Course for STS/ TB-HV in NTEP

​

Resources

• Global Tuberculosis Report, 2020; Geneva: World Health Organization, 2020
• Training Modules (1-4) for Programme Managers and Medical Officers India: Central TB Division, MoHFW, Government of India,July 2020

• Globally, an estimated 11 million people fell ill with TB (incidence) in 2021.
• Historically, it has been the top infectious disease killer. In 2021, there were an estimated 1.4 million TB deaths and an additional 187 000 deaths among HIV-positive people.
• Three countries accounted for 42% of global cases in 2021: India (26%), the Russian Federation (8.5%) and Pakistan (7.9%).

Image Figure: Estimated TB incidence in 2021, for countries with at least 100 000 incident cases; Source: Global TB Report, 2022.

Resources​

• Global tuberculosis report 2022.

TB is one of the top burdensome infectious diseases in India. It is estimated that, around 1/4th (26%) of the world's TB cases are in India, translating to about 30 Lakhs new TB cases emerging each year (TB incidence). Against this estimated incidence the National TB Elimination program reported around 19 lakh new and relapse cases in the year 2021.

An estimated 5 Lakhs deaths occur due to TB each year in the country, translating to about 1 case of TB death every one-two minutes. Compared to this, there are only about 60 thousand deaths due to HIV and about 77 deaths due to Malaria each year.

TB diagnosis and treatment services although provided free of cost in the public sector, the cost of accessing these services and related loss of wages drive the affected people with poverty (catastrophic costs). TB also has a huge impact on the world's and the country's economy because of loss of workdays (100 million workdays per year).

Assessment

Resources:

• ^*WHO Global TB Report 2021
• ^{^}Status of National AIDS Response
• ^$PIB MOHFW

The interaction between HIV and TB in co-infected persons is bidirectional and synergistic; on the one hand, HIV infection predisposes the development of active TB, and, on the other, the course of HIV-related immunodeficiency is worsened by active TB infection.

Globally and in India, TB is the most common opportunistic infection seen in HIV patients and a leading cause of death in these patients. The lifetime risk of TB in immune-competent persons is 5-10%, whereas, in an HIV-infected person, the annual risk of TB is 5-15%. Thus, people living with HIV are 18 (15-21) times more likely to develop active TB disease than people without HIV.

TB and HIV Burden Trends in India

India is one of the WHO’s 30 high TB/HIV burden countries; of the 3 million TB incident cases, close to 54000 occurred in HIV-infected persons (See Table 1 for more details). TB and HIV are major public health challenges in India and are leading causes of mortality and morbidity among all other infectious diseases.

Resources

• India TB Report, 2022
• Global TB Report, World Health Organisation, 2022
• Shastri, S., Naik, B., Shet, A. et al. TB treatment outcomes among TB-HIV co-infections in Karnataka, India: how do these compare with non-HIV tuberculosis outcomes in the province?. BMC Public Health 13, 838 (2013)

TB is caused due to the infection by a bacterium called Mycobacterium tuberculosis.

It often affects the lungs, and in such cases it is called Pulmonary Tuberculosis. But, it can affect almost any part of the body (except the hair and the nails), in which it is known as Extra-Pulmonary Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Tuberculosis is transmitted mainly through the air via droplet nuclei generated when a TB patient coughs or sneezes. 

It is estimated that every sputum smear-positive patient spreads the infection to 10 – 15 persons annually, if untreated..

Figure: Transmission of TB bacteria through air via droplet

Resources:

• Technical and Operational Guidelines for TB Control in India 2016
• WHO - Fact sheet details on Tuberculosis

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• TB Infection (or previously known as Latent TB infection) is a stage in between uninfected and having active TB. In this stage the person has no symptoms and can only be identified using laboratory tests.

• The vast majority of infected people may never develop TB disease. However, to achieve TB elimination, it is important to treat TB infection in people at risk of developing active TB disease.

• It is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

• There is no single acceptable/reliable test for direct identification of Mycobacterium tuberculosis infection in humans. Tuberculin Skin Test (TST) and Interferon-gamma release assay (IGRA) are commonly used tests for identifying TB infection.

Resources:

• Latent Tuberculosis Infection Guideline

• Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

After exposure to infective droplets containing M.TB, only a small proportion gets infected and further progresses to active TB disease.

• Majority of those that get infected persist in a stage of clinical latency known as TB infection (previously known as Latent TB infection). They do not have TB disease and do not show any symptoms of TB and no evidence of any TB related changes on chest X-ray.
• A small proportion of those with prior infection may progress to active TB disease due to various environmental/ agent/ host factors.

Figure: Flow chart for TB disease progression

Resources:

• Understanding delayed T-Cell Priming, Lung Recruitment, and AirwayLuminal T-Cell Responses in Host defence against Pulmonary Tuberculosis

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Resources:

• Technical and Operational Guidelines for TB Control in India 2016

The Epidemiologic Triad is a model used in the field of epidemiology to study diseases and how they are spread. It consists of a triangle with three vertices or corners. 

The three vertices for infectious diseases consist of:

1. Agent, or microbe that is the factor causing the disease.

2. Host, or organism harbouring the disease.

3. Environment, or those external factors that cause or allow disease transmission. 

In the Epidemiological Triad of TB (Figure), the agent is the TB causing bacteria Mycobacterium tuberculosis; the host refers to humans that are susceptible to TB. Susceptibility or the risk factors for acquiring TB can be:

• Close contact with a person having TB disease
• Nutritional status of the host
• Existing co-morbidities
• Low immunity.

Susceptibility of the host can also vary due to age, gender, genetic composition, race, ethnicity, etc. 

As TB is an airborne disease, environmental factors come into play for the transmission of TB. These include crowding, poor ventilation, bad sanitation, indoor air pollution, etc. 

The understanding between the interplay of agent, host and environment is essential to understanding the epidemiology of TB and taking measures to control it. The risk of TB due to environmental factors can be reduced by practising airborne infection prevention measures like good ventilation, hand hygiene and cough etiquette. 

Figure: Epidemiological Triad of TB

Resources

• Understanding the Epidemiologic Triangle through Infectious Disease, CDC. 

• Epidemiological Triad of TB.

   

Assessment

Determinants are any characteristics that affect the health of a patient.

TB can affect anyone but it is more prevalent in some communities which are vulnerable to TB disease due to various factors which are mentioned below:

Increased exposure of TB due to where they live or work

• prisoners
• slum dwellers
• miners
• hospital visitors
• healthcare workers

Limited access to Quality TB services

• Migrant workers
• Women in settings with gender disparity,
• Children
• Physically challenged
• Transgender population
• Tribal and population living in hard to reach areas
• Refugees or internally displaced people
• Illegal miners and undocumented migrants

Increased risk because of biological or behavioural factors that compromise immune functions in people who:

• People who live with HIV
• have diabetes or silicosis
• undergo immunosuppressive therapy
• are undernourished
• use tobacco
• suffer from alcohol use disorders.
• inject drugs 

As TB is an airborne infection, TB bacteria are released into the air when someone with infectious TB coughs or sneezes. The risk of infection can be reduced by taking simple precautions:

Figure: Measures for control and prevention of tuberculosis

TB Preventive Treatment(TPT) also has a very important role in prevention of TB. Presently, household contacts of sputum-positive TB patients are given TPT upon confirmation of TB infection and ruling our active Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Chemotherapy for TB is the use of an anti-TB drugs to kill, or prevent the replication of, TB mycobacteria in the patient’s body. Effective anti-TB chemotherapy renders the patient non-contagious and cures the patient, thereby interrupting the chain of transmission. Mortality rates of TB range from 50-80% in untreated smear-positive individuals and drop to lower than 5% under chemotherapy.

Most of the bacteria are killed during the first 8 weeks of treatment; however, there are persistent organisms that require longer treatment. TB disease must be treated for at least 6 months and in some cases even longer. The use of multi-drug therapy reduces the incidence of drug-resistant cases and increases the overall effectiveness of treatment.

If treatment is interrupted, any surviving bacteria may cause the patient to later become ill and infectious again, potentially with drug-resistant disease.

How infectious are tuberculosis patients under chemotherapy?

Under effective chemotherapy, there is a substantial decline in infectiousness in two weeks time, and may not be a major source of risk to any contacts. This decline is indicated by the rapid fall in the number of viable organisms in the sputum, and reduced frequency of coughing.  

Types of Chemotherapy in TB

1. Preventive Chemotherapy: Regimen for healthy but TB infected persons with a high risk of developing TB, in order to prevent them from developing TB.
2. Standard Chemotherapy: Two-phased chemotherapy for an average of 6-8 months based on the combination of at least four major drugs (HRZE) given for 2 months during the initial intensive phase of treatment and followed by a combination of at least 2 drugs given for at least 4 months during the continuation phase of treatment.
3. Chemotherapy for Drug-resistant TB: Two-phased chemotherapy varying from 9 - 24 months in patients having demonstrated resistance to drugs used in standard chemotherapy. The regimen varies with the drug to which the resistance is present, however, each regimen contains a mix of second-line anti-TB drugs including injectables.   

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Infectiousness and Host Susceptibility, The Journal of Infectious Diseases, Vol. 216, suppl_6, 2017.
• Tuberculosis chemotherapy: Current Drug Delivery Approaches, Respiratory Research 7, Article no. 118, 2006.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Incidence is an epidemiological measure of the occurrence of new cases of a disease in a population over a specified period of time. Tuberculosis (TB) incidence is the number of new cases of active TB disease during a certain time period (usually a year), and is better expressed as a rate, as shown in the figure below.

Figure: Deriving the Incidence of TB Disease for a Given Population

Tuberculosis incidence varies considerably in different populations and population segments.

In 2021, the Global TB incidence was 134 (125-143) per 100,000. The TB Incidence rate of India is  - 210 (178-244) per 100,000 in 2021 according to WHO Global TB Report 2022.

Resources

• India TB Report, 2022.
• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.
• Morbidity Frequency Measures, Centers for Disease Control and Prevention.
• Global Tuberculosis Report 2022.

Prevalence is an epidemiological measure of the proportion of a population with a disease or a particular health condition at a specific point in time (point prevalence) or over a specified period of time (period prevalence).

Tuberculosis (TB) prevalence refers to the number of people with TB that are present in a particular population at a given time. Calculation of the TB prevalence rate is shown in the figure below.

Figure: Deriving the Prevalence of TB Disease for a Given Population

TB prevalence rate is derived by adding the number of persons that develop new TB disease (i.e., incident cases​) and those who already have the disease (i.e., existing cases), and dividing the sum by the total population from which the cases arose.

TB prevalence varies widely and is affected by a number of factors such as age, gender, population density, rural/urban settings, as well as socioeconomic factors.

Resources

• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.

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TB notification rate is the number of TB cases notified over a specified time period for a specified population, usually per lakh. It indicates how many cases have been diagnosed and informed to the National TB Elimination Program.

It is mostly calculated annually, and the calculation formula is as follows: 

Figure: Deriving the Annualized TB Case Notification Rate

The National TB Elimination Program calculates TB notification rates based on TB cases notified using the digital surveillance system called Nikshay. Each state/district is provided with an annual target for TB case notification, the progress of which is measured periodically to understand efforts taken for the detection of TB cases.

Example

If the number of TB patients diagnosed in District X one year is 1000, and the mid-year population of District X is 10,00,000, then the annualized TB case notification rate is calculated as follows: 

100 cases/100 000/year

Resources

• NTEP training module for medical officers 5-9
• TB Notification Rate, TB Indicators WHO 2014

The National Tuberculosis Control Program (NTP) of India was launched in 1962. It relied on BCG, X-ray based diagnosis and Streptomycin and INH based treatment centralized at district level.  

Based on a review of the NTP, and WHO recommendations of the DOTS Strategy, Government of India then revised the NTP and launched new program with the title Revised National Tuberculosis Control Program (RNTCP) in 1997. It used Sputum microscopy at DMC(Designated Microscopy Centres) for diagnosis, and multi-drug Short Course Anti-TB Therapy,  decentralized to the TU (TB Unit) level. 

In recognition of the rising drug resistance problem the DOTS Plus/ PMDT (Programmatic Management of Drug Resistant TB) was launched in 2006 and scaled up to the entire country by 2012. 

Further to strengthen the monitoring and supervision system - a case based notification system - Nikshay was introduced in 2012. The same year Tuberculosis was added as a notifiable disease at the point of diagnosis by all health care providers.

Other key milestones from 2012 to 2020 were the availability of the Standards of TB Care in India (STCI) in 2014, introduction of the Daily weight band wise Fixed Dose combination (FDC) in 2016 and new drugs like Bedaquilline  and Delaminid were started in 2017 and 2018 respectively. 

To emphasise the commitment of the Government of India and to accelerate the efforts towards TB elimination, RNTCP was renamed as "National Tuberculosis Elimination Programme (NTEP)" in 2020.

Figure: Key milestones under NTEP

Resources:

• TBC India Website
• National Stratergic Plan for Tuberculosis Elimination 2017 - 2025

The Government of India has committed to achieving the Sustainable Development Goals(SDG) targets related to ending TB by 2025 (5 years ahead of the global target).  This would mean that in 2025, the 2030 target of achieving 80% reduction in incidence, 90% reduction in deaths due to TB compared to that of 2015, is to be achieved.

Table: India's commitment to End TB by 2025.

Resources:

• National Strategic Plan (NSP) - 2017 - 2025
• Global TB report 2021
• END TB Strategy

The National Strategic Plan (NSP) for TB elimination 2017–25 is a bold strategic framework to drive the  acceleration of progress toward TB Elimination, and achieving the Sustainable Development Goal (SDG) and End TB targets for India. It expects to guide the activities of all stakeholders including the national and state governments, development partners, civil society organizations, international agencies, research institutions, private sector, and many others whose work is relevant to TB elimination in India. It is adopts strategies under four groups DETECT, TREAT, PREVENT, BUILD.

VISION: TB-Free India with zero deaths, disease and poverty due to tuberculosis
GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB in India by 2025.

The results framework of the NSP outlines the various targets (impact and outcomes) to be achieved.

Resources

• Revised National Tuberculosis Control Program National Strategic Plan For Tuberculosis Elimination 2017–2025, Central TB Division, MoHFW, 2017

Assessment Questions

NSP 2012 - 2017 had the aim of achieving universal access to quality diagnosis and treatment. The NSP 2017-2025 which builds on the success and learnings of the last NSP, and articulates the bold and innovative steps required to move towards TB elimination. In 2020, RNTCP was renamed to "National Tuberculosis Elimination Programme" with the following objectives:

Figure: Objectives of NTEP

Resources:

• TBC India Website

National Tuberculosis Elimination Programme (NTEP) is a centrally sponsored programme being implemented under the aegis of National Health Mission.

