ISO 15189 Quality Management

System Implementation:
Look Before You Leap

Best Practice Guidance Document

1
ISO 15189 Quality Management System Implementation:
Look Before You leap
Best Practice Guidance Document

Valentina Anisimova, PhD, MD – KNCV Tuberculosis Foundation (KNCV)

Tjeerd A.M. Datema, MSc – KIT Biomedical Research, Royal Tropical Institute (KIT)
Mirjam F. Engelberts, BASc. – KIT Biomedical Research, Royal Tropical Institute (KIT)
Obert Kachuwaire, MPH – Independent consultant TB laboratory strengthening
Linda Oskam, PhD – KIT Biomedical Research, Royal Tropical Institute (KIT)
Jerod Scholten, MPH, DSc. – KNCV Tuberculosis Foundation (KNCV)

TB CARE
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 Contents

Acknowledgements..............................................................................................................................................................3
Executive Summary..............................................................................................................................................................4
Abbreviations........................................................................................................................................................................7

1. Introduction....................................................................................................................................8
What is this document about?.............................................................................................................................................8
Structure of this document..................................................................................................................................................8
Who can use this document and how should this document be used?.........................................................................9
How does this document fit with the GLI Tool?...............................................................................................................9

2. Review of Literature and Context of this Project............................................................................10

Review of Literature on QMS Implementation and Accreditation Experiences..........................................................10
About the GLI Tool..............................................................................................................................................................13

3. Methodology..................................................................................................................................16
Study Sites.............................................................................................................................................................................16
Conceptual Framework and Evaluation Questions..........................................................................................................16
Evaluation Procedure...........................................................................................................................................................17

4. Implementation of a QMS at the NTRLs........................................................................................20

NTRL of Botswana...............................................................................................................................................................20
NTRL of Uganda..................................................................................................................................................................22
NTRL of Benin......................................................................................................................................................................24

5. Best Practices Towards TB Laboratory Accreditation.....................................................................27

Organization.........................................................................................................................................................................27
Personnel ...............................................................................................................................................................................29
Equipment.............................................................................................................................................................................31
Purchasing & Inventory........................................................................................................................................................31
Facilities and Safety:.............................................................................................................................................................32

6. General Discussion.........................................................................................................................33
Consequences of Receiving Accreditation.......................................................................................................................33
Implementation of the QMS...............................................................................................................................................33
Limitations of this Evaluation..............................................................................................................................................38

7. Conclusion......................................................................................................................................39

References.........................................................................................................................................40

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Acknowledgements
The authors would like to express their gratitude to the management and staff of the National Tuberculosis
Reference Laboratories of Botswana, Uganda and Benin for their cooperation. Without their openness and
willingness to contribute to this evaluation it would have been impossible to successfully complete this best
practices document and allow others to benefit from the lessons learned during the quality management system
implementation projects at their facilities.

The authors would also like to thank the United States Agency for International Development (USAID) for
providing the necessary funding through TB CARE I to conduct this evaluation project.

The Global Health Bureau, Office of Health, Infectious Disease and Nutrition (HIDN), US Agency for
International Development, financially supports this publication through TB CARE I under the terms of
Agreement No. AID-OAA-A-10-00020. This publication is made possible by the generous support of the
American people through the United States Agency for International Development (USAID). The contents
are the responsibility of TB CARE I and do not necessarily reflect the views of USAID or the United States
Government.

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 Executive Summary
This guidance document is primarily designed to provide public tuberculosis (TB) laboratories with best practices
when considering embarking on implementing a quality management system (QMS) and seeking ISO 15189
accreditation. The document draws upon lessons learned from QMS implementation at three public National
Tuberculosis Reference Laboratories (NTRLs) in Africa—specifically in Botswana, Uganda and Benin — with
expert opinion from international consultants in QMS implementation.

The target audience of this guidance document consists of TB laboratory managers, quality officers (QOs),
National Tuberculosis Program (NTP) managers, policy makers and other stakeholders involved in TB laboratory
strengthening, primarily in low- and middle-income countries (LMIC) in sub-Saharan Africa, but also in LMIC
in regions outside the African continent. It is recommended that laboratory professionals who are planning to
implement a QMS take note of the advice provided in this document before they initiate the process. This will
enable them to determine whether the challenges mentioned in this document are also present in their laboratory
and, if so, to start efforts to mitigate those that could become obstacles to the efficient QMS implementation
process.

A mixed-method approach was used to evaluate the QMS implementation projects at the aforementioned
NTRLs, including a desk review, a literature review, the collection of quantitative data on laboratory performance
and the collection of qualitative data to identify factors that either propelled the QMS implementation forward, or
alternatively, hindered the process.

Interestingly, all the best practices identified in this evaluation are related to two particular areas: organization
(including management) of the laboratory, and the resources of the laboratory (personnel, equipment, purchasing
& inventory, facilities & safety). This second key aspect can logically be explained as resources form the basis of
the QMS and the primary laboratory process in general. Sub-optimal resources influence the quality of services
at all levels. For good quality resources the laboratory is partly dependent on external factors. This requires timely
assessment of the quality and availability of resources and identification and anticipation of potential challenges at
an early stage. Because the implementation a QMS is a big process of change that affects all laboratory processes,
strong management, leadership and organizational skills are needed to facilitate and coordinate this process such
that the change is achieved as efficiently as possible.

The findings of this evaluation led to the following best practices for the efficient rollout of a QMS in TB
laboratories:
1. Laboratory management should ensure funding for the entire QMS implementation process. The amount
needed should be estimated based on identification of the required improvements through a thorough pre-
QMS implementation assessment.
2. Laboratory management should try to ensure sustainable funding for QMS maintenance (including
equipment maintenance and calibration), e.g. through a dedicated budget line in the Ministry of Health
(MoH)/government budget.
3. Laboratory management should initiate and lead the QMS implementation process and show active
commitment by spearheading the QMS implementation, providing direction and applying leadership skills
from the start to ensure that all staff are engaged in the process.
4. Laboratory management should create efficient and effective internal and external communication channels.
Internal communication fosters staff engagement and provides clarity on the quality objectives. External
communication allows the laboratory to identify customer requirements and enables the laboratory to inform
stakeholders about the needs of the laboratory and what the stakeholders can expect from the laboratory.
5. Laboratory management should appoint a competent, qualified and dedicated QO from the start of the
QMS implementation process. The position of QO should be full-time and they should not undertake any
other tasks.
6. Laboratory management should create possibilities for physical access to already accredited laboratories at
the beginning and during the QMS implementation process, especially for key personnel. This provides them
with a tangible example of an accredited laboratory and enables them to have a clearer picture of the desired

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 end result of QMS implementation.
7. Laboratory management should arrange communication with peers (if possible in-country peers) for the
QO to discuss issues related to QMS implementation and to enable setting up bilateral support mechanisms
between the laboratories (such as assessment schemes, shared equipment maintenance capacity, bench
marking, exchange of equipment as well as parts and supplies).
8. Laboratory management should be competent to using change management principles and apply the proper
management and leadership skills to facilitate the process of change created by QMS implementation.
9. Laboratory management should create transparency in the QMS implementation process for all staff and
ensure that all staff are involved when a technical expert provides advice. This facilitates staff engagement.
Yet, caution must be taken by the technical expert to not demand too much time from the laboratory staff
members when advice is not relevant to them. There is no use in providing advice that is for specific positions
to all staff members. In this case, a summary of this advice should be provided to all staff members during a
debriefing.
10. At the start of the QMS implementation process laboratory management should ensure adequate training for
key positions particularly for the laboratory manager, QO, and Biosafety Officer (BSO). This enables them to
perform their tasks competently and to be able to effectively engage staff.
11. Laboratory management and, if applicable, external experts, should ensure that all laboratory staff understand
their role in the QMS implementation through targeted, relevant continuous internal and external training.
12. Relevant stakeholders (e.g. laboratory representatives, national and international public health organizations)
should advocate at the level of national government and education sector to make training on laboratory
quality management principles part of the pre-service laboratory training curriculum, to maximize
indoctrination on QMS implementation and maintenance on a national scale.
13. Laboratory management should anticipate the initial increased workload when initiating QMS implementation
and take appropriate measures. The increase in workload depends on the availability of staff and the
amount of work to be done to achieve ISO 15189 compliance. The latter could be estimated by performing
a thorough pre-QMS implementation assessment to identify the improvements that need to be made to
achieve full ISO 15189 compliance.
14. The laboratory management should continuously monitor workload through regular workload assessments.
This enables the laboratory management to adequately react when workload becomes too high and prevent
that this hampers QMS implementation and affects routine work.
15. Laboratory management should assess adequate equipment maintenance capacity for all critical laboratory
equipment at the start of the QMS implementation process. This activity could be part of a pre-QMS
implementation assessment. If in-country equipment maintenance capacity is inadequate, laboratory
management must timely plan to compensate for this, as this may cause delays due to the fact that this
often lies beyond the control of the laboratory. The appropriateness of the strategies used to compensate
inadequate maintenance capacity depend on the local situation. Examples of possible interventions could be:
a. Training of one or more staff members to perform equipment maintenance themselves.
b. Outsourcing equipment maintenance to competent companies in-country or otherwise abroad, dependent
on in-country capacity (and timely anticipating the extra funds required).
c. Including a service contract for preventive maintenance as requirement in the tender when purchasing new
equipment.
16. If in-country equipment maintenance capacity is inadequate, relevant stakeholders (laboratories/laboratory
societies, national and international public health organizations, etc.) should advocate at the level of national
government to increase in-country equipment maintenance capacity for the (medical) laboratory sector.
17. Prior to QMS implementation the laboratory management should assess the capacity of procurement and
supply chains to provide quality supplies and cope with a potential increase of demand for supplies. This
activity should be part of a pre-QMS implementation assessment. If the capacity of the procurement and
supply chains is inadequate timely actions should be taken as improvement of this situation can take long due
to the fact that this often lies beyond the control of the laboratory. The appropriateness of the strategies used
depends on the local situation. If the routine procurement of supplies lies beyond the control of the NTRL,
the NTRL management should advocate to the relevant authorities for having its own budget available for
procurement of supplies in case of failures in the supply chain and for emergencies that require an extra
demand for supplies.

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 18. If lead times for supply delivery are long due to circumstances that have their root cause within the country,
relevant stakeholders (laboratories/laboratory societies, national and international public health organizations,
etc.) should advocate to the proper sources to eliminate these causes and improve supply chains.
19. Laboratory management should assess if the facilities comply with the (bio)safety and biosecurity
requirements prior to QMS implementation. This could be part of a pre-QMS implementation assessment.
If the facilities do not meet the requirements the laboratory management must immediately set the
improvement of the facilities in motion as funding limitations and limited in-country availability of contractors
competent to renovate or newly construct laboratory facilities can affect QMS implementation.

Applying these best practices, based on empirical data and experiences, enables NTRLs to more efficiently and
successfully implement a QMS and achieve ISO 15189 accreditation.
 

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Abbreviations
AFB Acid-Fast Bacilli
AGHPF A Global Healthcare Public Foundation
APHL Association of Public Health Laboratories
ASLM African Society for Laboratory Medicine
BOBS Botswana Bureau of Standards
BOTUSA Botswana-United States of America Partnership
BSL Biosafety Level
BSO Biosafety Officer
CDC US Centers for Disease Control and Prevention
DST Drug Susceptibility Testing
EQA External Quality Assessment
FHI Family Health International/ FHI 360
FM Fluorescence Microscopy
GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria
GLI Tool GLI Stepwise Process towards TB Laboratory Accreditation
GLI Global Laboratory Initiative
KIT Royal Tropical Institute (The Netherlands)
KNCV KNCV Tuberculosis Foundation (The Netherlands)
LIMS Laboratory Information Management System
LMIC Low- and Middle-Income Countries
LPA Line-Probe Assay
MGIT Mycobacteria Growth Indicator Tube
MoH Ministry of Health
MTB Mycobacterium tuberculosis
NTP National Tuberculosis Program
NTRL National Tuberculosis Reference Laboratory
PCR Polymerase Chain Reaction
QMS Quality Management System
QO Quality Officer
RIF Rifampicin
SADC Southern African Development Community
SANAS South African National Accreditation System
SCMS The Partnership for Supply Chain Management Systems
SLIPTA Stepwise Laboratory Improvement Process Towards Accreditation
SLMTA Strengthening Laboratory Management Towards Accreditation
SOP Standard Operating Procedure
TAT Turnaround Time
TB Tuberculosis
UPS Uninterrupted Power Supply
WHO World Health Organization

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 1. Introduction
Introduction

This guidance document is primarily designed to provide public TB laboratories with best practices when
considering embarking on the implementation of a QMS as well as seeking ISO 15189 accreditation. This guidance
document draws upon lessons learned from three public NTRLs in Africa — specifically in Botswana, Uganda and
Benin — with the expert opinion from international consultants in QMS implementation.

What is this document about?

