Joint WHO - CDC Conference On Health Laboratory Quality Systems
Joint WHO - CDC Conference On Health Laboratory Quality Systems
Joint WHO - CDC Conference On Health Laboratory Quality Systems
Lyon, France
9 - 11 April 2008
WHO/HSE/IHR/LYO/2008.3
Lyon, France
9 - 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Contents
Abbreviations and acronyms
Summary
1.
Introduction
1.1
Objectives
1.2
1.3
1.4
Welcome statements
1.5
Introductory remarks
1.5.1
1.5.2
8
8
2.
Setting the stage: why quality systems are essential for good laboratory practices
11
3.
15
4.
5.
3.1
Expected legal and managerial role of the resource-limited governments and health
care leadership
15
3.2
Challenges inherent in establishing full implementation of quality standards: the use
of staging to meet local requirements
17
3.3
Organizational challenges and national laboratory policies in combining vertical
quality systems for an integrated quality system approach
18
21
4.1
Caribbean countries
21
4.2
A Malaysian perspective
23
4.3
24
29
29
6.
31
7.
31
8.
7.1
31
7.2
32
7.3
33
35
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
35
Group 1: How to develop national laboratory policies and statements to support quality
systems
35
36
37
9.
39
9.1
Conclusions
39
9.2
Recommendations
40
10.
Closing remarks
41
10.1
Rapporteurs
41
10.2
Delegates
41
Bibliography
43
Annex 1
45
45
47
47
57
Agenda
57
Annex 4.1
61
List of participants
61
Annex 4.2
69
69
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
ADB
AIDS
AMREF
AMTT
APLAC
CDC
CLIA
CLSI
COLABIOCLI
CVN
DANIDA
DFID
EA
EQA
EQAS
EU
European Union
EPR
HIMS
HIV
HPA
IAAC
IAF
IDSR
IEC
IHR
ILAC
ISO
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
JCDCMAS
JDSC
KIMMS
LIMS
LIS
MDR-TB
Multidrug-Resistant Tuberculosis
MOH
Ministry of Health
MOHSW
MOPH
MOU
Memorandum of Understanding
NATA
NHLS
NIBSC
NICD
NPHL
PAC
PAHO
PT
Proficiency Testing
QC
Quality Control
QM
Quality Management
QMS
RCPA
SADCA
SARS
SEARO
SOP
TB
Tuberculosis
UK
USA
WHA
WHO
ZINQAP
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Summary
The World Health Organization (WHO) Lyon Office for National Epidemic Preparedness and
Response and the US Centers for Disease Control and Prevention (CDC), Atlanta, USA,
organized a joint Conference on Health Laboratory Quality Systems from 9 to 11 April 2008.
The specific objectives were:
1. To review and discuss the quality systems suitable for health laboratories.
2. To discuss the development of laboratory quality systems within well-organized
integrated national laboratory plans.
3. To share successful experiences and challenges of countries that have already made
steps towards meeting the objectives.
4. To discuss other important issues relevant to the development of quality systems on a
national basis.
The conference brought together over 200 health professionals from more than 70 countries and
included laboratory professionals, senior government officers, academic institutions specialists,
and staff from headquarters, regional and in-country offices of both CDC and WHO.
The conference included presentations on why quality systems were important, how to introduce
such systems into resource-constrained countries, the value of integrating systems with existing
disease programme laboratory networks and the challenges faced by those implementing such
systems. In particular, an advocacy statement had been agreed upon, which was a standalone
WHO CDC joint document to be used by individual delegates when advocating for investment
in laboratory quality with their governments.
Four breakout groups discussed how to develop national laboratory standards, external quality
assessment (EQA), the advocacy statement, and integrated approaches to quality programmes.
The groups made specific and general recommendations, which included the following:
For WHO
WHO should set up a resource and advisory group to assist Member States in the
development of their national laboratory plans.
It is accepted that donor aid is essential but WHO should consider coordination to enable
more efficient use of these valuable resources.
WHO should develop potential models of legislation and accreditation for adaptation and
use in Member States.
For laboratory professionals
Laboratory professionals should use the advocacy document to convince ministries of
health of the need for strategic development.
When implementing quality management systems, use should be made of the
WHO/CDC/CLSI toolkit.
Laboratory professionals should provide the business rationale and evidence required for
the investment in quality systems.
5
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
1. Introduction
1.1 Objectives
The World health Organization (WHO) Lyon Office for National Epidemic Preparedness and
Response and the US Centers for Disease Control and Prevention (CDC), Atlanta, USA,
organized a joint Conference on Health Laboratory Quality Systems from 9 to 11 April 2008.
The specific objectives were:
1. To review and discuss the quality systems suitable for health laboratories
2. To discuss the development of laboratory quality systems within well-organized
integrated national laboratory plans.
3. To share successful experiences and challenges of countries that have already made
steps towards meeting the objectives.
4. To discuss other important issues relevant to the development of quality systems on a
national basis.
The detailed agenda of the meeting is attached as Annex 3.
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Dr Rodier said that the Conference had been in part stimulated by the need for all signatory
countries to the International Health Regulations (2005) agreement to ensure that there was
capacity to provide quality laboratory results to identify any agents and substances likely to
cause public health emergencies of concern to the international community at large. Among the
objectives was the reduction in the risk of the spread of diseases. There were three paradigm
changes in the revised regulations:
These measures entered into force on 15 June 2007 and all WHO Member States undertook to
have action plans prepared by June 2009. There is a need to share the experience from the
sophisticated countries with those from resource-limited countries. There needs to be
cross-fertilisation of ideas and breaking of the isolation faced by many laboratories. Much was
expected of this Conference.
1.5.2 CDC Dr J. Ridderhof (Associate Director)
Dr Ridderhof explained that the drive towards generalized quality standards improvement in the
USA occurred as a result of the 1988 Clinical Laboratory Improvement Amendments (CLIA)
Program. The key features of the law included:
its application to virtually all clinical laboratories in the USA (approximately 180 000 vs
the 13 000 previously regulated),
The package, which would be available towards the end of 2008, would consist of 12
individualized packages or modules that can be customized locally and include the following:
8
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
organization, personnel, equipment, purchasing and inventory, process control (QC & specimen
management), information management, documents and records, occurrence management,
assessment, process improvement, customer service and, facilities and safety.
In addition, it was hoped that an advocacy document could be agreed by the conference
participants; this advocacy document would emphasize the need to work with the country
laboratory infrastructure at all levels from the ministries of health, through national reference,
provincial and district health centres.
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
10
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
The result is that over-treatment is the norm. A prime example is the overuse of antibiotics for
inappropriate clinical circumstances which leads to the emergence and predominance of
resistant microorganisms. Examples include multi-drug resistant TB, overuse of chloroquine for
malaria and overuse of broad spectrum antibiotics for non-specific bacterial or viral infections.
Because reliable laboratory services are not available, misdiagnosis occurs resulting in:
inadequate treatment,
11
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
The challenge is to develop affordable and sustainable quality to support the diagnosis of
infectious diseases and other medical conditions. For example, in Sub-Saharan Africa, WHO has
designated essential laboratory services as malaria microscopic evaluation, haemoglobin,
glucose and HIV. Ultimately, the goal has to be better patient care.
Furthermore, the IHR request all WHO Member States to develop the capacity to assess, detect
and report to WHO any potential event of public health emergency of international concern
through, among other criteria, accurate and reliable laboratory results in a timely way.
The critical importance of health laboratory quality in this process is now widely
recognized and greater demands arise for implementing laboratory quality systems,
including the development of national laboratory quality standards. Laboratories play an
essential part in both the detection and prevention of diseases. This starts with doing the right
test, at the right place, at the right time and achieving the right result.
The principles of high quality laboratory testing are the same anywhere in the world. It can,
therefore, be standardized. Most laboratory errors are caused by systems and processes and not
people. They are the areas where standards can help most. It does not matter how complex the
environment is in which the quality management system is applied, the principles are the same.
For example, the standards to be applied for simple point of care tests are the same as for the
more complex CD4 tests to monitor HIV/AIDS therapy. A laboratorys quality management
system (QMS) provides a framework for managing and monitoring quality standards in order to
achieve organizational goals. The question is about which quality system should be
implemented and built upon.
There are two systems in wide use: those of the International Standards Institute (ISO) and those
of the Clinical and Laboratory Standards Institute (CLSI). Both are built on the same concepts
but differ in the amount of specificity described. ISO is broader and CLSI has more specifics.
They are complementary and do not conflict. However, for resource-constrained countries the
requirements are for systems that are both comprehensive, simple to understand and scalable to
meet local needs and settings. The 12 essential elements were described by Dr Ridderhof earlier.
The choice of framework should be based on internationally recognized standards, simplicity,
quality performance of the total process and detecting and reducing errors. However, the system
will require political will to implement it, and the importance of laboratories must be recognized
when resources are allocated.
A value of a QMS should be to achieve:
high productivity,
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
an educational system,
There have to be appropriate policies for equipment, which will include selection, appropriate
installation and calibration, maintenance, the requirement for routine calibration,
troubleshooting and documentation review.
Policies for the supplies procurement must include the role of central stores, purchasing,
customs and best price versus customer requirements, and delivery to the laboratory concerned.
Process control concerns all laboratory operations, including method evaluation and standard
operating procedures (SOPs), specimen management, quality control and EQA. In addition,
methods have to be found for controlling documents and records by adopting a uniform
approach, systems for writing, approval and revision, and for storage retrieval and destruction.
