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Background: The declining trend of malaria and the recent prioritization of containment of antimicrobial resistance have created a momentum to implement clinical bacteriology in low-resource settings (LRS). Successful implementation relies on guidance by a quality management system (QMS). Over the past decade, international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and malaria. Aims: To describe the progress towards accreditation of medical laboratories and to identify the challenges and "Best practices" for implementation of QMS in clinical bacteriology in LRS. Sources: Published literature, online reports and websites related to the implementation of laboratory QMS, accreditation of medical laboratories and initiatives for containment of antimicrobial resistance. Content: Apart from the limitations of infrastructure, equipment, consumables and staff, QMS are challenged with the complexity of clinical bacteriology and the healthcare context in LRS (small-scale laboratories, attitudes and perception of staff, absence of laboratory information systems). Likewise, most international initiatives addressing laboratory health strengthening have focused on public health and outbreak management rather than on hospital based patient care. "Best Practices" to implement quality-assured clinical bacteriology in LRS include alignment with national regulations and public health reference laboratories, participating in external quality assurance programmes, support from the hospital's management, starting with attainable projects, conducting error review and daily bench-side supervision, looking for locally adapted solutions, stimulating ownership and extending existing training programmes to clinical bacteriology. Implications: The implementation of QMS in clinical bacteriology in hospital settings will ultimately boost a culture of quality to all sectors of healthcare in LRS.
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Review
Implementation of quality management for clinical bacteriology in
low-resource settings
B. Barb
e
1
,
*
, C.P. Yansouni
2
, D. Affolabi
3
, J. Jacobs
1
,
4
1)
Institute of Tropical Medicine, Antwerp, Belgium
2)
JD MacLean Centre for Tropical Diseases, McGill University Health Centre, Montreal, Canada
3)
Clinical Microbiology, University Hospital Hubert Koutoukou Maga, Cotonou, Benin
4)
Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium
article info
Article history:
Received 17 February 2017
Received in revised form
28 April 2017
Accepted 7 May 2017
Available online xxx
Editor: Gilbert Greub
Keywords:
Clinical bacteriology
Laboratory quality management
Laboratory strengthening
Low-resource setting
Quality management system
Sub-Saharan Africa
abstract
Background: The declining trend of malaria and the recent prioritization of containment of antimicrobial
resistance have created a momentum to implement clinical bacteriology in low-resource settings. Suc-
cessful implementation relies on guidance by a quality management system (QMS). Over the past decade
international initiatives were launched towards implementation of QMS in HIV/AIDS, tuberculosis and
malaria.
Aims: To describe the progress towards accreditation of medical laboratories and to identify the chal-
lenges and best practices for implementation of QMS in clinical bacteriology in low-resource settings.
Sources: Published literature, online reports and websites related to the implementation of laboratory
QMS, accreditation of medical laboratories and initiatives for containment of antimicrobial resistance.
Content: Apart from the limitations of infrastructure, equipment, consumables and staff, QMS are
challenged with the complexity of clinical bacteriology and the healthcare context in low-resource
settings (small-scale laboratories, attitudes and perception of staff, absence of laboratory information
systems). Likewise, most international initiatives addressing laboratory health strengthening have
focused on public health and outbreak management rather than on hospital based patient care. Best
practices to implement quality-assured clinical bacteriology in low-resource settings include alignment
with national regulations and public health reference laboratories, participating in external quality
assurance programmes, support from the hospital's management, starting with attainable projects,
conducting error review and daily bench-side supervision, looking for locally adapted solutions, stim-
ulating ownership and extending existing training programmes to clinical bacteriology.
Implications: The implementation of QMS in clinical bacteriology in hospital settings will ultimately
boost a culture of quality to all sectors of healthcare in low-resource settings. B. Barb
e, Clin Microbiol
Infect 2017;:1
©2017 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and
Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction
The relevance of clinical bacteriology laboratories in low-
resource settings is increasingly recognized in light of the reduc-
tion of malaria burden [1,2] and the crisis of antimicrobial
resistance (AMR) [3,4]. In contrast to HIV/AIDS, tuberculosis (TB)
and malaria, clinical bacteriology does not benet from disease-
specic control programmes and advances towards implementing
quality systems are conspicuously few. This review describes the
current state of laboratory quality management in clinical bacte-
riology in sub-Saharan Africa and reects on the challenges and
best practices for moving forward. The target setting is a referral
hospital in sub-Saharan Africa with a moderate infrastructure(i.e.
including a basically equipped laboratory) [5], where clinical
bacteriology (culture-based detection, identication and antibiotic
susceptibility testing of bacterial pathogens) is either available or
planned. Although this review focuses on sub-Saharan Africa, the
recommendations and best practices are applicable to the general
context of low-resource settings.
*Corresponding author. B. Barb
e, Institute of Tropical Medicine, Department of
Clinical Sciences, Nationalestraat 155, 2000 Antwerp, Belgium.
E-mail address: bbarbe@itg.be (B. Barb
e).
Contents lists available at ScienceDirect
Clinical Microbiology and Infection
journal homepage: www.clinicalmicrobiologyandinfection.com
http://dx.doi.org/10.1016/j.cmi.2017.05.007
1198-743X/©2017 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under
the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Clinical Microbiology and Infection xxx (2017) 1e8
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e B, et al., Implementation of quality management for clinical bacteriology in low-resource settings,
Clinical Microbiology and Infection (2017), http://dx.doi.org/10.1016/j.cmi.2017.05.007
Quality, Quality Management Systems (QMS) and
accreditation
Quality in medical laboratories can be dened as accuracy, reli-
ability and timeliness of reported results [6] and a QMS describes the
approach to meet the quality objectives [7]. QMS for medical labo-
ratories are described in international standards [8]. Among them,
International Organization for Standardization (ISO) 15189 [9] and
Clinical and Laboratory Standards Institute (CLSI) QMS01-A4 [7] are
the most widely used and are comparable. They bothcover the three
laboratory phases: (a) preexamination (indication and test selection,
sample collection, transport, reception and accessioning), (b) ex-
amination (analysis and quality control) and (c) postexamination
(interpretation, reporting, record keeping and notication). In
addition CLSI QMS01-A4 introduced 12 Quality System Essentials
(Fig. 1). Accreditation is the procedure to formal recognition that a
medical laboratory is competent to carry out specic tasks [6].Na-
tional regulations either formulate own standards for accreditation
or refer to existing QMS standards. For example, ISO 15189 is the
standard for accreditation of medical laboratories in Europe.
Progress towards accreditation of medical laboratories in
Sub-Saharan Africa
A decade ago an assessment of medical laboratories in sub-
Saharan Africa portrayed a failing system with unreliable analyses
leading to compromised patient care, unnecessary expenditures
and distrust from clinicians and health authorities. The dysfunc-
tional system was declared a barrier to healthcare in Africa[10,11].
There were urgent calls to do better.
Starting with the Maputo declaration in 2008, successive
landmark events induced global efforts to strengthen national
laboratory health systems in low-resource settings (Tab le 1 ). Ini-
tiatives from HIV/AIDS and TB control programmes extended to
strengthen the general health laboratory system [13,14,15,16].An
unprecedented increase in international funding supported these
efforts [12e14,17e19]. Accreditation according to ISO 15189 qual-
ity standards was pledged [15]. In 2009 the World Health Orga-
nization regional ofce for Africa (WHO AFRO) launched the
Stepwise Laboratory Quality Improvement Towards Accreditation
(SLIPTA) programme, which prepares clinical laboratories for ISO
15189 accreditation (Annual ASLM Newsletter 2016) [20].In
addition, WHO-AFRO developed the Strengthening Laboratory
Management Toward Accreditation (SLMTA) toolkit to support
implementation of SLIPTA [20] (https://www.slmta.org/toolkit/
english). In 2011 the African Society of Laboratory Medicine
(ASLM) was created to advocate for the critical role and needs of
laboratory medicine and networks throughout Africa [13].Bythe
end of 2016, SLMTA had been implemented by 1103 laboratories in
47 countries worldwide, with Kenya, Ethiopia and Uganda as top
three countries (Annual ASLM Newsletter 2016). Of those, 23 Af-
rican laborator ies currently achieved accred itation to international
standards (K. Yao, personal communication, February 22, 2017). In
addition, the total number of medical laboratories accredited to
international standards in sub-Saharan Africa has increased from
380 in 12 countries by May 2013 [21] to 485 in 18 countries by
April 2017 (T. Mekonen, personal communication, April 24, 2017)
(Fig. 2).
