Digital Adaptation Kit For Tuberculosis: Operational Requirements For Implementing WHO Recommendations in Digital Systems

SMART GUIDELINES
Digital
adaptation kit for
tuberculosis
Operational requirements for
implementing WHO recommendations
in digital systems
SMART GUIDELINES
Digital
adaptation kit for
tuberculosis
in digital systems
Digital adaptation kit for tuberculosis: operational requirements for implementing WHO recommendations in digital systems
ISBN 978-92-4-008661-6 (electronic version)

ISBN 978-92-4-008662-3 (print version)
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Contents
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Part 1. Overview of SMART guideline digital adaptation kits

Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Digital adaptation kits within a strategic vision for SMART guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Components of a digital adaptation kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Methods for content development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
How to use this digital adaptation kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Links to the broader digital health ecosystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Part 2. Digital adaptation kit content for tuberculosis

Component 1. Health interventions and recommendations 16
Component 2. Generic personas 19
User scenarios
c ome
To
Component 3. 24
Component 4. Business processes and workflows 32
Component 5. Core data elements 76
Component 6. Decision-support logic 84
Component 7. Indicators and performance metrics 92
Component 8. High-level functional and non-functional requirements 98
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Annexes
Annex 1. Examples of detailed personas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Annex 2. Guidance for adapting data dictionary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Implementation tools
Core data dictionary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . smart.who.int/dak/tb/dictionary
Decision-support logic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . smart.who.int/dak/tb/decision-logic
Indicators and performance metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . smart.who.int/dak/tb/indicators
Functional and non-functional requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . smart.who.int/dak/tb/system-requirements
iii
Acknowledgements
The World Health Organization (WHO) is grateful for the contributions of many individuals throughout the development of this document. This digital adaptation kit
was coordinated by Constantin Corman, Marek Lalli, Cicilia Gita Parwati and Charalampos Sismanidis, under the overall guidance of Katherine Floyd, of the WHO Global
Tuberculosis Programme (GTB); Carl Leitner, Akshita Palliwal, Natschja Ratanaprayul and Ritika Rawlani, under the overall guidance of Garrett Mehl of the WHO Digital
Health and Innovations (DHI).
The following individuals provided feedback throughout this process:
Institute for Health Measurement [IHM] Southern Africa

Kuwani Banda
Independent consultant
Filippa Pretty
WHO Global Tuberculosis Programme

Annabel Baddeley, Annemieke Brands, Marzia Calvi, Dennis Falzon, Medea Gegia, Ernesto Jaramillo, Avinash Kanchar, Alexei Korobitsyn, Cecily Miller, Fuad Mirzayev,
Carl-Michael Nathanson, Ismail Nazir, Linh Nhat Nguyen, Hazim Timimi, Samuel Schumacher, Sabine Verkuijl and Kerri Viney.
WHO Global HIV, Hepatitis and STIs Programmes

William Probert and Elena Vovc
WHO Department of Mental Health and Substance Use

Aiysha Malik
WHO Department of Sexual and Reproductive Health and Research

Rosemary Muliokela and Tigest Tamrat
This work was funded by The Global Fund to fight AIDS, Tuberculosis and Malaria through the 2021–2023 Strategic Initiative for Data: data generation and use for action
and programme improvement, The United States Centers for Disease Control and Prevention and The Rockefeller Foundation.
iv
Abbreviations
ART antiretroviral therapy MDR-TB multidrug-resistant tuberculosis
ARV antiretroviral MTB Mycobacterium tuberculosis
BMI body mass index MTBC Mycobacterium tuberculosis complex bacteria
CXR chest radiograph (chest X-ray) mWRD molecular WHO-recommended rapid diagnostic test
DAK digital adaptation kit PLHIV people living with HIV
DHIS2 District Health Information Software 2 RIF rifampicin
DMN Decision Model Notation RR-TB rifampicin-resistant tuberculosis
DR-TB drug-resistant tuberculosis SMART standards-based, machine-readable, adaptive, requirements-based

and testable
DST drug susceptibility testing
TB tuberculosis
DS-TB drug-susceptible tuberculosis
TBST Mycobacterium tuberculosis antigen-based skin test
DTDS digital tracking and decision support
TST tuberculin skin test
HMIS health management information system
TPT tuberculosis preventive treatment
Hr-TB rifampicin-susceptible, isoniazid-resistant tuberculosis
UHC universal health coverage
IGRA interferon-gamma release assay
WHO World Health Organization
LF-LAM lateral flow urine lipoarabinomannan assay
WRD WHO-recommended rapid diagnostic test
INH isoniazid
XDR-TB extensively drug-resistant tuberculosis
LFT liver function test
v
Glossary
Business A set of related activities or tasks performed together to achieve the objectives of Health An information system specifically designed to assist in the management and
process the health programme area, such as registration, counselling and referrals (1, 2). management planning of health programmes, as opposed to delivery of care (6).
information
Data A centralized repository of information about the data elements that contains system
dictionary their definition, relationships, origin, use and type of data. For this DAK, the data Inter- The ability of different applications to access, exchange, integrate and use data
dictionary is provided as a spreadsheet. operability in a coordinated manner through the use of shared application interfaces and
Data element A unit of data that has specific and precise meaning. standards, within and across organizational, regional and national boundaries,
to provide timely and seamless portability of information and optimize health
Decision- A set of decision rules for standard and exceptional cases that is separate from the
support logic outcomes.
business process. This would help reduce the complexity of the business process
depiction without losing the detail necessary for coding the rules required for Non- General attributes and features of the digital system to ensure usability and
system functionality. functional overcome technical and physical constraints. Examples of non-functional
requirement requirements include the ability to work offline, multiple language settings and
Decision- Digitized job aids that combine an individual’s health information with the health
support password protection.
worker’s knowledge and clinical protocols to assist health workers in making
(for health diagnosis and treatment decisions (3, 4). Persona A generic aggregate description of a person involved in or benefitting from a
workers)
health programme.
Decision- Semi-structured way to depict each discrete decision that will need to be
support table SMART WHO standards-based, machine-readable, adaptive, requirements-based and
embedded in the system. Depending on the complexity of the clinical guidelines, guidelines testable (SMART) guidelines.
there will likely be multiple decision-support tables.
Standard In software, a standard is a speciﬁcation used in digital application development
Digital health The systematic application of information and communications technologies,
that has been established, approved and published by an authoritative
computer science and data to support informed decision-making by individuals,
organization. These rules allow information to be shared and processed in a
the health workforce and health systems, to strengthen resilience to disease and
uniform, consistent manner independent of a particular application.
improve health and wellness (1, 5).
Task A specific action in a business process.
Digital The use of a digitized record to capture and store clients’ health information to
tracking enable follow-up of their health status and services received. This may include Terminologies For clinical care, terminologies are structured vocabularies covering health-
digital forms of paper-based registers and case management logs within specific related concepts, such as diseases, diagnoses, laboratory tests and treatments,
target populations, as well as electronic medical records linked to uniquely to enable the storage, analysis and exchange of data in a consistent and standard
identified individuals (3, 4). way (7).
Functional Capabilities the system must have to meet the end users’ needs and achieve tasks Workflow A visual representation of the progression of activities (tasks, events, decision
requirement within the business process. points) in a logical flow illustrating the interactions within the business process (2).
Health A system that integrates data collection, processing, reporting and use of the Note: Terms in the definitions also defined in this glossary are shown in italics.
information information necessary for improving health service effectiveness and efficiency
system through better management at all levels of the health services (6).
GLOSSARY REFERENCES
1. Digital implementation investment guide (DIIG): integrating digital interventions into health programmes. 5. Key terms and Theory of Change Small Working Group. Digital health & interoperability [presentation].
Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/334306). Slide 5: Consensus definition (of digital health); 2019 (https://docs.google.com/presentation/d/1TnTFaunk-
2. Public Health Informatics Institute. Collaborative Requirements Development Methodology (CRDM). In: Public 1WLlG4sKJQ_aSfjmfmivvcENil4mY4XxJs, accessed 19 May 2023).
Health Informatics Institute [website]. Decatur (GA): The Task Force for Global Health; 2016 (https://www.phii. 6. Developing health management information systems: a practical guide for developing countries. Manila:
org/crdm/, accessed 19 August 2023). World Health Organization Regional Office for the Western Pacific; 2004 (https://apps.who.int/iris/
3. WHO guideline: recommendations on digital interventions for health system strengthening. Geneva: World handle/10665/207050).
Health Organization; 2019 (https://iris.who.int/handle/10665/311941). 7. International Statistical Classification of Diseases and Related Health Problems (ICD) [website]. Geneva: World
4. Classification of digital health interventions v1.0. Geneva: World Health Organization; 2018 (https://iris.who. Health Organization; 2023 (https://www.who.int/standards/classifications/classification-of-diseases, accessed
int/handle/10665/260480). 19 August 2023).
vi
1
Part 1.
Overview
of SMART
guideline digital
adaptation kits
1
OVERVIEW
Background
Digital health – defined broadly as the systematic application of information and communications technologies, computer science and data to support informed
decision-making by individuals, the health workforce and health systems, to strengthen resilience to disease and improve health and wellness (1) – is increasingly
being applied as an essential enabler of health-service delivery and accountability. Ministries of health have recognized the value of digital health as articulated
within the World Health Assembly resolution (2) and the Global strategy on digital health (3). Likewise, donors have advocated for the rational use of digital tools
as part of efforts to expand the coverage and quality of services and promote data use and monitoring efforts (4–6). Despite the investments into and abundance of
digital systems, there is often limited transparency in the health data and logic contained in these digital tools, or the relationship with evidence-based clinical or
public health recommendations, which not only undermines the credibility of such systems, but also impedes opportunities for interoperability and threatens the
potential for continuity of care.
Evidence-based recommendations, such as those featured in World Health Organization (WHO) guidelines, establish standards of care and offer a reference point
for informing the content of digital systems that countries adopt. However, guidelines are often only available in a narrative format that requires a resource-
intensive process to be elaborated into the specifications needed for digital systems. This translation of guidelines for digital systems often results in subjective
interpretation for implementers and software vendors, which can lead to inconsistencies or inability to verify the content within these systems, potentially
leading to adverse health outcomes and other unintended effects. Where digital systems exist, the documentation of the underlying data and content may be
unavailable or proprietary, requiring governments to start from scratch and expend additional resources each time they intend to deploy such a system. This lack of
documentation of the health content can lead to dependence on one vendor and haphazard deployments that are unscalable or difficult to replicate across
different settings.
WHO standards-based, machine-readable, adaptive, requirements-based and testable (SMART) guidelines provide essential ingredients to facilitate digital health
transformation of health programmes in a way that is consistent with recommended clinical, public health and data practices and interoperability standards. As
a type of SMART guideline, digital adaptation kits (DAKs) are designed to facilitate the accurate reflection of WHO’s clinical, public health and data use guidelines
within the digital systems countries are adopting. DAKs are operational, software-neutral, standardized documentation that distils clinical, public health and data
use guidance into a format that can be transparently incorporated into digital systems. Although digital implementations comprise multiple factors, including
(1) health domain data and content, (2) digital intervention or functionality, and (3) digital application or communication channel for delivering the digital
intervention, DAKs focus primarily on ensuring the validity of the health content (Fig. 1) (1, 7). Accordingly, DAKs provide the generic content requirements that
should be housed within digital systems, independently of a specific software application and with the intention that countries can customize them to local needs.
2 Digital adaptation kit for tuberculosis

For this particular DAK, the requirements are based on
OVERVIEW
systems that provide the functionalities of digital tracking Fig. 1
and decision support (DTDS) (Box 1) and include components
such as personas, workflows, core data elements, decision- Digital adaptation kits and their role within digital health
support algorithms, scheduling logic and reporting indicators. implementations
Operational outputs, such as spreadsheets of the data
dictionary and the detailed decision-support algorithms,
are included as part of the DAK as practical resources that HEALTH CONTENT
implementers can use as starting points when developing Information that is aligned DIGITAL
with recommended health DIGITAL HEALTH APPLICATIONS
+ +
digital systems. Furthermore, data components within the practices or validated health INTERVENTIONS ICT systems and
content A discrete function of digital communication channels
DAK are mapped to standards-based terminology, such SMART GUIDELINES technology to achieve that facilitate delivery of the
health-sector objectives digital interventions and
as the International Classification of Diseases, to facilitate Digital
adaptation kit for health content
tuberculosis
interoperability. Operational requirements for
in digital systems
DAKs follow a modular approach in detailing the data and

content requirements for a specific health programme area,
such as antenatal care and HIV, among the different health
areas for which DAKs have been developed. This DAK focuses Foundational Layer: ICT and enabling environment
on providing the content requirements for a digital tracking LEADERSHIP & GOVERNANCE
and decision-support system used in primary health care
STRATEGY AND SERVICES AND LEGISLATION, WORKFORCE
settings by health workers for tuberculosis (TB). INVESTMENT APPLICATIONS POLICY AND
COMPLIANCE
STANDARDS AND
INTEROPERABILITY
INFRASTRUCTURE
ICT: information and communications technology.
Overview 3
OVERVIEW
Box 1
What is DTDS?
Digital tracking is the use of digitized records to capture and store clients’ health information to enable follow-up of their
health status and services received (8). This may include digital forms of paper-based registers and case management logs
within specific target populations, as well as electronic patient records linked to uniquely identified individuals (7, 8).
Digital tracking makes it possible to register and follow up patient services, and may be done through an electronic medical record or other digital forms of health
records. Digital tracking aims to reduce lapses in continuity of care by stimulating timely follow-up
Digital contacts, and may incorporate decision-support tools to guide
health
Expected
health workers in executing clinical protocols to deliver appropriate care; scheduling upcoming services; and following checklists for appropriate case management
intervention
Contribution
at point of care. Some other descriptors include: digital versionstoof universal
paper-based (accessible
registers
health at ahealth Recommendation
for specific domains; digitized registers for longitudinal health
coverage (UHC) minimum via mobile
programmes, including tracking of migrant populations’ benefits and health status; and case
devices) management logs within specific target populations, including migrant
populations (8).
Contact coverage Targeted client Recommendation 6: WHO recommends digital targeted client
communication communication for health issues knowledge
regarding sexual,
Health worker decision support is defined as digitized job aids that combine an individual’s health information
Continuous with the health worker’s andreproductive,
clinical
coverage maternal, newborn, and child health under the condition that
protocols to assist health workers in making diagnosis and treatment decisions (8). Thus, a person-centred DTDS system is one used by health workers at the point of
potential concerns about sensitive content and data privacy can be
care; it includes a persistent record of health events and encounters that links to clinical decision-support systems to reinforce good practice. It also links to reporting
addressed
and management tools to reinforce accountability. A DTDS record includes all the information required for detailing an individual’s
(Recommended health
only in specific status
contexts and the health
or conditions)
interventions provided to them.
Effective coverage Health worker Recommendation 7: WHO recommends the use of digital decision
DTDS end users are all cadres of health workers operating at all care levels, including those operating
decision supportoutside formal
support health-care
accessible facilities
via mobile (e.g.
devices forcommunity
community and health
facility-
workers, health volunteers). DTDS systems emphasize the use of “collect once, use for many purposes” (9), in which data collected for service delivery can also be
based health workers in the context of tasks that are already used
defined
within the scope of practice for the health
for accountability (i.e. they can be used to calculate aggregate indicators required for reporting, including monitoring provider, stock and system performance).worker.
(Recommended only in specific contexts or conditions)
WHO has provided the following
context-specific recommendation for Effective coverage Digital tracking of Recommendation 8: WHO recommends digital tracking of clients’
clients’ health status health status and services, combined with decision support under
the use of an integrated system that Accountability and services (digital
coverage these conditions:
provides both a digital track of client’s tracking) combined
with decision Ⱥ in settings where the health system can support the
health status and decision support (7). support implementation of these intervention components in an integrated
manner; and
Ⱥ for tasks that are already defined as within the scope of practice for
the health worker.
(Recommended only in specific contexts or conditions)
Effective coverage Digital tracking Recommendation 9: WHO recommends the use of digital tracking
combined with: combined with decision support and targeted client communication
Accountability
coverage (a) decision under these conditions:
4 support and Digital adaptation kit for tuberculosis
Ⱥ where the health system can support the implementation of these
Continuous (b) targeted client intervention components in an integrated manner;
OVERVIEW
Digital adaptation kits within a strategic vision for SMART guidelines
The operational and standardized documentation reflected within the DAKs represents one of the steps within a broader vision of standards-based, machine-
readable, adaptive, requirements-based and testable (SMART) guidelines. SMART guidelines aim to maximize health impact through improved fidelity and uptake of
recommendations within standards-based digital systems through a systematic process for transforming guideline development, delivery and application (10, 11).
Within this vision, DAKs serve as a prerequisite for developing computable, or machine-readable, guidelines, as well as executable reference software and advanced
analytics for precision health. Fig. 2 provides an overview of the different layers of the SMART guideline continuum and where DAKs fit within this strategy (10).
Fig. 2
Progressive layers across SMART guideline components
Paper
systems Narrative Evidence-based guideline recommendations and accompanying
L1 Narrative guidelines implementation and data guidance
SMART GUIDELINES
Human-readable software-neutral documentation of operational and

Digital Digital
functional requirements (e.g. personas, workflows, relevant metadata,
L2 Operational
adaptation kit for
adaptation
tuberculosis
transparently documented algorithms, minimum data sets, priority metrics,

kits
in digital systems
listing of relevant health interventions, functional requirements)
Machine-
Machine </>
readable
Structured software-neutral specifications, code, terminology and
L3 readable interoperability standards
recommendations
Reference Software that is able to execute static algorithms and interoperable digital
L4 Executable software components to deliver the operational and functional requirements
Precision
Executable dynamic algorithms that are trained and optimized with
Smart L5 Dynamic
health
advanced analytics to achieve prioritized outcomes
model
digital
systems
Overview 5
OVERVIEW
Objectives
This DAK focuses on TB and aims to provide a common language across several audiences – TB programme managers, software developers and implementers of
digital systems – to ensure a common understanding of the appropriate health information content within a defined health programme area, as a mechanism to
catalyse the effective use of these digital systems. The key objectives of the DAK are:
» to ensure adherence to WHO clinical, public health and data use guidelines, and facilitate consistency of the health content that is used to inform the
development of a person-centred DTDS system;
» to enable both health programme leads and digital health teams (including software developers) to have a joint understanding of the health content within
the digital system, with a transparent mechanism to review the validity and accuracy of the health content; and
» to provide a starting point of the core data elements and decision-support logic that should be included within DTDS systems for TB.
Information detailed in this DAK reflects generic workflow processes, data and decision-support algorithms, as derived from TB and other related WHO documents
described below. Note that the outputs of the DAKs are intentionally generic and will need to be contextualized to local policies and requirements.
DAKs have also been developed for antenatal care, family planning and HIV, and this approach is being expanded to additional health domains, such as
immunizations, postnatal care and child health. All of these DAKs work towards a comprehensive approach for standardized software requirements for primary
health care settings.
Components of a digital adaptation kit

The DAK consists of eight interlinked components: (1) health interventions and recommendations; (2) generic personas; (3) user scenarios; (4) generic business
processes and workflows; (5) core data elements; (6) decision-support logic; (7) indicators and performance metrics; and (8) high-level functional and non-
functional requirements. Table 1 provides an overview of each of the contributing components of the DAK, which this document then elaborates. All information
within the adaptation kit represents a generic starting point, which can then be adapted according to the specific context. Box 2 provides notation guidance that is
used in the Web annexes.

Table 1 Overview of DAK components
OVERVIEW
Component Description Purpose Outputs Adaptation needed
Overview of the health interventions and Setting the stage to » List of related health » Contextualization to
1. WHO recommendations included within this understand how this interventions based on reflect current or planned
DAK. DAKs are meant to be a repackaging and DAK would be applied WHO’s UHC essential national policies
Health integration of WHO guidelines and guidance to a DTDS system in interventions
interventions documents in a particular health domain. the context of specific » List of related WHO
and The list of health interventions is drawn from health programmes and recommendations
recommendations the universal health coverage (UHC) menu of
interventions compiled by WHO (12).
interventions based on guidelines and
guidance documents
Depiction of the end users, supervisors and Contextualization to » Description, competencies » Greater specification and
related stakeholders who would be interacting understand the wants, and essential details on the end users
with the digital system or involved in the care needs and constraints of interventions performed based on real people (e.g.
pathway. the end users by targeted personas health workers) in a given
2. context
» High-level information
Generic to describe the provider
personas of the health service (e.g.
the general background,
roles and responsibilities,
motivations, challenges
and environmental factors)
Contextualization to » Example narrative of how

3. Narratives that describe how the different
personas may interact with each other. The user understand how the the targeted personas may
» Greater specification and
details on the real needs
User scenarios are only illustrative and are intended
to give an idea of a typical workflow.
system would be used,
and how it would fit into
interact with each other
during a workflow
of end users in a given
context
scenarios existing workflows
A business process is a set of related activities Contextualization » Overview matrix » Customization of the
4. or tasks performed together to achieve the and system design to presenting the key workflows, which can
objectives of the health programme area, such understand how the digital processes in TB care include additional forks,
Generic as registration, diagnosis and referral (1, 13). system would fit into » Workflows for identified alternative pathways or
business Workflows are a visual representation of the existing workflows and business processes with entirely new workflows
processes and progression of activities (tasks, decision points, how best to design the annotations
workflows interactions) that are performed within the system for that purpose
business process (1, 13).
Overview 7
OVERVIEW
Component Description Purpose Outputs Adaptation needed
Data elements that are required throughout the System design and » List of data elements » Translation of data labels
different points of the workflow. interoperability to know » Link to data dictionary into the local language and
5. These data elements are mapped to the which data elements
need to be logged and
with detailed data additional data elements
created depending on the
International Classification of Diseases 11th specifications in
Core data revision codes and other established concept how they map to other
standard terminologies
spreadsheet format context
elements mapping standards to ensure that the data

dictionary is compatible with other digital (e.g. ICD, SNOMED) for
(available here).
systems. interoperability with other

standards-based systems
Decision-support logic and algorithms to System design » List of decisions that need » Change of specific
support appropriate service delivery in and adherence to to be made throughout thresholds or triggers in a
accordance with WHO clinical, public health and recommended clinical the encounter logic (IF/THEN) statement,
6. data use guidelines. practice to know what » Link to decision-support for example, BMI cut off,
underlying logic needs to tables in spreadsheet age trigger for youth-
Decision- be coded into the system format with inputs, friendly services
support outputs and triggers for » Additional decision-
logic each decision-support support logic formulae
logic (available here) depending on the context
» Link to scheduling logic for
services (available here)
Core set of indicators that need to be aggregated System design » Link to indicators table » Changing the calculation
7. for decision-making, performance metrics, and
subnational and national reporting.
and adherence to
recommended health
with numerator and
denominator of data
formulae of indicators
» Adding indicators
Indicators These indicators and metrics are based on data monitoring practices to elements for calculation,
» Changing the definition of
and that can feasibly be captured from a routine know what calculations
and secondary data use
along with appropriate
disaggregation
the primary data elements
performance digital system, rather than survey-based tools.
are needed for the system, (available here)
used to calculate the
metrics based on the principle of
indicator based on the
available data
collect once, use many (9)
List of core functions and capabilities the system System design to know » Link to functional » Adding or reducing
8. must have to meet the end users’ needs and what the system should be and non-functional functions and system
achieve tasks within the business process. able to do requirements tables with capabilities based on
High-level the intended end user of budget and end user needs
functional and each requirement, and and preferences
non-functional why that user needs that
requirements functionality in the system
(available here)
BMI: body mass index; ICD: International Classification of Diseases; SNOMED: Systematized Nomenclature of Medicine.

OVERVIEW
Box 2
Notation guidance
Throughout the DAK, there are identification numbers to simplify tracking and referencing each of the components. Note that the DAK represents an overview across
the different components, while the comprehensive and complete outputs of each component (e.g. data dictionary, decision-support tables) are included in the
appended spreadsheets. The notation guidance is as follows.
Component 1: Health interventions and recommendations Component 6: Decision-support logic

No notations used. » Each decision-support logic table should have a “decision-support table
(DT) ID” that should be structured as “activity ID” and “DT” (e.g. TB.B3.DT,
Component 2: Generic personas TB.B5.DT).
No notations used.
Component 7: Indicators and performance metrics
Component 3: User scenarios » Each indicator should have an “indicator ID” that should be structured as
No notations used. “abbreviated health domain”, “IND” and the “sequential number of the
indicator” (e.g. TB.IND.1, TB.IND.2).
Component 4: Business processes and workflows
» Each workflow should have a “process name” and a corresponding letter. Each Component 8: High-level functional and non-functional requirements
workflow should also have a “process ID” that should be structured as the » Each functional requirement should have a “functional requirement ID”
“abbreviated health domain” and “corresponding letter for the process” that should be structured as “abbreviated health domain”, “FXNREQ”
(e.g. TB.B). and “sequential number of the functional requirement” (e.g. TB.FXNREQ.1,
» Each activity in the workflow should be numbered with an “activity ID” that TB.FXNREQ.2).
should be structured as “process ID” and “activity number” (e.g. TB.B7). » Each non-functional requirement should have a “non-functional requirement
ID” that should be structured as “abbreviated health domain”, “NFXNREQ”
Component 5: Core data elements (data dictionary)
and “sequential number of non-functional requirement” (e.g. TB.NFXNREQ.1,
» Each data element should have a “data element (DE) ID” that should be
TB. NFXNREQ.2).
structured as “activity ID”, “DE” and “sequential number of the data element”
(e.g. TB.B7.DE.1, TB.B7.DE.2).
Overview 9
OVERVIEW
Methods for content development

A mapping of existing WHO guidelines, guidance and tools relevant for the development of a DAK for TB was carried out first. Key resources that were identified
included all WHO TB-related clinical guidelines and their associated operational handbooks, relevant TB guidance documents and the specifications for existing
digital tools, such as the PREVENT TB app and WHO District Health Information Software 2 (DHIS2) aggregate and case-based packages for TB surveillance.
Upcoming WHO TB guidelines and guidance documents were also considered to ensure that the TB DAK will remain relevant in the context of upcoming
recommendations.
A desk review of the above resources was conducted, where the recommendations from clinical guidelines were extracted and synthesized to form the components
of the TB DAK. This process also guided the development of the workflows for key TB programmatic and data processes, decision-support logic algorithms and
a data dictionary. The indicators and performance metrics included in the TB DAK were informed by the TB surveillance guidance. The data elements required
to calculate the indicators and to build the algorithms in the decision-support logic were based on the relevant clinical guidelines and TB surveillance guidance
document. The data elements were mapped onto standardized terminologies and classifications by a medical terminologist to facilitate the adoption of
interoperability standards into digital systems.
All components of this TB DAK were refined through a series of in-depth technical consultations with relevant teams from the Global Tuberculosis Programme,
which were responsible for developing the WHO guidelines and guidance used to guide the development of this DAK; DAKs are derivative guidance documents to
support the implementation of WHO guidelines and guidance in digital systems. These teams also reviewed and validated the sections of the TB DAK relevant to
their area of expertise to ensure that each component reflects the narrative in WHO guidelines and guidance.
Other published DAKs, including the team responsible for their development, were consulted as needed to ensure alignment across the SMART guidelines programme.

OVERVIEW
How to use this digital adaptation kit
Target audience
The primary target audience for this DAK is health programme managers within the ministry of health, who will be working with their digital or health information
system counterparts in determining the health content requirements for a TB DTDS system. The health programme manager is responsible for overseeing and
monitoring the implementation of the clinical practices and policies for the health programme area, in this case TB.
The DAK also equips individuals responsible for translating health system processes and guidance documents for use within digital systems with the necessary
components to kick-start the process of developing a DTDS system in a standards-compliant manner. These individuals are also known as business analysts who
interface between health content experts and software development teams. Specifically, the DAK contains key outputs, such as the data dictionary and decision-
support algorithms, to ensure the validity and consistency of the health content with the DTDS system.
Additionally, using this DAK requires a collaboration between health programme managers responsible for TB and counterparts in digital health and health
information systems. Although each DAK focuses on a particular health programme area (in this case TB), DAKs are envisioned to be used in a modular format and
link to other health programme areas within primary health care settings, in an effort to support integration across services.
Scenarios for using the DAK

The DAK may be used across several scenarios, some of which are listed here.
Scenario 1 Countries that already have digital systems in place, such as electronic medical records and decision-support tools, may use the
Incorporating WHO guideline information in the DAK to cross-check whether the underlying content and data for specific health programme areas are aligned
content into existing DTDS
to WHO guidelines. Users of the DAK can identify and extract specific decision algorithms that would need to be incorporated into
systems
their existing digital systems. By reviewing this systematic documentation, health programme managers and implementers can
more readily identify differences in workflows, data inputs and decision-support logics to examine the rationale for deviations
and understanding local adaptations of guideline content.
Overview 11
OVERVIEW
Scenario 2 Some countries may currently have paper-based systems that they would like to digitize. The process of optimizing paper-based
Transitioning from paper to client-level systems into digital records and decision support may be overwhelming. Users in this scenario may review the DAK
DTDS systems
as a starting point for streamlining the necessary data elements and decision support that should be in the optimized client-level
digital system. Users may also then refer to the paper-based tools to determine whether there are missing fields or content that
should also be included within the digital system.
Users should also review the WHO Digital transformation handbook for primary health care (14), which provides stepwise
guidance on how to map data on paper-based forms into a digital system, including ways of accounting for data elements that are
redundant or may not add value to the health system.
Scenario 3 In some instances, countries may already have a digital system for aggregate reporting and HMIS, but may not yet have
Linking aggregate health implemented digital systems that function at the service delivery level. The DAK can guide the development of a digital client
management information
record system that operates at point of care, and ensure that there are links between the aggregate and service delivery levels
system (HMIS) (e.g. DHIS2) to
DTDS systems used at point of (e.g. community or facility level).
care
As such, a component of the DAK provides aggregate indicators derived from individual-level data to provide the link between
these different levels. Complementary guidance dedicated specifically to aggregate-level data, such as WHO consolidated
guidance on tuberculosis data generation and use – Module 1: Tuberculosis surveillance (15), should also be consulted for
supporting the use of routine data at the facility management and district levels.
Scenario 4 This DAK includes data elements mapped to International Classification of Diseases (ICD) codes, and other standards, to support
Leveraging data standards to the design of interoperable systems. The data dictionary provides the necessary codes for the different data elements, thus
promote interoperability and
reducing the time for implementers to incorporate these global standards into the design of their digital systems.
integrated systems
In addition, a critical part of service delivery in any health domain relies on engaging with clients. Digital interventions aimed at
clients themselves, such as on-demand information services, targeted client communication (e.g. transmitting health information
and reminders), reporting of health system feedback by clients on the quality of care, accessing their own medical records and
home-based records, and self-monitoring of their health and diagnostic data (8), are all emerging approaches for complementing
the services provided by health workers.