National Level: Managed by Central TB Division (CTD), the technical arm of the Ministry of Health and Family Welfare (MOHFW)

State Level: State TB Cell coordinates the overall TB elimination programme in state under the guidance of State Health Society. The training ,supervision, monitoring and evaluation NTEP at state level are looked after by STDC (State TB Training and Demonstration Centre).

District TB Centre (DTC) is the nodal point for all TB elimination activities in the district under the guidance of the District Health Society.

Tuberculosis Unit (TU) Level: NTEP activities at block/sub-district level are implemented through TU which comprises Designated Medical Officer (MO) supported by two full-time NTEP staff - STS (Senior Treatment Supervisor) & STLS (Senior TB Lab Supervisor).

PHI (Peripheral Health Institute): PHI is a health facility manned by a Medical Officer (MO). Some of the PHIs are also the Tuberculosis Diagnostic Centres, which are the most peripheral level laboratories in the NTEP structure. All the Private Health Facilities like Private Practitioners / Private Hospitals / Clinics / Nursing Homes are also PHI.

Figure: Organisational structure of NTEP

Resources:

• TB India Report 2021
• Technical and Operational Guidelines for TB Control in India 2016

The State TB Cell or STC is the state-level implementing structure of the National TB Elimination Program (NTEP). It is the leading institution for management of NTEP activities at the state level. 

The STC is a State Government entity that acts as the bridge between the Central and State Governments for implementing the NTEP. It works under the guidance of the Central TB Division (CTD), and it oversees the program implementation at the districts.

1. The State TB Cell is supported by the State TB Training and Demonstration Centre (STDC) for its technical functionalities. STDC mainly supports training, supervision and monitoring.
2. The nodal laboratory for the State is the Intermediate Reference Laboratory (IRL). This supports quality assurance of the smear microscopy network and laboratory services in the state.
3. The STC has a fully operational State Drug Store (SDS) which is responsible for the effective management and uninterrupted supply of good-quality of medicines and other logistics.

Human Resources at the State TB Cell are:

1. State Tuberculosis Officer (STO). A dedicated official from the state health system, at the rank of a Joint Director is designated as the STO and heads the implementation of the NTEP at state level.
2. Medical Officer STC (MO-STC): A medical officer from the state health system assists the STO in overseeing various activities.
3. State DRTB Coordinator​: Assist the STO in DRTB activities monitoring across the districts
4. TB - HIV Coordinator: Assist the STO in overseeing TB comorbidities across the district.
5. State PPM Coordinator: Looks at the private sector engagement
6. State IEC Officer/ACSM Officer: Oversees the implementation of advocacy, communication and social mobilisation activities across different districts.
7. STC - Epidemiologist: Assist the STO and STDC Directors by analyzing state-level data and preparing review materials
8. Other support staff at the STC include
   1. Accounts Officer
   2. Technical Officer-PSM
   3. Secretarial Assistant
   4. Data entry operators/Nikshay operator

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Training Modules (5-9) for Programme Managers and Medical Officers, 2020.

Assessment

The State Tuberculosis (TB) Cell (STC) is supported by the State TB Training and Demonstration Centre (STDC) in many states through its three units – Training Unit, Supervision and Monitoring Unit and an Intermediate Reference Laboratory (IRL). This relationship is shown in the figure below.

1. Training Unit: It is involved in estimating the training load, organizing state level training (Induction and Refresher) and evaluating the performance of those who undergo training.
2. Supervision and Monitoring Unit: It consists of a team which is dedicated to the supervision of TB elimination activities through supervisory visits, periodic desk review of Nikshay and Nikshay Aushadhi data, and plans state internal evaluations apart from assisting in other supervision and monitoring activities of National Reference Laboratories, Central TB Division and other national/international monitoring missions.
3. Intermediate Reference Laboratory: This supports an effective quality assurance system of the sputum smear microscopy network and laboratory services for the programmatic management of drug-resistant TB (molecular drug resistance and culture and drug susceptibility testing) in the state.

The STDC is also involved in operational research.

Human Resources in the STDC

• The STDC functions under the leadership of STDC Director. 

Training and Supervision & Monitoring Units:

• 1 Epidemiologist
• 1/more Medical Officer
• 1 Nikshay Operator
• 1 Secretarial Assistant

Intermediate Reference Laboratory (IRL):

• 1 Microbiologist
• 1 Microbiologist- External Quality Assistance (EQA)
• 1 Senior Laboratory Technician- EQA

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Training Modules (5-9) for Programme Managers and Medical Officers, 2020.

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The key level for the management of public health services is the district​ level. The District Tuberculosis Centre (DTC) is the nodal point for tuberculosis (TB) control activities in the district​.

Functions of the DTC

The primary role of the DTC is a managerial one. The DTC is the central program management unit of the district responsible for all activities related to National TB Elimination Programme (NTEP) implementation such as:

• Advocacy
• Active case finding
• Diagnosis, treatment (both for drug-susceptible and drug-resistant TB cases) and follow up
• Managing comorbidities
• Service delivery
• Maintaining diagnostic and treatment infrastructure
• Setting up Drug-resistant TB (DR-TB) centres
• Ensuring community engagement and TB forums
• Multi-sectorial involvement for drug management, and supervision and monitoring
• Financial management
• Drugs, logistics and supply chain management.

Components of the DTC

1. District Drug Store (DDS)
2. Nucleic Acid Amplification Test machine (Cartridge Based NAAT or TrueNAT)
3. Designated Microscopic Center (DMC)
4. Treatment Support Center
5. Drug Resistant TB (DR-TB) Center
6. X-Ray Unit

With expansion of TB services and ongoing collaboration with various national programs, the structure of DTC is highly integrated as part of general health system and some components may cater to non-TB patients as well e.g., the DMC may be a part of general laboratory, and X-ray unit can be functional for all departments and not just chest/TB section.

Human Resources Deployed at the DTC

The Chief District Health Officer (CDHO) / Chief District Medical Officer (CDMO) / Civil Surgeon or an equivalent functionary in the district is responsible for all medical and public health activities including control of TB.

A full-time District TB Officer (DTO), trained at the national level and based at the DTC, is responsible for planning, training, supervising and monitoring the programme in the district. The DTO is assisted by other technical and secretarial staff:

1. Medical Officer- District TB Center
2. District DR-TB-HIV Coordinator
3. District Public Private Mix Coordinator
4. District Program Coordinator
5. District Drug Store Pharmacist
6. District Data Entry Operator-Nikshay
7. District Accountant
8. Senior TB laboratory Supervisor
9. Senior Treatment Supervisor
10. Laboratory Technicians for DMC and NAAT site
11. Counsellor for District DR-TB center
12. TB Health Visitors

While the National TB Elimination Program (NTEP) approves the above positions through National Health Mission NTEP Project Implementation Plan, the district always has the flexibility for additional resource deployment based on the need and existing epidemic. The DTO and his/her team are supported by various other program officers/staff and non-governmental organizations working in the field for Tuberculosis and Health.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

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Tuberculosis (TB) unit (TU) is the sub-district level supervisory unit of National TB Elimination Program with the following organogram:

Figure: Organogram of a TB Unit

(PHI: Peripheral Health Institution)

TUs are based mainly on National Health Mission (NHM) health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.

The TUs have been created based on a population of 1 per 2,00,000 (range 1.5 – 2.5 lakh) for rural and urban populations and 1 per 1,00,000 (0.75 – 1.25 lakh) population in hilly/tribal/difficult areas.

The TU consists of a designated Medical Officer-Tuberculosis Control (MO-TC), as well as one full-time supervisory staff - Senior Treatment Supervisor (STS). However, one Senior TB Laboratory Supervisor (STLS) will be there in every 5 lakh population (one per 2.5 lakh population for tribal/hilly/difficult areas), mostly covering 2-3 TUs.

TB Unit manages the provision of TB services (Diagnosis, Treatment, Prevention, etc.) and programme management in the assigned geographical area. 

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India 2016.
• Training Modules (1-4) for Programme Managers & Medical Officers, 2020.

Under the National Tuberculosis Elimination Programme (NTEP), a Peripheral Health Institute (PHI) is a health facility that is manned by at least a Medical Officer (MO), where diagnosis and management of Tuberculosis (TB) are done.

At this level, there are dispensaries, Primary Health Centres (PHCs), Community Health Centres (CHCs), referral hospitals, major hospitals, speciality clinics or hospitals (including other health facilities), TB hospitals, Anti-retroviral Treatment (ART) centres and medical colleges within the respective district.

All health facilities in the private and Non-government Organisation (NGO) sectors participating in NTEP are also considered PHIs. Some of these PHIs also function as Designated Microscopy Centres (DMCs).

Role of PHIs in Program Management for TB Elimination

• PHIs undertake tuberculosis case-finding and treatment activities as a part of the general health services.
• In situations where more than one MO is posted in any of the PHC, one of them may be identified and entrusted with the responsibilities of the NTEP.
• Additionally, NTEP provides 1 TB Health Visitor (TBHV) per one lakh urban population to support the urban TB control activities in urban settings/ medical colleges.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

Drug-resistant Tuberculosis Centres (DR-TBCs) are specialized centres for the clinical management of Drug-resistant TB (DR-TB). ​

Each DR-TBC needs to have established a DR-TB committee to carry out the clinical management of DR-TB patients.​

DR-TBCs can be established in the public sector where appropriate facilities are available. ​

• The DR-TBC can also be established in the private sector on mutually agreeable terms and conditions based on the Guidance Document on Partnerships, 2019.

District level:  There are District Drug-resistant TB Centres (DDR-TBCs) to manage DR-TB cases. ​These centres will function under the guidance of Nodal Drug-resistant TB Centres (NDR-TBCs). Almost every district has a mandate to establish a DDR-TBC in India. There are around 620 DDR-TBCs established in the country.​

State/ Regional level: At the state/ regional/ division level, there are NDR-TBCs to manage seriously ill DR-TB cases. ​There are 173 NDR-TBCs established in India.​

Decentralized DR-TB services through an expanded network of DR-TB centres has helped the National TB Elimination Program in improving access to DR-TB services and has also resulted in improved DR-TB treatment linkage and better management of DR-TB patients.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

Image

DRUG STORE

Central TB Division, MoHFW, has

Under NTEP, there is a large network of drug stores across the country to ensure a regular and uninterrupted supply of drugs and consumables. The Drugs and consumables are procured at the Central level and supplied at Central warehouses (GMSDs & CMSS); further drugs and consumables are supplied to the State Drug Stores and further dissemination to district and sub-district levels following the stocking norms to ensure uninterrupted supply of drugs and consumables to the patient.

To provide overall policy guidance and coordination, the Procurement and Supply Chain Management (PSM) Unit has been established at Central TB Division (CTD), MoHFW, for procurement and Supply Chain Management of all types of anti-TB drugs, diagnostics and consumables.

The Standards for TB Care in India (STCI), which is a locally customized version of the International Standards of Tuberculosis Care, mentions 26 standards that every citizen of India should receive irrespective of the sector of treatment. 

STCI were developed based on a series of discussions involving various stakeholders including clinicians, public health specialists, community workers and patient advocates. 

STCI represent what is expected for quality TB care from the Indian healthcare system including both public and private systems. 

It was first published in 2014 and outlines standards across the four themes of TB diagnosis, TB treatment, public health action and social inclusion.

Following are the list of the 26 Standards:

Table 1: Categorisation of the Standards for TB Care in India, Source: Standards for TB Care in India, World Health Organisation, pp. 13-23

Resources

• Standards for TB Care in India, World Health Organisation, 2014

Assessment

Those who are suspected of having TB disease are first screened for symptoms like cough and fever for more than 2 weeks, blood stained sputum and weight-loss. If found positive on screening, then TB patients are referred for testing to the nearest health facility. If diagnosed with TB, then they are subsequently initiated on treatment. The TB patients initiated on treatment are regularly monitored with the help of field staff or digital interventions like 99DOTS and MERM (Medication Event Reminder Monitor) technology. NTEP staff also ensures that the TB patients are regularly followed up on monthly basis till their treatment completion.

Figure: Patient Flow

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Senior Treatment Supervisor (STS) is one of the key programme staff working under NTEP at TU level. 

Roles and responsibilities of STS include:

• Ensure that all presumptive cases undergo TB diagnosis as per National TB Elimination Programme (NTEP) guidelines
• Ensure screening for TB disease and TB infection among contacts of all microbiologically confirmed pulmonary TB patients and refer for appropriate management
• Notify every TB patient in Nikshay at the earliest and update information of patients on comorbidity, treatment adherence, treatment outcome, contact investigation, TB preventive treatment (TPT) including private sector
• Maintain the Tuberculosis Register, incorporating required information on smear result, laboratory number, name of DMC, date of sputum examination, results of follow up sputum examinations in respect of all cases diagnosed
• Support updation and completing the information in the TB notification register and Nikshay
• Ensure bank details of all diagnosed TB patients and other beneficiaries are collected and updated in Nikshay and facilitate timely payment of Direct Benefit Transfer schemes to them
• Prepare quarterly reports on case-detection, sputum conversion and treatment outcome
• Record observations in supervisory register for visit to DMCs with regards to laboratory performance

Resources

1. Module for Senior Treatment Supervisor.,Central TB Division, MoHFW , June 2005
2. Training Modules for Programme Managers and Medical Officers.Central TB Division, MoHFW 2020

Assessment

The Senior Treatment Supervisor (STS) interacts with the patient care ecosystem from the time a TB case is notified, diagnosed and anti-TB treatment is initiated.

The key interactions include:

• Coordination with laboratory technician and Senior TB Lab Supervisor (STLS) for results of TB diagnosis, follow-up, diagnosis, sending samples for drug susceptibility testing whenever required.
• Clinical evaluation of the patient by a Medical Officer (MO) and follow-up evaluation.
• The STS conducts home visits to provide health education and counselling on nutrition and treatment adherence to the patient and family/ caregivers, and for monitoring treatment progress till successful completion of treatment.
• The STS supports the health facility staff to update the information of patients on Nikshay, including on comorbidity, treatment adherence, treatment outcome, contact investigation and their TB Preventive Treatment (TPT).
• Interactions with the District Drug Store (DDS), pharmacist and District TB Centre (DTC) to ensure an adequate supply of drugs for the patient.
  • Uses Nikshay Aushadhi for drug request generation, managing drug inventory, dispatch and issue to patients.
• The STS supports assigning treatment support centres and treatment supporters for the patient. The treatment supporters may be community volunteers accessible, willing and acceptable to the patient and who can be accountable to the health system. These include Anganwadi workers, dais, teachers, panchayat leaders, religious leaders, and others.
• The STS coordinates with District TB Officer (DTO) and DTC to ensure the disbursement of incentives to patients under Nikshay Poshan Yojna, incentives to treatment supporters and travel incentives to Drug-resistant TB (DR-TB) patients.
• The STS is crucial in organising community-based Information, Education and Communication (IEC) activities like patient-provider group interaction meetings and community meetings in coordination with the support of field staff, which includes the Community Health Officer (CHO), Multipurpose Health Worker (MPHW), Auxiliary Nursing Midwife (ANM).
• STS works in coordination with the DR-TB coordinator to ensure diagnosis, pre-treatment evaluation, treatment initiation, adherence and follow-up for all DR-TB patients.
• Ensures standards of TB care in India are followed for patients diagnosed in private health facilities.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, NTEP, 2020.  
• Module for Senior Treatment Supervisors, RNTCP, CTD, 2005. 
• Guidelines for PMDT in India, 2021.

