Field experience in implementing ISO 15189 in Kisumu, Kenya.

Abstract

Quality medical laboratory services are an integral part of routine health care, medical research, and public health systems. Despite this vital role, quality laboratory services in Africa are scarce. The crucial need for expanding quality laboratory services throughout sub-Saharan Africa is especially critical because of the region's burden of disease. Fortunately, several plans from supporting international partners are underway to help strengthen laboratory infrastructure in this region. A key component of these initiatives is the enforcement of quality assurance services through accreditation by international standards such as the International Organization for Standardization (ISO) 15189. However, acquisition and maintenance of these standards are a significant challenge, especially in resource-limited settings. The most common limiting factors can include funding, government support, equipment, training opportunities, and poor procurement infrastructure. In this article, we discuss the challenges and benefits accrued in pursuing and sustaining ISO 15189 accreditation for the Kenya Medical Research Institute/Centre for Disease Control HIV-Research Laboratory in Kisumu, Kenya.

Full text

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410 Am J Clin Pathol 2010;134:410-418
410 DOI: 10.1309/AJCPZIRKDUS5LK2D
© American Society for Clinical Pathology
Kigali Conference / Implementing ISO 15189 in Kisumu, Kenya
Field Experience in Implementing ISO 15189 in Kisumu,
Kenya
Clement E. Zeh,1 Seth C. Inzaule,2 Valentine O. Magero,2 Timothy K. Thomas,1 Kayla F. Laserson,1
Clyde E. Hart,3 John N. Nkengasong,3 and the KEMRI/CDC HIV Research Laboratory2
Key Words: ISO 15189 implementation; Laboratory quality assurance; Quality management systems
DOI: 10.1309/AJCPZIRKDUS5LK2D
A b s t r a c t
Quality medical laboratory services are an
integral part of routine health care, medical research,
and public health systems. Despite this vital role,
quality laboratory services in Africa are scarce. The
crucial need for expanding quality laboratory services
throughout sub-Saharan Africa is especially critical
because of the region’s burden of disease. Fortunately,
several plans from supporting international partners
are underway to help strengthen laboratory
infrastructure in this region. A key component of these
initiatives is the enforcement of quality assurance
services through accreditation by international
standards such as the International Organization for
Standardization (ISO) 15189. However, acquisition
and maintenance of these standards are a significant
challenge, especially in resource-limited settings. The
most common limiting factors can include funding,
government support, equipment, training opportunities,
and poor procurement infrastructure. In this article, we
discuss the challenges and benefits accrued in pursuing
and sustaining ISO 15189 accreditation for the Kenya
Medical Research Institute/Centre for Disease Control
HIV-Research Laboratory in Kisumu, Kenya.
HIV, malaria, and tuberculosis continue as diseases of
great public health concern, especially in resource-limited
countries.1 A variety of multinational organizations have
undertaken immense efforts to develop strategies to combat
these diseases. Such efforts have included vaccine research
and other prevention research and service delivery in such
areas as HIV testing and treatment. Great success has been
reported from some of these initiatives, as is the case with the
rollout of antiretroviral therapy (ART) in resource-limited set-
tings, where at least 4 million people are currently receiving
therapy.2,3 However, much emphasis has been placed on the
quantity of services, as seen for example in the World Health
Organization (WHO) “3 by 5” initiative, which aimed to have
3 million people receiving ART by 2005 and, more recently,
universal access by 2010.
Unfortunately, less concern has been given to quality-
assured scale-up and ways of ensuring long-term ART effi-
cacy.4 Development of a quality health care system is essential
for successful scale-up of ART and to support clinical research
in resource-limited regions. This includes upgrading laboratory
services to ensure accurate disease diagnosis, efficient treat-
ment monitoring, good public health disease surveillance, and
effective clinical research. Plans are already underway to help
strengthen national laboratory systems in Ethiopia, Nigeria,
Tanzania, and other countries.5,6 The key areas for develop-
ment include the national laboratory network, physical infra-
structures, supply-chain management, human resource training
programs, and quality service delivery. Providing quality
services that are accurate, reliable, and reproducible will most
effectively come through adopting laboratory standards that
guide daily laboratory practices and institute a framework for
quality management at the facility and network levels.