Due to increasing recognition of the importance of QMS implementation in medical and public health
laboratories, many TB laboratories in high burden TB countries are considering moving towards QMS
implementation and accreditation. Few have achieved this, particularly in the public sector, and many have limited
knowledge of what to anticipate and the preparations needed to implement a QMS and achieve accreditation. In
2008, the Maputo declaration was developed which could be seen as the first indication of increased recognition
of the need for laboratory strengthening (1). In 2010, sub-Saharan Africa counted 340 accredited laboratories, the
majority of which were located in South Africa. Only 28 were located in other sub-Saharan African countries and
were almost exclusively private, parastatal or donor-supported research facilities (2). Since the Maputo declaration,
many guidance materials have been developed such as the Global Laboratory Initiative (GLI) Stepwise Process
towards TB Laboratory Accreditation (GLI tool: www.GLIquality.org (3)), the Stepwise Laboratory Improvement
Process Towards Accreditation (SLIPTA) checklist (2) and Strengthening Laboratory Management Towards
Accreditation (SLMTA) training and mentoring program (4). These tools and programs assist laboratories in
translating the ISO 15189 requirements into practice, i.e. they assist with the implementation of a QMS. However,
laboratories in LMIC embarking on laboratory strengthening projects are frequently confronted with unexpected
challenge, many of which are similar for a majority of the laboratories. This can also be concluded when comparing
literature on the topic. This situation leads to unnecessary waste of limited resources (human and otherwise)
that could have been avoided if laboratories were aware of, and could anticipate the critical factors that affect
QMS implementation before they embarked on this process. However, the identification of the most common
challenges and their root-causes has never been systematically and empirically documented.

Over the past eight years, public NTRLs in Botswana, Uganda and Benin were assisted through the USAID
funded TB CAP/TB CARE I projects with the implementation of a QMS and in achieving ISO 15189
accreditation. In all projects the laboratories received technical assistance from external experts. Evaluation of
the QMS implementation process at these three NTRLs forms an excellent opportunity to draw lessons learned.
The purpose of this evaluation project was, therefore, to analyze the progress of implementation of a QMS at
the aforementioned NTRLs through a mixed-methods approach and identify common factors that facilitated
QMS implementation and challenges that blocked efficient QMS implementation, and to subsequently transform
these into recommendations for best practices for efficient QMS implementation. It is envisaged that these best
practices can help other laboratories become aware of factors that may affect their QMS implementation efforts
and therefore anticipate and mitigate them as much as possible. The question that was central in this evaluation
project was:

What are the best practices to facilitate the efficient implementation of a QMS based on ISO 15189?

This guidance document presents the results of this evaluation project and the recommendations for best
practices for implementing a QMS based on ISO 15189.

Structure of this document

This document starts by reviewing the experiences of QMS implementation in medical laboratories as published
in literature, providing a context to which the findings of this evaluation and resulting best practices can be
compared. Chapter 3 describes the methodology used for this evaluation and Chapter 4 describes the progress
of implementation of the QMS at each NTRL within this evaluation project and the service characteristics of the
NTRLs before/after accreditation. This is the result of an extensive desk review of all reports and other documents
produced during QMS implementation at the three NTRLs. Chapter 5 presents the best practices, including the

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results of the on site qualitative evaluation and the argumentation of how these results, in combination with the
desk review data, led to formulation of each best practice. Chapter 6 discusses the results and best practices and
compares these with the literature review findings of Chapter 2. A final overview of the best practices is given in
Chapter 7.

Who can use this document and how should this document be used?
The insights presented in this document are likely applicable to other laboratories pursuing QMS implementation.
Taking note of the findings and recommendations in this report should therefore be considered key for TB
laboratory managers and QOs prior to embarking on the QMS implementation process. Public TB laboratories
are dependent on external bodies for many aspects of their functioning. When the decision to initiate QMS
implementation at a TB laboratory is made by a higher authority it is essential that this authority has taken note
of the best practices for QMS implementation to have the proper insights in the consequences of this decision
and to anticipate these. Therefore, this document should also be read by NTP managers, policy makers and other
stakeholders involved in TB laboratory strengthening, primarily in sub-Saharan Africa, but also in LMICs outside
the African continent.

How does this document fit with the GLI Tool?

The GLI tool translates each individual ISO 15189 requirement into simple practical steps on how to establish a
QMS and can be used by TB laboratories worldwide in high-, low- and middle-income countries. The tool does
not provide specific instructions on how to overcome common challenges faced by laboratories in LMIC, meaning
this best practices guidance document forms a supplement to the GLI tool. The best practices document should
be a fixed part in the roll-out of the GLI tool as it makes the laboratories aware of the common challenges and
preconditions to QMS implementation (i.e. to implementing the GLI tool), enabling them to anticipate problems
at an early stage and prevent interruptions in the process later-on.

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 2.Review of Literature and Context of this Project
A literature review was carried out to investigate the efforts and experiences of other laboratories worldwide with
the implementation of a QMS and accreditation. This enables our findings to be compared with and discussed in
the global context.

A tool to guide the process of QMS implementation in TB laboratories is the GLI tool (www.GLIquality.org). The
authors used this as a backdrop for the country assessments and analysis. The authors recommend using this tool
to guide this process in TB laboratories. Information on the structure and use of this tool is included in this chapter.

Review of Literature on QMS Implementation and Accreditation Experiences

A search of scientific literature engines including MEDLINE and Web of Science (search terms: medical
laboratory AND quality management AND ISO 15189 AND accreditation, language filter: English, publication
date: 2003-2014) and the (publicly available) KIT Information Portal on Laboratory Quality Strengthening (search
term: experience, language filter: English), led to the selection of 13 publications about experiences with the
implementation of QMSs in medical laboratories. The rationale for excluding publications before 2003 is the fact
that the first edition of the ISO 15189 standard was published in 2003. Since we are only interested in experiences
with implementation of this standard, there is no point in searching for QMS implementation experiences prior to
2003.

Many authors state that QMS implementation improves the performance of the laboratory (5-9) and is
beneficial to both laboratory customers and laboratory personnel (10). This is based on their own experience,
customer feedback and the use of indicators to monitor performance improvement over the course of QMS
implementation. The QMS improves reliability, reproducibility, traceability, transparency, uniformity, work
satisfaction and focus on critical points (5;6). However, many also indicate that QMS implementation is a time
consuming process (6;8;11) which leads to a higher workload (6;11). Despite this, staff prefer to work in an
accredited laboratory due to the common idea that staff become more specialized and experienced by working
in an accredited laboratory (11). Berwouts et al. indicate that the QMS brings with it a danger of losing a critical
perspective on laboratory performance and can curb innovations, which emphasizes the importance of creating a
culture of continuous quality improvement (6).

The most frequently mentioned requirement for successful QMS implementation is the engagement of staff with
the process (5;6;8;10;12), but this was also mentioned as one of the most difficult factors (5;9).

Berwouts et al. elaborate on the issue of staff engagement in their article on the accreditation of genetic testing
laboratories. They indicate that staff have a natural reluctance to change and that convincing them of the
value of a QMS is pivotal to success. The implementation of the QMS is a linear process that can be planned
chronologically, but change is a process in which staff members go through different stages of resistance and
acceptance at different speeds (Figure 1) which can not usually be planned. This combination of processes can
cause tensions that form challenges to QMS implementation. The authors mention several strategies to facilitate
the process of change and diminish tensions as much as possible, which include force-field analysis (a group
discussion tool to identify enabling and disabling factors towards reaching an objective and discuss solutions to
minimize the disabling factors and maximize the enabling factors) and the stakeholder approach (management
identifies stakeholders that have varying degrees of influence on realizing objectives and designs strategies to
involve, inform or mobilize those stakeholders according to their degree of influence). In addition, Berwouts et al.
indicate that international workshops on quality management positively influence QMS implementation because
they form a platform where ideas can be shared and facilitate discussions with and learning from peers (6). Other
authors mention that recognizing staff for excellent performance (5;10) and the organization of regular meetings
to create awareness on QMS principles, also contribute to creating staff buy-in (5;11).

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Performance

Shock & Denial

Frustration

Acceptance & Commitment

Negotiation

Experiment & Learning

Depression

Time

Figure 1: Stages which people go through in times of change and the influence on performance over time. Based
on the Kübler-Ross model as presented by Berwouts et al. (6)

Many authors indicate factors that are especially important in QMS implementation or provide preconditions to
the success of this process, including the following:
• QMS implementation requires strong commitment from management and laboratory staff.
Commitment is required from the top management to the most junior positions (8;10). Management at all levels
should propagate QMS implementation. The decision to initiate the accreditation process should be made by
top management (7) and top management should fully support the laboratory team in every aspect (8;10;11).
The management has to define responsibilities and authorizations (7) and advocate the laboratory’s needs (5). In
addition, QMS implementation is a team approach and requires motivation of all personnel (8;10).
• QMS requires considerable and continuous training.
Continuous training of staff is needed to decrease errors (7) and to get staff to engage in the QMS
implementation process (5;8;12).
• Fostering a culture of continuous improvement.
Communication is pivotal in creating a culture of continuous improvement. Frequent and regular meetings
create staff buy-in and serve to address issues in the accreditation process (5;13). Kibet et al. also mention that
intentional and sustained interaction with clinical staff contributed to QMS implementation (13). It was indicated
by several authors that performing internal audits, recording non-conformities and complaints, and monitoring
quality indicators was important to foster communication and create a culture of continuous improvement. It
helped to identify many errors which sped-up the implementation of the QMS and made the QMS more alive
(7;9-11). It is important to prevent a blame culture: people should be encouraged to identify and react to non-
conformities but discouraged from denouncing individuals because this discourages reactions to problems and
severely impairs the possibility of quality improvement (8).

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 • Creating better job security, career attractiveness and remuneration conditions.
Some countries deal with high staff turnover and brain drain (or “brain circulation”), this affects the efficient
implementation of a QMS. Measures such as creating better job security, career attractiveness and remuneration
conditions were mentioned as being pivotal to laboratory quality improvement and retaining and recruiting
personnel (5;14;15).
• Good cooperation is needed with laboratory suppliers and service engineers.
A QMS has high demands with regards to supplies and equipment. Discussion between laboratory management
and the suppliers/vendors is needed to provide clarity about these requirements and demands and resolve issues
with supply delivery (5) and equipment maintenance (7).
• Hiring an external consultant is advised for QMS implementation.
Both Guzel et al. and Wadhwa et al. advise to hiring a consultant to guide QMS implementation. This helps save
time and effort (11;16).
• Establishment of a quality team.
A quality team or unit facilitates QMS implementation by coordinating the implementation process and
nurturing of a quality culture (9;11).
• Designating responsible persons for each item of equipment.
This helps the management to oversee equipment and provides clarity on who to contact in case of
malfunctioning or other equipment-related issues (8).

Several articles reported about QMS implementation and laboratory strengthening specifically in LMIC. Specific
challenges related to this environment were mentioned to be:
• Supply availability and quality (5;9;17).
Adequate availability of supplies is reported by many to be problematic in LMIC and the root of the problem is
often beyond the control of the laboratory (5). Stringent government procurement laws and the fact that supplies
often have to come from abroad are reported as factors that lead to long lead times (9).
• Equipment maintenance (9).
Availability of specialized service engineers for equipment maintenance is reported to be problematic in LMIC.
These services often have to be hired from abroad which increases costs (9;14) Kibet et al. partly solved this issue
by making maintenance part of the placement contract when purchasing equipment (13).
• Human resource availability, turnover and training (5;9).
High staff turnover rates were mentioned as a factor causing problems with retaining skills and competence.
Audu et al. mention the brain circulation syndrome: staff frequently move to another job in search of better wages
and conditions (5). Severe lack of health workers due to inadequate training capacity, brain-drain and low career
attractiveness also affect laboratory strengthening on national scale (14;15). Insufficient in country availability of
training capacity, especially on QM, increases the cost of accreditation (9).
• The majority of laboratories in LMIC lack adequate physical and man power infrastructure to implement
international quality standards (14;15).
Ahmad et al. reported that nearly 90% of the laboratories in one country studied fell into this category. To make
laboratory quality improvement also accessible to these laboratories the ISO 15189 standard was simplified into a
national standard (14). Alemnji et al. indicate that the development of a checklist and training program for step-
wise laboratory improvement (called SLIPTA and SLMTA respectively) contribute to resolving this problem (15).

Many problems specific to LMICs require action from authorities (e.g. national governments and international
agencies) and are beyond the direct control of the individual laboratories (14;15). The resolution of these
types of problems often ask for action (in the form of dialogue and advocacy) from management. Examples
are procurement, supply and maintenance of equipment, and also the education of the personnel. Audu et al.
indicate that problems with supply/delivery at the Human Virology Laboratory in Nigeria were resolved when the
management of the laboratory discussed the issue with supporting partners (5). Dahim et al. describe the attempt
to resolve the problem related to availability and quality of equipment and supplies in Iran by creating a national
directory of reliable providers and manufacturers of supplies and equipment (17).