Assessment 

Overview of the organisational structure of the health system in relation to the National TB Elimination Programme (NTEP) is shown in the figure below.

Image

• Sub-centre: Most peripheral units under the public health system are designed to bring about behavioural change and provide preventive health care services.
• Primary Health Centre (PHC): First contact point between the village, community and the medical officer envisaged to provide integrated, curative and preventive health care.
• Community Health Centre/ Sub-district Hospitals: Serve as a referral centre for four PHCs and provides facilities for obstetric care and specialist consultations.
• Peripheral Health Institute (PHI): Most Peripheral Unit under the NTEP provides TB treatment and diagnostic services to the population.
• Tuberculosis Units: Nodal point for TB elimination activities in the sub-district level and are also responsible for stacking and supply of drugs to the PHI.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, CTD, MoHFW, India, 2020.
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD.

Assessment

• The public health system in India through the National Health Mission (NHM) visualises the attainment of Universal Health Coverage (UHC) for all its citizens, which provides access to equitable, affordable and quality health care services, which is also accountable and responsive to the needs of the people.

• Under the umbrella of NHM, the National TB Elimination Programme (NTEP) ensures the provision of free TB services (diagnostics and drugs) and management of TB as per the Standards for TB Care in India (STCI).

• Furthermore, the NHM, under the Ayushman Bharat initiative has taken measures to strengthen the primary care facilities including Primary Health Centres (PHCs) and Sub Health Centres (SHCs) in the Ayushman Bharat Health & Wellness Centres (AB-HWCs).

Need for integration of NTEP with the Health System at Different Levels

1. Closer to community TB Services: The integration of TB services with the health system provides an opportunity for the TB programme to leverage the resources under the Ayushman Bharat initiative to take TB interventions closer to the community which were otherwise provided at the primary care level.
2. Improved population coverage: Active empanelment and HWC database will help to monitor and identify the left-out population and contribute significantly to the NTEPs case finding activity coverage.
3. Improved population health outcomes: Improved availability, access and utilisation of advanced TB treatment services under the ambit of UHC is essential in reducing morbidity and mortality from TB which may in turn also contribute to overall equitable health outcomes.
4. Reduced out-of-pocket expenditure: The integration will improve the access to TB services, assure within-reach TB medicines and diagnostic services, provide linkages for care coordination with Medical Officers/ specialists across various levels of care, etc., all of which will reduce the catastrophic expenditures faced by the patients and their families.
5. Decreased crowding at the secondary and tertiary health facilities: A strong network of peripheral level TB care services would facilitate in reduction of the overcrowding and the case burden at the secondary and tertiary facilities, which could be utilised for cases with follow-up referral to higher level facilities.
6. Increased responsiveness and addressal of social determinants of TB: Provision of TB treatment at the nearest point of care for the communities and engaging the most peripheral workers from the health system like the Accredited Social Health Activists (ASHA) in the TB programme may lead to comfort in accessing the care by the patients and also enable addressing psycho-social determinants of TB.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, CTD, MoHFW, India, 2020.
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD.

Assessment

The National Health Mission (NHM) was launched by the Government of India in 2013, subsuming the National Rural Health Mission (NRHM) and National Urban Health Mission (NUHM). Figure 1 shows the history of the NHM.

The vision of NHM is “Attainment of Universal Access to Equitable, Affordable and Quality health care services, accountable and responsive to people's needs, with effective intersectoral convergent action to address the wider social determinants of health.”

Image

Figure 1: History and Make-up of the NHM; Source: Annual Report 2015-16, Ministry of Health and Family Welfare (MoHFW)

NHM further aims to support the existing national programmes of health and family welfare (Figure 2) including reproductive and child health, malaria, blindness control, iodine deficiency, filariasis, kala-azar, tuberculosis (TB), leprosy, and integrated disease surveillance.

Image

NHM and the National Tuberculosis Elimination Program (NTEP)

Integrating the NTEP with the health system increases the effectiveness and efficiency of TB care and control. India's TB control programme has been mainstreamed efficiently with the NHM.

The overall responsibility for the financial management of the NTEP is with the MoHFW, Director General of Health Services (DGHS) through the NHM.

At the state level, the State Health Society or its equivalent under the NHM of the state manages the financing of the TB Control Programme.

At the sub-district level, the TB Unit (TU) is the nodal point for TB control activities. TUs are based mainly in NHM health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.

Resources

• Annual Report 2015-16, Chapter 2: NHM, Ministry of Health and Family Welfare (MoHFW).
• Information on the NHM, NHM India, 2020.
• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

As per India’s Tuberculosis (TB) notification rule, each diagnostic laboratory, including private labs, must report diagnosed TB patient details to the National TB Elimination Program (NTEP) utilizing the digital surveillance system called Nikshay. As of March 2021, 20899 private laboratories are mapped in the Nikshay online portal for notification of diagnosed TB cases.

Private laboratories provide a variety of TB diagnostic services which includes:

1. Smear microscopy
2. Molecular diagnostic test for TB (CBNAAT and TrueNAT)
3. Culture and Drug Susceptibility Testing (C&DST)
4. Fine Needle Aspiration Cytology
5. Histopathology

These private laboratories can be stand-alone laboratories, part of private laboratories/ diagnostic chains or part of any multispecialty hospital.

Under NTEP, accreditation of labs by the Central TB Division and calibration of CBNAAT and TrueNAT machines existing in the private sector, is crucial to ensuring optimal quality care.

The program has promoted partnership and certified 16 private sector and 4 NGO laboratories to provide quality-assured TB diagnostic services. Their services are being used by the program under the private public partnership model for providing TB diagnostic services under the NTEP .

Resources

• India TB Report 2021, NTEP, MoHFW, GoI.

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Integrated patient-centred care and prevention are one of the pillars of the End TB strategy. This requires TB services to be made affordable and accessible by integrating them with the general health system. 

In 2005, the National Rural Health Mission (NRHM) was established and was merged with the National Urban Health Mission (NUHM) in 2013, to form the National Health Mission (NHM).The National TB Elimination Programme (NTEP) is a flagship programme under the NHM and fund allocation to NTEP occurs through the NHM.

NTEP integrates with the public healthcare system at various levels as follows:

• Community level – Accredited Social Health Activists (ASHA)/ Community Health Volunteers (CHVs)/ Multipurpose Workers (MPWs)
• Ayushman Bharath Health and Wellness Centre - Sub Health Centre (ABHWC - SHC)
• Ayushman Bharath Health and Wellness Centre - Primary Health Centre (ABHWC - PHC)
• Community Health Centre (CHC)
• District/ Taluka hospital
• Medical Colleges
• Other health institutions in the public sector – ESI, railways, ports and the ministries of mines, steel, coal, etc.

Note: As far as NTEP is concerned, a Peripheral Health Institution (PHI) is a health facility headed by a Medical Officer

TB services are provided free of cost through the public health system.

Services provided include:

1. Advocacy, Communication and Social Mobilisation (ACSM) and Information Education and Communication (IEC)
2. Screening for TB – Active Case Finding (ACF), Passive Case Finding (PCF), Intensified Case finding (ICF)
3. Diagnosis of TB and drug resistance – Designated Microscopy Centre (DMC) or TB diagnostic centres. Some of the PHIs themselves act as DMCs or Sputum Collection Centres
4. Treatment for DS-TB and H Mono/Poly DR-TB through PHIs
5. Treatment for DR-TB through District/Nodal DR-TB Centres
6. Treatment Support through out treatment course
7. Clinical follow-up and comorbidity management
8. Referral services for those with Adverse Drug Reactions (ADRs)
9. Screening for Tobacco and Alcohol addiction and linkage to de-addiction services
10. TB preventive therapy
11. Data management in Ni-kshay

References

• Technical and Operational Guidelines for Tuberculosis, 2016.                        
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD. 
• Detect-Treat-Prevent-Build: Strategy for TB Elimination in India by 2025, Indian J Community Med., 2018.

Assessment

Ayushman Bharat (AB) is an attempt to move from a selective approach to health care to deliver comprehensive range of services spanning from preventive, promotive, curative, rehabilitative and palliative care. AB-HWCs are envisaged to deliver expanded range services that go beyond maternal and child health care services to include care for non-communicable diseases, palliative and rehabilitative care, oral, eye and ear nose and throat care, mental health and first level care for emergencies and trauma, including free essential drugs and diagnostic services.

It has two components which are complementary to each other.

1. Under its first component, 1,50,000 Health and Wellness Centres (HWCs) will be created to deliver Comprehensive Primary Health Care, which is universal and free to users, with a focus on wellness and the delivery of an expanded range of services closer to the community.
2. The second component is the Pradhan Mantri Jan Arogya Yojana (PM-JAY) which provides health insurance cover of Rs. 5 lakhs per year to over 10 crore poor and vulnerable families for seeking secondary and tertiary care.

On 14th April 2018, the Honorable Prime Minister of India launched the first Health and Wellness Centre at Jangla, Bijapur, Chhattisgarh. Health Sub-Center (HSC), PHC (Primary Health Center) and Urban PHCs are currently being upgraded to reach a goal of 1.5 lakhs AB-HWC by 2022.

The National TB Elimination Program (NTEP) has also integrated TB services as part of the health and wellness center service delivery package.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, MoHFW, 2021.
• Ayushman Bharat - Health and Wellness Centre Website, Government of India.

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Medical colleges in the country are integrated with the National TB Elimination Programme (NTEP) to widen access and improve the quality of TB services. Medical colleges provide specialized services for seriously ill TB patients.

The integration of medical colleges in the program is in a structured task force mechanism at different levels:

• National
• Zonal
• State  

One national and six zonal task forces have been formed under the programme along with task forces for all states. A core committee is also formed in each medical college. These task forces are created with defined roles and responsibilities for the effective involvement of medical colleges in the programme.

Core Committee

Every medical college will have core committees representing various hospital departments and NTEP nodal officers. These committees meet quarterly and review the implementation of the program in the medical college.

Functions of the core committee:

• They organise sensitisation workshops and training for faculty members, postgraduates, undergraduates, interns, paramedical staff, etc. ​
• Ensure that teachings on TB/ NTEP form part of the curriculum for all medical colleges.
• Coordinate between various departments so that patients get the services under one roof.
• Coordinate with the district TB programme. ​

​Role of Medical College in NTEP

1. Medical colleges coordinate with the district TB programme for participation in quality assurance, supervision, monitoring, review and evaluation.
2. Operational research is one of the important activities of medical colleges. 
3. Every medical college should have TB detection facility and treatment support centres. These centres are equipped with trained additional human resources such as medical officers, laboratory technicians and TB health visitors.
4. The National Medical Commission insists that all Medical Colleges should also have facilities to manage DR-TB patients.
5. Medical colleges undertake advocacy for the programme.
6. Medical colleges also functions as peripheral health institutes (PHI), maintain TB notification registers and submit monthly PHI reports​: They have Nikshay user access and need to enter TB-related data on a real-time basis. 

Resources

RNTCP Technical and Operational Guidelines for Tuberculosis Control in India, 2016.

Assessment

Nikshay is an integrated Information, Communication and Technology (ICT) platform adopted by the National Tuberculosis (TB) Elimination Programme (NTEP) for TB patient management and care.

The patient management workflow in Nikshay streamlines a series of activities required for TB patients from identification of presumptive TB cases to recording treatment outcomes. Nikshay uses in-built modules in the platform to perform these tasks. There are also different user logins that allow certain functions (see figure below).

Figure: Overview of the TB Patient Management Workflow in Nikshay; Source: Module 1: Introduction to Nikshay

Summary of the Patient Management Workflow in Nikshay

Resources

• Nikshay FAQ Modules: Module 1: Introduction to Nikshay, 2021.

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Video: Patient Management in Ni-kshay

Video: Deduplication while enrolling a new patient - Web

Video: Deduplication while enrolling a new patient - Mobile 

Video: Searching and viewing patient lists

Once a presumptive TB patient is identified, the patient is enrolled online by a healthcare worker or doctor in Nikshay online portal. For diagnosis of Tuberculosis, the treating physician can request a test utilizing the request test option of Nikshay online portal. The step-by-step approach for test request is as follows:

Step 0: Go to the Patients Page.

Step 1: Select the “Tests” tab.

Step 2: Click the “Add Test” button.

Step 3: Fill the form.

Step 4: Select the “Test Status” as “Results Pending”.

Step 5: Click the “Add Test” button by selecting the appropriate test for the patient.

In a situation where the patient is referred to another health facility for TB testing, one needs to select the test requested along with the facility name where the patient will visit for undergoing the TB test. the results are added by the concerned healthcare worker only after the test is conducted and the result is available.

In the absence of such results, it will show ‘Result pending’ instead of ‘Result available’ status.

Video: Process to add tests on Ni-kshay

Resources

• Nikshay Portal Training Resource Material.

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Video: Add Comorbidity in Ni-kshay - Web

Video: Add Comorbidity in Ni-kshay - Mobile App

Video: Patient Engagement

Video: Unified Patient Page

Video:

Task List (Web)

Video: Task List on Ni-kshay - Mobile 

National Tuberculosis Elimination Programme (NTEP) strives for all presumptive TB patients to be microbiologically confirmed. Under NTEP, the acceptable methods for microbiological diagnosis of TB are: 

Rapid diagnostic molecular test: Rapid molecular tests that use techniques like NAAT are very specific. They amplify the genomic material in the patient sample and hence enhances detection

• Nucleic Acid Amplification Test (NAAT) e.g., GeneXpert, TrueNat

  

  Figure: Genxpert Machine for CBNAAT

  

  Figure:  Truenat Machine

• Line Probe Assay

Microscopy is a TB diagnostic technology that utilizes the acid-fastness property of Mycobacterium tuberculosis to visualize it under a microscope. Results of sputum smear microscopy can either be smear-negative, or smear-positive (with various grades). 