OVERVIEW
Links to the broader digital health ecosystem
DAKs represent one piece of Fig. 3

the resources in the broader
digital health ecosystem Digital adaptation kits within the broader digital health ecosystem
and should be used once
there is a strategic vision STEPS
by the ministry of health PHASE ASSESSING THE + Conduct an inventory of existing or previously used Global Digital
CURRENT STATE software applications, ICT systems and other tools WHO HIS stages of
01
digital health
to use a DTDS system. AND ENABLING to better understand the requirements for reuse and digital
health atlas
health investment
continuous
improvement
ENVIRONMENT interoperability monitor review tool
In contexts where such
vision may not exist, ESTABLISHING + Develop a national digital health strategy outlining WHO–ITU WHO WHO
PHASE A SHARED overarching needs, desired activities and outcomes national guideline: classification Principles Principles for
users should first consult
02 UNDERSTANDING eHealth of digital for donor digital
recommendations
AND STRATEGIC + Define a vision for how the health system will be strategy
on digital
interventions for health alignment development
PLANNING strengthened through the use of digital technology
the WHO–International
health system
toolkit strengthening interventions
Telecommunication + Formulate a digital health investment roadmap to Digital UNICEF

PHASE support the national digital health strategy Square human-
Union National eHealth DEFINING THE WHO digital
strategy toolkit (16), WHO

03 FUTURE STATE + Plan and identify appropriate digital interventions,
alongside the health and data content, to improve health
system processes and address programmatic needs Digital ITU SDG
ITU digital
global
goods
guidebook
centred
design
toolkit
clearing-
house
implemen- digital
health
investment
Recommendations on + Review the current state and develop an architecture tation
investment framework
platform
handbook
blueprint for the design of the digital health Open
guide (eGov) The Open
Guidance World Bank
digital interventions for PHASE PLANNING THE implementations Health Group
04 ENTERPRISE for investing digital

Information Architecture
ARCHITECTURE + Identify validated open standards to ensure data Exchange Framework
in digital identity
health system strengthening exchange, systems integration and future-proofing of (Open HIE) (TOGAF)
health toolkit
digital health implementations
(7) and the WHO Digital WHO Be
+ Identify validated health content appropriate for the WHO SMART guidelines
implementation investment PHASE DETERMINING implementation context
handbook
WHO core He@lthy,
05 HEALTH CONTENT for Digital Machine- Be Mobile

indicator
REQUIREMENTS + Ensure use of content aligned with identified standards digitalizing adaptation readable handbooks
guide (1) to establish a for the future state primary kits recommen-
sets for non-
communicable
health care (this document) dations diseases
better understanding of
M&E OF DIGITAL
+ Monitor implementation to ensure digital PATH
MEASURE
how to select and apply PHASE HEALTH implementations are functioning as intended and WHO Defining
data
06 IMPLEMENTATIONS having the desired effect M&E and

demand WHO SCORE
digital health building a
appropriate digital health AND FOSTERING
DATA USE + Foster data-driven adaptive change management within interventions data use
and use of
resources
the overall health system culture
interventions. Fig. 3 situates
WHO Asian
DAKs within the broader set PHASE IMPLEMENTING, + Maintain and sustain digital health implementations
MAPS toolkit: Development
07 MAINTAINING AND mHealth Bank total

of resources for planning SCALING + Identify risks and appropriate mitigations assessment
and planning
cost of
ownership
PDF for print
Online environment
for scale tool
and implementing digital
ICT: information and communications technology; ITU: International Telecommunication Union; M&E: monitoring and
health systems. evaluation; MAPS: mHealth Assessment and Planning for Scale; SDG: Sustainable Development Goal.
Source: Adapted from WHO (1).
Overview 13
OVERVIEW
2
Part 2.
Digital
adaptation kit
content for
tuberculosis
Overview 15
1
recommendations
Health interventions
Component and recommendations
personas
This DAK focuses on the following health interventions and recommendations related to TB.
scenarios
1.1 Interventions referenced in this DAK

The key interventions for TB referenced in this DAK, as defined in the WHO » Case detection and diagnosis of tuberculosis by using:
universal health coverage (UHC) list of essential interventions and WHO TB – targeted history and physical examination for TB;
workflows
guidelines and guidance documents, are the following. – laboratory work;

– imaging studies;
» Prevention by implementing:
– diagnostic procedures.
– Bacillus Calmette–Guérin vaccination based on individual characteristics;
– social protection and poverty alleviation measures and actions on » Management of TB by means of:
data
determinants of TB (17);
– non-pharmacological treatments;
– TB preventive treatment (TPT), preferably using shorter regimens.
– oral medications;
decisions
» Screening by means of: – injectable agents;

– procedures (including surgeries);
– active case-finding for TB among at-risk populations;
– management of TB and comorbidities;
– screening for tuberculosis among clinically at-risk groups and vulnerable
populations to exclude active TB disease. – rehabilitation services;
– treatment monitoring.
indicators
requirements

recommendations
1.2 WHO guidelines, recommendations and guidance
DAKs are intended to reflect health recommendations and content that has already been published in WHO guidelines and guidance documents. The health content
and interventions for this DAK are based on the following WHO documents.
personas
WHO consolidated WHO consolidated
WHO consolidated WHO consolidated
guidelines on guidelines on tuberculosis
guidelines on tuberculosis guidelines on tuberculosis
tuberculosis – Module 1: – Module 3: diagnosis
– Module 1: prevention – Module 2: screening
prevention (tuberculosis (rapid diagnostics for
(infection prevention and (systematic screening for
preventive treatment) tuberculosis detection
control) (19) tuberculosis disease) (20)
(18) 2021 update) (21)
scenarios
WHO consolidated
WHO consolidated WHO consolidated WHO consolidated
guidelines on
guidelines on tuberculosis guidelines on tuberculosis guidelines on tuberculosis
tuberculosis – Module
– Module 4: treatment – Module 4: treatment – Module 4: treatment
3: diagnosis (tests for
(drug-resistant tuberculosis (drug-susceptible (tuberculosis care and
tuberculosis infection)
workflows
treatment, 2022 update) (23) tuberculosis treatment) (24) support) (25)
(22)
Consolidated guidance on
tuberculosis data generation and use
Module 1
WHO consolidated Joint WHO/ILO policy Tuberculosis surveillance
WHO consolidated
guidelines on guidelines on improving
Guideline: nutritional care guidance on tuberculosis
tuberculosis – Module health worker access to
and support for patients data generation and use
data
5: management of prevention, treatment and
with tuberculosis (28) – Module 1: tuberculosis
tuberculosis in children care services for HIV and TB
surveillance (15)
and adolescents (26) (27)
decisions
indicators
requirements
Health interventions and recommendations 17
recommendations
Other WHO documents represented in the DAK include:
» WHO operational handbook on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (29)
» Tuberculosis laboratory biosafety manual (30)
» WHO operational handbook on tuberculosis – Module 2: screening (systematic screening for tuberculosis disease) (31)
» WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid diagnostics for tuberculosis detection, 2021 update) (32)
personas
» WHO operational handbook on tuberculosis – Module 3: diagnosis (tests for tuberculosis infection) (33)
» WHO operational handbook on tuberculosis – Module 4: treatment (drug-resistant tuberculosis treatment, 2022 update) (34)
» WHO operational handbook on tuberculosis – Module 4: drug-susceptible tuberculosis treatment (35)
» WHO operational handbook on tuberculosis – Module 4: treatment (tuberculosis care and support) (36)
scenarios
» WHO operational handbook on tuberculosis – Module 5: management of tuberculosis in children and adolescents (37)
» Framework for collaborative action on tuberculosis and comorbidities (38)
» Ethics guidance for the implementation of the End TB strategy (39)
» WHO operational handbook on tuberculosis – Module 6: tuberculosis and comorbidities – mental health conditions (40)
workflows
» Policy brief on tuberculosis-associated disability (41)

data
decisions
indicators
requirements

2
recommendations
Component
Generic personas
personas
A persona is a depiction of a relevant stakeholder, or end user, of the system. Although the specific roles and demographic profiles of the personas will vary
depending on the setting, generic personas are based on WHO core competencies and credentials of different health worker personas. Please note that these
scenarios
are developed based on synthesis across multiple contexts as a starting point; further contextualization will be required according to the needs, motivations and
challenges of the targeted personas in each setting. The personas providing care, described in Table 2, might be practising activities in private, public or both type of
health clinics.
workflows
2.1 Targeted generic personas
In the case of TB, physicians, nurses and clinical officers are the primary personas for the digital client health record and decision-support system. In the health
systems surveyed for this DAK, the common combination of service providers was a physician along with a nurse. The key competences of physicians, nurses and
clinical officers are defined by WHO (Table 2) (42).
data
decisions
indicators
requirements
19
recommendations
Table 2 Descriptions of key generic personas
Occupational Description Different names International Standard for

title Classification of Occupations code (43)
Physician A legally qualified and licensed practitioner of medicine, concerned with maintaining or restoring Family doctor, general practitioner, 2211 (generalist medical practitioner)
human health through the study, diagnosis and treatment of disease and injury, through the medical doctor, specialist doctor 2212 (specialist medical practitioner)
science of medicine and the applied practice of that science. A medical doctor requires training (e.g. paediatrician, pulmonologist,
personas
in a medical school. Depending on the jurisdiction and on the university providing the training, psychiatrist), non-specialist doctor
these may be either undergraduate- or graduate-entry courses. Gaining a basic medical degree
may take 5–9 years, depending on the jurisdiction and the university providing the training.
Nurse A graduate who has been legally authorized (registered) to practise after examination by a state Registered nurse, nurse practitioner, 2221 (nursing professionals)
board of nurse examiners or similar regulatory authority. Education includes 3, 4 or more years in clinical nurse specialist, advance
nursing school, and it leads to a university or postgraduate university degree, or the equivalent. practice nurse, practice nurse,
scenarios
A registered nurse has the full range of nursing skills. licensed nurse, diploma nurse, BS
nurse, nurse clinician
Clinical Health professionals who provide advisory, diagnostic, curative and preventive medical services Primary care paramedic, advanced 2240 (paramedical practitioners)
officer more limited in scope and complexity than those carried out by medical doctors. They work care paramedic
autonomously or with limited supervision of medical doctors, and perform clinical, therapeutic
and surgical procedures for treating and preventing diseases, injuries and other physical or
workflows
mental impairments common to specific communities.
BS: Bachelor of Science.
2.2 Related personas

data
In addition to the targeted personas detailed in Table 2, there may be value in exploring other cadres and personas within the context of TB services, such as
laboratory technicians or community health workers. However, these were not identified as the central personas for the data and decision-support content detailed
decisions
in this DAK. Additional related personas are listed in Table 3.
Table 3 Descriptions of related personas
Name Description Different names (if relevant) International Standard

for Classification of
indicators
Occupations code (if

relevant) (43)
Client In the context of this document, a client is a person who is given medical care, which may include TB prevention, Patient, health service user, N/A
screening, diagnosis, care or treatment services. Clients may be TB-confirmed, TB-presumptive or they may not individual seeking care, person
know their TB status. with TB
requirements

recommendations
relevant) (43)
At-risk group A member of an at-risk group is someone who manifests an increased risk of progression from TB infection to Vulnerable groups N/A
active TB disease, due to specific clinical conditions, social conditions or the activities this person performs.
At-risk groups also often have legal and social issues related to their behaviours that increase their vulnerability
personas
to TB.
Three key populations are included in this kit: (1) people living with HIV; (2) contacts (household contacts or
close contacts); (3) other people at risk (people who are initiating anti-tumour necrosis factor treatment, or
receiving dialysis, or preparing for an organ or haematological transplant, or who have silicosis, prisoners,
health workers, immigrants from countries with a high TB burden, homeless people, people who use drugs,
people with diabetes, people who engage in the harmful use of alcohol, tobacco smokers and underweight
scenarios
people). At-risk groups are important to the dynamics of TB transmission and are essential partners in an
effective response to the epidemic.
Contact A contact is any individual who has been exposed to a person with TB disease. Household contact, close contact N/A
There are two types of contacts.
(1) Close contact, that is, a person who is not in the household but has shared an enclosed space, such as at a
social gathering, workplace or facility, for extended periods during the day with the index patient during the 3
workflows
months before commencement of the current TB treatment episode.
(2) Household contact, that is, a person who has shared the same enclosed living space as the index case (the
initially identified person of any age with new or recurrent TB) for one or more nights or for frequent or extended
daytime periods during the 3 months before the start of current treatment (29).
Community Community health workers provide health education, referral and follow-up; case management and basic Health extension worker, 3253 (community health
health preventive health care; and home visiting services to specific communities. They provide support and assistance community health volunteer, workers)
data
worker to clients seeking TB-related services and their families in navigating the health and social services system. village health worker, treatment 3259 (health associate
supporter, outreach worker, lay professionals not classified
health worker, peer counsellor elsewhere)
Counsellor A person who provides counselling, therapy and mediation services to individuals, families, groups and Psychotherapist, psychologist, 2634 (psychologists)
decisions
communities in response to social and personal difficulties. They assist clients to develop skills and access social worker 2635 (social work and
resources and support services needed to respond to issues arising from health problems, life transitions, counselling professionals)
addictions and other personal, family and social problems. They liaise with other social service agencies,
educational institutions and health-care providers to advocate for client and community needs. They have a
key role in palliative care, which represents the prevention and relief of the physical, psychological, social and
spiritual suffering of adults and children with serious illnesses and offering psychosocial support services for
indicators
their families.
Laboratory A person who performs clinical tests on specimens of bodily fluids and tissues to get information about Medical laboratory technician, 3212 (medical and
technician the health of a patient or cause of death. They use approved assays (e.g. phenotypic culture-based, line- pathology laboratory technician, pathology laboratory
probe assays) and operate equipment such as microscopes, polymerase chain reaction machines and flame medical laboratory assistant, technician3)
photometers for analysis of biological material including sputum, stool, blood, urine, pleural fluid, cerebrospinal pathology technician, laboratory
fluid and respiratory samples. This category includes occupations for which competent performance usually personnel, laboratory worker
requirements
requires formal training in biomedical science, medical technology or a related field.
Generic personas 21
recommendations

relevant) (43)
Pharmacist Pharmacists store, preserve, compound and dispense medicinal products. They counsel on the proper use Chemist, clinical pharmacist, 2262 (pharmacists)
and adverse effects of drugs and medicines following prescriptions issued by medical doctors and other community pharmacist, hospital
health professionals. They contribute to researching, testing, preparing, prescribing and monitoring medicinal pharmacist, retail pharmacist,
personas
therapies for optimizing human health. dispensing chemist

Health A manager supervising the monitoring system to track quality of care and data. This person provides a link District health manager, health 1342 (health service
information between the health centre and central level to ensure that patient monitoring needs are met (e.g. adequate management information systems manager)
officer staffing, tools and other resources) and implements changes to data standards or norms. focal point, monitoring and
evaluation focal point, facility
supervision manager, district
scenarios
health information officer, national

monitoring and evaluation officer
Data entry An individual who helps to record, organize, store, compute and retrieve information, including patient records Data capturer 4132 (data entry clerks)
clerk and registers. The knowledge and skills required are usually obtained through on-the-job training but may
include post-secondary education. Clerks may also transcribe data, tally data, fill in routine reports and review
the quality of data with others.
workflows
Medical office An individual responsible for receiving and welcoming visitors, guests or clients; making appointments for General office clerk, general 4226 (receptionists
receptionist clients; dealing with telephone requests for information or appointments; directing clients to an appropriate receptionist, accounts clerk, [general])
location or person; supplying information pamphlets, brochures or forms. Skills required: relatively advanced health insurance clerk, medical
literacy and numeracy skills, good interpersonal communication skills and a high level of manual dexterity. appointments schedule clerk
The knowledge and skills required are usually obtained because of secondary education and, in some cases,
specialized post-secondary vocational education or prolonged on-the-job training.
data
2.3 Additional considerations for contextualizing personas

decisions
Although this section provides an overview of the generic roles of the targeted personas, it is important to contextualize these personas to your setting. The generic
personas described in Tables 2 and 3 can be supplemented by reflecting on these additional considerations:
» Background and demographics: for example, sex, age, whether they are from the community, familiarity with digital devices, whether they own a mobile
phone or smartphone.
indicators
» Local environment and any relevant contextual information about their surroundings: for example, work-site characteristics; rural or urban; availability of
electricity, water, internet; distance from nearest referral facility.
» Expected roles and responsibilities: What are the expected roles and responsibilities based on the country context? How does this differ from the roles and
responsibilities defined by WHO?
requirements
» Actual roles and responsibilities: What are their actual roles and responsibilities, if there is any difference from what is expected?

recommendations
» Context: What is the level of internet connectivity? How are they compensated? How far away is the nearest referral facility? What other personas or health
workers do they interact with?
» Challenges: What are the day-to-day challenges the end user might face?
» Motivations: What does success look like to them? Are there targets they need to achieve?
See Annex 1 for examples of contextualized personas. For more details on persona development, please refer to the WHO Handbook for digitalizing primary
personas
health care: optimizing person-centred tracking and decision-support systems across care pathways (14).
2.4 Additional considerations for at-risk groups
scenarios
Data relating to an individual’s risk behaviour and at-risk group status are important to provide appropriate services and for programme monitoring. However,
in many settings, TB status, HIV status, drug use and possession, and alcohol use are criminalized and associated with stigma and discrimination. Collecting
identifiable information linked to these behaviours and clinical status from individuals accessing health services raises the potential for negative consequences both
to individuals and to service providers. Because of these sensitivities it is recommended that data collected on criminalized and stigmatized populations remain
workflows
anonymous (39).
It is important to keep confidential all private information of persons with, or being investigated for TB, in keeping with the necessary public health functioning of
a TB programme or unit. Keeping people’s TB status private will also help combat the stigma that is still associated with TB and help ensure the trust of patients
and their communities. TB prevention services can be provided effectively and efficiently, and individuals can be followed longitudinally using anonymous unique
data
identification codes, without the collection of personally identifying information.
In the context of TB treatment services where personally identifying information is routinely collected on treatment recipients, it is not recommended to collect
information that might indicate an individual’s engagement in stigmatized or criminalized behaviours or their at-risk group status. Only information that is clinically
decisions
relevant should be included in clinical records where individuals are personally identified.
Any data collection or data sharing scheme must have in place adequate safeguards to protect privacy and confidentiality, to minimize, mitigate or eliminate the
risks of bias and stigma, and to ensure correct use by appropriate users.
indicators
requirements
Generic personas 23
3
recommendations
Component
User scenarios
personas
User scenarios are a narrative description of how the end user would interact with the digital system. The user scenario is provided to help the reader better
understand how the system will be used and how it would fit into existing workflows. It is to provide context in a story telling format. Furthermore, within the user
scenarios
scenario, it should be possible to derive the key components that are further elaborated in the rest of the DAK. This includes the core data elements, decision-
support logic and core functionality of a digital system that would be needed. Although there is no clear template for a user scenario, it should:
» include personas involved based on the generic personas component;

» have narrative description of who and how a digital system would be used;
workflows
» provide details on what kinds of data are collected and decisions are made; and
» reflect the workflows that will be further elaborated on in Component 4: Business processes and workflows.
3.1 How to interpret user scenarios

data
User scenarios are helpful tools not only to better understand the context in which a digital tool would operate, but also for some insights into what key data
elements would need to be recorded and accounted for in the database. Additionally, the context in which the tool would operate, illuminated by the user scenarios,
decisions
provides insight into some functional and non-functional requirements that the system would also need. For example, highlighted in orange are some key data
elements that need to be recorded or calculated. Highlighted in blue is the decision-support logic that can be automated in the system. Highlighted in green are
some key functional and non-functional requirements that should be included in the system.
For example, the interpretation of the user scenario “Household contact: tuberculosis (TB) screening and infection testing” is shown in Table 4.
indicators
Table 4 Interpretation of the scenario “Household contact: tuberculosis (TB) screening and infection testing”
Data elements to be collected Decision logic to be embedded Functional and non-functional requirements
» Risk group » Sex » Determine the screening algorithm » Search for a client using at least two identifiers
» Age » Phone number » Determine if the TB infection test is relevant » Possibility to work offline
requirements
» First name » Occupation » Possibility to send referral letters via email

» Last name » Email address » Possibility to send SMS (text message) reminders

recommendations
3.2 User scenarios for tuberculosis screening and tuberculosis preventive treatment
3.2.1 Household contact: tuberculosis (TB) screening and infection testing

Key personas Community health worker: Arno
personas
Client: Mieke
Household contact: Johan, a 21-year-old man
Arno is a community health worker working for a health clinic. Today he is in the field, in a small village, to perform TB screening and TB infection testing on the household contacts of individuals
with confirmed TB disease. Because there is a high HIV prevalence in the country, HIV testing is also offered. He used his tablet to access the digital system and obtain the list of contacts to be visited,
which were entered into the system by the nurse working in the health clinic.
Arno is visiting the house of Mieke, a 41-year-old woman who was recently diagnosed with pulmonary TB disease and who provided information about her household contacts. Mieke agreed in
scenarios
advance to receive the visit.
Arno meets Johan, Mieke’s son and finds out that he is 21 years old. Arno opens on the tablet the application he is using for client management and contact tracing and searches using Johan’s first
and last name, but the app warns him that there is no internet connection; therefore, no results are returned. The app then suggests saving Johan’s data locally, temporarily, until the app goes
back online. Once the app is connected to the internet, it will check whether a client with Johan’s identifiers exists on the system or not; based on the result, it will propose creating a new client or
updating an existing one, matching Johan’s data. After entering into the system basic personal and demographic information about Johan, such as sex, telephone number and occupation, Arno asks
the young man if he lives in the same house as Mieke. Johan confirms and explains that occasionally he goes outside of his town for several days because of his work, but most days he is living in the
workflows
same house as his mother.
As soon as the registration process finishes, Arno informs Johan about the purpose of the visit, the benefits and risks of the screening process, the chosen screening algorithm and the tuberculin skin
test (TST) for TB infection. Arno highlights the importance of a follow-up visit in 48–72 hours when the TST result shall be read. He also suggests that Johan should take an HIV test and explains the
reason for the test (the high HIV prevalence), outlining that people living with HIV (PLHIV) are around 20 times more likely to develop TB disease than those without HIV infection. Arno asks the young
man if he has any questions or concerns related to what was presented and asks for his verbal informed consent before starting the screening process.
Next, Arno checks if Johan has any signs or symptoms suggestive of TB. Because none are present, Arno decides to administer a TST on site. Then, Arno informs Johan about the next steps, which
data
consist of reading the TST result and performing a chest X-ray (CXR) at the clinic, followed by further diagnostic tests if the CXR looks abnormal. If the CXR does not present any abnormalities and the
TST result is positive, then Johan will be evaluated for TPT eligibility. Arno briefly provides counselling on what TPT is and its benefits. The TST reading and CXR will be performed during the same
visit to limit the inconvenience related to multiple visits to the clinic, such as time lost due to travel, financial expenses and delays in obtaining the test results. Because the TST should be read within
a maximum of 72 hours from when it is administered, Johan agrees with Arno to schedule a follow-up visit at the clinic in 2 days’ time. A rapid antibody HIV test is also administered because Johan
has given his consent for this test to be carried out; this test is negative.
decisions
He then asks Johan if he would like to receive the referral letter for the CXR via email, using the email address provided during registration (i.e. Johan could receive the referral letter immediately via
email), instead of a hard copy at the end of the consultation. This could help with faster check-in at the clinic and avoid other inconveniences, such as losing it. Johan agrees.
He also checks with Johan if he would like to receive SMS (text message) reminders for the next visits. As Johan agrees, Arno ticks the corresponding checkbox in the app, which indicates that the
client has given the permission to receive this kind of notification.
Arno asks if Johan has any other concerns or questions.
indicators
Corresponding This scenario refers to the following business processes:
business A. Registration
processes
B. Screening
(Component 4)
E. TPT
F. Referral
requirements
User scenarios 25
recommendations
3.2.2 TPT assessment and counselling

Key personas Nurse: Annika
Receptionist: Lerato
Client: Johan, a 21-year-old man
Johan presents to the health clinic for the follow-up visit scheduled 2 days ago. He shows the receptionist at the registration desk the referral sent to his email address by Arno, at the previous visit.
personas
Lerato, the receptionist, checks if Johan has any appointment scheduled by searching the digital system using Johan’s national health ID. The system returns a result that matches Johan’s data
and displays a pop-up informing the receptionist that the visit should start in 30 minutes. Lerato suggests to Johan having the CXR before going for the consultation. Because of the new technology
available at the clinic, computer-aided detection, which is used to interpret the digital CXR images, the waiting time is only 5–10 minutes. She tells Johan how to find the room where the CXR is going
to be performed and then tells him the consultation room number where he should meet Annika, the nurse waiting for him.
With the results of the CXR, Johan makes his way to the consultation room indicated by Lerato. After reading the TST, Annika tells Johan that the result is positive. The CXR showed no abnormalities
in the lungs. She then explains to Johan that the TB infection detected by the test does not mean that he has TB disease or that he is infectious, and that the best way to avoid developing TB disease
scenarios
would be by taking TPT. Annika provides further counselling on TPT, which includes the rationale for TPT and benefits to the individual, the household and the wider community. She also asks about
medical conditions that would contraindicate TPT and discusses the potential risks of treatment.
Johan shows interest in TPT, so Annika checks in the system if the information provided during the previous encounters would allow a complete TPT eligibility evaluation. This is not the case, so she
starts asking Johan about his personal history, which may be relevant for TPT initiation, such as allergy to TB drugs, previous TPT use, alcohol use, smoking and concurrent medication(s).
While registering the information on the system, Annika reassures Johan that all the information collected and his decision on whether to take TPT or not, will be kept confidential.
workflows
The assessment reveals that the benefits of TPT outweigh the potential risk of acquiring TB or drug toxicity, so Johan decides to take TPT. He is the primary breadwinner in the household and
is concerned that losing his job because of TB could have important consequences. Hearing that, Annika decides to promptly introduce Johan to the national nutritional and financial support
programmes available that could lessen the financial burden for his family in case of need.
After discussing the treatment regimen options, Johan decides to take a shorter rifamycin-based TPT regimen because it is shorter and has fewer adverse events. Nevertheless, Annika discusses the
potential adverse drug reactions associated with rifamycins, such as gastrointestinal reactions (abdominal pain, nausea, vomiting), hepatitis and discolouration of bodily fluids.
Annika works out the medication dosage, provides medication for the next month and agrees with Johan to schedule a follow-up visit in 1 month. She then asks Johan if he would like to receive SMS
reminders on the days when he needs to take the treatment. Johan likes the idea and accepts. Annika registers this information on the system.
data
Before leaving the room, Annika makes sure that Johan knows how and who to contact in case of any signs or symptoms of adverse drug reactions or other TPT-related issues.
decisions
processes
B. Screening
(Component 4)
E. TPT
indicators
requirements