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© American Society for Clinical Pathology
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The International Organization for Standardization
(ISO) 15189 (medical laboratories: particular requirements
for quality and competence), a hybrid of ISO/IEC 17025 and
ISO 9001 management standard, is the current internation-
ally recognized standard for medical laboratory practice.7
This standard provides a framework for a laboratory to plan
and operate a medical testing laboratory with an effective
quality management system (QMS) that has strong elements
of quality assurance (QA), quality control, and quality
improvement. It not only focuses on assay performance,
but also has a holistic approach for global medical patient
care, targeting all processes from preanalytical to postana-
lytical procedures. It further encompasses personnel labora-
tory safety and medical laboratory ethics. An award of ISO
15189 accreditation is a formal international recognition
that a laboratory performs medical laboratory tests that are
reliable, accurate, and reproducible and that the results are
reported within an acceptable time frame.
In this article, we discuss the challenges and benefits
accrued in pursuing and sustaining ISO 15189 accreditation
for the Kenya Medical Research Institute (KEMRI)/Center
for Disease Control (CDC) HIV-Research Laboratory in
Kisumu, Kenya.
Background on the KEMRI/CDC HIV-Research
Laboratory
The KEMRI/CDC HIV-Research Laboratory was estab-
lished in March 2003 to provide support to KEMRI/CDC-
sponsored HIV epidemiologic and clinical research. This
research included a survey to assess HIV prevalence among
adolescents and adults and a therapeutic clinical trial aimed
at preventing mother-to-child transmission. Since 2003, the
laboratory has grown tremendously and supports multiple
HIV studies initiated by KEMRI/CDC and other collabora-
tive groups, including the WHO. Currently the laboratory
has 2 main sections: the clinical laboratory section based
at the KEMRI/CDC clinical research center on the campus
of New Nyanza Provincial General Hospital in Kisumu and
the molecular diagnosis and research laboratory section
located at the KEMRI/CDC Field Station in Kisian, about
12 km from Kisumu. These sections are further subdivided
into various units in which a variety of HIV and sexually
transmitted infection diagnostics and monitoring tests are
done ❚Table 1❚.
The KEMRI/CDC HIV-Research Laboratory is certified
by the Kenya Medical Laboratory Technician and Technology
Board and the RUSH virology QA program (Chicago, IL) for
molecular assays. In addition to ISO 15189 certification, the
laboratory is WHO accredited as the national reference labo-
ratory for HIV drug-resistance testing in Kenya.
Journey Toward Accreditation
Pursuing ISO 15189 accreditation was a major chal-
lenge; it required the revision of existing or development of
new systems, while at the same time continuing to provide
laboratory support for ongoing HIV research activities. The
preparation for accreditation was a collective work involving
the entire staff under the guidance of the laboratory manage-
ment. We commenced the process in March 2006, with the
aim of improving overall client services and to meet the
criteria required to participate in the proposed US National
Institutes of Health–funded Partnership for AIDS Vaccine
Evaluation 100 HIV vaccine trials (http://www.cdc.gov/hiv/
topics/research/vaccine_unit/index.htm). We first began by
outsourcing consultation services from the South African
Contract Laboratory Services, who helped us in identify-
ing ISO 15189 as the appropriate international accreditation
standard for our laboratory. Contract Laboratory Services
conducted an initial gap analysis of our laboratory QMS and
advised us on ways to implement the standard requirements.
We established an independent quality systems unit (QSU) to
help evaluate the areas of improvement as guided by the gap
analysis report from Contract Laboratory Services. The QSU
developed various documents and systems, including the
laboratory quality manual, quality policies, various standard
operating procedure manuals, staff competency assessment
guidelines, complaint/incidence reporting systems, quality
indicator systems, internal QA auditing systems, and docu-
ments and records control systems.
Following the ISO 15189 requirements, we began enroll-
ing our assays in external QA programs: the College of
American Pathologists, the Virology Quality Assurance
program, the United Kingdom National Quality External
Assurance Services, and the Humane Quality Assurance
Services. We instituted an advisory board, staffed by clinical
laboratory and QA experts, whose purpose was to review and
provide counsel for our laboratory’s QA and QMS activities.
Other units that were established or improved as a requirement
for the ISO 15189 included the safety unit, procurement unit,
data management unit, and the training coordination group. In
addition, a laboratory information management system was
adopted to streamline sample reception and repository and
tracking. We also installed and verified an automated tem-
perature monitoring system to ensure integrity of samples and
reagent storage. Following all these preparations, we request-
ed ISO 15189 certification from the South Africa National
Accreditation System (SANAS). In July 2007, before the
SANAS assessment visit, our laboratory was assessed by
Pharmaceutical Product Development (PPD), contracted by
the US National Institutes of Health to assess the site’s prepa-
ration for Partnership for AIDS Vaccine Evaluation 100 HIV
vaccine trials. PPD identified 75 nonconformances (17 major
and 58 minor) ❚Figure 1❚. Addressing these nonconformances