Despite these efforts, the 2014e2015 West African Ebola
outbreak highlighted the role of weak diagnostic infrastructure in
the affected countries. As a response, the Global Health Security
Agenda (GHSA) was launched to promote global health security as
an international priority [22].
Challenges to implement QMS in clinical bacteriology in sub-
Saharan Africa
The strengthening of the general health laboratory system has fallen
short
The intention to leverage HIV-networks and the SLMTA pro-
gramme to boost general health laboratory systems has yielded
Organization
Management, Laboratory quality manual
Customer focus
Facilities and safety
Personnel
Job qualifications, Orientation, Competence assessment,
Continuing education, Performance evaluation
Purchasing and inventory
Inventory management, Inspection and verification,
Storage and handling
Equipment
Equipment qualifications,
Calibration and maintenance program
Process management
Sample management, Process validation, Quality control
Information management
Paper-based versus computer-based, Confidentiality
Fig. 1. Twelve quality system essentials of CLSI document QMS01-A4: Quality Management System: A Model for Laboratory Services [7]. General themes displayed horizontally,
transversal themes vertically.
B. Barb
e et al. / Clinical Microbiology and Infection xxx (2017) 1e82
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e B, et al., Implementation of quality management for clinical bacteriology in low-resource settings,
Clinical Microbiology and Infection (2017), http://dx.doi.org/10.1016/j.cmi.2017.05.007
limited results. Though there has been some success at integration
of HIV with TB services, other examples are few [19]. The encour-
aging data on the uptake of SLMTA belie the fact that the vast
majority of accredited laboratories are HIV and TB reference labo-
ratories [16,20] with few (4/23, 17%) accredited SLMTA laboratories
in sub-Saharan Africa performing clinical bacteriology. Moreover,
most external quality assurance (EQA) programmes centre on HIV,
TB and malaria [23e28].
Antimicrobial resistance enters the scene, but tools are lacking and
performance is poor
Although the critical need for diagnosis of bacterial in-
fections is long established [10], clinical bacteriology has only
recently achieved prominence with policymakers, prompted by
the increasing recognition of the looming crisis of AMR
(Table 2). In October 2015, the Freetown declaration launched a
framework to establish functional tiered public health labora-
tory networks to AMR surveillance in Africa [22,58]. In addition,
the United Nations General Assembly recently launched several
internationally coordinated actions on AMR. Of note, most of
these initiatives focus on public health implicationsdparticu-
larly outbreak management (in line with the International
Health Regulations [29]) rather than on individual patient care.
The predicted impact of the AMR crisis casts a new urgency on
the need to improve performance levels. In 2012 a publication of an
EQA session among reference laboratories in sub-Saharan Africa
revealed serious shortcomings in bacterial identication and anti-
microbial susceptibility [30]. Adding to the difculty is the lack of
appropriate tools for training and implementation of QMS in clin-
ical bacteriology. For instance, the SLMTA toolkit includes only few
examples about clinical bacteriology.
Table 1
Landmarks towards accreditation of medical laboratories in sub-Saharan Africa
No. Landmark Outcome
1 Maputo declaration on Strengthening of Laboratory Systems, Maputo,
January 2008
Maputo declaration,issued by 33 countries together with WHO, World
Bank and Global Fund for AIDS, TB and Malaria, calls on low-resource
countries to develop national laboratory strategic plans and policies to
strengthen laboratory services and systems as integral part of overall
health system (tiered lab networks for multiple diseases) [12].
2 Joint WHO-CDC Conference on Health Laboratory Quality Systems, Lyon,
April 2008
Statement issued calling for countries with limited resources to develop
quality laboratory systems using staged approach leading to
accreditation. It was suggested that national laboratory standards
establish minimum requirements, and national reference laboratories
were encouraged to meet international standards (ISO 15189).
3 58th session of WHO Regional Committee for Africa, Yaound
e,
September 2008
During the 58th session of the WHO Regional Committee for Africa,
member states adopted resolution AFR/RC58/R2 to strengthen public
health laboratories in WHO African region at all levels of the healthcare
system.
4 5th meeting of Regional HIV/AIDS network for Public Health
Laboratories, Dakar, September 2008
It was agreed that the network should broaden its scope beyond HIV/
AIDS and associated diseases to become an integrated network
encompassing all labs, without limitation of a disease-specic
designation.
5 WHO-AFRO Stepwise Laboratory Accreditation preparedness scheme,
Kigali, July 2009
WHO-AFRO launched Stepwise Laboratory Quality Improvement
Towards Accreditation (SLIPTA) and Strengthening Laboratory
Management Toward Accreditation (SLMTA), in presence of its partners
and government health ofcials from 13 African countries.
6 59th session of WHO Regional Committee for Africa, Kigali, September
2009
During the 59th session of the WHO Regional Committee for Africa,
member states adopted resolutions AFR/RC59/R2 and AFR/RC59/WP/3,
calling for strengthening of public health laboratories and other centres
of excellence to improve disease prevention and control.
7 African Society of Laboratory Medicine (ASLM), Addis Ababa, March
2011, http://www.aslm.org/
This pan-African professional body aims to set up integrated laboratory
services, to develop national laboratory policies and strategic plans for
tiered laboratory networks and to improve quality systems and
accreditation preparedness.
8 Ministerial Call for Action on Strengthening of Laboratory Services in
Africa, Cape Town, December 2012
During the rst international ASLM conference in Cape Town, this
ministerial call was undersigned by six African countries. By November
2014, this call was signed by 13 African countries.
9 Global Health Security Agenda (GHSA), Washington, DC, February 2014,
https://www.ghsagenda.org/
GHSA is collaborative effort from governments, international
organizations and civil society to promote global health security as
international priority. GHSA currently includes almost 50 countries and
is coordinated by a multilateral steering group of 10 countries together
with international organizations such as WHO, FAO, OIE, Interpol,
ECOWAS, UNISDR and the European Union.
10 Freetown declaration on Developing Resilient Laboratory Networks for
GHSA, Freetown, October 2015
Freetown declaration was issued by more than 20 African countries,
together with ASLM and WHO AFRO. It calls for a new framework for
functional tiered laboratory networks into disease surveillance systems
and public health institutes.
Adapted from Alemnji [13] and Andiric and Massambu [14].
ASLM, African Society of Laboratory Medicine; CDC, Centers for Disease Control and Prevention; ECOWAS, Economic Community of West African States; FAO, Food and
Agriculture Organization of the United Nations; GHSA, Global Health Security Agenda; HIV, Human Immunodeciency virus; MOH, Ministry of Health; OIE, World Organi-
zation for Animal Health; SLIPTA, Stepwise Laboratory Quality Improvement Towards Accreditation; SLMTA, Strengthening Laboratory Management Toward Accreditation;
TB, Tuberculosis; UNISDR, United Nations Ofce for Disaster Risk Reduction; WHO, World Health Organization; WHO-AFRO, World Health Organization Regional Ofce for
Africa.