Information management requires control of all incoming and outgoing information. Patient
privacy and confidentiality must be protected and standardization of information captured. The
provision of adequate and safe facilities and environments are essential.
It is important to ensure customer satisfaction by actively seeking information using surveys and
focus groups whilst at the same time rewarding staff that provide a good service. QC and EQA
are essential requirements and must include the pre- and post analytic phases as well as
analytical process control, setting performance goals and instituting corrective measures.
In summary, laboratories are essential to the total health care system and are capable of being
standardized on a global basis because quality systems can be applied in any environment
providing they are scaled to the local environment. The WHO/CDC/CLSI harmonized
laboratory quality systems package will be a great implementation aid.
Quality is a journey that must be taken in order to provide better health care.
13
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
14
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Private (%)
Government (%)
Argentina
5000 (90.6)
500 (9.1)
20 (0.3)
Brazil
12000
Chile
700
250
Dominican
Republic
468 (63.3)
207 (28.0)
64 (8.7)
Ecuador
3000 (90.1)
300 (9.0)
30 (0.9)
Guatemala
450 (92.6)
18 (3.7)
18 (3.7)
Honduras
127
Mexico
4000 (50.0)
1000 (12.5)
3000 (37.5)
Panama
80 (30.4)
124 (47.2)
59 (22.4)
Paraguay
339 (95.5)
15 (4.2)
1 (0.3)
Uruguay
84
59
Venezuela
1500 (79.1)
328 (17.3)
68 (3.6)
15
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Fifteen countries now have a licensing process and, at the time of writing, five do not. Twelve
countries now have functioning EQA schemes. Three countries have accreditation systems
based on national standards and four have systems based on the ISO 15189 standard. There are
difficulties in the application of the ISO 15189 which relate to management and technical
requirements. However, the COLABIOCLI/PAHO strategy is to support countries prepare their
laboratories for the achievement of international standards requirement by:
Tools currently in use include publications on subjects such as distance learning (2005),
equipment maintenance (2005), bio safety manual (2005) and guidance on achieving
accreditation (2002).
There are, in addition, two further major considerations: ethics and bioethics. Guidance
documents exist for clinical laboratories that include ethical principles, collaboration, patient
rights, internal procedures and confidentiality. For clinical research, there is guidance on ethics,
people vulnerability, conflict of interests, informed consent, research on children and
confidentiality.
The strategies adopted have produced successes:
The conclusion is that quality improvement and quality management can be achieved with
strategic alliances between PAHO/WHO, COLABIOCLI and national ministries of health.
16
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
you have available access to relevant resources and supporting infrastructure; and
the fact that accreditation expects full implementation of all parts of the standard.
What is there to learn from the two countries under consideration? There are differences in the
two approaches used.
In Australia, the international and national standards were used, there was active collaboration
between the accreditation and professional bodies, a peer process was adopted for assessment, a
comprehensive EQAS was provided by the professional bodies and there is emphasis on
education and not compliance.
In Thailand, the Ministry of Public Health and associated agencies were drivers, there is regular
and coordinated training in laboratory management systems, comprehensive provision of EQAS,
national standards which can be applied in any order and be staged, and an accreditation body
that provides review and registration at each stage.
There are some basic steps that can be followed. Preparation and knowledge are required and
professional body and government support appear to be key features. It is also important to
investigate and understand the environment in which the national laboratory system operates.
Study the experiences of those countries that have faced similar constraints.
It is important to develop national standards and supporting documents to suit local needs. When
implementing them, identify standards that allow early achievement and encourage the need for
ethics and professionalism. Establishment of a framework to enable review of implementation is
important and give laboratories something to aim for by providing a staged approach. Providing
opportunities for networking and mentoring provides a two-way effect of support.
There are other important additional features that should be addressed which include access to
EQA, relevant training, opportunities to share experiences of success and failure, regular
reviews to assess outcomes and to enable training needs to be identified and new policy
directions to be set. Where necessary, areas of improvement of the national standards can be
identified and acted upon.
Other issues for consideration will include:
17
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Polio,
In addition, there are other initiatives that place a strain on the laboratory structures. For
instance, less than 5% of MDRTB is detected using current technologies. As a result, there is an
urgent need to scale-up the TB laboratory network and make use of different testing strategies
including the use of liquid culture media, LED-based fluorescence microscopy and line probe
assay molecular screening for MDRTB. All have to be integrated into existing structures and
there is a need to not only do this within country settings but also between countries to ensure an
effective global network. It is inevitable that such efforts compete for resources with existing
generalized laboratory strengthening. However there is a need to embrace the technical
programmes because they already have introduced the concepts of quality systems. There are
18
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
staff training/retention,
quality assurance.
The global programmes for TB, HIV, Malaria, Vaccine preventable diseases and EPR require a
common structure comprised of national institutes, provincial laboratories, district laboratories
and health centres. The lack of an integrated structure has led to specific problems at a district
level, which appear to be: too many forms, too many bosses, different definitions, conflicting
priorities, no feedback, and duplication of work. There is a need to ensure integration of the
service at all levels and across all diseases in order to make the most efficient use of resources.
There is also a need to ensure that national reference laboratories are accredited to international
standards and that provincial, district and health centre laboratories are accredited within the
country. Why are laboratory quality management and accreditation important? Primarily
because they:
assure reliability and accuracy of all tests which enhances the credibility of the
laboratory,
As already described there are internationally recognized standards to which all can aspire.
The common components of these include: personnel, test method validation, quality assurance,
equipment calibration and maintenance, EQA, document management including SOPs,
information management and safety and facilities.
There are examples of integrated quality systems that have a focus on EQA in Zimbabwe and
South Africa. In the former the ZINQAP not only provides an EQA service but also makes
on-site visits to participating laboratories, runs workshops to rectify non-conformities, and
collaborates with partners to produce national laboratory standards. In South Africa, the features
of these programmes include:
PT based EQA for TB and HIV extending to provincial and district laboratories; and
19
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
There is a model to integrate the TB and HIV programmes, which would include promoting
national QA units, combine scarce resources, general strengthening. Implementation at
peripheral laboratories though will require strong intermediate/provincial laboratories, integrated
on-site supervision, the provision of QA samples by national centres and some rechecking of
AFB smears. It seems self evident that there is a need to formulate national policies and strategic
laboratory plans based on a generic framework of linkages between laboratories at all levels of
the service. Eight key interventions have been identified:
There are critical steps to be taken, which include: not assuming models from developed
countries, defining priorities, determining who makes policy and plans, determining what
defines development in terms of law, financial leverage, culture, best practices, politics and
following existing standards.
There are critical partners in policy development and all should be involved. In addition, it is
important to harness the expertise of professional associations, medical and laboratory
scientists/leaders, nurses and midwives, hospital authorities and clients. This will require the
setting of objectives with specific timed aims. For example: Reverse the declining case
detection rate and aim to increase to 70% by 2008. This might require the provision of
equipment, maintenance, provision of reagents and staff training. Start and finish dates would be
set, and the responsible partner would be identified.
As mentioned previously by Glen Fine, there is already a set of modules for laboratory quality
management system, which was developed as a result of partnership between WHO, CDC and
CLSI, that will provide many of the necessary training packages. The next critical steps will
include:
promoting a vision of integrated national laboratory systems that support the specific
requirements of public health programmes,
including all partners in strategic planning and policy development that include
integrated quality systems,
accrediting other laboratories within countries to their own integrated national standards.
20
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Evaluations conducted in 2003 showed that there were some particular challenges, which
included the loss of experienced staff, shortages of equipment and supplies, deteriorating
physical facilities, inadequate planning, technological and administrative infrastructures, weak
laboratory management and operational systems, no regulation and limited government
commitment and the absence of national or regional standards. For example, more than 21
countries had no strategic health plan, more than 68% of countries had no laboratory regulation,
more than 71% had no staff training programme, fewer than 75% had no assigned responsibility
for quality management and 92% had no safety programme.
Specific project strategies were adopted that included a focus on governance mechanisms and
the formation of national laboratory advisory committees, creating strategic alliances and
partnerships, inclusive and participative approach to decision making. (For example, 2 000
stakeholders were engaged in the projects decision making process). Empowering staff and
stakeholders and encouraging ownership of the change process was a key feature as was belief
in sustainability. Identifying champions to advocate and promote quality operations in
laboratories, training institutions and support services were key features of the project. Key
strategic alliances were made, which included staff from the private as well as the public sectors,
engagement with MOH staff, hospital administrators and health care providers, curriculum
coordinators, the Caribbean and international standards bureau, EQA providers and biomedical
and procurement professionals.
21
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
fifty-four laboratory and quality managers trained to obtain the postgraduate certificates
from the Michener Institute,
2006
QA coordination
35%
67%
QA manual
20%
70%
QC programme
20%
45%
HR development policy
10%
30%
EQA
25%
60%
Monitor error
35%
50%
Budgets
25%
50%
Legislation
6%
26%
Clinician surveys in six countries demonstrated that there had been improvements in turnaround
time, accessibility, accuracy, and communication. Stakeholder comments indicated that a quality
culture had been imbued, that training had become infectious, that laboratories had broken
ground for others to follow, the road map is set and the project has been a great success was
stated by a Minister of Health. A further comment indicated that the real results would be seen
in a few years because changing peoples behaviour takes time.
There have been major capacity building outcomes, networks have been developed, there are
private/public partnerships and there are common goals for improvement. There are plans for
further development and many stakeholders are committed to the cause and there are changes in
policy within and external to the laboratories. There were lessons to be learned but the countries
that obtained the maximum benefit had established national advisory committees, developed
22
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
strategic plans, had developed systems for monitoring, had active support from MOHs and had
wide stakeholder involvement. They also made maximum use of resources and had identified
supporters with a personal commitment who were proactive leaders and champions of the
project.