recommendations
3.2.3 Active case-finding (ACF) campaign
Key personas Nurse: Azeeb
Data entry clerk: Maira
Client: Rohaan, a 38-year-old man
Azeeb is a nurse working for a district health clinic in a large rural district. The clinic started an ACF campaign that focuses on TB detection and today Azeeb is in the field, together with his colleague
personas
Maira, on a mobile outreach screening campaign to a small mine in the district.
Maira, the data entry clerk, invites the next man in the line to take a seat. His name is Rohaan, a 38-year-old man who has worked in the mining sector for the last 5 years. Maira registers Rohaan as a
new client because he was not yet registered in the electronic system.
Once Rohaan is fully registered, he waits for the nurse to call him into the screening room. Azeeb invites Rohaan to the room and checks if he attended the group information session where the
purpose of the campaign, the benefits and risks of the screening process and the screening algorithm were presented. As Rohaan attended the session, Azeeb asks if he has any questions or concerns
related to what was discussed.
scenarios
After obtaining Rohaan’s verbal informed consent to start the screening process, Azeeb asks questions about any current TB symptoms and when it was the last time he had a CXR.
As Rohaan has not had a CXR recently, Azeeb performs a CXR using a mobile X-ray device. The image shows no abnormal results.
Rohaan does not manifest any TB symptoms; Azeeb tells him that he might be eligible for TPT, as someone who has been exposed to silica. After recording the screening results on his tablet, Azeeb
offers Rohaan counselling on TPT.
Rohaan looks interested in getting TPT, so Azeeb continues with assessing his TPT eligibility. The digital system helps Azeeb by offering examples of questions he should ask related to Rohaan’s
workflows
personal and medication history, and social and financial status.
He then asks for permission to perform an interferon-gamma release assay (IGRA) test, which may increase the certainty that TPT would be beneficial for Rohaan.
Azeeb asks Rohaan if he would like to be called on his phone number, collected during the registration, to be told about the test result. As Rohaan has nothing against this, Azeeb marks in the system
that the client accepts to be contacted using this communication channel.
Rohaan receives a phone call on the second day after seeing Azeeb, when he finds out that the IGRA test is positive. He then schedules a visit to the clinic where Azeeb is working to be counselled
further on TPT and decide about his preferred TPT regimen.
data
processes
B. Screening
(Component 4)
decisions
E. TPT
indicators
requirements
User scenarios 27
recommendations
3.3 User scenarios for tuberculosis diagnosis and treatment
3.3.1 Diagnosis of pulmonary TB for a child (Mycobacterium tuberculosis complex bacteria [MTBC] not
detected with molecular WHO-recommended rapid diagnostic test [mWRD])
personas
Key personas Clinical officer: Retha | Client: Iso, a child aged 1 year and 9 months | Household: Thandi, Iso’s mother | Receptionist: Luan
Luan is a receptionist at a health centre. The digital system alerts Retha with a pop-up message that a test for HIV is recommended for
A young mother, Thandi, comes to the registration desk with her little girl, Iso. When asked about clients investigated for TB with unknown HIV status. Retha finds this alert useful, so she suggests
the reason for today’s visit, Iso’s mother mentions that she is a bit worried about her daughter’s to Thandi to perform an HIV test for Iso because this test might be important for an eventual TB
health and that she would like Iso to be seen by a health worker (HW). Luan asks Thandi for treatment decision and provision of timely HIV care in case of a positive result. The mother agrees,
Iso’s national ID and searches in the system using this ID. The system retrieves one record that so Retha performs the test.
scenarios
matches Iso’s profile. Luan can see in the system that Thandi already gave permission to collect The next morning, Thandi and her daughter are back to the clinic with a stool sample. Thandi
and process her daughter’s personal data for clinical investigations and treatment purposes. asks Luan if it is possible to see Retha. He quickly checks on the digital system the appointments
Luan verifies in the system whether there are HWs available who could take over the case. Retha, scheduled for that day and finds a free time slot in the afternoon on Retha’s calendar. Thandi
the clinical officer, is available in 20 minutes. After confirming with Thandi that the waiting time is confirms that they can come back in the afternoon for the visit, as they have stuff to do in the city
OK, Luan directs Thandi and her daughter to the appropriate room. until that time anyway, so it will not be difficult for them to return. Luan confirms with Retha her
When entering the consultation room, Iso notices the wall stickers representing some of her availability; Retha asks the data entry clerk to inform Thandi that the results of all the tests will
preferred cartoon characters. Retha starts the visit by showing Iso the characters on the wall. also be ready by then. Luan communicates this information and creates the appointment on the
system.
workflows
After interacting for a few minutes with the child, the HW can see that the little girl is feeling
more relaxed and comfortable. She then starts asking her mother more information about what A few hours later, the clinical officer is in the consultation room with Iso and her mother. She
worried her and what is different lately in Iso’s behaviour. Iso’s mother explains that Iso has not informs Thandi that the result of the HIV test is negative and communicates the result of the
been very playful in the last few weeks, as she used to be, and that she had a few episodes of mWRD test, which indicates “MTBC not detected”. Nevertheless, based on the clinical examination
fever and cough lately. She also mentions that she saw some weight loss in the last months and and Iso’s history of close contact with a patient with TB (her grandfather) in the previous
that sometimes she thinks Iso has difficulty breathing. 12 months, clinically diagnosed pulmonary TB is established. To assess the severity of pulmonary
After performing a quick check for danger signs (none identified), the clinical officer continues the TB disease, which is required to determine the TB treatment regimen, Retha needs the CXR
clinical examination on Iso, including checking for an elevated temperature (fever) and increased results. The chest radiography image is available and because Retha is experienced in reading
data
respiratory rate, measuring her weight and checking other clinical signs through a thorough paediatric CXR, she reads the CXR, which shows dense alveolar opacification in a segment of
physical examination, which is followed by recording the information collected on the digital the right lower lobe. There are also enlarged hilar lymph nodes on the right side, without airway
system. She then verifies the growth curve generated by the system and identifies that the growth compression. There is no pleural effusion and no miliary picture. Retha assesses that the features
curve has flattened since the last visit. of the CXR show non-severe pulmonary TB.
Retha continues the evaluation by asking if Iso was recently in contact with anyone with TB or Based on the clinical assessment and the CXR result, Iso is eligible for the 4-month TB
decisions
with a chronic cough. The mother tells the HW that 6 months ago Iso spent 2 weeks with her treatment regimen; the medication Iso will take consists of 2 months of isoniazid, rifampicin
grandfather who was recently diagnosed with TB. and pyrazinamide followed by 2 months of isoniazid and rifampicin. Retha tells Thandi that
As Iso presents with TB symptoms (fever and cough episodes, increased respiratory rate, poor weight dispersible, child-friendly, fixed-dose combined formulations are available for this regimen and
gain, reduced playfulness in the last few weeks), Retha suspects she may have pulmonary TB. explains how the medication will be administered.
She decides to perform an mWRD test to obtain bacteriological confirmation. Retha explains to All the information given, and the actions taken by Retha, make Thandi confident about the skills
the mother the advantages of using stool as a specimen (non-invasive, can be collected anytime). and goodwill of the care provider, so that at the end of the visit she is comfortable with starting
Because it was not possible to collect the specimen on the spot, Retha asks the mother to collect the treatment for her daughter. Retha enters the information about the diagnosis and treatment
indicators
the specimen, whenever feasible, and return with it to the clinic as soon as possible. A CXR is also initiation into the electronic system.
available in the health centre, so Retha suggest doing a chest radiography, in parallel with the Retha ends the visit by letting Thandi know that the health-care team is there to answer any other
mWRD test, to help with the clinical diagnosis. Thandi agrees with this intervention, so that Iso questions she or her family might have. She also schedules, on the dates suggested by the digital
can get it done before leaving the health-care facility. system, a follow-up encounter for Iso and an initial TB assessment visit for her mother.

business processes A. Registration C. Diagnosis D. TB treatment
requirements
(Component 4)

recommendations
3.3.2 Diagnosis of drug-susceptible extrapulmonary TB for an adult
Key personas Client: David
Physician: Laura
Nurse: Emily
Receptionist: Amy
personas
David, a 39-year-old man, arrives at the reception desk of the local health-care facility. He has an appointment scheduled today and when Amy, the receptionist, asks for identification information, he
shows a quick response (QR) code. Amy is able to find David’s record and verifies his personal information.
After being checked in, David waits to be called into the consultation room. Laura, the family doctor, welcomes him. David underwent a series of examinations in the last few weeks, triggered by the
appearance of an excrescence in the neck area and general apathy. He took antibiotics, but the treatment did not help.
This time Laura proposes TB investigations because the non-tender, enlarged cervical lymph node David has could be a sign of extrapulmonary TB.
She starts by assessing the TB contact history. As far as he knows, David has not interacted with a person confirmed with TB, but a few months ago he returned from a 3-month work trip in a country
scenarios
with high TB burden.
Laura also looks for signs and symptoms of pulmonary TB. No signs or symptoms of pulmonary TB are identified. Laura suggests that David should undergo diagnostic testing for TB, for both
pulmonary and extrapulmonary TB, because, according to Laura, the two forms can coexist. David accepts, so he goes to the test room, accompanied by Emily, the nurse, where a sputum specimen is
collected. This specimen will be used to test for pulmonary TB using a molecular WHO-recommended rapid diagnostic test (mWRD).
Knowing that the testing capability for extrapulmonary TB is not available at the clinic, Laura issues a referral to the regional hospital, asking for a TB diagnostic test using a lymph node aspirate or
biopsy specimen. Laura decides to add in the referral note a request for an initial diagnostic test that detects resistance to rifampicin (RIF) and isoniazid (INH). Because this clinic is the custodian of
workflows
David’s electronic record, in the referral Laura requests to receive a copy of the test result using the digital system as soon as the result is available.
A few hours are needed before getting the test result of the mWRD test performed on the sputum, so Laura suggest communicating the result to David by calling him on the phone number shown on
the digital system and scheduling an in-person visit once the extrapulmonary TB test result is ready. David thinks this is a good idea. Laura advises performing the test for extrapulmonary TB as soon
as possible so that the diagnosis can be made based on the results of both tests.
The following day Laura informs David that the result of the mWRD test is “MTBC not detected”. Three days later, David is back in the consultation room. The result of the extrapulmonary TB test was
sent to Laura, so she scheduled a follow-up visit.
data
Laura communicates the results of the test: “MTBC detected, RIF resistance not detected, INH susceptible”. Therefore, the diagnosis is extrapulmonary TB. Laura prescribes a 6-month regimen
(2HRZ/4HR: 2 months of INH, RIF and pyrazinamide, followed by 4 months of INH and RIF). Because HIV, diabetes, smoking, alcohol consumption and mental disorders are factors associated with
poorer TB treatment outcomes, Laura asks a series of questions, suggested by the system, to assess the presence of these comorbidities. She also performs, after obtaining David’s consent, a rapid
antibody HIV test (the result is negative) and collects a blood specimen that will be used to screen for diabetes. If diabetes or other comorbidities are identified, a referral to the nearest appropriate
decisions
health service might be necessary for further management.
Next, she uses the system to generate the follow-up visit schedule and links it to David’s profile. David is also interested in having a copy, so Laura sends the PDF version to him via email. According to
the schedule, the first follow-up visit is due the following week to assess whether David tolerates the treatment, and to monitor adverse events and discuss the result of the diabetes screen.
When checking out, David tells Amy that he would like to receive SMS reminders for the next follow-up visits, so the receptionist saves this information on the system. The next stop is the pharmacy,
where David picks up the medication for the first week as prescribed by Laura.
indicators
business processes A. Registration
(Component 4)
C. Diagnosis
D. TB treatment
requirements
User scenarios 29
recommendations
3.3.3 Adult with two TB episodes: drug-susceptible TB (DS-TB) followed a few years later by multidrug-
resistant TB (MDR-TB)
FOLLOW-UP VISIT FOR AN ADULT DIAGNOSED WITH DS-TB

personas
Key personas Nurse: Aria

Client: Amar
Amar is a 32-year-old man who lives in a poor rural community in an isolated area. One month ago, he was diagnosed with DS-TB and today he presents to the health-care facility for a follow-up visit.
He had to take the bus because his village is 20 km away from the health centre.
Aria, the nurse, welcomes Amar and invites him to the consultation room. The consultation starts with searching the system for Amar’s record and to validate his details. The visit continues with
scenarios
the clinical assessment: the health worker checks for resolution or persistence of TB-related symptoms and for signs of medication side-effects. Amar’s weight is also measured. The results reveal
symptomatic improvement and a slight weight gain.
Aria verifies if Amar took the drugs as prescribed. Amar tells her that he took the pills regularly.
Aria continues with the assessment and counselling on treatment adherence. To make sure that the risk of financial hardship due to TB is minimized, the nurse provides information and education
on available social protection services, such as nutritional support, employment guarantee, safe housing and poverty alleviation.
At the end of the visit, Aria records the results of the examination performed on the system. She then checks the monitoring examination schedule to see when Amar should be scheduled for the next
workflows
follow-up visit and what examinations should be performed at that time.

Aria schedules the next visit in 1 month and provides a 1-month prescription. As smears and culture after the second month of treatment are necessary to monitor treatment response, Aria gives
Amar a sputum container so that he can bring back a sputum sample at the next visit. Then, she gives to Amar an appointment card detailing the date and time of the next follow-up visit.
processes
data
D. TB treatment
(Component 4)
decisions
indicators
requirements

recommendations
DIAGNOSIS OF MDR-TB FOR AN ADULT WITH A PREVIOUS DS-TB EPISODE
Key personas Nurse: Navi
Client: Amar
Amar is 35 years old. He moved from his small village 2 years ago to a city where he got employment in a penitentiary facility. He has a cough that does not go away, so he has come to the health-care
facility, where he is currently registered, for a consultation.
personas
Navi, the nurse, searches the system using Amar’s first name and date of birth. The system retrieves an exact match. Because Amar is already registered in the system, Navi only needs to validate his
details and moves on to the clinical evaluation.
During the discussion, Navi finds out that Amar’s cough started 3 weeks ago. Amar also mentions that lately he sweats during the night, which is something new for him. While registering the findings
in the digital system, Navi also checks his medical history. He finds out that a TB episode, which occurred 3 years ago, with a “lost to follow-up” outcome, is registered on the system. When asked
about his previous TB episode, Amar confirms that he took the treatment for around 2 months, but decided not to continue after feeling much better and because the distance between his house and
the health centre was quite significant.
scenarios
Based on the symptoms and the clinical examination, Navi suggests that Amar should have an Xpert MTB/RIF test using a sputum specimen. Amar accepts and is invited to the test room, where the
specimen can be collected safely by following biosafety and infection prevention and control best practices. Once the procedure is done, Navi asks Amar if they can meet again in the afternoon to
analyse the test result and discuss the next steps. Amar is living close by and he is free that day, so he confirms his availability.
Four hours later, Amar is in the consultation room with Navi. Pulmonary TB, resistant to RIF, is confirmed by the mWRD test. After entering the test result in the digital system, the system alerts Navi
that a follow-on test for additional evaluation of resistance to other anti-TB drugs is recommended in Amar’s case. A low-complexity automated nucleic acid amplification test (LC-aNAAT) is available
at the health centre; therefore, the nurse recommends follow-on testing to Amar. He accepts, so they go one more time to the test room where a new specimen is collected. The second test reveals
INH resistance and fluoroquinolone susceptibility.
workflows
The next day, Amar meets Navi again in the consultation room. This time Navi tells Amar that he has MDR-TB based on the results of the mWRD tests.
To ensure appropriate co-management of TB and comorbidities and to decrease the risk of a poor TB outcome, the nurse performs an assessment for comorbid conditions and other risk factors,
such as diabetes, disorders due to alcohol or drug use, HIV, smoking, undernutrition, coronavirus disease 2019, mental disorders and viral hepatitis. Because additional examinations and tests that
are part of the baseline assessment need to be performed before starting MDR-TB treatment, Navi decides to issue a referral to a hospital where Amar can get the necessary examinations done and
initiate treatment. He explains that once treatment has been initiated, Amar can continue treatment at this health-care facility.
With all the information provided and the care Navi showed in quickly assessing Amar’s health, Amar is feeling confident in taking the next step and accepts being referred to follow the necessary
data
baseline examinations and start treatment.
decisions
processes
C. Diagnosis
(Component 4)
D. TB treatment
F. Referral
indicators
requirements
User scenarios 31
4
recommendations
Business processes and

Component
workflows
personas
A business process is a set of related activities or tasks performed together to achieve the objectives of the health programme area, such as registration, counselling
and referrals (1, 13). Workflows are a visual representation of the progression of activities (tasks, events, interactions) that are performed within the business
scenarios
process (13). The workflow provides a “story” for the business process being diagrammed and is used to enhance communication and collaboration among users,
stakeholders and engineers.
This DAK focuses on the key business processes conducted by the personas (described in Component 2) as part of TB care service provision. These business
processes are described in Table 5. For each of these business processes, the corresponding business processes, data elements and decision-support needs are
workflows
detailed within the following sections of this document.
Table 5 Overview of key TB module business processesa
No. Process Process ID Personas Objectives Task set

name
data
Title ID used to reference Individuals interacting to complete A concrete statement The general set of activities performed within the process
this process the process describing what the process
throughout the DAK seeks to achieve
decisions
A Registration TB.A » Client (TB-confirmed, TB-presumptive To identify and register or update Starting point: The client arrives at the facility and checks in with
or unknown TB status) the client’s personal details so clerk, receptionist or health worker. Another option is when the health
» Contact that they can benefit from TB- worker makes contact with the client at his location (home, workplace,
related services. detention place).
» Data entry clerk, medical office
receptionist or health worker » Search for client record
» Review and update client record
indicators
» Create a new client record

requirements

recommendations
name
B Screening TB.B » Client To reach people who are not Starting point: The client or contact has been registered and called
» Contact reached by the patient-initiated in for screening activities. TB screening can happen alongside
pathway and to detect TB other health services (e.g. HIV testing, nutrition counselling, child
» Health worker (physician, nurse or
disease early, thereby improving immunizations).
community health worker)
outcomes for individuals and » Provide pre-screening information
personas
reducing transmission and
» Assess medical history and risk factors
incidence at the population level.
» Screen for TB using a screening algorithm
C Diagnosis TB.C » Client To determine TB status in clients Starting point: The client has been screened positive (provider-
» Health worker by performing bacteriological initiated pathway) or the client is seeking care at the health-care
and clinical investigations. facility (patient-initiated pathway) and further investigation is needed
» Laboratory technician
scenarios
to confirm or rule out TB disease. At this stage, for patients with
confirmed TB, drug susceptibility testing (DST) will be performed.
» Clinically evaluate the client
» Collect specimens
» Perform initial diagnosis tests using a diagnosis algorithm
» Perform follow-on testing for evaluation of resistance to anti-TB
workflows
drugs
» Interpret and review results
» Take diagnostic decision
D TB treatment TB.D » Client To initiate the appropriate TB Starting point: The client has been diagnosed with TB disease.
» Health worker treatment and perform necessary » Perform additional clinical examinations: evaluate risk for drug–drug
follow-up examinations to ensure interactions, assess for comorbidities, consider corticosteroid use,
data
» Pharmacist
that the correct treatment is perform baseline evaluations
followed, and that the patient
» Determine treatment regimen and dosage
adheres to it.
» Develop monitoring examinations schedule
decisions
» Initiate treatment and discuss treatment adherence
» Monitor treatment considering the monitoring examinations
schedule
» Report treatment outcome
indicators
requirements
Business processes and workflows 33
recommendations

name
E TPT TB.E » Client To identify clients eligible for Starting point: The client has been screened negative for TB or TB
» Health worker TPT, select the appropriate TB disease has been ruled out after TB diagnosis activities.
preventive treatment regimen for » Provide TPT counselling
» Pharmacist
each client and ensure treatment
» Test for TB infection
adherence.
personas
» Perform TPT eligibility evaluation

» Determine TPT regimen and dosage
» Develop TPT adherence plan
» Report TPT completion
F Referral TB.F » Client To provide timely and Starting point: The clinician determines client needs for services that
appropriate referrals to another are not available at this facility.
scenarios
» Health worker
health-care facility that can » Determine whether it is an emergency referral
provide services unavailable
» Discuss referral locations
within this facility.
» Contact destination facility
» Provide information to destination facility
» Discuss any questions with the client
workflows
G Aggregate TB.G » Health worker To aggregate client-level data Starting point: Time for periodic (usually monthly) reporting.
reporting and » District health information officer into validated, aggregate reports, » Check data quality
data use use the data and submit reports
» Correct fixable errors
at the facility level.
» Generate and review aggregate reports
» Submit for approval
data
» Provide feedback and any changes required
DST: drug susceptibility testing; TB: tuberculosis; TPT: tuberculosis preventive treatment.
a
The business processes described in the DAK are the ones listed in this table. Processes that are part of TB service delivery but are not included in this DAK include billing, dispensing and the definition of the TB strategy
decisions
(coloured in grey in the overview of key TB processes diagram [Fig. 4]). These processes may be required, although this is highly country-specific and context-specific. If applicable, the billing business process could include
an insurance or coverage check, which could take place at any one of many points during a TB visit. All the processes that are part of TB service delivery are shown in Fig. 4. The editable files of each business process in
.bpmn format can be found in here.
indicators
requirements

recommendations
4.1 Overview of key processes
This section illustrates the workflows of the identified processes using standardized notations for business process mapping (Fig. 4). Table 6 provides an overview of
this notations.
Table 6 Notations used in business process mapping
personas
Symbol Symbol name Description
Pool A pool consists of multiple “swim lanes” that depict all the individuals or types of users involved in carrying out the business process or workflow.
Lane 1
Diagrams should be clear, neat and easy for all viewers to understand the relationships across the different swim lanes. For example, a pool would
depict the business process of conducting an outreach activity, which involves multiple stakeholders represented by different lanes in that pool.
Lane 2
Pool
scenarios
Lane 3
Swim lane Each individual or type of user is assigned to a swim lane, a designated area for noting the activities performed or expected by that specific actor.
Lane 1
For example, a TB health worker may have one swim lane; the supervisor would be in another swim lane; and the clients or patients would be
classified in another swim lane.
Lane 2
Pool
workflows
Lane 3
Start event or The workflow diagram should contain both a start and an end event, defining the beginning and completion of the task, respectively.
trigger event
Start event The flow starts with a message. The meaning of “message” in business process model and notation (BPMN) is not restricted to letters, emails or
data
message calls. Any action that refers to a specific addressee and represents or contains information for the addressee is a message.
End event There can be multiple end events depicted across multiple swim lanes in a business process diagram. However, for diagram clarity, there should
only be one end event per swim lane.
decisions
Activity, process, Each activity should start with a verb, for example, “register client”, “calculate risk”. Between the start and end of a workflow, there should be a
step or task series of activities noting the successive actions performed by the actor in that swim lane. There can also be subprocesses of each activity.
Activity with This denotes an activity that has a much longer subprocess to be detailed in another diagram. If the diagram starts to become too complex and
subprocess unhelpful, the subprocess symbol should be used to reference another process depicted on another page.
indicators
Activity with This denotes a decision-making activity that requires the business rule, or decision-support logic, to be detailed in a decision-support table. This
business rule means that the logic described in the decision-support table will come into play during this activity, as outlined in the business process. This is
usually reserved for complex decisions.
Sequence flow This denotes the flow direction from one process to the next. The end event should not have any output arrows. All symbols (except for start
event) may have an unlimited number of input arrows. All symbols (except for end event and gateway) should have one and only one output
requirements
arrow, leading to a new symbol, looping back to a previously used symbol or to the end event symbol. Connecting arrows should not intersect
(cross) each other.

recommendations
Symbol Symbol name Description

Message flow This denotes the flow of data or information from one process to another. This is usually used for when data are shared across swim lanes or
stakeholder groups.
Exclusive gateway This symbol is used to depict a fork, or decision point, in the workflow, which may be a simple binary (e.g. yes/no) filter with two corresponding
output arrows, or a different set of outputs.
personas
There should only be two different outputs that originate from the decision point. If you find yourself needing more than two output or sequence
flow arrows, you most likely are trying to depict decision-support logic or a business rule. This should be depicted as an activity with business
rule (above) instead.
Parallel gateway The parallel gateway can be used to model concurrency in a process. This type of gateway allows forking into multiple paths of execution or
joining multiple incoming paths of execution. An important difference with other gateway types is that the parallel gateway does not evaluate
conditions.
scenarios
Terminate end A terminate end event indicates that all activities in the process have to be immediately ended, including all the instances of multi-instance
event activities. The process will be ended without any compensation or event handling. It marks the fact that the business process terminated without
reaching the intended end.
Throw – link event The throw – link event serves as the start of an off-page connector. It is the end of the process when there is no more room on your page for that
workflow. It is the end of a process on your current page or the end of a subprocess that is part of a larger process. A catch – link will need to
workflows
follow the throw – link.

Catch – link event The catch – link serves as the end of an off-page connector. It is the start of the new process on a different page from the throw – link or the start
of a subprocess that is part of a larger process. A throw – link must be aligned to the catch – link.
Annotations Annotations are used to supplement the diagrams. Annotations contain useful (additional) information and can be connected to other elements
with associations.
data
Ad hoc marker A container with an ad hoc marker can contain multiple activities (tasks or subprocesses), which can be executed in any order, executed several
times, or skipped.
However, not all these activities need to be finished before moving on to the next activity.
decisions
Loop marker A loop marker indicates that the activities inside the container repeat until a defined condition either applies or ceases to apply. The condition on
which a loop executes is included as an annotation.
indicators
requirements

recommendations
Fig. 4 Overview of key TB processesa
TB care
B. Screening E. TPT
personas
Health-care facility / community
A. Registration C. Diagnosis F. Referral
scenarios
D. TB treatment
Support services
workflows
Billing
data
Pharmacy
Dispensing
decisions
Health-care facility
management
G. Aggregate
reporting
indicators
Define TB
NTP
strategy
requirements
NTP: National TB programme; TB: tuberculosis; TPT: tuberculosis preventive treatment.
a
For the key TB processes, see Table 5.

recommendations
Fig. 5 Workflow A: registration business process

4.2 Workflows
Workflows represent the progression
of activities performed within the 1. Visit initiated
by the client or by
business process. They help users the provider?
personas
and stakeholders understand the
Client
relationship between activities, 2. Arrive at
facility
data elements and decision-support Patient-initiated
visit
needs. The workflows shown depict
processes that have been generalized Provider-initiated
scenarios
visit
and may not reflect variation and
nuances across different settings. Also,
the simplicity of the workflow may

not adequately illustrate non-linear
Health worker / data entry clerk / medical office receptionist

workflows
steps that may occur. Even though

in some workflows counselling and 6. Has the correct
client record been
obtaining informed consent activities identified?
are illustrated and described only
YES
in one activity, those actions occur 3. Arrive at the 4. Gather the 5. Search for the
data
throughout the entire TB care process. client’s location client's details client record
A. Business process for NO

decisions
registration
Objective: To identify and register or
update the client’s personal details so
that they can benefit from TB-related 7. Create a new
indicators
services (Fig. 5). client record

requirements
TB: tuberculosis.

recommendations
personas
scenarios
LinkLink
to TB
to care
TB care
processes:
processes:
C, D,
C, D,
E E
workflows
8.Validate
8.Validate
the the
client
client
details
details
8.2 Is
8.2anIsupdate
an update
Patient-initiated
Patient-initiated
needed?
needed?
8.1 8.1
Review
Review flowflow
socio-
socio-
YESYES 8.3.8.3.
Update
Update
the the 9. Check
9. Check
in the
in the
data
demographic
demographic
client
client
details
details client
client
datadata
withwith
the the
client
client
Provider-initiated
Provider-initiated
flowflow
NO NO
decisions
LinkLink
to TB
to care
TB care
processes:
processes:
B, C,
B, C,
indicators
D, ED, E
requirements
recommendations
REGISTRATION BUSINESS PROCESS NOTES AND ANNOTATIONS

General notes » When digital tools, such as video-supported treatment, are used for
Registration may be conducted as a stand-alone process by a data entry clerk communicating with the client (e.g. follow-up checks) this activity could be
initiation of a video call, phone call or other appropriate digital interaction.
or administrative persona ahead of the encounter in which TB-specific services
(screening, diagnosis, treatment) are offered or it may be conducted directly
personas
3. Arrive at the client’s location

by the health worker as part of the overall encounter. These activities can be
» The health worker arrives at the client’s location.
performed either in the health-care facility or in the community (e.g. client’s
home, workplace, mobile van), depending on where the encounter takes place. 4. Gather the client’s details
» Ask the client whether they have previously been issued with a unique
1. Was the visit initiated by the client or by the provider?
scenarios
identifier.
» Depending on the reasons that triggered the encounter, the starting activity
» Does the client have a card, number or barcode?
could be represented either by client’s arrival at the health-care facility or
by the health worker’s arrival at the client’s location. Client’s arrival at the » Does client say they are a returning or referred client?
health-care facility could also happen as part of a provider-initiated pathway » If a referral, check for the referral slip or data from the community.
(e.g. client referred for additional screening activities, people living with HIV » Determine whether the client is new to the health-care facility or health post.
workflows
[PLHIV] screened for TB by the health worker in the HIV clinic). » For returning clients, details will be retrieved from the registry of clients or,
» Patient-initiated health-care pathway: The patient-initiated pathway to TB if possible, from a central client registry.
diagnosis relies on patients seeking care and on health systems to respond
quickly and appropriately. 5. Search for the client record
» Provider-initiated TB screening pathway: The provider-initiated TB » This search process can be done through several different means
data
screening pathway systematically targets people at high risk of exposure depending on what mechanisms are available in-country. For example,
to or of developing TB disease and screens them by assessing symptoms, clients can be searched for by using their name, unique identifier, a quick
using tests, examinations or other procedures to identify those who response (QR) code or even biometrics.
decisions
might have TB, following up with a diagnostic test and additional clinical
assessments to make a definite diagnosis. 6. Has the correct client record been identified?
» Guidelines and guidance: » If multiple records are found for the client, consider merging or deleting
– WHO operational handbook on tuberculosis – Module 2: screening duplicate records, according to the HMIS guidelines.
(systematic screening for tuberculosis disease) (31). » It is also possible for the same episode of TB disease in a given individual to
indicators
be recorded multiple times in the system. Any duplicate records of the same
2. Client arrives at facility episode of TB must be removed (de-notify duplicate case) to avoid over
» The client arrives at the health-care facility and notifies the outpatient reporting.
department of their arrival to be further guided.
7. Create a new client record
requirements
» The client could already be registered at the health-care facility for another
service, for example, HIV, diabetes. » Issue a unique identifier if used and possible at the facility.

recommendations
8. Validate the client details
» Review and update client record.
– 8.1. Review the sociodemographic data with the client
Review the client’s non-clinical information, that is, name, address,
contact information, etc.
– 8.2. Is an update needed?
personas
Has the client moved? Have they changed their contact information or
has any other sociodemographic information changed?
– 8.3. Update the client details
The client can provide updated information if they have moved or
changed their details recently.
scenarios
» Merge or update client records.
» This activity could also happen during other TB-specific processes, for
example, screening, diagnosis, TB treatment, TPT.
workflows
9. Checking in the client
» Record the client’s updated details in the client registry.
» Add the client to the relevant queue for TB-related services. In case of
patient-initiated flow, new clients will be redirected to “C. Diagnosis” while
existing clients could continue the workflow with any of “C. Diagnosis”,
data
“D. TB treatment” or “E. TPT business processes”. For new clients following
a provider-initiated flow, the workflow continues with “B. Screening” while
existing ones might be redirected to any of “B. Screening”, “C. Diagnosis”,
decisions
“D. TB treatment” or “E. TPT business processes”.
» Send or share intake confirmation to or with the referring facility as
warranted.
indicators
requirements
recommendations
B. Business process for screening

