AMR Lab Quality Scorecard: a path to lab quality improvement

Cassandra Kelly, FIND

2nd International Conference on (Re-)Emerging Infectious Diseases 2019, Addis Ababa, Ethiopia.

Many AMR drivers can be impacted by diagnostics

+40% global consumption of antibiotics 2000–20101

Majority of children with fever and a negative malaria test estimated to receive antibiotics

unnecessarily2

Neonatal sepsis caused by resistant bacteria is a major cause of death in babies worldwide3

Use of first-, second- or third-line treatment mostly based on empirical diagnosis, especially in

LMICs

Rapid spread of superbugs in hospitals and communities4

Paucity of data delaying prioritization and action5

Effective lifetime of new drugs is ~10 years

5% of global antibiotics used are counterfeit; counterfeit artesunate responsible for spread of

artemisinin-resistant malaria6

1. "Rapid diagnostics: stopping unnecessary use of antibiotics", Jim O'Neill, 2015; “Antimicrobial resistance: tackling a crisis for the health and wealth of nations”, Review on AMR, 2014; 2. Bastiaens, 2011, Malaria Journal ; experts’ interviews; 3. AMR Gram-neg Opn Inf Dis. 2017 Jun; 4. Fighting bacterial resistance at the root: need for adapted EMEA guidelines, Lancet Inf Dis 2011 Jan; 5. WHO Priority Pathogens Report, Sep 2017; 6. Fake artesunate in Southeast Asia. Lancet Jun 2001

Diagnosis as “first prescription” impacts the causes and

challenges of AMR

1. Tonkin-Crine et al., Cochrane Review. 2. Banerjee et al., Clin Infect Dis 2015;61:1071. 3. "Clinical Impact and Provider Acceptability of Real-Time Antimicrobial Stewardship Decision Support for Rapid Diagnostics in Children With Positive Blood Culture Results", Messacar et al., 2016. 4. Peterson et al. J Clin Microbiol 2016

• Active surveillance testing (AST) for MRSA can lead to a cost-

benefit of >$80.000/1000 patients4

• Rapid molecular diagnostics can reduce the time to pathogen

identification2

• Use of blood culture diagnostics, coupled with stewardship

practices, is associated with improved times to optimal and effective

antimicrobial tx3

• CRP POC testing can reduce antibiotic prescribing in general

practice by 20-40%1

• Procalcitonin-guided management can reduce antibiotic prescribing

in both general practice (OR 0.10) and emergency departments (OR

0.34)1

Saving “the global good”

Saving money

Saving patients’ lives

$

AMR Diagnostic situation

• Very high rates of resistance in bacteria that cause common health-care associated and community-acquired infections globally1

• Significant gaps in surveillance and lack of standardization

• Limited access to quality clinical bacteriology in LRS

• Limited number of accredited labs in LMICs (e.g. 100 labs in Africa, outside SA)

• Of those accredited few perform clinical bacteriology (e.g. 17% (4/23) accredited SLMTA laboratories in Africa)2

• Most EQA programmes focus only on HIV, TB and malaria

• Until availability of new technologies, conventional culture-based techniques are still the best option for clinical bacteriology in these settings

1. WHO. Antimicrobial Resistance. Global Report on surveillance. 2. Barbe et al.

AMR Dx challenges

• Lack of access to clinical microbiology (infrastructure, training and implementation)

• Lack of emphasis on lab diagnosis of infectious diseases – clinician apathy and a culture of syndromic approach

• Diagnostic delay and perception that lab results are unreliable, leading to clinician reliance on empiric treatment

• Concept that microbiology is expensive and time consuming

• Microbiology needs specific equipment seen as an avoidable expense as compared to hematology or chemistry

• Investment focus on HIV, TB and malaria capacity building

Antimicrobial Resistance (AMR) Laboratory Quality ScorecardObjectives

• Improve the appropriate use of diagnostics to identify pathogens and guide patient treatment and management

• Optimize surveillance and early detection of AMR

• Initial focus on culture, detection, identification & AST from blood, urine and faecal samples

• Leverage and align with existing tools and initiatives for AMR and lab quality improvement

• Structured approach, including technical and quality systems elements and strengthening lab-clinical interface to ensure effective use of lab data to inform patient management and surveillance

AMR Diagnostics QI elements

AMR Dx MOOC

Free, online training course

Covers WHO & CDC priority AMR pathogens

Facility-based AMR Lab Quality Scorecard assessment

SLIPTA checklist eTool, with integrated:

•General AMR Dx module

•Blood culture, ID & AST module

•Urine culture, ID & AST module

•Faeces culture, ID & AST module

•Laboratory-clinical interface checklist

Assessment report

•Identify gaps in technical procedures and quality systems

• Recommendations for QI

Targeted QI

• Structured training & mentoring approach across lab-clinical team

• Customised AMR Dx QI modules

• Links to existing training & resources

₋ Baseline and follow on AMR Dx assessments

₋ Leveraging SLIPTA trained assessors and other national/regional experts

Outputs

₋ SLIPTA Score₋ AMR DX module scores

(blood, urine, faeces)

₋ Targeted recommendations for AMR Dx QI

₋ Establish mentorship plans and measure impact of AMR Dx QI

₋ Integrate with existing lab QI & AMR initiatives

₋ Raise awareness among clinicians, health officials and laboratorians on AMR diagnostics

1. Strengthen, coordinate and institutionalize inter-disciplinary efforts through national and health establishment level governance structures implementation plan

2. Improve the appropriate use of diagnostics to identify pathogens and guide patient treatment and management

3. Optimize surveillance and early detection of AMR

4. Enhance infection prevention and control

5. Promote appropriate use of antimicrobials in human and animal health

* Taken from Implementation plan for the Antimicrobial Resistance Strategy Framework in South Africa, 2014-2019.

Where this fits within the broader AMR context

AMR Lab Quality Scorecard overview• Specifies requirements for delivering quality-assured laboratory testing for

antimicrobial resistance (AMR) and ensuring effective use of laboratory data for patient management and surveillance

• Enables tracking of progress of clinical microbiology laboratories towards meeting established national or international standards, based on ISO standard 15189: 2012 (E)

• Recognition uses a five stage approach, based on percentage attainment of requirements

• Target audience: Ministries of Health officials, health facility and laboratory managers, donors, implementing partners, quality assurance personnel, programme managers and supervisory staff at national, regional and facility level

AMR Lab Quality Scorecard: leveraging and aligning with existing tools

WHO AFRO SLIPTA Checklist• Aligned with ISO 15189 standard for

lab quality management systems

ICMR, CDC & Partners: Antibacterial Resistance Surveillance Readiness Tool• In-depth evaluation of clinical microbiological:

• Infrastructure• Quality Assurance• Sample processing• Bacterial identification & AST

Next steps• Expand use of the AMR Lab Quality Scorecard to other countries

• Establish partnerships for scale up

• Develop and implement a structured quality improvement package to support closing of gaps identified

• Monitor impact of AMR lab quality improvement on patient and health system outcomes

Acknowledgements• Ethiopia Public Health Institute (EPHI)

• Kenya National Public Health Laboratory Service (NPHLS)

• Global Health Systems Solutions (GHSS), Cameroon

• Ministry of Health, Cameroon

• Andre Trollip, Heidi Albert, Cecilia Ferreyra, Zachary Katz, FIND

• Renuka Gadde, Kamau Gatwechi, Courtney Maus, BD

• Tjeerd Datema, Linda Oskam, DATOS

• Andrew Whitelaw, NHLS / University of Stellenbosch

• Assessment teams

• Participating laboratories and facilities