What is required is sustainability. There needs to be an endorsement by ministers of health who
will adopt and enforce legislation for licensing, provide resources and ensure that the national
laboratory advisory committees continue to implement the strategic plans. In addition, there will
be continuing activities on a regional basis to ensure that there are continuing curriculum
updates, distance education and accreditation mechanisms.
In summary, Ms Wilson said that the strategy and the criteria used to define quality were vital to
make the intervention sustainable. The measuring of success should be defined. Perhaps most
important of all is facilitating and sustaining behavioural change.
23
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
changing technology,
increased workload due to the increasing burden of disease and emerging diseases,
donor dependency,
poor infrastructure,
25
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
4.4
Thailand
Dr P. Silva (Bureau of Laboratory Quality and Standards, MOPH)
Dr Silvas opening remarks indicated that the challenges originally faced had been that there
were many laboratories with a wide variation in sizes and varying workloads. A large budget
had been spent. However, there was a limited resource with no clear policy. There had been a
need to improve motivation and sustain improvements. Objectives had been set which required
high output, and that there were improvements that were sustainable and measurable. These
changes had to be accepted by all parties and be easy to implement. In addition, they had to be
flexible, suit the local organization and structure, had to be achieved with a small budget and
required high participation rates. Although there were international standards, particularly
ISO 17025 (2005) and ISI 15189 (2003), it had been decided to develop and implement national
standards.
There was a national focal point for laboratories, and national standards were drafted and
consensus built by peer review. After ratification by national authorities, an implementing
agency had been identified which had trained the participating institutes, facilitated the adoption
of the standards and monitored and evaluated the process. This was also supported by the local
professional body (AMTT) and WHO and CDC.
The process was linked to the accreditation of hospital quality improvement and made use of the
international standard (the red book) with the national standards version (the blue book). The
sections of the national standards mirrored those of the international standard. There were 10
implementation stages:
results analysis and adjustment of the plan for the following year.
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
type of evaluation enables laboratories to assess their own progress and groups of laboratories to
be regularly evaluated.
Some important lessons had been learnt. Simple systems are easy to implement, a step-wise
approach can be used, a comprehensive checklist is vital, voluntary participation makes a good
start and that it was important to recognise that different laboratories are at differing levels of
quality development. Implementation is more rapid in medium sized hospital laboratories and
there are critical factors that influence quality development including training in practical skills.
National standards facilitate progress towards meeting accreditation to ISO standards, the use of
EQAS is an additional benefit, there had to be flexibility and it is important to have a positive
approach.
Dr Silva posed some challenges for the audience: why do we have to do this, when will we do
it, where will we start, whose responsibility is it, and how will we implement.
27
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
28
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
patient information including identity, accuracy of patient records and whether the
patient was a regular attendee or a single attendance,
the request which needed to be clear and unambiguous where a doctors handwriting and
understanding of the relevant test are important,
collection of a sufficient volume of the right specimen in the right way and to ensure
that any special conditions have been met,
transportation at the right temperature and at the right time with due regard for
infectious specimens,
selection of the correct specimen type e.g. the need for plasma or serum, and comments
about problems including haemolysis or lipaemia etc.
The analytical phases included all the activities taking place within the laboratory, including the
selection of the best methods and quality control, EQA, etc. It is the area where the laboratory
can achieve the highest level of quality. The post-analytical phase however comprised areas over
which the laboratory had some control and other areas that were more problematic. These were:
the LIMS,
machine interfaces,
correct doctor identification, courier delivery of results and correct filing in patient
notes; and
action on the results to ensure correct interpretation, relevant follow-up tests ordered
and counselling of the patient.
29
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
30
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
how to develop national laboratory policies and standards to support quality systems,
The results, reports, conclusions and recommendations from the groups were presented in a
plenary session and are summarised in section 9.
CDC had divisions that were responsible for specific diseases including HIV/AIDS and TB. Its
policy was also to integrate with other programmes and to publish technical information,
develop community surveillance frameworks and support and document best practises.
Although under the direction of a single director, CDC had integrated its efforts, had a focus on
31
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
public health, strengthened its regional networks for rapid detection of emerging infections. It
also engaged with many partners including MOHs, multilateral organizations such as WHO,
global non-government organizations such as the Red Cross and philanthropic agencies
including the UN Foundation and the Gates Foundation. It is important to note that detection of
new viruses will occur where they originate and not in the US, and that it was, therefore, crucial
to have a global pathogen surveillance system. A number of factors were required in order to
respond and this included the assistance of laboratories.
CDC is able to provide assistance including advocacy, direct technical assistance, materials, QA,
a network of laboratories, training and collaboration, facilities design, safety recommendations,
management and LIMS and further advice on testing algorithms. It also had many laboratory
partners world-wide with whom it worked. These partnerships had led to the formulation of
guidelines which included IHR and EQA of TB smear microscopy. Finally Dr Martin identified
the following future considerations:
ILAC was established initially to promote communication and provide peer evaluation. There
were 59 signatories representing 46 economies. In all 30 000 laboratories and 5 000 bodies have
been accredited. ILAC is structured in such a way that it was governed by a general assembly
and a series of committees. A fundamental premise was the use of MOUs between the various
bodies that ensured that a laboratory accredited by one partner had equivalent recognition by
other partners.
A new strategic and business plan had set new directions for ILAC that enabled it to collaborate
with WHO, with whom it shared common goals. Factors that affect a laboratorys performance
have already been discussed and ILAC can help with the achievement of these goals by
32
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
example PAHO has a network for dengue with a series of collaborating centres and reference
laboratories. In the African Region there is an EQA scheme now in 45 countries and three
consignments per year have been sent to all participants since 2002. There is good evidence, for
example EQA for CD4 counts that such distributions help in the quality improvement process.
Dr Bhatia also described the important activity of kit evaluations that WHO carries out in order
to achieve pre-qualification. It is able to purchase test kits at advantageous prices on behalf of
more than 50 States; some 15 million test kits have been purchased for priority diseases.
Biosafety is of major importance and WHO has held workshops for information exchange, it
gives advice on regulations for safe transport, runs training courses and provides technical
support. It is also able to mobilize resources from, for example, the World Bank, DFID, ADB,
the global fund and CDC. Strengthening quality as an integral part of a national laboratory
system is a priority and there are global networks that support countries whose efforts are
coordinated by WHO/HQ in Geneva.
In his final remarks Dr Bhatia posed the question: What is Quality? In his view it is about
science and philosophy. Quality is consistency and happiness.
34
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
35
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Specific recommendations:
1. EQA must fit the needs of the local situation; blends of national, local and vertical
programmes are appropriate.
2. Transportation costs and complexity are major impediments. WHO and other
organizations must work with ICAO and other agencies to have exemptions for
transporting quality materials.
3. The process of accreditation of EQA providers should be examined to look for barriers
that hinder widespread compliance.
4. The use of internal quality indicators and confidential release of performance
information can be beneficial to advocate for capacity building and should be
considered by all.
Laboratories need to be aware that they have three customers: the patient, the clinician and the
public health sector.
After the general discussion it was further recommended that all national reference laboratories
participate in international EQA schemes.
37
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
4. Countries should develop an advocacy plan and tools to solicit programme support for
integrated laboratory strengthening. Advocacy must include a business rationale and
evidence for investing in systems. Also the case are strengthening laboratory leadership
and management to integrate public health programmes and patient care.
5. There are organizational components to be addressed that include the fact that the global
framework of disease programmes is required to support quality systems and
organizational changes. The MOH should have a strong national director of national
laboratory systems. The director should ensure that programme resources are combined.
6.
7. A national quality system organization must develop national policies that support and
mandate the system. There will be requirements for a national steering committee that is
inclusive of all programmes and that can guide implementation. EQA functions should
be combined or integrated. There must be guidance on biosafety and ethics, and there
must be programmes for education and training at all levels.
38
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
39
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
9.2 Recommendations
These main recommendations are a combination of those made by consensus in the main body
of the meeting and those made by the breakout groups and include those for WHO, laboratory
professionals and ministries of health. These are in addition to those made by the specific
breakout groups.
For WHO
WHO should set up a resource and advisory group to assist Member countries in the
development of their national laboratory plans.
It is accepted that donor aid is essential but WHO should consider coordination to enable
more efficient use of these valuable resources.
WHO should develop potential models of legislation and accreditation for adaptation and
use in Member States.
For laboratory professionals
Laboratory professionals should use the advocacy document to convince ministries of
health of the need for strategic development.
When implementing quality management systems, use should be made of the
WHO/CDC/CLSI toolkit.
Laboratory professionals should provide the business rationale and evidence required for
the investment in quality systems.
For ministries of health
There is a need to develop a fully integrated structure and referral system within which all
health laboratories, including those involved in WHO technical programmes should
operate. The objective is to develop a national laboratory organization, within the national
health plan, that is responsive to the needs of patients and all users of the service.
The strategy for implementing quality management must include an examination of the
potential constraints as listed in this report. A focal point within the ministry is essential,
with a core advisory committee or group of experts, which will legitimise the process.
Those able to drive or act as champions of the programme should be engaged.
Quality Management Systems and quality standards should be introduced at all levels of
the laboratories organization.
External Quality Assessment (EQA) is an essential tool and it should be coordinated at a
national level. Other tools should be developed and used to measure success and
progress.