Objective: The primary goal of TB screening is to reach people who are not reached by the patient-initiated pathway and to detect TB disease early, thereby
improving outcomes for individuals and reducing transmission and incidence at the population level (Fig. 6).
Secondary goals of TB screening are to: (1) rule out TB disease to identify people who are eligible for TPT; (2) identify people who are at particularly high risk of
personas
developing TB disease and thus may require repeated screening, such as people with an abnormal CXR (e.g. fibrotic lesion) that is compatible with TB but who
were not diagnosed with TB disease at the time of screening, people living with HIV, health workers and prisoners; and (3) better characterize TB risk factors by
combining screening for TB with screening for TB risk factors (such as HIV, diabetes mellitus, chronic obstructive pulmonary disease, undernutrition or smoking) to
map individual or community-level risk factors and socioeconomic determinants that should be addressed to prevent the disease more effectively. This may be an
scenarios
additional objective in settings where information about the prevalence and distribution of TB risk factors is lacking.
Fig. 6 Workflow B: screening business process

workflows
Consent NOT
2. Make an given
Client
informed
Health-care facility / community / residential or occupational setting
decision
Consent given
data
9. Offer other
clinical and
support services
decisions
YES
6. Is referral
Health worker
C. Diagnosis
needed?
1. Provide pre-
3. Assess 4. Determine the NO 7. Evaluate the
screening 5. Perform the
medical history screening screening
information and TB screening
and risk factors algorithm results
ask for consent 8. Positive
A. Registration
screen?
YES
indicators
NO
E. Referral E. TPT
requirements
TPT: tuberculosis preventive treatment.

recommendations
SCREENING BUSINESS PROCESS NOTES AND ANNOTATIONS
General notes » Principle 5: TB screening should be synergized with the delivery of
Systematic screening for TB fulfils the classic screening criteria. The following other health and social services. Synergies are best identified during the
development and implementation of screening approaches for different
key principles are to be considered when planning a TB screening initiative.
target populations, which may have particular patterns of use of health and
social services (e.g. TPT among relevant populations screened for TB).
personas
» Principle 1: TB screening should always be done with the intention to
follow up with appropriate medical care and ideally implemented where » Principle 6: A screening strategy is expected to maximize coverage and
high-quality TB diagnostic and treatment services are available. If a frequency of screening to achieve its aims. Regular monitoring is necessary
community lacks access to appropriate follow-up care but would benefit to inform any re-prioritization of risk groups, resource use, adaptation
from TB screening, this should be an impetus for investment by national of screening approaches and discontinuation of screening. This includes
TB programmes in TB diagnosis and treatment services to complement TB assessing the risk of false-positive diagnoses resulting from screening.
scenarios
screening.
» Principle 2: Screening should reach people at the greatest risk of Guidelines and guidance:
developing TB disease, including high-risk groups and communities with a » WHO consolidated guidelines on tuberculosis – Module 2: screening
high prevalence of TB. Prioritization of risk groups for screening should be (systematic screening for tuberculosis disease) (20)
workflows
based on an assessment for each group of the potential benefits and harms, » WHO operational handbook on tuberculosis – Module 2: screening
the feasibility and acceptability of the screening approach, the number (systematic screening for tuberculosis disease) (31)
needed to screen and the cost-effectiveness of screening. The benefits » Framework for collaborative action on tuberculosis and comorbidities (38)
and harms of TB screening in different groups and populations need to be
» Ethics guidance for the implementation of the End TB strategy (39).
carefully assessed to maximize the common good while minimizing harm
to individuals. TB threatens the health not only of an affected individual but
data
also of their communities and the broader population. 1. Provide pre-screening information and ask for consent
» The health worker presents the potential risks and benefits of the screening
» Principle 3: TB screening should follow established ethical principles for
procedure and familiarizes the client with the screening tools and
screening for infectious diseases, including obtaining voluntary informed
procedure.
decisions
consent before proceeding with screening individuals and observing
human rights, and be designed to minimize the risks of discomfort, pain, » TB screening should follow established ethical principles for screening for
stigmatization and discrimination. Informed consent is a basic right and an infectious diseases, including obtaining voluntary informed consent before
important means of respecting an individual’s autonomy. proceeding with screening. It is an ongoing, dynamic process that must
be continually monitored and renewed during the whole time a patient
» Principle 4: The choice of algorithm for screening and diagnosis is based on
indicators
is receiving health services. It is a basic right and an important means of
an assessment of the accuracy of the algorithm for each risk group, as well
upholding a patient’s autonomy.
as the availability, feasibility and cost of the screening tests. After a positive
screening test result, the diagnosis of TB should be confirmed before TB » Informed consent refers to the process of engaging patients in the delivery
treatment is started. of health services by giving them sufficient and relevant information to
enable them to make decisions for themselves.
requirements
recommendations
» Guidelines and guidance: – silica exposure, silicosis;

– WHO operational handbook on tuberculosis – Module 2: screening – viral hepatitis;
(systematic screening for tuberculosis disease) (31): – other clinical risk factors, for example, treatment with anti-tumour
• 1.2 Principles of TB screening necrosis factor α3 (TNFα3), dialysis, organ or haematological
transplantation.
• 2.4 Identifying and prioritizing risk groups
personas
– Ethics guidance for the implementation of the End TB strategy (39):

» Guidelines and guidance:
• 5. Education, counselling and the role of consent.
– WHO operational handbook on tuberculosis – Module 2: screening
(systematic screening for tuberculosis disease) (31):
2. Make an informed decision
» The client makes an informed decision regarding the acceptance and • 2.4 Identifying and prioritizing risk groups
scenarios
continuation of the process. – Framework for collaborative action on tuberculosis and comorbidities (38):
» Consent given by the client includes agreement to follow various TB • Table 2: Health-related risk factors and TB comorbidities, with
screening tests and evaluations (signed or witnessed consent if the patient related interventions recommended in current WHO guidelines.
is illiterate, or signed or witnessed consent from a child’s parent or legal
guardian). 4. Determine the screening algorithm
workflows
» Patients who refuse to consent should be counselled about the risks to both » The health worker chooses a screening algorithm based on:
themselves and the community. – the specific objectives of screening;
– the accuracy and yield of the screening and diagnostic tests;
3. Assess medical history and risk factors
– the risk group;
» Discuss medical history with the client and review available records.
data
Examples of history may include other diagnoses and medications. – TB prevalence in the risk group;
» Capture information related to the client’s occupation, socioeconomic – the costs, availability and feasibility of different screening methods;
risk factors (e.g. homelessness, imprisonment), recent interactions with – the ability to engage the person to be screened.
decisions
individuals with confirmed TB and other health-related risk factors for TB, » Decision logic: TB.B4.DT.
such as: » Guidelines and guidance:
– diabetes; – WHO operational handbook on tuberculosis – Module 2: screening
– disorders due to alcohol use; (systematic screening for tuberculosis disease) (31):
– HIV; • 3.2 Algorithms for screening.
indicators
– smoking; 5. Perform the TB screening

– undernutrition; » The health worker performs a TB screening according to the screening
– disorders due to drug use; algorithm selected.
requirements

recommendations
6. Is referral needed? 8. Screen result
» When at least one method part of the screening algorithm is not available in » A positive or abnormal result in screening tests is an indication for referral
the location (due to lack of skills or tools), a referral is needed to complete towards a diagnostic evaluation.
the screening activity. » Although systematic testing and treatment is not specifically recommended
» A referral can also be issued when risk factors requiring close clinical in some cases (e.g. people with diabetes, people who engage in harmful use
management are identified to ensure that the patient receives the care they of alcohol, tobacco smokers and underweight people), these populations
personas
need. may still be considered for TPT on a case-by-case basis to reduce the risk of
TB, especially if they have a heightened likelihood of unfavourable outcome
7. Evaluate the screening results
should the disease develop or if the person has multiple risk factors for TB.
» Once the results of the screening evaluations or the test part of the
screening algorithm are available, the health worker can interpret them » In case of a negative screen result, the process will continue with “TPT”
and decide what could be the next actions to take: refer for diagnostic process, according to the existing national policy.
scenarios
evaluation or assess for TPT.
9. Offer other clinical and support services
» Decision logic: TB.B7.DT.
» The health worker might offer other relevant clinical and support services
to the client if the client does not give their consent for proceeding with TB
– WHO operational handbook on tuberculosis – Module 2: screening screening.
workflows
(systematic screening for tuberculosis disease) (31):
• Annex 1 Screening algorithms for the general population and high-
risk groups (not including people living with HIV)
• Annex 3 Screening algorithms for adults and adolescents living with
HIV
data
• Annex 5 Screening algorithms for children.
decisions
indicators
requirements
recommendations
C. Business process for diagnosis

Objective: To determine Fig. 7 Workflow C: diagnosis business process
TB status in clients, by
performing bacteriological
personas
and clinical investigations,

starting TB treatment or
TPT based on the results of 13.
Bacteriolog
confirme
the investigations (Fig. 7). 10. Collect
11. Perform the
initial test(s) 12. Interpret the
specimen(s) for the diagnosis test(s) results
of TB
scenarios
F. Referral
N
Clinical evaluation YES

YES
5. Is referral
Health worker
3. Assess TB needed? F. Referral

1. Clinical N
workflows
contact
examination 16. Evaluate R
history NO
YES
A. Registration NO
13.
1
6. Is the client Bacteriologically

presumed to confirmed? YES
2. Assess 4. Assess 11. Perform
haveTB?the 7. Determine the 16.1 Interpret
NO
YES YES NO
medical history history 10. Collect
of prior initial test(s) 7. Determine
12. Interpretteststhe
the RIF 22. Cond
diagnostic
and risk factors specimen(s)
TB treatment for the diagnosis diagnostic
test(s) tests for
results susceptibility furthe
B. Screening YES for the initial
the initial testing
of TB test results investigat
F. Referral(positive) testing
NO the 15. Was mWRD
NO 8. Can 9. Is referral
data
with drug-
specimen be needed?
resistance
collected?
detection used?
1
23. App
Clinical evaluation YES th
YES 14. Repeat the clinica
initial test? judgem
5. Is referral
decisions
Health worker

1. Clinical NO
contact
examination
history NO
YES
A. Registration
6. Is the client
presumed to YES mWRD
2. Assess 4. Assess haveTB? on t
7. Determine the NO NO
medical history history of prior 22. Conduct evalu
diagnostic tests
further susce
B. Screening and risk factors TB treatment YES for the initial
investigations
indicators
(positive) testing
NO 8. Can the 9. Is referral
specimen be needed?
collected?
23. Apply
E. TPT
Client
clinical
judgement
requirements
mWRD: molecular WHO-recommended rapid diagnostic test; RIF: rifampicin.

recommendations
personas
F. Referral F. Referral
16. Evaluate RIF susceptibility 16. Evaluate RIF susceptibility
NO NO
13. 13.
16.2 Repeat the 17. Follow-on 16.2 Repeat the 17. Follow-on
Bacteriologically Bacteriologically NO NO
test ? testing capability test ? testing capability
confirmed? confirmed?
11. Perform the available? available?
16.1 Interpret 16.1 Interpret
12. Interpret the YES
10. Collect YES
initial test(s) 12.16.1 Interpret
Interpret the NOYES YES NO
RIF RIF
test(s) results specimen(s) for the diagnosis RIF susceptibility
test(s) results
susceptibility susceptibility
test results 16. Evaluate RIF susceptibility
of TB test results test results
scenarios
YES YES YES YES
NO 15. Was mWRD NO 15. Was mWRD NO
with drug- with drug- 13.
16.2 Repeat the
resistance resistance Bacteriologically
test ?
detection used? detection confirmed?
11. Perform the 16.4.used?
Interpret 16.4. Interpret
16.1 Interpret
RIF YES 18.
YESPerform RIF 18. Perform
10. Collect initial
16.3test(s)
Perform 12.16.4 Interpret
Interpret the 16.3 Perform RIF NO
susceptibility
RIF susceptibility follow-on testing susceptibility follow-on testing
YES specimen(s) for
YES thethe mWRD
diagnosis
test test(s) results the mWRD test susceptibility
14. Repeat the of TB testresults
14. Repeat the test results
forfor
the test results
test for
results
F. Referral initial test? initial test? theretest
retest the retest YES
s referral NO 15. Was mWRD
eeded? F. Referral with drug-
NO NO 19. resistance
Do the RIF 19. Do the RIF
workflows
YES YES
detection used?
susceptibility 16.4. Interpret
susceptibility
YES results from the results from RIF
the
mWRD need to 16.3 Perform mWRDsusceptibility
need to
al evaluation Evaluate RIF the mWRD test Evalu
YES be interpreted? NO be interpreted? NO
client YES 14. Repeat the susceptibility test results for susc
ed to YES mWRD as follow- initial test? mWRD as follow- the retest
B? 5. Is referral on test to on test to
7. Determine the NO
O 3. Assess TB 22. Conduct needed? NO F. Referral
22.
evaluate Conduct
RIF 20.evaluate
InterpretRIF
the 20. Interpret the
contact diagnostic tests further susceptibility
further
NO
follow-on test(s)
susceptibility follow-on test(s)
S history for the initial
investigations
NO investigations results results
testing YES
8. Can the 9. Is referral
data
specimen
6. Is the clientbe needed?
collected?
presumed to YES mWRD as follow-
4. Assess haveTB? 21. Testing for on test to 21. Testing for
7. Determine the NO NO additional drug YES additional drug YES
history of prior 22. Conduct evaluate RIF
23. Apply diagnostic tests 23. Apply susceptibility susceptibility
TB treatment further susceptibility
clinical YES for the initial clinical needed? needed?
investigations
judgement testing judgement
decisions
NO 8. Can the 9. Is referral NO NO
specimen be needed? 24. Make a 24. Make a
collected? diagnostic diagnostic
decision decision
23. Apply
clinical
judgement
26. Identify 26. Identify
contacts contacts
24.
dia
indicators
de
NO YES NO YES
25. Diagnosed 25. Diagnosed

D. TB treatment
requirements
TB? TB?
NO
E. TPT
Business processes and workflows 47 25. D

recommendations
DIAGNOSIS BUSINESS PROCESS NOTES AND ANNOTATIONS

Guidelines and guidance: 2. Assess medical history and risk factors
» WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid » Discuss medical history with client and review the available records.
diagnostics for tuberculosis detection, 2021 update) (21) Examples of history may include other diagnoses and medications.
» WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid » Capture information related to the client’s occupation, socioeconomic risk
personas
diagnostics for tuberculosis detection) (32). factors (e.g. homelessness, imprisonment) and other health-related risk
» WHO operational handbook on tuberculosis – Module 5: management of factors for TB, such as:
tuberculosis in children and adolescents (37) – diabetes;
» Framework for collaborative action on tuberculosis and comorbidities (38). – disorders due to alcohol use;
– HIV;
scenarios
1. Carry out clinical examination

– smoking;
» A clinical evaluation is usually required before performing tests that would
provide a bacteriological confirmation of the disease. Usually, a decision – undernutrition;
to undertake a diagnostic work-up of an individual for TB begins with – disorders due to drug use;
assessing the symptoms and signs of TB disease. In addition, a variety – silica exposure, silicosis;
workflows
of nonspecific signs are also evaluated to identify the features that raise – viral hepatitis;
clinical suspicion: vital signs, signs of respiratory distress, signs of advanced
– other clinical risk factors, for example, treatment with anti-TNFα3,
HIV disease, seriously ill PLHIV based on four danger signs (respiratory rate
dialysis, organ or haematological transplantation.
of more than 30 breaths per minute, temperature of more than 39°C, heart
rate of more than 120 beats per minute and unable to walk unaided), CD4 » For clients evaluated for TB disease, with unknown HIV status, HIV testing
should be performed in accordance with national guidelines.
data
cell count, and so on.

3. Assess TB contact history
– WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid » Close contact with a source case with TB often involves sharing a living,
decisions
diagnostics for tuberculosis detection) (32) learning or working space with them. Contact may also occur with a source
– WHO operational handbook on tuberculosis – Module 5: management of case from outside the household (e.g. a neighbour, caregiver or relative)
tuberculosis in children and adolescents (37): with whom the client has had frequent contact.
• 4. TB diagnostic approaches for children and adolescents. » Guidelines and guidance:
– WHO operational handbook on tuberculosis – Module 5: management of
indicators
tuberculosis in children and adolescents (37):

• 4. TB diagnostic approaches for children and adolescents
– WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid
diagnostics for tuberculosis detection) (32).
requirements

recommendations
4. Assess history of prior treatment – WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid
» Previous TB treatment shall be discussed. diagnostics for tuberculosis detection) (21):
» Guidelines and guidance: • 2. Recommendations
– WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid – WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid
diagnostics for tuberculosis detection) (32): diagnostics for tuberculosis detection) (32):
• 3. Implementing a new diagnostic test • 2. Diagnostic tests with WHO recommendations.
personas
• 4. Model algorithms. 8. Can the specimen be collected?
5. Is referral needed? » In some cases, the specimen cannot be collected. Examples of such cases
» If, during the evaluation for TB disease, signs are identified requiring urgent are: the client cannot produce the specimen (e.g. children who cannot
medical care (e.g. gastrointestinal, circulatory, respiratory, neurological), a produce sputum), the health worker lacks the necessary skills or tools to
scenarios
referral to the first referral level of care as per national guidelines, shall be collect the specimen, or the client refuses the intervention.
considered.
» Guidelines and guidance: 9. Is referral needed?
– WHO operational handbook on tuberculosis – Module 5: management of » A referral to another facility may be needed if the specimen cannot be
tuberculosis in children and adolescents (37): collected because of the lack of skills or tools or at client’s wish. The client
workflows
might resume the workflow, with the appropriate activity, if they come
• Annex 5. Treatment decision algorithms.
back to the facility that issued the referral to continue the process (e.g. the
6. Is the client presumed to have TB? client was referred to a secondary-level health-care facility for specimen
» Depending on the findings of the initial clinical evaluation, the health collection and diagnostic test execution and they come back to the original
worker decides whether the client should be further evaluated for TB facility for the interpretation of the test results and eventually for treatment
disease or whether a TPT eligibility evaluation should be performed. This initiation). Otherwise, the TB care process will be continued at the referral
data
does not mean that every client evaluated as not being “presumptive TB” facility.
will get a TPT. The evaluation for TPT will be performed according to the
“E.TPT” workflow.
10. Collect specimen(s)
decisions
» The decision on which type of specimen should be collected depends on
7. Determine the diagnostic tests for the initial testing the type of TB being evaluated (pulmonary or extrapulmonary), the tests
» The health worker selects a diagnosis algorithm and the diagnosis tests to intended to be used, age and other criteria.
be used depending on HIV status, the age of the client and other criteria.
When selecting the diagnosis algorithm, it is important to consider the
– WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid
indicators
findings of the client’s clinical evaluation and the characteristics of the
population to which the client belongs. diagnostics for tuberculosis detection) (21):
» Decision logic: TB.C7.DT. • 2. Recommendations
» Guidelines and guidance: – WHO operational handbook on tuberculosis – Module 5: management of
requirements
• 4. TB diagnostic approaches for children and adolescents.

recommendations
11. Perform the initial test(s) for the diagnosis of TB 15. Was mWRD with drug-resistance detection used?
» At this step, the diagnostic test(s) is/are performed according to the » When a molecular WHO-recommended rapid diagnostic test (mWRD)
corresponding test procedure. test with drug-resistance detection is used and the result confirms the
presence of Mycobacterium tuberculosis, RIF susceptibility evaluation will
12. Interpret the test(s) results be performed.
» The test(s) results are interpreted according to the diagnosis algorithm » If a conventional diagnosis test or a WRD without drug-resistance detection
personas
selected to determine if TB disease is confirmed bacteriologically. was used and indicates bacteriological confirmation, the flow continues
» Decision logic: TB.C12.DT. directly with diagnostic decision and follow-on testing in parallel.
» Guidelines and guidance: For example: TB was bacteriologically confirmed by lateral flow urine
lipoarabinomannan assay (LF-LAM) as the initial diagnostic test; the health
– WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid worker establishes the TB diagnosis result “diagnosed TB” and initiates
diagnostics for tuberculosis detection) (21):
scenarios
TB treatment immediately; an mWRD test is performed in parallel with the

• 2. Recommendations purpose of assessing RIF susceptibility.
– WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid 16. Evaluate RIF susceptibility
diagnostics for tuberculosis detection) (32): » If testing was done with an mWRD test capable of detecting RIF resistance,
• 4.1 Algorithm 1 – mWRD as the initial diagnostic test for TB the health worker needs to interpret the results of the RIF susceptibility test
workflows
• 4.2 Algorithm 2 – LF-LAM testing to aid in the diagnosis of TB among and decide on the next steps accordingly.
PLHIV. – 16.1 Interpret RIF susceptibility test results
13. Is the TB bacteriologically confirmed? The health worker interprets the RIF susceptibility test results.
» When bacteriological confirmation cannot be obtained (negative test • Decision logic: TB.C16.1.DT.
results), the recommendations could consist of repeating the test(s) and/or
data
perform further investigations. – 16.2 Repeat the test?

Repeating the mWRD test is recommended in some cases, for example,
14. Repeat the initial test when the RIF result is indeterminate and false RIF resistance is suspected.
» When the diagnosis test gives an inconclusive result, such as “error”, When there is no need to repeat the test, the subprocess ends and the
decisions
“invalid”, “no result” or a negative result, the health worker might decide to workflow continues in parallel with follow-on testing and diagnostic
repeat the test, using any portion of the sample remaining after the first test decision-taking (e.g. when the mWRD test indicates “MTB detected, RIF
or by collecting a fresh specimen. The result of the second test is usually the resistance NOT detected”, the health worker establishes the TB diagnosis
result that is considered for clinical decisions. result “diagnosed TB” and initiates TB treatment with a first-line regimen;
» Guidelines and guidance: drug susceptibility testing [DST] for isoniazid [INH] is performed in
indicators
parallel).
diagnostics for tuberculosis detection) (32): – 16.3 Perform the mWRD test
The health worker repeats the mWRD test. Probe binding delay and
• 4.1.1 Decision pathway for Algorithm 1 – mWRD as the initial
samples with a low bacillary load have been associated with increased
diagnostic test for TB.
false resistance or an “RIF indeterminate” result. A fresh specimen should
requirements
be used to repeat the test.

recommendations
– 16.4 Interpret RIF susceptibility test results for the retest 20. Interpret the follow-on test(s) results
The results of the second test are analysed and a decision regarding » The results of the follow-on testing are interpreted and further used for
treatment initiation and the next steps is made. The subprocess ends and treatment adjustments, if needed.
the workflow continues in parallel with follow-on testing and diagnostic » Decision logic: TB.C20.DT.
decision-taking. » Guidelines and guidance:
• Decision logic: TB.C16.4.DT.
– WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid
personas
» Guidelines and guidance: diagnostics for tuberculosis detection) (21):
– WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (rapid • 2. Recommendations
diagnostics for tuberculosis detection) (21): – WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid
• 2. Recommendations diagnostics for tuberculosis detection) (32):
scenarios
– WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid • 2. Diagnostic tests with WHO recommendations
diagnostics for tuberculosis detection) (32): • 4.3 Algorithm 3 – DST for second-line drugs for patients with RR-TB
• 4.1 Algorithm 1 – mWRD as the initial diagnostic test for TB. or MDR-TB
17. Availability of follow-on testing capability • 4.4 Algorithm 4 – mWRD as the initial or follow-on test to detect
» If the follow-on testing capability for resistance to additional anti-TB drugs Hr-TB.
workflows
is missing at the current facility, the client needs to be referred to another 21. Testing for additional drug susceptibility
facility. The flow might be resumed, with the appropriate activity, at the » The health worker may recommend conducting further DST in line with the
original facility if the client returns for the interpretation of the results and available test results. If this is necessary, the activities of “perform follow-
treatment initiation or treatment adjustments. Otherwise, the TB care on testing” and “interpret follow-on test results” will be repeated while
process will be continued at the referral facility. concurrently modifying TB treatment, if deemed necessary.
data
18. Perform follow-on testing » Examples:
» Follow-on testing is used once TB disease is confirmed, with the goal of – Case 1: TB was bacteriologically confirmed using sputum microscopy as
identifying resistance to TB drugs. If the results are inconclusive, such as the initial diagnostic test. RIF resistance was detected using an mWRD test
decisions
“error”, “invalid”, “no result”, or a negative result is recorded, the health as the follow-on test; therefore, TB treatment will need to be reviewed
worker might decide to repeat the test. A new specimen might be needed (change of TB treatment regimen: from first-line to second-line treatment
for follow-on testing. given that the client is at high risk of MDR-TB), while a DST for second-line
19. Do the RIF susceptibility results from the mWRD need to be interpreted? drugs is performed in parallel.
– Case 2: TB susceptible to RIF was detected by mWRD as an initial test. INH
indicators
» When the goal of the follow-on test is to assess for RIF resistance using
an mWRD diagnostic test (e.g. TB was bacteriologically confirmed by resistance was detected using molecular DST as follow-on testing for INH;
“microscopy – sputum” used as the initial diagnostic test, followed by a therefore, the treatment regimen is changed from first-line regimen to Hr-
(follow-on) mWRD test with the purpose of confirming or excluding RIF TB regimen, at the same time a specimen is referred for molecular DST for
resistance), the flow will continue with the subprocess “16. Evaluate RIF fluoroquinolone.
susceptibility”, otherwise the flow will continue with interpretation of the
requirements
follow-on test results.

recommendations
22. Conduct further investigations 24. Make a diagnostic decision

» When a diagnostic test cannot be performed or the test(s) is/are performed » Clinical decisions should be made based on clinical judgement, the results
but the result is inconclusive or negative, the health worker should conduct of available laboratory tests or the results of further investigations (or both).
additional investigations. Among such investigations, could be a chest X-ray » Currently, there are algorithms in the TB guidelines regarding making
(e.g. in case of a negative mWRD test or when the client cannot produce diagnostic decisions for children (<10 years old); therefore, the decision
the specimen[s] necessary for bacteriological confirmation), analysis of the logic mentioned below refers to children younger than 10 years.
personas
clinical response after treatment with antimicrobial agents or conducting

» Decision logic: TB.C24.DT.
additional testing (e.g. additional mWRD testing or culture in case of
symptomatic persons with negative results for the initial diagnostic tests). » Guidelines and guidance:
» Guidelines and guidance: – WHO operational handbook on tuberculosis – Module 5: management of

scenarios
diagnostics for tuberculosis detection) (32): • Annex 5. Treatment decision algorithms.
• 4.1.1 Decision pathway for Algorithm 1 – mWRD as the initial 25. When TB is diagnosed
diagnostic test for TB » Clients diagnosed with TB will need TB treatment whereas clients in whom
TB disease was ruled out can be evaluated for TPT.
• 4.2 Algorithm 2 – LF-LAM testing to aid in the diagnosis of TB among
PLHIV. 26. Identify contacts
workflows
23. Apply clinical judgement » Once a client is diagnosed with TB, it is important to identify their contacts
» The health worker assesses all the information available before making a as soon as possible to conduct screening activities on people recently
diagnostic decision. exposed to TB with a high risk of developing the disease.
data
decisions
indicators
requirements

recommendations
D. Business process for TB treatment

Objective: To initiate Fig. 8 Workflow D: TB treatment business process
the appropriate TB
treatment and perform
the necessary follow-
personas
Client
up examinations to
ensure that the correct
treatment is followed
and that the patient
scenarios
adheres to it (Fig. 8).

workflows
Clinical review
F. Referral
6. Evaluate risk
3. Assess for
for drug–drug Bacter
comorbidities 8. Is the client
interactions eligible11.
forPerform the con
9. Determine the
treatment usinginitialatest(s)
YES regimenthe
Health worker
10. Collect 12. Interpret

9. Determine the
specimen(s) regimen designed
for the diagnosis designed to treat
test(s)designed
regimen results to
2. Capacity for
data
NO to treat of TB treat rifampicin-

treating TB exists? F. Referral
rifampicin-
4. Issue rifampicin- susceptible TB
1. Determine 7. Consider susceptible TB
YES referral for susceptible TB?
eligibility for corticosteroid
management of Bacter
TB treatment use
comorbidities 10. Determine
con
regimen type 11. Perform the
A. Registration 10. Collect initial test(s) 12.the regimen
Interpret the
10. Determine the
decisions
Clinical evaluation specimen(s) for the diagnosis designed to treat

test(s)designed
regimen results to YES
YES of TB NO treat rifampicin-
rifampicin-
F. Referral resistant TB
5.5.IsPerform
referral other resistant TB
Health worker
3. Assess TB baseline
needed? clinical F. Referral
1. Clinical evaluations
contact
C. Diagnosis (TB examination
history NO
disease YES
confirmed)
A. Registration Clinical evaluation YES
Health-care facility Health-care facility
YES
6. Is the client
indicators
presumed to YES
5. Is referral
haveTB?
Health worker
2. Assess 4. Assess needed? 7. Determine the NO

3. Assess TB F. Referral NO 22. C
medical history
1. Clinical history of prior diagnostic tests
contact fu
B. Screening and risk factors
examination TB treatment YES for the initial
history NO inves
(positive) testing YES
A. Registration NO 8. Can the 9. Is referral
6. Is the client specimen be needed?
MTB: Mycobacterium tuberculosis; TB: tuberculosis. presumed to collected? YES
2. Assess 4. Assess haveTB?
7. Determine the NO
requirements
NO 22. C
medical history history of prior diagnostic tests 23.
fu
B. Screening and risk factors TB treatment YES for the initial cl
inves
(positive) testing judg
NO 8. Can the 9. Is referral
specimen be needed?