Advantages:

• It is currently the most accessible and cheapest TB diagnostic test available under National TB Elimination Programme (NTEP) in India.
• It has the shortest turnaround time for diagnosis.
• It has high specificity. 

Limitations:

• Low sensitivity. It becomes positive only when more than 5000 bacilli/ml of sample are present. Hence, cases would be missed in early disease, or when an inappropriate biological specimen is provided, where bacterial load in sputum is less.
• It is unable to differentiate between M. tuberculosis and Non-tuberculous Mycobacteria (NTM). This is predominantly an issue in geographies with lower burden.

There are two types of microscopies used in NTEP: Ziehl-Neelsen (ZN) Microscopy and Fluorescence Microscopy (FM). These vary in the type of stain and microscope used. FM is newer of the two types and is currently recommended for use over ZN.

Resources

• WHO Policy Statement - Fluoresence Light-emitted Microscope for the Diagnosis of TB, 2010.

Cartridge Based Nucleic Acid Amplification Test (CBNAAT) is a rapid molecular diagnostic test. It is used for diagnosis of Tuberculosis (TB) and Rif-resistant Tuberculosis (RR-TB) in NTEP. Results are obtained from unprocessed sputum samples in about 2hours which helps in early detection and treatment of TB patients. 

India has vast number of CBNAAT laboratories which are utilized for TB/RR-TB detection and Universal Drug Susceptibility Testing (UDST) under the National TB Elimination Program (NTEP).  

Figure: CBNAAT Cartridge and Machine in Use (Image courtesy: USAID supported Challenge TB Project)

The CB-NAAT system detects DNA sequences specific for Mycobacterium tuberculosis complex and rifampicin resistance by Polymerase Chain Reaction (PCR). It concentrates Mycobacterium tuberculosis bacilli from sputum samples, isolates genomic material from the captured bacteria by sonication and subsequently amplifies the genomic DNA by PCR. The process identifies clinically relevant rifampicin resistance-inducing mutations in the RNA polymerase beta (rpoB) gene in the Mycobacterium tuberculosis genome in a real-time format using fluorescent probes called molecular beacons.

Video: Cartridge-Based Nucleic Acid Amplification Test [CBNAAT] - GeneXpert Technology 

Resources

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020.
• India TB Report 2021, National TB Elimination Program (NTEP), MoHFW, 2021.

Assessment Questions

Truenat is an indigenous rapid molecular test platform that is currently under use in NTEP for diagnosis of TB and Rif Resistance. It is a platform utilising real-time Polymerase Chain Reaction (PCR) technology built into micro-PCR chips.

Testing on Truenat involves three components:

1. Workstation (consisting of 2 devices)
   • Trueprep AUTO Universal Cartridge-based Sample Prep Device for the automated extraction and purification of DNA
   • Truelab Real-time micro PCR Analyzer for performing real-time PCR. It is available as 1 (Uno), 2 (Duo) or 4 (Quattro) chip ports.
2. Cartridge and Chip
3. Reagent kits (Sample Pre-treatment and Prep kits)

Figure: Truenat  Source: MolBio Products.

Test results for MTB detection and Rif Resistance has a turn around time of 1-2 hours. Depending on the micro-PCR chips used various tests can be performed using Truenat. Truenat MTB micro-PCR chips detect Mycobacterium tuberculosis bacteria for TB diagnosis. Truenat MTB RIF micro-PCR chip is used as a reflex test to detect resistance to Rifampicin (RIF), the first-line drug for TB treatment

Truenat has many advantages. Truenat is designed to be mobile and is battery operated (~8 hours on full charge). It can be deployed in peripheral laboratories and microscopy centres with minimal or no added facilities and hence it is more point-of-care. Biosafety requirements are similar to smear microscopy. However, it is multi staged and partially automated, requiring the presence of a Lab Technician through out the test.

Resources

1. Truenat MTB Kit Insert.
2. Trueprep AUTO Universal Cartridge-based Sample Prep Device.
3. Practical Guide to Implementation of Truenat Tests for the Detection of TB and Rifampicin-resistance, 2021.

Assessment

Line Probe Assay (LPA) is a rapid molecular test available at centralised laboratories.

The assay is based on Polymerase Chain Reaction (PCR) that can simultaneously detect Mycobacterium tuberculosis complex as well as drug sensitivity to anti-TB drugs.

Figure 1: The GenoType MTBDRplus Molecular LPA Procedure; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Advantages of LPA

• Rapid molecular test. (Turnaround time: 3-5 days)
• Highly sensitive and specific.
• Performed directly from sputum smear-positive specimens and on isolates of M. tuberculosis complex grown from smear-negative and smear-positive specimens.
• Detects multiple gene mutations in anti-TB drugs.
  • First-line LPA detects mutations to rifampicin and isoniazid
  • Second-line LPA detects mutations to fluoroquinolones and aminoglycosides.
• Suitable for low and high-throughput labs.

Disadvantages of LPA

• Cannot be used as a point-of-care test.
• Requires appropriate laboratory infrastructure, equipment and biosafety precautions.
• Different rooms (DNA extraction, pre-amplification, amplification, post-amplification/ hybridization) are required to perform different steps (Figure 2).
• Requires trained manpower to perform tests and interpret test results.
• Stringent internal quality control is required to prevent contamination.

Figure 2: Amplification (A) and Post-amplification Laboratory (B) for LPA; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Resources

• Guidelines for PMDT in India, 2021.
• Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Assessment

Culturing TB Bacilli is well known and historic method for detection/ confirmation of Tuberculosis. It is a highly sensitive and specific phenotypic test; it can detect even a few viable bacilli in the sample (Upto 10 Colony Forming Units- CFUs). TB bacilli multiply in the culture and form colonies of TB bacilli which can are easily be identified.

Based on the growth media used Culture is divided in to two types, Solid and Liquid Culture methods. Types Culture:

• Solid Culture on Lowenstein Jensen media : Historic gold standard culture test. Results take usually upto 2 months (60 days).
• Modern Liquid culture systems: (e.g. BACTEC MGIT 960, BacT Alert or Versatrek etc.) Results take usually up to 42 days. 

Uses

1. Solid culture is the gold standard diagnostic test for TB. But it is not used for the purpose of TB diagnosis due to the long turn around time of 2 months. It is largely used for research purposes where it is used as the baseline test on which the sensitivity and specificity of other tests are calculated.
2. Liquid Culture is being used for follow-up monitoring of patients on drug resistant TB treatment to detect treatment failure. Liquid culture is also used for long term follow up patients who have successfully completed treatment to detect recurrence.
3. Liquid culture is used as a previous step to grow bacilli and obtain isolates prior to Drug Susceptibility Testing.
4. Liquid cultures are also used in TB prevalence surveys for its high sensitivity and specificity

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India 2021

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Culture Drug Susceptibility Testing (CDST) is a growth-based phenotypic method used to check the susceptibility of Mycobacterium tuberculosis strains to various first and second line anti-TB drugs. Mycobacterial resistance to a particular drug is identified if there is growth observed in culture in presence of that drug.

In NTEP CDST is the standard method to detect resistance in samples of patients who have tested positive on followup. While CDST is possible on both Solid and Liquid culture, currently, the NTEP utilizes only liquid culture as a method for DST, due to faster Turn around times.

CDST testing services are available under NTEP in designated, specialized laboratories called CDST Labs both in public and private sector. Currently there are 80 such laboratories (60 certified for First Line and 49 for Second line drugs). Such designated laboratories are subject to regular external quality assessment, often by the National Reference Laboratory at that region.

Quality assured DST to R, H, Z, Mfx, Lfx, Lzd, Am, Km and Cm are available across the country. 

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.
• Training Manual for Mycobacterium tuberculosis Culture & Drug Susceptibility Testing, NTEP, 2009.
• RNTCP Laboratory Network Overview, CTD, 2009.

NTEP laboratory network is comprising of National Reference Laboratories (NRLs), state level Intermediate reference laboratories (IRLs), Culture & Drug Susceptibility Testing (C & DST) laboratories and peripheral level laboratories. Peripheral level laboratories consist of  designated microscopy centres (DMCs) and NAAT labs.

NTEP has a quality assured laboratory network for bacteriological examination of sputum in a 3-tiered system.

Figure: Laboratory network of NTEP

Resources:

• TB India Report 2021

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The National Reference Laboratories (NRLs) constitute the third tier of the National Tuberculosis Elimination Programme (NTEP) laboratory network hierarchy. 

They provide quality assurance and certification services for the Culture and Drug Susceptibility Testing (C&DST) labs and coordinate with the World Health Organisation (WHO) Supranational Reference Laboratory (SNRL) network.

There are six designated NRLs which are delineated in the figure below.

Image

Figure: Six National Reference Laboratories under NTEP in India

NIRT, Chennai, in addition to being one of the NRLs is also one of the WHO designated SNRLs for the Southeast Asia Region.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• NTEP Laboratory Network: Overview.

Some Culture and Drug Susceptibility Test (C&DST) laboratories host an Intermediate Reference Laboratory (IRL) under the National TB Elimination Programme (NTEP). 

There is at least one IRL per state at an identified location, usually in a secondary or tertiary level public health facility. There are 34 IRLs in India.

The IRLs are responsible for:

• Undertaking training on laboratory technologies for district and field level staffs
• Conducting on-site evaluation visits to districts for sputum microscopy at least once a year
• Undertaking panel testing of Senior TB Laboratory Supervisors (STLS) at each district linked to it
• Ensuring the proficiency of staff performing National Tuberculosis Elimination Programme (NTEP) smear microscopy activities by providing training to laboratory technicians and STLS

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• NTEP Laboratory Network: Overview.

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Under the National Tuberculosis Elimination Programme (NTEP), many labs are established at the regional level within states for providing Culture and Drug Susceptibility Testing (C&DST) facilities for presumptive TB/DRTB and for TB/DRTB patients. C&DST laboratories are mostly located in intermediate reference laboratories (IRLs) or medical colleges. There are 42 C&DST laboratories established under the programme in different geographies. Dedicated human resources are provided for the laboratories under the programme. Districts are linked with laboratories for providing facilities for Culture and DST using: Phenotypic Methods (Solid – Lowenstein Jensen (LJ), and Liquid Culture – Mycobacteria Growth Indicator Tube (MGIT)) Genotypic technology (Line Probe Assay (LPA) and Cartridge Based Nucleic Acid Amplification Test (CBNAAT))

Figure: Culture and Drug Susceptibility Testing (C&DST) facility, Source: The Foundation For Innovative New Diagnostics (FIND)

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021
• Training Modules (1-4) for Programme Managers and Medical Officers; New Delhi, India: Central TB Division, July 2020

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The National Tuberculosis (TB) Elimination Program (NTEP) has a network of Nucleic Acid Amplification Tests (NAAT) laboratories coupled with Designated Microscopy Centers (DMCs) to form the backbone of the diagnostic component of TB services.

Nucleic Acid Amplification Tests (NAAT) laboratories includes Cartridge-based NAAT (CBNAAT) and TrueNat tests. These tests detect tuberculosis as well as rifampicin resistance and are more sensitive than smear microscopy.

Functions of Nucleic Acid Amplification Test (NAAT) Laboratories:

1. Acting as a hub for collection of samples from public and private health facilities (spokes)
2. Universal Drug Susceptibility Testing (UDST) to rule out rifampicin resistance among confirmed TB patients
3. Timely provision of NAAT test result to the TB patient, medical officer of the concerned health facility and NTEP staff for related actions
4. Acting as a sample dispatch center for the Culture DST laboratory for subsequent processing of samples for first-line line probe assay (LPA) and second-line drug resistance testing utilizing second line LPA and liquid culture DST
5. Recording and reporting including digitization of diagnostic process from collection to test result in NTEP Nikshay portal and Laboratory Information Management System
6. Management of supplies and logistic associated with laboratory logistic (CBNAAT cartridges and TrueNAT chips) and reporting any additional requirement thereof
7. Supporting the quality assurance activities undertaken by District or Intermediate Reference Laboratory under NTEP
8. Support health system in carrying out special drives for vulnerable and at-risk population and their testing directly by CBNAAT (slum population, diabetic population, smoker, malnourished people, patients of silicosis and kidney dialysis etc.)

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India, 2016.
• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, 2021.

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Functions and Integrated Services of the DMC

• Testing of Sputum samples by Microscopy.
• Request/ referral for microscopy or Nucleic Acid Amplification Test (NAAT) or Culture and Drug Susceptibility Test (C&DST) or Chest X-ray (CXR) or Tuberculin Skin Test (TST) is generated at the PHI-DMC, as well as follow-up tests.
• Maintain consumables and logistics required for testing/ packaging and transport.
• Maintain TB laboratory registers for recording and reporting.
• Notify every TB patient in Nikshay at the earliest and update information of patients on comorbidity, treatment adherence, treatment outcome, contact investigation and TB Preventive Treatment (TPT).
• Biomedical waste management for the waste generated at DMCs.
• A DMC is required to participate in the External Quality Assurance system(EQA) of NTEP to ensure standardized quality diagnostic testing. 

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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To increase access to diagnostic services, NTEP has a provision for sputum collection centres in areas where the health facility is not equipped with key requirements to conduct sputum microscopy, molecular tests, drug susceptibility testing or follow up examinations.

Sputum collection centres are dedicated locations where sputum samples are collected, packaged and then transported to nearby TB diagnostic centres. It could be attached to any near-by health-facility as well.

Requirements of a Sputum Collection Centre

To function as sputum collection centres, the following is essential:

• Linkage/ mapping (time and distance) to testing laboratory
• Availability of adequate number of sputum cups and falcon tubes, logistics for sample packaging and transport
• Identification of open areas for sputum collection
• Staff trained in NTEP guidelines on sputum collection, sample packaging and transport, complete and correct documentation of laboratory request form, and infection control practices
• Feasibility and financial measures required for sample transport
• Inclusion of local volunteers, courier services, sample transportation under National Health Mission Free Diagnostic Services or other mechanisms as decided by the state/district
• Availability of Information, Education and Communication (IEC) material, training modules, and job-aids
   

 Sputum collection centres are established in:

• Ayushman Bharat Health and Wellness Centres/Sub-centres
• Urban primary health centres
• Tribal, hilly, desert and difficult-to-reach areas of the country

Resources

• Training Modules for Programme Managers and Medical Officers
• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres
• Mycobacteriology Laboratory Manual, GLI Initiative, 2014

Assessment:

Screening for active tuberculosis (TB) a process to filter out people who are less likely to have TB, from a group. Screened positive people are likely to have TB and are confirmed subsequently using a TB diagnostic test. This will allow finite diagnostic testing resources to be used on the remaining.

Screening in TB may be performed ​using simple field tools (4 Symptom complex) and tests such as Chest X-ray, or a combination of both. ​Combination of both is the most effective, but is often not applied due to the practical difficulties in making a chest X-ray conveniently available.