National Reference Laboratories should seek to be accredited by international bodies to
internationally accepted standards. Other laboratories will require a phased or staged
approach to achieve appropriate accreditation.
40
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
10.2 Delegates
Dr R. Amini (Iran (Islamic Republic of))
On behalf of all delegates Dr Rana Amini thanked WHO and CDC for organizing the
Conference which had come at an appropriate time. Delegates had had the opportunity to
discuss the changes that needed to be made in order to meet the expectations of users of
laboratory services. The question had been posed: what is the answer? Many questions had been
answered and she thanked those who had made presentations and for the discussions that had
taken place. Delegates now faced the challenge of what they should take from the Conference
and how they should commence the implementation of what had been learned.
41
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
42
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Bibliography
1. Browning DM. Standards for the medical laboratory, World Health Organization
Regional Office for the Western Pacific, 2003 (unpublished data).
2. Browning DM, Hill PG, Vasquez R. Olazabal. Preparation of stabilized liquid quality
control serum to be used in clinical chemistry, World Health Organization, 1986
(LAB/86.4).
3. El-Nageh MM et al. Basics of Quality Assurance for Intermediate and Peripheral
laboratories, World Health Organization Regional Office for the Eastern Mediterranean
Eastern Mediterranean Series, 1992, N2.
4. Forsman FW. Why is the laboratory an afterthought for managed care organizations?
American Association for Clinical Chemistry, 1996, 42: 813-816.
5. Kusum M, Silva P. Quality standards in health laboratories, implementation in
Thailand: a novel approach, World Health Organization Regional Office for South-East
Asia, 2005, SEA-HLM-386.
6. Lewis SM. Quality Assurance in Haematology, World Health Organization, 1998
(LAB/98.4).
7. Martin R et al. Implementation of a quality laboratory system approach for laboratory
practice in resource-constrained countries, AIDS 2005, 19(Suppl. 2):S59-S65, 2005.
8. Quality management systems requirements, International Standards Organization,
2008, ISO 9001:2000 E TC 176/SC.
9. Medical laboratories particular requirements for quality and competence, International
Standards Organization, 2008, ISO 15189:2007 E TC 212.
10. Ridderhof JC et al. Roles of laboratories and laboratory systems in effective tuberculosis
programmes. Bulletin of the World Health Organization, 2007, 85:354-9.
11. Whitehead TP. Principles of Quality Control, World Health Organization, 1976,
(LAB/76.1).
43
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
44
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Annex 1
Joint WHO-CDC statement: Laboratory quality systems
in the 21st century
As we move into the 21st century, diseases of public health importance continue to be a
significant global threat. Widespread epidemics could cost millions of lives, and many countries
are still struggling with a longstanding battle against rampant infectious diseases. In addition,
chronic diseases, which in the past have been primarily of concern in wealthier countries, are
now affecting other populations.
In order to deal effectively with the detection, treatment and prevention of these global threats to
the health of the public, it is essential that accurate and reliable health laboratory testing be
available in every country. Early detection and management of disease outbreaks can only be
accomplished if responsive laboratory systems are in place. Many therapeutic decisions rely
heavily on data from health laboratories. Prevention of infectious and noncommunicable
diseases requires accurate diagnostic information. The critical importance of high-quality health
laboratory services is now widely recognized.
Given the vital role that laboratories play in every aspect of health services, it is imperative that
countries undertake the necessary measures for support and improvement. A laboratory quality
system that engenders trust and confidence in laboratory services is essential. The ultimate goal
is to ensure the provision of accurate, reliable and timely laboratory test results that are
indispensable to all health activities and to support international health security. Cost and social
benefits also result from high-quality laboratory services.
To ensure that health laboratories, irrespective of their location, can meet international
requirements, laboratory systems in all countries will require strong political support and the
means to institute measures for improvement and compliance.
Recommendations:
Organize national structures to support a country-wide laboratory quality system
National structures capable of supporting a quality system for laboratories at country level will
require the following measures.
Creation of a national laboratory quality office and appointment of a quality officer with
authority and responsibility for oversight of national laboratory quality programmes;
45
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Each country should establish its own set of standards according to country-specific
needs based on internationally agreed standards.
National laboratory standards need to take into account local factors, including any
pertinent regulations, organization of the countrys laboratory system(s), and resource
constraints.
ensure that laboratory facilities and infrastructure are adequate and properly maintained
for all testing being performed;
ensure safety in all health laboratory facilities to protect workers within the laboratory,
visitors to the facility and the general public at large;
establish long-range plans for ensuring adequate and sustainable numbers of properly
trained personnel for conducting laboratory operations;
apply appropriate quality systems to all parts of laboratory management and operations,
including the procurement process for supplies and equipment;
develop national resources for ensuring internal quality control and for external quality
assessment;
The governments of Member States led by ministries of health are urged to involve all
stakeholders and interested parties in order to achieve these objectives.
46
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Annex 2
Conclusions and recommendations of the
working groups
Group 1: How to develop national laboratory policies and standards to
support quality systems
Prior to the general discussion two presentations were made by Dr V. Bevan, and Dr C. Mwangi
1. Ms Bevans presentation was on the contributions of the UK Health Protection Agency
towards quality systems in UK laboratories. She began her presentation by emphasizing
that the HPA was dedicated to protecting peoples health. It was involved in assuring
quality and described the standards necessary which included QA, a service culture that
focused on the user of the service, met accreditation standards and had a quality manual
and other specified standards. SOPs were key as were the use of standard methods. At
present, there are 75 bacteriology methods, 36 virology and 37 for food, water, dairy and
environmental assays. There specifications given for culture media and 41 guidance
notes. All were developed in conjunction with national health service bacteriologists.
Testing strategies were set, as were the minimum acceptable standards for front line and
confirmatory testing. The standard methods gave comprehensive information on all
theoretical and technical matters and contained literature reviews and references. The
objectives were to help accreditation and to have information on existing best practices.
There is guidance on pre-analytical sampling and to help users make informed decisions.
Some quality control reagents were supplied to assist laboratories with their IQC; future
reagents included molecular quality control materials for, among others, chlamydia.
International collaborative work was undertaken with NIBSC and CVN for more
molecular standards. All these efforts towards standardization helped to ensure consistent
high quality services by individual and groups of laboratories.
2. In her presentation, Dr Mwangi described the contribution that the Central Public
Health Laboratory, Republic of Tanzania, has made introduced her remarks by pointing
out that the laboratory services in Zambia had commenced in 1897 when Dr Robert Koch
had established a government laboratory in Dar es Salaam. Many changes had taken place
since. In 1961 the original laboratory had grown to become the Central Pathology
Laboratory (CPL) which functioned as a reference and public health laboratory. Its
original functions included the distribution of equipment and supplies, the provision of
support to the school of medical technology, training technicians and writing SOPs. As
health care developed, the CPL gradually became a laboratory for the national hospital
and lost its role in giving oversight or supervision to other laboratories. This eliminated
support to the periphery and reduced policy formulation and its regulatory role. In 1972,
the laboratory services were aligned with new government administration structures.
Laboratories became managed by health centre and regional development directorates.
Referral laboratories were managed separately by central government. In 1991, the
laboratory services were further organized to establish better managerial systems,
coordination and improvement of the structure. The changes were expected to promote
training of staff, standardize equipment, promote local production of all supplies and
establish and enforce an ethical code for all laboratory health professionals. The result
47
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
A lively and participative discussion followed which resulted in a number of good options for
individual country representatives to take part and for internationally focused organizations to
consider. In addition to recommendations on the need for strategic planning, there were six
main recommendations. It was agreed that the strategic planning for laboratories had to be
integrated into the overall health plan and that all major stakeholders should be involved.
Developing consensus was important as was making the goals and timelines realistic.
Identifying champions to drive the programme was vital. There are two main approaches;
bottom up and top down, neither are perfect. There is already considerable information on
planning and implementation available, including that from similar environments so we do not
re-invent the wheel. Rather, we should:
define the difference between strategic planning (three years plus timescale) and
and ensure that all are integrated into the whole system;
educate stakeholders to understand that quality is key.
WHO should set up a resource and advisory group to assist countries in advocating on behalf of
quality systems to be implemented by WHO regional offices. There are many donors with
differing goals but donor funds should be used in accordance with the country national plan and
be coupled with government support and accountability.
Strong policy level support is required. Champions are required within the political structure
and the MOH. We must also be mindful that MOH officials have broad mandates of which
laboratories are but one. There is often less understanding of laboratory issues than is wished.
International organizations can and should help. It is important to measure results. (For example
the % of the population that knows its HIV status). We need to remember that what gets
watched gets fixed!
Specific recommendations:
1. Each country should have a national public health laboratory that has identified
competencies based on minimal appropriate internationally recognized standards (for
example ISO 17025 and 15189, CLSI etc.) and includes all phases of the quality cycle
from pre-analytical through to, and including, the post-analytical phase that comply with
IHR 2005 regulations and core capacity requirements (a reasonable timeframe to be
determined by WHO).
2. Develop model legislation (perhaps developed by WHO?) for the national use of
international laboratory standards. There should be national regulations.
3. Be accountable for the results. There needs to be a combination of carrot and stick
approaches with the use of rewards and recognition, and punitive actions that might
include loss of job, loss of laboratory accreditation and laboratory closure. Such actions
have to be taken with the use of undisputable driven evidence.