National governments play an important role by creating national laboratory policy and strategic plans (14;15).
Alemnji et al. indicate that the creation of an international coordination and support society in sub-Saharan Africa

12
(called the African Society for Laboratory Medicine, ASLM) is key in increasing awareness and advocacy for
laboratory strengthening (15). They further indicate that countries should also take greater responsibility for public
health laboratory challenges and rely less on the global community to increase the sustainability of laboratory
strengthening, given the global economic recession which threatens donor funding (which many laboratories
in LMIC still heavily rely on). The establishment of public-private partnerships is also important in this context.
Alemnji et al. further indicate that the establishment of national laboratory networks should be encouraged to
ensure better coordination and effective utilization of available resources (15).

About the GLI Tool

The GLI tool was developed with the purpose of assisting national TB laboratories with implementing a QMS and
complying with ISO 15189. It is constructed in such a way that laboratory quality improvement is already gained
from step one of the process.

The GLI tool is a digital guidance tool in the form of a website that provides a stepwise plan for implementing a
QMS in compliance with ISO 15189:2012. The tool divides the QMS implementation process into four phases
with each phase having a specific focus and the next phase building logically on the activities of the previous one.
However, is also constructed in such a way that if laboratories are stuck with implementation of certain activities
of the previous phase, they can still proceed with other activities in the next phase, i.e. the plan is not rigid and
allows for significant adaptation to the laboratory’s specific situation. The individual steps explain the activity that
should be done in a standardized format, explaining why the activity should be done, what should be done, how
it should be done and by whom (the most appropriate laboratory position for implementing the activity). Where
appropriate, background reading, document templates and other tools are provided.

The first phase of the GLI tool focuses on implementing the absolute basic elements that all laboratories should
have in place regardless of size or location. Without these elements it is impossible to guarantee adequate and
safe services. Phase 2 focuses on the fundamentals of the QMS: quality control and quality assurance. Quality
control mechanisms are implemented in the complete primary process of the laboratory (3;18). Quality assurance
is further improved with establishment of a standardized stock and ordering system, equipment management
system, document control and information management system and the development of SOPs for all procedures
performed in the laboratory.

Implementing a QMS is a systems approach, meaning it is not limited to merely implementing controls,
procedures and forms, but it also affects the management and structure of the organization. Proper organization,
management and leadership are needed to coordinate the quality management activities, which Phase 3 will focus
on (3;18).

A QMS according to ISO 15189 is based on the Plan-Do-Check-Act cycle developed by Edward Deming (Figure
2). Not only mechanisms are implemented to assure quality, but the organization must also learn from mistakes
and use these to continually improve the work. In Phase 4 systems are implemented that enable passive and active
identification of points for improvement and use these to optimize quality services. This phase ends with the
finalization and optimization of all quality system elements so that the laboratory is ready to apply for accreditation
(3;18).
Plan

Act Do

Check
Figure 2: Plan-Do-Check-Act cycle for continuous improvement

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 Each phase provides a roadmap that presents the activities in an order ideal for day to day implementation (Figure
3).

GLI Stepwise Process towards

TB Laboratory Accreditation
 
 
global laboratory initiative
 
advancing TB diagnosis

Home Quality Management User Instructions Phase 1 Phase 2 Phase 3 Phase 4 Checklists Miscellaneous

Home » Activities Phase 3 » Activities Phase 3

Activities Phase 1 - Create commitment Icons

Tool
Phase 1 Phase 2 Phase 3 Phase 4
Background information
Make procedures for
all tests (3) Template

Make procedures for all

equipment (4)
Create commitment (1) Ensure adequate and
competent personnel (2)
Start organizing an inventory Search this site
system (5)

Start organizing the

biosafety (6)

Create commitment to go for accreditation GLI tool version 2.0

Phase 1 Phase 2 Phase 3 Phase 4
Provide staff with basic orientation on principle of quality management and a quality management system

Appoint a Quality Project Team and appoint the chair of this team as Quality Focal Point Make procedures for
all tests (3)
Make and use action plans with SMART action points
Make procedures for all
Start organizing regular (weekly) staff meetings
equipment (4)
Create commitment (1) Ensure adequate and
competent personnel (2)
Start organizing an inventory
International Union Against system (5)
Tuberculosis and Lung Disease
Health solutions for the poor

Start organizing the

biosafety (6)

TB CARE

Figure 3: Activities presented in ideal order for day-to-day implementation using the roadmaps

In addition, the activities can also be structured according to the 12 Quality System Essentials to gain insight into
what needs to be done for specific parts of the QMS, such as equipment management, facilities and safety, or
process management (Figure 4).

14
 GLI Stepwise Process towards
TB Laboratory Accreditation
 
 
global laboratory initiative
 
advancing TB diagnosis

Home Quality Management User Instructions Phase 1 Phase 2 Phase 3 Phase 4 Checklists Miscellaneous
Road map structure
Home » Activities Phase 3 » Activities Phase 3
Quality systems Facilities & Safety
essentials structure
Organization
Activities Phase 3 - Organization
Personnel
Formulate the Vision of the laboratory, the reason why the laboratory exisits Equipment
Purchasing &
Formulate the Mission of the laboratory Inventory
Process Management Option to structure activities per
Formulate the long-term goals of the laboratory
Information phase according to the 12 Quality
Management
Formulate the Quality Policy Systems Essentials
Documents and
Plan for purchasing new equipment and equipment maintenance in the annual budget planning Records
Customer Focus
Formulate the goals for the coming years specifically with respect to the quality management system
Assessment
Formulate the first Quality Year Plan for the coming year Nonconforming Event
Management
Translate the Quality Year Plan into a SMART action plan Continual
Improvement
Develop a quality manual

Start monitoring the functioning of the quality management system and produce Quarterly Reports

Perform a management review at the end of the quality year

Develop a Quality Year Plan for the following year based on the conclusions from the management review

Standardize and document the policy cycle in SOPs

International Union Against

Tuberculosis and Lung Disease
Health solutions for the poor

TB CARE
Figure 4: Activities structured according to the 12 Quality System Essentials

Besides providing guidance on the implementation of the QMS, the GLI tool also provides the means to assess
the implementation process through an option that allows the user of the tool to develop tailor-made checklists
based on the desired focus of the assessment. These checklists can be used as support during internal audits, to
map progress or to verify correct implementation of the QMS.

The GLI tool is an online tool for which users need to have access to a reliable internet connection. It is possible to
request a copy of the tool for offline use for those users that do not have access to a reliable internet connection.
This allows the users to download the entire tool once, after which it can be used without an internet connection.

15
 3. Methodology
Methodology

Study Sites
Three NTRLs in Africa were supported with the implementation of an ISO 15189 QMS under the TB CAP and
TB CARE I projects between 2009 and 2014. The NTRL of Botswana was supported by KNCV Tuberculosis
Foundation which provided an embedded expert for technical support and hired a QO for QMS implementation.
The NTRLs of Uganda and Benin were assisted by KIT which provided three to four one-week mentoring visits
per year to guide the QMS implementation process. The NTRL of Botswana (enrolled in 2007) received ISO
15189 accreditation from the South African National Accreditation System (SANAS) in 2012. The NTRL of
Uganda (enrolled in 2008) was accredited by SANAS in 2013. The NTRL of Benin (enrolled in 2011) plans to
apply for accreditation in 2015. These NTRLs were selected as study-sites for this evaluation project.

Conceptual Framework and Evaluation Questions

The formulation of the evaluation questions and the development of the evaluation materials was guided by the
conceptual framework which includes the quality system essentials as used in the GLI tool (3;18).

Quality System Essential Framework

Progress of QMS
implementation

Challenges
Condition that
during QMS
facilitated QMS
implementation
implementation Best Practices
for QMS
Implementation

Perceived Effect on
preconditions performance

Figure 5: Conceptual framework

A mixed-method approach was used to evaluate the accreditation projects at the above-mentioned NTRLs. The
evaluation was guided by the following question:

What are the best practices to facilitate the efficient implementation of a QMS?

This evaluation question was defined by the following sub questions:

A. What were the consequences of receiving ISO 15189 accreditation for the laboratory services?
B. Which internal and external conditions of the laboratory formed challenges to the implementation of the
QMS?
C. Which internal and external conditions of the laboratory facilitated the efficient implementation of the
QMS?
D. What are the preconditions for efficient implementation of the QMS?

16
Evaluation Procedure
Data to answer the evaluation questions were collected both quantitatively and qualitatively. Quantitative data
informed primarily sub question A. Qualitative data informed primarily sub questions B, C, D and to a lesser
extent sub question A.

Quantitative Data Collection

To obtain insight into the consequences of receiving ISO 15189 accreditation for the laboratory, the effect of
implementation of the QMS on laboratory services was measured. The following indicators were collected:
1. Analytical methods offered at the NTRL (including the names of these methods), in the year before initiation
of the accreditation project and the year after receiving accreditation.
2. Number of tests performed in the year before initiation of the accreditation project and the year after receiv-
ing accreditation.
3. Average percentage of incorrect results in proficiency testing for AFB microscopy and culture/DST in the
year before initiation of the accreditation project and the year after receiving accreditation.
4. Number of staff members working at the laboratory in the year before initiation of the accreditation project
and the year after receiving accreditation.
5. Average number of staff members that left and the number of staff members recruited each year during the
accreditation process.
This data was collected during on-site visits to each laboratory. Laboratory registers were used for indicators 2 and
3, and laboratory management/quality officers were asked to provide data for indicators 1, 4 and 5. Data was only
collected if records could be provided.

To ensure proper data collection, a standardized form was used to collect the quantitative data.

The quantitative data was not sufficient for extensive statistical analysis, it was used as descriptive information to
support findings from qualitative data collection and to inform the qualitative data collection process during the
on-site visits.

Qualitative Data Collection

To be able to evaluate the accreditation projects at the three study sites it was necessary to get a deeper insight
into the progress of the accreditation project per NTRL. This provided the context against which the challenges
and conditions that facilitated efficient QMS implementation could be viewed. Desk review was the preferred
method for this part of the evaluation.

The TB CAP and TB CARE I mission reports/progress reports formed the backbone of the desk review. In
addition, audit/assessment reports, minutes, and action plans collected during the QMS implementation projects
were scrutinized. A standardized form was used to list the main findings from each document. This form included
the following parameters:
• Description of major activities carried out to implement the QMS.
• Date/period over which these activities were carried out.
• Names of person(s)/organization(s) that carried-out the activities.
• The deliverables, findings and challenges encountered.
• Reference for the document from which the information was extracted.

The interviewing of laboratory employees was the preferred evaluation method for the identification of the
conditions that facilitated efficient QMS implementation and the challenges encountered during the accreditation
projects. These persons were the ones actively engaged in QMS implementation and therefore were directly
confronted with the challenges and conditions that facilitated QMS implementation. Both semi-structured
interviewing and focus group discussion methods were utilized. Semi-structured interviews were held with
individuals from all layers of the organization. Focus group discussions were held with all employees of the NTRL
except for the management. The argumentation was that semi-structured interviewing provides better insight
in personal experiences and allows for comparison of these experiences in relation to the hierarchical positions.

17
 Focus group discussion provides the possibility to obtain an indication of the severity/significance of the different
challenges encountered and could also reveal challenges or conditions that facilitated QMS implementation that
were not brought up during semi-structured interviews. The semi-structured interviews may reveal experiences
which individuals might be reserved from sharing during the focus group discussion. The focus group discussions
were held after the semi-structured interviews to allow the findings of the latter to inform the former. Management
was excluded from participation in the focus group discussions to maintain objectivity in the answers of laboratory
employees (e.g. with management present the employees might not be comfortable sharing specific experiences
about the process of implementing the QMS out of fear of repercussions). The interviews were conducted in the
national languages, which meant that an interpreter was hired in Benin.

Semi-Structured Interviews
The development of the interview guides was directed by the conceptual framework which included the evaluation
questions and the quality system essential framework as used in the GLI tool (Figure 5). A general guide was
made that was tailored to the different positions of the laboratory. Interviews began with the consent procedure
(see below) and lasted between 45 and 90 minutes (partly depending on the positions of the interviewees). After
the interviewee had consented to participate, the interview continued with several closed questions to record
personal details (nationality, education, year interviewee started working at the NTRL, current position and year
interviewee started working in his/her current position). The interview continued with open questions to gain
insight in the interviewee’s daily work, the workload and the fringe benefits, both in the present time and during the
implementation of the QMS. Next, questions were asked to gain insight in the work atmosphere and environment,
The interview subsequently proceeded with in-depth questions regarding the process of implementing the QMS.
This part focused both on the process itself, the challenges, the conditions that facilitated the process, and the
method of external assistance that was provided.