Screening is an integral part of any general case finding effort. It is also applied systematically in specific situations.

1. At health care facilities (intensified case finding): Here those visiting are screened using the 4 symptom complex, often at the point of entry to the facility. Those screened positive may be fast-tracked to TB Diagnostic testing.
2. In vulnerable populations in active case finding efforts: Here the entire population identified for active case finding are screened using the pre-decided protocols by going door to door. 

Resources

• Systematic Screening for Active Tuberculosis; Principles and Recommendations, WHO 2013.
• National Strategic Plan for Tuberculosis Elimination 2020–2025.

People who have been exposed to patients with infectious TB are known as TB contacts; they constitute a high-risk group for TB. Case finding investigation contributes to the early detection of TB cases, and results in identifying a significant number of additional patients.

Figure: Approaches to Tuberculosis Case Finding

Active case-finding requires systematic screening and clinical evaluation of populations who are at high risk of developing TB, such as people living in slums, tribal areas, congregate settings, persons who are household contacts of TB cases

Resources:

• Assessing TB Case-Finding

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Systematic screening of all individuals of a defined population is known as active case finding.  It is applied outside of health facilities at the community level by the health system.

Objective of ACF is to:

1. identify cases early, initiate prompt treatment, reduce risk of poor treatment outcomes and reduce risk of further transmission of TB
2. to provide access to diagnosis services to populations that would have been otherwise unreached

It is effort intensive and is recommended only in population groups where there is estimated high case load. In NTEP, ACF is recommended only to be performed in Key / vulnerable population.

ACF can also be clubbed with suitable ACSM campaigns to create awareness about the signs and symptoms and about TB in the target population/ community. It can also be combined with other health activities/ campaigns (such as Pulse Polio/ Leprosy screening/ population based screening for NCDs) for increased efficiency.

Resources

1. Training Modules for Programme Managers and Medical Officers.
2. Active TB Case Finding, Guidance Document.
3. WHO recommendations for Systematic Screening for Active Tuberculosis

Assessment

Passive case finding is essentially where the patient self reports to the health care provider with symptoms. This requires that affected individuals are aware of their symptoms, have access to health facilities, and are evaluated by health workers or volunteers who recognise the symptoms of TB and link those individuals for TB testing services.

This approach to case finding has the least effort and cost and is a minimum expectation. In a Peripheral Health Institution (PHI), it is estimated that about 2-3% of new adult outpatients are symptomatic that require referral for TB diagnosis (presumptive TB cases).

Passive case finding may miss TB patients if :

1. The disease is mild/ transient.
2. Access to healthcare is poor.
3. Health providers do not have an adequate index of suspicion and are unable to reliably link respiratory symptoms to TB. 

Resources

1. Training Modules for Programme Managers and Medical Officers.

Assessment

Intensified Case Finding (ICF) is a case finding approach between Active and Passive approaches. Here individuals coming in contact with the health system through any activity are screened actively for symptoms of TB and referred for testing.

This approach brings the benefit of active case finding approach by active screening for TB symptoms, but does limit the extensive effort required by restricting to only those people who has some or the other healthcare problem. This approach is considered for people attending a healthcare facility.

Some examples of ICF are screening for TB symptoms and referral for testing in:

• all cases attending an HIV clinic.
• among children with malnourishment who attend a nutrition clinic.
• all mothers attending the antenatal clinics

Resources

1. Technical and Operational Guidelines.
2. Assessing TB Case Finding.

Assessment

Bidirectional screening is a method to identify cases in diseases which have predisposition to each other or has a significant influence on each other. For example TB and HIV, where having HIV increases risk of developing TB and cases with TB would have poor outcomes if co-infected with HIV.

Screening for TB is done through four-symptoms complex based screening or through Chest X-ray. Screening for the linked disease is carried out as per the policies of the corresponding health program.

Bi-directional screening policies are implemented by various disease control programs. For example, with NTEP the following disease control efforts implement a bidirectional screening policy:

1. HIV through NACO 
2. COVID19 
3. Diabetes Mellitus (DM) through NPCDCS
4. Tobacco  through National Tobacco Control Program

Both programs monitor bidirectional screening, referral and testing as per their own policies.

Resources

1. National Strategic Plan for TB Elimination.

Assessment

Why important, how is it done,

It is crucial to make an effort for microbiological confirmation in presumptive Extrapulmonary Tuberculosis (EPTB) cases. Appropriate specimens from the Extrapulmonary (EP) site are collected and, depending on the specimen type and availability of facilities, the specimens are sent for:

• Cartridge-based Nucleic Acid Amplification Testing (CBNAAT)
• Culture and Drug Susceptibility Testing (C&DST) for M. tuberculosis 
• Histopathological examination

The diagnostic algorithm (see the figure below) to be followed for EPTB cases depends on 2 main factors:

1. Availability of appropriate specimens from the EP site
2. Availability of CBNAAT (preferred test)

Figure: Diagnostic Algorithm of EPTB

• If an appropriate specimen from the EP site is available, specimens from the presumed sites of involvement must be tested with CBNAAT.
• CBNAAT detects MTB and RIF status and helps to identify microbiologically confirmed EPTB cases.
• If CBNAAT is not available, the specimen is sent for Liquid Culture (LC) at the C&DST lab. If the LC is positive, it is identified as a microbiologically confirmed EPTB case.
• If there is high clinical suspicion of TB even after a negative culture result, other diagnostic tools are used to clinically diagnose EPTB (usually with a specialist). If these tests indicate TB, they may be treated as clinically diagnosed EPTB or else arrive at an alternate diagnosis.

Clinical Diagnosis of EP-TB

If an appropriate specimen from the EP site is not available, in the presence of high clinical suspicion of TB, other modalities of diagnosis are used in consultation with a specialist. If with other diagnostic modalities, TB diagnosis still cannot be established, the specialist may explore an alternate diagnosis. 

A clinical diagnosis of EPTB is made if a consultative decision is made to treat with a full course of anti-TB drugs in spite of the situations listed above. Chest X-ray (CXR), ultrasonography, Computerised Tomography (CT) scan, Magnetic Resonance Imaging (MRI) and biochemical examinations are supporting tests that can be used to help arrive at a diagnosis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Technical Operational Guidelines, Chapter 3: Case Finding and Diagnosis Strategy, NTEP.

Assessment

​

All children with persistent fever with/without cough for two or more weeks; close contact with TB patients in the last 2 years; unexplained sudden weight loss or signs of malnutrition despite good nutrition, should be subjected to Chest X-ray (CXR).

1) If the CXR is normal, the child should be checked for signs of Extrapulmonary TB (EPTB) and referred for detailed investigations to higher centres in case of any symptoms.

2) If the CXR is suggestive of TB, the child should be subjected to a sputum test/ gastric aspiration / induced sputum for Mycobacterium tb (MTB) testing.

               - If the report is MTB positive, the child is microbiologically confirmed for TB and should be further tested for Rifampicin (Rif)-resistance and treated accordingly for Drug-sensitive (DS)/ Drug-resistant (DR) TB, based on Rif results.

               - If the report is MTB negative, look for significantly enlarged peripheral lymph nodes and also repeat the sputum test with a good sample and refer to a higher centre if required.

3) If the CXR displays non-specific shadows prescribe antibiotics (amoxiclav/ amoxicillin) if not already taken. Do not prescribe quinolones or linezolid and review the shadow and symptoms.

4) If CXR displays pleural effusion send the pleural fluid for examination at Nucleic Acid Amplification Testing (NAAT) lab as well for cytology and biochemical examinations.

              - If pleural fluid turns out MTB positive at the NAAT, treat as per guidelines

              - If the pleural fluid is MTB negative, but is a straw-coloured exudative effusion, treat the child as clinically diagnosed probable TB.

Image

Figure: Diagnostic Algorithm for Paediatric TB; Source: Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, 2022.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, ICMR, MoHFW, GoI, CTD, 2022.
• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, GoI, 2021.

Assessment

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

All diagnosed TB patients are eligible for a NAAT test to know their Rifampicin sensitivity status. The integrated diagnostic algorithm for diagnosis of TB offers upfront Nucliec Acid Amplification Test (NAAT) for diagnosis of TB to vulnerable population. Among other eligible groups for NAAT are: non-responders to treatment and contacts of DR-TB patients are also offered upfront NAAT.

Rapid identification of DR-TB is achieved by using a combination of NAAT (CBNAAT/ Truenat) followed by sequential testing by first- and second-line Line Probe Assay (LPA) and Liquid Culture (LC) and Drug Susceptibility Testing (DST) for specific drugs as described below:

• When Rifampicin resistance is not detected by NAAT, the patient is offered First-line (FL) LPA.FL-LPA provides information on Isoniazid resistance.
• For Rif resistance/Inh resistance cases, SL-LPA  is done and it provides information on resistance to Levofloxacin, Moxifloxacin and Amikacin.
• For all Rif resistance cases, LC and DST is done for Pyrazinamid, Moxifloxacin (if resistance detected by LPA), Linezolid, Clofazimine*, Bedaquiline* and Delamanid*.

(* when available)

Resources

• Guidelines for PMDT in India, 2021.

Assessment

Check

All childhood TB patients’ sputum and other relevant samples (e.g. gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, CSF, tissue biopsies etc.) should be subjected to genotypic or the phenotypic Drug Susceptibility Tests (DSTs). Based on the bacteriological confirmation, the child should be treated for DS/DR TB as required.

But in cases where the child’s DST is unknown, the source patient’s DST should be considered.

If the source is a known DS TB, treat the child for DS TB. If the child responds poorly to the DS TB treatment consult the pediatrician and re attempt the necessary investigations.

If the source patient is a known DR TB patient, consult with the pediatrician and re-attempt DST on an appropriate specimen from the child and treat as per the child’s DST (if the report is conclusive), if not then treat the child as DR TB after the source patient.

If the source patient’s DST status is not known perform DST on the child’s and the source patient’s specimen and treat the child as per the DST of the child or the source patient, whichever report is conclusive.

Pediatric TB patients should be presented to and discussed with a DR-TBC Committee (including the pediatrician) to decide the treatment.

Image

Figure:  Diagnostic Algorithm for Paediatric DR-TB; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India,2021, CTD, MoHFW, India, p39. 

Abbr: DR-TB: Drug-resistant TB; DS-TB: Drug-sensitive TB; NAAT: Nucleic Acid Amplification Test; MGIT: Mycobacterium Growth Indicator Tube; DST: Drug Susceptibility Testing; DRT: Drug Resistance Testing; BAL: Bronchoalveolar Lavage.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis.

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Assessment

Based on the site of disease, Tuberculosis can be classified as-

1. Pulmonary tuberculosis (PTB) refers to any microbiologically confirmed or clinically diagnosed TB involving the lung parenchyma or the tracheo-bronchial tree.
2. Extra Pulmonary tuberculosis (EPTB) refers to any microbiologically confirmed or clinically diagnosed TB involving organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc. 

Note: Miliary TB is classified as PTB because there are lesions in the lungs. A patient with both pulmonary and extra-pulmonary TB should be classied as a case of Pulmonary TB.

• New case - A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. 
• Previously treated patients have received 1 month or more of anti-TB drugs in the past. They could be further classified as:
• Recurrent TB case - A TB patient previously declared as successfully treated(cured/treatment completed) and is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. 
• Treatment After failure patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment.  
• Treatment after loss to follow-up A TB patient previously treated for TB for 1 month or more and was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB case 
• Other previously treated patients are those who have previously been treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented. 
• Transferred In: A TB patient who is received for treatment in a Tuberculosis Unit, after registered for treatment in another TB unit is considered as a case of transfer in.
• Transferred Out : A patient who has been transferred to another recording and reporting unit and whose treatment outcome is unknown.

Resources:

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021 
• WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug resistant TB Treatment, 2020

On the basis of diagnosis, Tuberculosis (TB) can be classified into 2 main types:

1. Microbiologically confirmed TB
2. Clinically diagnosed TB

Microbiologically Confirmed TB

• Microbiologically confirmed TB refers to a presumptive TB case from which a biological specimen is positive for acid-fast bacilli/ Mycobacterium tuberculosis on smear microscopy, culture, or on a rapid diagnostic molecular test (such as Cartridge-based Nucleic Acid Amplification Test (CBNAAT)/ Truenat).
• All such diagnosed cases should be notified at the source, regardless of whether TB treatment has started.

Clinically Diagnosed TB

• Clinically diagnosed TB refers to a presumptive TB case that is not microbiologically confirmed but has been diagnosed with active TB by a clinician who has decided to give the patient a full course of anti-TB treatment.
• This definition includes cases diagnosed on the basis of X-ray abnormalities or suggestive histology or extrapulmonary cases without laboratory confirmation.
• Clinically diagnosed cases subsequently found to be microbiologically positive (before or after starting treatment) should be reclassified as microbiologically confirmed.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Definitions and Reporting Framework for Tuberculosis, WHO, 2013.

Assessment

Active Case Finding (ACF) is a provider-initiated activity with the primary objective of detecting TB cases early by active case finding in targeted groups and to initiate treatment promptly.

• It can target people who anyway would have sought health care with or without symptoms or signs of TB and also people who do not seek care.
• Increased coverage can be achieved by focusing on clinically, socially and occupationally vulnerable populations.
• ACF activities in a campaign mode will create mass awareness about the signs and symptoms in general population

Objective of ACF campaign activities- Reaching the unreached in a campaign mode to enhance TB case finding

Figure 1: Objectives of active case finding

Beyond TB disease, screening can also identify individuals who are eligible for and would benefit from TB preventive treatment (TPT) once TB disease is ruled out, thus further averting future incident TB.

General process is as below:

Figure 2: ACF campaign general process

Resources

1. WHO consolidated guidelines on tuberculosis: Module 2: Screening, Systematic screening for TB disease;WHO 2021
2. India TB Report 2022, Central TB Division, MoHFW 2022
3. Active TB Case Finding- Guidance document, Central TB Division & DGHS, MoHFW 2017

Assessment:

Mapping of vulnerable population is a pre-requisite for conducting an efficient ACF campaign. It involves understanding the population characteristics, identifying and enumerating and mapping the target population. 

Guidelines for mapping

• Identify & map high risk/ vulnerable populations in the local area with the following guidance. If additional information is available locally, it can be used for the prioritisation of target groups.

Figure 1: Schematic map for house to house survey of identified vulnerable population

• Without proper mapping, there is a high chance of missing cases. The success of the active TB case finding campaign relies on how good the mapping is.

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment

Active case-finding (ACF) approaches bring essential TB services closer to the community. It has high potential for improving TB case detection and reach people with TB currently missed by the health system. To maximize gains from ACF, it is important that the interventions are planned in advance. 

