ASSESSMENT OF TB DIAGNOSTIC ASSESSMENT OF TB DIAGNOSTIC NETWORKS: A NEW TOOL AMY PIATEK USAID, WASHINGTON DC McGill Advanced TB Diagnostics June 20, 2018 8/1/2018`1 1
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ASSESSMENT OF TB DIAGNOSTIC ASSESSMENT OF TB DIAGNOSTIC NETWORKS: A NEW TOOL
AMY PIATEK
USAID, WASHINGTON DC
McGill Advanced TB Diagnostics
June 20, 2018
8/1/2018`1 1
TB Di i N k A T l
Why do we need such a tool? How did
TB Diagnostic Network Assessment Tool
Why do we need such a tool? How did we get here?
How can we prioritize network strengthening interventions that will g gmake a difference?
8/1/2018 2
When/why did the shift to thinking about “di i ” k ?
Very soon after first introduction of Xpert into a few high
“diagnostic” networks start?
y f f f p f gburden countries:The initial attitude around implementation from high-level policy/strategic experts and other stakeholders downplayed policy/strategic experts and other stakeholders downplayed potential complexities:o “Once policy reform is done, implementation of the Xpert technology does
not require major TA effort or cost.”q j
o “…current experience suggests that no more than 20% of the initial implementation cost (including hardware, software, staff cost, specimen referral, contingencies), should be sufficient to address the TA needs.”
o “Xpert is so simple that I could teach my mother in one day to run the test.”
o “All we need to do is get the instruments in country – it will be easy for countries to introduce and scale-up”.
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o “We’re buying instruments but have no budget for TA – can we use your partners if there are any problems?”
Wh h hif ?
Several studies show that Xpert is not the magic bullet…
Why the shift?
p g• Theron Lancet 2014: Conclusion: “However, the benefits (of Xpert testing)
did not translate into lower tuberculosis-related morbidity, partly because of high levels of empirical-evidence-based treatment in smear-negative patients.”
• Churchyard Lancet Global Health, 2015: Conclusion: ”Xpert did not reduce mortality at 6 months compared with sputum microscopy. Improving
t i d iti t b l i i ht i t outcomes in drug-sensitive tuberculosis programmes might require not only better diagnostic tests but also better linkage to care.”
Initial testing algorithms restricting to “high risk” populations l l k l l f resulting in slow uptake, low utilization of instruments
Seeing “unimpressive” results – EXCEPT in the time to diagnosing DR-TBdiagnosing DR TB
8/1/2018 FOOTER GOES HERE 4
Number of Sites with Smear Microscopy or Xpert MTB/RIF
Number of sites: smear microscopy Number of sites: Xpert MTB/RIF
5000
6000
60,000
80,000
y • UNITAID EXPAND TB Project (2009 2013) $87m to increase
3000
4000
40,000
es with
Xpe
rt M
TB/R
IF
with
smea
r microscop
8002000
Number of sites with Phenotypic or Molecular DST
Number of sites: DST Number of sites: LPA
• UNITAID EXPAND TB Project (2009-2013) - $87m to increase MDR-TB detection capacity in 27 countries
• South Africa national policy for upfront Xpert testing for all patients (2011), with other countries slowing following
1000
2000
20,000
Num
ber o
f site
Num
ber o
f site
s
600
700
1400
1600
1800
STST(2011), with other countries slowing following
• Introduction of Xpert MTB/RIF with demonstration and scale-up supported by many external donors (2011 - )
• Xpert MTB/RIF cartridge “buy down” (2012)
0
1000
02010 2011 2012 2013 2014 2015 2016 400
500
1000
1200
1400
sites with
Gen
otyp
ic DS
ites with
Phe
notypic D
p g y ( )• Number of WHO policies and GLI implementation guidance around
diagnostics- with uptake by countries• Increased Global Fund grants supporting MDR-TB diagnosis and
200
300
400
600
800
Num
ber o
f s
Num
ber o
f streatment
5
0
100
0
200