Focus Group Discussions

The focus group discussion guide were also constructed based on the conceptual framework presented above
(Figure 5). The duration of the focus groups discussion was 1.5 to 2 hours and began with a presentation of the
purpose/aim of the evaluation project and an introduction of the facilitators. The facilitation team consisted of one
discussion leader and one person making notes. A PowerPoint presentation was used to guide the focus group
discussion. After introduction of the facilitators the consent procedure was performed (see below). Subsequently,
the method of the focus group discussion was explained to the participants: they were shown a statement that
was meant to provoke discussion. The discussion leader probed when necessary and fueled the discussion with
questions which provoked further discussion and exploration of interesting areas. The following statements were
shown (in chronological order):
1. The implementation of the QMS was difficult.
2. The quality of the facilities has changed over the past few years.
3. The quality of equipment has deteriorated over the past few years.
4. The quality and availability of supplies has improved over the past few years.
5. The safety in the laboratory has not improved over the past few years.
6. The workload over the past few years has not changed.
7. I have plenty of opportunities to participate in trainings/courses.
8. The work atmosphere at the laboratory could be better.
9. Without the QMS the laboratory performance would be the same.

Consent Procedure
A two-person team, consisting of a lead interviewer who asked the questions and a second person making notes,
conducted both the semi-structured interviews and focus group discussions. The interviews were conducted
with permission from the management of the NTRLs and during the interviewees’ working hours and were
recorded with the interviewee’s permission. Participation was voluntary and they were conducted in a private office
without any other persons present. At the start of the interview the persons present were introduced by the lead
interviewer, the interview procedure was explained and the consent letter was read to the interviewee.

18
The following explanations were given to the interviewees:
–– This interview is part of an international research project within the USAID TB CARE I project.
–– The information gained will be used to optimize the GLI tool and be reported in a document called a “Best
Practices Document” that will be submitted to TB CARE I.
–– The interview will be conducted to learn more about the interviewee’s experiences and perspectives on the
process of implementing the QMS.
–– The interview will have a duration of a maximum 1.5 hours (for the focus group discussion a maximum of 2
hours).
–– The interviewer will ask for permission to record the interview.
–– The interview is not a test.
–– The information provided by the interviewee will solely be used to gain knowledge on QMS implementation,
which will be used to help other laboratories in LMIC by learning from the interviewee’s experiences.
–– The interviewee will remain anonymous.
–– Participation in the interview is voluntary and the interviewee can stop participation at any time.

The interviewee was given the consent letter (in their national language) and allowed to read it before providing
their consent by signing the form. Interviews followed the flow of discussion while making sure all topics were
covered. Probing questions were asked to gain more clarity on certain points. At the end of the interview the
interviewee was thanked for their participation and again allowed to ask any questions or discuss any issues. The
interviewees were provided with the contact details of the principle evaluator to allow them to ask questions at a
later stage.

To ensure confidentiality and anonymity the interview reports were coded and all the personal identifiers were
removed. Only the principal evaluator had access to the coding sheet enabling the direct connection of interview
reports to specific persons.

Data Processing and Analysis

Directly after the interviews were conducted interview reports were made using the notes made during the
interview and the sound recording of the interview. Validation of the interview processing method was done by
having both members of the interview team process a subset of interviews separately after which they compared
and merged their interview reports. There were no significant differences between the interview reports of both
team members, indicating that the method of processing interviews was reliable.

After conducting all the interviews during the on site visits, the interview reports were scrutinized and relevant
statements in each interview report were categorized according to the four sub evaluation questions. One
compilation sheet per evaluation question was made with statements from interviews from all three countries
which facilitated comparison of statements. A list of observations was made per research question, per country, by
accumulating and grouping similar statements that all pointed to the same observation.

Data was further analyzed during a final workshop where the evaluation team reviewed the findings of the desk
review, the quantitative data and the observations from the qualitative evaluation activities. They proceeded by
listing all their observations per country, categorized according to the quality system essential framework. The
team subsequently continued with addressing their observations per quality system essential and formulating
best practices through a discussion and consensus approach. The team formulated their general findings per best
practice and recorded their argumentation on how the findings resulted in the formulation of the best practice.
The final list of best practices and the underlying findings and argumentations were transformed into this best
practices document.

19
 4.
Implementation of a QMS at the NTRLs
Implementation of a QMS at the NTRLs
The data in this chapter are the result of the desk review of each accreditation project. General characteristics of
the NTRLs are provided and a chronological description of the progress of the implementation of the QMS at
each laboratory is provided.

Table 1: General characteristics of the NTRLs within this study

NTRL Botswana NTRL Uganda NTRL Benin
Human Resources 23 29 21
MoH > Dept. of Clinical MoH > National
Governance Services > National Health Tuberculosis and Leprosy MoH > NTP > NTRL
Laboratory > NTRL Program > NTRL
• Supporting routine • Supporting routine • Testing for diagnosis
TB testing incl. TB testing of TB and Buruli ulcer
culture, DST, • Conducting • Conducting
identification (excl. operational research operational research
routine microscopy) • Organizing EQA • Organizing EQA
Priority Functions
• Conducting for the national TB for the national TB
operational research laboratory network laboratory network
• Organizing EQA
for the national TB
laboratory network
National Tuberculosis and
Disease Program NTP NTP
Leprosy Program
National reference
National reference
National and supranational laboratory and candidate
laboratory and
Level of Functioning reference laboratory in the supranational reference
supranational reference
SRL network2 laboratory for the SRL
laboratory for the SADC1
network

1. SADC: Southern African Development Community.

2. This is the worldwide supranational reference laboratory network coordinated by the World Health Organization (WHO).

NTRL of Botswana
Pre-QMS Implementation
The Botswana NTRL was established in 1999 through the assistance of the U.S. Centers for Disease Control and
Prevention (CDC) Botswana (formerly Botswana-United States of America partnership (BOTUSA)).

The NTRL exists to provide quality TB culture and DST with regard to diagnostic services. It also has a role
as the overseer of all the laboratories in Botswana performing Acid Fast Bacilli (AFB) microscopy through its
coordination of the four pronged external quality assurance program which involves on site supervisory visits,
proficiency testing, blinded rechecking and training. As the reference laboratory, the NTRL also provides TB
research support to the health system in Botswana.

First Year
The implementation of the QMS at the NTRL of Botswana was started in 2007 after a gap analysis revealed that
the NTRL was ready for this process (19). There was no progress on QMS implementation in the first months of
the QMS implementation project due to staff shortages (20), so a QO was appointed in March 2007. With the
help of external consultants the documentation of the NTRL was developed using a documentation development
plan drafted in April 2007 (21). In August 2007 an audit showed that the required documentation was in place,
but that the QMS was still in its infancy. The major non-conformities indicated that it was imperative that more

20
training as well as full control had to be given to the technical management team to facilitate the effective
implementation of the QMS. With training the NTRL attempted to increase the ownership of the staff over
the QMS implementation process (22). A corrective action plan was developed and implemented to address
gaps raised during this audit (personal communication O. Kachuwaire, November 2014). In addition, from 2007
onwards the NTRL received support from the Association of Public Health Laboratories (APHL) by appointment
of an embedded mentor for technical support. This mentor continued from 2008 under TB CAP and under the
guidance of the mentor the liquid media system was validated in August of 2008 (personal notes O. Kachuwaire,
(23)).

Second Year
In the second year of the project, six new members of staff were hired to cover the increase in workload caused
by an increase in routine testing and a drug resistance surveillance study being performed by the NTRL (personal
notes O. Kachuwaire). The implementation of the QMS continued with a gap analysis, revealing six major
and five minor non-conformities related to quality assurance and three major and 21 minor non-conformities
related to safety (24). In August of 2008 the first management review was organized by the QO revealing that
some progress was made by the laboratory in terms of reducing the non-conformities noted, but there were
problems with calibration, maintenance and infrastructure. The BSL-3 laboratory facility was not able to maintain
negative pressure, there were challenges with the laboratory infrastructure characterized by aging of facilities and
equipment (25)and no funds were allocated to address these challenges (personal communication O. Kachuwaire,
November 2014).

Third Year
In 2009, the third project year, the NTRL received support from many different sources: A Global Healthcare
Public Foundation (AGHPF) started to provide backstopping support to QMS implementation, The Partnership
for Supply Chain Management Systems (SCMS) procured new equipment and the QO was trained in ISO 15189
by the Botswana Bureau of Standards (BOBS). Subsequently, the QO trained laboratory staff on ISO awareness
(personal notes O. Kachuwaire).

AGHPF performed an audit using the SLIPTA checklist and reported that the laboratory scored 46 out of 100
points (26). A later progress report revealed that the NTRL still had work to do on all areas of the QMS, it had
made the most effort on documents and records and the least on occurrence management, process improvement
and customer service (27).

In November 2009 a laboratory information system was installed by CDC/APHL as a country pilot site (personal
notes O. Kachuwaire).

Fourth Year
In February 2010, the start of the fourth project year, an assessment was done by Family Health International
(FHI)/AGHPF to assess readiness for accreditation. This assessment revealed that the laboratory had adequately
posted safety signs and controlled access, and sufficient eye wash and safety shower stations were also present.
The laboratory had appointed a safety officer and a deputy safety officer. Although the terms of reference of
the safety committee of the NTRL state that safety committee meetings should be held every fortnight, the
safety committee meetings had not been held for two years. The assessment revealed that the laboratory was in
possession of a validated Laboratory Information Management System (LIMS) and information was backed up
automatically and the reports were stored in a central location on a separate server. With regard to documentation
the assessment showed that the NTRL had a quality manual and Standard Operating Procedures (SOPs) in
place as required by the standard. However, in many areas the assessment revealed discordances between
documentation and practice. A lack of adequate corrective actions affected all areas of the laboratory: discordant
External Quality Assessment (EQA) results were not followed-up and problems with supply management were
not addressed. Internal audits were not held in accordance with the internal audit plan. The laboratory was also
not registered by any legal body or the government. The assessment revealed also that personnel files were
present but there was no continuous education program for staff members and competency assessment was not
performed. There were no service contract present for laboratory equipment (28). In the subsequent months of
21
 2010 the NTRL worked on correcting these non-conformities. Many activities were undertaken such as arranging
equipment calibration and servicing through support from CDC/SMCS (personal notes O. Kachuwaire). In
September 2010 the NTRL deemed itself ready for accreditation and sent the application for accreditation to
SANAS.

Fifth Year
In January 2011 the NTRL received a document review report from SANAS which indicated that the
documentation was deemed to be assessable but that there were several areas of noncompliance with ISO
requirements. Therefore corrections had to be submitted before the initial on site assessment by SANAS could be
scheduled (29).

The fifth project year was further marked with renovation of the laboratory. After having bought new equipment
in 2009, the CDC now financed significant renovation of the laboratory, including the separation of administrative
areas from testing areas, ensuring access to the safety shower by all laboratory technologists, the installation of
a new epoxy coated floor and new BSCs in the Biosafety Level (BSL)-3 laboratory, reworking of the heating,
ventilation and air conditioning system in the entire laboratory building and separation of air-conditioning systems
to single units in each laboratory area (personal notes O. Kachuwaire).

Delays in renovations were experienced which caused the laboratory to close for a period of 3 months (between
May and July 2011), therefore the initial site assessment by SANAS, scheduled for July 2011 was postponed to
October 2011. This site assessment revealed eight findings of which five were major and three were minor. The
NTRL was recommended for accreditation by SANAS after the findings were resolved and accreditation was
received in February 2012 (personal communication O. Kachuwaire, July 2014; (30)).

NTRL of Uganda
Pre-QMS Implementation
A pre-QMS implementation assessment was performed at the NTRL of Uganda in 2007 to determine readiness
to initiate the process. The main findings of this assessment were that the NTRL had already invested efforts in
QMS implementation through the preparation of several SOPs and planning the renovation of its facilities. Points
for improvement were the absence of a personnel training plan, no implementation of safety practices, absence
of SOPs on culture and drug susceptibility testing (DST), and no possibility for quantification and specification
of supplies in the procurement system for the TB laboratory network, leading to a substandard quality of reagents
(31). The latter affected both the TB laboratory network and the NTRL, although the procurement system of the
NTRL itself was found to be running well (32;33). This issue was eventually solved by improving communication
between the NTRL and the national procurement office (personal communication M. Engelberts, June 2014;
(34)).

First Year
The implementation of the QMS formally began in 2008. The external expert performed an assessment of which
the main findings were similar to the assessment performed in 2007 (31). Organization of EQA was found to be
impressive; data were consistently and properly verified and archived, but the documentation of procedures was
less well organized. The NTRL was found to be understaffed by 15 employees and infrastructure, equipment
and biosafety management were evolving very slowly. Nevertheless, staff showed a great commitment to QMS
implementation and had enthusiastically begun the writing of SOPs (32).

Directly after the assessment the external experts provided a one-week introductory training on quality
management principles for all members of staff, as well as for people from other organizations such as the Mulago
Hospital, Central Public Health Laboratories, government laboratories and health care centers (35).

An external assistance visit at the end of the first project year found that the NTRL had not made progress since
the training provided 5 months earlier due to understaffing and insufficient daily coordination and renovation of
facilities and SOP development had also not progressed (33).