Planning for ACF includes identifying the right target population/area, designing the intervention, finding the right implementing partners, training of workforce, microplanning for daily activities, logistics, ensuring that the complete pathway of care is followed, reporting and recording.

Steps involved in planning for ACF

1. Identification of population based on:

a. increased risk for TB eg: prisoners, miners, urban slums, co-morbidities like HIV, diabetes etc.

b. those with limited access to health services eg: migrants, homeless, tribal, live in hard to reach areas etc.

2. Identification of stakeholders including district and sub-district TB program staff, non-government organizations, community based organizations, community health workers to support with ACF activities

3. Strengthening the health system e.g. training of staff, ensuring sufficient lab supply and lab technicians. Staff trainings should be done to eliminate gaps in knowledge about TB, cough hygiene, infection control measures, conducting screening, collecting quality sputum, transporting sputum or referring people with presumptive TB to the health facility/laboratory, TB testing, data collection, data entry 

4. Microplanning for ACF includes:

a. when and where to conduct ACF-day, time, duration, methodology-camp, door-to-door, community gatherings, home visits, place of work etc

b. availability of trained manpower, team composition, logistics and consumables

c. screening and diagnostic algorithm to be used

d. number of screenings and tests done per day

e. accessibility and linkage with TB testing laboratories, use of mobile van with CXR, CBNAAT/Truenat 

f. laboratory workload to accommodate additional testing due to ACF

g. laboratory turn around time, availability of test reports for clinical management 

h. advocacy on ACF activities with the target population, pre-sensitization meetings, addressing perceived risks of TB screening and diagnosis (e.g. job loss, loss of income)

i. data collection tools (paper based, smartphones, tablets etc.), TB notification, recording and reporting

Resources

1. Systematic screening for active tuberculosis: an operational guide (http://www.who.int/tb/publications/ systematic_screening/en/)

2. Experience of active tuberculosis case finding in nearly 5 million households in India (Prasad BM, Satyanarayana S, Chadha SS, Das A, Thapa B, Mohanty S, et al. Public Health Action. 2016;6(1):15–8. doi:10.5588/pha/15/0035)

3. Community-wide screening for tuberculosis in a high-prevalence setting (Marks GB, Nguyen NV, Nguyen PTB, et al. N Engl J Med 2019; 381: 1347-57)

Assessment

A targeted approach is considered as an appropriate public health response to identify the hidden cases of TB in the communities. In this regard the National TB Elimination Programme (NTEP) expects that 110,000 per million vulnerable population (11%) should be mapped for community-based screening and >90% of the mapped target vulnerable population should be screened for symptoms of TB.

Mapping of target population from the identified vulnerable population helps the programme to screen out the persons into: 1) those who are at high risk of progression to active TB disease; 2) those who are eligible for TB preventive treatment 3) Enhance the cost-effectiveness of the programme

Following are various methods for identifying and mapping the target population from the vulnerable population:

• Tuberculosis symptom screening

• Sputum testing

• Chest X-ray

Various modalities used to conduct mapping of target population from the identified vulnerable population under the ACF campaign are:

a) House-to-house TB symptom interviews through community volunteers

• Relatively minimal costs

• Needs community awareness session as a pre requisite before conducting ACF

• May be affected by self and perceived stigma

• Community volunteers may require monetary/ no monetary incentives.

b) Door-to-door Sputum collection / sputum drop-off clinics

• Has the potential for higher yield of TB cases

• Involvement of Trained TB staff is required for appropriate collection of sputum

• The sputum has to be non-contaminated in order to avoid compromising the results.

c) Conducting Camps in prisons, migrant localities, old age homes and other such institutional settings

• Accessible to the population who are at high risk but otherwise have limited access to TB testing services

• Essential to detect TB early and stop the spread of infection in such institutional settings.

• Requires skilled TB staff in such settings

d) Mobile vans equipped with X-ray units and Truenat machines

• Feasible yet resource-intensive modality

• Requires skilled staff to handle the testing

• Requires resources - electricity, internet, computer/ tablet etc.

Image

Resource 

• Optimizing active case finding for tuberculosis, Implementation lessons from South-East Asia, World Health Organization,2021.

• Burugina Nagaraja, S.; Thekkur, P.; Satyanarayana, S.; Tharyan, P.; Sagili, K.D.; Tonsing, J.; Rao, R.; Sachdeva, K.S. Active Case Finding for Tuberculosis in India: A Syntheses of Activities and Outcomes Reported by the National Tuberculosis Elimination Programme. Trop. Med. Infect. Dis. 2021, 6, 206. https://doi.org/10.3390/ tropicalmed6040206

Assessment

A good screening algorithm should have the following characteristics:

• High specificity (to reduce the number of false positives, ideally around 70%)
• High sensitivity (to reduce the number of false negatives, ideally around 90%)
• Low Number Needed to Screen (NNS)
• Low cost
• Rapid and simple to apply
• High client acceptability

The algorithm should be optimised so that the maximum number of cases can be detected with available resources.

Usually verbal screening using  symptom complex (4S) are used. However ACF campaigns targeting high risk populations (household contacts, elderly homes etc.)can consider using X ray also as a screening tool. Chest X ray helps in picking up sub-clinical TB cases also which will be usually missed through verbal screening of symptoms.   

A more sensitive test like NAAT is preferred over sputum microscopy in ACF campaigns as the cases will be in early stage and may be missed by testing using Microscopy.

References

• Optimising Active Case Finding – Implementation Lessons from South-East Asia. WHO SEAR, 2021.
• WHO Consolidated Guidelines on Tuberculosis – Module 2: Screening, WHO, 2021.
• High-priority Target Product Profiles for New Tuberculosis Diagnostics: Report of a Consensus Meeting, 28–29 April 2014, Geneva, Switzerland. Geneva: World Health Organisation, 2014.

Assessment

1. Financial Resources

• Financial resources for ACF may be procured from the Centre/State or through local Private Provider Support Agencies (PPSA). When the funds for ACF are procured from the centre, it should be included under a separate budget head (DSTB Pool) under PIP. 
• Each team would be eligible for an incentive of INR 500 for every new case of TB diagnosed and put on treatment under this activity OR as per approvals in the Programme Implementation Plan (PIP) in the National Programme Coordination Committee (NPCC) of the respective state or as approved by the state National Health Mission (NHM). 
• Each state should ensure that local travel arrangements from the general health system are made available for the field visits by the team, supervisory visits, etc.
• Allowances to ensure Travel Allowance (TA)/ Dearness Allowance (DA) and refreshments as per entitlement are to be made from the respective source of salary for the field teams and supervisory teams.

2. Consumables

Logistics for an ACF campaign include:

a. IEC materials: Appropriate IEC materials are to be designed and printed in the local language. A prototype of the same will be shared with states from the CTD. IEC material printing/ distribution should be completed by two weeks before the start of field activities.

b. Additional logistics for testing:

• Additional slides, laboratory reagents, sample transport boxes, X-ray films, CBNAAT cartridges,  falcon tubes (minimum 1000 per 1 lakh population) should be procured and supplied to health staff for collecting sputum samples from the eligible symptomatic at least two weeks before the start of field activities. Boxes for sputum sample transport should be provided to the health staff for carrying samples to DMCs.
• Additional sputum examination request forms needed – 500 per 1 lakh population

c. Recording and reporting forms: All recording and reporting formats requirement assessment is to be done by DTOs three weeks before the start of field activities

3. Human resource

Human resource for ACF is required for the following:

a. Field activities: House-to-house visits, symptom screening, sputum collection and transport to the Designated Microscopy Centre (DMC).

• One field visit team will comprise two members - one health worker from National TB Elimination Programme (Senior Treatment Supervisor (STS)/ Senior TB Lab Supervisor (STLS)/ TB Health Volunteer (TB-HV)) or a partner organisation (NGO outreach worker) or general health services (Auxiliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW)/ Multipurpose Healthcare Supporters (MPHS) and one Accredited Social Health Activist (ASHA) or community volunteer. The states should decide on the team composition based on available resources and the population to be covered (as obtained from vulnerability mapping).
• House-to-house visits by health workers should involve community leaders, panchayat members particularly the women members, religious leaders and other local influencers like medical practitioners, local moneylenders, grocery shop owners, popular teachers, prominent youth, etc.
• Local community members/ influencers must accompany search teams during house-to-house visits in such areas, especially during revisit to houses.

b. Testing additional sputum samples for Mycobacterium tuberculosis (MTB): Laboratory technicians of the linked DMC and Cartridge-based Nucleic Acid Amplification Test (CBNAAT) labs should be well-informed about the increase in workload and recording of information during ACF activities. 

c. Supervision and Monitoring of ACF activities: Supervision and monitoring of the campaign are done at various levels under the leadership of designated officers. It is  required during the preparatory phase as well as the implementation phase of the campaign.The list of observers along with the districts/ blocks/ urban areas allotted must be shared with Central TB Division (CTD).

• Village level - Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC)
• Block level - Block Medical Officer (BMO)/ Block Health Officer (BHO)
• District level - District TB Officer (DTO)
• State level - State TB Officer (STO)
• Regional level – Regional Directors of the Regional Office of Health and Family Welfare (ROH&FW) will be in charge of supervising activities in their respective states.
• National level - One national level officer for each state will be nominated by CTD to supervise and monitor activities including field visits to the states prior to and during the campaign.

References

• Active TB Case Finding Guidance Document, Central TB Division, Ministry of Health and Family Welfare, 2017.

Assessment

Microplanning for ACF Campaign

A microplan is a detailed plan of action in terms of human resources, materials, money and time. A good microplan ensures that the health intervention reaches each individual beneficiary and is crucial to the success of the activity. For Active Case Finding (ACF), microplanning is performed at the health facility level and collated at the block, district and state levels. Training for the same is given to concerned personnel during state, district and block level meetings prior to the campaign. Microplan at PHI, Block, District and State levels should be ready at least 15 days prior to the initiation of field activities.

Microplanning is done with respect to:

I. Advocacy, Communication and Social Mobilization (ACSM)

 A comprehensive IEC plan should be made with communication material for mass media, mid-media and print media to reach out up to the remotest village in advance.

II. Logistics

• Microplan should include planning additional consumables required for the campaign
• It includes additional slides, laboratory reagents, sputum cups, falcon tubes, sample transport boxes, X-ray films, Cartridge-based Nucleic Acid Amplification Test (CBNAAT) cartridges, etc. Additional sputum containers (minimum 1000 per lakh population) will be procured and supplied to health staff for collecting sputum sample from the eligible symptomatic two weeks before the start of field activities
• Linkages of Peripheral Health Institute (PHI) areas with Designated Microscopy Centre (DMC), X-ray facilities, CBNAAT lab, Extra Pulmonary (EP) sample collection and EP testing should be included in the planning up-front. 
• Laboratory technicians of the linked DMC and CBNAAT labs should be well informed about the increase in workload and recording of information during ACF activities.

III. Field activities including human resources

• Maps prepared for other campaigns like Pulse Polio, Leprosy Case Detection Campaign (LCDC), etc. must be used while planning. If maps are not available with local bodies, search team members and supervisors should be sent to the area before the ACF campaign, in order to become familiar with the area and develop maps. 
• The number of houses to be covered each day should be mentioned in the microplan. This number may vary from day to day depending upon the geographical situation of the area planned to be covered by the team on a particular day. 
• Teams of two persons each should go house-to-house. Out of the two members in each team, one should be a local volunteer (including Accredited Social Health Activist (ASHA)).
• Each team should be allocated clear-cut, well-demarcated areas clearly mentioning the starting and ending points, identifiable with landmarks; for each day of House to House (h-t-h) activity.
• In special areas, one additional person from the local community, where the team will be working, should accompany the team. 
• Human resources required for covering the mapped vulnerable population during field activities should be calculated and recorded.
• For planning and implementation purposes, urban areas should be divided into smaller planning units based on municipal wards or assemblies, or by roads or prominent landmarks. Each such unit should be put under the charge of a medical officer or nodal officer.
• Involvement of the local community, leaders, health officials, municipal bodies and their staff is essential in planning.
• Local staff is familiar with the layout of the urban areas and their inputs are vital for planning and supervision of house-to-house activities.

Execution of Microplan

The ACF campaign is executed as per the microplan and supervision is done with reference to the microplan

The House to House (h-t-h) survey is done for 2 weeks

A survey team consisting of 2 persons - one NTEP staff/ partner organization staff/ General Health services staff and one local volunteer / ASHA worker. They go from house to house in the mapped vulnerable areas/ key population groups and screen individuals for symptoms of TB. After screening, the eligible population for sputum examination includes: Persistent cough for ≥2 weeks, Fever for ≥2 weeks, Significant weight loss (>5% weight loss over last 3 months), Presence of blood in sputum any time during the last 6 months, Chest pain in the last one month, History of Anti-TB Treatment (previous/ current). If any one of these is present, a sputum cup or falcon tube is given to them and a sputum sample is collected. Sputum samples thus collected are transported to a designated lab using the sample transport system existing in the area. testing using smear microscopy/CBNAAT will be done for all symptomatic persons as per the state policy. Those who are microbiologically confirmed to be positive should be initiated on treatment within 2 days. Additionally, the team will look for other symptoms/diseases also. If person is having any symptoms or other ill health, s/he will be referred for evaluation by a Medical Officer for further management, if needed. Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of the Peripheral Health Institution

Resources

• Active TB Case Finding – Guidance Document, 2017, Central TB Division, MoHWF, New Delhi.
• Active Case Finding for Tuberculosis in India: A Syntheses of Activities and Outcomes Reported by the National Tuberculosis Elimination Programme, Burugina Nagaraja S et al, Trop Med Infect Dis., 2021.

Assessment

Vulnerability mapping and Microplanning are 2 important activities of Active Case Finding which precede field activities. Vulnerable populations should be mapped and recorded in prescribed formats from health facility level onwards. Mapping data from PHI are consolidated at Block level, those at Block level are consolidated at district level and those at district level are consolidated at state level. Data from mapping formats is used for microplanning. Microplanning forms the basis of field activities. Microplans are also consolidated at subsequent levels. During supervision and monitoring, it is important to assess the activities with respect to the microplan. 

The recording formats for ACF include:

1. Formats for mapping - Health Facility Level, Block Level, District Level and State Level                     

2. Formats for microplanning - Manpower, Logistics, Field Activity

FORMATS FOR MAPPING

Mapping details should also be entered in Ni-kshay under the section shown below:

Image

Fig: Ni-kshay section for reporting various ACF activities

FORMATS FOR MICROPLANNING

Based on the requirement obtained from the mapping exercise, microplanning is done with respect to human resource, logistics and field activities

Human Resource Planning Form

Field activities are captured in Form 1 & 2 of the ACF. The data from field activities are compiled at the PHI level and submitted to the District and State using google sheets at present. Although there is no specific mechanism to demarcate the presumptive TB patients and the confirmed (clinical and microbiological) TB cases in Ni-kshay, States follow different mechanism including marking in the Laboratory register as ACF testing and sending a separate sheet to the district in paper format.