2010 2011 2012 2013 2014 2015 2016WHO Global TB Database 2016
TB Case DetectionGlobal, 2010‐2016
Total new and relapse TB case notificationsProportion of estimated cases detected
Proportion of New TB Cases with Bacteriological Confirmation Global, 2010‐2016
Total new and relapse TB case notificationsProportion of new TB cases bacteriologically confirmed
80%
100%
6,000,000
Proportion of estimated cases detected
80%
100%
6,000,000
Proportion of new TB cases bacteriologically confirmed
20%
40%
60%
2,000,000
4,000,000
20%
40%
60%
2,000,000
4,000,000
0%02010 2011 2012 2013 2014 2015 2016
0%02010 2011 2012 2013 2014 2015 2016
2010– 2016• Overall detection of new TB cases increased from 5.8 m to 6.4 m• Proportion of estimated TB cases detected increased from 53% to 61%
BUT• Proportion of new TB cases bacteriologically confirmed decreased from
50% to 44%
6WHO Global TB Database 2016
50% to 44%
PROPORTION OF NEW TB CASES BACTERIOLOGICALLY CONFIRMED2016
90%
100%
DR CongoNigeria70%
80%
Malawi AfghanistanIndia
UkraineIndonesia
KenyaSouth Africa
BangladeshUganda
50%
60%
Uzbekistan
Philippines
Myanmar
CambodiaEthiopia
Zambia
KyrgyzstanMozambique
Tanzania
Malawi
Tajikistan
gZimbab…
30%
40% Global 44%
10%
20%
8/1/2018 7
0%
WHO Global TB Database 2016
Proportion of RR/MDR‐TB Cases Tested for 2nd Line ResistanceGlobal, 2015‐2016
Number of lab‐confirmed RR/MDR‐TB cases identifiedProportion of RR/MDR‐TB cases tested for 2nd line resistance
RR/MDR‐TB Case DetectionGlobal, 2010‐2016
Number of lab‐confirmed RR/MDR‐TB cases identifiedProportion of estimated RR/MDR‐TB cases detected
60%
80%
100%
120,000
140,000
160,000
180,000
p
60%
80%
100%
120,000
140,000
160,000
180,000
p
20%
40%
60%
40,000
60,000
80,000
100,000
20%
40%
60%
40,000
60,000
80,000
100,000
0%0
20,000
2010 2011 2012 2013 2014 2015 20160%0
20,000
2010 2011 2012 2013 2014 2015 2016
2010– 2016• Overall detection of RR/MDR-TB cases increased from 53k to 156k• Proportion of estimated TB cases detected increased from 9% to 26%
• Proportion of RR/MDR-TB cases tested for 2nd line resistance remains slightly below 40%
8WHO Global TB Database 2016
Transitioning from “tiered” laboratory services…
…to a comprehensive, person-centered p pdiagnostic cascade
8/1/2018 9
LABORATORY SERVICES
DIAGNOSTIC NETWORK
How did we define the diagnostic cascade
Learning from introduction of Xpert in countries:
How did we define the diagnostic cascade, determine which components are critical?
- Xperts were scattered around a country without an informed plan
- Data on placement, performance or clinical management was non-existent or very difficult to obtain
- What was the time from sputum collection to test, test to result and result to treatment initiation?
- Were modules failing? Were instruments working optimally? How were countries forecasting?g
- Clinicians and non-laboratory staff were not included in trainings or sensitized; private providers and labs were not included and had no access
- There were no quality or proficiency plans around testing
- Instruments were not POC and sometimes not even “near” POC
- ”Xpert” is not a case-finding strategy
- No specimen transport or referral system planned or in place
8/1/2018 10
No specimen transport or referral system planned or in place
- The “promise” of “fast followers” went unrealized
A l b k dAssessment tool - background
There are many tools available to evaluate individual components of a laboratory system or diagnostic network; however, no one comprehensive tool available to assess complex TB diagnostic networks
• To meet this need, a tool was developed that incorporates the approach of the ASLM/APHL LABNET scorecard and the laboratory core capacity described in the International Health Regulations with TB-specific components from GLI and other internationally-recommended guidance.