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Zeh et al / Implementing ISO 15189 in Kisumu, Kenya
especially in quality system essentials and good clinical labo-
ratory practices, coupled with the lack of professional trainers
in the country, required contracting trainers from abroad, and
this was costly. In addition, all equipment had to be placed
on preventive and corrective maintenance service contracts,
which were also costly. Owing to lack of laboratory equip-
ment engineers among local vendors, some services had to
be provided by out-of-country contractors. Implementing an
efficient procurement infrastructure was also challenging, in
part owing to stringent government procurement laws and the
fact that many reagents are unavailable in Kenya. There were
challenges in implementing safety standards such as waste
management owing to the absence of or unclear government
policies on disposal of certain waste products. A major hurdle
was the nurturing of a quality culture, previously lacking
helped us in preparing for the SANAS assessment in October
2007, in which only 23 nonconformances (11 major and 12
minor) were identified. These were addressed within the
required time of 25 working days. In March 2008, 2 years
after commencing the journey, we were awarded full accredi-
tation and became the first ISO 15189–accredited independent
laboratory in Kenya.
Challenges on the Road Toward Accreditation
Although the benefits of accreditation are numerous, the
journey toward accreditation had a number of challenges.
Establishing the various standard quality requirements was
expensive and labor-intensive. Lack of trained personnel,
❚Table 1❚
Clinical and Research Capacity of Laboratories and Platforms Used
Technical Unit
Assay
Platform, Method, and/or Equipment
Tests at clinical monitoring section, New Nyanza Provincial Hospital grounds, Kisumu, Kenya
Hematology unit
counts
Immunophenotyping unit
Biochemistry unit

Liver function test
Renal profile
Fatty acid tests
Hormonal tests
Electrolytes
Tests at HIV Research Section, KEMRI/CDC Kisian campus, Kisian, Kenya
Serology unit

HIV serology




Hepatitis B and C
STI diagnostics unit

HSV-2
Syphilis
Trichomonas vaginalis
Bacterial vaginosis
Candida
Chlamydia trachomatis and ELISAs from urine and swabs
Neisseria gonorrhoeae
Early infant diagnosis unit
DNA PCR; sample types: DBS,

Viral load unit
HIV RNA viral load; sample types:
DBS, plasma, breast milk,
and serum
Nucleic acid testing
HIV drug resistance unit
HIV drug resistance testing; sample
types: DBS, plasma, breast milk,

Differential cell count, full blood
Manual peripheral blood film examination; Coulter ACT
5Diff CP analyzer (Beckman Coulter, Roissy, France)
Flow cytometry by BD FACSCalibur (BD Biosciences, San Jose, CA)CD3, CD4, CD8, CD45
ALT, AST, bilirubin
Creatinine, urea
Total cholesterol, triglycerides, lipase COBAS Integra 400
β-Human chorionic gonadotropin
Sodium, phosphate
COBAS Integra 400 plus (Roche Diagnostics, Mannheim, Germany)
COBAS Integra 400
Immunochromatographic (Roche Diagnostics)
COBAS Integra 400