collected?
23.
recommendations
personas
Consent NOT
12. Make an given
informed
decision
Consent given
scenarios
C. Diagnosis
(follow-on and until the end of 25. Offer other
other testing the treatment clinical and
results) support services
workflows
Follow-up visit
15. Perform the 18. Perform the F. Referral F. Referral

21. Adjust the
clinical follow-up
16. Evaluate RIF susceptibility treatment 16. Evaluate RIF susceptibility
assessment examinations 23. Is the case
e
NO NO de-notified
13. 13. because
t 16.2 Repeat the 16.2 Repeat the found
17. Follow-on 17. Follow-on
Bacteriologically Bacteriologically NO NO
data
test ? not?to have testing
test MTB? capability testing capability
confirmed? 14. Develop TB confirmed?
erform the 11. Perform available? available?
11. Determine 13. Initiatethe
the monitoring 16.1 Interpret
16. Assess 19. Manage
16.1 Interpret
al test(s) 12.
10.
Interpret
Collect the initial test(s)YES 12.14.YES
Develop
Interpret the YES
RIF
YES NO TB NO NO
11.
the Determine
dosages of treatment and examinations
TB monitoring 22. IssueRIFa 24. Report the
e diagnosis specimen(s)
test(s)
the results
dosages of for the diagnosis test(s) results treatment
susceptibility treatment susceptibility
medicines for
medicines for discuss examinations
and a schedule and referral outcome(s)
of TB of TB a schedule of adherence
test results interruptions test results
TB
TB treatment
treatment adherence of follow-up
follow-up visits YES YES YES YES
NO 15. Was mWRD visits NO 15. Was mWRD G. Aggregate
decisions
with drug- with drug- reporting
t resistance resistance YES
detection used? 17. Evaluate theused?
detection 16.4. Interpret 16.4. Interpret
presence of RIF 18.RIF
Perform 18. Perform
16.3 20.
Perform
Reassess 16.3 Perform follow-on testing follow-on testing
adverse drug susceptibility susceptibility
YES YES the mWRD test
for comorbidities the mWRD test
14. Repeat the reactions
14. Repeat the (if test results for test results for
initial test? initial
any)test?
and report the retest the retest
Referral F. Referral
NO NO 19. Do the RIF YES 19. Do the RIF YES
indicators
susceptibility susceptibility
YES results from the results from the
mWRD need to Evaluate RIF mWRD need to
be interpreted? NO be interpreted? NO
susceptibility
YES YES mWRD as follow- mWRD as follow-
on test to on test to
Determine the NO NO NO
22. Conduct 22. Conduct evaluate RIF evaluate RIF 20. Interpret the 20. Interpret the
gnostic tests
further further susceptibility susceptibility follow-on test(s) follow-on test(s)
or the initial
investigations investigations results results
testing
requirements
Is referral 8. Can the 9. Is referral
needed? specimen be needed?
collected?
21. Testing for 21. Testing for
additional drug YES additional drug Y
23. Apply 23. Apply susceptibility susceptibility
Business processes and workflows clinical

judgement
clinical
judgement
needed? needed?
55
NO NO
recommendations
TB TREATMENT BUSINESS PROCESS NOTES AND ANNOTATIONS

Guidelines and guidance: 3. Assess for comorbidities
» WHO consolidated guidelines on tuberculosis – Module 4: treatment (drug- » There are some comorbidities and risk factors that increase the risk of
resistant tuberculosis treatment 2022 update) (23) poor TB treatment outcomes, or further transmission, which may require
» WHO consolidated guidelines on tuberculosis – Module 4: treatment (drug- close clinical management. The assessment of comorbidities and risk
factors (e.g. diabetes, disorders due to alcohol or drug use, HIV, smoking,
personas
susceptible tuberculosis treatment) (24)

undernutrition, coronavirus disease 2019, mental disorders, viral hepatitis)
» WHO operational handbook on tuberculosis – Module 4: treatment (drug-
as part of the baseline clinical review is also important to determine
resistant tuberculosis treatment 2022 update) (34)
additional needs for co-management, to correctly interpret adverse drug
» WHO operational handbook on tuberculosis – Module 4: treatment (drug- reactions, if such reactions are identified during or after the treatment ends,
susceptible tuberculosis treatment) (35) and for providing advice and counselling as necessary.
scenarios
» WHO operational handbook on tuberculosis – Module 5: management of » Guidelines and guidance:

tuberculosis in children and adolescents (37)
– Guideline: nutritional care and support for patients with tuberculosis (28)
» Framework for collaborative action on tuberculosis and comorbidities (38).
– Framework for collaborative action on tuberculosis and comorbidities (38):
1. Determine eligibility for TB treatment regimen type • Table 2. Health-related risk factors and TB comorbidities, with
workflows
» The health worker determines whether the client is eligible based on related interventions recommended in current WHO guidelines
laboratory results and previous clinical evaluation, for a regimen designed – WHO operational handbook on tuberculosis – Module 6: tuberculosis and
to treat rifampicin (RIF)-susceptible TB or if a regimen for TB resistant to RIF comorbidities – mental health conditions (40)
is more appropriate.
– Consolidated guidelines on HIV prevention, testing, treatment, service
2. Capacity for treating TB exists delivery and monitoring: recommendations for a public health approach
data
» When treatment cannot be started or continued in the current facility (e.g. (44)
lack of skills, knowledge, stock of medicines), a referral is issued to transfer – HEARTS D: diagnosis and management of type 2 diabetes (45)
the patient to a new treatment facility. – mhGAP intervention guide Mental Health Gap Action Programme version
decisions
» All children and adolescents with severe forms of TB (tuberculosis 2.0 for mental, neurological and substance use disorders in non-specialized
meningitis [TBM], peritonitis, pericarditis, renal, spinal, disseminated or health settings (46)
osteoarticular TB) and those suspected of having MDR/RR-TB (in contact – A WHO/the Union monograph on TB and tobacco control: joining efforts to
with a person with confirmed or suspected MDR/RR-TB, or children and control two related global epidemics (47)
adolescents diagnosed with TB who are not responding to first-line TB – Consolidated guidelines on person-centred HIV strategic information:
indicators
treatment) should be referred to a specialist for further management if strengthening routine data for impact (48).
management capacity where they present is insufficient.
requirements
• 5.2.8.1. Indications for referral and hospitalization.

recommendations
4. Issue referral for management of comorbidities 8. Is the client eligible for treatment using a regimen designed to treat
» Beyond the impact on TB, collaborative action on TB and comorbidities rifampicin-susceptible TB?
may also improve efficiency of resource use, reduce health-care visits,
address fragmentation in health systems and improve health outcomes. 9. Determine the regimen designed to treat rifampicin-susceptible TB
Therefore, the health worker must ensure that once a comorbidity or » The health worker selects the most appropriate regimen designed for
impairment is identified, the patient receives the care they need, preferably rifampicin-susceptible TB based on specific considerations, such as age, HIV
status, site of TB disease, severity of the disease, previous TB treatment and
personas
at the same place or via referral to an appropriate health service in case of
need. This may include referral to mental health or substance use services, DST results.
preventive and rehabilitation services, and social protection services to » In settings where rapid, molecular-based DST is available, the results
improve the health and social outcomes of people with TB. should guide the choice of regimen. In settings where rapid DST results are
not routinely available to guide the management of individual patients, the
scenarios
5. Perform other baseline clinical evaluations approach to treatment selection can be guided by clinical judgement and
» TB treatment poses special issues in some subgroups of patients (pregnant consideration of the epidemiology of TB and its drug-resistant forms in the
women, people aged over 65 years, those with chronic kidney or liver specific setting.
disease). For patients belonging to these subgroups, a set of baseline » Decision logic: TB.D9.DT.
examinations (clinical, electrocardiography, laboratory evaluations) are » Guidelines and guidance:
recommended before starting TB treatment.
workflows
– WHO operational handbook on tuberculosis – Module 4: treatment (drug-
susceptible tuberculosis treatment) (35)
6. Evaluate drug–drug interactions
» For patients taking other medicines (older people, people with
comorbidities), interaction between the drugs taken as part of the TB
treatment regimen and other drugs taken by the patient must be evaluated. • 5.2. Treatment of drug-susceptible TB in children and adolescents.
data
7. Consider corticosteroid use 10. Determine the regimen designed to treat rifampicin-resistant TB
» Treatment with corticosteroids is recommended for tuberculous meningitis » The health worker selects the most appropriate regimen designed for
decisions
and tuberculous pericarditis because the benefits outweigh the potential TB resistant to rifampicin based on specific considerations, such as age,
harms of corticosteroid therapy. DST results, eligibility criteria for the drug-resistant tuberculosis (DR-TB)
regimens, pregnancy status, severity of the disease.
» The inability to undertake DST routinely for all patients despite all possible
efforts should not be a barrier to starting patients on a potentially life-
resistant tuberculosis treatment 2022 update) (34):
indicators
saving DR-TB regimen; however, treatment should always be considered
• 8.2 Use of corticosteroids in a context of the potential risk of prescribing ineffective treatment and
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- amplifying drug resistance, with a subsequent decrease in the likelihood of
susceptible tuberculosis treatment) (35): treatment effectiveness.
• 7.3 Use of adjuvant steroids in the treatment of tuberculous
requirements
meningitis and pericarditis. » The findings of the clinical review are also considered in the treatment

recommendations
selection decision. 12. Make an informed decision

» Decision logic: TB.D10.DT. » All treatment delivered should align with WHO-recommended standards,
including obtaining informed consent where necessary (signed or
witnessed consent if the patient is illiterate, or signed or witnessed consent
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- from a child’s parent or legal guardian).
resistant tuberculosis treatment 2022 update) (34)
» Patients who refuse to consent to TB treatment should be counselled about
personas
the risks to both themselves and the community.

• 5.3 Treatment of multidrug-resistant and rifampicin-resistant TB in 13. Initiate the treatment and discuss adherence
children and adolescents. » Once the appropriate treatment regimen is identified, the correct medicine
dosages are determined and the consent from the patient (parent or legal
scenarios
11. Determine the dosages of medicines for TB treatment guardian in case of children or adolescents) is obtained, treatment can be
» The health worker determines the dosage for the medicine part of the initiated.
treatment regimen, based on age and weight band. » The health worker should undertake the relevant measures to support
» Decision logic: TB.D11.DT. adherence and ensure favourable treatment outcomes, such as:
» Guidelines and guidance: – consider directly observed treatment;
workflows
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- – optimize access of the patient to social protection services;
resistant tuberculosis treatment 2022 update) (34): – provide psychosocial support (psychosocial assessment should offer an
• Annex. Weight-based dosing of medicines used in multidrug- opportunity to assess supportive factors for treatment adherence and
resistant TB regimens, adults and children should be directly linked to relevant interventions wherever possible, as
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- per country-specific questionnaires);
data
susceptible tuberculosis treatment) (35): – consider the use of digital technologies.

• Annex. Dosages of anti-TB medicines by weight band for treatment » Guidelines and guidance:
of DS-TB – WHO operational handbook on tuberculosis – Module 4: treatment
decisions
– WHO operational handbook on tuberculosis – Module 5: management of (tuberculosis care and support) (36):
tuberculosis in children and adolescents (37): • 4.4. Counselling to provide information about TB treatment and to
• 5.2.7. Recommended dosing of first-line medicines in children ensure adherence to treatment
• Annex 6. Dosing of medicines used in second-line multidrug- • 4.5. Counselling to provide psychological support
resistant TB regimens by weight band (below 46 kg).
indicators

• Box 7.6 Proposed interventions to address needs of adolescents
with or at risk of TB
• 5.2.11. Treatment adherence.
requirements

recommendations
14. Develop TB monitoring examinations and a schedule of follow-up visits » TB-associated disabilities can be long term or temporary and may result
» Patients should undergo appropriate evaluation at baseline, as well from TB disease affecting tissues and organs, adverse reactions to TB
as during and after treatment. This should include necessary clinical medicines and comorbid mental health disorders. Therefore, clinical
evaluations (e.g. laboratory tests, electrocardiography), and bacteriological evaluation may also include early identification and screening for
and radiological examinations. impairments, disabilities and subsequent rehabilitation needs.
» Clinical visits should coincide with bacteriological and clinical laboratory
personas
examination schedules, to limit time and transportation constraints for the 16. Assess treatment adherence
patient. » The most common challenge in TB care is when a patient discontinues
» Decision logic: TB.D14.S. taking medicines or misses treatment appointments. Measures to support
patient adherence tailored to patient needs are important to retain patients
on treatment and ensure good treatment outcomes. Support should be
scenarios
provided through an effective model of care and measures should include
resistant tuberculosis treatment 2022 update) (34): support in the community or at home, social support and digital health
• 4.5 Treatment monitoring interventions for communication with the patient.
• 5.5 Treatment monitoring » The following actions should be taken in case of poor adherence:
• 6.5 Treatment monitoring – home visit to engage with the patient;
workflows
• 7.4 Treatment monitoring – assess the reasons for discontinuing treatment;
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- – discuss the patient’s concerns that caused non-adherence;
susceptible tuberculosis treatment) (35): – educate the patient about the need to continue treatment;
• 3.5 Treatment monitoring – counsel and support the patient to resume treatment promptly; and
• 4.5 Treatment monitoring
data
– engage community health workers, family members and caregivers to
• 5.5 Treatment monitoring ensure treatment adherence.
• 9 Monitoring treatment response.
17. Evaluate the presence of adverse drug reactions (if any) and report
decisions
15. Perform the clinical assessment
» Active pharmacovigilance should be performed, as well as proper
» Clinical assessment should focus on monitoring response to treatment management of adverse events and prevention of complications from
and addressing common symptoms associated with TB treatment and drug–drug interactions. An appropriate schedule of laboratory tests and
long-term antibiotic use, with the goal of supporting adherence. Persistent clinical examinations should be included on the patient’s treatment chart
fever, weight loss or recurrence of any of the classic symptoms of TB should to identify adverse events.
indicators
prompt investigation for possible treatment failure, undetected resistance
» All patients, their treatment supporters and health workers should ideally
to one or more drugs in the current treatment regimen or untreated
be instructed to report the appearance, persistence or reappearance of
comorbidities.
adverse drug reactions.
requirements
recommendations
» Adverse drug reactions should be reported to the spontaneous or treatment. Counselling should be offered in a way that makes the client
pharmacovigilance systems required by national regulations, as for feel empowered in their choice to continue the treatment.
other drug-related harms. Where digital tools are not available, at least
a written record of all medications given, bacteriological response and 20. Reassess for comorbidities
adverse events should be maintained for every TB patient on the TB » Some undetected comorbidities mimic treatment failure through clinical
treatment card. In settings where active TB drug safety monitoring and and chest radiographic deterioration that occurs simultaneously with
personas
management has not yet been fully rolled out and national guidelines have repeated culture-negative and smear-negative results. These comorbidities
not been updated, patients should not be left to wait until all programme (e.g. non-tuberculosis mycobacteria, fungal infections, lung infections or
components are fully in place before they can receive potentially life-saving a pulmonary malignancy) should be diagnosed and treated appropriately.
interventions. Illnesses that may decrease absorption of medicines (e.g. chronic
» Guidelines and guidance: diarrhoea) or may result in immune suppression (e.g. HIV infection) should
scenarios
– WHO operational handbook on tuberculosis – Module 4: treatment (drug- also be excluded.

resistant tuberculosis treatment 2022 update) (34): » Additionally, people at the end of anti-TB treatment may also be assessed
• 3.2 Safety monitoring and management, provision of patient for mental health conditions or substance use disorders if they were
support and management of comorbidities previously identified as having mental health or substance use issues (as
part of follow-up visit).
workflows
susceptible tuberculosis treatment) (35): » Guidelines and guidance:

• 9 Monitoring treatment response. – WHO operational handbook on tuberculosis. Module 6: Tuberculosis and
comorbidities – Mental health conditions (40).
18. Perform the follow-up examinations
21. Adjust the treatment
» Regular microscopy and culture of sputum or other specimens are » Based on the examination results, comorbidity assessment, adverse
data
important to assess response to treatment. Other examinations, according drug reaction evaluation and the patient’s medical condition, treatment
to the monitoring examination schedule (if available), should be performed composition or duration may require modifications. The health worker
to identify in a timely manner adverse events and to manage comorbidities needs to assess treatment efficiency and adjust the treatment accordingly.
appropriately.
decisions
» Reasons for adjusting the dosages of the medicine part of the TB treatment
regimen might include weight gain, malabsorption and co-management of
19. Manage TB treatment interruptions
comorbidities.
» In clients who have had treatment interruption, the reason for the
» Changing the treatment regimen should also be considered. If the decision
interruption should be addressed, such as medicine stock-outs, adverse
taken is to change the treatment regimen, then the health worker will
events from medicines or need for additional patient or provider education.
indicators
assess the capacity for initiating and continuing the new regimen. When
The duration, time on treatment at which the interruption occurs and the
capacity exists, all (previously described) activities needed to identify and
bacteriological status of the client before and after the interruption should
initiate the appropriate (new) treatment regimen should be performed.
be considered.
A referral should be issued if capacity to further treat the patient does
» The health worker should take the opportunity to express support for the not exist. Treatment outcome should be reported for a failed treatment
requirements
patient and their family and to address any issues that may require referral regimen.

recommendations
22. Issue a referral 24. Report the outcome(s)
» Referrals may be needed for ongoing management of TB-associated » It is important to monitor TB treatment outcomes both for individual care
disability and comorbidities on completion of TB treatment. This may and programme management. TB treatment outcomes should be recorded
include referral to mental health or substance use services, preventive and reported for each individual diagnosed with TB, regardless of whether
and rehabilitation services, and social protection services to improve the treatment was started.
health and social outcomes of people with TB. The preferences of the
personas
person with TB and comorbidities should be considered, for example, 25. Offer other clinical and support services
separate services may be appropriate to maintain continuity of care for » The health worker might offer other relevant clinical and support services
pre-existing comorbidities, to provide highly specialized medical care, to the client if the consent for initiating TB treatment is not given or
or may be preferred among people who experience stigma in relation to treatment could not be started because of other reasons. Nevertheless, a
comorbidities, such as injecting drug use. treatment outcome should be reported for these cases.
scenarios
» Patients with systemic adverse events might require referral to specialized
care.
» Change of treatment regimen may lead to referrals if capacity to further
treat the patient does not exist in the current health-care facility.
» In the absence of co-located services, clear referral pathways should be
workflows
ensured.
23. Is the case de-notified because found not to have MTB?

» Sometimes people are treated for TB disease, when in fact they do not have
TB. This can occur, for example, because of delays in receiving laboratory
data
speciation results, and it subsequently transpires that an individual does
not have TB but is instead infected with a non-tuberculous mycobacterium.
When such a situation occurs, records of a non-TB disease episode must be
de-notified.
decisions
» Reason for de-notification should be recorded.
» Change of TB diagnosis (TB ruled out) can also happen before initiating TB
treatment.
indicators
requirements
recommendations
E. Business process for TPT

Objective: To identify Fig. 9 Workflow E: TPT business process
clients eligible for TPT,
Opts in
select the appropriate 2. Make an
Client
informed
personas
TB preventive decision
treatment regimen for Opts out
each client and ensure

treatment adherence
(Fig. 9).
scenarios
3. TB infection testing
NO
13.
Health-care facility / community / residential or occupational setting
Bacteriologically
confirmed?
11. Perform the 3.1 Determine
10. Collect initial test(s) 12.3.1. Determine
Interpret the YES YES
whether TB
specimen(s) for the diagnosis whether
test(s) TB
results
infection testing
of TB infection testing
is relevant
workflows
F. Referral is relevent
NO 15. Was mWRD
with drug-
resistance
detection used?
3.2 Is TB infection NO
testing relevant?
Clinical evaluation A. Registration YES
YES 14. Repeat the
YES initial test?
5. Is referral
data

Health worker
1. Clinical 1. Offer TB NO
contact prevention
examination
history NO counselling 3.4 Interpret the
YES 3.3 Test for TB
TB infection test
A. Registration B. Screening infection
(negative) result
6. Is the client
decisions
presumed to YES
2. Assess 4. Assess haveTB?
7. Determine the NO NO
medical history history of prior 22. Conduct
diagnostic tests
and risk factors TB treatment further
B. Screening YES for the initial
(positive) investigations
testing
C. Diagnosis (that
NOout TB
ruled 8. Can the 9. Is referral
disease) specimen be needed?
collected?
15. Offer other
clinical and
indicators
support services 23. Apply

clinical
judgement
requirements
LFT: liver function test; TB: tuberculosis; TPT: tuberculosis preventive treatment.

recommendations
personas
Until the end of
scenarios
the treatment
4. TPT eligibility evaluation
4.3 Assess Follow-up visit

4.1 Elicit 4.2 Assess
social and
personal history medication
financial
information history
situation
workflows
10. Perform the 12. Manage
clinical TPT G. Aggregate
assessment interruptions reporting
14. Report TPT

4.4 Is LFT test NO 4.7 Determine completion
needed? TPT eligibility
13. Schedule
YES 11. Assess
the follow-up
adherence
data
visit
4.5 Order an 4.6 Interpret the

LFT test LFT test results
decisions
16. Evaluate RIF susceptibility
NO
13.
7. Is referral 16.2 Repeat the
Bacteriologically
needed? test ?
confirmed?
11. Perform the NO 8. Determine the 16.1 Interpret
10. Collect initial test(s) 12.8. Determine
Interpret the YES
9. Initiate TPT YES NO
6. Determine dosages of RIF
the dosages of and develop an
indicators
specimen(s)
the TPT regimen for the diagnosis test(s) results
medicines for susceptibility
NO YES of TB medicines for adherence plan test results
F. Referral TPT
YES TPT YES
5. Is the client NO 15. Was mWRD
eligible for TPT? with drug-
resistance
detection used? 16.4. Interp
RIF
16.3 Perform
susceptibi
YES the mWRD test
YES 14. Repeat the test results
requirements
F. Referral initial test? the retes
5. Is referral
needed? F. Referral
NO
NO
YES
6. Is the client
presumed to YES mWRD as follow-
recommendations
TPT BUSINESS PROCESS NOTES AND ANNOTATIONS

Guidelines and guidance: the possible uncertainties, as well as prospects of risk reduction (often
» WHO consolidated guidelines on tuberculosis – Module 1: prevention uncertain due to risk of reinfection).
(tuberculosis preventive treatment) (18) » Consent given by the client includes agreement to follow various tests
» WHO operational handbook on tuberculosis – Module 1: prevention as part of TPT evaluation and to follow treatment if indicated (signed or
personas
(tuberculosis preventive treatment) (29) witnessed consent if the patient is illiterate, or signed or witnessed consent
from a child’s parent or legal guardian).
» WHO operational handbook on tuberculosis – Module 3: diagnosis (tests for
tuberculosis infection) (33) » Patients who refuse to consent should be counselled about the risks to both
themselves and the community.
» WHO operational handbook on tuberculosis – Module 5: management of
tuberculosis in children and adolescents (37). » It is important that an informed decision to not take treatment by a person
scenarios
offered TPT is respected; people should not feel coerced to take treatment.
1. Offer TB prevention counselling » Guidelines and guidance:
» Provide information on TB infection, the rationale for TPT and the benefits – WHO operational handbook on tuberculosis – Module 1: prevention
from completing the course to the individual, the household and the wider (tuberculosis preventive treatment) (29):
community. • Chapter 9. Ethics and TB preventive treatment.
workflows
» Mention possible adverse effects and the likelihood of their manifestation.

3. TB infection testing
» Educate the client regarding the risk of not taking the TPT.
» Just as excluding TB disease is a critical step before starting TPT, confirming
» Inform the client about the TPT short regimens that can be completed in TB infection before starting TPT may increase the certainty that individuals
4–12 weeks, unlike the treatment of TB disease, which lasts 6 months or targeted for TPT would benefit from it.
data
longer.
– 3.1 Determine whether TB infection testing is relevant
» Guidelines and guidance: The decision on whether to test for TB infection before TPT is influenced
– WHO operational handbook on tuberculosis – Module 1: prevention by the expected prevalence of TB infection in the at-risk population, risk
(tuberculosis preventive treatment) (29):
decisions
of progression to TB disease and the risk of harms due to unnecessary

• TPT initiation and pre-TPT baseline assessment TPT.
• Key implementation steps in contact investigation • Decision logic: TB.E3.1.DT.
• Messages for the community. – 3.2 Is TB infection testing relevant?
Some risk groups, such as PLHIV who are on antiretroviral therapy (ART),
indicators
2. Make an informed decision benefit from TPT regardless of whether they test positive or negative
» Explicit consent is generally required for TPT since the subject does for TB infection. Similarly, children under 5 years who are contacts of
not pose an immediate risk to others and the potential benefits are a patient with bacteriologically confirmed TB have a high risk of TB
highly context-specific and may be outweighed by risk of harm for some and would benefit from TPT regardless of the test result. Therefore, TB
individuals. The provider usually has a professional obligation to do this. infection testing is not relevant in such cases and the recommendation is
requirements
Whether this is documented in writing or not depends on local practice. to consider TPT.
Informed consent requires effective and adequate communication of

recommendations
– 3.3 Test for TB infection – 4.3 Assess social and financial situation
A tuberculin skin test (TST), Mycobacterium tuberculosis antigen-based The social and financial situation of the family should be assessed and
skin tests (TBSTs) or interferon-gamma release assay (IGRA) can be used the support required to overcome the barriers for TPT completion should
to test for TB infection. be identified.
– 3.4 Interpret the TB infection test result – 4.4 Assess the need for liver function test (LFT)
Once the test result is available, a health worker with the appropriate There is insufficient evidence to support mandatory or routine LFT
personas
level of knowledge will interpret it. Older contacts and other risk groups at baseline, and perhaps the benefit of TPT without LFT would likely
who test positive are likely to benefit more than those with a negative outweigh the harms, particularly with a less hepatotoxic regimen.
test. Where feasible, baseline testing is strongly encouraged for individuals
» Guidelines and guidance: having risk factors – such as history of liver disease, regular use of
alcohol, chronic liver disease, HIV infection, age more than 35 years and
– WHO consolidated guidelines on tuberculosis – Module 1: prevention
scenarios
pregnancy or immediate postpartum period (within 3 months of delivery).
In individuals having abnormal baseline LFT results, sound clinical
• 1.3 Testing for latent tuberculosis infection judgement is required to determine if the benefit of TPT outweighs the
– WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (tests risk of adverse events. These individuals should be tested routinely at
for tuberculosis infection) (22) subsequent visits.
workflows
– WHO operational handbook on tuberculosis – Module 1: prevention – 4.5 Order an LFT test
(tuberculosis preventive treatment) (29): Collect a blood sample and order an LFT test from the laboratory if the
• 4. Testing for TB infection decision is to perform an LFT.
– WHO operational handbook on tuberculosis – Module 3: diagnosis (tests for – 4.6 Interpret the LFT test results
tuberculosis infection) (33). Once the test result is available, a health worker with the appropriate
data
level of knowledge will interpret it.
4. TPT eligibility evaluation – 4.7 Determine TPT eligibility
» Once TB disease is ruled out, and the decision to consider TPT is made, Based on the information gathered in the previous steps, a decision will
baseline assessment to determine the eligibility of an individual for TPT be made on whether the TPT benefits outweigh the risks.
decisions
should be undertaken. The baseline assessment includes personal and • Decision logic: TB.E4.7.DT.
medication history and investigations as per national guidelines.
– 4.1 Elicit personal history information » Guidelines and guidance:
Information relevant for TPT initiation and continuation should be asked, – WHO operational handbook on tuberculosis – Module 1: prevention
such as allergy to TB drugs, previous intake of TPT, alcohol use, smoking,
indicators
concurrent medication, contacts with drug-resistant TB and potential
• TPT initiation and pre-TPT baseline assessment
contraindications to TPT.
• Provision of TPT for special populations.
– 4.2 Assess medication history
Elicit medication history to guide the choice of TPT regimen. Certain drug
requirements
classes, for example, antiretroviral (ARV) drugs, opioids and antimalarials,
often affect TPT.

recommendations
5. Is the client eligible for TPT? 8. Determine the dosages of medicines for TPT
» If the decision in step 4 is that TPT is beneficial, the health worker will » The health worker determines the dosages of medicines for TPT based on
proceed with discussing the treatment regimen. the client’s age and weight.
» The health worker might offer other relevant clinical and support services if » Decision logic: TB.E8.DT.
the client is not eligible for TPT. » Guidelines and guidance:
personas
6. Determine the TPT regimen (tuberculosis preventive treatment) (18):

» When choosing a regimen, the caregiver and the person taking the
• Table 3. Recommended dosages of medicines for TB preventive
treatment should consider the circumstances under which TPT would be
treatment
given to increase the likelihood of it being completed. The choice may
also depend on the availability of resources, fixed-dose combinations, – WHO operational handbook on tuberculosis – Module 1: prevention
scenarios
child-friendly formulations, concomitant medication (such as ARV drugs,

opioid substitution therapy, oral contraception), as well as acceptability to • Recommended dosages of TPT medication.
recipients in the country context.
» Decision logic: TB.E6.DT. 9. Initiate TPT and develop an adherence plan
» Guidelines and guidance: » TPT is initiated if the client (parent or legal guardian in case of children or
workflows
adolescents) gives their consent.