22
Second Year
This situation changed in the second project year (2009): a laboratory administrator was appointed, internal
quality control improved, personnel files were updated and SOPs and worksheets were introduced. Internal audit
training was provided by the external expert. The main bottleneck was the organization of the NTRL: the view of
the MoH on the laboratory organization did not reflect reality which gave rise to problems when designing the
organogram. There was a lack of control over the work being done due to continued vacancy of the positions
of laboratory manager and technical supervisor (36;37). This situation changed at the end of the second project
year when a laboratory manager was appointed (38). At this time a start was also made with renovation of the
laboratory facilities. Therefore the laboratory operations were temporarily moved to Mulago hospital. Due to the
high number of changes the laboratory personnel struggled to comply with procedures (38) and the fact that the
quality team members were still part of the routine operational process slowed down QMS implementation (37).

Third Year
The third project year was marked by poor laboratory staff motivation caused by a high workload that failed to
yield any visible benefits. The rapid rotation system used in the laboratory meant staff members never saw the
results of their work which also decreased motivation and affected QMS implementation. To tackle this situation
the external expert organized a workshop to increase the intrinsic motivation of staff members by making
them realize that they do the work to help patients and decrease morbidity and the burden of TB (39). This, in
combination with improvement of the rotation system increased staff motivation significantly, after which QMS
implementation got back up to speed in the second half of the third project year (39-41). From that moment
internal communication improved, many SOPs were developed, the internal audit system was running properly
and the management started establishing a policy cycle. A BSO was trained and appointed, but there were still
some organizational issues such as infrequent meetings between management, director and QO and no clarity for
staff members about the roles and responsibilities of the QO and laboratory manager. This led to conflicts in the
coordination of QMS implementation and increased the workload of the QO (40;41).

Following-up the high number of action points started to become a problem in the second half of the third project
year, this was solved by better communication and coordination. A refresher training on QM, provided by the
external expert improved communication (41).

Fourth Year
At the start of the fourth project year the QMS was nearing completion and the process of implementation
gradually moved to optimization. Nearly all the SOPs were implemented and the quality manual was ready for
to be put into action. The number of action points was drastically cut, but there were still problems with staff
members not indicating when they did not understand action points, use of non-realistic deadlines and not signing
off on completed action points, all of which were addressed by the external expert (42).

In the fourth project year the QMS implementation process was marked by equipment and method validation,
which was perceived as a complex process. A start was also made with the implementation of non-conformity and
complaint management. The renovation of the facilities was completed but deployment of the BSL-3 laboratory
was delayed due to lack of an Uninterrupted Power Supply (UPS) (43;44). The implementation of a suitable LIMS
was also a challenge: the NTRL switched supplier three times before finding an adequate LIMS for the laboratory’s
data management (44). Although meetings between the QO, laboratory manager and director were still on an
ad hoc basis (affecting proper planning and communication within the QMS), in the middle of the fourth project
year, the NTRL was deemed ready for an external audit to determine readiness for accreditation (42).

This audit was performed by an independent external auditor at the end of the fourth project year. Strong points
noted were: quality awareness of staff, communication of quality issues, designation of staff to different duties,
personnel training and competency assessment. Areas for improvement noted were implementation of assurance
procedures, involvement of staff in document review and lack of information on the results of improvement
activities (no information on follow-up of non-conformities and complaints, and no trend analysis was performed).
It was not surprising that this was flagged as an area of improvement given the fact that this area was part of one of
the last stages of the QMS implementation plan (45;46).
23
 Fifth Year
In the fifth project year the technical assistant focused on the follow-up of action plans resulting from the external
audit, optimization of the analytical process to decrease the turnaround time (TAT), and optimization of the
complaints and non-conformity management system (34;47). In March 2012 the NTRL was deemed ready for
accreditation (47). SANAS performed a documentation audit followed by the accreditation audit in 2012. In
March 2013 the NTRL received ISO 15189 accreditation and in July 2013 it was formally appointed as an SRL by
the WHO (48).

NTRL of Benin
Pre-QMS Implementation
The accreditation project at the NTRL of Benin started in 2011. Before this time the NTRL was assessed by
different partners to determine readiness for QMS implementation and identify strengths and weaknesses in the
laboratory system. These assessments revealed that the NTRL functioned well and had already assured technical
quality to a certain extent (49). Points of concern were:
• Non-compliance of facilities and staff with biosafety regulations.
• Sufficient equipment and backup equipment was available but equipment maintenance possibilities were
limited (49-51).
Points that were not of immediate concern, but attention points for the future were:
• Supply management: the NTRL could only order supplies once a year at a central stock center. There labo-
ratory did not have insight in the budget, orders were sometimes not received and the orders took several
months to be delivered. However, after years of working with this system the NTRL was able to mitigate most
of the problems arising from this system (52).
• Staff management: dependence on Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) for
most technician salaries, ageing of key staff and increasing demands on both the head and deputy head were
marked at points of concern (53).

First Year
The QMS implementation was started in the first half of 2011 with two trainings on QM provided by external
experts (51;54). After provision of these trainings the first practical steps towards implementation were the analysis
of the primary process and developing flowcharts of various analytical techniques to identify the SOPs that
needed to be written. The development of SOPs started with the design of the master SOP, which provides the
guideline for writing all types of SOPs.

Other activities started in the first year were the design of the digital document control system and the NTRL
decided to send the aspirant equipment officer on a one-year training course on equipment maintenance in
France to increase equipment maintenance capacity. In addition, the organizational chart was reviewed and revised
and personnel files were developed (55;56).

At the NTRLs own request internal auditing was started by the provision of training by the external experts. This
turned out to be too ambitious: the first internal audits yielded a high number of non-conformities which could not
be immediately solved. It was decided to continue internal auditing after implementation of all the SOPs needed
for the sections to be audited (50;52).

Second Year
In the second year of QMS implementation, significant progress was made with SOP development and validation,
with most technical and general SOPs drafted and validated (57). The document control system was further
expanded with establishment of a physical document archive. The external expert noticed that the NTRL already
had a good policy cycle in place and that this only needed streamlining to get it in compliance with the ISO 15189
requirements, which was done during the second year (50;55).
At the end of the second year several issues already noted during the pre-implementation assessments started to
become obstacles to QMS implementation: the high workload of laboratory management started to spread to
other staff members which put the implementation of the QMS under pressure. This problem was addressed by
24
recruiting more personnel, which was a slow process and beyond the control of the NTRL (58). The high workload
demanded extra effort in planning capacity which demanded a change in culture (57).

Third Year
The application of biosafety regulations in facilities and by staff started to become an obstacle to the progress of
the QMS implementation. At the start of the QMS implementation the NTRL had already decided to construct a
new laboratory building with the capacity to house a BSL-3 laboratory compliant with all the biosafety regulations
(49). Due to slow tendering processes the construction of the new building only started at the beginning of
the third project year (59). In addition, the provision of the biosafety training to staff, initially planned for the
end of the first project year, was postponed by the supplier several times and was delayed by one year in total
(50;55;57;60). The training was ultimately provided at the end of the second project year (60). This all delayed
the biosafety improvement and therefore the QMS implementation as well. As a consequence, the TB CARE I
accreditation project was put on hold at the beginning of the third project year. Two assessments were performed
to re-determine the NTRL’s capacity to achieve accreditation within the span of the project period. Both assessors
concluded that biosafety needed urgent attention, but indicated that the TB CARE I project should continue.
Both assessors noted the high level of motivation and commitment of NTRL staff to the QMS implementation
(59;60), and this was also noticed by the external expert who observed that the NTRL staff had continued QMS
implementation activities during the disruption of TB CARE I support (58).

Upon resumption of the QMS implementation support in mid-2013, the external expert noted that the NTRL’s
capacity did not meet the demand for training, support and supervision activities. The follow-up of action points
remained an issue, as well as the receipt of supplies. At this point the external expert provided training on the
registration of non-conformities and complaints and an internal audit plan was developed, after which internal
auditing was restarted (58).

Fourth Year
External experts noticed that at the start of the fourth year the workload of the NTRL staff and management
increased due to their involvement in many supervision tasks, meetings, training of students and project activities.
On top of that, four member of staff retired and an additional staff member left the laboratory for another job
(61). This resulted in a delay of the QMS implementation: the NTRL was not able to register non-conformities
and complaints, and perform internal audits according to planning (62). At the same time it became known that
the initial five-year duration of the TB CARE I project for accreditation support was to be cut short by one year.

The external expert provided training in root cause analysis to address non-conformity and complaint
management and provided assistance in planning techniques to get the NTRL ready for the external audit
to determine readiness for accreditation, that was now planned for the end of the fourth project year (62). By
this time, the NTRL had to make most progress on biosafety improvement and establishing the continuous
improvement cycle. Nevertheless, during the second visit of the external expert in the fourth project year, it
became clear that the NTRL would not achieve full QMS implementation at the end of the fourth project year.
The NTRL had decided to implement the QMS at its own speed, creating a more sustainable system having
all the staff on board. The NTRL itself had made provisions to guarantee continued external support to QMS
implementation which is another sign of its commitment to the process (63). When the TB CARE I project closes
out, the NTRL will receive continued support from external experts from the Institute of Tropical Medicine in
Belgium. The NTRL envisages readiness for accreditation in the first half of 2015, which is in line with the initial
planning made in 2011 at the start of the TB CARE I project (64).

25
 Consequences of Implementing a QMS
Table 2 provides an overview of several service characteristics of the three NTRLs before and after QMS
implementation.

The qualitative data revealed that accreditation of the NTRLs of Botswana and Uganda brought numerous
positive consequences for the NTRLs. Amongst others, the capacity and quality of services of the NTRLs
improved considerably. This resulted in both NTRLs acquiring a better reputation, which led to more test requests
and research projects. Staff said that they experience a sense of pride to work at the accredited NTRLs.

Table 2: Quantitative performance characteristics of the NTRLs before and after accreditation
NTRL of Uganda NTRL of Botswana NTRL of Benin
Number of routine Period Period Period
Jun 11
diagnostic tests in the No over which No over which over which
3200 2006 17220* – May
year before the start data this was data this was this was
12
accreditation project calculated: calculated: calculated:
Number of routine Period Period Period
Oct 13
diagnostic tests in the No over which No over which over which
21492 2012 19212* – Sep
year after receiving data this was data this was this was
14
accreditation calculated: calculated: calculated:
• FM and ZN smear
• FM and ZN smear
microscopy
microscopy
• LJ culture
List of analytical • Direct FM smear • LJ culture
• MGIT culture
methods available at microscopy • 1st line LJ DST
• 1st line LJ DST
the NTRL before the • Concentrated FM • LPA
• 1st line MGIT DST
start of the accreditation • LJ culture • Serology
• 2nd line LJ DST
project • 1st line LJ DST • Biochemical testing
• 2nd line MGIT DST
• Buruli ulcer culture
• Identification (MP64
• Buruli ulcer PCR
antigen)
• FM and ZN smear
microscopy • FM and ZN smear
• LJ culture • Concentrated FM microscopy
• MGIT960 liquid microscopy • LJ culture
culture • MGIT960 liquid • 1st line LJ DST
List of analytical
• 1st line LJ DST culture • LPA
methods available at the
• 1st line MGIT DST • 1st line LJ DST • Serology
NTRL after receiving
• 2nd line LJ DST • LPA • Biochemical testing
accreditation
• 2nd line MGIT DST • Capilia/SD Bioline • Buruli ulcer culture
• LPA for identification of • Buruli ulcer PCR
• RIF/geneXpert MTB • RIF/GeneExpert
• Identification (MP64 • Spoligotyping.
antigen)
*The data on number of routine diagnostic tests for Benin were not available in the year before accreditation. Therefore this parameter was calculated over the first year
of QMS implementation at the NTRL of Benin. The same applies to this result of this parameter in the year after accreditation: since the NTRL of Benin was not yet
accredited at the time this evaluation was conducted, this parameter was calculated from the date of the evaluation visit until the same date one year earlier.

26
5.
Best Practices Towards TB Laboratory Accreditation
Best Practices Towards TB Laboratory Accreditation
The quality system essential framework is used to present the findings, argumentations and resulting best practice
recommendations in a structured way. All findings are related to the organization and the resources of the QMS
and laboratory: personnel, equipment, purchasing & inventory, and facilities & safety.

Organization
Funding:
Findings/Observations:
All three NTRLs received some level of financial support from their respective government for funding the basic
routine activities of the NTRLs. However, the donors’ contribution was larger than the financial input by the
governments. Donors provided financial support to fill in the gaps when government funding was insufficient/
not available. Lack of funding resulted in a delay of the QMS implementation process. For example, all three
NTRLs were lacking BLS-3 facilities and needed either renovation of the existing facilities or construction of a new
building which required a substantial financial input. All three NTRLs faced a delay of this facility upgrade due to,
amongst other things, a lack of funding.