HIV rapid assays
Bioline (Taunton, MA); Uni-Gold (Trinity Biotech, Bray, Ireland);
Determine (Abbott Laboratories, Tokyo, Japan)
Vironostika (bioMérieux Clinical Diagnostics, Marcy l’Etoile, France);
Murex (Murex Biotech, Dartford, England); Bio-Rad (Hercules, CA)
Avidity assay
HIV ELISA
HIV incidence assay
ELISA
ELISA
Affinity/agglutination tests
Microscopy
Microscopy
Microscopy
RPR, TPPA
In-pouch TV culture system (BioMed Diagnostics, White City, OR)
Nugent score
Wet mount
Amplicor CT/NG test (Roche Diagnostics)
HIV-1 Roche Amplicor (Roche Diagnostics) (manual); automated by
COBAS TaqMan (Roche Diagnostics)
Roche Amplicor, standard and ultrasensitive (Roche Diagnostics)
(manual); COBAS Amplicor (Roche Diagnostics); COBAS TaqMan
(Roche Diagnostics)
COBAS AmpliPrep (Roche Diagnostics)
ViroSeq (Abbott Molecular/Celera Genomics Group, Rockville, MD)
(FDA approved); TRUGENE (Siemens Medical Solutions
Diagnostics, Walpole, MA) (FDA approved); in-house system
whole blood, pellets
and serum
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CT/NG, Chlamydia trachomatis/Neisseria gonorrhoeae; DBS, dried blood spots; ELISA, enzyme-linked
immunosorbent assay; FDA, US Food and Drug Administration; HSV, herpes simplex virus; KEMRI/CDC, Kenya Medical Research Institute/Centers for Disease Control
and Prevention; PCR, polymerase chain reaction; RPR, rapid plasma reagin; STI, sexually transmitted infection; TPPA, Treponema pallidum particle agglutination; TV,
Trichomonas vaginalis.

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among the staff. The adoption of this standard required major
alterations in the daily laboratory operations, which were not
initially welcomed by staff. However, regular training with
emphasis on postaccreditation benefits and persistence by the
QSU led to increased understanding and cooperation.
Essential Elements for Managing an
Accredited Laboratory
Obtaining accreditation is not a certificate to practice but
an assurance for providing quality services. Consequently,
maintaining high-quality standards is equal in importance
to achieving them. Some of the key elements adopted in
maintaining quality standards included establishing a well-
organized laboratory management system, strengthening of
the QSU, establishing a laboratory technical advisory commit-
tee, establishing and monitoring laboratory quality indicators,
and promoting continuous quality improvement.
Establishing a Well-Organized Laboratory Management
System
A component of the QA laboratory infrastructure is a
well-organized management system. Our laboratory man-
agement system is headed by the chief of HIV research
at KEMRI/CDC, followed by the laboratory director and
laboratory supervisors, and ends with the unit heads. Each
job title in the management structure has distinct responsibili-
ties that are well documented in the quality manual. The unit
heads primarily oversee the daily operations of the laboratory
activities and are involved in the development, implemen-
tation, maintenance, and improvement of quality systems
in their specific units. There are 2 section supervisors (the
research section supervisor and the clinical and monitoring
section supervisor) who oversee the activities implemented
by the different units’ heads and act to advise and direct the
quality plans being implemented in the different units. The
laboratory director reviews and approves all technical and
management quality plans established by the technical staff,
laboratory supervisors, safety staff, data staff, administra-
tive and procurement staff, and the quality systems unit and
ensures a good working environment that complies with good
clinical laboratory practices. The chief of the HIV research
branch functions at an independent level from the laboratory
and periodically reviews laboratory activities with a focus on
assigned laboratory projects in progress and a biannual review
of the laboratory’s QMS.
All levels of laboratory management are charged with
ensuring that continuous communication exists among the
staff so that complaints can be quickly identified, addressed,
and resolved. To this end, the management and all laboratory
personnel attend regular biweekly laboratory meetings in
which progress in every unit is assessed and any challenges
are addressed. In addition, the biweekly meetings provide
an open forum for presenting problems and opportunities
for improvement.
Strengthening of the QSU
A cornerstone of laboratory QA infrastructure is the QSU.
Owing to this unit’s central role in maintaining and improving
laboratory QA, our QSU was made independent of routine
laboratory management supervision and reports directly to the
laboratory director and the chief of the HIV research branch at
KEMRI/CDC. This reporting scheme was particularly impor-
tant to ensure the unit’s autonomy in monitoring the laboratory
QA and management systems. Continuous training, provided
through local and international mentorship programs, also
helped expand personnel competency in the unit. To further
aid the implementation and maintenance of QA, many of the
quality systems activities were decentralized to the technical
units where the unit heads became fully responsible for QA
in their specific units. These measures supported the “own-
ership” of the standard by technical personnel and reduced
discord between the technical units and the QSU. The unit
holds regular meetings with laboratory management to advise
on areas requiring improvement. Apart from regular internal
meetings, the QSU also participates in formal in-country QA
meetings every 3 months with other local research labora-
tories, the US Army Medical Research Unit laboratory at
Kericho, Kenya, and the Academic Model Providing Access
to Healthcare laboratory in Eldoret, Kenya, to assess ways for
improving and maintaining quality standards.
0
10
20
30
40
50
60
70
Major NC
Minor NC
No. of Nonconformances
PPD
Initial Audit
July 2007
SANAS
Initial Audit
Oct 2007
17
11
1
PPD
Audit
May 2009
8
0
6
12
58
SANAS
Audit
Sept 2009
❚Figure 1❚ Preaccreditation and postaccreditation external
audit findings by South Africa National Accreditation
System (SANAS) and Pharmaceutical Product Development
(PPD). Accreditation occurred in March 2008. Major
nonconformances (NCs) are deviations from the standard
indicative of a total breakdown in the system or one that
would significantly affect the patients’ results, whereas
minor NCs are those that are indicative of partial breakdown
in the system.