4. Introduce accreditation and use of international standards to give credibility (WHO to
take the lead to raise standards without the necessity of accreditation?). Use a phased
approach, an example being that of the approach used in Thailand, so that regional,
district and/or local levels use a scaled down nationally based accreditation or
49
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Prior to the general discussion three presentations were made by Dr R. Amini, Dr J. Carter, and
Mr J. Elliot
1. Dr Amini described the reasons for performing EQA. The main reason in her view was
the need to establish the point of failure in the analytical and correct it. This is important
for the laboratory as well as policy makers. There are key points when designing an
EQAS, which include identification of priority areas, the spectrum of tests, laboratory
capability, reproducibility, programme continuity, costs and cost effectiveness. There are
international providers who provide high quality services which save time and trouble
and who have a wide spectrum of tests at a fixed timescale and with data analysis.
However, they are costly, there are shipment problems, they are not designed to address
the specific needs of each laboratory and may not be able to detect the problem areas.
The answer has to be to carry out a situation analysis and asses cost effectiveness. It is
important to know the number of laboratories in a country, the spectrum of tests and the
number of laboratories that perform them, to prioritize the aims and goals for
improvement, to know the budget and the shipment costs.
The goals are to verify the quality of results obtained at all levels of the service, to detect
problems and evaluate kits and reagents, give assistance to solve problems, to stimulate
and maintain good performance and to ensure the performance of national health
programmes and to help verify the epidemic preparedness. The spectrum of disciplines
and numbers of analyses are very wide. Dr Aminis experience led her to the conclusion
that mixed materials should be used and the choice based on needs. The materials should
always be analysed centrally so that the quality control materials themselves are
controlled. It is wise to run a pilot trial before the introduction of a national scheme.
Customer satisfaction was important.
50
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
2. Dr Carter described the East African Regional External quality Assessment Scheme
(EA-REQAS). This is a pilot programme underway involving laboratories in Kenya,
Tanzania, Uganda, and Zanzibar. It involved scheme development, organization at a
regional level and national coordination, the use of reference laboratories, participating
laboratories and a method of providing support by supervisors to enable remedial action.
It is currently in a pilot phase and involves 200 laboratories in nine districts/countries and
laboratories at all levels of the services.
There was a set of criteria for the selection of tests, including clinical importance, public
health importance, those performed at a primary level using techniques of accepted
accuracy, where materials could be preserved and using materials that were stable at
warm temperatures. The range of tests and techniques reflect the priority of the countries,
e.g. haemoglobin for anaemia, thick blood film for malaria and trypanosomes, and
sputum for TB, to name a few.
The survey material is prepared by selected reference laboratories and SOPs for their
preparation have been prepared; MOUs have been signed with each. There are reference
laboratories in each of the countries. In the first year, eight tests were surveyed and in the
second year a second set of tests were surveyed, including plus the two worst from the
previous distributions. Tasks have been assigned to the national and regional coordinating
centres which include preparation of materials, purchasing of supplementary supplies,
organizing the delivery of the material, further QA checks, repackaging and preparation
of instruction sheets. In addition, payments have to be made to the reference laboratories.
The advantages of local material preparation include:
reduced costs ;
regional cooperation.
This approach also generated great enthusiasm, however some disadvantages and
problems do occur with locally produced materials, such as delays in preparation and
submission, communication and payments to centres in different locations, the variability
in the quality of the preparations and the fact that it is very manpower intensive.
3. Mr Elliot indicated that of the 12 essentials in the quality system suggested by the
WHO/CDC/CLSI collaboration each was amenable to being monitored and quality
indicators were used for all. The methods employed to monitor quality included IQC,
participation in EQA, internal audits and external audits (peer review audits). The
difficulty was about where to begin. Many of the drivers were the need to achieve
accreditation. Besides, implementing quality is a journey. There were advantages such as
introducing a quality system that lead to quality improvements, improved staff training,
better relationships between laboratory and clinical staff, gaining international
recognition, the subsequent improvements in patient care and subsequent cost savings.
There were also some perceived disadvantages such as the apparent costs of getting there
and the additional challenges for laboratories in resource-constrained countries. It is
possible to set quality indicators. They are:
51
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
turnaround times;
continual monitoring of IQC and EQA results and taking corrective action; and
Documents and records are central to an effective quality system and the production of
SOPs is a good place to start.
During the discussion that followed, it was concluded that there are advantages and
disadvantages to international and local EQA programmes and both have their challenges.
Transport is a serious difficulty locally and particularly internationally where customs officers
had difficulty in recognizing the importance of quality materials. In some countries, the ambient
temperatures presented particular problems. EQA samples can be a safety problem for some end
users. Some reference and research laboratories may not benefit from EQA because of their
particular needs.
EQA providers see their role as primarily an educational one and methods of grading and
assessment are part of the education process. Quality improvement activities that are based on
external agencies are difficult to sustain when those agencies leave. Political and financial
support is essential. Motivation, training and empowerment are powerful drivers of laboratory
quality. EQA enables the evaluation of kits, reagents and equipment and provide assistance in
decision making for policy makers. The most important useful approach to the introduction of
quality measures is the bringing together of the laboratory with the clinician and government.
Specific recommendations:
1. EQA must fit the needs of the local situation; blends of national, local and vertical
programmes are appropriate.
2. The costs and complexity of transportation are major impediments. WHO and other
organizations must work with ICAO and other agencies to have exemptions for
transporting quality materials.
3. The process of accreditation of EQA providers should be examined to look for barriers
that hinder widespread compliance.
4. The use of internal quality indicators and confidential release of performance
information can be beneficial to advocate for capacity building and should be
considered by all.
The discussion closed with the reflection that laboratories need to be aware that they have 3
customers: the patient, the clinician and the public health.
52
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
One objective of the Conference was to give delegates an agreed statement and recommendation
from the Conference for them to use, as a stand alone document, to be used in advocacy to
governments. A draft was prepared prior to the meeting, circulated for comment to WHO, CDC
and an expert group, modified in the light of comment and presented to the group for
discussion. Extensive discussion took place and further modifications made which were put to
the plenary session for further comment, discussion and modification. The agreed statement is
in annex 1
Group 4: Integrated approaches for quality programmes
Prior to commencing the discussion the group heard three presentations from Dr Y. Issabre,
Dr J-M Gabastou and Dr S. Van Beers
1. Dr Issabre described the quality implementation project in Mali, which was a
collaboration and partnership agreement with the Mrieux Foundation, the EU, the MoH
Mali and with technical support from WHO Lyon. The overall objectives were to
strengthen the capacities of the medical laboratories network and standardize laboratory
practices. There were specific objectives, including the regular maintenance of laboratory
equipment, training for staff, monitoring activities, setting up QA and to set up a
centralized system for stock management and purchase.
In Mali, the laboratory network is organized into three levels: at the central or national
level there are reference laboratories, focal points for integrated disease surveillance and
specialized private and public laboratories for reference activities for all specialities. At
the intermediate or regional level are the regional hospital laboratories and at peripheral
and operational level will be found the health reference centres and community health
centres.
In 2005, an assessment showed that quality systems were not in place. There was weak
involvement by laboratory technicians, infrequent use of IQC, equipment checks rarely
performed, poor equipment maintenance and with the exception of the national TB
programme, almost no external evaluation.
During a workshop held in 2006 a national plan for QA was formed. The objectives were
to ensure the adoption of a national quality policy, training staff in QA, implementation
of QA, the setting up of a programme for EQA and monitoring the results of these
activities. There were specific planned activities which included the implementation of
EQA in 38 laboratories, supervision of laboratories and the setting up of a QA steering
committee to coordinate the programme.
Training of trainers was carried out and network stakeholders trained at regional level;
further training of directors and health managers and laboratory staff was conducted.
Standardized diagnostic methods for priority diseases were introduced in order to
improve performance. An EQA unit was formed in the national institute of research and
public health. A capacity assessment of laboratories ability to participate in the EQAS
was undertaken. Training in supervision of quality was performed.
The project has been coordinated by a steering committee which includes staff from the
MOH and reference laboratories and a representative from Mrieux Mali Foundation. Its
53
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
mandate is to adopt and circulate guides for good execution of analyses, training
coordination, support to the EQA scheme, supervision of the EQA unit, to coordinate the
supervision of network laboratories and to provide access to accreditation bodies.
Initial achievements include the use of SOPs, capacity strengthening of the national EQA
unit, strengthening the capacity of the equipment and reagents procurement unit,
validation of the QA plan by stakeholders. A capacity assessment of the network of
laboratories participating in the EQA schemes for malaria, TB, HIV and meningitis. In
addition, two biologists have been trained in Johannesburg to further strengthen the EQA
unit.
In conclusion, Dr Issabre believed that further achievements in network building and
monitoring included:
the analysis of quarterly reports from the regional network in order to provide
an evaluation of biological analyses framework and take corrective action
where necessary.
54
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
3. Dr Van Beers began her remarks with a quote Quality costs money; No quality costs a
fortune. Quality can only be assured by a well-defined quality system aimed at ensuring
consistency, reproducibility, traceability and efficacy of the products and services. There
were several levels of quality implementation and a systematic approach is required. This
starts with user requirements through the examination process and user satisfaction or
dissatisfaction. There were resource needs and these were required by all laboratories
including those for TB, HIV and malaria. Support systems were also required and these
overlapped between the diseases. The quality improvement systems also overlapped. It is
therefore logical to integrate the systems and embrace all diseases simultaneously. There
are essential factors in quality management according to ISO 15189 that apply to all
laboratories. Identified problems in quality systems show that 23% are process related
and 77% are structure related. The various elements of ISO 15189 define essential
elements in the quality management system for medical laboratories to meet service
delivery and patient care goals. However, these standards are highly resource demanding
and are not suited to every level of laboratory; resource-constrained countries need to
develop their own minimum standards depending on the size and degree of
sophistication.