Extra funding accelerated the QMS implementation process. When funding became available to fill in key
positions (e.g. QO and laboratory manager), to buy equipment (e.g. safety cabinets, centrifuges, autoclaves) and
to arrange for maintenance of equipment (for example for pipettes and to provide training of a staff member to
do maintenance and calibration of equipment) the implementation process gained momentum.

Argumentation/Analysis:
Additional funding led to the acceleration of the QMS implementation process whilst lack of funds led to a delay
of the QMS implementation process. Implementation of the QMS requires many elements of the laboratory
to be improved such as the equipment and facilities, which is an additional effort to the routine laboratory work
and requires extra staff time. The QMS also requires the sustained maintenance of these elements. Depending
on the initial state of these elements additional funding is required for improvement and establishing continuous
maintenance.

BestPractice
Best PracticeRecommendations:
Recommendations:
Laboratory
Laboratory management
management should
should ensure
ensure funding
funding forfor
thethe entire
entire QMS
QMS implementation
implementation process.
process. The
The amount
amount needed
needed
should
should bebe estimated
estimated based
based onon identification
identification of of
thethe required
required improvements
improvements through
through a thorough
a thorough pre-QMS
pre-QMS imple-
implementa-
mentation assessment.
tion assessment.

Laboratory
Laboratory management
management should
should tryconsideration
give and ensure sustainable
to ensuringfunding for QMS
sustainable maintenance
funding for QMS (including
maintenanceequipment
(including
maintenance
equipment and calibration),
maintenance e.g. through
and calibration), e.g.athrough
dedicated budget line
a dedicated in theline
budget MoH/government budget. budget.
in the MoH/government

Laboratory Management:
Findings/Observations:
In the NTRLs where the management showed good leadership and commitment to the QMS, the implementation
process went faster and smoother and staff engaged earlier in the implementation process. Examples of strong
leadership demonstrated at the NTRLs:
• Pro-active fund raising resulting in sufficient staff and functional equipment.
• Restructuring of the organization in collaboration with the staff, resulting in clear organograms and the ap-
pointment of backup staff for key positions.
• Ensuring that job descriptions were in place so that all roles and responsibilities were clear to all staff creating a
conducive work environment with efficient collaboration and team work.
• Adequate planning, resulting in the delegation of tasks and the timely maintenance of equipment.
• Supportive supervision, resulting in competent staff as they were trained when needed, leading to assured
standardization and competence in conducting laboratory procedures.

27
 • Supporting the QO. The QO’s role is to monitor QMS implementation and maintenance, and provide advice
about this to the management. The management needs to make decisions and direct staff on quality manage-
ment, based on the advice of the QO (The QO cannot assign tasks and duties to fellow staff members).

Argumentation/Analysis:
In the NTRLs where the laboratory management was spearheading the QMS implementation process by
providing direction and showing leadership to engage and involve staff, the QMS implementation process was
smoother compared to those where this was not the case.

Best
BestPractice
PracticeRecommendation:
Recommendation:
Laboratory
Laboratory management
management should initiate
should and
initiate lead
and thethe
lead QMS
QMS implementation
implementationprocess and
process andshow
show active commitment
active commitment by
spearheading the QMS
by spearheading the QMSimplementation, providing
implementation, direction
providing and applying
direction leadership
and applying skills skills
leadership from from
the start to ensure
the start to that
allensure
staff are engaged in the process.
that all staff are engaged in the process.

Communication:
Findings/Observations:
At NTRLs with short, clear and effective communication lines at all levels (internally and externally) the
implementation process was more efficient. Internally it helped to get all the laboratory staff engaged and to
increase team spirit. Good external communication meant partners and donors stepped in when there was a lack
of resources as they were quickly consulted.

Argumentation/Analysis:
Good communication helps to engage staff, government, donors and partners in the QMS implementation
process and to mitigate problems.

Best
BestPractice
PracticeRecommendation:
Recommendation:
Laboratory
Laboratory management
management should
shouldcreate
createefficient and
efficient andeffective communication
effective channels
internal and external both internallychannels.
communication and externally
toInternal
the laboratory. Internal communication
communication fosters staff
fosters staff engagement andengagement and provides
provides clarity clarityobjectives.
on the quality on the quality objectives.
External
Externalcommunication
communication allows thethe
allows laboratory
laboratory toto
identify customer
identify customerrequirements
requirementsand
andenables thethe
enables laboratory toto
laboratory inform
stakeholders about theabout
inform stakeholders needstheof the
needslaboratory and whatand
of the laboratory the what
stakeholders can expect
the stakeholders canfrom the from
expect laboratory.
the laboratory.

Quality Manager:
Findings/Observations:
In one laboratory a full-time QO was appointed three months after the initiation of the implementation process
and at that moment tangible implementation began. In another laboratory, the QO was involved in other activities
besides the QMS tasks, which had an impact on the speed of QMS implementation.

Argumentation/Analysis:
The absence of a QO delayed the start of the QMS implementation process and when the QO was occupied
with other activities besides the QMS implementation activities, the process was delayed. This indicates that
efficient QMS implementation needs a full-time dedicated QO without involvement in activities unrelated to
QMS implementation.

Best
BestPractice
PracticeRecommendation:
Recommendation:
Laboratory management
Laboratory management should appoint
should a competent,
appoint a competent,qualified and
qualified anddedicated QO
dedicated QO from thethe
from start ofof
start thethe
QMS
QMS
implementation process.
implementation The
process. position
The ofof
position QO QO should bebe
should full-time
full-timeand they
and should
they notnot
should undertake
undertake any other
any tasks.
other tasks.

28
In-country Laboratory Quality Peers:
Findings/Observations:
All countries expressed the need to have access to peers in quality management. For the QO this would enable
more accessible discussion possibilities with experts to find (alternative) solutions to issues related to QMS
implementation. For the general laboratory staff this would provide an example of the desired end result of QMS
implementation so that they have a better picture of what they should work towards.

Argumentation/Analysis:
All three NTRLs in this project were the first TB laboratories in the public sector to implement an ISO 15189
QMS. This meant they did not have access to other routine diagnostic TB laboratories that were already
accredited. Not having an example situation made QMS implementation more complex for staff as they did not
have a clear vision of the necessary end results. The QOs of two NTRLs did not have access to a discussion forum
in addition to the external expert. Having access to this would help in finding alternative solutions to issues arising
in the QMS implementation and could also contribute in terms of equipment maintenance, setting up assessment
schemes, bench marking, learning from each other, exchange of equipment and supplies, etc.

BestPractice
Best PracticeRecommendations:
Recommendations:
Laboratorymanagement
Laboratory managementshould shouldcreate
createpossibilities
possibilitiesforforphysical
physicalaccess
accesstotoalready
alreadyaccredited
accreditedlaboratories
laboratoriesatatthethe
beginningand
beginning andduring
duringthetheQMS
QMSimplementation
implementationprocess,
process,especially
especiallyforforkey
keypersonnel.
personnel.This
Thisprovides
providesthem
themwithwitha a
tangible example of an accredited laboratory and enables them to have a clearer picture of the
tangible example of an accredited laboratory and enables them to have a clearer picture of the desired end result desired end resultof
of QMS
QMS implementation.
implementation.

Laboratorymanagement
Laboratory managementshould shouldarrange
arrangecommunication
communicationwithwithpeers
peers(if(ifpossible
possiblein-country
in-countrypeers)
peers)forforthetheQO
QOtoto
discussissues
discuss issuesrelated
relatedtotoQMS
QMSimplementation
implementationandandtotoenable
enablesetting
settingupupbilateral
bilateralsupport
supportmechanisms
mechanismsbetween betweenthethe
laboratories (such as assessment schemes, shared equipment maintenance capacity, bench marking, exchange ofof
laboratories (such as assessment schemes, shared equipment maintenance capacity, bench marking, exchange
equipmentasaswell
equipment wellasasparts
partsand
andsupplies).
supplies).

Personnel
Change Management:
Findings/Observations:
In all the NTRLs the staff initially showed different levels of reluctance and lengths of time to fully take part in
the QMS implementation process. Better involvement of staff in the QMS planning and implementation process
by the management, and the presence of short communication lines within the organization, led to increased
acceptance of the new working culture. Thorough training and explaining the importance of the QMS helped to
get staff on board.

Argumentation/Analysis:
Reluctance to any change is normal and the implementation of a QMS is a big process of change. Laboratory
staff need to adopt and get used to a new way of working, which takes time. The implementation of a QMS also
requires a change in culture.

Best
BestPractice
PracticeRecommendations:
Recommendations:
Laboratory
Laboratorymanagement
managementshould
shouldbebecompetent
competentin inusing
usingchange
changemanagement
managementprinciples
principlesand
andapply
applythetheproper
proper
management and leadership skills to facilitate the process of change created by QMS implementation.
management and leadership skills to facilitate the process of change created by QMS implementation.
Laboratory
Laboratorymanagement
managementshould
shouldcreate
createtransparency
transparencyin inthetheQMS
QMSimplementation
implementationprocess
processforforallallstaff
staffand
andensure
ensurethat
allthat
staffallare involved when a technical expert provides advice. This facilitates staff engagement.
staff are involved when a technical expert provides advice. This facilitates staff engagement. However,However, technical
expert should
technical not demand
expert toodemand
should not much timetoo from
muchthe laboratory
time from thestaff members
laboratory staffwhen the advice
members whenisthenotadvice
relevant to them.
is not
There is notouse
relevant in providing
them. There is advice
no use that is for specific
in providing advicepositions tospecific
that is for all staff positions
members.toInallthis case,
staff a summary
members. of case,
In this this
advice should be provided to all staff members during a debriefing.
a summary of this advice should be provided to all staff members during a debriefing.

29
 Training:
Findings/Observations:
At all three NTRLs the QOs and laboratory managers were trained in QMS principles, only two NTRLs trained all
other staff on QMS principles. At two NTRLs the staff indicated they needed more training on QMS principles
and implementation and at all three, new staff were inducted to the QMS by the QO which resulted in rapid
engagement. The BSOs of all the three NTRLs were trained on (bio)safety issues. All NTRLs were supported in
continuous education through trainings provided by the external experts, which was positively perceived by staff.

In all three countries laboratory quality management principles are not part of the pre-service training curriculum.

Argumentation/Analysis:
Training facilitates the implementation process by increasing staff knowledge and competence with regard to
quality management, which in turn results in better staff engagement in the QMS implementation process.
Training also enables laboratory management to apply better management and leadership skills and guide the
process of change. Continuous training ensures that all staff remain engaged in the QMS implementation process.

Best
BestPractice
PracticeRecommendations:
Recommendations:
AtAt
thethe
start of of
start thethe
QMS
QMS implementation
implementation process laboratory
process management
laboratory managementshould ensure
should adequate
ensure training
adequate forfor
training key
positions particularly for the laboratory manager, QO and BSO. This enables them to perform their tasks
key positions particularly for the laboratory manager, QO and BSO. This enables them to perform their tasks competently
and to be able to
competently andengage staff to
to be able effectively.
engage staff effectively.

Laboratory
Laboratory management
management and, if applicable,
and, external
if applicable, experts,
external should
experts, ensure
should that
ensure allall
that laboratory staff
laboratory understand
staff understand their
role in the
their roleQMS
in theimplementation throughthrough
QMS implementation targeted, relevantrelevant
targeted, and continuous internalinternal
and continuous and external training.training.
and external

Relevant
Relevantstakeholders
stakeholders (e.g. laboratory
(e.g. laboratoryrepresentatives, national
representatives, and
national andinternational public
international health
public organizations)
health should
organizations)
advocate at the level
should advocate at of
thenational
level ofgovernment and education
national government sector to sector
and education make training
to makeon laboratory
training quality management
on laboratory quality
principles part of the pre-service laboratory training curriculum, to maximize indoctrination on QMS implementation
management principles part of the pre-service laboratory training curriculum, to maximize indoctrination on QMS
and maintenance on
implementation anda national scale.on a national scale.
maintenance

Workload:
Findings/Observations:
All NTRLs indicated shortage of staff although not all NTRLs could provide exact numbers on the level of
workload of routine work.

Argumentation/Analysis:
Implementation of a QMS initially increases the workload as it requires work to be done in addition to the routine
work of the laboratory. This includes, for example, implementation of new work methods, SOP development
and implementation, improvement of recording and reporting of information, development of equipment
maintenance programs, etc.

Recommendations:
Best Practice Recommendations:
Laboratory
Laboratorymanagement
managementshould
shouldanticipate
anticipatethetheinitial
initialincreased
increasedworkload
workloadwhen
wheninitiating
initiatingQMS
QMSimplementation
implementationand
take
andappropriate measures.
take appropriate The increase
measures. in workload
The increase depends
in workload on theon
depends availability of staffofand
the availability stafftheandamount of workof
the amount
towork
be done to achieve ISO 15189 compliance. The latter could be estimated by performing a
to be done to achieve ISO 15189 compliance. The latter could be estimated by performing a thorough pre-thorough pre-QMS
implementation assessment
QMS implementation to identify
assessment to the improvements
identify that needthat
the improvements to be made
need to betomade
achieve to full ISO full
achieve 15189 compliance.
ISO 15189
compliance.
The laboratory management should continuously monitor workload through regular workload assessments. This
enables the laboratory
The laboratory management
management shouldtocontinuously
adequately react monitorwhen the workload
workload throughbecomes too high and
regular workload prevent this
assessments. This
hampering QMS implementation and affecting routine work.
enables the laboratory management to adequately react when the workload becomes too high and prevent this
hampering QMS implementation and affecting routine work.

