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A feasible laboratory-strengthening intervention yielding a sustainable clinical bacteriology sector within 18-months of implementation in a large referral hospital in Ethiopia || Oral Presentation #O0734

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Background Access to clinical bacteriology in low resource settings (LRS) is a key bottleneck preventing individual patient management of treatable severe infections, detection and control of antimicrobial resistance (AMR), and epidemiologic surveillance. We sought to demonstrate the feasibility of a practical bundle of interventions aimed at implementing sustainable clinical bacteriology services at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia, and report on cost and intensity of supervision. Materials/methods A minimal intervention bundle based on the CLSI QMS01-A guideline was established, consisting of (i) an initial needs assessment, (ii) development of key SOPs, (iii) adaptation of processes for LRS, (iv) training and supervision of laboratory staff via consultant visits and existing online resources, and (v) implementation of a practical quality systems approach. A guiding principle of the bundle was sustainability of all interventions post implementation. Results An initial investment of Can$ 35,000 for laboratory reagents, and a total of 50 visit days per year from 3 Canadian microbiologists were committed. Twelve SOPs, including antimicrobial susceptibility testing, were adapted, and an automated blood culture platform was donated (bioMerieux). In the first 18 months of implementation of the intervention, the average volume of specimens analyzed in the lab went from 15/day to 75 specimens /day. The number of blood cultures tested increased from an average of 2/day to over 20/day. Standardized antimicrobial susceptibility testing with cumulative antibiograms were generated for the institution. Quality control was implemented for all procedures and quality assurance tools implemented included external quality assurance and proficiency testing of 5 technologists with longitudinal follow-up. At present the laboratory is applying for SLIPTA certification by ASLM. Reagent costs, staff training and retention, and engagement of clinical personnel with the lab proved to be manageable challenges. Key external challenges include in-country supply-chain management issues related to lack of competition among distributors and foreign-currency exchange distortions. Conclusions Using a relatively low-intensity intervention based on existing training tools and accreditation schemes, we demonstrate that establishment of sustainable high-quality clinical bacteriology is not only within reach but also a critical step towards assessing the burden of AMR in settings like this one.
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A
feasible laboratory-strengthening intervention
yielding a sustainable clinical bacteriology sector
within 18-months of implementation in a large
referral hospital in Ethiopia
Cedric P Yansouni
, Daniel Seifu, Michael Libman, Solomon Gizaw, Mequanint
Mitiku, Getachew Seyoum, Freyhiwot Tekle-Haimanot, Mane Asres, Øystein H
Johansen, Workeabeba Abebe,
Makeda Semret
28th ECCMID 2018 -Madrid, Spain 21-24 April 2018
Disclosures
2
The authors have received in-kind research support from BD Molecular Diagnostics
and bioMérieux in the last 2 years.
This project receive in-kind support from bioMérieux in the form of a BactiAlert 3D
blood culture instrument
Clinical bacteriology in LRS can no longer be regarded as optional
Maputo declaration meeting 2008, Annex C: http://www.who.int/management/facility/laboratory/MaputoAnnexCSummaryTestsbyLevel.pdf
2018:
unavailable in
MOST of
Africa
Clinical bacteriology in LRS can no longer be regarded as optional
AMR Non-malarial febrile illness
malaria transmission è
↑ alternative illnesses that
have to be considered
2 roles for diagnostics:
pathogen-specific treatment
discontinuation of
unnecessary antimicrobials
when bacterial disease is
ruled out
4
>10-15% of hospitalized
patients develop
healthcare -associated
infections in LMIC
oAMR ↑ in LRS
oHAI ↑ in LRS
oAMR ↑ impact of HAI
oHAI èAMR
Healthcare-Associated
Infections (HAI)
O’Neill J. HM Government and the
Wellcome Trust, May 2016.
Glob Heart 2014; 9: 347-358.
Lancet 2011; 377: 228-241.
Bull World Health Organ 2011; 89: 757-765.
Lancet Infect Dis 2018; 10.1016/s1473-3099(18)30101-4.
Context
2009: AAU-McGill Infectious
Diseases subspecialty training
programme
2015: Funded project
– “Burden of hospital-acquired infections in the
largest referral hospital in Ethiopia, and impact
of a sustainable laboratory intervention on
antimicrobial prescribing practices
2017: AMP-ID collaboration
5
Objective of this talk:
Report on the laboratory-
strengthening intervention
towards a sustainable clinical
bacteriology sector
6
Also from this project at ECCMID 2018:
• “Alarming rates of drug-resistance in gram-negative blood stream infections among
hospitalized patients in Ethiopia: an urgent call to strengthen diagnostic bacteriology
and antimicrobial stewardship in low-resource settings” (P0947)
• “Opportunities and barriers to implementing Antibiotic Stewardship in Low-Resource
Settings: lessons from a mixed-methods study in a tertiary care hospital in Ethiopia”
(P1722)
Intervention
1. initial needs assessment
2. development of key SOPs
3. adaptation of processes for LRS
4. training and supervision of
laboratory staff via consultant
visits and existing online
resources
5. implementation of a practical
quality systems approach
Exploratory visits late 2015
Very low volume of specimens
Problematic quality!
50-bottle automated blood culture
platform donated, but infrequent use
Variable staff proficiency
Support from Norwegian cooperation
Few SOPs
Little relationship with clinicians
7
Intervention
1. initial needs assessment
2. development of key SOPs
3. adaptation of processes for LRS
4. training and supervision of
laboratory staff via consultant
visits and existing online
resources
5. implementation of a practical
quality systems approach
Decision to prioritize BSI
12 core SOP were adapted
from MUHC protocols
No epi to guide SOP content
8
PLoS Negl Trop Dis 2016; 10: e0005053.