(tuberculosis preventive treatment) (18): » An adherence plan is developed in collaboration with the client. Such a
plan may include information on:
• 1.4 Tuberculosis preventive treatment options
– motivators for the person to want to be TB free;
– WHO operational handbook on tuberculosis – Module 1: prevention
(tuberculosis preventive treatment) (29): – using the person’s individual and family routines and their variations to
data
identify the best time to take the medicines; and

• Chapter 5. TB preventive treatment.
– taking medicines with food to reduce nausea and vomiting or at night
3–4 hours after dinner.
7. Is referral needed?
decisions
» In some cases, the client might prefer to start TPT in another health-care » Guidelines and guidance:
facility, for example, closer to their house. In those cases, the client might – WHO operational handbook on tuberculosis – Module 1: prevention
need a referral. (tuberculosis preventive treatment) (29):
» If the treatment medication is not available at the health-care facility, • Chapter 7. Adherence to TB preventive treatment
the client will be referred to another clinic or to the pharmacy to get the • Box 7.1: Example of an adherence plan.
indicators
necessary medication.
requirements

recommendations
10. Perform the clinical assessment » Guidelines and guidance:
» Clinical assessment should focus on monitoring response to treatment, – WHO operational handbook on tuberculosis – Module 1: prevention
presence of adverse drug reactions and common symptoms associated (tuberculosis preventive treatment) (29):
with TB treatment and long-term antibiotic use, with the goal of supporting
• Chapter 7. Adherence to TB preventive treatment.
adherence.
» Persistent fever, weight loss or recurrence of any of the classic symptoms of 12. Manage TPT interruptions
personas
TB should prompt investigation for possible treatment failure, undetected » Any interruptions in treatment should be discussed with the person on
resistance to one or more drugs in the current treatment regimen, or treatment and their treatment supporter, and interventions to address
untreated comorbidities. problems in adherence should be instituted.
» Overall, the occurrence of serious adverse events leading to death or
requiring withdrawal of TPT is rare. However, it is critical to identify any sign 13. Schedule the follow-up visit
scenarios
of drug toxicity early on and manage it vigorously. Obtaining a detailed and » The next visit is scheduled depending on the treatment regimen, clinical
accurate medical history (inclusive of medicines being taken and known condition and client’s availability. The visit could take place either at the
past adverse drug reactions) and keeping up-to-date information at every health-care facility or in the community, or at the client’s location.
contact with the person on TPT, can help identify persons who require close
monitoring and the most appropriate course of action if an adverse event
14. Report TPT completion
workflows
emerges.
» It is important to monitor TPT completion both for individual care and
» National programmes are encouraged to use communication technology, programme management.
including SMS and video-calls, for early reporting of adverse events and
» TPT may be considered completed when an individual takes 80% or more of
prompt action by health workers. A mechanism to record data on the
the prescribed number of doses of treatment within 133% of the scheduled
occurrence and management of adverse events is advised.
duration of the respective TPT regimen and remains well or asymptomatic
data
» Guidelines and guidance: during the entire period.
– WHO operational handbook on tuberculosis – Module 1: prevention » Guidelines and guidance:
– WHO operational handbook on tuberculosis – Module 1: prevention
decisions
• Chapter 6. Safety, management of adverse reactions and other drug- (tuberculosis preventive treatment) (29):
related issues in TB preventive treatment.
• Chapter 8. Monitoring and evaluation.
11. Assess adherence

15. Offer other clinical and support services
» Adherence to treatment is a complex behaviour that is influenced by
» The health worker might offer other relevant clinical and support services
indicators
many factors, such as personal motivation, beliefs about health, risks and
to the client if the TPT is not accepted, the client is not eligible or TPT is not
benefits from treatment, comorbidities, competing demands that conflict
recommended.
with the taking of medicine, family environment, complexity of the drug
regimen, drug toxicity, trust and relationship with the health provider. The
health worker needs to reinforce supportive educational messages at each
requirements
contact during treatment.

recommendations
F. Business process for referral

Objective: To Fig. 10 Workflow F: referral
provide timely and
appropriate referrals
Client
personas
to another health-
care facility that can
provide services
unavailable within
this facility (Fig. 10).
scenarios
2. Emergency referral
B. Screening
2.2 Is the client
3. Identify and
NO stable enough to discuss referra
location option
Health worker
1. Emergency transport?
referral?
workflows
2.1 Stabilize the

C. Diagnosis YES YES
client and give 2.3 Organize
pre-referral transport
treatment
4. Contact
NO referral facility
D. TB treatment
data
E. TPT
decisions
Request for
referral received
Receiving health-care facility
8. Check
indicators
whether th
client can b
accommoda
requirements
TB: tuberculosis.

recommendations
Client goes to
the receiving
personas
facility
scenarios
7. Discuss any
questions with
the client
3. Identify and
discuss referral
location options NO
workflows
6. Provide
YES information to
the
4. Contact receiving facility
referral facility 5. Can the
facility
accommodate?
data
decisions
Request for
referral received
9. Is it possible
to accommodate
the client?
8. Check
YES
indicators
whether the 10. Receive the
client can be client
accommodated
A. Registration
NO
requirements
recommendations
REFERRAL BUSINESS PROCESS NOTES AND ANNOTATIONS

General notes 3. Identify and discuss referral location options
Examples of reasons for referral include: » In discussion with the client and their relatives, decide where the client will
be referred to. Discussions include:
» the health worker cannot provide the service because of a lack of training • how to get to the referral facility, including location and
and skills;
personas
transportation options;
» the facility does not have the supplies needed to provide the service; • who to see and what is likely to happen;
» the facility cannot perform the service for other reasons; • whether to follow up on return.
» there is an emergency and the client needs immediate referral. » Either the client or the client’s relatives should decide on a referral location
based on their preferences.
scenarios
1. Emergency referral?
» If the client needs immediate referral due to an emergency situation, 4. Contact referral facility
bypass standard referral steps. » Health workers should contact the referral facility to determine whether
» In an emergency, a referral can be made at any time, including during that facility can accommodate such a referral.
diagnosis and treatment encounters.
workflows
5. Can the facility accommodate?

2. Emergency referral » Check whether facility can accommodate the client and provide the
» 2.1 Stabilize the client and give pre-referral treatment services needed.
The client is assumed to need emergency referral if their condition requires » If the facility can accommodate the client, move on to step 6.
immediate medical attention. Stabilize the client’s condition and provide
» Otherwise, find a different facility that is able to accommodate the client.
data
any necessary treatment.

» A system can be set up to catalogue referral facilities, and what type of
» 2.2 Is the client stable enough to transport?
referral needs they can handle to accommodate a referral.
Once the client is stable enough to transport, immediately organize it. If the
decisions
client is still not stable, provide pre-referral treatment for stabilization.

» 2.3 Organize transport
For emergency referrals, the health-care facility usually arranges for an
ambulance or other vehicle.
indicators
requirements

recommendations
6. Provide information to the receiving facility
» Make an appointment, if needed.
» If not an emergency referral, the client or family arranges transport.
» For emergency referrals, the health-care facility arranges transport, usually
by phoning the district for an ambulance or other vehicle, and informing
the receiving facility that the emergency client is on the way.
personas
» Fill out a referral form, which can include notification of the referral
destination.
» Provide the necessary clinical, sociodemographic and identity information
to the referral facility. This can be done digitally if the appropriate systems
are in place.
scenarios
7. Discuss any questions with the client
» Discuss any of the client’s questions or concerns.
8. Check whether the client can be accommodated
workflows
» The receiving facility evaluates the needs and assesses whether the client
can receive the services needed.
9. Is it possible to accommodate the client?

» If the receiving facility cannot accommodate the client, it will inform the
data
source facility. If accommodation for the client is possible, move on to step
10.
decisions
10. Receive the client
» The receiving facility receives the client, along with all the necessary
clinical, sociodemographic and identification information, and provides the
services. If both facilities use digital systems with interoperability standards
in place, the information can be exchanged digitally in a faster and more
indicators
reliable way.
requirements
recommendations
G. Business process for aggregate reporting and data use

Objective: To aggregate Fig. 11 Workflow G: aggregate reporting business process
client-level data into
validated, aggregate
personas
reports, use the data and

submit reports (Fig. 11). NO 6. Issue
facility
NO the re
6. Issue
facility
3. Correct 4. Generate 5. Check the the re
YES
health-care
1. Check data
worker
fixable data
3. Correct 4.aggregate
Generate 5.aggregate
Check the
health-care qualitydata
1. Check YES
worker
scenarios
quality issues
fixable data reports
aggregate reports
aggregate
quality
quality issues reports reports
Health
Health 2. Data quality
issues
Datafound?
Reporting
2. quality
issues found?
Reporting
workflows
data
decisions
officer
officer
clinic
information
clinic
information
health
health
indicators
health
District
health
District
District
District
requirements

recommendations
personas
6. Issues found in
the reports?
6. Issues found in
the reports? 7. Analyse and 8. Take actions
7.interpret
Analysetheand 8.based
Take on the
actions
scenarios
NO reportsthe
interpret findings
based on the
NO reports findings
YES
YES 9. Submit data
workflows
electronically
9. Submit data
electronically
data
decisions
Reports to review
received
Reports to review
received
indicators
10. Review the 11. Provide
10.submitted
Review the feedback
11. Provide
data
submitted tofeedback
the facility
data to the facility
requirements
recommendations
AGGREGATE REPORTING AND DATA USE BUSINESS PROCESS NOTES AND ANNOTATIONS
General notes 5. Check the aggregate reports
National, digital, case-based surveillance systems for TB have several » Check for any potential remaining data quality issues such as implausible
advantages compared with the more traditional paper-based aggregated values or outputs.
systems, such as reduction in the recording and reporting workload of frontline
personas
6. Were issues found in the reports?

workers, better data quality, faster access to data at all levels, more flexible data
» If so, return to step 3.
analysis and enhanced use of data through record linkage between databases.
For this reason, WHO encourages countries to make the transition from paper-
7. Analyse and interpret the reports
based aggregated to case-based digital TB surveillance. » The analyses and interpretation of the reports should identify opportunities
scenarios
to improve the performance of the health-care facility, such as tracing

1. Check data quality
missing data or contacting patients who have not attended a clinic.
» Health-care facility data are reviewed for accuracy, validity and
» Data analysis and interpretation can be done regularly and should not be
completeness.
limited to the reporting schedule.
» This can be supported through automated checks in a digital system.
workflows
» Guidelines and guidance: 8. Take actions based on the findings

• WHO consolidated guidance on tuberculosis data generation and use » Findings from the reports can inform corrective actions.
– Module 1: tuberculosis surveillance (15).
9. Submit data electronically
2. Were data quality issues found? » This can be automated in digital systems.
data
» Depending on the local policies and system design, an active “submission”

3. Correct fixable data quality issues may not be needed and the district-level, provincial-level and national-
» Where possible, inaccurate, invalid or incomplete data should be checked level ministry of health should be able to access data directly for reporting
against source records and corrected according to the national standard
decisions
purposes.
operating procedures.
» It is also possible for the same episode of TB disease in a given individual 10. Review the submitted data
to be recorded multiple times in the system. Any duplicate records of » The district health office reviews the quality of the submitted data.
the same episode of TB must be removed (de-notify duplicate case[s]) to
avoid overreporting. Depending on local policy, this step might need to be
indicators
11. Provide feedback to the facility

delegated to a person with the appropriate data access rights. » The focal person at the district level will provide feedback to the facility. If
data quality issues are identified, the facility may be required to restart the
4. Generate aggregate reports process and resubmit the reports.
» The health worker generates aggregate reports of predefined indicators
requirements
aligned with national monitoring and evaluation guidelines.

» This can be automated and done digitally.

recommendations
4.3 Additional considerations for adapting workflows
As a reminder, these workflows are meant to be generic and high-level workflows. They will require a level of customization and adaptation because they are being
translated into a digital system for a specific context. These workflows are considered to be 80% complete, so the other 20% will need to be done through a series
of human-centred design methods and mechanisms to complete the workflows for an implementation. For example, additional workflows may need to be drawn
personas
out or there might be additional activities expected of a health worker in the facility. Some workflows are not included because of the high level of contextualization
required, including billing, dispensing (if separate from service provision), and defining and planning a TB strategy, which represents a high-level process, not within
the scope of primary care activities. Alternatively, there might be some activities and tasks a health worker would not be expected to do. Although these workflows
can be considered as a starting point, it is helpful to conduct further validation through interviews with the targeted personas or shadowing their work to obtain a
better sense of the differences that would need to be reflected in the digital system.
scenarios
workflows
data
decisions
indicators
requirements
5
recommendations
Component Core data elements

personas
This section outlines the minimum set of data corresponding to different points of the workflow within the identified business processes. This data set can be
used on any software system and lists the data elements relevant for service delivery and executing decision-support logic, and for populating indicators and
scenarios
performance metrics. Although this section provides a high-level overview of the data elements, a more complete data dictionary in spreadsheet form detailing the
input options, validation checks and concept dictionary codes is available here.
Inclusion of a data element in the table does not by itself indicate that collection of the data is required. Additionally, some data elements are dependent on other
data elements (e.g. test results are only entered when a test has been performed). The collection of data should not prevent clients from accepting screening,
workflows
diagnosis, TPT, TB treatment or affect clinical care. This will require review and adaptation.
5.1 Simplified list of core data elements

data
Table 7 provides a simplified list of core data elements and is merely a snapshot of the comprehensive data dictionary. As with the workflows, this data dictionary is
80% generic with the expectation that the other 20% will be supplemented and modified through country adaptation.
decisions
Table 7 Workflow core data elements for identified business processes
Activity ID and name Data element ID Data element name Description and definition
Business process TB.A: registration
TB.A4. Gather the TB.A4.DE.1 First name Client’s first name
client’s details
indicators
TB.A4.DE.2 Last name Client’s family name or last name

TB.A4.DE.3 Unique ID Unique ID of the client moving through the health system. It can be based on a national unique ID, a national health ID,
biometrics, a system-generated unique ID or something else
TB.A4.DE.4 Encounter date The date and time of the client’s encounter with the health system
TB.A4.DE.5 Source of referral Indicates the source of the referral
requirements

recommendations
TB.A8.1 Review TB.A7.DE.1 Date of birth The client’s date of birth, if known
sociodemographic TB.A7.DE.2 Date of birth unknown Indicates if the client’s date of birth is unknown
data with the client
TB.A7.DE.3 Age Age (number of years, rounded to the nearest integer) of the client calculated based on their date of birth. If the date of
OR birth is unknown, the client’s estimated age is stored
TB.A7 Create a new TB.A7.DE.17 Sex Sex of the client assigned at birth
personas
client record
Business process TB.B: screening
TB.B2. Make an TB.B2.DE.1 Consent for screening Indicates if the client gave their consent for screening based on the information provided by the health worker
informed decision provided
TB.B2.DE.2 Date informed consent The date when the client gave consent for proceeding with screening or refused to do so
scenarios
obtained
TB.B3. Assess medical TB.B3.DE.1 Risk group Indicates the risk group to which the client belongs, if any. A risk group is any group of people in which the prevalence or
history and risk factors incidence of TB is significantly higher than in the general population
TB.Comm.DE.23 Risk factors/ Indicates which specific risk factors or comorbidities (when TB disease is confirmed) the client presents
comorbidities
TB.B4. Determine the TB.B4.DE.1 TB screening algorithm Screening algorithm selected for the screening activities
workflows
screening algorithm
TB.B5. Perform the TB TB.Comm.DE.57 Symptoms of TB Symptoms that may indicate active TB
screening TB.Comm.DE.68 Symptom screening The result of the TB symptom screening
result
TB.Comm.DE.71 Date of symptom The date when the result of symptom screening is available
data
screening result
TB.B7. Evaluate the TB.B7.DE.1 TB screening result Record the result of the TB screening
screening results
Business process TB.C: diagnosis
decisions
TB.C1. Carry out TB.C1.DE.2 Danger signs present Indicates if danger signs were identified and required urgent medical care
clinical examination TB.Comm.DE.1 Body height (cm) The client’s height in centimetres
TB.Comm.DE.3 Body weight (kg) The client’s current weight in kilograms
TB.Comm.DE.7 z-score The client’s weight-for-height z-score
TB.Comm.DE.8 Body mass index (BMI) BMI for adults and adolescents
indicators
TB.C1.DE.6 Presumptive TB The client is presumed to have TB
TB.C1.DE.7 Date of presumptive TB The date when the client was considered a presumptive TB case
registration
requirements
Core data elements 77
recommendations
TB.C2. Assess medical TB.Comm.DE.9 Nutritional status Indicates the nutritional status of adults and adolescents (age ≥10 years)
history and risk factors (adults and
adolescents)
TB.Comm.DE.16 Nutritional status Indicates the nutritional status of children (age <10 years)
(children)
personas
TB.Comm.DE.126 HIV status HIV status reported after applying the national HIV testing algorithm. No single HIV test can provide an HIV-positive
diagnosis
TB.C3. Assess TB TB.C3.DE.1 Risk of multidrug- Indicates the results of the MDR-TB risk assessment for the client
contact history resistant TB (MDR-TB)
TB.Comm.DE.46 History of contact with Client had a history of a contact with a person with TB
a person with TB
scenarios
TB.C3.DE.4 TB contact in the Indicates if the client had contact with a person with TB in the previous 12 months
previous 12 months
TB.C4. Assess history TB.Comm.DE.48 Year of previous TB Indicates the year when the previous treatment was completed or stopped. This can be calculated automatically by the
of prior TB treatment treatment system, with a greater precision when digital systems are used and already store this information
TB.C4.DE.1 TB treatment history History of previous TB treatment
workflows
TB.C10. Collect TB.Comm.DE.72 Test sample collected Whether a test sample was collected from the patient
specimen(s)
TB.C11. Perform the TB.C11.DE.1 TB diagnostic test A TB diagnostic test was performed and completed
initial test(s) for the performed
diagnosis of TB
TB.C11. Perform the TB.C11.DE.2 TB diagnostic test type Indicates whether the test is an initial TB diagnostic test or a follow-on test
data
initial test(s) for the TB.C11.DE.5 TB diagnostic test This is the category of diagnostic test performed to detect active TB or TB drug resistance
diagnosis of TB category
TB.C18. Perform
decisions
follow-on testing
TB.C16.1. Interpret TB.C16.1.DE.9 Rifampicin Indicates the results of the rifampicin susceptibility testing
RIF susceptibility test susceptibility test result
results
TB.C16.4. Interpret
indicators
RIF susceptibility test

results for the retest
TB.C20. Interpret
the follow-on test(s)
results
requirements

recommendations
TB.C24. Make a TB.C24.DE.1 TB diagnosis result Final result of the TB investigation (TB confirmed or excluded)
diagnostic decision TB.C24.DE.4 Date of TB diagnosis The date when the diagnosis was established
TB.C24.DE.6 Method of diagnosis Method used to establish the diagnosis (bacteriologically confirmed or clinically diagnosed)
TB.Comm.DE.102 Site of TB disease Anatomical site of TB disease
Business process TB.D: TB treatment
personas
TB.D1. Determine TB.D1.DE.1 TB treatment regimen Indicates for which regimen the client is eligible, based on the diagnosis
eligibility for TB type
treatment regimen TB.Comm.DE.49 Hypersensitivity Indicates if the client has a personal history of allergy or hypersensitivity or potential contraindication to TB drugs
type or allergy or
contraindication to TB
scenarios
drugs
TB.D1.DE.5 Additional eligibility Contains the eligibility criteria for the DR-TB regimens
criteria for drug-
resistant TB (DR-TB)
regimens
TB.D5. Perform other TB.D5.DE.2 Willing to use effective The client is a premenopausal woman who is willing to use effective contraception
workflows
baseline clinical contraception
evaluations TB.Comm.DE.44 CD4 count CD4 cell count in cells per mm3
TB.D9. Determine the TB.D9.DE.1 TB treatment regimen TB treatment regimen proposed to the client or taken by the client
regimen designed
to treat rifampicin-
susceptible TB
data
TB.D10. Determine
the regimen designed
to treat rifampicin-
decisions
resistant TB
TB.D12. Make an TB.D12.DE.1 TB treatment accepted Indicates if the client accepted to take the TB treatment
informed decision
TB.D13. Initiate the TB.D13.DE.1 TB treatment started Indicates if TB treatment was started
treatment and discuss TB.Comm.DE.136 Reason treatment was Indicates the reason why treatment was not started
indicators
adherence not started
TB.D14. Develop TB.D14.DE.1 Monitoring Indicates the examinations and testing part of the monitoring examination schedules
monitoring examinations
examinations and a
schedule of follow-up
visits
requirements
recommendations
TB.D18. Perform TB.D18.DE.2 Bacteriologically The client has at least two consecutive negative cultures (for DR-TB and DS-TB) or smears (for DS-TB only), taken on
the follow-up converted (to negative) different occasions at least 7 days apart
examinations TB.D18.DE.3 Conversion date The specimen collection date of the first negative culture or smear is used as the date of conversion
TB.D24. Report TB.D24.DE.1 Treatment outcome Indicates client’s treatment outcome
outcome
personas
Business process TB.E: TPT

TB.E1. Offer TB TB.E1.DE.1 TB preventive Whether the client was provided with TPT counselling
prevention counselling treatment (TPT)
counselling offered
TB.E2. Make an TB.E2.DE.1 TB prevention services Indicates if the client accepts to be evaluated for TB infection and take the treatment if they are eligible
informed decision accepted
scenarios
TB.E3.1. Determine TB.E3.1.DE.1 TB infection test Indicates if the client should be tested for TB infection
whether TB infection recommended
testing is relevant
TB.E3.3. Test for TB TB.E3.3.DE.1 TB infection test Indicates if a TB infection test was performed
infection performed
workflows
TB.E3.4 Interpret the TB.E3.4.DE.1 TB infection test result Records the result of the TB infection test
TB infection test result
TB.E4.2. Assess TB.E4.2.DE.1 Medication affecting The medication history is used to guide the choice of TPT regimen or determine the need for modification of the treatment
medication history TPT of comorbid conditions. Certain drug classes such as ARV drugs, opioids and antimalarials often affect TPT
TB.E4.7. Determine TB.E4.7.DE.1 Eligible for TPT Client is eligible for TPT according to national guidelines
data
TPT eligibility
TB.E6 Determine the TB.E6.DE.1 TPT regimen The TPT regimen is proposed to the client or taken by the client
TPT regimen
TB.E9. Initiate TPT and TB.E9.DE.3 TPT status Indicates the current status of TPT
decisions
develop an adherence
plan
TB.E14. Report TPT TB.E14.DE.1 TPT completion date The date on which the client completed TPT
completion
indicators
requirements

recommendations
Business process TB.F: referral
TB.F6. Provide TB.F6.DE.1 Client transferred Indicates if the client was transferred “in” or “out”. The client permanently changes facilities to continue TB care. The
information to the transferring facility can consider the record as closed on its side
receiving facility TB.F6.DE.12 Source facility ID Unique code of the facility from where the client moved
TB.F6.DE.13 Destination facility ID Unique code of the facility to whose care the client moved
personas
TB.F6.DE.14 Destination facility Address of the facility to whose care the client moved
address
TB.F6.DE.15 Referral date The date the referral was made
TB.F6.DE.16 Reason for the referral Indicates the reason why the client is referred to another health-care facility. The client is expected to return to the
referring facility to continue further TB diagnosis or treatment or care
scenarios
TB.F6.DE.29 Referral notes Any additional relevant details of clinical significance for the receiving facility to provide quality care
TB.F6.DE.30 Transfer notes Any additional relevant details of clinical significance for the receiving facility to provide quality care, in case of transfer
TB.F6.DE.31 Client history summary With interoperable systems, the provider receiving the referral or transfer should be able to access the client’s health
record digitally. However, in the absence of this, the receiving provider should receive a summary of the client’s health
records that include the client’s history, reported issues and concerns, and any other relevant clinical information the
referring health-care provider has already obtained
workflows
ARV: antiretroviral; BMI: body mass index; DR-TB: drug-resistant TB; DS-TB: drug-susceptible TB; TB: tuberculosis; TPT: tuberculosis preventive treatment.
data
decisions
indicators
requirements
recommendations
5.2 List of calculated data elements

The previous section outlines the core data elements that should be included within digital systems to facilitate the decision-support logic or indicators. There are
additional derived data elements that are based on calculations from core data elements and these are shown in Table 8.
Table 8 Calculated data elements

personas
Calculated Core data elements used Calculation

data element for calculation (i.e. the
label variables)
BMI » Body weight Body weight (kg)/([Body height (cm)/100]2)
scenarios
» Body height
Age » Date of birth (TODAY – “Date of birth”)/365.25
z-score » Body weight z = (raw score − population mean)/standard deviation

» Body height Use WHO chart tables for sex (49)
» Age
workflows
Children » Body weight Defined as weight-for-height z-score below −3

with severe » Body height OR
acute » Age Mid-upper-arm circumference below 115 mm
malnutrition
» Mid-upper-arm
circumference
data
Underweight » Body weight Adults and adolescents: BMI <18.5

» Body height Children aged under 10: weight-for-age z-score below −2
» Age
decisions
Age group » Age » Infant: aged under 1 year (12 months)

» Child: aged under 10 years
– Young child: aged under 5 years
» Adolescent: aged 10–19 years (inclusive)
– Young adolescent: aged 10–14 years
– Older adolescent: aged 15–19 years
indicators
» Adult: aged 20 years or older
BMI: body mass index.

requirements

recommendations
5.3 Additional considerations for adapting the data dictionary
Some settings may require the inclusion of additional data elements into the full data set or changes to response options based on contextual differences.
Additionally, the transition from paper-based forms to digital systems may require some reflection on whether data elements currently on the paper forms should
be incorporated into the digital system. Table 9 is an initial list of considerations anticipated for each implementation to review and customize based on the national
personas
guidelines and local context. Annex 2 provides further guidance for adapting the data dictionary.
Table 9 Characteristics for local customization and configuration
Points of customization Description

and configuration
scenarios
Unique identifier The unique identifier of the client can be based on a national unique ID, a national health ID, biometrics, a system-generated unique identifier or something else.
National ID The format of the national ID varies from country to country.
Facility identifier The unique identifier of the facility. A reference to a facility registry or a reporting system (e.g. DHIS2, formerly District Health Information Software) should be
included where possible.
Facility name The name of the different health-care facilities based on a facility registry or a reporting system (e.g. DHIS2) should be included where possible.
workflows
Ownership This denotes whether the facility is public or private, where relevant.
Type of health-care facility Type of facility, which is based on country terminology (e.g. health centre, health post, dispensary, hospital).
Global positioning system Latitude and longitude coordinates can be included, if relevant for mapping purposes. This can be helpful especially in the context of community health workers who
coordinates could be given TB tasks based on their catchment area and client’s visit history.
Administrative areas can be based on geographical location, catchment area or another mechanism the country uses for managing health-care facilities.
data
Administrative areas
Catchment population If known, the catchment population would be useful to include in the automated calculation of indicators.
Laboratory tests available Whether or not certain laboratory tests are available at the health-care facility could impact the health worker’s workflow and the client’s TB service experience (e.g.
haemoglobin, LFT and HIV screening tests, molecular WHO-recommended rapid diagnostic tests for TB, other rapid diagnostic tests).
decisions
LFT: liver function test; TB: tuberculosis; WHO: World Health Organization.
indicators
requirements
6
recommendations
Component
Decision-support logic
personas
The decision-support logic component of the DAK provides the decision logics and algorithms, and the scheduling of services, in accordance with WHO guidelines.
In this DAK, the decision logics and algorithms deconstruct the recommendations within the TB guidelines and guidance into a format that clearly labels the inputs
scenarios
and outputs that would be operationalized in a digital decision-support system.
6.1 Overview
Table 10 provides an overview of the decision-support tables and algorithms for the different TB module business processes. The structure of the decision-support
workflows
tables is based on an adaptation of the Decision Model and Notation (DMN), an industry standard for modelling and executing decision logics (50). These decision-
support tables detail the business rules, data inputs and outputs to support the TB module business processes.
Table 10 Overview of the decision-support tables for the TB module

data
Activity ID and name Decision- Decision-support table Reference/source

support table description
ID
TB.B4. Determine the screening TB.B4.DT Determine the screening WHO operational handbook on tuberculosis – Module 2: screening (systematic screening for tuberculosis disease)
decisions
algorithm algorithm (31)

TB.B7. Evaluate the screening TB.B7.DT Evaluate the screening WHO operational handbook on tuberculosis – Module 2: screening (systematic screening for tuberculosis disease)
results results (31)
TB.E3.1. Determine whether TB TB.E3.1.DT Determine whether TB WHO consolidated guidelines on tuberculosis – Module 3: diagnosis (tests for tuberculosis infection) (22)
infection testing is relevant infection testing is relevant WHO operational handbook on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (29)
indicators
WHO operational handbook on tuberculosis – Module 2: screening (systematic screening for tuberculosis disease)
(31)
TB.E4.7. Determine TPT TB.E4.7.DT Determine TPT eligibility WHO consolidated guidelines on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (18)
eligibility WHO operational handbook on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (29)
TB.E6. Determine the TPT TB.E6.DT Determine TPT regimen WHO consolidated guidelines on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (18)
requirements
regimen WHO operational handbook on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (29)

recommendations
Activity ID and name Decision- Decision-support table Reference/source
support table description
ID
TB.E8. Determine the dosages TB.E8.DT Determine the dosages of WHO operational handbook on tuberculosis – Module 1: prevention (tuberculosis preventive treatment) (29)
of medicines for TPT medicines for TPT
TB.C7. Determine the TB.C7.DT Determine the diagnostic WHO operational handbook on tuberculosis – Module 3: diagnosis (rapid diagnostics for tuberculosis detection,
personas
diagnostic tests for the initial test(s) 2021 update) (32)
testing WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection:
recommendations for a public health approach, 2nd ed (51)
TB.C12. Interpret the test(s) TB.C12.DT Interpret the TB “Initial WHO operational handbook on tuberculosis – Module 3: diagnosis: (rapid diagnostics for tuberculosis detection,
results testing” results 2021 update) (32)
TB.C16.1 Interpret RIF TB.C16.1.DT Interpret the RIF WHO operational handbook on tuberculosis – Module 3: diagnosis: (rapid diagnostics for tuberculosis detection,
scenarios
susceptibility test results susceptibility test results 2021 update) (32)
TB.C16.4 Interpret RIF TB.C16.4.DT Interpret the RIF WHO operational handbook on tuberculosis – Module 3: diagnosis: (rapid diagnostics for tuberculosis detection,
susceptibility test results for susceptibility test results for 2021 update) (32)
the retest the retest
TB.C20. Interpret the follow-on TB.C20.DT Interpret the “Follow-on WHO operational handbook on tuberculosis – Module 3: diagnosis: (rapid diagnostics for tuberculosis detection,
workflows
test(s) results testing” results 2021 update) (32)
TB.C24 Make a diagnostic TB.C24.DT Treatment decision WHO operational handbook on tuberculosis – Module 5: management of tuberculosis in children and adolescents
decision algorithm for children (37)
TB.D9. Determine the regimen TB.D9.DT Determine the regimen WHO operational handbook on tuberculosis – Module 4: treatment (drug-resistant tuberculosis treatment, 2022
designed to treat rifampicin- designed to treat update) (34)
susceptible TB rifampicin-susceptible TB WHO operational handbook on tuberculosis – Module 4: drug-susceptible tuberculosis treatment (35)
data
WHO operational handbook on tuberculosis – Module 5: management of tuberculosis in children and adolescents
(37)
TB.D10. Determine the regimen TB.D10.DT Determine the regimen WHO operational handbook on tuberculosis – Module 4: treatment (drug-resistant tuberculosis treatment, 2022
designed to treat rifampicin- designed to treat
decisions
update) (34)
resistant TB rifampicin-resistant TB WHO operational handbook on tuberculosis – Module 5: management of tuberculosis in children and adolescents
(37)
TB.D11. Determine the dosages TB.D11.DT Determine the dosages of WHO operational handbook on tuberculosis – Module 4: treatment (drug-resistant tuberculosis treatment, 2022
of medicines for TB treatment medicines for TB treatment update) (34)
WHO operational handbook on tuberculosis – Module 4: drug-susceptible tuberculosis treatment (35)
indicators
WHO operational handbook on tuberculosis – Module 5: management of tuberculosis in children and adolescents
(37)
requirements
Decision-support logic 85
recommendations
6.2 Decision-support tables