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Zeh et al / Implementing ISO 15189 in Kisumu, Kenya
Establishing a Laboratory Technical Advisory Committee
Another key activity was establishing a technical advi-
sory committee composed of laboratory experts from the
CDC, Atlanta, GA; principal investigators, pathologists,
other physicians (medical), and laboratory QA experts from
outside the CDC; and our laboratory management team. This
committee meets annually to review key quality manage-
ment indicators set by the laboratory and to assess opportu-
nities for improvement.
Establishing and Monitoring of Laboratory Quality
Indicators
Quality indicators form an integral part of the QMS and
are vital for objective monitoring of the laboratory quality
systems and for identifying improvement opportunities. The
quality indicators chosen in our laboratory involve assessing
the following 7 parameters:
1. Quality management assessment: The laboratory’s
project targets are periodically assessed to monitor
whether the set targets were achieved within their
allocated time. Overall QA is also assessed using
findings from internal and external audits.
2. Resource utilization and financial performance: The
laboratory’s budget for a fiscal year is assessed against
the achieved targets, and resource utilization is reviewed
against the set targets. Apart from overall assessment of
resource utilization, unit-specific checks are done via the
unit’s inventory system. Reagent control is monitored
using reagent tracking logs, and stock management is
done by assessing our reorder levels in the inventory.
Supplier performance is monitored using score sheets
that assess parameters such as delays and damaged or
incorrect supplies. Procurement performance is assessed
by checking on timely ordering, follow-up, and delivery
of laboratory supplies and reagents.
3. Process efficiency and effectiveness: The entire
laboratory’s processing systems are monitored
from preanalytical to analytical and postanalytical
components. Parameters such as turnaround time, rate of
sample rejection, control failures, process documentation
assessment, instrument performances, external QA
performance, personnel competency assessment,
corrective and preventive action assessment, daily
quality control plots, daily temperature monitoring
charts, internal and external audit findings, and internal
and external complaints are used in this assessment.
4. Risk management and safety: Incidence reports are
assessed over time and also include periodic safety drills,
quizzes, and audits.
5. Client satisfaction: Service delivery to clients is checked
by assessing the number of complaints, turnaround time,
and feedback.
6. Personnel performance and satisfaction: This component
involves staff competency assessment, training program
attendance and completion assessment, staff turnover
rate, supervisor appraisals, and analysis of internal
complaints.
7. Data management: This parameter involves periodic
check of data integrity, ease of data retrieval, and the
frequency of data backup.
Promoting Continuous Quality Improvement
A key component of good laboratory management is the
continuous promotion of quality improvement. Establishing
quality standards requires a conscientious assessment and
informed implementation via multiple approaches, which
usually takes time. Furthermore, relying solely on recom-
mendations from external auditors and consultants can be
misleading because they usually have limited time on site and
are likely unable to identify all the significant improvement
opportunities in the laboratory’s quality systems. Thus, it is
paramount to identify and monitor improvement opportuni-
ties through a scheduled routine assessment of quality indica-
tors. This continuous quality improvement has borne fruits
as seen in the number of nonconformances identified during
the postaccreditation assessment by SANAS and PPD (Figure
1). In addition, working closely with management, the QSU
routinely assesses areas requiring improvement using internal
and external audit findings and information provided by local
peers and mentors.
Accreditation Benefits
Establishing standardized operations for technical sup-
port and laboratory management has led to a well-organized
laboratory with clear staff responsibilities and a good com-
munication framework. It has also led to the creation of a
reliable and competent workforce that has high esteem and
pride in their daily activities. The adoption of these standards
has led to a greater degree of internal control, a good tracking
system for all laboratory processes, an efficient and controlled
documentation system, and a reliable infrastructure for tracing
errors and complaints.
The adoption of key quality indicators has helped in time-
ly identification of system weaknesses and rapid resolution of
problems. The adoption of this standard has also assisted us in
rapidly detecting redundant and ineffective systems, leading
to reduction in operation costs and increased time savings.
A major benefit in the adoption of these standards was the
reduction in reagent wastage leading to increased cost savings
to the laboratory. The assessment of reagent wastage from the
preaccreditation period (July 2006) through the postaccredi-
tation time revealed a remarkable decline in reagent waste