B. Barb
e et al. / Clinical Microbiology and Infection xxx (2017) 1e83
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e B, et al., Implementation of quality management for clinical bacteriology in low-resource settings,
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Clinical bacteriology and QMS: a difcult t
Clinical bacteriology deals with multiple specimens, indications
and requirements for sampling and transport. Culture-based bacte-
riology requires skilled operators, is difcult to automate and leaves
much to the individual laboratorian's discretion. In the post-
examinationphase, there are issues of interpretation (contaminating
or colonizing ora) and reporting (e.g. preliminary results of Gram
stain, cultures in progress) and application of expert rules [31e33].
Clinical bacteriology is therefore less amenable to QMS than other
laboratory disciplines, which have single targets and generate
automated quantitative results that allow for statistical monitoring.
Particular challenges in sub-Saharan Africa
Adapting QMS to local realities proves difcult in sub-Saharan
Africa [34]. Besides the well-known limitations of infrastructure,
equipment, consumables and staff, additional issues merit
comment. Most laboratories in sub-Saharan African hospitals are
small [34] and provide haematology, clinical chemistry, parasi-
tology and sometimes blood transfusion services on a 24/7 basis.
Staff not familiar with QMS may associate quality with goodness
rather than with conformance to requirement [6]. In view of the
small scale and daily burdens, quality essentials such as assess-
ments, customer focus and process management may be perceived
as superuous, and the concept of prospective risk management
may be too unfamiliar [34]. Further, the digitalization of laboratory
and hospital information, automation and bar code trackingd-
which have dramatically reduced errors at all examination phases
[6,35]dare not yet implemented in sub-Saharan laboratories and
the requirement to validate and secure laboratory information
software (LIS) tools is difcult to meet [34]. An additional challenge
in many low-resource settings is the lack of unique identiers for
patients with naming practices leading to many people with the
same name or names that change over time, lack of identity cards
and exact birth dates.
MOZAMBIQUE
2
MADAGASCAR
SOUTH
AFRIC A
383
LESOTHO
SWAZI LAND
1
BOTSWANA
10
NAMIBIA
11
ANGOLA
ZAMBIA
TANZANIA
10
KENYA
31
BURUNDI
RWANDA
ZIMBABWE
5
MALAWI
ERITREA
SOMALIA
ETHIOPIA
8
DJIBOUTI
DEMOCRATIC
REPUBLIC
OF THE
CONGO
UGANDA
9
SUDAN
NIGER
CHAD
NIGERIA
3
SENEGAL
1
THE GAMBIA
1
SIERRA
LEONE
CAMEROON
1
EQUATORIAL
GUINEA GABON
CONGO
WESTERN
SAHARA
SOUTH
SUDAN
MAURITANIA
MALI
1
BENIN
TOGO
2
GHANA
1
BURKINA
FASO
LIBERIA
CÔTE
D'IVOIRE
GUINEA
MAURITIUS
5
GUINEA-BISSAU
CENTRAL AFRICAN
REPUBLIC
Fig. 2. Map of sub-Saharan Africa showing countries with medical laboratories that have been accredited to internationally recognized standards by April 2017. Numbers below
countries' names refer to number of accredited laboratories in that country.
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Implementing QMS in clinical bacteriology in low-resource
settings: best practices
Implementation of a QMS comprises all 12 Quality System Es-
sentials, but approaches and priorities may vary according to the
local situation [6]. Below, we present some best practices about
how to implement QMS in clinical bacteriology on site. They are
compiled from existing literature (though mainly conducted in
high-resource settings) complemented with our own experience.
Connect to national regulations and public health laboratories
Alignment with national regulations is imperative and will
guide towards legal requirements such as participation in EQA
programmes [36]. Much can be adopted from the expertise of the
disease-specic control programmes of malaria, HIV/AIDS and TB
and their respective reference laboratories: they provide logistic
support (equipment and quality-assured consumables and stains)
and dedicated procedures, job descriptions, forms and logbooks in
local languages [37]. In addition, they organize trainings, external
quality controls, on-site supervision visits and meetings with the
laboratory heads. They further offer advanced techniques, coordi-
nate surveillance activities and create national laboratory networks
for diffusing of knowledge and competencies [22,38].
Participate in EQA programmes
EQA programmes improve laboratory performance (provided
implementation of corrective actions in case of failures) and are
cost-effective [30,39]. They allow the participants to benchmark
and monitor their competence and to verify their methods; in
addition, they provide didactic and educational stimulus [6,40].
Beyond that, EQA programmes provide health authorities with
information about overall competence of laboratories, in vitro di-
agnostics' performance and training needs [6,28,39,41]. EQA pro-
grammes further generate excellent opportunities to integrate
vertical disease control programmes, for instance by sharing dis-
tribution canals and increasing nationwide coverage [28,39]. Short
turnaround times, swift communication (e.g. sending correct an-
swers directly after closure), well-structured didactic reports
anddin our experiencedpersonalized feedback and EQA-oriented
trainings are instrumental to a productive EQA session [39].
Observe and understand the local scene, nd support and allies
Support from the healthcare facility management at all levels is
essential to success, as is a well-functioning relationship between
clinicians and laboratory staff. A strategy that has proved powerful
in antibiotic stewardship activities is the engagement of peer
Table 2
Overview of main international initiatives dedicated to containment of antimicrobial resistance
No. Initiative Scope
1 Advisory Group on Integrated Surveillance of Antimicrobial Resistance
(AGISAR), 2008 (http://www.who.int/foodsafety/areas_work/
antimicrobial-resistance/agisar/en/)
WHO AGISAR consists of a multidisciplinary team of over 30
internationally renowned experts and supports WHO's effort to
minimize the public health impact of antimicrobial resistance
associated with the use of antimicrobials in food animals.
2 Global Antibiotic Resistance Partnership (GARP), 2009 (http://www.
cddep.org/garp/home)
GARP is a project of CDDEP and is funded by the Bill &Melinda Gates
Foundation. GARP has supported the creation of multisectoral national-
level working groups in eight selected low- and middle-income
countries whose mandate is to understand and document antibiotic use
and antibiotic resistance in the human and animal population and to
develop evidence-based proposals to encourage introduction of
measures to contain antimicrobial resistance.
3 Global Health Security Agenda (GHSA), 2014 (https://www.ghsagenda.
org/)
a
One of the 11 GHSA action packages focuses on AMR, and includes
development of a national action plan based on a one healthapproach;
development and implementation of guidelines and standards for
infection prevention; development and use of guidelines for antibiotic
use; access to at least one reference laboratory for each country capable
of identifying at least three of seven WHO priority AMR pathogens.
b
4 Global Action Plan on Antimicrobial Resistance (GAP-AMR), 2015
(http://www.who.int/antimicrobial-resistance/global-action-plan/en/)
This WHO action plan sets out ve strategic objectives: (a) improve
awareness and understanding of AMR, (b) strengthen knowledge
through surveillance and research, (c) reduce incidence of infection, (d)
optimize use of antimicrobial medicines in human and animal health,
(e) ensure sustainable investment in countering AMR. The action plan
underscores the need for a one healthapproach, involving human and
veterinary medicine, agriculture, nance, environment and well-
informed customers.
5 Global Antimicrobial Resistance Surveillance System (GLASS), 2015
(http://www.who.int/drugresistance/surveillance/glass-enrolment/en/)
GLASS, developed by WHO, is a platform for global data sharing on AMR
worldwide, initially focusing on eight priority bacterial pathogens in
humans.
c
Currently more than 30 countries are participating.
6 United Nations General Assembly, 2016 Global leaders met at the United Nations General Assembly to commit to
ghting antimicrobial resistance together.
This was only the 4th time in the history of the UN that a health topic
was discussed at the General Assembly (HIV, noncommunicable
diseases and Ebola were others).