However, is one standard applicable for all irrespective of the level and environment?
Perhaps different levels of quality implementation are required. The model in Thailand
offers one approach that can be adopted. In some industrialized countries, including the
USA, there is recognition that laboratory requirements can be defined for differing
categories of test. These situations offer the opportunity for a staged approach. Public
health programmes, disease control programme and clinical service laboratories share the
same quality goals and should therefore join forces in improving overall quality. It is
important for all to share the vision.
In the discussion that followed , specific recommendations were made concerning the need to
develop the message, challenges and obstacles, planning requirements, the need for advocacy
and the organizational components required.
Specific recommendations:
1. Devise the message that there is a need to develop a systems approach, with a focus on
quality systems and standards to achieve the common goals of quality patient care and
public health programmes. Programmes gain through a shared approach.
2. There are particular challenges and obstacles to be overcome. Resources are allocated
through disease-specific programmes and at national level people and institutions are
managed by separate programmes. Public laboratory systems do not intersect with the
private sector.
3. Quality system planning should be part of a larger national laboratory system that is
managed by the MOH which will coordinate the contributions of donors and
programmes including all disease specific programmes, clinical services and
stakeholders. Strategic planning provides an opportunity to combine programme
resources for an integrated system.
4. Countries should develop an advocacy plan and tools to solicit programme support for
integrated laboratory strengthening. Advocacy must include business rationale and
evidence for investing in systems and strengthening laboratory leadership and
management to integrate public health programmes and patient care.
5. There are organizational components to be addressed that include the fact that the global
framework of disease programmes is required to support quality systems and
organizational changes. The MOH should have a strong national director of national
55
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
laboratory systems. The director should ensure that programme resources are combined
to strengthen core functions and that there is a disease-specific national reference
system.
6. A national quality system organization must develop national policies that supports and
mandates the system. There will be requirements for a national steering committee that
is inclusive of all programmes and that can guide implementation. EQA functions
should be combined or integrated. There must be guidance on biosafety and ethics, and
there must be programmes for education and training at all levels.
56
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Annex 3
Agenda
Wednesday 9 April 2008
08:00 09:00
Registration at Sofitel
09:00 09:40
S. Guillaume
(Deputy Mayor, health &
social services)
G. Rodier (Director, IHR)
J. Ridderhof
(Associate Director)
10:40
11:10 12:30
Break
How to institutionalize integrated quality systems
in the national laboratory system
Expected legal and managerial role of the resourcelimited governments and health care leadership
Challenges inherent in establishing full
implementation of quality standards scalability to
meet local requirements
Organizational challenges and national laboratory
policies in combining vertical quality systems for an
integrated quality system approach
12:30 14:00
14:00 16:40
Lunch
Successes and challenges in implementing quality
standards
Caribbean countries
China
United Republic of Tanzania (the)
15:45 16:00
Break
Thailand
Chair: K. B. Chua
(NPHL, Malaysia)
G. Fine (CLSI)
N. Cabutti
(COLABIOCLI)
R. Robertson (NATA)
J. Ridderhof (CDC)
Chair: J. Carter
(AMREF, Kenya)
V. Wilson (CAREC)
P. Mingting (NCCL)
C. Massambu (MoH)
P. Silva (MoH)
57
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
16:40 17:15
17:15 18:00
18:00
I. Gardner (RCPA)
Breakout discussions
Group 1: How to develop national laboratory
policies and standards to support quality systems?
Quality system essentials utilizing the international
standards; practical hands-on session
Group 2: External Quality Assessment (EQA) and
development of monitoring tools
Discussions on the necessity of
international/regional/national EQAs
How to monitor the progress of quality systems
implementation?
To seek and propose monitoring tools, or quality
indicator, useful for assessing the achievement
objectively
K. Klugman (Chair)
G. Fine (moderator)
F. Fuchs (moderator)
C. Mwangi (moderator)
P. Silva moderator)
M. Noble (Chair)
R. Amini (moderator)
J. Carter (moderator)
J. Elliot (moderator)
V. Fensham (moderator)
M. Niedrig (moderator)
Y. Ipuge (Chair)
C. Collins (moderator)
J. Elliot (moderator)
C. Heuck (moderator)
J. James (moderator)
J. Hughes (Chair)
S. Beers (moderator)
J.M. Gabastou (moderator)
J. Ridderhof (moderator)
10:30 11:00
Break
11: 00 12:30
12:30 14:00
Lunch
14:00 17:00
Chair: S. Al Busaidy
(C PHL, Oman)
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Group 1
Break
Group 2
Group 4
Discussions
17: 00 18:30
Chair: K. Stinshoff
11:00 11:20
Break
11:20 11:50
11:50 12:20
R. Martin (CDC)
R. Robertson (ILAC)
R. Bhatia (WHO/SEARO)
Wrap-up Discussion
Endorsement of the Advocacy paper
Conclusions and recommendations
12:20 12:30
Closing remarks
12:30
Close of Conference
Dr R. Amini (Participants
representative)
59
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
60
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Annex 4.1
List of participants
Dr Almaz Abebe, Ethiopian National Health and Nutrition Research Institute, Addis Ababa,
Ethiopia
Dr Criselda Abesamis, National Center for Health Facilities Development, Department of
Health, Building, Santa Cruz, Manila, Philippines (the)
Ms Blasina Aguilar, Ministry of Health, Panama, Republica de Panama
Dr Siriwat Akapirat, Armed Forces Research Institute of Medical Sciences, United States
Army Medical Component, Bangkok, Thailand
Dr Suleiman Al-Busaidy, Central Public Health Laboratory, Ministry of Health, Muscat, Oman
Dr Mrio Csar Althoff, Public health laboratory coordinator, Ministry of Health, Brasilia,
Brazil
Dr Rana Amini, Reference Laboratories of Iran Research Centre, WHO Collaborating Centre,
Bo-Ali Hospital, Teheran, Iran (Islamic Republic of)
Dr Adoh Barthlmy Anon, National public health laboratory, Abidjan, Cte d'Ivoire
Dr Anne Badrichani, William J. Clinton Foundation, Quincy, Massachussets, USA
Dr John Ball, American Society for Clinical Pathology, Chicago, Illinois, USA
Ms Anne Berndt, International Federation of Biomedical, Laboratory Science, Hamilton,
Ontario, Canada
Dr Valerie Bevan, Health Protection Agency, Centre for Infections Evaluation and Standards
Laboratory, London, England
Mr Iga Boaz, SAIC-Frederick, Inc., Clinical Monitoring Research Program, Rakai Health
Sciences Program, Kampala, Uganda
Dr Jacques Boncy, National public health laboratory, Ministry of public health, Port-au-Prince,
Haiti
Dr Michel Bonnier, BioMrieux, Marcy lEtoile, France
Dr Eka M. Buadromo, Consultant Pathologist, Colonial War Memorial Hospital, Suva, Fiji
Dr Norberto Cabutti, Latin American Biochemical Confederation, Buenos Aires, Argentina
Dr Jane Carter, Head Clinical Services, African Medical & Research Foundation, Nairobi,
Kenya
Dr Wilai Chalermchan, Department of Medical Sciences, National Institute of Health,
Muang Nonthaburi, Thailand
Dr Sujatha Chandrasekaran, Suryodaya Centre for Health Information, Abhiramapuram,
Chennai, India
Mr Jean-Franois Charpentier, BIOLABO, Maizy, France
Dr Kaw Bing Chua, Makmal Kesihatan Awam Kebangsaan, National Public Health
Laboratory, Ministry of Health, Sungai Buloh Selangor, Malaysia
Professor Christian Collombel, Biologie sans Frontires, Lyon, France
Dr Andr Deom, Swiss Centre for Quality Control, Chne Bourg, Switzerland
Dr Seydou Diarra, National Public Health Research Institute, Bamako, Mali