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❚Figure 2❚. These cost savings came about largely because of
increased staff competency and an effective inventory system.
The enhanced staff competency resulted in a reduction in
redundant retesting, thereby saving on reagents and supplies.
The effective inventory system enabled accurate forecast-
ing on reorder levels and helped facilitate interlaboratory
exchange of reagents before expiration, therefore minimizing
reagent waste.
In addition, there has been a profound improvement in
our performance on external quality proficiency testing. This
improvement was due to our increased staff competency and
an assay validation requirement that ensures reproducibility
of the given tests.
Having a well-designed and implemented QMS, based on
ISO 15189, has helped the laboratory create an infrastructure
that provides accurate, reliable, quality, and timely service
delivery. This has led to an increase in our clients’ and stake-
holders’ confidence, which is reflected in the reduction in
number of complaints. In assessing the number of complaints
over time from the preaccreditation to the postaccreditation
period, we observed a remarkable decline of 82% within the
first 12 months of the accreditation preparation period that has
since been maintained at levels below 5% ❚Figure 3❚.
Another benefit observed after adoption of these standards
was a reduction in sample rejection. Before standards imple-
mentation, there was a high rate of sample rejection owing
to lack of clear rules for sample reception and rejection. The
implementation of this standard led to a significant percent-
age decrease in the number of sample rejections from 4.5% in
2006 to less than 1% in 2007 ❚Figure 4❚. This improvement
was due to an improvement of preanalytical QA, largely from
defined systems for sample collection and transportation. Our
laboratory currently has a policy on retraining clients in the
field on QA regarding field preanalytical processes when the
rate of sample rejection exceeds 3% at a given site. This low
rate of sample rejection further enhanced reduction in com-
plaints from clients.
Our newly recognized standard of excellence has also
increased demand for the services offered, as well as QA
training and postacademic field training from KEMRI/CDC-
affiliated groups, the Ministry of Health, private health institu-
tions, and students in the region.
Adopting the ISO 15189 standard has greatly assisted
the KEMRI/CDC HIV-Research Laboratory in pursuing and
achieving WHO accreditation for HIV drug-resistance geno-
typing in less than 6 months during 2008. Our selection as the
national WHO reference laboratory for HIV drug resistance
has led to increased international acceptance of our services,
reduced the need for international reference testing for drug-
resistance tests, and, thus, reduced the cost for patients and
ongoing clinical trials in the region.
In summary, accreditation benefits are numerous, includ-
ing reduction in costs, ease in management and process con-
trol, increased quality service delivery and client satisfaction,
and enhanced staff competency.
Postaccreditation Issues
As noted previously, the accreditation certificate
acts as an identity for QA services and implies that all
processes from this point forward are carried out within
0
2,000
4,000
6,000
8,000
10,000
12,000
Jul 06Jul 07
Reagent Waste (US$)
Jul 08Jul 09
❚Figure 2❚ Reduction in the waste of reagents. Accreditation
occurred in March 2008.
Jan 06 Jan 07
No. of Complaints
Jan 08Jan 09
0
10
20
30
40
50
60
❚Figure 3❚ Trends in the number of complaints from January
2006 (preaccreditation) to January 2009 (postaccreditation).
Accreditation occurred in March 2008.
Jul 06
0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
Jul 07
% of Samples Rejected
Jul 08 Jul 09
❚Figure 4❚ Percentage of samples rejected from the
preaccreditation period to the postaccreditation period.
Accreditation occurred in March 2008.