30
Equipment
Equipment Maintenance and Backup:
Findings/Observations:
All NTRLs reported insufficient competent in-country maintenance capacity for the maintenance and calibration
of equipment.

Argumentation/Analysis:
It is critical that equipment maintenance systems are functional to guarantee good laboratory services and to
comply with ISO 15189 requirements.

Best
BestPractice
PracticeRecommendations:
Recommendations:
Laboratory
Laboratorymanagement
management should
should assess if there
assess is is
if there adequate
adequate equipment
equipment maintenance
maintenance capacity forfor
capacity allall
critical laboratory
critical
equipment
laboratoryatequipment
the start ofatthe theQMS implementation
start of process. Thisprocess.
the QMS implementation activity This
couldactivity
be partcould
of a pre-QMS
be part of implementation
a pre-
assessment. If in-country equipment maintenance capacity is inadequate, the laboratory
QMS implementation assessment. If in-country equipment maintenance capacity is inadequate, the laboratory management must plan to
compensate
management for must
this, as thistomay
plan cause delays
compensate due as
for this, to this
the fact
maythatcause thisdelays
oftendue
lies to
beyond thethat
the fact control of thelies
this often laboratory.
beyond
The appropriateness of the strategies used to compensate inadequate maintenance capacity
the control of the laboratory. The appropriateness of the strategies used to compensate inadequate maintenance depend on the local
situation.
capacityExamples
depend on of the
possible interventions
local situation. could be:
Examples of possible interventions could be:
• • Training
Trainingofof oneoneoror
more
more staff members
staff members toto
perform
perform equipment
equipment maintenance
maintenance themselves.
themselves.
• • Outsourcing equipment maintenance to competent companies
Outsourcing equipment maintenance to competent companies in-country or in-country or otherwise
otherwiseabroad,
abroad, dependent
dependent on
in-country capacity
on in-country (and (and
capacity anticipating the extra
anticipating fundsfunds
the extra required).
required).
• • Including a service contract for preventive maintenance
Including a service contract for preventive maintenance as as a requirement
a requirement in in
thethe
tender
tenderwhen
when purchasing
purchasing new
new
equipment.
equipment.
If in-country equipment
If in-country equipment maintenance
maintenance capacity is is
capacity inadequate,
inadequate,relevant stakeholders
relevant stakeholders(laboratories/laboratory
(laboratories/laboratory societies,
national andnational
societies, international public healthpublic
and international organizations, etc.) shouldetc.)
health organizations, advocate
should at advocate
the national level
at the of government
national level of to
increase in-country
government equipment
to increase maintenance
in-country equipmentcapacity for the (medical)
maintenance laboratory
capacity for sector. laboratory sector.
the (medical)

Purchasing & Inventory

Procurement of Supplies:
Findings/Observations:
Inflexible administration of in-country supplies management resulted in slow procurement processes and
substandard supplies for all NTRLs. At all NTRLs donors were relied upon for the provision of supplies where the
government supply system was insufficient. At one NTRL this was perceived as have a negative impact on QMS
implementation. A lack of certified suppliers was an issue for one NTRL.

Argumentation/Analysis:
Timely delivery of good quality supplies leads to uninterrupted quality services and is a requirement of the QMS.
In areas where there is a lack of proper suppliers, and/or supply/delivery have long lead times, adequate actions
must be taken to find alternative solutions and improve this situation.

Best
BestPractice
PracticeRecommendations:
Recommendations:
Prior
Priortoto
QMSQMS implementation
implementation thethe
laboratory
laboratorymanagement
management should
shouldassess
assessthethe
capacity
capacity ofofprocurement
procurement andandsupply
chains
supply to chains
providetoquality
providesupplies
quality and copeand
supplies withcope
a potential increase of
with a potential demand
increase of for supplies.
demand This activity
for supplies. Thisshould
activitybe
part of a pre-QMS implementation assessment. If the capacity of the procurement and
should be part of a pre-QMS implementation assessment. If the capacity of the procurement and supply chains supply chains is inadequate
timely actions should
is inadequate timelybe taken should
actions as improvements
be taken asinimprovements
these situations can take
in these a long time
situations (as they
can take often
a long timelie(as
beyond
they the
control
often ofliethe laboratory).
beyond Theofappropriateness
the control the laboratory).ofThe the appropriateness
strategies used depends upon theused
of the strategies localdepends
situation.upon
If thetheroutine
local
procurement of supplies lies beyond the control of the NTRL, the NTRL management
situation. If the routine procurement of supplies lies beyond the control of the NTRL, the NTRL management should advocate to the relevant
authorities to have to
should advocate their
theown budget
relevant availabletoforhave
authorities the their
procurement of supplies
own budget availablein for
case theofprocurement
failures in theofsupply
supplies chain
in and
forcase
emergencies that require an extra demand for supplies.
of failures in the supply chain and for emergencies that require an extra demand for supplies.

31
 If Iflead
leadtimes
timesforforsupply
supplydelivery
deliveryarearelong
longdue
duetotocircumstances
circumstancesthatthathave
havetheir
theirroot
rootcause
causewithin
withinthethecountry,
country,relevant
relevant stakeholders
stakeholders (laboratories/laboratory
(laboratories/laboratory societies,and
societies, national national and international
international public health public health organizations,
organizations, etc.) shouldetc.)
should advocate to the proper sources to eliminate these causes
advocate to the proper sources to eliminate these causes and improve supply chains. and improve supply chains.

Facilities and Safety:

Findings/Observations:
At all the NTRLs the (re)construction of the BSL-3 facility delayed the QMS implementation process due to
inadequate planning and/or communication between the NTRL and donor, slow tendering procedures, and/or
unavailability of competent BSL-3 laboratory construction firms.

Argumentation/Analysis:
A safe work environment is a prerequisite for health of the staff, especially in TB (culture) laboratories. Renovation
of the laboratory facilities can be a long process which requires timely planning.

Best
BestPractice
PracticeRecommendation:
Recommendation:
Laboratory
Laboratorymanagement
managementshould shouldassess
assessif the
if thefacilities
facilitiescomply
complywith
withthethe(bio)safety
(bio)safetyand
andbiosecurity
biosecurityrequirements
requirementsprior
toprior
QMStoimplementation. This could be part of a pre-QMS implementation assessment.
QMS implementation. This could be part of a pre-QMS implementation assessment. If the facilities If the facilities do not meet
do
thenot
requirements, the laboratory management must immediately set the improvement of
meet the requirements, the laboratory management must immediately set the improvement of the facilitiesthe facilities in motion
asinfunding
motionlimitations
as fundingand limited in-country
limitations and limitedavailability
in-countryofavailability
contractorsof competent
contractors to renovate or
competent to newly
renovateconstruct
or newly
laboratory facilities can affect QMS implementation.
construct laboratory facilities can affect QMS implementation.

32
6. General
General Discussion
Discussion
Implementing ISO 15189 remains an important pillar in laboratory strengthening to ensure quality healthcare.
However, implementing an ISO 15189 QMS is a huge intervention that is a huge challenge for laboratories in
high income countries and even more so for laboratories in LMIC. This evaluation sought to determine the best
practices that laboratories should take into consideration before embarking on this undertaking.

Consequences of Receiving Accreditation

It is difficult to collect quantitative data on laboratory performance such that the effect of the QMS
implementation can be visualized. In unaccredited laboratories many parameters are not structurally recorded, it
is therefore often impossible to obtain baseline performance data from the years before accreditation. The same
applies to the indicators used in this evaluation project. Data on EQA performance and staff turnover was not
complete or could not be obtained. The fact that the proper collection of data from the years before the start of
the accreditation projects is not possible while this can be done for the years after QMS implementation is in itself
a sign of the effect of implementing a QMS; this indicates that the QMS requirements related to information
management indeed optimize accessibility and availability of laboratory data.

Table 2 (page 26) shows that the number of test requests increased both at the NTRL of Benin and Botswana. In
Botswana, this increase was said to be due to the improved reputation of the NTRL following accreditation and
the fact that TB laboratory testing was included in the national diagnostic algorithms of Botswana. In Benin, the
number of tests mainly increased because of the adoption of new techniques, but the effect of accreditation could
not be measured as this NTRL is not yet accredited. At the Uganda NTRL data about the increase of test requests
could not be collected. This makes it impossible to indicate whether the substantial increase of test requests at the
NTRL of Botswana is something that is to be expected by other laboratories after receiving accreditation.

The number of different examinations performed increased at all three NTRLs, this is due to the development of
new TB diagnostic test methods. The implementation of the QMS probably did not influence this, although the
QMS might have facilitated easier uptake of the new diagnostic test methods.

The qualitative data indicates that the QMS indeed influenced the quality of services according to the majority of
those interviewed. The reputation and status of the NTRLs improved and customers are more satisfied with the
NTRLs’ services.

Implementation of the QMS

The NTRLs in this evaluation have received different levels of support from the respective MoHs. They are
situated in low to middle income African countries and represent settings similar to laboratories in other African
countries where multi-partner support in collaboration with the government has been used to achieve laboratory
accreditation (65;66). As much as partner support is essential to start the implementation of the accreditation
processes, without long-term government support national accreditation programs will not improve or be
sustainable (15;67). To ensure sustainability, advocacy by relevant stakeholders at the national level will be required
for governments to include international ISO 15189 accreditation through QMS implementation in national
laboratory policies and national strategic plans (15;66;68;69).

Expected Findings
Many factors that are very likely to affect the implementation of a QMS were observed, such as the availability
of funding, the role of laboratory management, training, supply chain and equipment maintenance capacity, and
change management/staff resistance. The importance of these elements in implementing a QMS has also been
indicated by many other before (5-15;17).

What is striking is that all the best practices are related to two elements in general: the organization (including
management) of the laboratory and the resources required for laboratory work (personnel, equipment, purchasing
& inventory and facilities & safety). This could logically be explained by the fact that resources are needed to

33
 build the rest of the QMS. Without the proper resources, the rest of the QMS implementation process cannot be
completed properly either. As stated before, QMS implementation is a big process of change, as demonstrated in
chapter 2, strong management and organization is needed to coordinate and facilitate this process, without these
elements, the efficiency of QMS implementation directly decreases.

The Quality Management System

Organization and Management

Continuous
Resources Process Improvement

Personnel Process Assessment

Management
Equipment
Nonconformity
Documents & Management
Purchasing & Records
Inventory

Information Continual
Facilities & Safety Management Improvement

Customer Focus

The Primary Laboratory Process

Pre-Analytical Analytical Post-Analytical
Sample Sample Sample Sample Sample Sample Sample Sample Recording Reporting Storage of Disposal of
Request Collection Transport Reception Registration Preparation Processing Examination of Results of Results Sample Sample

Figure 6: Graphical display of the individual quality system elements within the QMS

Funding facilitated QMS implementation by enabling the recruitment of additional staff, the procurement of
reagents, the improvement of facilities, etc. When funding was lacking, it delayed some of the processes at
the NTRLs in this evaluation such as the construction of BSL-3 facilities. This obstacle was often resolved by
interventions from donors who financially supported the majority of the QMS activities. The same was seen in
Ethiopia, where laboratories implementing a QMS using the SLMTA model only progressed in areas that required
no financial commitment, which shows the importance of funding for this process (70). The advantage of donor
funding is that the QMS implementation process can continue; the disadvantage is that the sustainability of
funding is not ensured. The maintenance of the QMS that is required after it has been implemented, requires
sustained funding and in the public sector this should ideally be provided by the MoH. This indicates the need for
sensitization at MoH level about the requirements of ISO 15189 by the laboratory management as this provides
the MoH with insight into the resources required to implement/sustain a QMS. Further to this, the authors
recommend that the laboratory management raise awareness about QMS requirements and their implications on
the support and resource demands at the authorities that provide the support and resources (including human
resources) to the NTRL. This way the extra demand during QMS implementation can be anticipated by these
authorities.
34
It is clear that the role of the laboratory management is crucial to the success of QMS implementation. Nearly all
the best practices recommended in this evaluation require action from the laboratory management. Therefore,
the fact that the laboratory management is strong, has good leadership skills and actively directs and controls
the implementation of the QMS is of critical importance. The laboratory management has the responsibility to
propagate the QMS and explain the consequences both internally and externally.