AGISAR, Advisory Group on Integrated Surveillance of Antimicrobial Resistance; AMR, antimicrobial resistance; CDDEP, Center for Disease Dynamics, Economics and Policy;
GAP-AMR, Global Action Plan on Antimicrobial Resistance; GARP, Global Antibiotic Resistance Partnership; GHSA, Global Health Security Agenda; GLASS, Global Antimicrobial
Resistance Surveillance System; UN, United Nations.
a
Refer to Table 1 for a general description of GHSA.
b
WHO list of AMR pathogens of concern includes [3]:Escherichia coli, resistance to third-generation cephalosporins (ESBL) and to uoroquinolones; Klebsiella pneumoniae,
resistance to third-generation cephalosporins (ESBL) and to carbapenems; Staphylococcus aureus, methicillin resistance (MRSA); Streptococcus pneumoniae, resistance
(nonsusceptibility) to penicillin; nontyphoidal Salmonella (NTS), resistance to uoroquinolones; Shigella species, resistance to uoroquinolones; Neisseria gonorrhoeae,
decreased susceptibility to third-generation cephalosporins.
c
GLASS priority pathogens for surveillance are: Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus, Streptococcus pneumoniae, Salmonella
spp., Shigella spp., Neisseria gonorrhoeae.
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champion advocates[42], which means engaging individual lab-
oratorians, clinicians and administrators to promote a culture of
quality. Clinicians can play a role at the pre- and postanalytical
processes, for example, by promoting de-escalation of antibiotics
based on culture results. Insights in the perceptions, attitudes and
interactions of the clinical, nursing and laboratory staff are there-
fore helpful to guide and prepare interventions [43,44]. In line with
what has proved to be successful in malaria treatment, joint
training for clinicians and laboratory staff are recommended [45].
Further, the overarchingQMS of the hospital can be used to connect
for support in logistics (transport, procurement, maintenance,
biosafety and waste management) and staff management (training,
orientation and evaluation).
Start softlydchoose for feasibility and impact
Before formally starting-up a QMS, time to observe and analyse
the laboratory activities must be taken, to get acquainted with the
workow, terminology and vocabulary, product names and ab-
breviations used as well as with laboratory and hospital staff and
the healthcare's context. As noted elsewhere, personal interactions
provides a solid basis for collaboration [46].
Starting with a project that can be easily accomplished and has a
high impact is recommended [6]. Topics can be found close to the
work space and include for instance biosafety (rational use of
gloves and masks), labelling of shelves and storage space and
standardization of labelling of consumables. In addition, fewer are
better,which means that no more than one topic every six months
should be addressed [6].
Keep documents and communication simple and straightforward
Communication must be efcient and adapted to the size and
complexity of the laboratory [6]. Standard operating procedures
(SOPs) will be among the rst documents to be written or updated.
A good SOP is presented in an appropriate font type and lay-out
(legible), easy to understand (readable) and conveys clear and
unequivocal information (comprehensible); it presents sufcient
procedural details [47] is pretested and veried [6,48]. Given the
extended templates of QMS-recommended SOPs (CLSI QMS02-A6
template lists 17 sections [49]), so-called bench aids or job aids are
welcome as a quick reference at the work placedprovided docu-
ment control [6,47,48]. The urge for legibility, readability and
comprehensibility also applies to other documents particularly if
used at the workplace: stock cards, check lists, ow diagrams and
graphs. In the African context, the importance and impact of
respectful verbal communication cannot be overemphasized and
occasions for face-to-face interactions with clinicians and other
stakeholders should be fully exploited [47,48].
Learn from your mistakes
Reducing medical errors ranks rst among the benets of a
successful QMS implementation and error review has been the
oldest approach of the Nonconforming Event Management[7].
Error review consists of tracking errors up to the identication of
root cause(s) and subsequent design and implementation of
corrective and preventive actions [50]. Most errors occur in the pre-
and postexamination processes (about 60% and 25% respectively)
[6,51], but given its manual and subjective workup, clinical bacte-
riology is also vulnerable to errors in the examination phase [52].
Apart from expectedand easily detectable errors (e.g. failing to
comply with SOP, not acting on out-of-range quality controls), there
are hidden errors such as failures of Gram stain reading, species
identication and antimicrobial susceptibility testing [32,53].
In our experience, error review is an excellent portal of entry to
activate QMS and it can be applied from the early phase of
implementation of the QMS, whereas alternative approaches such
as monitoring of quality indicators and internal audits require a
more advanced implementation. Of note, most analytical errors in
clinical bacteriology proved to be related to knowledge and skills
and therefore can be efciently addressed by teaching, training
and learning [52]. Educational programmes should be straight-
forward, explain the science behind the error and stress the do's
and don'ts'; moreover, overlap and redundancy are appropriate
[47].
Be present at the bench and organize daily supervisory review
Supervision of culture workup is another traditional approach
towards laboratory quality and is particularly relevant for clinical
bacteriology [54]. Supervision at the workplacedin preference at a
daily basis and at a xed timedis a valuable tool for bench-side
teaching, tuning of operator-subjective examinations (such as
Gram stain) and boosting compliance with SOPs. Daily supervision
also allows for timely detection of procedural deviations such as
unapproved modications, ill-advised shortcuts and use of
outdated products inserts [47].
Look for locally adapted solutions
A creative mind helps to design local solutions on the road to
ISO 15189. Low-cost low-tech, feasibility and acceptability are key.
As an example, printed request forms may guide the prescriber
towards harmonized indications and relevant requests. Stan-
dardized abbreviations may be agreed upon and recorded. Risks to
sample mismatch and mislabelling of subcultures can be mitigated
by arranging the physical space and workow at the bench and
sticking to the one-by-one rule used at specimen transfer and
distribution [55]. A particular risk is inoculating multiple isolates
on a single petri agar, which should be limited and well controlled.
Electronic sign-off of documents may be replaced by hand-signing
before or after laboratory meetings. Other tools of traceability
include writing in different colours according to the day of incu-
bation, use of standardized laboratory forms and implementing a
journal passing along information between staff covering night
shifts [6].
Stimulate ownership and create a positive climate
A QMS must be visible in the laboratory and must express
progress and achievements. A clear workplace such as described in
the SLMTA toolkit (Module 1dProductivity management) with
well-designed bench aids displayed is conducive to QMS but also
attractive for staff, trainees and visitors. Staff should be invited to
SOP and document writing and verication, but should not be
overloaded. A constructive and critical attitude including reporting
and reviewing errors should be encouraged. As stated above, lab-
oratory management must assure clear commitment and involve-
ment in the implementation of the QMS, amongst others by visible
presence at meetings and trainings, respecting short feedback
loops and keeping good and timely records [6,50].
Needs and opportunities to extend QMS and training tools to clinical
bacteriology
Existing tools to facilitate QMS (Table 3), such as the WHO AF-
RO's SLMTA toolkit and the WHO, Centers for Disease Control and
Prevention and CLSI Laboratory QMS Training Handbook and
Toolkit can be easily extended with real-life cases of clinical
B. Barb
e et al. / Clinical Microbiology and Infection xxx (2017) 1e86
Please cite this article in press as: Barb
e B, et al., Implementation of quality management for clinical bacteriology in low-resource settings,
Clinical Microbiology and Infection (2017), http://dx.doi.org/10.1016/j.cmi.2017.05.007
bacteriologydfor instance in the SLMTA's Meet the Clinicianac-
tivities and the Clinicians Handbook,or its modules of specimen
collection, work area management and test result reporting.
Although hardware and network costs remain barriers, imple-
mentation of a LIS has benets at all three examination processes;
LIS further provides opportunities to educate prescribers, guide
therapeutic decisions and detect hospital infection outbreaks in
real-time. LIS supports other Quality System Essentials such as
purchasing, inventory and assessments (e.g. analysis of corrected
reports as a proxy for near errors) [6,52]. Currently, free-of-charge
LIS are made available (Table 3).
