days to reach the scheme organisers.
Some of these delays are due to poor postal services to
remote areas; however, the scheme organisers are also
aware of instances where materials were stored for many
months before being processed. Some very remote hos-
pitals returned results very quickly using postal services.
Clearly, introducing the scheme as a mandatory activity
as part of a national programme could play a major role
in improving the quality of laboratory services.
An external quality assessment scheme can also be
used to evaluate the performance of laboratory tech-
niques. Most laboratory tests performed at primary
health care level in developing countries are qualitative
in nature and utilise direct microscopy. However, the one
quantitative test performed is haemoglobin estimation,
and participating laboratories are asked to indicate the
method they are using. The haemoglobin lysate solution
supplied can be used to determine haemoglobin values
with all techniques, whether colorimetric or visual. A
comparison of the results from laboratories using the
haemiglobincyanide method and two visual methods
(Sahli and Lovibond) between 1992 and 2000 was made.
The results of haemoglobin estimation using the haemi-
globincyanide method showed a mean difference of less
than 0.5 g/dl from the target values; the Sahli method
and Lovibond methods showed mean differences of
1.6 g/dl and 2.0 g/dl respectively from the target values.
These results emphasise the poor performance of the vi-
sual techniques, suggesting that they are too inaccurate
for use as a clinical diagnostic and management tool, and
should be discarded.
The limitations of utilising results from laboratories
that use different techniques, some of which perform
poorly, are also reflected in the method used to obtain
the target values for haemoglobin estimation. The
scheme organisers have opted initially to utilise the re-
sults obtained from a group of central reference laborato-
ries; however, as more participating laboratories employ
the recommended techniques, it will be increasingly pos-
sible to utilise the scheme results to set the target values.
The Ministries of Health of Kenya, Tanzania and
Uganda have recognised the need to expand and improve
the national external quality assessment schemes to de-
velop and sustain the quality of the health laboratory ser-
vices; however, the logistics of operating national
schemes to serve every laboratory, including govern-
ment, non-governmental and private facilities which
number several hundred in each country, are formidable.
The regional scheme in Tanzania resulted in problems
with standardisation, and constraints faced by all the na-
tional schemes have included difficulties in maintaining
production of standardised materials, problems with
country coverage, and difficulties in assessing the results
and taking appropriate remedial action. In addition, the
schemes operated by the vertical disease control pro-
350

grammes have been poorly coordinated with the govern-
ment schemes.
Due to the difficulties of travel and communication
and the nature of the common diseases affecting the pop-
ulation in eastern Africa, particularly malaria, it is cru-
cial to maintain small laboratories at peripheral level
which are accessible to the majority of the population; a
move towards centralised laboratory services is not fea-
sible or desirable. One solution would be to establish
centres of excellence in the region producing large num-
bers of materials of a single type for submission to a cen-
tralised unit for packaging and distribution. The Minis-
tries of Health of Kenya, Tanzania and Uganda have now
expressed a desire to share resources and experience on a
regional basis, and AMREF is currently developing a
Regional External Quality Assessment Scheme (REQAS)
as a pilot project which will involve the development of
a national scheme in each country. Standard Operating
Procedures (SOPs), quality manuals and other education-
al materials will be produced appropriately for use
across the region.
Acknowledgements The authors would like to thank the Minis-
tries of Health in Kenya, Tanzania and Uganda for allowing the
AMREF Laboratory Programme to collaborate with the central
laboratory authorities and to carry out work in the health facilities
in their countries. The authors would also like to thank the World
Health Organization, Geneva, for their financial and logistical sup-
port in the development and operation of the AMREF External
Quality Assessment Scheme in eastern Africa, and for their con-
tinued support in the development of a Regional External Quality
Assessment Scheme.

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