61
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Mr Franois Diaz, Scientific and Technical Department, World Organization for Animal
Health, Paris, France
Ms Antoaneta Dragoescu, Ministry of Public Health, Bucharest, Romania
Dr Varalakshmi Elango, TDR Clinical Laboratory Network, Thammasat University, Bangkok,
Thailand
Mr John Elliot, Pacific Paramedical Training Centre, Wellington, New Zealand
Dr Sittana Elshafie, Hamad Medical Corporation, Department of Laboratory Medicine and
Pathology, Doha, Qatar
Ms Vivian Fensham, National Institute for Communicable Diseases, Microbiology EQA Unit,
Johannesburg, South Africa
Dr Paula Fernandes, Association of Public Health Laboratories, Silver Spring, Maryland, USA
Mr Glen Fine, Clinical and Laboratory Standards Institute, Wayne, Pennsylvania , USA
Dr Moiss Francisco, Instituto Nacional de Saude Publica, Luanda, Angola
Dr Florence Fuchs, French Health Products Safety Agency, Lyon, France
Dr Florentina Furtunescu, Ministry of Public Health, Bucarest, Romania
Dr Tura Galgalo, National Public Health Laboratory Services, Ministry of Health, Nairobi,
Kenya
Dr Ian Gardner, The Royal College of Pathologists of Australasia Quality Assurance
Programs, Surry Hills, New South Wales, Australia
Dr Marc Anthony Germain, Haitian Group for the Study of Kaposi's Sarcoma and
Opportunistic Infections, Port-au-Prince, Haiti
Dr Christopher Gilpin, International Organization for Migration, Geneva, Switzerland
Ms Martina Gliber, Fondation Mrieux, Lyon, France
Dr Gudeta Tibesso Gudeto, The Federal Democratic Republic of Ethiopian Health and
Nutrition Research Institute, Addis Ababa, Ethiopia
Mr Gaspard Guma, Central Public Health Laboratories, Ministry of Health, Kampala, Uganda
Dr Monique Gueguen, Medical Department, Mdecins Sans Frontires, Paris, France
Dr Aktham Haddadin, Central Laboratories, Ministry of Health, Amman, Jordan
Dr Lu Han, National Institute for Viral Disease Control and Prevention, Centers for Disease
Control, Beijing, China
Dr Bader Hasan Baig, Ministry of Health, Public Health Laboratory Services, Manama,
Bahrain
Mr Armen Hayrapetyan, Implementation Unit State Agency, Ministry of Health, Yerevan,
Armenia
Ms Silke Heller, Instand e.V. Sankt Gertrauden-Krankenhaus, Berlin, Germany
Ms Lucia Hernndez Rivas, Control de Muestras y Servicios, National Institute for
Epidemiology Diagnostics and References, Col. Santo Tomas, Mxico
Professor Claus Heuck, Institute for Laboratory Medicine, University Hospital, Dsseldorf,
Germany
Ms Thi Minh Ly Ho, Department of training and Research Management, National Institute of
Hygiene and Epidemiology, Hanoi, Viet Nam
Dr Mark Hotz, Bundeswehr Institute of Radiobiology, Munich, Germany
Dr James Hughes, Emory University, Atlanta, Georgia, USA
Professor Paata Imnadze, National Center of Disease Control and Public Health, Medical
Statistics, Tbilisi, Georgia
62
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Dr Yahya A. Ipuge, Clinton Foundation, HIV/AIDS Initiative, Dar es Salaam, United Republic
of Tanzania (the)
Mr Issa Ishtaieh, Central Public Health Laboratories, Ministry of Health Ramallah, Al-Bireh
Palestinian National Authority
* Dr Youssouf Issabre, Fondation Mrieux, Bamako, Mali
Mr John Lawrence James, Holly Tree House, Wimborne, Dorset, England
Dr Vivienne James, United Kingdom National External Quality Assessment Service for
Microbiology, Quality Assurance Laboratory, Centre for Infections, Health Protection Agency,
London, England
Dr Marc Jouan, Institut Pasteur, Paris, France
Dr Yamina Kabrane, French Health Products Safety Agency, Saint Denis, France
Ms Susanne Karlsmose, National Food Institute, Copenhagen, Denmark
Dr Kaliya Kasymbekova, Department of the State Sanitary and Epidemiological Surveillance,
Ministry of Health, Bishkek, Kyrgyzstan
Dr Nyamdavaa Khurelbaatar, National Center for Communicable Diseases, Ministry of
Health, Ulaanbaatar, Mongolia
Dr Juvent Kinigi, Laboratoire de Biologie clinique, Centre Hospitalier Universitaire,
Bujumbura, Burundi
Ms Juliana Kinkese, Ministry of Health, Lusaka, Zambia
Professor Keith Klugman, Department of International Health, The Rollins School of Public
Health, Emory University, Atlanta, Georgia, USA
Dr Vasily Kuklev, Russian Antiplague Research Institute Microbeof Rospotrebnadzor,
Saratov, Russian Federation (the)
Ms Linda Kuo, California Department of Public Health, Microbial Diseases Laboratory,
Richmond, California, USA
Dr Ichiro Kurane, National Institute of Infectious Diseases, Department of Virology, Tokyo,
Japan
Dr Berthe-Marie Lafourcade, Agency of Preventive Medicine, Paris, France
Dr Christophe Leculier, Laboratoire P4 Jean Mrieux, Institut National de la Sant et de la
Recherche Mdicale, Lyon, France
Dr Evan Lee, Foundation for Innovative New Diagnostics, Cointrin, Switzerland
Mr Jacques Lemius, BioMrieux, Marcy lEtoile, France
* Dr Christophe Longuet, Fondation Mrieux, Lyon, France
Dr Khue Luong Ngoc, Medical Administration, Ministry of Health Viet Nam, Hanoi, Viet Nam
Ms Sibongile Nyaradzo Makhanda, Zimbabwe National Quality Assurance Programme, Trust
Parirenyatwa Hospital, Harare, Zimbabwe
Dr Manuel Ismael Mancilla Morales, National Health Laboratory, Villa Nueva, Guatemala
Dr Douglas Mangwanya, Ministry of Health and Child Welfare, Causeway, Harare, Zimbabwe
Dr Charles Massambu, Diagnostic Services, Ministry of Health and Social Welfare,
Dar es Salaam, United Republic of Tanzania (the)
Dr Barbara Mc Kinney, American Society for Clinical Pathology, Chicago, Illinois, USA
Dr Upul Ajith Mendis, Health Services, Ministry of Healthcare and Nutrition, Colombo,
Sri Lanka
* unable to attend
63
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Dr Ling Meng, Office of Disease Control and Emergency Response, Center for Disease
Control, China, Beijing, China
Mr Benoit Miribel, Fondation Mrieux, Lyon, France
Dr Thoraya Mohsin Saleh, Hamad Medical Corporation, Department of Pathology and
Laboratory Medicine, Doha, Qatar
Dr Modisa S. Motswaledi, Ministry of Health, Gaborone, Botswana
Dr Agrippa Mtambara, NatPharm, Harare, Zimbabwe
Ms Therese Mukankwiro, Department of Microbiology, National Reference Laboratory,
Ministry of Health, Kigali, Rwanda
Ms Fales Zulu Mwamba, Ministry of Health, Laboratory Services Unit, Lusaka, Zambia
Dr Katalin N. Szomor, Department for Viral Diagnostic, National Centre for Epidemiology,
Ministry of Health, Budapest, Hungary
Dr Gourou Iremine Nahoua, National Program to Fight Against Tuberculosis, Abidjan,
Cte dIvoire
Dr Pierre Nicolas, Meningococcus Unit, WHO Collaborating Centre for Reference and
Research on Meningococci, Institut de Mdecine Tropicale du Service de Sant des Armes,
Marseille, France
Dr Matthias Niedrig, Laboratory Group, Robert Koch Institute, Berlin, Germany
Professor Michael Noble, Clinical Microbiology Testing Programme, Department of Pathology
and Laboratory Medicine, University of British Columbia, Vancouver, Canada
Mr Amato Ojwiya, Central Public Health Laboratory, Ministry of Health, Kampala, Uganda
Dr Mc Paul Okoye, U.S. Agency for International Development, Abuja, Nigeria
Ms Scholastica Okui, Central Public Health Laboratory, Ministry of Health, Kampala, Uganda
Dr Ali Onoja, Central Public Health Laboratory Service, Yaba, Lagos, Nigeria
Dr Chinnambedu N. Paramasivan, Foundation for Innovative New Diagnostics, Cointrin,
Switzerland
Ms Maria Adelina Pea Gomes, Dr Ricardo Jorge National Institute of Health, Lisboa,
Portugal
Dr Marcelo Omar Pellegrino, Servicio Nacional de Sanidad y Calidad Agroalimentaria,
Direccin de Laboratorios y Control Tcnico, Buenos Aires, Argentina
* Dr Mingting Peng, Hematology Laboratory of National Center for Clinical Laboratories,
Beijing, China
Professor Claude Petit, Centre Europen de Sant Humanitaire, Universit Claude Bernard,
Lyon, France
Dr Antoine Pierson, Eptisa Internacional, Strengthening the Services of Public Health
Laboratories in Serbia, Belgrade, Serbia
Dr Guillermo Pimentel, Naval Medical Research Unit 3, Disease Surveillance Program, Cairo,
Egypt
Dr Herv Raoul, Laboratoire P4 Jean Mrieux, Institut National de la Sant et de la Recherche
Mdicale, Lyon, France, Lyon, France