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Zeh et al / Implementing ISO 15189 in Kisumu, Kenya
peer groups, we have sent staff to local and international con-
ferences, an approach that has high cost implications.
A major internal challenge is the continuous nurturing of
the “culture of quality” that enables staff buy-in and owner-
ship of our QMS. This has been an uphill task owing to the
demands of the standards, such as the stringent requirement
for proper documentation of all laboratory processes, which
has been difficult owing to our large workload.
Informing and educating prospective clients on the need
for quality standards adoption in the field has also not been
an easy task. QA requires implementation of systems guid-
ing preanalytical steps to help assess sample integrity and the
adoption of a standardized test request and results reporting
system. Owing to the high number of poor-quality samples
necessitating rejection, it was vital to train our clients on better
sample collection, transportation, and storage methods. It was
equally important to train them on the laboratory requirements
for test requests and result interpretation. Such programs have
yielded positive results, but challenges still remain, with some
sites requiring periodic refresher training. Communicating
with clients on the increase in cost owing to the implemen-
tation of the given standards such as the annual or biannual
equipment service maintenance and the increase in controls
per test has also been challenging.
Implementation of Quality Standards in
Resource-Limited Settings
Although it may be feasible, as in our situation, to imple-
ment and maintain international standards in laboratories sit-
uated in resource-limited settings, this may not be the case for
most laboratories in Africa. The entire accreditation process
did cost approximately US$126,553 in the initial phase and a
further US$71,143 were required to effectively maintain the
accreditation ❚Table 2❚. These costs, however, exclude the
required good clinical laboratory practices such as preventive
and corrective equipment maintenance, the need for backup
equipment, and other infrastructure maintenance, which are
equally expensive. As observed, the accreditation process can
be expensive and requires commitments, especially from the
management team. The KEMRI/CDC laboratory is donor-
funded and operates on a platform supported mainly by the
CDC laboratory infrastructure. For this reason, we were able
to address most of the impediments inherent in most resource-
limited settings. Lack of local government support and health
policies to ensure provision of quality health care, training
programs, reliable equipment, and funding opportunities and
the absence of a well-organized national laboratory network
are some of the difficulties faced by public laboratories in
resource-limited settings.8,9 These challenges make it diffi-
cult for laboratories in such regions to acquire internationally
certain standards. Consequently, to ensure quality service
delivery, the standards must be maintained or, better yet,
superseded, which may sometimes offer certain challenges.
In our case, the challenges included staff retention and hiring
of a motivated and qualified staff. Owing to the increased
training and enhanced competency and experience of our staff
members, they are now coveted by other laboratories in our
region. Subsequently, it is becoming more difficult to find and
retain the highly skilled personnel who are needed to maintain
the accredited standards now in place in our laboratory. This
lack of local trained personnel underlies the need for improv-
ing the skills of the country’s entire local health and research
scientist workforce.
In addition, there are challenges in maintaining a reliable
procurement infrastructure that provides a timely supply of
commodities at a manageable cost. This problem is com-
pounded because most laboratory commodities must come
from out-of-country vendors. These vendors frequently batch
the orders of multiple laboratories to reduce shipping costs. If
the goods are damaged or erroneously delivered, additional
delays occur, often for frustratingly long periods because sup-
plies must be reordered from overseas. Although interlabora-
tory borrowing or supply exchanges are viable solutions, the
processes and platforms for the same tests vary among labo-
ratories, thus limiting the use of such options. In addition, the
stringent government procurement laws sometimes slow the
procurement process.
The same procurement challenges affect equipment
service maintenance. Apart from the high cost of annual and
sometimes biannual preventive service of equipment, it is
equally difficult to ensure timely corrective maintenance of
equipment. This problem is usually due to limited availability
of qualified engineers and replacement parts, which usually
come from South Africa. This can lead to delays in service
delivery, resulting in increased complaints from clients, which
may lower staff morale.
Despite the many advantages achieved by accreditation,
accreditation can lead to increased demands by clients in need
of quality laboratory support; this can stretch the laboratory
capacity to provide quality services and negatively impact the
working environment for staff. In these instances, laboratory
management carefully assesses how an additional workload
would impact the KEMRI/CDC HIV-Research Laboratory
mission and goals and then decides whether to accept or reject
an outside client’s request.
Continuous improvement calls for continuous training
of personnel, especially in good clinical laboratory practices,
QA, and safety. Owing to the absence of local or online train-
ing for some courses, laboratory management has had to send
staff overseas for training or contract tutors from abroad. To
keep pace with the ever-changing elements of our scientific
research and maintain a knowledge base equal to that of our