Conclusion
Across sub-Saharan Africa and over the last decade amazing
strides have been made to implement QMS in the laboratory
diagnosis of HIV, malaria and TB. It is now time to extend this
success to clinical bacteriology, given the momentum generated by
the declining burden of malaria and the need to contain the
emergent AMR. Taking into account the particularities of both
clinical bacteriology and the context of low-resource settings,
existing national networks can be strengthened towards compe-
tences in clinical bacteriology and training tools can be adapted to
integrate clinical bacteriology. Best practices can facilitate the
implementation of QMS in clinical bacteriology in hospital settings.
Given the extensions of clinical bacteriology to antibiotic stew-
ardship and infection prevention, this step will ultimately boost a
culture of quality to all sectors of healthcare in low-resource
settings.
Acknowledgements
The authors acknowledge T. Mekonen, ASLM, for providing the
list of accredited laboratories in Africa, K. Yao for sharing the number
of laboratories in Africa that have implemented SLMTA and C. Kiyan,
Institute of Tropical Medicine, for help designing the gures.
Transparency Declaration
All authors report no conicts of interest relevant to this article.
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AFENET, African Field Epidemiology Network; BLIS, Basic Laboratory Information System; AMR, antimicrobial resistance; CDC, Centers for Disease Control and Prevention;
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e B, et al., Implementation of quality management for clinical bacteriology in low-resource settings,
Clinical Microbiology and Infection (2017), http://dx.doi.org/10.1016/j.cmi.2017.05.007
... Background Access to clinical bacteriology services in low-and middle-income countries (LMIC) is increasingly recognized as a crucial component in the adequate management of severe bacterial infections and in the prevention of antimicrobial resistance (AMR) [1][2][3][4]. LMIC are disproportionally affected by AMR and hospital-acquired infections [5], but laboratories in these countries are often ill-equipped to offer diagnosis of resistant infections in anything other than tertiary centres [2,6]. Especially sub-Saharan Africa is still underserved in terms of quality-assured clinical bacteriology services [6]. ...
... LMIC are disproportionally affected by AMR and hospital-acquired infections [5], but laboratories in these countries are often ill-equipped to offer diagnosis of resistant infections in anything other than tertiary centres [2,6]. Especially sub-Saharan Africa is still underserved in terms of quality-assured clinical bacteriology services [6]. As a consequence, meta-analyses describing antimicrobial resistance rates in Africa describe high rates of resistance but emphasize the scarcity of data, the bias towards tertiary centres in urban areas and the lack of microbiological quality control in most studies [7,8]. ...
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Background: Although global surveillance of antimicrobial resistance (AMR) is considered key in the containment of AMR, data from low- and middle-income countries, especially from sub-Saharan Africa, are scarce. This study describes epidemiology of bloodstream infections and antimicrobial resistance rates in a secondary care hospital in Benin. Methods: Blood cultures were sampled, according to predefined indications, in BacT/ALERT FA Plus and PF Plus (bioMérieux, Marcy-l'Etoile, France) blood culture bottles (BCB) in a district hospital (Boko hospital) and to a lesser extent in the University hospital of Parakou. These BCB were incubated for 7 days in a standard incubator and twice daily inspected for visual signs of growth. Isolates retrieved from the BCB were processed locally and later shipped to Belgium for reference identification [matrix-assisted laser desorption/ionization time-of-flight spectrometry (MALDI-TOF)] and antibiotic susceptibility testing (disk diffusion and E-tests). Results: From October 2017 to February 2020, 3353 BCB were sampled, corresponding to 3140 blood cultures (212 cultures consisting of > 1 BCB) and 3082 suspected bloodstream infection (BSI) episodes. Most of these cultures (n = 2471; 78.7%) were sampled in children < 15 years of age. Pathogens were recovered from 383 (12.4%) cultures, corresponding to 381 confirmed BSI. 340 of these pathogens were available and confirmed by reference identification. The most common pathogens were Klebsiella pneumoniae (n = 53; 15.6%), Salmonella Typhi (n = 52; 15.3%) and Staphylococcus aureus (n = 46; 13.5%). AMR rates were high among Enterobacterales, with resistance to third-generation cephalosporins in 77.6% of K. pneumoniae isolates (n = 58), 12.8% of Escherichia coli isolates (n = 49) and 70.5% of Enterobacter cloacae isolates (n = 44). Carbapenemase production was detected in 2 Escherichia coli and 2 Enterobacter cloacae isolates, all of which were of the New Delhi metallo-beta lactamase type. Methicillin resistance was present in 22.4% of S. aureus isolates (n = 49). Conclusion: Blood cultures were successfully implemented in a district hospital in Benin, especially among the pediatric patient population. Unexpectedly high rates of AMR among Gram-negative bacteria against commonly used antibiotics were found, demonstrating the clinical and scientific importance of clinical bacteriology laboratories at this level of care.
... To combat infectious diseases including AMR, a surveillance system has been developed at sentinel sites in Côte d'Ivoire among other West African countries as part of the African Network for improved Diagnostics, Epidemiology and Management of Common Infectious Agents (ANDEMIA, https://www.andemia.org) (13). ...
... For a good quality management system the implementation of external quality control programmes is essential (13,26). As no external quality control was in place at CHU-B at the time of the study, we retested isolates in a German routine microbiology laboratory. ...
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Background: Blood cultures (BC) have a high clinical relevance and are a priority specimen for surveillance of antimicrobial resistance. Manual BC are still most frequently used in resource-limited settings. Data on automated BC performance in Africa are scarce. We implemented automated BC at a surveillance site of the African Network for improved Diagnostics, Epidemiology and Management of Common Infectious Agents (ANDEMIA). Methods: Between June 2017 and January 2018, pairs of automated BC (BacT/ALERT ® FA Plus) and manual BC (brain-heart infusion broth) were compared at a University hospital in Bouaké, Côte d'Ivoire. BC were inoculated each with a target blood volume of 10 ml from the same venipuncture. Automated BC were incubated for up to 5 days, manual BC for up to 10 days. Terminal subcultures were performed for manual BC only. The two systems were compared regarding yield, contamination, and turnaround time. For quality assurance, isolates were retested in a German routine microbiological laboratory. Results: BC sampling was increased from on average 24 BC to 63 BC per month. A total of 337 matched pairs of BC were included. Automated BC was positive in 36.5%, manual BC in 24.0% ( p -value < 0.01), proportion of contamination was 47.9 and 43.8%, respectively ( p -value = 1.0). Turnaround time of positive BC was shortened by 2.5 days with automated compared to manual BC ( p < 0.01). Most common detected pathogens in both systems were Klebsiella spp. (26.0%) and Staphylococcus aureus (18.2%). Most contaminants were members of the skin flora. Retesting of 162 isolates was concordant in 79.6% on family level. Conclusions: Implementing automated BC in a resource-limited setting is possible and improves microbiological diagnostic performance. Automated BC increased yield and shortened turnaround times. Regular training and mentorship of clinicians has to be intensified to increase number and quality of BC. Pre-analytical training to improve diagnostic stewardship is essential when implementing a new microbiological method. Retesting highlighted that manual identification and antimicrobial susceptibility testing can be of good quality and sustainable. The implementation of automated tools should be decided individually according to economic considerations, number of samples, stable supply chain of consumables, and technical sustainability.
... There are a variety of tests, subjective assessment of cultures, difficulty in automation, expert rules, and statistical tools. 51 High reproducibility can be found among serological and molecular tests, while conventional microscopy, culture, and antibiotic susceptibility show discrepancies. Microscopy is highly subjective, with discrepancies approaching 39.5%. ...