The tool was:
- Influenced by checklists and questionnaires that were adapted or newly developed for use in a Nigeria TB Diagnostic Network Assessment in March 2016
- Further refined during a recent assessment of India’s TB diagnostic network (November 2017)
Wh t th t l i Wh t th t l i tWhat the tool is:
Will assess the functionality of a national TB diagnostic network from the perspective of its ability to meet the
What the tool is not:
✕A way to impose new algorithms, policies, recommendations onto countries blindlyperspective of its ability to meet the
needs of the country’s NSP for TB
Structured to use semi-quantitative scoring to identify the “capability” stage of
countries blindly
✕A way to find fault or blame within a country’s network or program
✕A scorecard to compare networks sco g to e t y t e capab ty stage o various aspects of the network
A means to help identify areas for improvement
✕A scorecard to compare networks among different programs
✕A way to provide a list of non-specific recommendations
Usable to monitor performance of national TB diagnostic networks and systems over time
recommendations
✕A means to conduct routine supervision at various levels or assess individual facility-level services
Country-led and ownedy
✕ Meant to be used only for large, international assessments
12
TB NETWORK ASSESSMENT TOOL– THE PROCESS
8/1/2018 13
1 – Standards, capacities and components
Standard Core Capacity Components1 The country has a fully endorsed political, legal and regulatory Political, legal, ‐ Legislation
p p
framework in place which supports the achievement of the NSP and that organizes and controls all public and private diagnostic services to support the NSP, with sufficient dedicated funding available.
regulatory and financial framework
‐ National policies and plans‐ Governance ‐ Financing
2A sustainable, rational and efficient TB diagnostic network provides
Structure and organization of the
‐ Diagnostic Network‐ Coordination and management
integrated, essential, quality diagnostic services for patient care and public health.
organization of the diagnostic network
‐ Coordination and management‐ Programmatic and operational
research3
The national TB diagnostic network provides complete coverage and universal access to TB diagnostic services to the entire population of
Coverage ‐ Diagnostic network coverage‐ Sample referral system
universal access to TB diagnostic services to the entire population of the country.
‐ Linkages ‐ Emergency preparedness
4 A national TB diagnostic algorithm(s) that is responsive to the epidemic, patient‐centered, includes appropriate use of diagnostic technologies, and is based on the current structure of the health
Diagnostic algorithm ‐ Algorithms‐ TB diagnosis‐ Drug‐resistant TB g
system is enforced at all levels of the TB diagnostic network. g
5 Testing is performed in a manner and in facilities that ensure safety for the staff, the customers, the community and the environment.
Biosafety ‐ Facilities‐ Biosafety and biosecurity
manualBiosafety systems
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‐ Biosafety systems‐ Waste management
Standard Core Capacity Components6 Testing is performed with state‐of‐the‐art and well‐maintained Equipment and ‐ Supply chain management 6 g p
equipment and an uninterrupted supply of quality reagents and consumables using standardized testing methods throughout the country.
qu p e a dsupplies
pp y g‐ Equipment
7Adequate numbers of competent well trained and motivated
Workforce ‐ Education and training StaffingAdequate numbers of competent, well‐trained and motivated
technical and managerial staff are available at all levels of the diagnostic network.
‐ Staffing‐ Human resources
development strategy‐ Competency‐based job
descriptions8 Inter‐operable and inter‐connected electronic recording and
reporting systems are in place that generate reliable data that are monitored and analyzed in real time.
Diagnostics data management
‐ Diagnostics connectivity and remote monitoring
‐ Data collection forms‐ Reporting‐ Data analysis and sharingData analysis and sharing‐ Surveillance and
epidemiology‐ Security and confidentiality
of information9 Hi h lit di ti i d i t d li bl Q lit f th D t d d t9 High quality diagnostic services producing accurate and reliable
results are available throughout the network.Quality of the diagnostic network
‐ Documents and document control
‐ Quality assurance ‐ Quality management system‐ Certification and
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accreditation
2 – Methodology to measure capacitiesgy p
Questions & Capability LevelsQuestions & Capability Levels
• Standardized questions are used to assess to what degree each component meets the diagnostic network standardmeets the diagnostic network standard
• Attributes of each component are used to define 6 stages/capability levels
• Stages (0–5) measure the progress towards accomplishing a component
8/1/2018 16
Examples of Questions & Capability Levels
Description of stageComponents Questions 0 1 2 3 4 5
AlgorithmRelates to the nationally recommended tests and testing algorithm, referral and confirmation capacity as well as surveillance systems throughout the national
Is a clear national TB diagnostic algorithm available that is responsive to the epidemic, patient‐centred, based on international best practice and appropriate to the current structure of the health system?
No National diagnostic algorithms for TB are available at some laboratories but not current or complete.
National TB diagnostic algorithms and SOPs are available at all facilities in the public sector, but not current or complete.
Current national TB diagnostic algorithm available, but not at all public facilities.
Current national TB diagnostic algorithm available at all public facilities and some private labs.
Current national TB diagnostic algorithm available at all public and private facilities and regularly reviewed and updated.
diagnostic network.