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Am J Clin Pathol 2010;134:410-418 417
417 DOI: 10.1309/AJCPZIRKDUS5LK2D 417
© American Society for Clinical Pathology
Kigali Conference / Special Article
may be more difficult for government-funded laboratories.
Even so, such laboratories may benefit from the proposed
WHO Regional Office for Africa stepwise accreditation sys-
tem that focuses on incremental quality advancements over
time rather than the shorter periods required under ISO and
similar accrediting programs.
From the 1US Centers for Disease Control and Prevention,
Kisumu, Kenya; 2Kenya Medical Research Institute (KEMRI),
Kisumu; and 3Centers for Disease Control and Prevention,
Atlanta, GA.
Supported by the Division of HIV/AIDS Prevention-
Surveillance and Epidemiology; National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention, Centers for Disease
Control and Prevention, Atlanta.
Address reprint requests to Dr Zeh: Centers for Disease
Control and Prevention, Kenya, Off Kisumu-Busia Highway, PO
Box 1578-40100, Kisumu, Kenya.
Disclaimer: The findings and conclusions in this article are
those of the authors and do not necessarily represent the views
of the US Centers for Disease Control and Prevention (CDC).
Use of trade names is for identification purposes only and does
not constitute endorsement by the CDC or the US Department of
Health and Human Services.
Acknowledgments: We thank the HIV-R Laboratory staff
who worked long hours in implementing and maintaining the ISO
15189 accreditation. We also thank the Kenya Medical Research
Institute and Kenya Ministry of Health, whose participation made
this possible.
References
1. The Global Fund to Fight AIDS, Tuberculosis and Malaria.
Global Fund 2010 Innovation and Impact. March 2010.
Available at http://www.theglobalfund.org/documents/
replenishment/2010/Global_Fund_2010_Innovation_and_
Impact_en.pdf.
2. Akileswaran C, Lurie MN, Flanigan TP, et al. Lessons
learned from use of highly active antiretroviral therapy in
Africa. Clin Infect Dis. 2005;41:376-385.
recognized accreditation. However, there is an increased need
for quality laboratory services to support research programs
and public health disease surveillance and to assist in early
detection of emerging drug-resistant pathogens and new
infectious diseases. As previously noted, various programs
have been initiated to help strengthen the laboratory infra-
structure systems in resource-limited settings, although such
programs have been project-specific. A preferred system for
implementation of quality standards in such regions would
likely be the newly proposed WHO Regional Office for
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focuses mainly on the assessment of implemented standards
with a “pass or fail” verdict and requires standards be imple-
mented within a short time frame.
Conclusion
The provision of quality medical laboratory services is
vital for global patient care, disease surveillance, and clinical
research. Laboratory accreditation gives a formal international
recognition of quality laboratory services. This allows for
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❚Table 2❚
Approximate Accreditation Cost

Consultancy Services by
Contract Laboratory Services
Cost of Service (US$)
Nature of Service Preaccreditation Postaccreditation

Training
EQA
Accreditation process

LIMS
Alarm monitoring system
Total
Preaccreditation site assessment, gap analysis, follow-up assessment
GCLP, QA training, biosafety, IATA, LIMS, retraining
Proficiency testing enrollment
Purchase of the standard, preaccreditation visit, postaccreditation
assessment
Implementation
Temperature alarm monitoring system

60,000
30,400
14,130
16,459
—
13,200
21,195
30,620
5,000
564
126,553
5,000
1,128
71,143
EQA, external quality assessment; GCLP, good clinical laboratory practice; LIMS, laboratory information management system; QA, quality assurance.

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418 Am J Clin Pathol 2010;134:410-418
418 DOI: 10.1309/AJCPZIRKDUS5LK2D
© American Society for Clinical Pathology
Zeh et al / Implementing ISO 15189 in Kisumu, Kenya
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10. World Health Organization Regional Organization for Africa.
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