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“Right to health” is a universal right inclusive of a culture of safety. This review aims to highlight how clinical microbiology laboratories can contribute to patient safety. They can bring down medical errors through clinical collaboration and quality control. Timely and accurate inputs from microbiology laboratory help in clinical correlation and aid in safe patient care. Through internet search, using keywords such as “medical errors” and “quality assurance,” global burden of medical errors has been compiled. References have been taken from guidelines and documents of standard national and international agencies, systematic reviews, observational studies, retrospective analyses, meta-analyses, health bulletins and reports, and personal views. Safety in healthcare should lay emphasis on prevention, reporting, analysis, and correction of medical errors. If not recorded, medical errors are regarded as occasional or chance events. Global data show adverse events are as high as 10% among hospitalized patients, and approximately two-thirds of these are reported from low- to middle-income countries (LMICs). This includes errors in laboratories as well. Clinical microbiology can impact patient safety when practiced properly with an aim to detect, control, and prevent infections at the earliest. It is a science that integrates a tripartite relationship between the patient, clinician, and a microbiology specialist. Through collaborative healthcare, all stakeholders benefit by understanding common errors and mitigate them through quality management. However, errors tend to happen despite standardization and streamlining all processes. The aim should be to minimize them, have fair documentation, and learn from mistakes to avoid repetition. Local targets should be set and then extended to meet national and global benchmarks.
... Clinical microbiology laboratories in low-and low middle-income countries (LIC-LMIC) face significant challenges in implementing quality-assured diagnostic services [17]. A number of such challenges were identified by our study, and prominent amongst them was resource limitation, better-resourced units scored higher. ...
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Objectives Implementation of standard laboratory practices towards accurate antimicrobial susceptibility testing (AST) is challenging in resource-constrained settings. Efforts to improve AST are required to address knowledge and practice gaps in such settings. In this study, we aimed to address these gaps through external quality assurance surveys and mentoring of laboratories in Pakistan. Methods This prospective study (May 2017–September 2019) included 10 consenting laboratories. External quality assessment (EQA) was conducted quarterly and performance scored. Each EQA cycle was followed by an on-site technical visit during which AST methodology, quality procedures and laboratory safety were evaluated using a questionnaire developed for this study. Cumulative scores of performance in the EQA and in the technical evaluation were designated “Composite Laboratory Performance Score; CLPS”. During on-site visits, feedback provided was to each participating laboratory towards addressing gaps identified. Results Over the course of the study, our data show significant improvement in CLPS amongst the laboratories included. While improvement in the CLPS scores varied between laboratories, a linear regression model showed improvement within the cohort from 21.37 (May 2017) to 91.5 (September 2019); a significant overall increase of 70.13 points (p = 0.001). Conclusion Interventions to improve AMR surveillance include quality assured reporting of antimicrobial resistance. Our data show that in resource-limited settings EQA surveys and on-site evaluations followed by guidance contribute towards such improvement. We propose that this model would be a useful tool for laboratory strengthening in such settings.
... This situation is not unique to Uganda as only 2 out of 591 patients that received antibiotics in a PPS study conducted in Tanzania were specifically treated based on antimicrobial susceptibility testing results [52]. Among the challenges in antimicrobial sus-ceptibility testing in sub-Saharan Africa are inadequate resources, weak supply chains for consumables for microbiological laboratory procedures, the timely turn-around of results for clinical decision-making (approximately 22 days in Uganda), and laboratory workforce limitations, such as staffing levels and training [69]. Underuse of culture sensitivity tests in hospitals is pervasive in resource-constrained countries. ...
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Standardized monitoring of antibiotic use underpins the effective implementation of antimicrobial stewardship interventions in combatting antimicrobial resistance (AMR). To date, few studies have assessed antibiotic use in hospitals in Uganda to identify gaps that require intervention. This study applied the World Health Organization’s standardized point prevalence survey methodology to assess antibiotic use in 13 public and private not-for-profit hospitals across the country. Data for 1077 patients and 1387 prescriptions were collected between December 2020 and April 2021 and analyzed to understand the characteristics of antibiotic use and the prevalence of the types of antibiotics to assess compliance with Uganda Clinical Guidelines; and classify antibiotics according to the WHO Access, Watch, and Reserve classification. This study found that 74% of patients were on one or more antibiotics. Compliance with Uganda Clinical Guidelines was low (30%); Watch-classified antibiotics were used to a high degree (44% of prescriptions), mainly driven by the wide use of ceftriaxone, which was the most frequently used antibiotic (37% of prescriptions). The results of this study identify key areas for the improvement of antimicrobial stewardship in Uganda and are important benchmarks for future evaluations.
... Laboratory capacity strengthening is an ongoing priority in low-and middle-income countries (LMICs), most typically as part of a health systems strengthening agenda. There is a good evidence base regarding the challenges and supporting factors that influence progress towards effective implementation of a QMS in clinical laboratories [5][6][7][8][9][10][11]. However, non-clinical laboratories have been less scrutinised. ...
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Background Insecticidal mosquito vector control products are vital components of malaria control programmes. Test facilities are key in assessing the effectiveness of vector control products against local mosquito populations, in environments where they will be used. Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products. In 2013–4, seven insecticide testing facilities across sub-Saharan Africa, with technical and financial support from Innovative Vector Control Consortium (IVCC), began development and implementation of quality management system compliant with the principles of Good Laboratory Practice (GLP) to improve data quality and reliability. Methods and principle findings We conducted semi-structured interviews, emails, and video-call interviews with individuals at five test facilities engaged in the IVCC-supported programme and working towards or having achieved GLP. We used framework analysis to identify and describe factors affeting progress towards GLP. We found that eight factors were instrumental in progress, and that test facilities had varying levels of control over these factors. They had high control over the training programme, project planning, and senior leadership support; medium control over infrastructure development, staff structure, and procurement; and low control over funding the availability and accessibility of relevant expertise. Collaboration with IVCC and other partners was key to overcoming the challenges associated with low and medium control factors. Conclusion For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors. Project plans should allow additional time for interaction with external agencies to address medium-control factors, and partners with access to expertise and funding should concentrate their efforts on supporting institutions to address low-control factors. In practice, this includes planning for financial sustainability at the outset, and acting to strengthen national and regional training capacity.
... However, surveillance of clinical samples has shortcomings particularly when applied in LMIC. First, LMIC face problems of access to competent and quality-assured clinical bacteriology (4). As a result, samples processed in LMIC settings may be biased to more advanced disease stages and collected under coverage of empiric antibiotic treatment. ...
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Introduction: In low- and middle-income countries, surveillance of antimicrobial resistance (AMR) is mostly hospital-based and, in view of poor access to clinical microbiology, biased to more resistant pathogens. We assessed AMR among Escherichia coli isolates obtained from urine cultures of pregnant women as an indicator for community AMR and compared the AMR results with those from E. coli isolates obtained from febrile patients in previously published clinical surveillance studies conducted within the same population in Nanoro, rural Burkina Faso. Results: Between October 2016 – September 2018, midstream urine samples collected as part of routine antenatal in Nanoro district were cultured by a dipslide method and screened for antibiotic residues. Among 6018 consenting women (median (IQR) age 25 (20 - 30)), 84 (1.4%) were excluded because of symptoms of urinary tract infection and 96 (1.6%) screened positive for antibiotic residues. Significant growth - defined as a monoculture of Enterobacterales at counts of ≥ 10⁴ colony forming units/ml – was observed in 202 (3.4%) cultures; E. coli represented 155 (76.7%) of isolates. Among these E. coli isolates, resistance rates to ampicillin, cotrimoxazole and ciprofloxacin were respectively 65.8%, 64.4% 16.2%, compared to 89.5%, 89.5% and 62.5% among E. coli from historical clinical isolates (n = 48 of which 45 from blood cultures). Proportions of extended spectrum beta-lactamase producers and multidrug resistance were 3.2% and 5.2% among E. coli isolates from urine in pregnant women versus 35.4%, and 60.4% respectively among clinical isolates. Adding urine culture to the routine urine analysis (protein and glucose) of antenatal was feasible. The dipslide culture method was affordable and user-friendly and allowed on-site inoculation and easy transport; challenges were contamination (midstream urine sampling) and the semi-quantitative reading. Conclusions: The E. coli isolates obtained from healthy pregnant women had significantly lower AMR rates compared to clinical E. coli isolates, probably reflecting the lower antibiotic pressure in the pregnant women population. Provided confirmation of the present findings in other settings, E. coli from urine samples in pregnant women may be a potential indicator for benchmarking, comparing, and monitoring community AMR rates across populations over different countries and regions.