Quality assurance Relates to the routine monitoring of quality (performance) indicators of TB testing.
Are quality indicators and performance measures monitored and evaluated for all TB tests?
No Quality indicators and performance measures are not routinely monitored for any TB tests.
Quality indicators and performance measures are routinely monitored for some TB tests at some tiers, but infrequently analyzed.
Quality indicators and performance measures are routinely monitored and evaluated for all TB tests at all tiers of the public sector. Results are reported to the supervisory laboratory.
Stage 3 with corrective actions routinely taken for non‐conformities identified by the quality indicators and performance measures for all tiers of public sector and some private sector.
Stage 4 for all public and private sector laboratories. Includes regular review of quality indicators and monitoring systems.
Specimen referral This relates to the coverage of the specimen referral system. Can any laboratory or facility refer any type of approved specimen to the appropriate level for testing or for confirmation according to NTP guidelines?
Are TB specimen referral and transportation systems in place at the local, regional and national levels?
No system in place fortransporting specimens between tiers. Only ad hoc transportation takes place.
A non‐structured specimenreferral system exists between some tiers in some parts of the country.
A specimen referral system isin place to transport TB specimens from lower to appropriate higher tier laboratories in less than 50% of the districts.
A specimen referral system isin place to transport TB specimens from lower to appropriate higher tier laboratories in 50‐80% of the districts.
A specimen referral systemwith national (>80% of the districts) coverage is in place to transport TB specimens from all lower to appropriate higher tier laboratories. A specimen tracking system is in place for some samples or in some part of the country.
An integrated specimenreferral system with national coverage is in place for TB specimens, connecting all tiers of the network with appropriate higher levels. A specimen tracking system is in place for multiple specimens throughout the country. The system can be used foremergency situations or for other purposes such as Proficiency panel testing distribution.
8/1/2018 17
3 – Country self-assessment y
The country should perform a self-assessment of their capacity in key The country should perform a self assessment of their capacity in key diagnostic network areas by identifying their capability stage
The self-assessment should be performed by a small technical group including representatives of the national TB program national TB reference including representatives of the national TB program, national TB reference laboratory and intermediate reference laboratories as well as other national level laboratory, program and clinical experts.
8/1/2018 18
4 –Verification of Country Self-Assessmenty
During the in-country visit, the assessment team reviews and verifies the g y ,country’s self-assessed stages for each component
Many components can be verified by reviewing documents (e.g., the NSP) provided by the national program
– The Tool contains a list of documents to review for the corresponding questions.
Stages for other questions are assessed during ‘verification’ visits to national Stages for other questions are assessed during verification visits to national, intermediate and peripheral laboratories, and during interviews with national, intermediate and peripheral program staff
– The Tool contains a list of points to verify for the corresponding The Tool contains a list of points to verify for the corresponding questions during the verification visits.
– A standard list of questions to guide the verification process for each core capacity and component is in the Tool.
8/1/2018 19
p y p
5 – Determining Capability Stagesg p y g
No.
Questions 0 1 2 3 4 5
Component 4. Algorithm Overall stage 1
1 Is a clear national TB No National National Current national Current national Current national“Weakest Link”:
1 Is a clear national TB diagnostic algorithm available that is responsive to the epidemic, patient‐centered, based on international best practice?
No Nationaldiagnostic algorithms for TB are available at some laboratories but not current or complete.
Nationaldiagnostic algorithms and SOPs are available at all facilities in the public sector, but not current or complete.
Current nationaldiagnostic algorithm available, but not at all public facilities.
Current nationaldiagnostic algorithm available at all public facilities and some private labs.
Current national diagnostic algorithms available at all public and private facilities and regularly updated.
A capability stage is determined for every ‘question’ of a component, and the overall capability2 Does the algorithm focus on
the whole diagnostic cascade, from screening to treatment completion?
No The algorithmfocuses only on the laboratory testing but is not current or complete.
The algorithmfocuses on laboratory testing and does not address the whole diagnostic cascade.
The algorithm atleast partially addresses the whole diagnostic cascade from screening to treatment completion.
The algorithmaddresses the whole diagnostic cascade from screening to treatment completion.
The algorithm addresses the whole diagnostic cascade from screening to treatment completion and is regularly updated.
and the overall capability stage assigned to the component is the lowest stage assigned to any of
3 Are diagnostic tests ordered according to standard diagnostic algorithms and based on national policy and patient risk factors and history? d patient preference)
No National TB diagnostic algorithm is followed by some clinicians in the public sector for some patient categories.