Dr Nivo Hanitra Rasoanaivo, Head of Pharmacy, of Laboratory and of Traditional Medecine,
Ministry of Health, Familz Planning and Social Welfare, Antananarivo, Madagascar
Ms Tiana Rasolonavalona, Pasteur Institute, Antananarivo, Madagascar
Professor Lala Rasoamialy Razanakolona, National Reference Laboratory, CHUA-JRA
Ampefiloha, Antananarivo, Madagascar
* unable to attend
64
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
65
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Rapporteurs
Dr David Browning, Heritage, Crewkerne, Somerset, England
Dr Joanna Zwetyenga, Cavignac, France
U.S. Centers for Disease Control and Prevention (CDC)
Ms Ramatou Toure Hamidou Adechoubou, Abidjan, Cte dIvoire
Dr Adilya Albetkova, Atlanta, Georgia, USA
Mr Edi Bile, Gaborone, Botswana
Dr Kyle Bond, Global AIDS Program (GAP), Dulles, Nigeria
Dr Thu Hien Bui, Hanoi, Viet Nam
Ms Eileen Burke, Kisumu, Kenya
Dr Carlyn Collins, Atlanta, Georgia, USA
Dr Tracy Dalton, Atlanta, Georgia, USA
Dr Yohannes Mengistu Eshete, Addis Ababa, Ethiopia
Dr Sergey Karapetyan, Yerevan, Armenia
Dr Olen Kew, National Center for Immunization and Respiratory Diseases, Atlanta, Georgia, USA
Dr Debra Kuehl, International Laboratory Branch, Global Aids Program, Atlanta, Georgia, USA
Dr Bereneice Madison, Global AIDS Program, Lusaka, Zambia
Dr Ernest Makokha, Global Aids Program, Kisumu, Kenya
Dr Robert Martin, Coordinating Center for Health Information and Service, Atlanta, Georgia, USA
Dr Jessina Masamha, Maputo, Mozambique
Dr David Mc Alister, Kigali, Rwanda
Dr Christina Mwangi, Laboratory Support, United Republic of Tanzania (the)
Dr Richard Clive Nkunda Mwesigwa, Head of Molecular Biology Laboratory, Global Aids
Program, Kisumu, Kenya
Dr Mark Rayfield, Atlanta, Georgia, USA
Dr John Ridderhof, Atlanta, Georgia, USA
Dr Colin Roach, Global Aids Program, Georgetown, Guyana
Dr Ritu Shrivastava, Hanoi, Viet Nam
Dr Angela Starks, Mycobacteriology Laboratory Branch, Atlanta, Georgia, USA
Dr Ruth B. Walkup, Harare, Zimbabwe
Dr Rajesh Bhatia, Regional Office for South-East Asia, New Dehli, India
Dr Caroline Sarah Brown, Regional Office for Europe, Copenhagen, Denmark
Dr Jean-Marc Gabastou, Regional Office for the Americas, Washington, D.C., USA
Dr Gayatri Ghadiok, Regional Office for the Western Pacific, Manila, Philippines (the)
* Dr Nabila Metwalli, Regional Office for the Eastern Mediterranean, Cairo, Egypt
Dr Jean-Bosco Ndihokubwayo, Regional Office for Africa, Brazzaville, Republic of Congo
Dr Christopher John Oxenford, Regional Office for the Western Pacific, Manila, Philippines (the)
* unable to attend
66
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Headquarters
Dr Awa Aidara-Kane, Food Safety, Zoonoses and Foodborne Diseases, Health Security and
Environment
Dr May Chu, International Health Regulations Coordination, Health Security and Environment
Dr Renu Dayal-Drager, Biorisk Reduction for Dangerous Pathogens, Health Security and
Environment
Mr David Featherstone, Expanded Programme on Immunization, Immunization, Vaccines and
Biologicals, Family and Community Health
Dr Pascal Haefliger, Evidence and Policy on Emerging Environmental Health Issues, Public
Health and the Environment, Health Security and Environment
Dr Jean Joly, Research for Neglected Priorities, Quality Assured Diagnostics, Special
Programme for Research and Training in Tropical Diseases, Information Evidence and Research
Dr Danilo Lo-Fo-Wong, Food Safety, Zoonoses and Foodborne Diseases, Health Security and
Environment
Mr Dominique Metais, International Health Regulations Coordination, Health Security and
Environment
Dr Mercedes Perez Gonzalez, Diagnostics and Laboratory Technology, Essential Health
Technologies, Health Systems and Services
Dr Nicoletta Previsani, Reduction for Dangerous Pathogens, International Health Regulations
Coordination, Health Security and Environment
Dr Katarina Prosenc, Global Influenza Programme, Health Security and Environment
Dr Gunael R.M. Rodier, Director, International Health Regulations Coordination Programme,
Health Security and Environment
Dr Anita Sands, Diagnostics and Laboratory Technology, Essential Health Technologies,
Health Systems and Services
Professor Willy Urassa, Diagnostics and Laboratory Technology, Essential Health
Technologies, Health Systems and Services
Dr Gaby Vercauteren, Diagnostics and Laboratory Technology, Essential Health
Technologies, Health Systems and Services
Dr Veronique Vincent, TB/HIV and Drug Resistance, Stop TB, HIV/AIDS, TB and Neglected
Tropical Diseases
Dr Wenqing Zhang, Global Influenza Programme, Health Security and Environment
Headquarters, International Health Regulations Lyon Office
67
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
68
Joint WHO CDC Conference on Health Laboratory Quality Systems, Lyon, France, 9 11 April 2008
Annex 4.2
Composition of breakout working groups
Working Group 1
How to develop national
laboratory policies and
standards to support
quality systems?
ANON Adoh
BALL John
BEVAN Valerie (moderator)
BHATIA Rajesh
BONCY Jacques
DALTON Tracy
DIAZ Franois
ELANGO Varalakshmi
ELSHAFIE Sittana
ESHETE Yohanens
FINE Glen (moderator)
FUCHS Florence
(moderator)
FURTUNESCU A.
GLAVIN
HAEFLIGER Pascal
HAYRAPETYAN Armen
HO Thi Minh Ly
IMNADZE Paata
KABRANE Yamina
KALASNIKOVA Tatiana
KARAPETYAN Sergey
KASYMBEKOVA Kaliya
KHURELBAATAR
Nyamdavaa
KLUGMAN Keith (Chair)
LEE Evan
MAKOKHA Ernest
MANCILLA Manuel
MANGWANYA Douglas
MASSAMBU Charles
MOHSIN Thoraya
MWANGI Christina
(moderator)
NICOLAS Pierre
OJWIYA Amato
ONOJA Ali
PELLEGRINO Marcelo
PEREZ GONZALEZ
Mercedes
ROBERTSON Regina
SANDS Anita
SILVA Panadda (moderator)
STARKS Angela
SUKATI Hosea
TIMPERI Ralph
VERNET Guy
WilILLIAMS M
WIN THEIN Win
YESMAGAMBETOVA Aizhan
YOUSSEF Mohammad
Working Group 2
External Quality Assessment
(EQA) and development of
monitoring tools
ABESAMIS Criselda
ADECHOUBOU Ramato
AMINI Rana (moderator)
BAIG Badr
BERNDT Anne
BOND Kyle
CABUTTI Norberto
CARTER Jane (moderator)
CHALERMCHAN Wilai
CHARPENTIER Jean-Franois
COGNAT Sebastien
COLLOMBEL Christian
DRAGOESCU Antoaneta
ELLIOT John (moderator)
FENSHAM Vivian (moderator)
FERNANDES Paula
FRANCISCO Moiss
GARDNER Ian
GHADIOK Gayatri
GILPIN Christopher
GUDETO Gudeta Tibesso
HAN Lu
HELLER Silke
JAMES Vivienne
KASYMBEKOVA Kaliya
KUO Linda
LECULIER Christophe
LEMIUS Jacques
MARTIN Robert
MC ALISTER David
MC KINNEY Barbara
MENDIS Upul
NIEDRIG Matthias (moderator)
NOBLE Michael (Chair)
OKUI Scholastica
PARAMASIVAN C.N.
PECA GOMES Maria Adelina
PIMENTEL Guillermo
PROSENC Katarina
RAOUL Herv
RASOLONAVALONA Tiana
RAZNAKOLONA Lala
ROACH Coline
SAKANDE Jean
SCHEUTZ Flemming
TORDO Nol
UDO Stella
URASSA Willy
VINCENT Vronique
WILLIAMS Maxfield
ZELLER Herv
69
Working Group 3
Advocacy for setting
and implementing
national quality
standards
ALBETKOVA Adilya
BILE Edi
BUI Thu Hien
BURKE Eileen
CABUTTI Norberto
CHU May
COLLINS Carlyn
(moderator)
DAYAL-DRAGER Renu
DE LOS ANGELES
Valera
DEOM Andr
ELLIOT John
(moderator)
GERMAIN Marc Anthony
GUMA Gaspard
HEUCK Claus
(moderator)
HOTZ Mark
IPUGE Yahya (Chair)
JAMES John
(moderator)
KALASHNIKOVA Tatyana
KINIGI Juvent
KINKESE Juliana
KOJIMA Kazunobu
KUEHL Debra
KURANE Ichiro
LECULIER Christophe
MADISON Bereneice
MAKHANDA Sibongile
MENDIS Upul
MUKANKWIRO Therese
NDIHOKUBWAYO JeanBosco
OKOYE Mac Paul
PALADIN Julia
PROSENC Katarina
SAFADEL Nooshafarin
SHOTT Joseph
SHRIVASTAVA Ritu
STINSHOFF Klaus
WHITE Jenny
WILSON Valerie
WONGRAKPANICH
Amorn
ZEICHHARDT Heinz
ZELLER Herv
Working Group 4
Integrated approaches
for quality
programmes
ABEBE Almaz
AGUILAR Blasina
AL-BUSAIDI Suleiman
ALTHOFF Mario Csar
BEERS Stella
(moderator)
BOAZ Iga
BOEHM Emmanuelle
BONNIER Michel
BUADROMO Eka
CHANDRASEKARAN
Sujatha
CHUA Kaw Bing
DIARRA Seydou
DUBOIS Philippe
GABASTOU Jean-Marc
(moderator)
GALGALO Tura
HADDADIN Aktham
HERNANDEZ RIVAS
Lucia
HUGHES James
(Chair)
ISHTAIEH Issa
JOLY Jean
KARLSMOSE Susanne
KUKLEV Vasily
LAFOURCADE BertheMarie
MASAMHA Jessina
MENG Ling
MOTSWALEDI Modisa
MWAMBA Fales
OXENFORD Christopher
PIERSON Antoine
PREVISIANI Nicoletta
RASOANAIVO Nivo
Hanitra
RIDDERHOF John
(moderator)
SMITH Nadine
SOKHENG Chuop
SUTEHALL Gordon
SZOMOR Katalin VAN
WAKU Diane
WALKUP Ruth
YANG Chen-Fu
ZULUMWAMBA Fales