... The most effective and credible way to obtain accurate, reliable, and cost-effective results is through the implementation of a laboratory quality management system (LQMS) [5]. The healthcare system in developing countries has immeasurably recognized the impacts of LQMS when it comes to patient care and is gradually applying it [6]. It has indeed become necessary for all countries to strengthen the capacity of clinical laboratories and this can be achieved through setting up systems that monitor performance such as external quality assurance (EQA) [7,8]. ...
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Background Following the WHO’s endorsement of GeneXpert MTB/RIF assay for tuberculosis diagnosis in 2010, Uganda’s ministry of health introduced the assay in its laboratory network in 2012. However, assessing the quality of the result produced from this technique is one of its major implementation challenges. To bridge this gap, the National tuberculosis reference laboratory (NTRL) introduced the GeneXpert MTB/RIF proficiency testing (PT) Scheme in 2015. Methods A descriptive cross-sectional study on the GeneXpert PT scheme in Uganda was conducted between 2015 and 2018. Sets of panels each comprising four 1ml cryovial liquid samples were sent out to enrolled participants at preset testing periods. The laboratories’ testing accuracies were assessed by comparing their reported results to the expected and participants’ consensus results. Percentage scores were assigned and feedback reports were sent back to laboratories. Follow up of sites with unsatisfactory results was done through “on and off-site support”. Concurrently, standardization of standard operating procedures (SOPs) and practices to the requirements of the International Organization for Standardization (ISO) 17043:2010 was pursued. Results Participants gradually increased during the program from 56 in the pilot study to 148 in Round 4 (2018). Continual participation of a particular laboratory yielded an odd of 2.5 [95% confidence interval (CI), 1.22 to 4.34] times greater for achieving a score of above 80% with each new round it participated. The “on and off-site” support supervision documented improved performance of failing laboratories. Records of GeneXpert MTB/RIF PT were used to achieve accreditation to ISO 17043:2010 in 2018. Conclusion Continued participation in GeneXpert MTB/RIF PT improves testing accuracy of laboratories. Effective implementation of this scheme requires competent human resources, facility and equipment, functional quality management system, and adherence to ISO 17043:2010.
Article
Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach to establishing sustainable laboratory capacity for clinical trials in Africa. Methods: IAVI identified 9 CRCs where a capacity building program that supports immunology and clinical testing was established. Information from the 9 CRCs was collected retrospectively and compiled in Microsoft excel for descriptive statistics. Mapping was done in Quantum Geographic information system. Results: Newly built and refurbished laboratories have been equipped with the required testing laboratory equipment. All CRC laboratories (n=10, 100%) received Good Clinical Laboratory Practice (GCLP) accreditation between 2004 and 2016, and accreditation maintained annually. A total of 89 audits were done between 2005-2019. KAVI and KEMRI had the highest number of audits (n=11, 12.4%). IAVI successfully trained a total of 1811 individual, of which (n=1130, 62.7%) trained on GCLP, (n=330, 18.3%) Quality Management Systems, (n=311, 17,2%) laboratory techniques and (n=32,1.8%) between 2004 and 2021. All the 13 Assays were registered in either College of American pathologist (CAP) or Royal college of pathologists of Australasia (RCPA) for Proficiency testing. Conclusion: The establishment of GCLP accredited laboratories and well-trained personnel has created centers of excellence and it has enabled them to attract independent competitive research funding. The GCLP accreditation and standardized testing procedures ensured reliable and accurate data, especially important for multi-country and multi-center studies.
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Background Culture media are fundamental in clinical microbiology. In laboratories in low- and middle-income countries (LMIC), they are mostly prepared in-house, which is challenging. Objectives This narrative review describes challenges related to culture media in LMIC, compiles best practices for in-house media preparation, gives recommendations to improve access to quality-assured culture media products in LMIC and formulates outstanding questions for further research. Sources Scientific literature was searched using PubMed and predefined MeSH terms. In addition, grey literature was screened, including manufacturer’s websites and manuals as well as microbiology textbooks. Content Bacteriology laboratories in LMIC often face challenges at multiple levels: lack of clean water and uninterrupted power supply, high environmental temperatures and humidity, dust, inexperienced and poorly trained staff, and a variable supply of consumables (often of poor quality). To deal with this at a base level, one should be very careful in selecting culture media. It is recommended to look for products supported by the national reference laboratory, that are being distributed by an in-country supplier. Correct storage is key, as is appropriate preparation and waste management. Centralized media acquisition has been advocated for LMICs, a role that can be taken up by the national reference laboratories, next to guidance and support of the local laboratories. In addition, there is an important role in tropicalization and customization of culture media formulations for private in vitro diagnostic manufacturers, who are often still unfamiliar with the LMIC market and the plethora of bacteriology products. Implication The present narrative review will assist clinical microbiology laboratories in LMICs to establish best practices for handling culture media by defining quality, regulatory and research paths.
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OBJECTIVE: To describe findings from an external quality assessment programme involving laboratories in Africa that routinely investigate epidemic-prone diseases. METHODS: Beginning in 2002, the Regional Office for Africa of the World Health Organization (WHO) invited national public health laboratories and related facilities in Africa to participate in the programme. Three surveys comprising specimens and questionnaires associated with bacterial enteric diseases, bacterial meningitis, plague, tuberculosis and malaria were sent annually to test participants' diagnostic proficiency. Identical surveys were sent to referee laboratories for quality control. Materials were prepared, packaged and shipped in accordance with standard protocols. Findings and reports were due within 30 days. Key methodological decisions and test results were categorized as acceptable or unacceptable on the basis of consensus feedback from referees, using established grading schemes. FINDINGS: Between 2002 and 2009, participation increased from 30 to 48 Member States of the WHO and from 39 to 78 laboratories. Each survey was returned by 64-93% of participants. Mean turnaround time was 25.9 days. For bacterial enteric diseases and meningitis components, bacterial identification was acceptable in 65% and 69% of challenges, respectively, but serotyping and antibiotic susceptibility testing and reporting were frequently unacceptable. Microscopy was acceptable for 73% of plague challenges. Tuberculosis microscopy was satisfactorily performed, with 87% of responses receiving acceptable scores. In the malaria component, 82% of responses received acceptable scores for species identification but only 51% of parasite quantitation scores were acceptable. CONCLUSION: The external quality assessment programme consistently identified certain functional deficiencies requiring strengthening that were present in African public health microbiology laboratories.
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For a clinical study in the European research network on better diagnosis for neglected infectious diseases (NIDIAG) project (Better Diagnosis of Neglected Infectious Diseases: www.nidiag.org), we developed Standard Operating Procedures (SOPs), which we implemented in a basically equipped laboratory in a 380-bed rural hospital (“Hopital General de Reference Mosango”) in the Kwilu province in the Democratic Republic of the Congo (DRC). The study aimed to improve the early diagnosis of severe and treatable infections among patients with neurological disorders and took place over a 20-month period (14/09/2012–24/05/2014) (ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01589289","term_id":"NCT01589289"}}NCT01589289). The set of 50 SOPs (S1 Appendix), all in French, include procedures related to the inclusion and clinical management of patients with neurological disorders (n = 4), diagnostic testing (n = 33), data collection and management (n = 5), and quality assurance (n = 8).
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The role of national health laboratories in support of public health response has expanded beyond laboratory testing to include a number of other core functions such as emergency response, training and outreach, communications, laboratory-based surveillance and data management. These functions can only be accomplished by an efficient and resilient national laboratory network that includes public health, reference, clinical and other laboratories. It is a primary responsibility of the national health laboratory in the Ministry of Health to develop and maintain the national laboratory network in the country. In this article, we present practical recommendations based on 17 years of network development experience for the development of effective national laboratory networks. These recommendations and examples of current laboratory networks, are provided to facilitate laboratory network development in other states. The development of resilient, integrated laboratory networks will enhance each state’s public health system and is critical to the development of a robust national laboratory response network to meet global health security threats.