Intervention
1. initial needs assessment
2. development of key SOPs
3. adaptation of processes for LRS
4. training and supervision of
laboratory staff via consultant
visits and existing online
resources
5. implementation of a practical
quality systems approach
Visits
Tota l of 50 visit-days/year from 3
McGill microbiologists committed
(i.e. 4-5 x 2-wk visits)
Training sessions
Daily plate rounds
Formal lectures
Strong promotion of SOP awareness
Outside resources
Online weekly proficiency testing
program from UBC, Canada
cmpt.ca
Intervention
1. initial needs assessment
2. development of key SOPs
3. adaptation of processes for LRS
4. training and supervision of
laboratory staff via consultant
visits and existing online
resources
5. implementation of a practical
quality systems approach
Promoting the quality mindset
QC implemented for all procedures
QA approaches implemented
EQA participation (EPHI, nascent)
Proficiency testing of 7 techs (tailor-made
exams)
Online weekly proficiency testing (cmpt.ca
more used as training tool)
Selected QA audits (mostly analytical)
Path to accreditation
10
Results so far
Initial investment of Can$ 35,000 for laboratory reagents
In the first 18 months of implementation:
Specimens received 15/day è75 /day.
Blood cultures tested 2/day è>20/day.
Standardized AST with cumulative antibiograms generated
Aiming for SLIPTA certification by ASLM èISO 15189.
11
Results so far
In the first 18 months of
implementation:
Specimens received 15/day è
75 /day.
Blood cultures tested 2/day è
>20/day.
Standardized AST with cumulative
antibiograms generated
Aiming for SLPTA certification by
ASLM èISO 15189.
12
Standardizing practice
Addressing misconceptions among staff
Earning trust of entire team
OUTSIDE OBSTACLES
Overcoming local supply
and ForEx issues
Engagement from hospital &
university community toward
importance of lab sector
Attractiveness of microbiology as
a career path without
institutional prestige
Attractiveness of ID as
subspecialty given lower
revenue compared to procedural
specialties.
Generating demand from clinicians
Quality specimen
Requisition neglect
mislabled specimens è
Main Challenges
No telephone system in hospital!
No in-hospital LIS and connectivity to individual
ordering physicians
Data analysis responsibility
Strengthening relationship with clinicians in
absence of MD homologue in lab
Strengthening synergies with tiered lab network
Post-
analytical
In-lab
Pre-
analytical
Overcoming post-analytical obstacles
connectivity to users using off-the-shelf commercial tools
Local cumulative antibiograms Real-time locally adapted treatment guidelines
Screenshots from https://webedition.sanfordguide.com/comparisons-1/activity-
spectra/interactive-antibiogram#view=xxx
Next steps
Post-
analytical
In-lab
Pre-
analytical
Accreditation SLMTA, ISO
New technologies
BIG PICTURE
Improving individual
patient care
Reducing
antimicrobial
resistance with OUR
actions each day
Getting in-hospital LIS
connectivity to individual
ordering physicians
Strengthening relationship with
clinicians
Updating empiric guidelines
according to local data
Working better with today’s tools
Smarter application of
current tools
Enabling quality assurance
and quality improvement
Using connectivity and
transport innovations
16
The Lancet Infectious Diseases. 2018.
Clin Microbiol Infect. 2017;23(7):426-33.
M Semret, M Ndao, J Jacobs & CP Yansouni; Clin Microbiol Infect 2018 (in press)
Point-of-care and point-of-“can”:
Leveraging reference-laboratory capacity for integrated diagnosis of fever
syndromes in the tropics
Evaluating new tools for bacteriology in low-resource settings
many options for bacterial identification, very few for AST
Liu et al; J Clin Microbiol 2016;54:49-58
Roche gobbles Smarticles. Nat Biotechnol. 2015;33(10):1012.
MALDI-TOF Mass Spectrometry: A Powerful Tool for Clinical Microbiology at Hopital
Principal de Dakar, Senegal (West Africa). PLoS One. 2015;10(12):e0145889.
Usefulness of MALDI-TOF Mass Spectrometry for Routine Identification of Candida
Species in a Resource-Poor Setting. Mycopathologia. 2015;180(3-4):173-9.
Multiplex/serial monoplex
NAAT approaches MALDI-TOF MS Innovative new approaches for rapid PHENOTYPIC
antimicrobial susceptibility testing
Conclusions
1. Reliable bacteriology and AST are now implemented at TASH
2. For sustainability optimists:
Current budget for staff and reagents can be sustained locally
Institutional buy-in: hospital now has a head of quality-management
Clinician buy-in: results are used, specimens are sent, and post-analytical efforts are
bearing fruit
Many tools used were off-the-shelf commercially available, or adapted from existing ones
3. For sustainability pessimists, many obstacles outside of lab:
Foreign exchange distortions
Supply chain challenges and distributor monopolies
4. Availability has lead to recognition of critical importance of bacteriology
18
Funding and key partners
Questions?
cedric.yansouni@mcgill.ca
makeda.semret@mcgill.ca
... • Prioritizing Blood Culture processing to diagnose Blood Stream Infection • Implementation of 12 core SOPs including standardized identification and susceptibility testing • Training and supervising of laboratory personnel via consultant visits and existing online training • Implementation of a practical Quality approach (169). ...
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