National diagnostic algorithm is followed by some public sector clinicians for all patients.
National diagnostic algorithm is followed by all clinicians in the public sector in some districts for all patient
Stage 3 with all public sector in all districts and some private sector.
Stage 4 with all public and private sector clinicians.
the questions used to evaluate that component.
g
p
categories.
4 Are health care workers provided with standardized sensitization content (e.g., algorithm diagrams, brochures, training materials)?
No Sensitization content is available at some facilities but not current or complete.
Sensitization content is available at all facilities in the public sector, but not current or complete.
Current sensitization content is available, but not at all public facilities.
Current sensitization content is available at all public facilities and some private labs.
Current sensitization content is available at all public and private facilities and regularly updated.
8/1/2018 20
5 – Determining Capability Stagesg p y gProgress towards reaching stage 5 (or 100% capability) for all components within a
b
Core Capacity 3. Coverage Component StageStandard: Coverage The national TB diagnostic network provides complete coverage and universal
Diagnostic network coverageQuestion 1 4
core capacity can be determined:1. Translate each question’s capability stage into ‘points’.
network provides complete coverage and universal access to TB diagnostic services to the whole population throughout the country. Referral mechanisms exist to rapidly and safely refer specimens upstream to the appropriate level for testing and to provide timely results to enable
Question 1 4Question 2 2Question 3 4
Sample referral systemQuestion 1 3Question 2 5 p y g p
2. Add up the points for all of the questions within the core capacity. 3 C l l t th bilit
g p yinitiation of appropriate treatment. An efficient diagnostic‐clinical interface allows for appropriate diagnostic tests to be ordered and performed and ensures the timely linkage of diagnosed patients to appropriate care and treatment.
QQuestion 3 5Question 4 2Question 5 1
LinkagesQuestion 1 3
3. Calculate the capability percentage as: [(Total number of points for all questions within a core
pp pQuestion 2 1Question 3 4
Emergency preparednessQuestion 1 4
Total 38 qcapacity) / (total number of questions x 5)] x 100. In the example, the percentage is::
8/1/2018 21
percentage is:: [38/(12x5)]x100 = 63%
6 – Key findings and priority interventionsy g p y
• A mixed methods approach is used which includes both qualitative and A mixed methods approach is used which includes both qualitative and quantitative data.
• Findings from both the site level and national level assessments should inform the team’s final findings and recommendationsinform the team’s final findings and recommendations.
• The assessment team will prepare a final report, and submit all documents to the National TB Program.
• There will be a follow-up exercise done together with the NTP/NRL in a timely manner – to ensure that priority interventions have been operationalized – and if not, that proper and specific TA is identified p , p p p
– A follow-up staging is ideal to re-prioritize interventions given the rapidly changing landscape and needs of the diagnostic network
8/1/2018 22
Next steps
The “final” version is undergoing review by a subset of GLI core team members high burden country programs and other technical experts members, high burden country programs and other technical experts.
– It will eventually be endorsed by GLI available to be used to assess any country’s TB diagnostic network.
N d t d l l t i i /t bl t f i dl f f d t – Need to develop an electronic version/tablet friendly for ease of data collection and analysis
Designing a shorter, condensed version of the Tool that will “triage” the capacities during a desk review or by a local partner, or NTP.p g y p ,
– Areas will be prioritized for a more in-depth assessment according to the standard Tool
– For example, if the country or external consultant identifies that the For example, if the country or external consultant identifies that the “coverage”, “biosafety” and “quality” capacities are weakest by doing the self-assessment,, then specific technical experts in these three areas can use the tool to assess specific components and verify the capacitiesp
8/1/2018 23
Amy Piatek Acknowledgements:
T Shi i k H idi Alb t (FIND)Bureau of Global Health, USAID,
Washington DC USA
Tom Shinnick, Heidi Albert (FIND)
Heather Alexander (CDC), Wayne van Gemert (STB/GDF)
p @ g
https://www.usaid.gov/what-we-do/global-health/tuberculosis
MoHFW/CTD India and all facilities and staff contributing to the assessment
FMoH/NTP Nigeria and all facilities and staff contributing to the assessment
GLI, GLI Africa
8/1/2018 FOOTER GOES HERE 24
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