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External Quality Assessment (EQA) surveys performed by the World Health Organization Regional Office for Africa (WHO AFRO) revealed the need for the strengthening of publichealth microbiology laboratories, particularly for testing of epidemic-prone diseases in theAfrican Region. These surveys revealed common issues such as supply chain managementskilled personnel, logistical support and overall lack of quality standards. For sustainableimprovements to health systems as well as global health security, deficiencies identified needto be actively corrected through robust quality assurance programmes and implementation oflaboratory quality management systems.Given all the pathogens of public health importance, an external quality assessment programmewith a focus on vaccine-preventable diseases and emerging and re-emerging dangerouspathogens is important, and should not be stand-alone, but integrated within laboratorynetworks as seen in polio, measles, yellow fever and rubella.In 2015, WHO AFRO collaborated with the US Centers for Disease Control and Preventionthe London School of Hygiene & Tropical Medicine and partners in a series of consultationswith countries and national and regional EQA providers for the development of qualityassurance models to support HIV point-of-care testing and monitoring. These consultationsrevealed similar challenges as seen in the WHO AFRO surveys. WHO AFRO brought forthits experience in implementing quality standards for health programmes, and also openeddiscussions on how lessons learned through such established programmes can be utilised tosupporting and strengthening the introduction of early infant diagnosis of HIV and viralload point-of-care testing.An optimised external quality assessment programme will impact the ability of countries tomeet core capacities, providing improved quality management systems, improving theconfidence of diagnostic network services in Africa, and including capacities to detect eventsof international public health importance.
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In 2015, UNAIDS launched the 90-90-90 targets aimed at increasing the number of people infected with HIV to become aware of their status, access antiretroviral therapies and ultimately be virally suppressed. To achieve these goals, countries may need to scale up point-of-care (POC) testing in addition to strengthening central laboratory services. While decentralising testing increases patient access to diagnostics, it presents many challenges with regard to training and assuring the quality of tests and testing. To ensure synergies, the London School of Hygiene & Tropical Medicine held a series of consultations with countries with an interest in quality assurance and their implementing partners, and agreed on an external quality assessment (EQA) programme to ensure reliable results so that the results lead to the best possible care for HIV patients. As a result of the consultations, EQA International was established, bringing together EQA providers and implementers to develop a strategic plan for countries to establish national POC EQA programmes and to estimate the cost of setting up and maintaining the programme. With the dramatic increase in the number of proficiency testing panels required for thousands of POC testing sites across Africa, it is important to facilitate technology transfer from global EQA providers to a network of regional EQA centres in Africa for regional proficiency testing panel production. EQA International will continue to identify robust and cost-effective EQA technologies for quality POC testing, integrating novel technologies to support sustainable country-owned EQA programmes in Africa.
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Health system and HIV epidemiology in Mozambique> Medical care in Mozambique is mostly provided through the national health service of the Ministry of Health. All primary healthcare and HIV-related services are provided free of charge. There are over 1500 public sector health facilities in Mozambique and most of these are primary healthcare centres. Although all hospitals have a laboratory, only a quarter of the health centres have a formal laboratory. In this context, point-of-care (POC) testing and syndromic management of diseases play an important role in the health system. Both communicable and non-communicable diseases are prevalent in the Mozambican population. Mozambique has a population of 28 million and is among the nine countries with the highest HIV prevalence in the world. HIV prevalence in the country among people aged 15-49 years is 11.5%, ranging from 3.7% in the Niassa province in the north to 25.1% in the Gaza province in the south. HIV prevalence is higher among women (13.1%) than among men (9.2%), and higher in urban areas (15.9%) compared with rural areas (9.2%). Among children aged between 0 and 11 years,HIV prevalence is 1.4%, and 2.3% in those younger than one year. It is estimated that 102 new infections in children occur daily in Mozambique (Ministry of Health, unpublished data). Demographic impact studies show that an estimated 1.6 million Mozambicans were living with HIV in 2009.
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Objective To implement a mentored laboratory quality stepwise implementation (LQSI) programme to strengthen the quality and capacity of Cambodian hospital laboratories. Methods We recruited four laboratory technicians to be mentors and trained them in mentoring skills, laboratory quality management practices and international standard organization (ISO) 15189 requirements for medical laboratories. Separately, we trained staff from 12 referral hospital laboratories in laboratory quality management systems followed by tri-weekly in-person mentoring on quality management systems implementation using the LQSI tool, which is aligned with the ISO 15189 standard. The tool was adapted from a web-based resource into a software-based spreadsheet checklist, which includes a detailed action plan and can be used to qualitatively monitor each laboratory’s progress. The tool – translated into Khmer – included a set of quality improvement activities grouped into four phases for implementation with increasing complexity. Project staff reviewed the laboratories’ progress and challenges in weekly conference calls and bi-monthly meetings with focal points of the health ministry, participating laboratories and local partners. We present the achievements in implementation from September 2014 to March 2016. Findings As of March 2016, the 12 laboratories have completed 74–90% of the 104 activities in phase 1, 53–78% of the 178 activities in phase 2, and 18–26% of the 129 activities in phase 3. Conclusion Regular on-site mentoring of laboratories using a detailed action plan in the local language allows staff to learn concepts of quality management system and learn on the job without disruption to laboratory service provision.
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Background: The increase in disease burden has continued to weigh upon health systems in Africa. The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases. In response, the World Health Organization Regional Office for Africa (WHO AFRO) and its partners created the WHO AFRO Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. Slipta implementation process: WHO AFRO defined a governance structure with roles and responsibilities for six main stakeholders. Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Laboratory performance was measured using the WHO AFRO SLIPTA scoring checklist and recognition certificates rated with 1-5 stars were issued. Preliminary results: By March 2015, 27 of the 47 (57%) WHO AFRO member states had appointed a SLIPTA focal point and 14 Ministers of Health had endorsed SLIPTA as the desired programme for continuous quality improvement. Ninety-eight auditors from 17 African countries, competent in the Portuguese (3), French (12) and English (83) languages, were trained and certified. The mean score for the 159 laboratories audited between May 2013 and March 2015 was 69% (median 70%; SD 11.5; interquartile range 62-77). Of these audited laboratories, 70% achieved 55% compliance or higher (2 or more stars) and 1% scored at least 95% (5 stars). The lowest scoring sections of the WHO AFRO SLIPTA checklist were sections 6 (Internal Audit) and 10 (Corrective Action), which both had mean scores below 50%. Conclusion: The WHO AFRO SLIPTA is a process that countries with limited resources can adopt for effective implementation of quality management systems. Political commitment, ownership and investment in continuous quality improvement are integral components of the process.
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Evidence-based guidelines for implementation and measurement of antibiotic stewardship interventions in inpatient populations including long-term care were prepared by a multidisciplinary expert panel of the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. The panel included clinicians and investigators representing internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties. These recommendations address the best approaches for antibiotic stewardship programs to influence the optimal use of antibiotics.
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This practical, easy-to-use guide addresses interference issues in all laboratory tests, including patient epigenetics, process of specimen collection, enzymes, biomarkers. Clinicians and laboratory scientists can therefore rely on one reference which speaks to both their needs of accurate specimen analysis and optimal patient care. Erroneous hospital and pathology laboratory results can be confusing and problematic, especially in acute care situations. While some factors creating interference, can be identified in the laboratory, detecting many others is often dependent on clinical details unavailable to the laboratory scientists or pathologists. Therefore, clinicians must become proficient in identifying such erroneous reports, and working with pathologists and laboratory scientists so that they can understand the source of such interferences, correct the results, and then decide what course of action must be followed for proper patient management.