Each of the decision logics listed in the overview table is elaborated in the decision-support implementation tool found here. These decision-support tables include
the components described in Table 11. Table 12 is an example of a decision-support logic table for determining if a TB infection test is relevant.
Note that the decision-support logic here is translated directly from WHO guidelines and guidance documents, and has been reviewed by the panel of experts that
personas
has created these guidelines. We do not anticipate the decision-support logic to change much because the logic has been created and reviewed by clinical experts.
However, some level of adaptation may be needed depending on changes to the workflow or changes to the data dictionary.
Any changes to the decision-support logic should be considered carefully because an embedded decision-support system can greatly affect quality of care at the
point of care. As helpful as decision-support logic can be to the health worker, an incorrect decision-support logic can also be detrimental. Thus, any new decision-
scenarios
support logic should be carefully reviewed and agreed on by in-country clinical experts.
Table 11 Components of the decision-support tables
Decision ID The ID of the decision. The decision ID should correspond to the ID in the overview table (e.g. TB.B4.DT, TB.C7.DT.)
Business The description of the decision that needs to be made based on IF/THEN statements with the appropriate data element name for the variables. The rule should demonstrate the
workflows
rule relationship between the input variables and the expected outputs and actions within the decision-support logic.
Trigger The event that would indicate when this decision-support logic should appear within the workflow, such as the activity that would trigger this decision to be made.
Hit policy Displays the hit policy selected for the table. The hit policy determines the output of a decision table from the output cells of matched rules. A rule is matched when all of its condition
indicator cells match the inputs of the decision table. First (F): The first hit by rule order is returned (and evaluation can halt). Rule order (R): returns all hits in rule order.
R or F Input expression 1 Input expression 2 Output type Action Guidance Annotation(s) Reference(s)
data
Rule ID: Input entry: the If there are multiple Select an output type that best A specific action Pop-up alert messages This column should be used for any other Add the
“Process value of the input input entries in the describes the type of action detailing the for the health notes, annotations or communication reference
ID”.“activity expression; the same row (such detailed in the next column. output type; the worker; these should messages within the team. This should to the
number”. data type of the as here), these For additional guidance, please action will always include the written include any additional information that appropriate
start with a verb.
decisions
“DT”.“Rule input entry cells is different inputs are refer to the ReadMe section that content that would does not fit into the other columns. guidance
number” determined by the considered as “AND”, describes each option in detail. The action will appear in the pop-up Please note, this message will not document.
E.g. data type of the that is, conditions If there are multiple outputs trigger the system messages notifying appear as a pop-up message. While
TB.B4.DT.01 input expression. that need to be in that apply for the given rule, to perform a the health worker of noting down the annotations, please
place at the same then select “Plan Definition”. decision-support the appropriate next note the correct audience for the
time. outcome. steps. annotation (i.e. Who is this message for?).
Rule ID: Inputs placed in
indicators
“Process different rows are

ID”.“activity considered as “OR”
number”. conditions that
“DT”. “Rule can be considered
number” independently of the
E.g. inputs in other rows.
requirements
TB.B4.DT.02

recommendations
Table 12 Example decision-support logic table for determining if a TB infection test is relevant
Decision ID TB.E3.1.DT
Business The results of the screening activities and the risk group to which the client belongs are used to determine if a TB infection test is relevant
rule
Trigger TB.E3.1. Determine whether TB infection testing is relevant
personas
Hit policy Rule order
indicator
R Risk group Age Output type Action Guidance Annotations Reference(s)

TB.E3.1.DT.01 “Risk group” – ActivityDefinition “Assess for TPT TB infection test People living with HIV who are on antiretroviral WHO consolidated guidelines on
in “PLHIV” eligibility” is optional. WHO therapy (ART) benefit from TPT regardless of whether tuberculosis – Module 3: diagnosis
recommends they test positive or negative for TB infection. People (tests for tuberculosis infection) (22)
scenarios
that testing for living with HIV who are not on ART and who test
TB infection positive for TB infection are shown to benefit more
should not be from TPT than those with a negative test. However, WHO operational handbook on
a requirement WHO recommends that testing for TB infection tuberculosis – Module 1: prevention
for initiating should not be a requirement for initiating TPT among (tuberculosis preventive treatment)
TB preventive people living with HIV (29):
treatment (TPT) Chapter 4. Testing for TB infection
workflows
among people
living with HIV
TB.E3.1.DT.02 “Risk “Age” ≥5 ActivityDefinition “Test for TB TB infection test The use of TB infection tests limits unnecessary
group” in ‘year’ infection” is recommended. treatment of uninfected individuals (such as settings
“Contacts” Test the client for with low prevalence of TB infection). Availability of
and not TB infection using a positive test for TB infection among HIV-negative
data
(“Risk TST, IGRA or TBST contacts may reassure clinicians and health workers
group” in that TB infection is likely and to start TPT
TB.E3.1.DT.03 “PLHIV”) “Age” <5 ActivityDefinition “Assess for TPT TB infection test WHO recommends that testing for TB infection
‘year’ eligibility” is optional. The should not be a requirement for initiating TPT among
decisions
benefits of TPT child contacts below 5 years of age, particularly in
(even without countries with high TB incidence, given that the
testing) clearly benefits of treatment (even without testing) clearly
outweigh the risks outweigh the risks
indicators
requirements
recommendations
TB.E3.1.DT.04 “Risk – ActivityDefinition “Test for TB TB infection test For individuals or populations with a higher risk WHO consolidated guidelines on
group” in infection” is recommended. of harms due to TPT or (relatively) lower risk tuberculosis – Module 3: diagnosis
“Other risk Test the client for of progression to TB disease, confirmation of (tests for tuberculosis infection) (22)
group” and TB infection using TB infection may be preferred. Availability of a
not (“Risk TST, IGRA or TBST positive test for TB infection among individuals
WHO operational handbook on
group” in in other clinical risk groups (clients initiating
tuberculosis – Module 1: prevention
“PLHIV, anti-tumour necrosis factor treatment, receiving
(tuberculosis preventive treatment)
Contacts”) dialysis, preparing for organ or haematological
personas
(29):
transplantation) may reassure clinicians and health
Chapter 4. Testing for TB infection
workers that TB infection is likely and to start TPT
WHO operational handbook on
tuberculosis – Module 2: screening
(systematic screening for tuberculosis
disease) (31):
scenarios
Chapter 3. Screening tools and

algorithms
ART: antiretroviral therapy; IGRA: interferon-gamma release assay; PLHIV: people living with HIV; TB: tuberculosis; TBST: Mycobacterium tuberculosis antigen-based skin tests; TPT: tuberculosis
preventive treatment; TST: tuberculin skin test; WHO: World Health Organization.
workflows
For all the decision-support tables that are available for the TB DAK, please refer to the decision-support implementation tool.
6.3 Decision trees

data
Decision trees are a graphical depiction of your decision-support logic (Fig. 12). Although the decision-support tables, linked to specific activities in the workflow,
should be comprehensive in covering all the logic that will need to be included in the system, sometimes a visual depiction of the decision logic in a decision tree
form can be helpful. Depending on the complexity of the care pathway algorithm, this decision tree can be too overwhelming and unhelpful. However, less complex
decisions
decisions can easily also be depicted in graphical form, which may prove helpful if included.
EXAMPLE DECISION TREE

indicators
Decision trees may be used to supplement the structured format of the decision-support tables and can help in visualizing different pathways. The addition of
decision trees may be especially useful for decision points that consist of multiple inputs and outputs. An example of a decision tree is given in Fig. 12. Each box
represents a single decision that needs to be made. The tree depicts how the outputs of one decision will serve as inputs to another decision that will need to be
made.
requirements

recommendations
Fig. 12
Algorithm 2a: LF-LAM to aid in the diagnosis of TB among PLHIV in inpatient settings
2a
personas
All hospitalized PLHIV
Assess person for TB signs and symptoms, being seriously ill, having AHD and CD4 count
scenarios
No TB signs or symptoms and No TB signs or symptoms and
A Positive for TB signs and symptoms B AHD+ or seriously ill or CD4 <200 C CD4 >200 or unknown
Collect a urine sample & perform urine LF-LAM Collect a urine sample &
Clinical management
Collect a sample & perform mWRD test perform urine LF-LAM
workflows
LF-LAM LF-LAM LF-LAM LF-LAM
+ − − +
Initiate TB treatment
Initiate TB treatment TB is not ruled out Evaluate CD4 Collect specimen &
data
Evaluate mWRD result Evaluate mWRD result count perform mWRD test
mWRD mWRD mWRD mWRD

CD4 CD4 mWRD mWRD
+ − + − <200 >200 + −
decisions
Continue Continue
Adjust TB treat- Adjust TB treat-
treatment Initiate TB
Clinical management Apply treatment
ment ment
based on treatment AHD based on
mWRD Perform based on TB is not ruled out package WRD Perform
results if workup to mWRD of care results if workup to
exclude Conduct additional evaluations for TB exclude
needed needed
DR-TB DR-TB
indicators
AHD: advanced HIV disease; DR-TB: drug-resistant TB; LF-LAM: lateral flow urine lipoarabinomannan [assay]; mWRD: molecular WHO-recommended rapid diagnostic test; PLHIV: people living with HIV;
TB: tuberculosis.
Source: WHO (32).
requirements
recommendations
6.4 Scheduling logic overview

In addition to specific decision-support logic that needs to be detailed, there is also a scheduling logic that can be used to facilitate the digital tracking of clients. For
personas
example, it will be important for the health worker to know when the client’s next visit is due based on the recommendations for follow-up. The follow-up schedules
(examples) developed for TB DAK are meant to be used for clients with confirmed TB disease and are based on the client’s TB treatment regimen and recommended
monitoring examinations for that regimen. The overview of the follow-up schedules is provided in Table 13 and the corresponding logic is elaborated in the decision-
support implementation tool.
scenarios
Table 13 Overview of scheduling logic
Schedule Scheduling logic ID Scheduling logic description Reference/source

Monitoring examinations schedules TB.D14.S Scheduling logic for TB monitoring WHO operational handbook on tuberculosis – Module 4: treatment (drug-
examinations resistant tuberculosis treatment, 2022 update) (34)
workflows
WHO operational handbook on tuberculosis – Module 4: drug-susceptible

tuberculosis treatment (35)
data
6.5 Scheduling logic

Scheduling logic, as shown in Table 14, is at a much higher level than the decision-support logic; it describes how services overall should be scheduled based on
decisions
recommendations rather than specific decisions that need to be made at the point of care. For example, the scheduling logic developed in the decision-support
implementation tool would include the recommended follow-up schedule based on the treatment regimen and the recommended monitoring examinations for
that regimen. Clinical visits should coincide with bacteriological and clinical laboratory examination schedules to limit time and transportation constraints for the
client. This should be included in the DAK in a spreadsheet.
indicators
requirements

recommendations
Table 14 Scheduling logic
Columnsa Descriptionb Example: Monitoring schedule for clients receiving the 9-month all-oral MDR/RR-TB regimen
Service name What is the short name of the service? This can also be used as the service Monthly sputum smear test
schedule label in your digital client record system.
Service What is the longer description of the service? In 1 or 2 sentences, describe Sputum smear microscopy test performed on a monthly basis
description the service and when it is given.
personas
Trigger event What event signals the start of the service schedule? “TB treatment regimen” in “4–6 Bdq(6 m)-Lfx/Mfx-Cfz-Z-E-Hh-Eto / 5 Lfx/Mfx-Cfz-Z-E, 4–6
Bdq(6 m)-Lzd(2 m)-Lfx/Mfx-Cfz-Z-E-Hh / 5 Lfx/Mfx-Cfz-Z-E” and “TB treatment is started” = TRUE
Trigger date What is the date of the signalling event that will be used to determine a IF “Month of treatment” = 0 THEN “TB treatment start date” + 3 ‘week’ ELSE last “Triger
scenarios
service’s due date? date” + 1 ‘month’ (for every treatment month)
Create condition Are there any conditions that specify when a service should be given? If yes, Response to treatment is monitored by monthly sputum smear microscopy and culture
write the condition here. If no, write “N/A”.
Due date How is the due date of the service calculated? Write the formula here using “Trigger date” + 1 week
the trigger date.
workflows
Overdue Is the service overdue? If yes, write the formula that defines the overdue “Due date” + 1 day
date. If no, write “N/A”.
Expiration Does the service expire? If yes, write the formula that defines the expiration “Due date” + 1 week
date. If no, write “No expiration date”.
Completion How does the health worker complete the service? “Monitoring examinations” = ‘Follow-up microscopy – sputum acid-fast bacilli (AFB)’ and (“Date
of monitoring examination” is between “Due date” −1 ‘week’ and “Due date” + 1 ‘week’)
data
Potential risks What are the potential risks to client safety if the service is not delivered Not following the schedule for sputum smear microscopy and culture tests might represent a
and alternative according to the recommended schedule? What are the possible alternative missed opportunity in detecting treatment failure in a timely manner
schedules service schedules? Delayed detection of failure can increase transmission and increase the probability of
decisions
acquisition of resistance to the client’s strain, making it harder to cure the client after failure
Comments Any narrative or additional comments that need to be added by the –

implementation team should be written here.
References If there are any national or global guidelines (e.g. WHO guidelines) that WHO operational handbook on tuberculosis – Module 4: treatment (drug-resistant tuberculosis
dictate the health service schedule noted here, then they should be noted. treatment, 2022 update) (34):
If any guidelines or recommendations change, having a clear reference
indicators
» Chapter 5. The 9-month all-oral regimen
listed would help in updating or restructuring your service schedule.
» Table 5.1. Example of a monitoring schedule for patients receiving the 9-month all-oral MDR/
RR-TB regimen
» Web Annex 1. Tuberculosis medicines – information sheets
MDR: multidrug resistance; N/A: not applicable; RR-TB: rifampicin-resistant tuberculosis; WHO: World Health Organization.
a
Each of these should be a separate column in Excel, corresponding with each discrete service.
requirements
b
Description of what to note in each column for each discrete service.
7
recommendations
Component Indicators and

performance metrics
personas
This section details indicators and performance metrics that would be aggregated from the core data elements identified in Component 5. The list in Table 15 is
a selection of indicators from the indicators and performance metrics implementation tool for demonstration purposes and is non-exhaustive. These indicators
scenarios
can be aggregated for decision-making, performance metrics, and subnational and national reporting based on data collected from individual-level, routine health
systems. The indicators can be aggregated automatically from the digital tracking tool to populate a digital HMIS, such as the DHIS2. The complete list of indicators
and associated details are available here.
Table 15 Indicators and performance metrics

workflows
Indicator ID Indicator name Definition Numerator computation Denominator computation Disaggregation References
Business process B: screening
TB.IND.1 Percentage of clients Percentage of clients COUNT of clients where “Date of Estimated number of clients WHO
who were screened for screened for TB out TB screening result” is within the eligible for screening following consolidated
TB out of those eligible of those eligible for reporting period provider-initiated TB screening guidance on
data
screening following programme in the reporting tuberculosis

provider-initiated TB period data
screening programme generation
and use –
decisions
Module 1:
tuberculosis
surveillance
(15)
TB.IND.2 Percentage of clients The proportion of COUNT of clients where “TB COUNT of clients where “Date of WHO
diagnosed with TB clients diagnosed diagnosis result” = “Diagnosed TB screening result” is within the consolidated
with TB among those TB” AND “TB screening result” reporting period
indicators
out of those who were guidance on

screened screened for TB = “Screen positive for TB” AND tuberculosis
following provider- “Date of TB screening result” is data
initiated TB screening within the reporting period generation
programme and use –
Module 1:
tuberculosis
requirements
surveillance
(15)

recommendations
TB.IND.3 Percentage of clients Of all the clients COUNT of clients where “TB COUNT of clients where “Date of WHO
diagnosed with TB screened, the infection test result” = “Positive” TB screening result” is within the consolidated
infection out of those proportion of clients AND (“Date of TB infection test” reporting period guidance on
screened diagnosed with TB AND “Date of TB screening result” tuberculosis
infection is within the reporting period) data
generation
personas
and use –
Module 1:
tuberculosis
surveillance
(15)
Business process C: diagnosis
scenarios
TB.IND.8 Notifications: Number of new, COUNT of clients where (“TB N/A Sex: male, female, intersex, unknown or WHO
number of notifications recurrent or unknown treatment history” = “New” OR unspecified consolidated
of people diagnosed previous TB treatment “Recurrent” OR “Unknown”) AND Age group (in years): 0–4, 5–9, 10–14, 15–19, guidance on
with a new episode of history case of TB (i.e. “Client transferred” != “In” AND 20–24, 25–34, 35–44, 45–54, 55–64, 65+ tuberculosis
TB. This includes both any case apart from a “Date of TB diagnosis” is within Geographical area: administrative unit data
drug-susceptible and re-registered cases) the reporting period AND “Case (reporting entities such as provinces, generation
workflows
drug-resistant TB de-notified” != “True” regions and districts as opposed to and use –
individual health-care facilities, which are Module 1:
too small a unit for meaningful analysis) tuberculosis
Type of TB: pulmonary bacteriologically surveillance
confirmed, pulmonary clinically diagnosed, (15)
extrapulmonary
Treatment history: new, recurrent,
data
unknown
TB.IND.9 Notification rate: Number of people COUNT of clients where (“TB Total population in the specified Sex: male, female, intersex, unknown or WHO
number of people diagnosed with a new treatment history” = “New” OR area during the reporting period unspecified consolidated
diagnosed with a new episode of TB (all “Recurrent” OR “Unknown”) AND Age group (in years): 0–4, 5–9, 10–14, 15–19, guidance on
decisions
episode of TB per forms) per 100 000 “Client transferred” != “In” AND 20–24, 25–34, 35–44, 45–54, 55–64, 65+ tuberculosis
100 000 population population “Date of TB diagnosis” is within Geographical area: administrative unit data
the reporting period AND “Case generation
de-notified” != “True” and use –
Module 1:
tuberculosis
indicators
surveillance
(15)
requirements
Indicators and performance metrics 93
recommendations
TB.IND.11 Bacteriological Percentage of people COUNT of clients where “TB COUNT of clients where “TB Geographical area: administrative unit WHO
confirmation: diagnosed with a new diagnosis result” = “Diagnosed diagnosis result” = “Diagnosed consolidated
percentage of people episode of pulmonary TB” AND (“TB treatment history” TB” AND (“TB treatment history” guidance on
diagnosed with a new TB for whom biological = “New” OR “Recurrent” OR = “New” OR “Recurrent” OR tuberculosis
episode of pulmonary specimen are “Unknown”) AND “Site of “Unknown”) AND “Site of TB data
TB whose disease positive by a WHO- TB disease” = “Pulmonary” disease” = “Pulmonary” AND generation
personas
was bacteriologically recommended rapid AND “Method of diagnosis” = “Client transferred” != “In” AND and use –
confirmed diagnostics, culture or “Bacteriologically confirmed” AND “Date of TB diagnosis” is within Module 1:
smear microscopy “Client transferred” != “In” AND the reporting period AND “Case tuberculosis
“Date of TB diagnosis” is within de-notified” != “True” surveillance
the reporting period AND “Case (15)
de-notified” != “True”
scenarios
TB.IND.15 Documentation of HIV Percentage of people COUNT of clients where “TB COUNT of clients where “TB Geographical area: administrative unit WHO
status: percentage of diagnosed with a new diagnosis result” = “Diagnosed diagnosis result” = “Diagnosed consolidated
people diagnosed with episode of TB who TB” AND (“TB treatment history” TB” AND (“TB treatment history” guidance on
a new episode of TB were tested for HIV at = “New” OR “Recurrent” OR = “New” OR “Recurrent” OR tuberculosis
whose HIV status was the time of diagnosis “Unknown”) AND “HIV status” “Unknown”) AND “HIV status” data
documented or with known HIV != “Unknown” AND “Client != “Unknown” AND “Client generation
status at the time of TB transferred” != “In” AND “Date transferred” != “In” AND “Date and use –
workflows
diagnosis of TB diagnosis” is within the of TB diagnosis” is within the Module 1:

reporting period AND “Case de- reporting period AND “Case de- tuberculosis
notified” != “True” notified” != “True” surveillance
(15)
TB.IND.18 Testing for RR-TB: Percentage of people COUNT of clients where “TB COUNT of clients where “TB Geographical area: administrative unit WHO
percentage of people with a documented diagnosis result” = “Diagnosed diagnosis result” = “Diagnosed Treatment history: new (“TB treatment consolidated
data
diagnosed with susceptibility test TB” AND (“TB treatment history” TB” AND (“TB treatment history” history” = “New”), previously treated guidance on
bacteriologically result (susceptible = “New” OR “Recurrent” OR = “New” OR “Recurrent” OR (“TB treatment history” = “Recurrent” OR tuberculosis
confirmed pulmonary or resistant) for “Re-registered”) AND “Site of “Re-registered”) AND “Site of “Re-registered”), unknown (“TB treatment data
TB who were tested for rifampicin among TB disease” = “Pulmonary” TB disease” = “Pulmonary” history” = “Unknown”) generation
decisions
rifampicin susceptibility those diagnosed AND “Method of diagnosis” = AND “Method of diagnosis” = and use –
with bacteriologically “Bacteriologically confirmed” “Bacteriologically confirmed” Module 1:
confirmed pulmonary AND (“Rifampicin susceptibility AND “Client transferred” != “In” tuberculosis
TB test result” = “Susceptible” AND “Date of TB diagnosis” is surveillance
OR “Resistant”) AND “Client within the reporting period AND (15)
transferred” != “In” AND “Date “Case de-notified” != “True”
of TB diagnosis” is within the
indicators
reporting period AND “Case de-

notified” != “True”
requirements

recommendations
TB.IND.27 RR-TB: Percentage of people COUNT of clients where “TB COUNT of clients where “TB Geographical area: administrative unit WHO
percentage of people resistant to rifampicin diagnosis result” = “Diagnosed diagnosis result” = “Diagnosed Treatment history: new (“TB treatment consolidated
tested for RR-TB who (RR-TB) among those TB” AND (“TB treatment history” TB” AND (“TB treatment history” history” = “New”), previously treated guidance on
were resistant to diagnosed with = “New” OR “Recurrent” OR = “New” OR “Recurrent” OR (“TB treatment history” = “Recurrent” OR tuberculosis
rifampicin bacteriologically “Re-registered”) AND “Site of “Re-registered”) AND “Site of “Re-registered”), unknown (“TB treatment data
confirmed pulmonary TB disease” = “Pulmonary” TB disease” = “Pulmonary” history” = “Unknown”) generation
personas
TB with a documented AND “Method of diagnosis” = AND “Method of diagnosis” = and use –
susceptibility test “Bacteriologically confirmed” “Bacteriologically confirmed” Module 1:
result (susceptible or AND “Rifampicin susceptibility AND (“Rifampicin susceptibility tuberculosis
resistant) for rifampicin test result” = “Resistant” AND test result” = “Susceptible” surveillance
“Client transferred” != “In” AND OR “Resistant”) AND “Client (15)
“Date of TB diagnosis” is within transferred” != “In” AND “Date
the reporting period AND “Case of TB diagnosis” is within the
scenarios
de-notified” != “True” reporting period AND “Case de-
notified” != “True”
Business process D: TB treatment

TB.IND.32 Treatment initiation: Percentage of people COUNT of clients where “TB COUNT of clients where “TB Geographical area: administrative unit WHO
percentage of people who were started on diagnosis result” = “Diagnosed diagnosis result” = “Diagnosed Regimen type: consolidated
workflows
diagnosed with TB and TB treatment among TB” AND “TB treatment TB” AND (“TB treatment history” » Regimen designed to treat rifampicin- guidance on
registered as a TB case all people diagnosed started” = “True” AND (“TB = “New” OR “Recurrent” susceptible TB (irrespective of HIV- tuberculosis
who were started on TB with TB and registered treatment history” = “New” OR OR “Unknown” OR “Re- status) data
treatment as a TB case “Recurrent” OR “Unknown” registered”) AND (“Site of TB generation
» Regimen designed to treat rifampicin-
OR “Re-registered”) AND (“Site disease” = “Pulmonary” OR and use –
susceptible TB (people living with HIV)
of TB disease” = “Pulmonary” “Extrapulmonary”) AND (“Method Module 1:
OR “Extrapulmonary”) AND of diagnosis” = “Bacteriologically » Short (≤12 month) regimen designed
tuberculosis
data
(“Method of diagnosis” = confirmed” OR “Clinically to treat rifampicin-resistant TB (RR-TB/
surveillance
“Bacteriologically confirmed” OR diagnosed”) AND “Date of TB MDR-TB/pre-XDR-TB/XDR-TB)
(15)
“Clinically diagnosed”) AND “Date diagnosis” is within the reporting » Long (>12 month and ≤24 month)
of TB diagnosis” AND “Date TB period AND “Case de-notified” != regimen designed to treat rifampicin-
decisions
treatment started” are within the “True” resistant TB (RR-TB/MDR-TB/pre-XDR-
reporting period AND “Case de- (add people transferred in to TB/XDR-TB)
notified” != “True” start treatment at this facility and
(exclude those who did not start exclude people transferred out to
treatment or transferred out start treatment in another facility)
before start of treatment, add any
people transferred in before start
indicators
of treatment)
requirements
recommendations
TB.IND.35 Treatment outcome: Percentage of TB COUNT of clients where “Date of COUNT of clients where “Date of Geographical area: administrative unit WHO
percentage of TB patients who started TB diagnosis” is 12 months earlier TB diagnosis” 12 months earlier Regimen type: consolidated
patients who were TB treatment who than the reporting period AND than the reporting period AND » Regimen designed to treat rifampicin- guidance on
cured out of those who were cured (“TB treatment history” = “New” (“TB treatment history” = “New” susceptible TB (irrespective of HIV- tuberculosis
started TB treatment OR “Recurrent” OR “Unknown” OR “Recurrent” OR “Unknown” status) data
OR “Re-registered”) AND (“Site of OR “Re-registered”) AND (“Site of generation
personas
TB disease” = “Pulmonary” OR TB disease” = “Pulmonary” OR » Regimen designed to treat rifampicin-

and use –
“Extrapulmonary”) AND “Method “Extrapulmonary”) AND (“Method susceptible TB (people living with HIV)
Module 1:
of diagnosis” = “Bacteriologically of diagnosis” = “Bacteriologically » Short (≤12 month) regimen designed tuberculosis
confirmed” AND “TB treatment confirmed” OR “Clinically to treat rifampicin-resistant TB (RR-TB/ surveillance
started” = “True” AND “Treatment diagnosed”) AND “TB treatment MDR-TB/pre-XDR-TB/XDR-TB) (15)
outcome” = “Cured” AND “Case started” = “True” AND “Case de- » Long (>12 month and ≤24 month)
de-notified” != “True” notified” != “True”
scenarios
regimen designed to treat rifampicin-

(add people transferred in to (add people transferred in to resistant TB (RR-TB/MDR-TB/pre-XDR-
continue TB treatment after continue TB treatment after TB/XDR-TB)
starting at another facility starting at another facility
and remove people that were and remove people that were
transferred out to continue TB transferred out to continue TB
treatment in another facility after treatment in another facility after
workflows
starting at this facility) starting at this facility)
Business process E: TPT

TB.IND.49 Contact investigation Percentage of COUNT of clients where “TB COUNT of clients where “Index WHO
data
coverage: percentage of household contacts screening result” is not null AND case ID” is not null AND the linked consolidated
household contacts (or of people with a “Index case ID” is not null AND the index case has: [“Date of TB guidance on
all close contacts) who new episode of linked index case has: [“Date of TB diagnosis” is within the reporting tuberculosis
were evaluated for TB bacteriologically diagnosis” is within the reporting period AND (“TB treatment data
(disease or infection) confirmed pulmonary period AND (“TB treatment history” = “New” OR “Recurrent” generation
decisions
(This indicator can be