Resistance from staff caused by the required culture change during the accreditation process as shown in
this evaluation is similar to the findings from Kenya (9). In Rwanda, to increase staff buy-in, a performance
based incentive scheme was employed, which involved financial rewards for continued improvement during
implementation (71). In this evaluation the management of one NTRL showed very strong direction and
leadership skills with regard to the QMS implementation process. In this NTRL, staff were engaged earlier and
committed to the QMS implementation process in comparison to NTRLs where the laboratory management
did not actively commit to the QMS implementation process. This finding is supported by examples from other
laboratories. In Nigeria buy-in from top management was cited as a factor in the successful implementation of a
QMS (5). A culture of open communication also contributed to staff engagement and involvement at one of the
NTRLs. These findings confirm the importance of laboratory management showing proper management and
leadership skills and applying the principles of change management as described by Berwouts et al. (6).

In this evaluation, all the NTRLs experienced increases in workload, laboratory management must anticipate and
manage this change by reorganization and/or the recruitment of new staff.

The availability of a full time QO from the start of QMS implementation process made it move faster and
more efficiently, which supports the statement of Zeh et al. and Guzel et al. who point out the importance of
establishing a quality team to coordinate the process (9;11). When the QO was assigned duties other than QMS
tasks, the implementation process slowed down. It is important that the QO has an advisory position under the
laboratory manager/director, instead of a line-position. The QO has no authority to assign tasks to specific staff
members and can only provide advice to laboratory management, therefore the laboratory management should
not expect the QO to be authoritative and assign tasks to staff members.

This evaluation supports the statement made by many before, that initial and continuous training to build capacity
of staff, starting with key personnel, is essential for the QMS implementation process (5;7;8;12). In this evaluation
formal training in quality management principles was provided to key personnel at all NTRLs. In-country capacity
for QMS training was beneficial in one country as it reduced costs. In other mentoring models training of in-
country mentors has been shown to improve the speed of QMS implementation and the presence of a full-time
facility-based mentor in Nigeria, Botswana and Kenya had a positive impact on their accreditation processes
(4;65). The disadvantage is that the costs of these models are considerable and the presence of a full-time mentor
compromises staff ownership over the QMS and thus sustainability of the QMS (9;16). In two NTRLs in this
evaluation QMS implementation assistance was provided through four one-week visits by the external expert
per year. It was noted by staff and management that this was a suitable model to ensure sustainability and staff
ownership over the QMS as they implemented the QMS themselves. However, the external expert said that a visit
of a longer duration (two to three months) at the start of the project would facilitate earlier staff engagement and
more rapid start-up of QMS implementation.

The availability of a well-functioning supply chain system and reliable suppliers was identified as a necessity by all
three NTRLs. For two NTRLs the supply system was managed entirely by donors, while at the other the donors
only provided support to supply delivery during stock outs that could not be resolved in time by the routine supply
system. Availability of reliable (certified) in-country suppliers was a challenge at all three NTRLs, which made
the supply chain system cumbersome. This finding was no surprise as the availability of proper supply systems
in LMIC was reported to be challenging by many before (5;9;17). This indicates the necessity to improve this
situation and is a call for action by higher level authorities, starting with national governments. The same applies to
the frequently reported challenges around equipment maintenance capacity in LMIC (7;9;13;14), which was also
challenging for the three NTRLs evaluated in this study. They reported that the availability of a well-functioning
equipment maintenance system and qualified equipment maintenance vendors is critical to successful QMS

35
 implementation. In two of the NTRLs the equipment maintenance was carried out by vendors subcontracted
by donors, in the third a laboratory technologist was sent abroad for one year to be trained in basic equipment
maintenance. Unfortunately this solution was only partly effective in resolving equipment maintenance and
especially calibration issues as challenges persisted due to lack of tools required for maintenance and calibration of
several pieces of equipment.

The fact that challenges related to equipment maintenance and supply chain systems are similar in many LMIC
indicates that urgent action is needed to resolve these issues. Although many supplies have to be imported
from abroad which often leads to long lead times, the national governments could play a role in optimizing the
administrative procedures around ordering and importing supplies. This will prevent an increase in the already long
lead times of imported supplies. National governments can also play a role in the creation of in-country equipment
maintenance and calibration capacity by establishing proper policies and providing subsidies for the establishment
of these institutions.

Unexpected Findings
Although most of the factors mentioned above were expected to influence the QMS implementation, the
complexity of some of the problems was not fully expected, including the difficulties in solving them. These
factors were mostly beyond the control of the laboratory. Of note were issues that required policy changes, which
took a long time to realize and some that are still a challenge even after accreditation (e.g. supply chain systems,
laboratory budgets and ad hoc staff transfers). These findings are not unique to the NTRLs in this evaluation
and were also observed in other settings where, even after accreditation, government processes made equipment
maintenance and adequate delivery of supplies a challenging process (9).

Staff in some of the NTRLs said that they felt left out during the visits of the external expert because the external
expert often focused on working with key laboratory staff (QO and laboratory management). The external
experts who provided this assistance were not aware of this issue. This finding shows that deliberate engagement
of all staff by the external experts during each visit is necessary to facilitate more active involvement and
motivation of staff when implementing the QMS. However, the external expert should find a balance between
engaging all staff and aiming assistance at certain key positions that play an important role in the implementation
of specific QMS elements, because this type of assistance is often not relevant for the majority of other staff
members besides the key position on which assistance is focused.

Staff in two of the NTRLs said that they would have benefited from visiting laboratories that were already
accredited as this would enable them to visualize what the end result of their efforts would look like, especially
at the beginning of the QMS implementation process. In addition, staff in two NTRLs stated that they thought
that it was important to have opportunities to share experiences with a group of peers involved in QMS
implementation in laboratories in or outside their countries. Only one of the NTRLs had an in-country quality
forum, which was noted to be useful. Other countries would also benefit from setting up such a forum to provide
a supporting environment for laboratories implementing a QMS. In Kenya a laboratory implementing a QMS
formed an advisory committee with other experts from the US and held quarterly meetings in a formal in-country
QA meeting which supports the suggestions found in this evaluation (9). If possible, advisory committees with
peers from the same country are preferred to have more approachable discussion possibilities and keep control
over the costs.

A safe working environment in TB laboratories is an international requirement to ensure the safety of both staff
and patients, and the WHO TB laboratory biosafety manual advises that laboratories conduct a risk assessment
(72). This is an approach that promotes the consideration of risk and the development of appropriate biosafety
practices in laboratories based on the unique combination of test procedures, staff expertise and facilities present
in each laboratory. The NTRLs in all three countries had to upgrade their infrastructure by renovating or even
building a new laboratory facility, which resulted in unexpected delay of the process as this was one of the slowest
and one of the most expensive steps in implementing a QMS. The delay was augmented by the lack of competent
in-country contractors experienced in building BSL-2/3 laboratories in all the three countries. In some of the
countries delay was due to construction formalities with donors and the government. In some of the NTRLs the

36
quality of the upgrades were affected by shortages of funds allocated for the reconstruction. In all three countries
donors supported the construction or reconstruction of the laboratories. The challenges around facility upgrading
mentioned here confirm the statement made in the roadmap for ensuring quality TB diagnostic services within
national laboratory strategic plans as published by the WHO, saying that the establishment of well-maintained TB
laboratories with appropriate biosafety measures and equipment presents the greatest challenge for both initial
financing and sustainability (73). This shows the necessity to assess and identify the improvements that need to be
made to the laboratory facilities at the start of the QMS, so that the improvement process can be started at the
earliest convenience, leaving more time to mitigate challenges such as those described above.

Factors ‘In’ and ‘Beyond’ the Direct Control of the Laboratory

Prior to start of the implementation, a gap analysis of all the elements of the QMS at the NTRLs was conducted
with support from external experts. Following this, plans were developed to address the identified gaps, which
allowed for a structured approach to implementation. Despite this planning there were unexpected delays due to
some factors over which the NTRLs had no direct control, indicated in Table 3.

Table 3: Factors in and beyond the direct control of the NTRLs

Factors in the direct control of the laboratory Factors beyond the control of the laboratory
• Staff engagement • Supply chain system
• Laboratory leadership/management • Equipment maintenance
• Trainings • Availability of donors
• Assessments • Availability of peers
• Communication channels both internal and • Staff shortages/staff transfers
external to the laboratory
• Appointment of QO, BSO and supplies officer
• Fund-raising activities

We observed that some of the factors beyond the control of the NTRLs took a longer time to be resolved
compared to the factors over which the NTRLs had direct control. All the NTRLs with a strong management
actively engaged donors to resolve some of the external factors such as issues with the supply chain and
equipment maintenance. Laboratories that are planning to begin the process of implementing a QMS should
consider a pre-QMS implementation assessment that also identifies factors over which the NTRLs have direct
control and which are beyond their control. When there are elements that are beyond the control of the laboratory
but that need to be optimized as part of the QMS implementation process, these should be taken into account
in the planning and budgeting process. This basically means that the laboratory management should design
strategies to achieve the desired improvements, e.g. through advocacy and/or discussion with external institutions
that control these elements.

Technical Assistance
The format in which assistance was provided by external experts was similar at all NTRLs in this evaluation. To
date, two NTRLs are accredited and one NTRL is in the final stages of accreditation. At all the NTRLs, it has
taken five years of preparation to apply for accreditation. As all three NTRLs evaluated in this process worked
with external experts, we cannot make any conclusions on how critical the external assistance is in accelerating
the whole QMS implementation process, due to the lack of an appropriate control. However, in Nigeria a
laboratory which had intermittent assistance from an external expert progressed much further than one without,
despite the latter already having implemented ISO 9001. Some of the reasons stated in this situation were a lack
of understanding of audit findings and the ISO 15189 standard at the laboratory that did not receive external
assistance, which led to delays in implementation of corrective actions (65). This suggests that assistance of an
external expert is preferable when implementing a QMS according to ISO 15189.

37
 Limitations of this Evaluation
This evaluation was performed by the same persons that provided assistance during the QMS implementation
processes at the three NTRLs. This could have influenced the answers given during the interviews, predominantly
on questions regarding the method in which external assistance was provided. The evaluators minimized the risk
for bias by making sure that the interviews were led by evaluators that did not provide external assistance to the
NTRL at which the interviews were held, while the evaluator that had provided external assistance to the NTRL
before, made notes of the interviews. Answers to questions where evaluators suspected the presence of bias were
omitted from analysis.

Another potential limitation is that this evaluation focused on the African setting only, evaluating QMS
implementation in NTRLs in three different African countries. Indicating that the best practices are applicable
to continents other than sub-Saharan Africa would be an extrapolation that is not supported by empirical data.
Nevertheless, the literature review, in which reports of similar projects in other parts of the world were analyzed,
yielded similar results to the findings found in this evaluation. Therefore, the authors conclude that the findings
and resulting best practices of this evaluation project can to some extent be safely be extrapolated to countries
with similar conditions outside the African continent

The geographical location of the three countries where the NTRLs are located form a cross-section of Sub-
Saharan African countries. This provides more certainty that the recommendations for best practices in this
document are applicable to the majority of countries in sub-Saharan Africa. As the NTRLs that were evaluated
were located in one upper middle-income country and two low-income countries, there is also more certainty that
the recommendations for best practices are applicable to laboratories in both low- as middle-income countries in
sub-Saharan Africa.

38
7. Conclusion
Conclusion

After a literature review and extensive evaluation of the ISO 15189 QMS implementation processes at the NTRLs
of Botswana, Uganda and Benin using a mixed-methods approach, significant insights were obtained on important
factors influencing the QMS implementation process. Based on these insights, 19 best practice recommendations
were formulated. These best-practices should lead to more efficient implementation of QMSs according
to ISO 15189, when they are adhered to by TB laboratory managers, QOs, NTP managers, policy makers and
other stakeholders involved in TB laboratory strengthening. These best practices should also be used in the GLI
tool roll-out.

Our findings largely corroborate findings published by others. Several unexpected findings were related to the
method of assistance provided to the laboratories, the fact that staff often indicated the importance of visiting
an already accredited laboratory to obtain a clear vision on the target and know what was expected, and the
complexity of some of the problems due to the fact that their causes were not under the direct control of the
laboratory.

Interestingly, all of the best practices identified in this evaluation are related to two particular areas: organization
(including management), and the resources of the laboratory (personnel, equipment, purchasing & inventory,
facilities & safety). The importance of proper organization and management can be explained by the fact that
the implementation of a QMS is a big process of change, that affects all laboratory processes. To facilitate and
coordinate this process such that the change is achieved as efficiently as possible, strong management, leadership
and organizational skills are needed.

The fact that the majority of the best practices are related to the resources of the laboratory is logical as resources
form the basis of the primary laboratory process and the QMS and sub-optimal resources influence the quality of
services at all levels. In our evaluation we found that problems with sub-optimal or a lack of resources were often
caused by factors outside the direct control of the laboratory. This exacerbated the problems and solving them
often required large amounts of time, strong management and advocacy skills from the laboratory manager. It is
therefore of particular importance that laboratories that are planning to implement a QMS, perform a pre-QMS
implementation assessment, focused on the best practices laid out in this document. If points for improvement are
identified, actions should be taken immediately to decrease the chance that they will affect QMS implementation
at a later stage.

39
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