Reference: 

1. Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017 

Assessment:

Field supervision of Active Case Finding (ACF) is needed during both the preparatory phase and the implementation phase. Supervisory teams should be formed at the National, State, District, Block and Peripheral Health Institute (PHI) levels.

Field supervision during the preparatory phase: 

The Field Supervisors should: 

• Attend District and Block Coordination Committee meetings.
• Review the micro plan and check whether all components are present. 
  • All geographical areas have been included. 
  • Team composition is appropriate – all house-to-house teams have at least one Accredited Social Health Activist (ASHA) and at least one Non-government Organisation (NGO) worker and at least one National TB Elimination Programme (NTEP) field staff. 
  • Sensitisation training to detect the cases has been planned for all ASHAs and field staff. 
  • Workload of teams in terms of houses to be covered/ day has been rationalised.  
  • Areas requiring special attention have been identified and plans developed.
  • Information, Education and Communication (IEC)/ social mobilisation plans have been developed and documented. 

Field supervision during the implementation phase: 

• All officers should again visit their allotted districts/ blocks/ urban areas during the implementation phase to assess the quality as well as the completeness of coverage of the area through house-to-house visits. 
• Field Activity Report will be submitted by each health staff on a daily basis to the Medical Officer of PHI. The Field Activity reports from all health staff will be analysed and appropriate action will be taken by the Medical Officer of PHI and these reports will be combined and a report will be prepared and submitted to Block Medical Officer (BMO) on daily basis. 
• Ensure a mechanism of daily feedback from the observers to the block and district control rooms to facilitate immediate corrective action at all levels. Tracking the cascade of care is a useful tool for assessing quality. (Cascade of care: Track No. of people targeted, no. of people screened out of targeted, no. of presumptive TB identified out of screened, no. of presumptive TB patients examined out of identified, no. of presumptive TB completely evaluated {like smear-negative patients examined with chest X-ray and Cartridge-based Nucleic Acid Amplification Test (CBNAAT), no. of TB patients diagnosed out of examined, no. of TB patients put on treatment out of those diagnosed.})
• Qualitative and quantitative assessment of the ACF campaign activity from observers should be utilised for long-term corrective actions like problems faced by ASHAs & Frontline Workers (FLWs) during the campaign, review of micro-plans etc. or immediate corrective actions like repeating the activity in an area where a significant number of uncovered houses are found after completion of the activity. 

The Progress indicators and quality indicators for ACF should be monitored by the supervisory team while on field visit.

Resources

• Active TB Case Finding Guidance Document, CTD, DGHS, MoHFW, 2017.

Assessment

Monitoring should be an integral part of the Active Case Finding (ACF) interventions. It is accomplished by a strong data collection system enacted through a programme-based ACF data and recording in Nikshay.

Monitoring activities for ACF interventions broadly cover the number screened, number of presumptive TB cases based on symptoms or chest X-ray findings, samples collected for testing, samples transported for testing, samples tested, microbiologically and clinically diagnosed TB cases, TB notification and treatment initiation.

Monitoring Against the ACF Plan

1. Monitor the Number Needed to Screen (NNS), i.e., the number needed to be screened based on current TB symptoms, past history of TB, comorbidities, other socio-economic factors, etc. 

2. Monitor the Number Needed to Test (NNT) which helps understand the efficiency of diagnostic testing and the efficiency of screening for presumptive TB.

3. Monitor the yield of ACF activities, i.e., TB cases found and compare the yield of different screening and testing methods (X-ray, smear, Nucleic Acid Amplification Test (NAAT)).

4. Monitor whether there was an additional increase in TB notification of bacteriologically confirmed TB cases compared to the previous year (or in comparison to a control district).

• Monitor notification trends, treatment outcomes and mortality (TB prevalence should decrease over years based on repeated ACF in the same population).

5. Monitor engagement of National TB Elimination Programme (NTEP) staff, non-governmental organisations, community volunteers and the private sector in ACF activities.

Monitoring Against the Cascade of Care

1. Monitor the proportion of people with presumptive TB who provide sputum.

2. Monitor linkage to health facilities, sample collection, transportation and tests done.

3. Monitor drop-outs between screening and diagnosis, dropouts between diagnosis and treatment.

4. Monitor public health action provided to notified TB cases.

Resources

• Optimizing Active Case Finding for Tuberculosis, 2021. 
• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.

Assessment

The ACF campaign has to be reported for documentation, monitoring and evaluating the performance of the activity and guiding the policy decisions. 

The various formats used for reporting of performance of Active Case Finding (ACF) activities are as follows:

1. Field activity daily report

• Submitted by each health staff on a daily basis to the Medical Officer of Primary Health Centre (PHC)/ Community Health Centre (CHC)/ Urban Health Centre (UHC).

Table 1: Format for field activity daily report

2. ACF activity reporting by Health Facility

• The Field Activity reports from all health staff will be analysed and appropriate action will be taken by Medical Officer of PHC/ CHC/ UHC.
• These reports are combined and a report will be prepared as per the following format and submitted to Block Medical Officer (BMO)/ Block Health Officer (BHO) on daily basis.

Table 2: Format for ACF activity by health facility

At the block level reports from all the reporting units will be compiled in the below format and sent to the District on a daily basis.

3. ACF activity reporting by Block/ Town/ City

Table 3: Format for ACF activity reporting by block/ town/ city

And at the district level, reports from all blocks are to be compiled in the format below, and the consolidated report should be sent to the State.

4. ACF activity reporting by District

Table 4: Format for ACF activity reporting by district

5. ACF activity reporting by State

Table 5: Format for ACF activity reporting by state

• State TB Officer (STO) would be responsible for the overall coordination and implementation of campaign activities and reporting in the State/ UT.
• Data entry of district-level reports in electronic format will be ensured by District TB Officer (DTO) on a daily basis after the field activity is completed. Nikshay has a section on active case finding where the mapping of target population and reporting of various activities can be done.

Fig 1: Nikshay section for reporting various ACF activities

Resources

• Active TB Case Finding - Guidance Document, Central TB Division & DGHS, MoHFW, 2017.

Assessment

The goals of tuberculosis treatment are:

• Rendering the patient non-infectious, breaking the chain of transmission and decreasing the infection​ pool

• Decreasing case fatality and morbidity by ensuring relapse-free cure

• Minimising and preventing the development of drug resistance.  ​

To meet the goals of treatment, the regimens should be:

• Safe, easy to administer and aid treatment adherence
• Long enough to achieve the long-term cure of the disease, and short enough to increase patient compliance.

Any treatment regimen which reduces the pill count but increases the overall treatment success is an ideal regimen to meet the goals of tuberculosis treatment.  

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.

Assessment

​

Under the National TB Elimination Programme (NTEP), strategies adopted in the treatment of TB are based on the available scientific and operational researches. These strategies are combined to ensure better treatment outcomes for the TB patients. The main strategies include:

Domiciliary Treatment

• This is a strategy that allows for the treatment of TB in a patient’s home.
• Domiciliary chemotherapy proved to be as effective as sanatoria treatment (which was the historical way of treating TB) and achieved higher cure rates.
• The patients having the social benefits of being at home. 

Short Course Chemotherapy (SCC)

• Chemotherapy of TB underwent revolutionary changes in the 70s owing to the availability of two well-tolerated and highly effective drugs – rifampicin and pyrazinamide.
• These drugs allowed for SCC and made it possible to simplify treatment and reduce its duration without reducing the therapeutic effect.
• Now with SCC regimens, it is possible to treat and cure TB patients in 6 months.
• When given daily, these regimens are effective, achieve high cure rates, prevent the emergence of drug resistance and minimize relapses.
• The shorter duration also contributes to improvement in treatment adherence.

Directly Observed Treatment (DOT)

DOT is a method whereby a trained healthcare worker or another trained designated person (treatment supporter) watches a patient swallow each dose of anti-TB drugs and document it.

• DOT can reduce the development of drug resistance, treatment failure, or relapse after the end of treatment.
• Many patients who do not receive directly observed treatment stop taking drugs once they feel better.
• Hence, by providing DOT, the NTEP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration.

The modern treatment strategy is based on standardized short-course chemotherapy regimens largely administered on a domiciliary basis, utilising the DOTS strategy and proper case management to ensure completion of treatment and cure.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Treatment of Tuberculosis Disease, CDC, 2006.
• Guide on Tuberculosis Control for Primary Health Care Providers, WHO, 2015.
• Treatment of Tuberculosis: Guidelines for National Programmes, WHO, 2003.

Assessment

Tuberculosis treatment and its different regimens have scientific backgrounds for their formulations. To understand this, we need to know about the mode of action of each anti-TB drug first.

Mode of Action of Anti-TB Drugs

Anti-TB drugs have the following three actions:

1. Early bactericidal activity: Killing of actively growing bacilli (in the phase of rapid multiplication and uninhibited metabolic activity).
2. Sterilizing activity of persisting bacilli, i.e., metabolically inhibited organisms in a quasi-dormant state.
3. Ability to prevent the emergence of drug resistance.

The ranking of first-line drugs with respect to their type of activity is indicated in Table 1 below.

Table 1: Ranking of first-line anti-TB drugs used in the treatment of drug-sensitive TB, based on the mode of action and activity

Thus, each drug has unique characteristics and drug combinations will make the regimen more effective.

Need for Long Duration of Treatment of TB

• Anti-TB drugs mostly kill actively multiplying tubercle bacilli.
• When bacilli have low metabolic activity, i.e., when bacterial growth has almost come to a standstill and the organisms are “dormant”, they are not killed by otherwise bactericidal drugs. Such organisms are referred to as persisters*.
• Though they may survive in the presence of drugs, behaving as if they were drug-resistant, they are in fact susceptible to the drugs.
• Thus, if for some reason these organisms regain their ability to multiply freely, they would be killed by the very drugs that had not harmed them before.
• When dormant bacilli again become metabolically active and start multiplying during effective chemotherapy, they are soon killed.
• Once chemotherapy has been completed, the revived bacilli may continue to multiply and thus cause relapse.
• This explains why conventional chemotherapy needs to be of long duration.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Standard TB Treatment is divided into two phases

• Intensive Phase(IP): In this phase,
  • Kills most of the TB bacteria during the first 8 weeks of treatment, but some bacteria can survive longer
  • Therefore, more drugs are administered to kill the bacteria and reduce the severity of disease.
  • Treatment in this phase usually is of short duration(2 to 6 Months or more) in comparison to Continuation Phase(CP)

• Continuation Phase(CP): In this phase,
  • All the remaining TB bacteria are in the dormant stage i.e., stage when growth and development of bacteria are temporarily stopped.
  • Therefore, fewer but powerful antibiotics are administered to kill those bacteria. 
  • Treatment in this phase usually lasts longer than Intensive Phase(IP)(4 to 18 Months or more)

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Fixed-dose combinations (FDCs) are drug formulations where two or more drugs are combined physically into one formulation such as a tablet or pill.

This is more convenient to the patients taking medicines and it also simplifies the supply chain.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

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Fixed-Dose Combination(FDC) provides a simple approach to deliver the correct number of drugs at the right dosage as all the necessary drugs are combined in a single tablet. By altering the number of pills according to the patient’s body weight, complete treatment is delivered without the need for calculation of dose

Figure: Advantages of Fixed Dose Combination(FDC)

A regimen means a prescribed systematic form of treatment for a course of drug(s). For TB treatment, Multi drug combination of regimen is followed. 

All TB drug regimens have an initial intensive phase(IP) followed by a continuation phase(CP). 

Following are some of the main TB drug regimens used based on the drug resistance pattern detected for TB patients.

• First-Line Anti TB Drugs(Prescribed for Drug Sensitive TB DS-TB)
  • Daily weight band wise FDC

• Second-Line Anti TB Drugs (Prescribed for Drug Resistance TB - DR-TB)
  • H Mono Poly Regimen
  • Shorter oral Bedaquiline containing MDR-TB regimen
  • Longer oral Bedaquiline containing regimen
  • Shorter injectable containing MDR-TB regimen

It is extremely important for any type of TB patient to be initiated on the right treatment at the earliest in order to have better treatment outcomes. Therefore as soon as the patient is diagnosed, s/he should immediately be traced with the help of the Community Health Officer (CHO) of the Health and Wellness Centres (HWC), TB Health Visitors (TBHV) / Senior Treatment Supervisor(STS) and the health facility doctors and initiated on the appropriate treatment regimen.

Steps in TB Treatment Initiation

Image

Figure: Flowchart-Treatment Initiation

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

To know the TB treatment response and to determine that if patient is cured, TB patients are clinically evaluated at the end of every four weeks of treatment, and they are also followed up by performing sputum test at end of each treatment phase (i.e. Intensive phase and Continuation phase)

TB patients during clinical evaluations are assessed to

• Identify possible adverse reactions to medications;
• Check for any comorbid conditions;
• Weight change;
• monitor adherence; and determine treatment efficacy by observing their symptoms

Although each patient responds to treatment at a different pace, all TB symptoms should gradually improve and eventually go away.

Patients whose symptoms do not improve during the first 2 months of treatment, or whose symptoms worsen after improving initially, should be re-evaluated for adherence issues and development of drug resistance.

When a TB patient consumes all the doses under the prescribed regimen, then Treatment Outcome is declared for a Patient.

Treatment success is considered when a TB patient either Cured or Treatment completed is accounted in treatment success

Video:

Closing Cases and Assigning Treatment Outcomes (Web)

Video:

Closing Cases and Assigning Treatment Outcomes (Mobile)

Adverse Drug Reactions(ADR) are classified into serious and non-serious ADR depending upon the intensity of symptoms experienced by the patient. Below is the brief overview

1. Counsel and reassure the patient as the common occurring adverse effects usually resolve with time.
2. Advise the patient to take all the drugs together.
3. Advise patient to take light meal (biscuits, bread, rice etc.) before taking drugs.
4. Inform patients that they may take drugs embedded in banana or at the bedtime to reduce their associated side effects.
5. Encourage patients to keep themselves hydrated by increasing fluid intake.
6. Provide ORS (Oral Rehydration Solution) to counter dehydration due to loose motion and vomiting.

Figure: Referral to PHI for ADR

Resources:

• Training Guide for Peripheral Health Workers on Adverse Drug Reactions

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After completion of TB treatment, all patients should be followed up at the end of

• 6 months,
• 12 months,
• 18 months &
• 24 months

TB patients at the follow up should be screened for any clinical symptoms and/or cough. If found positive on screening, then sputum microscopy and/or culture should be considered. This is important in detecting the recurrence of TB at the earliest.