TB notified in the history” = “New” OR “Recurrent” OR “Unknown”) AND “Site of and use –
constructed for one or more reporting period who OR “Unknown”) AND “Site of TB disease” = “Pulmonary” Module 1:
subpopulations considered were evaluated for TB TB disease” = “Pulmonary” AND “Method of diagnosis” = tuberculosis
at particularly high risk of (disease or infection) AND “Method of diagnosis” = “Bacteriologically confirmed” surveillance
TB disease or infection; the “Bacteriologically confirmed” AND AND “Case de-notified” != “True”] (15)
example provided here is for a “Case de-notified” != “True”]
indicators
household contact)
requirements

recommendations
TB.IND.50 Initiation of TPT among Percentage of COUNT of clients where “TPT COUNT of clients where “Eligible Age group: <5 years WHO
contacts: percentage of household contacts started” = “True” AND “Index case for TPT” = “True” AND “Index consolidated
household contacts (or (all ages) of people ID” is not null AND the linked index case ID” is not null AND the linked guidance on
all close contacts) who with bacteriologically case has: [“Date of TB diagnosis” index case has: [“Date of TB tuberculosis
were started on TPT, out confirmed pulmonary is within the reporting period AND diagnosis” is within the reporting data
of those eligible TB notified in the (“TB treatment history” = “New” period AND (“TB treatment generation
personas
reporting period who OR “Recurrent” OR “Unknown”) history” = “New” OR “Recurrent” and use –
constructed for one or more were eligible for TPT AND “Site of TB disease” = OR “Unknown”) AND “Site of Module 1:
subpopulations considered and who were started “Pulmonary” AND “Method of TB disease” = “Pulmonary” tuberculosis
at particularly high risk of on TPT in the reporting diagnosis” = “Bacteriologically AND “Method of diagnosis” = surveillance
TB disease or infection; the period confirmed” AND “Case de- “Bacteriologically confirmed” (15)
example provided here is for notified” != “True”] AND “Case de-notified” != “True”]
household contacts of all
scenarios
ages)
TB.IND.51 Completion rate for Percentage of COUNT of clients where “TPT COUNT of clients where “Date TB Age group: <5 and ≥5 years WHO
TPT among contacts: household contacts started” = “True” AND “Date TB preventive treatment started” consolidated
percentage of of people with preventive treatment started” is is in the previous calendar year guidance on
household contacts (or bacteriologically 12 months before the reporting AND “Index case ID” is not null tuberculosis
all close contacts) who confirmed pulmonary period AND “TPT status” = AND the linked index case has: data
workflows
completed TPT TB who completed “Completed” AND “Index case ID” [“Date of TB diagnosis” 12 months generation
their course of TPT is not null AND the linked index before the reporting period AND and use –
constructed for one or more during the reporting case has: [“Date of TB diagnosis” (“TB treatment history” = “New” Module 1:
subpopulations considered period among those is 12 months before the reporting OR “Recurrent” OR “Unknown”) tuberculosis
at particularly high risk of who started TPT and period AND (“TB treatment AND “Site of TB disease” = surveillance
TB disease or infection; the were due to finish history” = “New” OR “Recurrent” “Pulmonary” AND “Method of (15)
example provided here is for a their treatment course OR “Unknown”) AND “Site of diagnosis” = “Bacteriologically
data
household contact) during the reporting TB disease” = “Pulmonary” confirmed” AND “Case de-
period AND “Method of diagnosis” = notified” != “True”]
“Bacteriologically confirmed” AND (add people transferred in to
“Case de-notified” != “True”] continue TPT after starting at
decisions
(add people transferred in to another facility and exclude
continue TPT after starting at people transferred out to
another facility and exclude continue TPT in another facility
people transferred out to continue after starting at this facility)
TPT in another facility after
starting at this facility)
indicators
For the full list of indicators defined for the TB DAK, please refer to the indicators and performance metrics implementation tool.
requirements
8
recommendations
Component High-level functional and

non-functional requirements
personas
This section provides an overview of illustrative functional and non-functional requirements that may be considered to kick-start the process of designing or
adapting the DTDS system. Functional requirements describe the capabilities the system must have to meet the end users’ needs and achieve tasks within the
scenarios
business processes. Non-functional requirements provide the general attributes and features of the digital system to ensure usability and overcome technical and
physical constraints. Examples of non-functional requirements include the ability to work offline, multiple language settings and password protection.
Table 16 highlights some key functional requirements for executing the business processes listed in Component 4 of this document; the complete set of functional
requirements can be accessed here. Table 17 provides non-functional requirements as general characteristics of the overall system. Please note that these are not
workflows
exhaustive lists and should be modified according to the context and user persona needs.
8.1 Functional requirements

data
Table 16 Functional requirements

Requirement ID Activity ID and description As a … I want … So that …
decisions
Business process A: registration

TB.FXNREQ.001 TB.A5. Search for the client record Health worker or data entry clerk or To search to see whether client is I can check whether this is a new or
medical office receptionist already in the system (using at least two existing client
identifiers)
TB.FXNREQ.007 TB.A7. Create a new client record Health worker or data entry clerk or To be able to enter identification I can enter new client information
medical office receptionist information
indicators
TB.FXNREQ.012 TB.A9. Validate the client details Health worker or data entry clerk or To display client information for validation I can ensure information has been
medical office receptionist (and be able to edit it) checked before submission
TB.FXNREQ.016 TB.A9. Validate the client details Health worker or data entry clerk or To be able to confirm the client’s identity I can be sure it is the right person
medical office receptionist
TB.FXNREQ.020 TB.A9. Check in the client Health worker or data entry clerk or Provide a list or roster of all clients due to I know which clients to follow up or
requirements
medical office receptionist arrive are due for services

recommendations
Business process B: screening
TB.FXNREQ.021 TB.B1. Provide pre-screening Health worker (e.g. nurse) To have available general pre-screening I can better answer the client’s
information and ask for consent information about potential risks and questions and better prepare them for
benefits, screening tools and procedure screening activities
to share with clients during counselling
activities
personas
TB.FXNREQ.022 TB.B1. Provide pre-screening Health worker (e.g. nurse) The system to prompt the health worker I can ensure that ethical principles for
information and ask for consent to get informed consent from the client screening for infectious diseases are
before proceeding with screening followed and that the clients’ rights
are protected
TB.FXNREQ.023 TB.B3. Assess medical history and Health worker (e.g. nurse) To be able to capture or update client I make sure that new relevant
scenarios
risk factors information related to medical history and information is not missed
risk factors for TB
TB.FXNREQ.024 TB.B4. Determine the screening Health worker (e.g. nurse) To have available general information I have a quick reference to help
algorithm about screening algorithms me choose the most appropriate
screening algorithm for a client or
group of clients
workflows
TB.FXNREQ.025 TB.B5. Perform the TB screening Health worker (e.g. nurse) To be able to send referral letters via I can speed up the referral process
appropriate digital tools (e.g. email, digital and check-in at the accommodating
health portal) health-care facility
Business process C: diagnosis
TB.FXNREQ.026 TB.C1. Carry out clinical Health worker (e.g. nurse) The system to use the data entered for a I can take better clinical decisions
examination client to generate statistics, graphs, pop-
data
ups (on demand or ad hoc)
TB.FXNREQ.027 TB.C2. Assess medical history and Health worker (e.g. nurse) To be able to route the consultation I do not have to start a new
risk factors via different health workers and save consultation for every health worker
in the system the information already that the client is involved with
decisions
entered during the consultation even
if the consultation is not yet complete,
enabling other health workers to see
the information already entered and to
be able to add or edit information as it
becomes available
indicators
TB.FXNREQ.028 TB.C4 Assess history of prior TB Health worker (e.g. nurse) To be able to check client’s medical I can use this information for
treatment history investigations or treatment
recommendations
TB.FXNREQ.029 TB.C12. Interpret test(s) results Health worker (e.g. nurse) The system to be capable to receive I can take the appropriate actions
TB.C20. Interpret the follow-on diagnosis test results from laboratories or more quickly
test(s) results other test centres
requirements
recommendations

Business process D: TB treatment
TB.FXNREQ.030 TB.D9. Determine the regimen Health worker (e.g. nurse) The system to propose TB treatment I can select the appropriate treatment
designed to treat rifampicin- regimens based on predefined criteria and regimen for the client
susceptible TB on the information available in the system
TB.D10. Determine the regimen
designed to treat rifampicin-
personas
resistant TB
TB.FXNREQ.032 TB.D13. Initiate the treatment and Health worker (e.g. nurse) The system to automatically calculate the I do not have to calculate this myself
discuss the adherence expected TB treatment completion date
TB.FXNREQ.033 TB.D14. Develop monitoring Health worker (e.g. nurse) To have the system automatically I do not have to calculate this myself
examinations and a schedule of calculate a date when the client should
scenarios
follow-up visits return for care, based on treatment

regimen, clinical condition and monitoring
examinations
TB.FXNREQ.035 TB.D19. Manage TB treatment Health worker (e.g. nurse) The system to be able to exchange I do not have to calculate this myself
interruptions information with digital adherence and fill in the information manually
technologies to automatically record and
workflows
calculate information related to treatment

progress or interruptions
TB.FXNREQ.036 TB.D24. Report the outcome(s) Health worker (e.g. nurse) The system to trigger an alert to assign Alignment between the number
treatment outcome in case the expected of cases notified and number of
TB treatment completion date is reached treatment outcome cohort (all
and there is no treatment outcome notified cases have assigned
assigned treatment outcomes) is ensured
data
Business process E: TPT

TB.FXNREQ.037 TB.E1. Offer TB prevention Health worker (e.g. nurse) To be prompted to provide counselling on I can ensure that the client is
counselling TPT educated on TPT before offering any
decisions
TPT-related service
TB.FXNREQ.038 TB.E2. Make an informed decision Health information officer The system to prompt the health worker I can ensure that client rights are
to get informed consent from the client protected
before proceeding with the TPT evaluation
TB.FXNREQ.040 TB.E4.7. Determine TPT eligibility Health worker (e.g. nurse) To have questions that guide me in TPT I can better evaluate client TPT
eligibility assessment eligibility
indicators
TB.FXNREQ.042 TB.E9. Initiate TPT and develop Health worker (e.g. nurse) To have available general information I can better prepare the TPT
an adherence plan about TPT adherence adherence plan
TB.FXNREQ.043 TB.E13. Schedule the follow-up Health worker (e.g. nurse) To be able to indicate if the client agrees I can send communications via the
visit to receive notifications and their preferred client’s preferred communication
communication channel (including channel
sending reminders for the next follow-up
requirements
visit)

recommendations
Business process F: referral
TB.FXNREQ.044 TB.F2.1. Stabilize the client and Health worker (e.g. nurse) To be able to bypass the standard flow at The client can be referred, if needed
give pre-referral treatment any point if danger signs are present or
emergency care is needed; urgent cases
should be flagged and seen promptly
personas
TB.FXNREQ.045 TB.F3. Identify and discuss Health worker (e.g. nurse) To be able to find out in the system where I can refer my client to another facility
referral location options the required service may be available to receive the appropriate services
TB.FXNREQ.047 TB.F4. Contact referral facility Health worker (e.g. nurse) To have a list of the contact information I can easily contact the facility when
for referral facilities making the referral arrangements
TB.FXNREQ.048 TB.F6. Provide information to the Health worker (e.g. nurse) To indicate in the system the referral I can identify ways to improve the TB
receiving facility reason care process at my health-care facility
scenarios
TB.FXNREQ.050 TB.F8. Check whether the client Health worker (e.g. nurse) To be able to check if the supplies and I can validate to the referring facility
can be accommodated skills needed to accommodate a referred (or directly to the client) where the
client are available at my facility client can be accommodated
Business process G: aggregate reporting and data use
TB.FXNREQ.052 TB.G4. Generate aggregate Health worker or data entry clerk To produce a range of prepared reports I do not need to create the reports
workflows
reports manually for reporting purposes
TB.FXNREQ.053 TB.G7. Analyse and interpret the Health worker (e.g. nurse) To view a range of standardized I am able to use data collected at
reports visualizations (e.g. charts, tables, maps) the facility for service delivery and
informing programmatic actions with
the aim of improving the quality of
care for clients with TB
data
For the full list of functional requirements defined for the TB DAK, please refer to functional and non-functional requirements implementation tool.
decisions
8.2 Non-functional requirements
Table 17 Non-functional requirements
Requirement ID Category Non-functional requirement
indicators
TB.NFXNREQ.001 Security – confidentiality Provide password-protected access for authorized users.
TB.NFXNREQ.002 Security – confidentiality Provide a means to ensure confidentiality and privacy of personal health information.
TB.NFXNREQ.003 Security – confidentiality Provide the ability for allowed users to view confidential data.
TB.NFXNREQ.007 Security – confidentiality Provide encrypted communication between components.
TB.NFXNREQ.008 Provide secure data transmission methods to prevent others from seeing data sent from one computer to another by
requirements
Security – confidentiality
using data encryption and private networks across public networks.

recommendations

TB.NFXNREQ.009 Security – authentication Notify the user to change their password the first time they log in.
TB.NFXNREQ.010 Security – authentication Adhere to complex password requirements.
TB.NFXNREQ.014 Security – authentication Lock a user out after a specified number of wrong password attempts.
TB.NFXNREQ.015 Security – authentication Notify a user if their account is locked due to wrong password attempts.
personas
TB.NFXNREQ.016 Security – authentication Provide role-based access to the system: users of the system get access on a need-to-know and need-to-use basis.
TB.NFXNREQ.017 Security – audit trail and logs Log system logins and logouts.
TB.NFXNREQ.018 Security – audit trail and logs Record all authentication violations.
TB.NFXNREQ.024 Security – audit trail and logs Log all data and system errors.
TB.NFXNREQ.025 Security – user management Allow user with permission to create a new user and temporary password.
scenarios
TB.NFXNREQ.026 Security – user management Provide role-based access.

TB.NFXNREQ.027 Security – user management Allow roles to be associated with specific geographical areas or health-care facilities.
TB.NFXNREQ.028 Security – user management Allow cascading user management and assignment of roles.
TB.NFXNREQ.033 Security – user management Support definitions of unlimited roles and assigned levels of access, viewing, entry, editing and auditing.
workflows
TB.NFXNREQ.034 System requirements – general Provide a unique version number for each revision.
TB.NFXNREQ.035 System requirements – general Enable earlier versions of a record to be recoverable.
TB.NFXNREQ.042 System requirements – general Show the number of records that are not yet synchronized.
TB.NFXNREQ.043 System requirements – general Have the ability to easily back up information.
TB.NFXNREQ.044 System requirements – general Warn user if no valid backup for more than a predefined number of days.
data
TB.NFXNREQ.045 System requirements – general Must have the ability to store images and other unstructured data.
TB.NFXNREQ.046 System requirements – scalability Scalable to accommodate new demands.
TB.NFXNREQ.047 System requirements – scalability Be able to accommodate at least [x number of]a health-care facilities.
decisions
TB.NFXNREQ.048 System requirements – scalability Be able to accommodate at least [x number of]a concurrent users.
TB.NFXNREQ.049 System requirements – usability Be user-friendly for people with low computer literacy.
TB.NFXNREQ.057 System requirements – usability Provide guidance to users to better support clinical guidelines and best clinical practices.
TB.NFXNREQ.058 System requirements – usability Be reliable and robust (minimize the number of system crashes).
TB.NFXNREQ.059 System requirements – usability Adjust display to fit small screens (e.g. mobile phones).
indicators
TB.NFXNREQ.060 System requirements – configuration Configure the system centrally.

TB.NFXNREQ.061 System requirements – configuration Configure business rules in line with guidelines and standard operating procedures.
TB.NFXNREQ.062 System requirements – configuration Configure error messages.
TB.NFXNREQ.063 System requirements – configuration Configure workflows and business rules to accommodate differences between facilities.
requirements
TB.NFXNREQ.064 System requirements – interoperability Communicate with external systems through mediators.

recommendations
TB.NFXNREQ.065 System requirements – interoperability Provide access to data through application programming interfaces.
TB.NFXNREQ.066 System requirements – interoperability Be interoperable with external systems through mediators.
TB.NFXNREQ.067 System requirements – interoperability Link with insurance systems to verify eligibility and submit claims.
TB.NFXNREQ.068 System requirements – interoperability Exchange data with other approved systems.
personas
TB.NFXNREQ.069 System requirements – interoperability Accept data from multiple input methods including paper and geocoding (GPS).
GPS: Global Positioning System.
a
This is dependent on each country being able to determine the scale of the system and system deployment.
For the full set of non-functional requirements defined for the TB DAK, please refer to functional and non-functional requirements implementation tool.
scenarios
workflows
data
decisions
indicators
requirements
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requirements indicators decisions data workflows scenarios personas recommendations
106
Annexes
Annexes
Digital adaptation kit for tuberculosis

annexes
Annex 1. Examples of detailed personas
Awe, Nurse, 42-year-old man

My tasks My workplace
» Clinical tasks (80%): » A rural clinic that provides both diagnostic and treatment
services for TB.
– TB consultations;
– provide diagnostic services for TB; and There are many forms » I am the only one responsible for the clinical management
of patients with TB in this clinic.
– provide treatment services for TB, that is, treatment
initiation and monitoring. to fill in, some of » I provide TB services to around 15 patients per day, on
average.
» Other tasks (20%): which collect similar » The health-care facility was recently equipped with a
– filling in TB registers;
– providing TB reports to the district; and
information. computer and a new digital system.
» The internet connection is very slow and sometimes does
not work.
– TB medication logistics in the clinic.
My typical day
» 08:00 Arrive at work, check the agenda and check the stock. » 13:00 Resume the work on the clinical tasks.
» 09:00 Check clients who have arrived and start clinical tasks. » 14:00 Community health worker calls and alerts that there is a man with symptoms of TB and asks if the man could be brought
» 12:00 Lunch break. urgently to the clinic for a consultation. The man is seen in the following 30 min.
» 15:30 Closing and completing the missing information in the register.
Challenges encountered working on TB services

PAPERWORK NEW WAY OF WORKING STOCK-OUT
» It is time-consuming to fill in the necessary information » A new computer was brought to the clinic. Awe finds it difficult to » Sometimes there is not enough medication at the clinic
(treatment initiation, dispensing of medication, laboratory use the computer instead of relying on the paper register. He is
results) on the forms provided by the district health authority. not sure why he needs to change his way of working. He is also not
» It is difficult to manually find the names of the clients in the sure why he needs to collect all this information on his clients.
register.
107
annexes
Ina, District Health Information Officer, 36-year-old woman

My tasks My workplace
» Administrative tasks (80%): » A district health clinic of a large rural district in Nigeria.
– undertaking data management and analysis; Ina is motivated in her » My primary focus is TB, leprosy, HIV, sexually transmitted
infections and vaccine-preventable diseases.
– supervising the health-care facilities within the district; and
– generating updates regarding the epidemiological situation in the
job and has the right » My preferred software for data management and analysis (and
district and reporting these data to higher administrative levels. intentions; however, other monitoring and evaluation [M&E] activities) is Excel.
» Other tasks (20%): she feels overwhelmed

– contributing to the development of financial reports; and
– undertaking medical ad-hoc tasks.
by the data.
Needs and goals
» Ina is interested in understanding the TB epidemic in the district and » She would like a better way to manage the collected data to keep it better organized, but she is not sure if it is possible,
how it is changing over time. especially with her level of training.
» She would like to know if the district is close to reaching its targets. » One day, she hopes to take formal classes in epidemiology to improve her skills, but due to the demanding nature of
» She would like to understand if there are areas that need more support her job, she does not have the time.
and use this information to advocate for additional resources.
Challenges encountered working on TB M&E

WORKLOAD LACK OF SUPPORT LACK OF HARDWARE
» Ina and other team members visit the health-care facilities in the district » Ina was shown how to do some analyses in Excel » She has access to one laptop and finds it very hard to navigate
to supervise their performance. They have a quick look at the registers from the person she replaced in this role, but she through all the sheets on such a small screen. She sometimes
and other TB data collection tools; however, not much time is spent on does not have an analytical plan to follow. While loses track of where she is and worries that she is introducing
this task because they have many health-care facilities to cover. she finds it useful, she does not enjoy doing the errors.
analysis – it takes a very long time and she does not
have much support for it.

annexes
Annex 2. Guidance for adapting the data dictionary
When adapting the data dictionary, data elements may need to be modified Data element The shorthand name for the data element (e.g. “educ_level” for “educational
or added because of the structure of existing paper registers or local reporting name level”, “weight_kg” for “weight” and “height_m” for “height”). This will be key
when coding the system and determining the calculations required. This data
requirements. If starting from paper-based registers and forms, you can find element name is what will reconcile any duplicate data elements in the digital
additional guidance in the Digital transformation handbook for primary health system.
care (1); Table A2.1 contains an overview of data mapping that can be used when Description The description of the data field, including any units that define the field (e.g.
“weight in kilograms [kg]”). Provide a clear explanation of what this data
adjusting the data dictionary. When amending the wording of data elements, it and
definition point is requesting, assuming the reader has never seen the form. Be sure
is important to ensure that the standard terminology codes still reflect the data to use consistent and easy-to-understand terminology across all forms. This
element as originally intended. is particularly important if the data element name differs across forms but
requires the same input.
Table A2.1 Overview of data mapping for data dictionary adaptation Data type The data type should be aligned with data types outlined by fast health
interoperability resources (FHIR) standards (2). Some common data types are:
What to » Boolean (e.g. true/false, yes/no);
note Description
» string (a sequence of Unicode characters, e.g. name);
Activity ID The ID number of the task in the workflow in which the data element is » date (e.g. date of birth);
collected. This will denote the point in time at which this data element is
» time (e.g. time of an appointment);
collected. This should align with the Activity ID that is provided in Form
Mapping. » ID (e.g. unique identifier assigned to the client);
» integer (a whole number, e.g. the number of previous appointments);
Data element Each data element should have an identification number or code that is unique
code across the entire project. Use existing serial or identification numbers when » decimal (rational numbers that have a decimal representation, e.g. the exact
available. If no identifiers exist, fields should be enumerated in a logical format. duration of time, location coordinates, all percentages);
» codable concept (a value that is usually supplied by providing a reference
Form ID and The Form ID should be from the ID listed. List the Form ID in which the data
to one or more data points, e.g. body mass index [BMI], contraceptive
form data element appears. This is important to ensure that the design of the digital
prevalence rate);
element system has taken into account all the required paper forms and data elements
on those paper forms. » signature (an electronic representation of a signature that is either
label
cryptographic or a graphical image that represents a signature or a signature
Also list the label of the data element as written on the original form (or
process, e.g. supervisor’s approval);
translated as closely as possible). This will be key in keeping track of which data
elements from the original paper forms are duplicated. Note that duplicate » attachment (additional data content defined in other formats, e.g. images).
data fields can be included purposely (client identifiers, such as name, date of Note that if there are multiple-choice data fields, the “parent” data field should
birth, village, ID number, would be included in multiple data instruments to be labelled “Multiple choice – Select one” or “Multiple choice – Select all that
identify an individual client). apply”. Then each individual option should be listed in the “Input” options
Data element The label of the data element written in a way in which the end users can easily column and be classified with one of the data types listed above.
label understand, for example, “educational level”, “weight”, “height”, “reasons for Although the list above should be sufficient to relay this information to a health
coming into the facility”, “which medication(s) is your client taking?” The data informatics specialist or technology vendor, there are many more data codes
element label in this column is what will be used in the digital form. The digital that can be applied to achieve a more precise classification. For other possible
register should not simply replace the paper registers; it should also streamline data types, please refer to the HL7 FHIR data types (2).
processes and link duplicated data elements; thus, the data element label
listed here should be what will be used in the digital system.
Annexes 109
annexes
Input options For multiple-choice fields only; otherwise leave this column blank. Write the Explain If the field is conditional on inputs from other data elements, denote what the
list of responses from which the health worker may select. Each of these input conditionality conditionality is here. A conditional data element will be interpreted as R for
options should be in a separate row and should be labelled with the data type implementation to support the field for interoperability purposes. The health
“Codes”. worker should fill in a value if the information is available, otherwise the data
element may be left empty.
Calculation If a calculation is needed to define the data element, write the formula
here. Leave this column blank if no calculation is needed. Use standard Linked to an Aggregate indicators should be called out and specified. If this data element is
mathematical symbols and the data element label of the data element aggregate linked to an aggregate indicator, then indicate the IDs of the linked indicators, if
names included in the formula (e.g. for the BMI calculation: “weight_ indicator known. If there is linkage to indicators for which the IDs are not known, indicate
kg / ([height_m]2)”. Yes here. If there is no link with aggregate indicators, indicate No.
Validation Yes or No to indicate whether there needs to be some form of validation given Annotations If there is an issue or inconsistency in how a data field is defined, make a note
required the constraints provided by a range of acceptable responses. of the issue here.
Irregularities and inconsistencies will need to be resolved at a later stage
Validation With digital systems, it is possible to incorporate data entry validation to ensure
through a process of team discussion and triangulation. This column should
condition that the data entered into the field are accurate at the time of data entry.
also be used for any other notes, annotations or communication messages
For example, if a health worker accidentally enters the height of an individual within the team.
as 1650 cm instead of 165 cm, the system should notify the health worker
that an erroneous height has been entered. This feature will help increase the Mapping to Depending on which systems you plan on interoperating with, other columns
fidelity of data entry. code systems will most likely need to be added to map to the concepts used in the other
(standardized system (e.g. International Classification of Diseases [ICD], Systematized
This should contain the range of acceptable responses, if validation is required
terminologies Nomenclature of Medicine [SNOMED]). Dedicated columns should be used for
(e.g. for a phone number, only 10 digits allowed; for a birthday, only past dates
and each concept dictionary.
are allowed).
classifications)
Editable Yes or No to indicate whether the end user, or health worker, would be able to (3)
edit the field after it has been input to the system.
Required Note whether or not this field is:

» required – R; ANNEX REFERENCES
» optional – O;
1. Digital transformation handbook for primary health care: optimizing person-centred point of
» conditional on answers from other data fields – C. service systems. Geneva: World Health Organization; in press.
Reason for If this field is required (R), state the reason here whether for: 2. HL7 FHIR Release 5 [website]. 2.1.28.0 Data types. Ann Arbor (MI): Health Level 7 International;
2023 (http://hl7.org/fhir/datatypes.html, accessed 19 August 2023).
required » accountability for national-level reporting;
data » service delivery or clinical decision-making; 3. International Statistical Classification of Diseases and Related Health Problems (ICD). Geneva:
World Health Organization; 2023 (https://www.who.int/standards/classifications/classification-
» client identification. of-diseases, accessed 19 August 2023).
The digital system should not simply replace your paper registers, but it should
also streamline processes; thus, it is important to understand why a certain
data field is actually required and seek opportunities to optimize data flows.
Given the high volume of data collection required of health-service providers, it
might be better to remove a data entry field if it serves no real purpose for the
clinician, public health reporting or any other identified purpose.

annexes
Annexes 111
annexes
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Digital Adaptation Kit For Tuberculosis: Operational Requirements For Implementing WHO Recommendations in Digital Systems

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SMART GUIDELINES

ISBN 978-92-4-008661-6 (electronic version)

© World Health Organization 2024

Cataloguing-in-Publication (CIP) data. CIP data are available at https://iris.who.int/.

Part 1. Overview of SMART guideline digital adaptation kits

Part 2. Digital adaptation kit content for tuberculosis

The following individuals provided feedback throughout this process:

Institute for Health Measurement [IHM] Southern Africa

WHO Global Tuberculosis Programme

WHO Global HIV, Hepatitis and STIs Programmes

WHO Department of Mental Health and Substance Use

WHO Department of Sexual and Reproductive Health and Research

ARV antiretroviral MTB Mycobacterium tuberculosis

BMI body mass index MTBC Mycobacterium tuberculosis complex bacteria

DAK digital adaptation kit PLHIV people living with HIV

DHIS2 District Health Information Software 2 RIF rifampicin

DMN Decision Model Notation RR-TB rifampicin-resistant tuberculosis

DR-TB drug-resistant tuberculosis SMART standards-based, machine-readable, adaptive, requirements-based

2 Digital adaptation kit for tuberculosis

DAKs follow a modular approach in detailing the data and

ICT: information and communications technology.

Progressive layers across SMART guideline components

Human-readable software-neutral documentation of operational and

transparently documented algorithms, minimum data sets, priority metrics,

listing of relevant health interventions, functional requirements)

Components of a digital adaptation kit

6 Digital adaptation kit for tuberculosis

Contextualization to » Example narrative of how

Component Description Purpose Outputs Adaptation needed

elements mapping standards to ensure that the data

systems. interoperability with other

8 Digital adaptation kit for tuberculosis

Component 1: Health interventions and recommendations Component 6: Decision-support logic

Methods for content development

10 Digital adaptation kit for tuberculosis

Scenarios for using the DAK

12 Digital adaptation kit for tuberculosis

DAKs represent one piece of Fig. 3

Telecommunication + Formulate a digital health investment roadmap to Digital UNICEF

strategy toolkit (16), WHO

04 ENTERPRISE for investing digital

05 HEALTH CONTENT for Digital Machine- Be Mobile

06 IMPLEMENTATIONS having the desired effect M&E and

07 MAINTAINING AND mHealth Bank total

1.1 Interventions referenced in this DAK

guidelines and guidance documents, are the following. – laboratory work;

» Screening by means of: – injectable agents;

16 Digital adaptation kit for tuberculosis

WHO consolidated Joint WHO/ILO policy Tuberculosis surveillance

Other WHO documents represented in the DAK include:

» Policy brief on tuberculosis-associated disability (41)

18 Digital adaptation kit for tuberculosis

Table 2 Descriptions of key generic personas

Occupational Description Different names International Standard for

mental impairments common to specific communities.

BS: Bachelor of Science.

2.2 Related personas

in this DAK. Additional related personas are listed in Table 3.

Table 3 Descriptions of related personas