After completion of TB treatment, if the patient has not developed any clinical symptoms and/or cough and also if the microscopy remains negative during their follow up, then the patient is considered as “Relapse Free Cure from TB.”

The Tuberculosis Treatment Card is a paper-based recording form that is kept in the institution treating the TB patient under the National TB Elimination Programme (NTEP). It is a pre-requisite documentation related to treatment services offered to TB patients under NTEP.

Uses of the TB Treatment Card

The TB treatment card is primarily used for:

1. Documenting administered drugs with their dosages
2. Documenting follow-up investigation results
3. Monitoring adherence to treatment
4. Recording adverse events
5. Recording treatment outcomes

There are two pages in the TB treatment card and details in each page is delineated in the table below.

Important Points to Note

• The TB treatment card is filled at the Peripheral Health Institution (PHI) when a patient is initiated on treatment.
• The original TB treatment card is kept at the PHI and updated fortnightly.
• A duplicate treatment card is to be given to the treatment supporter for documentation of daily events. 
• The treatment supporter should be trained on how to record the treatment card. 
• Details on the patient’s HIV status are not included in the treatment supporter’s copy to maintain confidentiality.

The figure below shows the 1^st page of the TB treatment card. Click here to access the full form in the NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223.

Figure: First Page of the TB Treatment Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

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In the National TB Elimination Programme (NTEP), the ‘NTEP TB identity card’ is provided for their identification and record of clinical follow-ups.

The identity card is completed for each patient who has a Tuberculosis (TB) Treatment Card, and it is kept with the patient. Information from the TB Treatment Card is used to complete the identity card.

There are 3 parts in the NTEP TB identity card and details in each part is delineated in Table 1.

The information contained in this card will help to continue treatment in case the patient is transferred or admitted to any other health facility any time during the treatment period. The TB identity card is shown in Figure 1.

Figure 1: NTEP TB Identity Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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TB patients may not stay in one place throughout the treatment duration. When they move from one place to other, there should be a mechanism to hand over the responsibility of continuing the patient's treatment in a facility near the new place of the patient. This is the concept of patient transfer and can be easily managed in Nikshay portal.

• The transfer module in Nikshay enables transfer requests of patients between Health Facilities (HFs) across the country.
• Provision of shifting of patient from one HF to another is possible if the patient changes his/her residence for the purpose of treatment.
• The requests are of two types: “Transfer In” and “Transfer Out”.
• All transfer requests needs to be accepted by the “District/ TB Unit (TU)/ Peripheral Health Institute (PHI)” where the transfer request is made in order for it to take effect.
• Transfer requests can be made to even the District/ TU level. However, it can be completed only once the “Transferred to PHI” has been assigned.

Figure: Transfer Management in Nikshay; Source: Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.

Steps in Transfer of TB Patient

1. In Nikshay, the referring HF updates details from the current HF of patient to the HF where patient is being transferred.

2. The receiving HF gets the intimation about the transfer.

The patient transfer module also provides the provision to pull the patient belonging to another HF to the recipient HF. The accountability of the transferred patients is now with the receiving HF and the treatment initiating facility.

A separate transfer register is also available to get details about various transfers from and to a given district, which can be downloaded from Nikshay reports.

Resources

• Nikshay Zendesk, Nikshay Knowledge Base, Advanced Transfer in Web.
• Guidelines for PMDT in India, 2021.

Assessment

Pharmacovigilance is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

• It is a fundamental public health surveillance activity to ensure patient safety measures in healthcare.
• Good pharmacovigilance will identify the risks within the shortest possible time after medicines have been marketed and help establish or identify risk factors.

Importance of Pharmacovigilance

Pharmacovigilance allows for intelligent, evidence-based prescribing with the potential for preventing many Adverse Drug Reactions (ADRs). Pharmacovigilance will help in:

• Improving patient care by assessing both the harms and benefits received from drugs (anti-tubercular treatment).
• Strengthening patient safety, safeguarding the patient’s interests and ensuring adherence to prescribed drug regimens.
• Preventing antimicrobial resistance.

Pharmacovigilance ultimately helps each patient in receiving optimum therapy at a lower cost to the health system.

Conducting Pharmacovigilance under the National TB Elimination Programme (NTEP)

The Pharmacovigilance Programme of India (PvPI) was set up by the Ministry of Health and Family Welfare, Govt. of India, in July 2010. PvPI is India’s national programme for surveillance of ADR-related information.

NTEP in collaboration with PvPI, and with support from WHO India, developed the comprehensive active Drug Safety Monitoring and Management (aDSM) system for ADR monitoring. Pharmacovigilance is prioritised in Drug-resistant TB (DR-TB) centres for drug-resistant cases.

Adverse events reporting for pharmacovigilance is done as follows:

1. DR-TB centres are linked with ADR Monitoring Centres (AMC) established in medical colleges to initiate reporting of ADR in a systematic manner.
2. Serious adverse events are reported to AMCs and Central TB Division (CTD) within 24 hours. This is done via a standardized suspected ADR reporting form (Annexure-11) which is filled by the treating doctor.
3. The data is entered in Nikshay on a regular basis by statistical assistants at the nodal DR-TB centre and senior DR-TB TB-HIV supervisors at the district DR-TB centre.
4. From Nikshay, the information is directly communicated to PvPI through a connecting bridge called Vigiflow.
5. The ADR data submitted to Vigifloware is analysed by PvPI and shared with CTD on a regular basis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019.
• Practical Handbook on the Pharmacovigilance of Medicines used in the Treatment of Tuberculosis, WHO, 2012.

Assessment

Follow-up Sputum Examination is useful for the clinical follow-up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Significance:

The most important tool in the diagnosis of tuberculosis is direct microscopic examination of appropriately stained sputum specimens for acid-fast bacilli (AFB). The technique is simple and inexpensive, and used in the detection of tuberculosis. Sputum microscopy is also useful for the clinical follow up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Schedule

In case of Drug-sensitive Tuberculosis (DS-TB), the follow-up is done at the end of Intensive Phase (IP) and at the end of Continuation Phase (CP).

In case of Drug-resistant Tuberculosis (DR-TB), the follow up schedule is different for all the three regimen described below:

Isoniazid (H) mono/ poly DR-TB regimen

• Monthly from month 3 onwards, till the end of treatment
• Conduct sputum microscopy within 7 days, if the smear at month 4 or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Shorter oral Bedaquiline-containing Multidrug-Resistant (MDR)/ Rifampicin-Resistant (RR)-TB regimen

• Monthly from 3^rd month onwards, till end of IP
• Monthly in extended IP, only if previous month S+ve
• Conduct sputum microscopy within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.

Longer oral M/ XDR-TB regimen

• With culture at Culture and Drug Susceptibility (C&DST) lab
• Conduct sputum microscopy within 7 days if any smear at 6 month or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Post Treatment Follow-Up

After completion of treatment, the patients should be followed-up at the end of 6, 12, 18 & 24 months for detecting recurrence of TB at the earliest. In presence of any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. This is important in detecting recurrence of TB at the earliest.

Implications

The sputum follow-up examination is a quick and reliable method which helps in monitoring the progress of the treatment and gives an early indication of any recurrence.

Assessment

​The management principles of Extrapulmonary Tuberculosis (EPTB) are shown in the figure below.

Figure: Ten principles about what every EPTB patient in India needs as a basic standard of care

Abbr: CBNAAT:Cartridge-based Nucleic Acid AMplification Test; PTB: Pulmonary TB; NTEP: National TB Elimination Programme

Diagnosis of EP-TB

• All efforts need to be made to get a microbiological confirmation whenever a sample is available. 
• Clinical diagnosis can be made by treating physician based on the clinical features, lab investigations, imaging studies and by ruling out other causes

Treatment Regimen and Duration for EPTB

The treatment regimen and schedule for EPTB cases will remain the same as for pulmonary TB (2HRZE/ 4HRE). However, the duration of the continuation phase in EPTB may be extended in special situations such as TB Meningitis, bone and spine TB etc.

Role of Surgery in EPTB Cases

• Surgery is sometimes required for the diagnosis of EPTB. It is reserved for management of late complications of the disease.

Monitoring Treatment Response

• Response to treatment in EPTB may be best assessed clinically. Clinical follow-up is the most important criterion for the follow-up of EPTB patients. The clinician can assess the patient’s condition by checking weight gain and a decrease/ increase in presenting clinical symptoms.
• Investigations such as Acid-fast Bacilli (AFB) microscopy, chest X-ray, liver function tests, serum creatinine, and USG-abdomen can be used to monitor the treatment status.

The treatment support and other monitoring activities remain the same as for pulmonary TB.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Index TB Guidelines on Extra-pulmonary Tuberculosis for India, Central TB Division, 2016.

Assessment

Treatment interruption is defined as a patient-initiated episode in which the patient discontinues TB treatment. All efforts must be made to ensure that TB patients do not interrupt treatment or are not lost to follow-up. Action should be taken to promptly retrieve patients who fail to come for their daily dose by the treatment supporter

The management of treatment interruptions is made based on the following criteria:

i. Type of case: Whether new, relapse or failure

ii. Duration of treatment taken: Less than one month/ more than one month. This helps in assessing the risk of the presence of drug resistance.

iii. Duration of Interruption: Less than one month/ more than a month.

If treatment interruption is more than one month, the outcome is declared as ‘lost to follow up’.

If a patient returns to the health facility after interrupting treatment for more than one month, the patient sample needs to be subjected to Drug Susceptibility Testing (DST) to determine resistance/ sensitivity status to anti-TB drugs.

In case the interruption is for less than one month, the same treatment regimen is completed to complete all doses.

Modes of Retrieval

TB treatment is supervised by a trained treatment supporter (a health worker, family member or community volunteer). The residential address is verified for all TB patients by home visits. However, in case of treatment interruption, patient retrieval action is required.

Retrieval can be done by the following modes:

1. Retrieval of patients interrupting treatment within 24 hours of discontinuation is done by the Treatment Supporter (TS) or Accredited Social Health Activist (ASHA)/ Auxilliary Nurse Midwife (ANM)/ Multipurpose Worker (MPW). The reason for interruptions should be reviewed carefully and efforts made to counsel and bring the patient back for treatment.

2. If the TS is not successful in retrieving such patients, it should be reported to the next higher level of supervisors, like Senior Treatment Supervisor (STS), and they should take all efforts to counsel and retrieve the patient.

3. If the patient interrupts treatment on more than one occasion, the Medical Officer of the Peripheral Health Institute (MO-PHI) should visit the patient’s home. The MO-PHI should give intensive counselling to the patient and may provide additional support to continue the treatment without interruption.

4. Innovative use of information and communication technologies for treatment adherence monitoring through 99 DOTS, Medication Event Reminder Monitor (MERM), etc. are also beneficial in finding missed doses and initiating retrieval action by the health staff.

Resources

1. Training Modules (1-4) for Programme Managers and Medical Officers.

2. Guidelines for PMDT in India, 2021.

Assessment

There are five principal ways to prevent Drug-resistant Tuberculosis (DR-TB), as given in the figure below.

Image

 Figure: Five Principal Ways to Prevent DR-TB; Source: Guideline for PMDT in India, 2021.

• Drug resistance cannot be prevented by mere diagnosis and treatment of DR-TB.
• Basic TB diagnostic and treatment services should receive priority for the prevention of drug resistance.
• Systems for early detection and treatment of DR-TB should be integrated into the existing TB services and the general health system.
• Healthcare facilities and congregate settings should be provided with proper infection control measures.
• Transmission should be prevented by addressing non-specific determinants like access to care, comorbidities and awareness.

Resources

• Guidelines for PMDT in India, 2021.
• Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis.

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The treatment for TB is demanding in terms of duration of treatment, adverse drug reactions, the requirement of prolonged adherence by patients and catastrophic expenditures. The presence of a special condition added on by a TB diagnosis makes it even more challenging.

To improve the outcomes for such challenging situations, the programme recommends certain modifications in the regimen, which are listed in the table below.

Table: Management of TB in Special Situations

Management of Adverse Drug Reactions (ADRs) in Special Situations

• The actual management of ADR begins during the treatment initiation counselling, where the patient should be instructed in detail about potential adverse effects due to the prescribed drug regimen and when they occur, to notify a healthcare provider.
• Treatment Supporter (TS) should be trained to closely monitor the patient for any signs of ADR (especially, since drug-drug interaction could happen) daily so that they can be recognized and managed quickly.
• The TS should also be trained to identify ADR as major and minor.
• A symptom-based approach should be followed to manage minor ADR where the patient is usually able to tolerate anti-TB drugs and continue medication with symptomatic treatment. Appropriate referrals should be made for all major ADRs that may require hospitalization of the patient.
• If the adverse effect is mild and not serious the treatment regimen must be continued with the help of ancillary drugs, if needed.
• For most second-line drugs related ADR, reducing the dosage/ terminating the offending drug can be considered and should be decided by the Nodal/District Drug-resistant TB Centre (N/DD- TBC) committee.
• Psychosocial support, patient education and motivation through TS and other patient support groups are also effective ways to manage the ADRs.

Resources

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

A death review or mortality audit is a means of documenting the causes of death and the factors that contributed to it, identifying factors that could be modified and actions that could prevent future deaths, putting the actions into place and reviewing the outcomes.

The aims of the audit or review of deaths in hospitals and health services are to:

• Ensure that all deaths are identified and discussed, and confidentiality is maintained.
• Assign a cause or causes to each death.
• Determine whether the care given was consistent with evidence-based clinical practice, standards of care or the care desired by professionals.
• Determine the social, environmental and nutritional risk factors for any death.
• Determine possible modifiable factors in the care of each person who dies.
• Change modifiable factors to improve the quality of care and avoid similar deaths in the future.
• Improve the quality and completeness of patient documentation.
• Provide an opportunity for reflection and support to HCWs.
• Let families know that their relative’s life was valued, the death is being taken seriously and HCWs are committed to learning and improving their practice.

Under the National TB Elimination Programme (NTEP), death audits provide insights into the chain of social, economic and clinical events leading to TB deaths and guide the programme in taking appropriate actions to prevent them.

Process for Undertaking Death Audits

An overview of the process for undertaking a TB death audit is shown in the figure below. Under NTEP, the following stakeholders are involved in the process:

• The medical officer should conduct an in-depth audit of all the deaths occurring amongst TB patients irrespective of initiation of treatment.
• Similarly, the District TB Officer (DTO) should conduct the death review of all Multidrug-resistant TB (MDR-TB) patients who died.

Figure: Overview of the process for undertaking a TB death audit

Resources